Case 3:14-cv-01191-JLS-KSC Document 174-6 Filed 05/08/17 PageID.10895 Page 2 of 94
REPORT BY E. H. MORREIM, JD, PHD IN THE MATTER OF CROSSFIT, INC., V. NATIONAL STRENGTH AND CONDITIONING ASSOCIATION CASE NO. 3:14-cv-01191-JLS-KSC
Outline (informal)
I. JSCR purports to be scientific appropriate to apply standards for biomedical/sci journals
II. Standards for properly managing a science journal
A. History of scientific misconduct scandals standards for science journals
B. Standards for scientific integrity: ICMJE, COPE, ORI
[1] Managing article submissions: peer review process etc [2] Managing allegations of scientific misconduct
III. JSCR and the standards: Managing submissions – peer review etc
A. Applicable standards: ICMJE
B. JSCR's failures to comport with applicable standards for manuscript review
IV. JSCR and the standards: Managing allegations of scientific misconduct
A. Applicable standards: COPE, ICMJE
B. JSCR's failures to comport with standards for managing allegations of sci. misconduct
V. Reasons to believe OSU would very likely have found scientific misconduct
A. Fabrication: statements about CrossFit subjects' injuries
B. Falsification
[1] Failure to secure IRB approval, contrary to statement in manuscript [2] Failure to secure informed consent, contrary to statement in manuscript [3] Failure to provide supervision for participants as described/promised
VI. Reasons why erratum rather than retraction was and is seriously inadequate
A. Applicable standard: retraction must follow a finding of scientific misconduct
B. JSCR's failure to conform to standards
VII. Conclusion
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REPORT BY E. H. MORREIM, JD, PHD, IN THE MATTER OF CROSSFIT, INC., V. NATIONAL STRENGTH AND CONDITIONING ASSOCIATION
April 1, 2016
This report contains my opinions regarding the case of CrossFit, Inc., v. National Strength and Conditioning Association, Case No. 3:14-cv-01191-JLS-KSC. My opinions are based on case materials and professional literature, including references in the report and footnotes. Federal regulations also play a limited role, per 42 CFR 93.
My expertise has been retained by Plaintiff to provide ethical and related analysis of two primary questions: [1] whether the editorial staff of the Journal of Strength and Conditioning Research (hereinafter, "JSCR") undertook appropriate processes for manuscript review of a paper authored by Michael Smith et al.1 (the "Devor article"), particularly as those review procedures concerned the manuscript's eventual inclusion of statements regarding injuries in the CrossFit study population; and [2] whether JSCR editors responded appropriately to allegations of scientific misconduct concerning the Devor article.
OVERVIEW AND EXPERT WITNESS CREDENTIALS
My discussion will proceed as follows:
[I] JSCR purports to be a scientific journal focusing on human exercise, strength training and conditioning. As such, it can be considered a journal of biomedical science and therefore can appropriately be measured against widely accepted standards of biomedical science publishing.
[II] There are, in fact, widely accepted standards to guide biomedical science publishing. Historically, in the wake of numerous instances of research misconduct, the biomedical science community has, over the past several decades, developed standards to guide the editors of scientific journals in such matters as: [a] processes for selecting which manuscripts to publish, including standards to guide peer review, and [b] processes for responding to allegations that a published article is tainted by scientific misconduct. These standards are now widely accepted across a broad variety of biomedical science publications, including journals focusing on exercise and sport.
[III] Widely accepted standards provide specific guidance regarding manuscript review. In some ways JSCR's peer review process comported with those standards, and in other ways it deviated significantly from them.
[IV] Widely accepted standards provide specific guidance for responding to allegations of scientific misconduct. JSCR deviated markedly from those standards. First, when an allegation came to JSCR's attention, editorial staff had an obligation to consider that allegation seriously. The editors chose instead to ignore it until long after its credibility was undeniable. Second, JSCR had an obligation to refer the issue to the institution at which the research was undertaken – in this case, Ohio State University (OSU). OSU has, per federal requirements under 42 CFR 93, established a detailed process for exploring allegations of scientific misconduct. Per OSU's
1 Michael M. Smith, Allan J. Sommer, Brooke E. Starkoff, Steven T. Devor, Crossfit-based high intensity power training improves maximal aerobic fitness and body composition, J Strength and Conditioning Research 2013; 27: 3159-72.
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federally endorsed "Policy and Procedures Concerning Research Misconduct," all research undertaken within its walls, not just that which is federally funded, is subject to this process. Therefore, OSU should have been given the opportunity to investigate the Devor article.
[V] Had OSU been permitted the opportunity to carry out an appropriate inquiry and then investigation, it would very likely have found misconduct in the form of [A] fabrication of injury data, and [B] falsification, via a claim to have secured IRB approval and human subjects protection in conjuction with research using human subjects.
[VI] In the face of JSCR's failure properly to pursue a credible allegation of scientific misconduct, its in-house decision to issue a limited "Erratum" in October, 2015 does not comport with widely accepted standards for maintaining the integrity of scientific literature.
[VII] Finally, I will offer a few concluding observations regarding the foregoing analysis.
My credentials for opining on these matters are as follows (highlighting and supplementing the Curriculum Vitae in the possession of counsel on both sides). Cumulatively I have been a member of the Institutional Review Board at the University of Tennessee Health Science Center for approximately 13 years. As part of its overall mission, an IRB does upon occasion discuss research design and methodology because serious deficiencies in these areas can constitute an ethical problem. Additionally I have been on the Board of Editors for the journal, IRB: Ethics and Human Research, for 15 years. I was on the Board of Editors for the journal, Accountability in Research, for a decade. For a number of years I co-taught an ongoing course on research ethics for Fellows in the Department of Pediatrics. My faculty colleague for this course included sessions on research methodology, biostatistics and the like. I am also a member of UTHSC's recently re-established committee on Research Conflict of Interest, now housed within the Office of the Vice Chancellor for Research. I have authored two books and over 150 articles, the substantial majority (though not all) of them peer-reviewed. A number of these publications concern ethical and related issues surrounding human subjects research.
Over the years I have served as a peer reviewer for a number of publications including Journal of the American Medical Association, Annals of Internal Medicine, Radiology, Annals of Thoracic Surgery, Journal of Law, Medicine & Ethics, Journal of Clinical Ethics, Hastings Center Report, and Journal of Health Politics, Policy and Law, among others.
Finally, from 2001 – 2005 I served as chair of the Independent Patient Advocacy Council (IPAC) for the AbioCor artificial heart project. This work is described in: Morreim EH, Webb GE, Gordon HL et al. Innovation in human research protection: The AbioCor artificial heart trial. The American Journal of Bioethics 2006; 6(5): W6-W16. Briefly, the AbioCor project was the first-in-human clinical trial of a completely implantable, total replacement artificial heart. The IPAC and its members not only assisted the patients/subjects who enrolled in the trial by receiving the AbioCor heart, but also served as advisors to the Abiomed company, which developed the device and conducted the trial. The IPAC was, so to speak, a front-row, 50-yard line seat on a one of the most innovative, far-reaching episodes of human subjects research.
CrossFit is being charged $695.00 per hour for my services. Appendix 1 contains my current CV. Appendix 2 provides a list of documents relied on for this report. There are no cases in which, during the previous four years, I have testified as an expert witness at trial or by deposition. My analysis in the case of CrossFit v. NSCA is as follows.
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[I] JSCR purports to be a scientific journal.
Based on statements found on JSCR's Internet pages and on statements made by its editorial staff, JSCR purports to be a scientific journal, and can properly be deemed a journal of biomedical science.
On its home page,2 JSCR states that its ranking among Sport Science journals is 23rd among 81. As members of its executive staff note, this is the Thompson Reuters listing of sports science journals.3 The home page's "Greetings from the Editor" states: "We publish more applied sport science and conditioning papers than any other journal in the world. . . . From studies on sets and reps for optimal resistance training programs to applied science of sport to nutritional interactions with training, manuscripts seek to improve the knowledge based practices in the world of strength and conditioning and improve our understanding of sport science."4
Moreover, the website's Instructions for Authors document states that
The editorial mission of the JSCR, formerly the Journal of Applied Sport Science Research (JASSR), is to advance the knowledge about strength and conditioning through research. Since 1978 the NSCA has attempted to 'bridge the gap' from the scientific laboratory to the field practitioner. . . . This journal wishes to promote the publication of peer-reviewed manuscripts that add to our understanding of conditioning and sport through applied exercise and sport science.5
Under "Original Research" on the same page, JSCR states: "A primary goal of JSCR is to provide an improved scientific basis for conditioning practices."6
Importantly, JSCR recognizes that, more broadly, its focus is on biomedical science. Its "Information for Authors" page7 contains a link to a sub-page providing "New Guidelines for Publication of Personal Patient Information," with instructions on how to protect the privacy of patients in a "specific hospital unit."8 Thus the journal expressly recognizes that research into strength and conditioning is a subset of research into human health and physiology.
Equally important, executives within the National Strength and Conditioning Association
2 Home page, Journal of Strength and Conditioning Research, available at http://journals.lww.com/nsca- jscr/Pages/default.aspx. 3 Keith Cinea deposition 7/16/15, at 61; Keith Cinea deposition 10/23/15, at 75; Triplett deposition, 7/17/15 at 124. 4 Id., emphasis added. 5 Available at http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed 12/31/15); emphasis added. 6 Id., emphasis added.
7 JSCR's "Information for Authors" page; available at http://journals.lww.com/nsca- jscr/Pages/InformationforAuthors.aspx (last accessed 12/31/15), features a link to its "New Guidelines for Publication of Personal Patient Information," available at http://journals.lww.com/nsca- jscr/Documents/New_Guidelines_for_Personal_Patient_Information_2.pdf (last accessed 12/31/15).
8 JSCR's "Information for Authors" page; available at http://journals.lww.com/nsca- jscr/Pages/InformationforAuthors.aspx (last accessed 12/31/15), features a link to its "New Guidelines for Publication of Personal Patient Information," available at http://journals.lww.com/nsca- jscr/Documents/New_Guidelines_for_Personal_Patient_Information_2.pdf (last accessed 12/31/15).
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(NSCA), which owns the JSCR, likewise regard the JSCR as a science journal. Numerous statements within various depositions describe it as scientific.9 It might also be noted that the authors of the article in question are, or were, faculty or students in the Ohio State University Department of Human Sciences, Kinesiology Program.
Finally, JSCR expresses an intent to comport with appropriate standards for scientific publication. The journal uses double-blind peer review, with at least two reviewers for each manuscript that passes initial perusal.10 And it requires that research must have been approved by the appropriate "Institutional Review Board (IRB) or Ethics Board" and must incorporate appropriate informed consent from research subjects.11
9 See William Kraemer deposition, at 12-15, 21, 47, 57, 84; Keith Cinea deposition, 7/16/15, at 61, 224, 230, 237, 248, 273-75; Keith Cinea deposition – 10/23/15 at 75; Travis Triplett deposition, 7/17/15, at 68- 69, 123-24. 10 See: JSCR's "Information for Authors" page; available at http://journals.lww.com/nsca- jscr/Pages/InformationforAuthors.aspx (last accessed 12/31/15) in first paragraph, also under "Editorial Mission Statement" and "Open Access" provisions. 11 See JSCR's "Information for Authors" page, available at http://journals.lww.com/nsca- jscr/Pages/InformationforAuthors.aspx and http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed 12/31/15). The need for Institutional Review Board (IRB) or similar ethics committee approval and an authorized informed consent is mentioned in three locations in those instructions.
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[II] HISTORY AND DEVELOPMENT OF GUIDANCE FOR ETHICAL AND SCIENTIFIC INTEGRITY OF RESEARCH
Today's widely accepted standards to guide biomedical science publishing are largely the product of history, which is replete with examples of scientific misconduct.12 Particularly in the 1970s and '80s and beyond, a series of incidents caught the attention of the scientific community, prompting increasing interest to create guidelines for averting scientific misconduct if possible and for suitably addressing it when it occurs. A few such incidents:13
* Summerlin, Sloan-Kettering, 1974; stained the skin of white rats with black magic marker to show "success" of allotropic black grafts; claimed to have transplanted human corneas onto rabbits; other ruses discovered thereafter; *Vijay Soman; Yale, 1980; fabricated data; had plagiarized an article sent to his supervisor for review, and onto which the (overcommitted) supervisor then signed as co-author; *Elias Alsabati; 1980, perhaps 80 plagiarized or otherwise fraudulent papers; together, the Soman and Alsabati cases prompted 1981 Congressional hearings on fraud in biomedical research; *John Darsee; Harvard, 1981; fabricated data in cardiology research; numerous published papers were eventually retracted; *Robert Slutsky; UC San Diego, ~1986; numerous fraudulent papers (e.g., inflating numbers in animal research); *Andrew Wakefield, 1998; paper linking vaccine and autism was eventually exposed as containing falsified and fabricated data; * Woo-suk Hwang; Seoul University, 2005; falsification and fabrication of data regarding human stem cells.
12 William Broad, Nicholas Wade, Betrayers of the Truth: Fraud and Deceit in the Halls of Science. New York: Simon and Schuster, 1982. 13 For simplicity, and because these paragraphs are not critical to the body of the report, sources providing information about the history and development of biomedical publishing guidelines over time are gathered here, in one footnote. Nicholas H. Steneck, Research Universities and Scientific Misconduct: History, Policies, and the Future. The Journal of Higher Education, Vol. 65, No. 3, Special Issue: Perspectives on Research Misconduct (May - Jun., 1994), pp. 310-330; Julie Brice, John Bligh, Author misconduct: not just the editors' responsibility. Medical Education 2004; 39: 83-89; Paul J. Friedman, Correcting the literature following fraudulent publication. JAMA. 1990;263:1416-1419; George Lundberg, Annette Flanagin, New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure. JAMA 1989; 262: 2003-04; Patricia Woolf, Ensuring Integrity in Biomedical Publication. JAMA 1987; 258: 3424-3427; George Lundberg, Perspective from the Editor of JAMA, Bull. Med Libr Assoc 1992; 80(2): 110-114; Drummond Rennie, Veronica Yank, Linda Emanuel, When authorship fails: a proposal to make contributors accountable. JAMA 1997; 278: 579-585; Richard Smith, Research Misconduct: the Poisoning of the Well; J Royal Society of Medicine 2006; 99: 232-237; Drummond Rennie, C. Kristina Gunsalus, Scientific Misconduct: New definition, procedures and office – Perhaps a new leaf. JAMA 1993; 269: 915-917; Barbara Mishkin, Responding to scientific misconduct: Due process and prevention. JAMA 1988; 260: 1932-1936; Carol Ann Kochan, John Budd, The persistence of fraud in the literature: The Darsee case, J. Amer. Soc. Information Science 1992; 43:488-493; Michel Atlas, Retraction policies of high-impact biomedical journals. J. Med Libr Assoc 2004; 92: 242-250; Fiona Godlee, Jane Smith, Harvey Marcovitch, Wakefield's article linking MMR vaccine and autism was fraudulent. British Medical Journal 2011; 342:c7452; David Resnik, International standards for research integrity: an idea whose time has come? Account Res. 2009: 16: 218-228; Robert McNutt, Arthur Evans, Robert Fletcher, Suzanne Fletcher, The effects of blinding on the quality of peer review. JAMA 1990; 263: 1371-76; Morton Hunt, A Fraud that Shook the World of Science, New York Times, November 1, 1981; available at http://www.nytimes.com/1981/11/01/magazine/a-fraud-that-shook-the-world-of- science.html?pagewanted=all (last accessed 12/31/15).
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In 1985 Congress ordered the first federal regulations concerning scientific misconduct. When little had improved thereafter, in 1989 the Department of Health and Human Service (DHHS) created the Office of Scientific Integrity and issued regulations defining scientific misconduct as "[f]abrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research."14 In 1992 the NIH's Office of Scientific Integrity merged with DHHS's Office of Scientific Integrity Review to become the Office of Research Integrity (ORI), which currently oversees research integrity within the Public Health Service.15
Separately, concerned editors of biomedical journals undertook their own efforts to protect the integrity of biomedical scientific research and publication. In 1978 a group of medical journal editors, often dubbed the "Vancouver Group," met to devise standards for everything from, initially, formats for references to, eventually, a broad set of guidelines for biomedical publishing.16 That group is now dubbed the International Committee of Medical Journal Editors (ICMJE). The ICMJE has issued "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals,"17 which currently is subscribed to by over 2600 biomedical publications (hereinafter, "ICMJE Recommendations").18
Independently, in 1997 the Committee on Publication Ethics (COPE) was created by, at that time, medical journal editors in the United Kingdom. Its ranks now exceed 100,000 worldwide as it "provides advice to editors and publishers on all aspects of publication ethics and, in particular, how to address cases of research and publication misconduct. It also provides a forum for its members to discuss individual cases."19
Importantly, ICMJE and COPE standards have been expressly endorsed not just by large publishers such as Blackwell,20 but also by the U.S. Office of Research Integrity, in its guidance for editors:
The role editors should play in responding to scientific misconduct has been articulated by their colleagues, asserted by two national reports, and demonstrated by the scientific
14 Drummond Rennie, C. Kristina Gunsalus, Scientific Misconduct: New definition, procedures and office – Perhaps a new leaf. JAMA 1993; 269: 915-917, at 915-16. 15 See Office of Research Integrity, Historical Background; available at https://ori.hhs.gov/historical- background (last accessed 12/31/15). 16 Edward Huth, Kathleen Case, The URM: Twenty-five years old. Science Editor 2004; 27: 17-21; available at http://www.icmje.org/recommendations/archives/summary78-04.pdf (last accessed 12/31/15); Julie Brice, John Bligh, Author misconduct: not just the editors' responsibiity. Medical Education 2004; 39: 83-89; George Lundberg, Annette Flanagin, New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure. JAMA 1989; 262: 2003-04. 17 International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals; Updated December 2015; available at http://www.icmje.org/icmje-recommendations.pdf (last accessed December 24, 2015). 18 ICMJE, Journals Following the ICMJE Recommendations; available at http://www.icmje.org/journals- following-the-icmje-recommendations/ (last accessed 12/31/15). 19 Committee on Publication Ethics, About COPE; available at http://publicationethics.org/about (last accessed 12/31/15). See also Julie Brice, John Bligh, Author misconduct: not just the editors' responsibiity. Medical Education 2004; 39: 83-89; Richard Smith, Research Misconduct: the Poisoning of the Well; J Royal Society of Medicine 2006; 99: 232-237. 20 Chris Graf, Elizabeth Wager, Alyson Bowman, Suzan Fiack, Diane Scott-Lichter, Andrew Robinson, Best practice guidelines on publication ethics: a publisher's perspective. J Clin Pract 2007; 61(Suppl 152): 1-26, at 4, 11.
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misconduct allegations investigated by institutions and the Office of Research Integrity (ORI). According to the International Committee of Medical Journal Editors (ICMJE), editors have a responsibility to pursue possible scientific misconduct in manuscripts submitted to or published in their journals and to publish a retraction of any fraudulent paper published in their journals. . . . In England, a group of medical editors have formed a Committee on Publication Ethics (COPE) to deal with breaches of research and publication ethics in our editorial capacities.21
Accordingly, in my opinion it is appropriate to examine JSCR's editorial conduct in the light provided by ICMJE and COPE guidelines written to maintain integrity in biomedical science research and publication.
21 Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000. https://ori.hhs.gov/images/ddblock/masm_2000.pdf (accessed December 27, 2015).
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[III] JSCR'S MANUSCRIPT REVIEW PROCESS
A. Features of JSCR's Manuscript Review Process that Comport with Standards
Peer review of papers submitted for potential journal publication is a standard feature in journals purporting to be of high quality. It is "another pair of eyes" to provide objective, independent analysis of the submission, identifying its merits and deficiencies. Peer reviewers must of course have expertise in the relevant field, and securing more than one reviewer enhances the likelihood that such merits and deficiencies will be identified. Blinding the peer review process has been shown to improve the quality of the reviews.22 Double-blinding, in which neither authors nor reviewers know each other's identity, can further reduce the likelihood that peer review might be inappropriately biased in one direction or another.23
Additionally it is standard for biomedical science journals to require that, where human beings are research subjects, appropriate IRB or other applicable research ethics board approval and surveillance be secured.24 Finally, it is standardly recommended that blinded reviewers' identities be kept confidential over time – with an important caveat, however:
Editors should not publish or publicize peer reviewers’ comments without permission of the reviewer and author. If journal policy is to blind authors to reviewer identity and comments are not signed, that identity must not be revealed to the author or anyone else without the reviewers’ expressed written permission. Confidentiality may have to be breached if dishonesty or fraud is alleged, but editors should notify authors or reviewers if they intend to do so and confidentiality must otherwise be honored. 25
JSCR subscribes to the practice of double-blind peer review: "Manuscripts are subjected to a 'double blind' peer review by at least two reviewers who are experts in the field."26 As noted just above, the journal also requires prior IRB/Ethics Board approval for human subjects research.27 JSCR also checks for plagiarism, using a specific software for that purpose.28
For the Devor article, JSCR's peer reviewers offered a number of reasonable questions and suggestions. Reviewer #2, for instance, cautions for page 10 that conclusions about endurance athletes reach beyond the scope of the study, which did not actually focus on endurance athletes.29 Similarly, Reviewer #1 questions, for instance, whether changes in body composition might be attributable to participants' special diet, and not just to the CrossFit exercise routines. Reviewer #1 also proposes that the CrossFit intervention needs to be described with a fair bit of detail
22 Robert McNutt, Arthur Evans, Robert Fletcher, Suzanne Fletcher, The effects of blinding on the quality of peer review. JAMA 1990; 263: 1371-76 23 ICMJE Recommendations, at 4-5. 24 ICMJE Recommendations, at 6-7. 25 ICMJE Recommendations, at 4. 26 JSCR Instructions for Authors, Online Submission and Review System; available at http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed 12/31/15). 27 See JSCR's "Information for Authors" page, available at http://journals.lww.com/nsca- jscr/Pages/InformationforAuthors.aspx and http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed 12/31/15). The need for Institutional Review Board (IRB) or similar ethics committee approval and an authorized informed consent is mentioned in three locations in those instructions: p. 2, 3, 4). 28 Keith Cinea deposition 1, 7/16/15, at 222. 29 Keith Cinea Exhibit 19: series of emails to Smith et al., beginning 6/15/12 and concluding 1/17/13. The first round of review comments was sent 8/28/12 for both reviewers.
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before readers can discern what, exactly, might or might not be the result of that intervention.30
That being said, the editorial process for the Devor article was seriously flawed.
B. Features of JSCR's Manuscript Review Process Not Comporting with Standards
The problems begin even before the first round of peer reviews. In an email dated June 20, 2012,31 Editor-in-Chief William Kraemer assigns the Devor article to Travis Triplett as senior editor for shepherding the piece through the review process. It appears that, even at that early point Kraemer is proposing that Triplett should ensure that a certain kind content must be included if the article is to be accepted for publication – namely, that "a lot of context is needed for this," that the paper should say there is a cost to becoming fit by way of CrossFit ("fit at what cost"). Kraemer further suggests that Triplett should secure "some good reviewers to take a close look at this as catabolism will break you down but while fit are you in a catabolic state etc, . . . " While I cannot be certain, Kraemer appears to be alerting Triplett to certain consequences of a catabolic state that he believes may lead to CrossFit-associated harm. In both these directives, then, Kraemer appears to be instructing Triplett to choose reviewers who will require the authors to say (or perhaps to instruct her reviewers to tell the authors to say) that CrossFit can cause harm, as a kind of prerequisite for publishing the article.
While it may be appropriate for editorial staff to be alert to certain kinds of issues that must be addressed if a research project is to be complete and credible, editors must be cautious about introducing particular conclusions at the earliest stage of the peer review process. The purpose of peer review, after all, is to secure independent, objective, outside perspectives – not to build in, from the outset, the conclusions one expects to see at the end. Such an approach would thwart the very purpose of peer review, which is to reduce if not eliminate bias by securing a completely separate, impartial perspective. An early infusion of "this is a conclusion I expect to see" would tend to build in bias from the beginning.
August 28, 2012 reviews
The first round of reviews comes in an email dated August 28, 2012. Peer reviewers #1 and #2 provide what appear to be useful suggestions. Neither mentions any need to describe injuries. However, the cover letter accompanying the peer reviewers' comments takes a significant step beyond an ordinary review process as Kraemer suggests that authors need to add some specific substantive content regarding injuries to the manuscript.32
Still at the onset your manuscript was not given a high priority score based upon experimental concerns. You also need to caution readers as to the context of your findings due to the fact many people do get injured doing these types of workouts. Typically a lack of general preparation is seen or people do to [sic] much to [sic] quickly and get hurt so how this was dealth [sic] with is of particular importance.
The statement is followed by a citation to an article by Bergeron et al.,33 the "CHAMP" paper that
30 Keith Cinea Exhibit 19: 8/28/12 email. 31 William Kraemer Exhibit 13. 32 Kraemer deposition at 171-173 33 Bergeron, MF, Nindl, BC, Deuster, PA, Baumgartner, N, Kane, SF, Kraemer, WJ, Sexauer, LR, Thompson, WR, and O'Connor, FG. Consortium for Health and Military Performance and American
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purportedly emerged from a conference discussing injuries associated with various kinds high- intensity training for military personnel. The injury information was not research-based. Rather, it was exclusively anecdotal, and the paper ultimately recommends that bona fide research be undertaken to discern, yes or no, whether injury rates are in fact higher or different with less conventional types of workout such as CrossFit. Thus, although the paper might be useful as a summary of some questions that have been asked, it could not be credibly cited as an evidence- based conclusion.
Kraemer's admonition that Smith et al. should "caution" readers that "many people do get injured" represents a significant deviation from usual and proper peer review processes. At this early stage, a serious scientific journal generally allows the peer reviewers to do their work. Independent, objective analyses are enlisted to guide editor and authors alike, first to discern whether the paper is even potentially publishable and if so, to offer suggestions for improvement. Final editorial decisions typically revolve around questions about whether flaws or inadequacies in the paper's earlier versions have been adequately remedied and whether, in the final analysis, the paper passes muster for publishability.
October 13, 2012 reviews
A distinctly different approach to the injury issue emerges in the second round of comments in an email dated October 13, 2012. The email begins with a fairly negative cover letter emphasizing that the paper can still be rejected if it does not satisfy reviewers' concerns, then adds: "and you have Editorial Notes to deal with too."
Here, Reviewer #1 says "I think it would be prudent to disclose the rate of injury and the reasons for dropout from the protocol (i.e. why 54 started, and 43 finished)." This is the first mention of injuries from peer reviewers.
The "Editorial Office Revisions" are considerably more directive. 34 In addition to earlier comments instructing the authors to tell readers that CrossFit causes injury, Kraemer now directs them to state that CrossFit supervision is "not too well done in most CrossFit gyms for exercise technique, Y-Tube is full of this." He tells authors not just to describe how techniques were monitored, but adds that Smith et al. must now describe how this gym "varies from other typical Crossfit [sic] gyms" (thereby apparently presupposing that this gym does, in fact, differ from the norm).
These two approaches to the injury issue provide a marked and instructive contrast. Reviewer #1's question is reasonable, limited, and careful. S/he simply points out that there was a significant dropout rate and asks for information about injuries. In a study such as this, injury rates might be important enough that, if they are not at least noted in some way, the paper might perhaps be found unworthy of publication. Or more broadly, a reviewer might reasonably propose that some sort of accounting for the dropout rate would be helpful. And it could likewise be legitimate for a reviewer to believe that, unless such loose ends are tied up adequately, the paper would not be publishable.
The editorial office's input is categorically different. It does not simply say "X needs to be credibly addressed, one way or another." It tells the authors, substantively, what they need to
College of Sports Medicine consensus paper on extreme conditioning programs in military personnel. Curr Sports Med Rep 2011; 10: 383-389. 34 Email of October 13, 2012; Kraemer deposition at 171-173, 187-189, 192-196.
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conclude about the subject, and what they need to tell readers. In the process, Kraemer is encouraging, indeed apparently requiring, bad science.
At this stage in the review process there was no evidence that Smith et al. had made any observations whatever about injuries, given that neither the first nor the second draft of the manuscript said anything on the subject. If Smith et al. did not, in fact, make any actual observations regarding injuries, then it follows that they would have no scientific basis on which to make any statements about injury hazards embedded in CrossFit.
On the other hand, for the investigators to go out, post hoc, to gather after-the-fact data about injuries would be bad science. High-quality science should be driven by hypotheses, not after- the-fact data-dredging. The longer the time gap between the training program and any subsequent examinations for injuries, the more difficult it will be to determine whether any putative injury was actually caused by the 10-week program, or was an earlier injury exacerbated by training, or was merely a subsequent event having nothing to do with the training but somehow retrospectively imputed to it. Injury data must be gathered at the time of the study, and must be based on a clear definition not only of what an "injury" is, but how it will be determined whether or not the training is what caused the injury. Moreover, those data need to be gathered by someone who has sufficient expertise to discern [a] whether a given individual actually has sustained an injury and [b] whether that injury was caused by the training. Clearly, the qualified person in question would have to examine the subjects directly. The Devor study provides no indication that any such definitions were provided, nor that any such examinations were undertaken, let alone by a qualified expert.
If Dr. Kraemer wanted the authors of the Devor study to undertake such work post hoc, he thus would be inviting bad science. If he were to be satisfied simply for them to assert that anyone who said "I have an owie!" would count as injured — by CrossFit workouts — sans such definitions and examinations, he would be inviting terrible science. And if he would be satisfied simply with a general assertion that people are injured by CrossFit, accompanied only by a citation to the non-evidence, purely anecdote-based CHAMP study, he would effectively be demanding an abdication of science, in a purportedly high-profile scientific publication.
The same observation applies to Kraemer's admonition to tell readers that CrossFit does not supervise adequately. First, he seems to ignore Smith et al's statement that "[a]ll training was performed . . . under the supervision of a fellow of the American College of Sports Medicine (ASCM) and an ASCM certified registered clinical exercise physiologist."35 If the editor wished to challenge the appropriateness or quality of ASCM supervision, he needed to do so more directly.
Moreover, the direction Kraemer provides regarding supervision is troubling. Leaving aside the question whether a few You-Tube videos constitute a sufficient empirical basis on which to conclude that "most" CrossFit gyms provide inadequate supervision, a critical question here concerns what, precisely, Kraemer is asking for. Scientifically, an editor might reasonably request some sort of verification that this gym actually provides bona fide CrossFit training. If, for instance, it provides only a pseudo-approximation of CrossFit that bears little resemblance to the real thing, then of course the authors could not legitimately draw conclusions about CrossFit training by providing results from something that is not, in fact, CrossFit.
In this case, however, Kraemer's question seems odd. He offers no concrete reason to believe that
35 Devor article, at 3168.
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this gym differed significantly from other CrossFit gyms. Indeed, elsewhere Kraemer expressly relies on trust that, e.g., the investigators really did secure IRB approval and that their data were honestly and correctly recorded.36 Hence it is not clear why there would suddenly be distrust regarding whether this particular gym sufficiently resembled other CrossFit gyms.
It could be that, parallel to the discussion regarding injuries, perhaps Kraemer is asking the authors to add information they likely did not possess at the time of submitting the article— namely, some sort of systematic comparison between this facility and other CrossFit gyms around the country. However, this would have required wide-ranging observation and expertise. Only an expert on CrossFit could verify whether the techniques taught at this particular gym are similar to, or different from, national CrossFit standards. And that could only have been properly done during the time the 10-week challenge was under way. If it were not built into the original study design, any information produced subsequently would be flawed. At best, a visiting expert might opine whether the techniques being used at such a later date did, or did not, resemble national CrossFit standards. S/he could not go back in time to opine whether, during the 10 weeks in question, the techniques being taught were faithful to CrossFit standards. Hence here too, a demand for post hoc data-production would invite bad science.
November 23, 2012 reviews
The final round of peer and editorial reviews was sent out by email on November 23, 2012. Reviewer #1 continues to pose reasonable challenges concerning how to sort out the effects of training versus diet, to produce the body composition changes observed at the study's conclusion. Where more than one force can cause a particular type of change, it can be important for peer reviewers to discern whether the authors truly have satisfactorily addressed the issue and whether, if they have not, the deficiency is sufficiently important to warrant declining to publish the piece.
The Editorial Office Revisions raise familiar concerns. Editorial comment #2 raises a genuinely interesting question, namely, whether CrossFit trainings just naturally have such wide variation from one time to the next, and from one place to the next, that they might preclude genuinely scientific study. To study "what does CrossFit do," it must be possible to define the entity sufficiently that one knows when one is seeing a true example of the phenomenon under study, and when one is not. The problem is likely solvable, however, by designating which characteristics are definitive of "CrossFit" (e.g., "constantly varied functional movements performed at relatively high intensity" 37 ) and then discerning, for any putative example of CrossFit, whether it satisfies the appropriate criteria. If CrossFit has very high variability from site to site and from time to time, a significantly larger study population might be necessary, to accommodate differences in workout routines from one site or occasion to the next.
Comment #3 again features "context": "The context for your findings are [sic] also related to these subjects and this sequence of workouts and this is important to point out as not all sequences might give the same result per se." It is unclear just what the editor wants in his request for information about the specific sequence of workouts. Throughout, however, the editor appears to want the authors to arrive at certain conclusions, not simply to address a particular issue in some scientifically satisfactory way.
Comment #4 responds to an addition in the authors' most recent version of the manuscript: they now say that 9 of the 11 subjects who did not return cited injury/overuse. Here too the editor
36 Kraemer deposition at 157. 37 See CrossFit website at http://www.crossfit.com/cf-info/what-is-crossfit.html (last accessed 12/31/15).
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appears to demand specific conclusions, not simply that the authors address a question in some way. The authors are told that "[t]his is very important and needs to be emphasized," ostensibly because overuse injuries come from "too much too soon"; participants must be "properly screen[ed]." As noted, to be credible, these kinds of conclusions must have been built into the hypothesis and data-gathering ab initio, lest such inferences constitute bad science in which conclusions are not based on careful and systematic observations.38
Comment #5 inserts yet another new element, namely certification: "CrossFit certification is not a certification that has met certification standards in Washington DC as ACSM and NSCA certifications and this needs again to be established as to the qualifications of the trainers in more detail as this is important." Although the comment is not clearly crafted, it appears the editor wants the authors to point out that CrossFit trainers are not certified by ASCM and/or NSCA – perhaps thereby to imply inferiority, given that readers of this journal will almost certainly recognize already that CrossFit has differences from conventional training. If so, the editor's reasoning commits the logical fallacy known as "begging the question" – presuming as true the very thing one seeks to establish. The fact that CrossFit trainers are not certified by ASCM or NSCA cannot, of itself, demonstrate or even suggest that CrossFit training is therefore inferior. Head-to-head comparison research would be required, and this particular piece does not purport to do any such thing. Hence, for the authors simply to say "A ≠ B" would tell the reader nothing of great value, other than simply that A is not the same as B. JSCR's readership is probably already aware of this point.
In Comment #6 the editor observes the study had "no control group and no comparative exercise training group and one might see the same benefits or more with a conventional program etc." This might be a good reason to decline to publish the piece, but the lack of comparison group cannot be good reason for the authors to change their report of results, post hoc. If the study design is deficient for lack of comparisons, this deficiency cannot be made up later. To try to do so would introduce bad science.39
Overall, the editorial process for a peer-reviewed journal purporting to publish science should be carefully undertaken. It may be entirely legitimate for editors and reviewers to note that "you cannot conclude X unless you have addressed A, B, and C," and, if a manuscript addresses A and B but not C, to decline to publish the piece because its conclusions are not warranted by its hypotheses, premises and data. In a scientific publication, editors and reviewers can and should challenge authors to show that their methodology was adequate to test the hypothesis, that their data-gathering was adequate to support the methodology, that they enrolled enough subjects to achieve adequate power as well as technical statistical significance. And they can suggest that, logically and empirically, the authors' methods and data support Conclusion Y rather than the Conclusion X they proffer. Editors can decline to publish because "this paper should have paid
38 The authors appear to accede to this request: "We agree that this is an important point with all extreme training programs and have added a short paragraph in the discussion with an emphasis on the injury rates associated with such programs." Devor Study Third Revision, authors' responses to editorial comments. Given that the statement has no scientific basis within the authors' work, nor in the reference they then cite in the article (the CHAMP study, which is based on anecdote rather than scientific study or data), the authors' response appears to be scientifically unfounded. 39 The authors appear to recognize that this is no time to redesign the study. "Our investigation is not claiming superiority to any other type of training program. We do make mention of high intensity interval training merely to provide context and background to the reader. However, this is an observational study for a novel training protocol. Our hypotheses do not include any mention of comparison to any other training program . . . " Devor Study Third Revision, authors' responses to editorial comments.
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attention to E and F, but it did not." And they can say "take another look – your methods and data (also) appear to support Conclusion G, which you did not articulate."
What editors must not do, is to pressure authors into asserting conclusions that their hypothesis did not envision or test, and which their data do not substantiate.
In the final analysis, per ICMJE standards,
Editors should base editorial decisions on the validity of the work and its importance to the journal’s readers, not on the commercial implications for the journal, and editors should be free to express critical but responsible views about all aspects of medicine without fear of retribution, even if these views conflict with the commercial goals of the publisher.40
It appears that JSCR's manuscript review process failed to comport with accepted standards in a variety of ways.
40 ICMJE at p. 6.
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[IV] JSCR failed to adhere to accepted standards for addressing allegations of scientific misconduct
As discussed above, the Committee on Publication Ethics (COPE) provides helpful guidance for editors of biomedical science journals to address allegations of possible scientific misconduct. As of 2009, over 3800 journals subscribed to COPE.41 That number might well be higher today, over half a decade later. As also noted above, COPE standards are expressly embraced by the United States's Office of Research Integrity and by ICMJE.42
COPE provides a flowchart – "What to do if you suspect fabricated data … in a published manuscript"43 – which provides specific steps that editors of biomedical science journals should follow in approaching an allegation of possible scientific misconduct. As extracted from the flowchart provided just below, the key steps in the instant case will be:
[1] "READER EXPRESSES SUSPICION OF FABRICATED DATA" [2] "THANK READER AND STATE YOUR PLANS TO INVESTIGATE" [3] "CONSIDER GETTING A 2ND OPINION FROM ANOTHER REVIEWER" [4] "CONTACT AUTHOR TO EXPLAIN YOUR CONCERNS BUT DO NOT MAKE DIRECT ACCUSATIONS" [5] [BIFURCATION: AUTHOR REPLIES V. NO RESPONSE] [6] AUTHOR REPLIES [BIFURCATION: SATISFACTORY V. UNSATISFACTORY RESPONSE] [7] UNSATISFACTORY EXPLANATION [8] "INFORM ALL AUTHORS YOU INTEND TO CONTACT INSTITUTION/REGULATORY BODY" [9] "CONTACT AUTHOR'S INSTITUTION REQUESTING AN INVESTIGATION" [10] [BIFURCATION: AUTHOR(S) GUILTY OF FABRICATION V. NOT GUILTY] [11] IF GUILTY: PUBLISH RETRACTION
41 David Resnik, International standards for research integrity: an idea whose time has come? Account Res. 2009: 16: 218-228, at 219. 42 Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000. https://ori.hhs.gov/images/ddblock/masm_2000.pdf (accessed December 27, 2015); ICMJE Recommendations, at 7-8 (III-B). 43 COPE/Committee on Publication Ethics, What to do if you suspect fabricated data (b) Suspected fabricated data in a published manuscript; available at http://publicationethics.org/files/Suspected%20fabricated%20data%20in%20a%20published%20manuscrip t%20(1).pdf (last accessed 1/1/16).
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[1] "READER EXPRESSES SUSPICION OF FABRICATED DATA" [2] "THANK READER AND STATE YOUR PLANS TO INVESTIGATE"
In the instant case, Russell Berger has written and testified that, once he became aware of the Devor article's online publication, he explored his concerns about the injury rate described there. He contacted Jeff Glassman, CrossFit's chief scientist; also Chelsea Rankin, the study coordinator, who indicated that claims about injury conflicted with her first-hand information about participants' (lack of) injuries; also Mitch Potterf, the owner of the gym, who denied ever having said anything about injury to the Devor article's authors; and also Steven Devor, the supervising faculty member, who indicated he had no direct knowledge about injuries and (initially at least) seemed interested to find out more.44
After undertaking these conversations Mr. Berger sent an email to the NSCA board of directors on May 23, 2013. In it he said:
"I'm not sure if this is the correct place to request a press inquiry from, but I hope this will be directed to the right persons. "I recently wrote and article, published in the CrossFit Journal, that investigated a study published in the NSCA's Journal of Strength and Conditioning Research [providing direct link to article]. "My investigation involved interviews with the corresponding author of the study, as well as the study coordinator, who indicated that she believed data presented in his study was fabricated. In my interview with the corresponding author, he assured me I had legitimate questions and he would resolve the apparent inconsistencies in his work, but since that interview he has refused further comment or explanation. Would the NSCA like to make a formal statement about the questionable data within this publication? "Here is the full article: http:/f!ournal.crossfit.com/2013/05/acsm.tpl "Thank you for your time."45
The email is somewhat inartfully crafted, as its subject line says "Inquiry" and its request is whether NSCA would like to make a formal statement about questionable data. Nevertheless, the email did provide direct evidence to place the Board of NSCA on notice of an allegation about potential fabrication of data in NSCA's flagship publication, the JSCR. Although it had been sent, generically, to the NSCA's board as a whole, the email did reach the people it needed to reach. Per 30-b-6 the testimony of Keith Cinea, the email initially went to Brenda McQuay, executive assistant to Dr. Carwyn Sharp, NSCA's chief science officer and/or education director, who then forwarded it to Keith Cinea, publications director for NSCA.46 Notwithstanding that the email was framed as a somewhat confusing request for some sort of press statement, Mr. Cinea did understand quite clearly that Berger expressed that he had reason to believe statements about injuries in the Devor article were incorrect or fabricated.47
44 Russell Berger, NSCA 'CrossFit Study' Fraud?, The CrossFit Journal May 22, 2013; available at http://journal.crossfit.com/2013/05/acsm.tpl (last accessed 1/1/16); Berger deposition; Russell Berger, Transcript of Phone Conversation Between Russell Berger and Steven Devor, The CrossFit Journal May 2013; available at http://library.crossfit.com/free/pdf/CFJ_Devor_Berger_3.pdf (last accessed 1/1/16).
45 Russell Berger email to [email protected], May 23, 2013 (Cinea Exhibit 3) (emphasis added). 46 Keith Cinea deposition 7/16/15, at 237; Keith Cinea deposition 10/23/15 at 44. 47 Keith Cinea deposition 7/16/15, at 240, 418-19.
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In the email Mr. Berger provided two web links providing detailed reasons for Mr. Cinea at least to question the validity of the Devor article. The first was Mr. Berger's CrossFit article laying out the basic concerns, and the second was a transcript of Berger's phone conversation with Devor. This latter indicated that, by the time Berger had spoken with Devor, Berger had directly contacted four of the nine participants who had not re-tested, learning that not one of them had ever stated to anyone that they had been injured during the 10-week CrossFit program.48
Mr. Cinea chose not to explore the matter.49 According to Mr. Cinea's 30-b-6 deposition, he contacted Editor-in-chief William Kraemer, conveying to him that he had received an email indicating that information in a JSCR article was not correct, though Cinea did not share Berger's links to either the article or the transcript of the Devor conversation.50 Kraemer responded that there was no need to respond to Berger's email.51 Cinea states that he took Kraemer's response "at face value," hence did nothing further at the time.52 Mr. Cinea also mentioned the matter to Executive Director Michael Embree, who also apparently saw no reason to question Kramer's instruction not to respond.53 Cinea also did not to suggest that Mr. Berger use, nor did he send the matter, himself, to the "manuscript clarification" process, allegedly on the ground that Mr. Berger had failed to provide evidence to support his theory.54
Mr. Cinea's decision to ignore the Berger email counts as a failure on the COPE flowchart. A suspicion had been expressed, and it was correctly understood to be an allegation of scientific misconduct. The correct response should have been for Mr. Cinea, as NSCA's director of publications, to thank Mr. Berger and state his plans to investigate.
Mr. Berger also reached out directly to the JSCR's editor in chief, William Kraemer. His 4- minute phone-call to Kramer on 10/30/13 was followed by a 30-minute call from Kraemer to Berger on 10/31/13. Although Kraemer indicates he does not recall either conversation,55 Berger testifies that the calls were part of his "specific attempts to put the NSCA and Dr. Kraemer on notice as to my investigation."56
Just as Mr. Cinea declined to follow up on the email, Kraemer declined to follow up on Berger's phone calls, which I will assume, arguendo, did put Kraemer on notice that an allegation of potential scientific misconduct was being made. If so then he, like Cinea, failed to take the appropriate next step: to "thank the reader and state [his] plans to investigate." Indeed, per Mr.
48 Russell Berger, Transcript of Phone Conversation Between Russell Berger and Steven Devor, The CrossFit Journal May 2013, at 5; available at http://library.crossfit.com/free/pdf/CFJ_Devor_Berger_3.pdf (last accessed 1/1/16).
49 Keith Cinea deposition 7/16/15, at 434. 50 Keith Cinea deposition 10/23/15, at 46. 51 Keith Cinea deposition 10/23/15, at 46-47. 52 Keith Cinea deposition 10/23/15, at 47. 53 Keith Cinea deposition 10/23/15, at 47. 54 Keith Cinea deposition 7/16/15, at 240. Of note, though less directly relevant for present purposes, Devor similarly ignored emails from gym owner Mitch Potterf. As supervising faculty member and co- author, Devor could and should have conferred with his students and, upon any finding that data had been fabricated or in any other way could not be properly accounted for, should have brought the matter to the journal himself. 55 William Kraemer deposition, at 275-77. 56 Russell Berger deposition, at 236.
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Berger's testimony, Kraemer expressly dismissed the importance of the allegation: "No, I don't [have an obligation to investigate] because, if I was [sic] to investigate every claim about every study that somebody had a problem with, we would never get anything published."57
Subsequently, after Mr. Cinea had seen a number of Facebook posts by Russell Greene, he brought the Berger email to Kraemer's attention. Kraemer indicated he did not recall the earlier conversation, and the matter was not pursued further at the time.58 Indeed, no investigation whatever was initiated until much later, when a lawsuit was well under way and Plaintiff had filed for summary judgment. 59
[3] "CONSIDER GETTING A 2ND OPINION FROM ANOTHER REVIEWER"
Given that both Mr. Cinea and Mr. Kraemer declined to take any action whatever in response to allegations, clearly they failed the next step, to consider seeking another reviewer's opinion. In his 5/23/13 email to the board, Berger had presented several prima facie credible reasons to think injury rates were not as described. For one thing, he observed, in a supposedly "blind" study, it is not clear how the authors would re-contact the participants who failed to appear, whether to find out about injuries or anything else. Moreover, Chelsea Rankin, the study coordinator who did know the participants by name, directly stated that they had not been injured.60 Kraemer could have brought this information to Reviewer #1, or Reviewer #2, to seek a genuinely outside perspective on whether there might be something worth pursuing. Importantly, the COPE flowchart does not require or even suggest that an editor undertake a full-fledged in-house investigation. Journals do not generally have the resources to do that sort of thing, and in any event it is virtually impossible for editors to be sufficiently free from their own conflicts of interest to do a fully credible job.61 Thus, the editor's job is not to make judgments, but simply to explore the threshold question whether to take the next step – to speak with the author.
[4] "CONTACT AUTHOR TO EXPLAIN YOUR CONCERNS BUT DO NOT MAKE DIRECT ACCUSATIONS" [5] [BIFURCATION: AUTHOR REPLIES V. NO RESPONSE] [6] AUTHOR REPLIES [BIFURCATION: SATISFACTORY V. UNSATISFACTORY RESPONSE]
The next several steps in the flowchart ask the editor to contact the author, avoiding an accusatory approach. After all, any given instance holds the possibility that someone is leveling false accusations out of malign intent. The author's perspective is thus important.
Here, had Kraemer contacted Michael Smith, he would likely have learned that Smith had no direct data whatever. At a minimum, Kraemer would have needed to recognize that there is
57 Berger deposition, at 233. 58 Keith Cinea deposition 7/16/15, at 284-85; Keith Cinea deposition, 10/23/15, at 48. 59 Keith Cinea deposition 7/16/15, at 304 ff, 352.
60 Russell Berger, NSCA 'CrossFit Study' Fraud?, The CrossFit Journal May 22, 2013; available at http://journal.crossfit.com/2013/05/acsm.tpl (last accessed 1/1/16).
61 Per the U.S. Office of Research Integrity, "editors are not responsible for conducting a full investigation or deciding whether scientific misconduct occurred. Those responsibilities rest with the institution where the work was conducted or with the funding agency." Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000, at 3. https://ori.hhs.gov/images/ddblock/masm_2000.pdf (accessed December 27, 2015)
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nothing scientific, or empirically observational, about an alleged statement by a gym owner that 9 people had failed to return because of injury. Proper scientific observation for injuries would have required not just a reasonably clear definition of what would count as an injury, but also a reliable way of discerning that such an injury was actually present in a participant and that it was, in fact, caused by the participation in CrossFit. As Berger himself noted, falling off a ladder would not count as a CrossFit-associated injury, even if it occurred during the 10-week period of the study.62 Neither would a pre-existing injury from, e.g., ordinary running or cycling.
Had Kraemer contacted another author, Devor, he would have learned that Devor had little or no personal knowledge of the study during the time it was under way. Smith did not describe to Devor the number who were tested, or the number that came back for re-testing.63 Devor appears to have done little more than help edit the manuscript.64 Additionally, Kraemer would have had to take seriously the report by Chelsea Rankin, the study coordinator who actually knew the participants, that there were no injuries.
Altogether, Kraemer would have gone away with serious reason to be concerned about the study: a flat statement about injuries had been made, with no scientific data whatever to back it up and, on the other side, credible statements indicated that there had been no injuries. Kraemer would have been obligated to pursue the next steps.
[7] UNSATISFACTORY EXPLANATION [8] "INFORM ALL AUTHORS YOU INTEND TO CONTACT INSTITUTION/REGULATORY BODY" [9] "CONTACT AUTHOR'S INSTITUTION REQUESTING AN INVESTIGATION"
Allegations about scientific misconduct should be referred to the institution at which the study took place, or to the federal government if the research was federally funded. The proper direction to send the manuscript – whether to OSU, or to the federal government's Office of Research Integrity (ORI) – is not entirely clear in the instant case. The Devor study was not federally funded. However, a federal investigation is required, not just for studies directly funded by the Public Health Service but also for any projects generated from a PHS-supported project.65 Hence, if anything used by Smith et al. was paid for by a PHS grant – e.g. the equipment used to assess VO2 max or body composition – it is at least possible that the referral should have gone to the federal ORI rather than OSU.
Let us assume, arguendo, that the project had neither direct nor indirect PHS funding. In that case the correct next step for Kraemer would have been to send the matter to OSU. Recipients of federal research funding are required to have a process for investigating allegations of scientific misconduct, and OSU's "University Policy and Procedures Concerning Research Misconduct" were approved by the OSU Faculty Senate in 2008 and thereafter by ORI.66
OSU emphasizes that its policy applies "to all research and scholarship conducted within the University community, irrespective of the funding source, if any, which supports the research or
62 Keith Cinea deposition 7/16/15, at 244; William Kraemer deposition at 259. 63 Devor deposition, March 13, 2015, at 64-65. 64 Devor deposition, March 13, 2015, at 64. 65 42 CFR 93.102. 66 Ohio State Research, Innovation for a global future: Research Misconduct; available at http://orc.osu.edu/regulations-policies/misconduct/ (last accessed 1/17/16).
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scholarship."67 The policy has a step-wise approach, beginning with informal proceedings such as an initial inquiry to determine whether there is sufficient substance in the allegations to warrant a full investigation which, if undertaken, would be conducted under OSU's disciplinary rules.68
The comparison is not favorable between these widely accepted guidelines and the conduct of NSCA and JSCR. Neither Keith Cinea, NSCA's director of publications, nor William Kraemer, Editor-in-Chief of JSCR, contacted OSU to invite them to conduct whatever investigation they deemed appropriate. Indeed Kraemer states, early in his deposition, that he is unaware of any rules or regulations regarding ethics in publishing, in the arena of sports science.69 Neither does the NSCA subscribe to any ethical guidelines for publishing.70
This is unfortunate. As editor-in-chief of what is touted to be a leading journal in the biomedical science of sport, conditioning and exercise, it is Kramer's job to know.71 By analogy, if someone purports to be a general contractor for building homes, she cannot credibly claim to be ignorant of local building codes. It is her job to know. Even if she is genuinely unaware, the knowledge can nonetheless be imputed to her, and she will be accountable for construction defects emanating from her ignorance.
The role editors should play in responding to scientific misconduct has been articulated by their colleagues, asserted by two national reports, and demonstrated by the scientific misconduct allegations investigated by institutions and the Office of Research Integrity (ORI). According to the International Committee of Medical Journal Editors (ICMJE), editors have a responsibility to pursue possible scientific misconduct in manuscripts submitted to or published in their journals and to publish a retraction of any fraudulent paper published in their journals. However, editors are not responsible for conducting a full investigation or deciding whether scientific misconduct occurred. Those responsibilities rest with the institution where the work was conducted or with the funding agency.72
67 Ohio State University, "University Policy and Procedures Concerning Research Misconduct", as I-A, p. 1; available at http://orc.osu.edu/files/2011/01/Misconduct_Policy.pdf (last accessed 1/1/16). The policy was adopted by OSU's Senate on May 29, 2008, and approved by the federal Office of Research Integrity. See OSU Office of Research Compliance re. Research Misconduct; available at http://orc.osu.edu/regulations-policies/misconduct/ (last accessed 1/1/16). 68 Id. 69 William Kraemer deposition, at 14-15. Indeed, Kraemer seems to think that the only approach to take when confronted with evidence of scientific misconduct is to trust the authors; beyond that he is not sure "what the credible evidence would be and how that would be litigated to make it so." Id. at 157. The only other option he offers is the "manuscript clarification" process, discussed below. 70 William Kraemer deposition, at 73-75. 71 The idea that an editor-in-chief of a biomedical science journal has an obligation to be aware of basic standards for protecting scientific integrity appears to run counter to the concept of Keith Cinea, NSCA's publications director, who states "That's not what – in his contract" (responding to the question whether an editor in chief has "a duty to ensure that accurate, scientifically sound information is published in the JSCR"). Keith Cinea deposition 7/16/15, at 248. Note also the position of Blackwell publishers on editors' responsibilities: "Journal editors have a responsibility to ensure the accuracy of the material they publish. Journals should encourage authors and readers to inform them if they discover errors in published work. . . . " Chris Graf, Elizabeth Wager, Alyson Bowman, Suzan Fiack, Diane Scott-Lichter, Andrew Robinson, Best practice guidelines on publication ethics: a publisher's perspective. J Clin Pract 2007; 61(Suppl 152): 1-26, at 10. 72 Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000, at 3; available at https://ori.hhs.gov/images/ddblock/masm_2000.pdf (last accessed 12/27/15).
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Also of note, of the more than 2600 journals subscribing to the standards set by the ICMJE, at least nine are similar to JSCR.73 Thus, editors of journals that are comparable peers to JSCR seem well aware of their responsibilities as editors – unlike Kraemer, it would appear.
ASIAN JOURNAL OF SPORTS MEDICINE (LIST DATE 8/13/12) ATHLETIC TRAINING & SPORTS HEALTH CARE (LIST DATE 4/19/10) INTERNATIONAL JOURNAL OF EXERCISE SCIENCE (LIST DATE 1/18/08) INTERNATIONAL JOURNAL OF SPORTS MEDICINE (LIST DATE 12/1/15) JOURNAL OF EXERCISE, SPORTS & ORTHOPEDICS (LIST DATE 5/7/14) JOURNAL OF EXERCISE SCIENCE & PHYSIOTHERAPY (LIST DATE 6/24/14) JOURNAL OF SPORTS SCIENCE (LIST DATE 6/3/14) OPEN ACCESS JOURNAL OF SPORTS MEDICINE (LIST DATE 9/16/14) THE PHYSICIAN AND SPORTS MEDICINE SOUTH AFRICAN JOURNAL OF SPORTS MEDICINE (LIST DATE 10/5/12) SPORTS MEDICINE (LIST DATE 4/8/08)
Given the plethora of research scandals and accompanying widespread media coverage in the 1980s it seems remarkable that in 1984, when Kraemer became JSCR's editor-in-chief, he seems to have been oblivious to the storms surrounding the very kind of work on which he was embarking. In contrast and perhaps somewhat surprisingly, the JSCR leadership was in step with wider realities enough to require IRB approval and informed consent. One is unsure what to make of their apparent ignorance of the parallel need to protect the integrity of science, scientific research, and scientific publication.
73 ICMJE | Journals Following the ICMJE Recommendations; available at http://www.icmje.org/journals- following-the-icmje-recommendations/ (last accessed December 26, 2015). Journals that appear particularly close to JSCR are highlighted in boldface.
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V. REASONS TO BELIEVE OSU WOULD VERY LIKELY HAVE FOUND SCIENTIFIC MISCONDUCT
OSU would very likely have found Devor et al. guilty of scientific misconduct via: [A] fabrication, specifically a fabrication of data regarding participants' injuries, and possibly also [B] falsification, via the authors' falsely stating that they had protected human subjects by obtaining IRB approval for the study, proper informed consents from research participants, and close supervision during the training program.
We begin with the definition and standards for identifying scientific misconduct. Per ORI:
Scientific misconduct. or misconduct in science means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data (42 C.F.R. 50.101).74
Per 42 CFR 93.103, defining "Research misconduct": Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Per OSU's own policy and procedures governing research misconduct:
A. 'Research Misconduct' means Fabrication, Falsification or Plagiarism in proposing, performing, or reviewing research, or in reporting research results. E. Fabrication. 'Fabrication' is making up data or results and recording or reporting them. F. Falsification. 'Falsification' is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.75
Note next the standards for finding a party guilty of scientific misconduct. Standards from 42 CFR 93.104:
A finding of research misconduct made under this part requires that— (a) There be a significant departure from accepted practices of the relevant research community; and (b) The misconduct be committed intentionally, knowingly, or recklessly; and (c) The allegation be proven by a preponderance of the evidence.76
74 Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000, at 5; available at https://ori.hhs.gov/images/ddblock/masm_2000.pdf (last accessed 12/27/15). 75 Ohio State University, "University Policy and Procedures Concerning Research Misconduct", Definitions at III-A, III-E, III-F, p. 5; available at http://orc.osu.edu/files/2011/01/Misconduct_Policy.pdf (last accessed 1/1/16). 76 42 CFR 93: Public Health Service Policies on Research Misconduct, emphasis added.
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Per OSU:
1. A finding of Research Misconduct requires: a. That there be a significant departure from accepted practices of the relevant research community; and b. The misconduct be committed intentionally, knowingly, or recklessly; and c. The allegation be proved by a Preponderance of the Evidence. 2. Research Misconduct does not include honest error or differences of opinion.77
As noted, OSU applies its research misconduct policy and procedures to all research conducted within the institution, regardless of funding source.78
We turn, then, to the question whether an OSU investigation would likely have found the Devor study's authors guilty of scientific misconduct. My answer is yes.
A. FABRICATION
Per the above, the preponderance of the evidence suggests that Smith et al. fabricated their injury data, and that they did so intentionally, knowingly, or recklessly. The only evidence supporting the authors' assertion that nine of the eleven who failed to re-test reported injury and/or overuse is Michael Smith's statement that gym owner Mitch Potterf reported that information to him.
In contrast: *Mr. Potterf denies making any such report, or having any conversation with Smith about who, if anyone, may have been injured;79 *Chelsea Rankin, the study coordinator, had direct contact with participants, and none reported being contacted by Michael Smith or any other authors;80 *per the declarations of Trevor Clark, Mike Wright, Kimberly Potterf, Theresa Clark, Parker Miracle, Michelle Doherty, Katherine Stefaniuk, Theresa Berner, David Ulmer, and Ryan Taylor, none were injured as a result of the CrossFit 10-week program, nor did they tell anyone that they had incurred any such injury;81 *the Devor study authors have produced no data and, indeed, Michael Smith expressly acknowledges that he did not contact subjects directly, and admits that he took no notes during or after his alleged conversation with Mr. Potterf.82
Michael Smith's protestations that he did not know the subjects' identities because of blinding, and that in any case he would not have been allowed to re-contact study subjects himself without
77 Ohio State University, "University Policy and Procedures Concerning Research Misconduct", Definitions at III-A, p. 5, emphasis added; available at http://orc.osu.edu/files/2011/01/Misconduct_Policy.pdf (last accessed 1/1/16). 78 "This Policy shall therefore apply to all research and scholarship conducted within the University community, irrespective of the funding source, if any, which supports the research or scholarship." Ohio State University, OSU: University Policy and Procedures Concerning Research Misconduct, at 1; available at http://orc.osu.edu/files/2011/01/Misconduct_Policy.pdf (last accessed 1/3/16). 79 Mitchell Potterf deposition, at 101 ff, 118. 80 Russell Berger, NSCA 'CrossFit Study' Fraud?, The CrossFit Journal May 2013, at 3; Keith Cinea deposition, 7/16/15, at 432, 436-37. 81 Declaration of Paul A. Serritella in support of Plaintiff's motion for partial summary judgment on the element of falsity. 82 Michael Smith deposition, at 72, 162, 205.
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express prior approval in the consent form,83 are disingenuous at best. In the first place, he could in fact have arranged to contact most if not all of the study subjects.84 Second, if indeed he had no opportunity to gather data on injuries, then he had no scientific right to enumerate them in the article.
In sum, the preponderance of the evidence strongly supports a conclusion that the Devor article's statement that nine subjects "cit[ed] overuse or injury for failing to complete the program and finish follow up [sic] testing"85 is false. The next question is whether this false statement was made intentionally, knowingly or recklessly (by the standard, preponderance of the evidence). The answer, I submit, is quite clearly yes.
To discern the Devor authors' relevant state of mind, we must look to the context of the statement enumerating injuries. If, in an ordinary conversation, I say "these two frogs walk into a bar and sit on the bar stool. The first frog says to the bartender . . . " no one will leap to his feet and shout "you liar!!" The context makes it obvious that no claim of literal truth is being made. At the other end of the spectrum, statements made in a peer-reviewed, avowedly scientific journal invite not merely the expectation that someone is proffering true statements, but additionally that the writer possesses systematic empirical evidence to back up the truth of those statements. If the evidence is not the product of direct observation, then the scientist is obligated to disclose the methodology behind the indirect observations that purportedly underlie the statement's truth.86
Smith claims to be a scientist.87 As such, he is presumed to know that an empirical claim, such as "nine people reported being injured" must be backed up, not just by vague hearsay, but by
83 Michael Smith deposition, at 101. 84 Although IRB issues will be discussed further just below, this particular question can be addressed here. On one hand, Smith is quite right that if an investigator wishes to re-contact subjects at a later date, and the subjects have not consented in advance to being re-contacted, an IRB might frown. However, there is a ready remedy for this. Assuming there exists a legitimate need to re-contact, then someone who is already in communication with the research subjects anyway can ask each person if s/he is willing to be re- contacted. Thus, for instance, in a medical study the primary care physician who sees the patient for routine care, and who perhaps initially referred the patient to the investigator/research study (e.g., testing a new medication) could simply ask the patient if s/he is willing to be called again by the investigator. In the instant case, the obvious route would have been to ask Chelsea Rankin, who had all the information linking study subjects with their respective 'blinding' numbers, to contact participants and ask whether they would be willing to discuss injuries with Smith. 85 Michael M Smith, Allan J Sommer, Brooke E Starkoff, Steven T. Devor, Crossfit-based high intensity power training improves maximal aerobic fitness and body composition, J Strength and Conditioning Research 2013; 27: 3159-72, at 3168. 86 See, e.g., The Science Council defines "science" as " Science is the pursuit and application of knowledge and understanding of the natural and social world following a systematic methodology based on evidence," and describes scientific methodology as including: • Objective observation: Measurement and data (possibly although not necessarily using mathematics as a tool) • Evidence • Experiment and/or observation as benchmarks for testing hypotheses • Induction: reasoning to establish general rules or conclusions drawn from facts or examples • Repetition • Critical analysis • Verification and testing: critical exposure to scrutiny, peer review and assessment. Science Council, What is Science? available at http://www.sciencecouncil.org/definition (last accessed 1/2/16). 87 Michael Smith deposition at 275.
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observational data. And he is expected to know that such data must be duly recorded in appropriate lab notebooks, whether that notebook be a computer document or a sheaf of papers. After all, editors of science journals are entitled (and sometimes obligated) to request that authors produce for their direct examination the data on which a manuscript is based.88
Clearly, Smith et al. knew very well that they had no data to back up their claim89 – hence at minimum they "knowingly" made a statement they could not verify as true. The complete lack of direct observational data, and the reliance on vague putative recollections of what a gym owner may or may not have said, is contrary to science's cornerstone precept that the scientist must not make claims for which he has no evidence. Thus additionally the Devor article's claims regarding injury are arguably "reckless."
Finally, some evidence points toward direct intent. The initial draft of the Devor article said nothing about injuries. Notwithstanding that the first round of editorial communication strongly encouraged the authors to discuss injuries,90 the first revision still said nothing about them. Only after continued pressure from the Editor did the second revision state, in the "Subjects" section: "Of the 11 subjects who dropped out of the training program, two cited time concerns with the remaining nine subjects (16% of total recruited subjects) citing overuse or injury for failing to complete the program and finish follow up testing." As Smith et al. knew full well at the time, they had no documentation whatever to substantiate that empirical claim. As the third round of editorial comments focused still more attention on injuries, Smith told co-authors that, although the editorial comments were "barely literate" and "barely worth replying to," he nevertheless "did incorporate a sentence or two to appease Joan Kraemer, BA, so hopefully that will tie things up."91
Any one of the three states of mind – knowing, reckless or intentional – proven by a preponderance of the evidence, suffices to find the Devor article authors guilty of scientific misconduct, specifically fabrication: proffering a significant empirical claim for which concrete data are nonexistent. Per Per 42 CFR 93.103, fabrication is defined as "making up data or results and recording or reporting them."
88 George Lundberg, Annette Flanagin, New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure. JAMA 1989; 262: 2003-04, at 2004: "The statement of authorship responsibility requires prospective authors to validate their authorship on five levels: . . . (5) to be able to produce the data on which the manuscript is based for examination if requested by the editors." See also Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000. https://ori.hhs.gov/images/ddblock/masm_2000.pdf (accessed December 27, 2015), at 11: "Respondents in several misconduct cases have been unable to produce the data reported in their manuscripts or articles. Some journals require authors to place the data supporting their manuscripts in depositories. Requiring that the data supporting all submitted manuscripts be deposited may not be feasible. However, authors could be explicitly informed that their data may be requested during the review process or if questions arise following publication." 89 Neither Smith nor anyone at OSU had spoken with the nine who did not return. Smith deposition, at 205. See also Smith deposition at 278 ff (acknowledging that he does not know how many were injured, how many were training for CrossFit games, and that all he knows is that data for those nine participants are missing). 90 You also need to caution readers as to the context of your findings due to the fact many people do get injured doing these types of workouts. Typically a lack of general preparation is seen or people do to much to quickly and get hurt so how this was dealt with is of particular importance (see [CHAMP article]). . . . Thus, you and your research team need to really revise your paper with these factors and concerns in mind as you revise your paper." Email of 8/28/12, from editor to Smith. 91 Michael Smith deposition at 242-43.
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B. FALSIFICATION
Per 42 CFR 93.103, "falsification" is "manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record" (emphasis added).
The Devor study is potentially vulnerable to charges of falsification along three lines: [1] falsely stating that the authors secured IRB approval when, in fact, they did not; [2] falsely stating the authors secured participants' informed consent when, in fact, they did not; and [3] falsely stating that the workouts were supervised by ACSM-certified experts when, in fact, they were not. 92
Admittedly, a failure to secure bona fide IRB approval, informed consent, or other protections for human subjects does not, of itself, constitute scientific misconduct. Although the issue is controversial, at present the scope of scientific misconduct, per federal regulations and institutions' corresponding obligations, is still largely limited to fabrication, falsification and plagiarism. However, falsely claiming that one did provide such protections arguably constitutes falsification because it misrepresents the research as comporting with accepted research standards when, in fact, it did not. That, in turn, enabled a paper to be published that, absent IRB approval and correlative human subjects protections, would not have seen the light of day in any reputable scientific journal.
[1] IRB approval Smith et al. stated that "all study methods and protocols were approved in advance by the Institutional Review Board at The Ohio State University"93 At the same time, Smith admits that he did not actually submit an IRB application for the CrossFit study.94 Nevertheless, he claims that the approval and consent form he secured for his dissertation would be valid for this study.95
The claim that an approval for his dissertation would encompass the instant study is incorrect. Perhaps Smith is implicitly claiming that his CrossFit project was exempt from IRB review because it was similar to his dissertation project. However, had Smith consulted OSU's guidance regarding exempt research he would have discerned that "similar to another project the IRB previously approved" does not satisfy any of the criteria for exemption.96 Moreover, the CrossFit project is not similar to the dissertation project in any meaningful sense. The research focus and hypotheses were completely different – one concerned aortic compliance, endothelial function and sympathetic nerve activity for those in high-intensity training, while the other was simply a before/after comparison looking at effectiveness of a particular type of fitness training.
Similarly, although Smith claims that the procedures between the two studies were the same,97 they were not. The dissertation, "Ventriculovascular Coupling in Resistance in Aerobic Athletes .
92 "All training was performed . . . under the supervision of a fellow of the American College of Sports Medicine (ASCM) and an ASCM certified registered clinical exercise physiologist."Devor article, at 3168. 93 Devor article at 3168. 94 Smith deposition at 296. 95 "A consent form was already in place for another study we had been approved for" – his doctoral dissertation, "measuring sympathetic nerve activity and endothelial function in aerobic and resistance athletes." Michael Smith deposition at 42. "All the methods we had used for data collection were approved by the IRB beforehand." Id. at 78. 96 See OSU, Human Research Protection Program Policies and Procedures: Exempt Research; available at http://orrp.osu.edu/files/2011/10/Exempt-Research.pdf (last accessed 1/17/16). 97 Smith deposition at 78, 296.
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. . Neural Sympathetic Nerve Activity and Endothelial Function,"98 used questionnaires, an EKG, a 2-tablespoon blood draw, blood pressure measurement, and microneurography in addition to body fat and VO2 max measurements for 20 participants. The CrossFit study, in contrast, involved 54 people in a 10-week CrossFit program, comparing pre- and post-program body fat and VO2 max. In no sense could the two projects' procedures be deemed "the same."
Smith attempts to rescue his failure by claiming that the two really do count as being the same, since the IRB had already approved doing VO2 max and body composition for the dissertation, and those two procedures, in particular, were the same for both studies. After all, he says, the exercise program wasn't actually part of the Devor study, just the before/after body fat and VO2 max testing.99
This reasoning also fails. IRBs do not review tests on human subjects, independently of the purpose for which those tests are performed. Per 45 CFR 46, IRBs are charged by the federal government with protecting the rights and welfare of human subjects in research. A particular test or evaluation such as VO2 max or body fat composition cannot be evaluated for risk except in the context of the purpose and population for which that test is being used. The correct parlance is "risk-benefit" balance: are the hoped-for benefits of the study worth the risks, given the study's purpose and target population.
For instance, although VO2 max testing likely does not carry the same risk as, e.g., a new chemotherapeutic agent for cancer, nevertheless it is not benign. Per Smith's consent form for his dissertation, the test "involves walking and then running on a treadmill, and the speed and grade will both increase every 3 minutes until you are no longer able to continue."100 The risks from exercise testing "include but are not limited to, pain, fainting, dizziness, fatigue, nausea, shortness of breath, chest pain or angina, swelling, bruising, muscle/bone/joint soreness, joint damage, bone fracture, ligament/tendon/connective tissue damage, hospitalization, and death. It is estimated that the risk of a cardiac event during exercise testing is approximately 6 events per 10,000 exercise tests."101 Thus, it is one thing to ask healthy normal volunteers to undergo this test. It would be another thing entirely to ask people with end-stage heart failure to do so. A competent IRB would never declare that VO2 max testing, or blood draws, or any other test intervention is inherently acceptable without regard to purpose or population.
98 Smith deposition at 298. 99 In Smith's view, the IRB would not need to approve what happened in the gym because the researchers were not providing or programming the exercises. Smith deposition at 297. "We had previously had a protocol which was my doctoral dissertation approved that used all the methodology and protocols that we used for this study.· So it was our understanding that we could use those protocols for other experiments if they arose as long as they were the exact same methods." Smith deposition at 296. Moreover, he had asked Dr. Devor about it and gotten the latter's agreement that no new IRB application need be made. "I recalled that we had both agreed and he had final say that if we -- his understanding was that if we had methodology approved by the IRB, that we could use that in pursuit of other research that doesn't necessarily have the same purpose or objective that was listed in the original IRB. . . . It was my understanding that Dr. Devor had that information firsthand from someone who had tested that or he had tested that himself." Smith deposition at 302. Notwithstanding Smith's testimony, Devor claims not to be knowledgeable about IRB regulations. Devor deposition at 166 ff. 100 Consent form, OSU IRB Protocol number 2011H0124, Study Title, "Ventriculovascular coupling in resistance and aerobic athletes … " at 3-4. 101 Consent form, OSU IRB Protocol number 2011H0124, Study Title, "Ventriculovascular coupling in resistance and aerobic athletes … " at 4-5.
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If Michael Smith and the other graduate students did not know this, it was their faculty supervisor's job to know. Unfortunately, Steven Devor, allegedly supervising the students throughout this study, admits to being uninformed about IRBs and IRB regulations.102
Moreover, evidence indicates that the Devor authors did not in fact consider their study as consisting only of pre- and post-testing. They asserted in the final Devor article that "[a]ll training was performed at a CrossFit affiliate under the supervision of a fellow of the American College of Sports Medicine (ACSM) and an ACSM certified, registered clinical exercise physiologist,"103 referring to Devor as the former and Smith as the latter.104 Additionally, the article's final analysis refers to "deliberate periodization and supervision of our CrossFit-based training program by certified fitness professionals."105 These statements are inconsistent with any suggestion that the ten weeks of CrossFit exercises were not, themselves, part of the study.
We can now consider the question whether an OSU investigation would likely judge the Devor article authors to be guilty of scientific misconduct as they falsely claimed IRB approval. I would argue yes. Per OSU's policy, "'[f]alsification' is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record." 106 The act of misconduct must be committed intentionally, knowingly, or recklessly, as proven by a preponderance of the evidence.
Clearly (and by more than a preponderance of the evidence), the authors' claim of IRB approval was false. And by being made prominently in the article, that claim lent a false note of credibility to the conduct and results of the research. Indeed, a substantial literature has emerged, discussing the question whether research that inadequately protects human subjects should even be published. 107 Although the case for falsification is not as black-letter clear as the case for fabrication, above, there is a significant likelihood that an OSU investigation would conclude that false claim to have assured human subjects protection had pervasively corrupted the entire
102 Devor deposition at 176, 178, 194-196. I might also note, in passing, a significant internal tension in Smith's testimony regarding his own knowledge of IRBs. On one hand, he claims not to know much about IRB regulations. Smith deposition at 162, 297, 302-3. On the other hand he asserts that it would have been inappropriate to re-contact CrossFit study subjects about injuries, since followup contacts were not mentioned in the consent forms. Smith deposition at 281. The latter statement exhibits a rather remarkable level of sophistication regarding IRB regulations. Many people with fairly extensive experience in research and IRBs are unaware of the need to include in the consent form an express permission to re-contact subjects after a study is closed. It is remarkable indeed that someone who claims to have little understanding of IRBs would have such in-depth acquaintance with such a relatively little-known point. 103 Devor article at 3168. 104 Smith deposition at 287. 105 Devor article at 3171, emphasis added. See also Smith deposition at 272 ff. 106 Ohio State University, "University Policy and Procedures Concerning Research Misconduct", Definitions at III-A, III-E, III-F, p. 5; available at http://orc.osu.edu/files/2011/01/Misconduct_Policy.pdf (last accessed 1/1/16).
107 See, e.g., Kristine Moe, Should the Nazi Research Data Be Cited? Hastings Center Report 1984; 14(6): 5-7; Isabel Wilkerson, Nazi Scientists and Ethics of Today, New York Times, May 21, 1989; available at http://www.nytimes.com/1989/05/21/us/nazi-scientists-and-ethics-of-today.html (last accessed 1/18/16); Jonathan Steinberg, The Ethical Use of Unethical Human Research, New York University, Graduate School of Arts and Sciences, Department of Bioethics, ~ 2005; available at http://bioethics.as.nyu.edu/docs/IO/30171/Steinberg.HumanResearch.pdf (last accessed 1/18/16).
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project, rendering the design, data and methodology inherently unreliable.
At that point the only element left to prove would be mental state – that these acts were committed intentionally, knowingly, or recklessly. For the moment let us suppose, arguendo, that Smith/Devor may genuinely have considered their only interventions to be the pre- and post- testing of body composition and VO2 max, and that IRBs are willing to approve such testing regardless of scientific purpose and population. Even if we assume such a belief, an OSU investigation board could well regard that approach, at the least, as reckless. It is a scientist's job to know what the IRB requires and, if there are questions, to ask the IRB. Failure to do so goes beyond mere negligence.
As supervisor of the graduate students undertaking human subjects research, it was Steven Devor's job to be thoroughly familiar with IRB requirements. His employer, The Ohio State University, makes this clear in its Training Requirements documents for human subjects research: "All investigators and key personnel who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects."108 Additionally, "[t]o comply with federal regulations, state laws, and university policies, investigators must be aware when their work requires IRB review or exemption."109 Since it was Devor's job to know these things, the requisite knowledge can properly be imputed to him.110 Hence, an OSU investigation would very likely find that the requisite state of mind existed: even if not intentional or knowing, the misconduct was at least reckless.
[2] Informed consent "All of the subjects provided written informed consent."111
Although the subjects signed a consent form, it was not a consent form expressly written this particular research project. It was for another project entirely. Smith's dissertation involved "Ventriculovascular Coupling in Resistance in Aerobic Athletes . . . Neural Sympathetic Nerve Activity and Endothelial Function,"112 with attention to aortic compliance. It used testing such as questionnaires, an EKG, a 2-tablespoon blood draw, blood pressure measurement, and microneurography in addition to body fat and VO2 max measurements. The focus was on athletes who do high-intensity resistance training, and anticipated enrollment was 20 subjects.
108 OSU, Office of Responsible Research Practices: Ohio State Research; Protecting the rights and welfare of human subjects; Training Requirements; available at http://orrp.osu.edu/irb/training-requirements/ (last accessed March 22, 2016). 109 OSU, Office of Responsible Research Practices: Ohio State Research; Protecting the rights and welfare of human subjects; Chapter 1 – Before You Begin; available at http://orrp.osu.edu/irb/investigator-guidance/before-you-begin/ (last accessed March 22, 2016). See also: OSU, Office of Responsible Research Practices: Ohio State Research; Protecting the rights and welfare of human subjects; Human Subjects; available at http://orrp.osu.edu/irb/ (last accessed March 22, 2016). 110 Smith stated that he had asked Dr. Devor about it and gotten the latter's agreement that no new IRB application need be made. "I recalled that we had both agreed and he had final say that if we -- his understanding was that if we had methodology approved by the IRB, that we could use that in pursuit of other research that doesn't necessarily have the same purpose or objective that was listed in the original IRB. . . . It was my understanding that Dr. Devor had that information firsthand from someone who had tested that or he had tested that himself." Smith deposition at 302. Notwithstanding Smith's testimony, Devor claims not to be knowledgeable about IRB regulations. Devor deposition at 166 ff. 111 Devor article at 3168. 112 Smith deposition at 298.
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The consent form for that study stated all these things in detail. The CrossFit study, in contrast, involved 54 diverse people in a 10-week exercise program, with two sets of body fat and VO2 max measurements. The studies had different hypotheses and different analyses. Surely it must have been odd for participants to read that their chests would be rubbed with sandpaper for an EKG, and that they would receive electrical wires inserted into their legs113 – and then be told, if they actually read the form and asked about these things, that "nah, that won't happen."
The same reasoning above, regarding the Devor authors' false statements about IRB authorization applies here, to their false statements regarding informed consent. Indeed, this was not merely a failure to obtain informed consent. Smith et al. actively deceived the CrossFit participants by securing their signatures on a document describing a thoroughly different research project.
[3] ASCM supervision Per the Devor article, all training sessions were supervised by "a fellow of the American College of Sports Medicine (ACSM) and an ACSM certified, registered clinical exercise physiologist."114 By plain language, the authors stated that, although they did not design the CrossFit regimen, they supervised it throughout.
Facts do not support this claim. Neither Smith nor Devor were present during the training, despite a number of invitations from Mr. Potterf.115 Although Devor claimed to have engaged in supervision, his actual "supervision" was apparently limited to knowing "what was happening," although he does not recall whether he received descriptions of the training before, or after, the workouts actually occurred.116 Finally, Mr. Potterf indicates that no one from OSU provided supervision, or was present at any time, during the workouts of the 10-week challenge.117
"Supervision" of high-intensity exercise – exercise that the JSCR editors themselves deem likely to cause injury – is not likely to be satisfied simply by someone sitting in a distant office, with a vague, perhaps only after-the-fact knowledge of what might be going on. If not, then a claim that human subjects were protected by highly trained, accredited exercise physiologists, while knowing full well that there was no such supervision, would be deemed a false statement, by at least a preponderance of the evidence.
Based on the same line of reasoning articulated above, an OSU investigation would likely find false statements about supervising participants' workouts to be another instance of scientific misconduct via falsification. The authors claimed to protect human subjects in an activity that they claimed caused injury, yet forsook those human beings by failing to provide any such expert supervision. An OSU investigation might very well conclude that this false claim, like the others, corrupted the entire project and enhanced the likelihood that an otherwise-unpublishable manuscript would be published.
In sum, had JSCR referred CrossFit's allegations of scientific misconduct to OSU for a proper inquiry and investigation, the process would likely have found guilt, assuredly via fabrication and quite likely also via falsification. At this point we can better evaluate the process that JSCR actually did use, for following up on an allegation of scientific misconduct.
113 Consent form, OSU IRB Protocol number 2011H0124, Study Title, "Ventriculovascular coupling in resistance and aerobic athletes … " at 2-3. 114 Devor article at 3168. 115 Smith deposition at 289; Potterf deposition at 74-75, 129. 116 Devor deposition at 233. 117 Potterf deposition at 97-98.
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VI. JSCR'S AD HOC PANEL AND "ERRATUM"
The final elements of the COPE pathway are: [10] [BIFURCATION: AUTHOR(S) GUILTY OF FABRICATION V. NOT GUILTY] [11] IF GUILTY: PUBLISH RETRACTION
As discussed above, JSCR and NSCA performed poorly in light of widely accepted standards for addressing allegations of scientific misconduct. Their only identified avenue is the so-called "manuscript clarification" process.118
Manuscript Clarifications will be considered and will be published online if accepted. Not all requests for manuscript clarifications will be published due to costs or content importance. Each will be reviewed by a specific sub-committee of Associate Editors to determine if it merits publication. A written review with needed revisions will be provided if it merits consideration. Clarifications questions are limited to 400 words and should only pose professional questions to the authors and not editorial comments (as of 19.2). If accepted, a copy will be sent to the author of the original article with an invitation to submit answers to the questions in the same manner again with a 400 word limit.119
To use that process here, one must somehow frame an accusation of fraud into 400 words, whereupon editors will decide whether it should be published, for possible response by an author.
Such a process would be misguided in several ways if used for scientific misconduct. Fabrication and falsification are not something to "clarify." They should be exposed. And disciplined appropriately. Additionally, allegations of misconduct must be treated with utmost confidentiality until and unless an adverse decision has been rendered.120 JSCR's Manuscript Clarification process may be well-suited for routine academic discourse in which scholars challenge each other's work and, in the ensuing discussion, stimulate a higher quality of work all around.
The manuscript clarification process was never actually used for the Devor article. Instead, NSCA and JSCR eventually created an ad hoc panel. The panel was not created until after Plaintiff filed for summary judgment, 121 producing declarations from nearly all the study participants. One person had a condition that was exacerbated, but not caused, by the CrossFit workouts; another sustained a weightlifting injury completely outside of the challenge; beyond that, no one reported any injuries whatever.122
NSCA's ad hoc panel123 was composed of two people: Travis Triplett, who had served as senior editor for the Devor article, and Jeff Chandler, editor of NSCA's Strength & Conditioning Journal.124 Their charge was to find out whether or not the reason for participants' not completing
118 Keith Cinea deposition 7/16/15, at 215 ff; Triplett deposition at 149 ff. 119 JSCR Instructions for authors; available at http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed (last accessed 12/31/15). 120 See OSU University Policy and Procedures Concerning Research Misconduct, I-D, at p. 2. 121 Keith Cinea deposition at 304 ff. 122 Declaration of Paul A. Paul Serritella in support of Plaintiff's motion for partial summary judgment on the element of falsity. 123 Keith Cinea deposition at 304 ff. 124 Keith Cinea deposition at 308.
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the post-test was due to injury – a charge given to them by Keith Cinea, NSCA's director of publications.125
This process was deeply flawed from the outset. NSCA's initial error was, of course, its failure to follow the COPE flowchart for pursuing an allegation of scientific misconduct, as discussed in section IV above.
Second, if regarded as the JSCR's one and only process for evaluating whether its published manuscript was defective, the panel was given the wrong charge. To be sure, learning whether participants had been injured was an important preliminary question. However, that question had already been answered by the participants' declarations. Far more important was the challenge to scientific integrity posed by a situation in which authors had made an empirical claim that was clearly false, and disturbingly devoid of data. The focus should have been on whether data had been fabricated, not merely on whether the piece contained factual errors. At best, the panel might have served to implement COPE's first steps – to contact the author and discern whether there was a satisfactory answer.
In this case the authors could not have provided a satisfactory answer, given that their factual claim about injury rates was devoid of data, false. The next step should have been to contact OSU and transfer the matter to their process for allegations of scientific misconduct. As argued above, OSU would at least have found fabrication, and very likely also falsification. Assuming there is no redeeming evidence as yet uncovered, JSCR was left with only one legitimate response.
If appropriate investigation concludes that fabrication, falsification and/or plagiarism have indeed occurred, the appropriate response is retraction. The COPE pathway is clear: "Author is found guilty of fabrication" "Publish retraction."126 Per the ICMJE Recommendations, "if the investigation proves scientific misconduct, publish a retraction of the article.127
125 Keith Cinea deposition at 308. 126 COPE/Committee on Publication Ethics, What to do if you suspect fabricated data (b) Suspected fabricated data in a published manuscript; available at http://publicationethics.org/files/Suspected%20fabricated%20data%20in%20a%20published%20manuscrip t%20(1).pdf (last accessed 1/1/16). 127 ICMJE Recommendations, III-A, at 7. See also OSU's policy: "G. Correction of Erroneous Research. If culpable research misconduct has been found under this Policy and erroneous research has been published, the Respondent shall have an obligation to work with the University and any other scholars or publishers involved to correct the published record and to rectify the situation to the extent possible." OSU: University Policy and Procedures Concerning Research Misconduct, at 16-17. See also Chris Graf, Elizabeth Wager, Alyson Bowman, Suzan Fiack, Diane Scott-Lichter, Andrew Robinson, Best practice guidelines on publication ethics: a publisher's perspective. J Clin Pract 2007; 61 (Suppl 152): 1-26, at 5-6: "Journals should publish ‘retractions’ if work is proven to be fraudulent." (Blackwell Publishing house) See also Michel Atlas, Retraction policies of high-impact biomedical journals. J. Med Libr Assoc 2004; 92: 242-250, at 248-49: To carry out their responsibility to their readers, editors are ethically responsible for ensuring the accuracy and validity of the material they publish. . . . ORI has also suggested that editors include in their Instructions to Authors a policy for handling suspect manuscripts and that, by submitting their manuscripts, authors accept this policy [48]. It is hoped that this will discourage authors from attempting misconduct, because they know that they will be subject to specific action if scientific misconduct concerns are detected. ORI also encouraged editors to incorporate the ICMJE standard for retractions into their policies. ORI believes that editors have the ability to promote research integrity by developing policies, procedures, guidelines, or requirements on
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At this point we can compare what should have happened with what NSCA and the JSCR actually did. NSCA's two-person panel found a discrepancy between the injury rates described in the Devor article versus the information provided by the participants themselves, and concluded that an erratum should be published. Debate surrounded the question how much detail should be provided. A limited description was chosen, purportedly to limit the amount of criticism the journal and authors might receive. 128 Legal counsel also had input, 129 sending an email concerning the erratum to Michael Smith and Steven Devor, as well as to various officials within the NSCA.130
The erratum, not published until October, 2015, states:
In reference to Smith, MM, Sommer, AJ, Starkoff, BE, and Devor, ST. Crossfit-based high intensity power training improves maximal aerobic fitness and body composition. J Strength Cond Res 27(11): 3159 — 3172, 2013, the authors have stated that the reasons for participants not completing follow-up testing, as reported in the article, were provided to the authors by the club owner. The club owner has denied that he provided this information. After the article was published, 10 of the 11 participants who did not complete the study have provided their reasons for not finishing, with only 2 mentioning injury or health conditions that prevented them from completing follow-up testing. In light of this information, injury rate should not be considered a factor in this study. This change does not affect the overall conclusion of the article.131
The erratum as JSCR's response features a number of deficiencies. First, it is merely an erratum, not a complete retraction. The article is corrupted by fabrication (sufficient of itself to warrant retraction) and by falsification (ditto). Accepted standards provide one, and only one, response to scientific misconduct: retraction.
Second, the erratum does not begin to convey the seriousness of the problem. It merely suggests a banal "Mike said/Mitch said" dispute, together with some indication that there is error in the data. Worse, it states that although injury rate should be ignored, "[t]his change does not affect the overall conclusion of the article." This is deeply problematic. The overall conclusion of the article includes an emphatic statement that injury rates are a significant problem. That must not be left intact when there are no data whatever to support it.
Third, evidence suggests that the erratum has not been sufficiently disseminated. When I visited
reporting of suspect manuscripts, handling of suspect manuscripts, coauthor responsibilities, submission of data, review of manuscripts, and submission and publication of corrections and retractions. (emphasis added) 128 Keith Cinea deposition, 10/23/15 at 102 ff. 129 Keith Cinea deposition, 10/23/15 at 80 ff, 95 ff, 102 ff, 108. 130 Keith Cinea deposition, 10/23/15 at 124, 127. 131 See http://ovidsp.tx.ovid.com.ezproxy.uthsc.edu/sp- 3.18.0b/ovidweb.cgi?WebLinkFrameset=1&S=OBPMFPKJPKDDGHNPNCJKMGOBIEFLAA00&return Url=ovidweb.cgi%3f%26TOC%3djb.search.95%257c1%257c50%26FORMAT%3dtoc%26FIELDS%3dT OC%26S%3dOBPMFPKJPKDDGHNPNCJKMGOBIEFLAA00&directlink=http%3a%2f%2fgraphics.tx.o vid.com%2fovftpdfs%2fFPDDNCOBMGNPPK00%2ffs046%2fovft%2flive%2fgv023%2f00124278%2f0 0124278-201510000- 00039.pdf&filename=Erratum.&PDFIdLinkField=%2ffs046%2fovft%2flive%2fgv023%2f00124278%2f0 0124278-201510000-00039&link_from=jb.search.95%7c1&pdf_key=B&pdf_index=jb.search.95&D=ovft (last accessed 1/3/16).
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the JSCR website directly on January 3, 2016, the online table of contents for November 2013 shows nothing amiss where the article is listed. Additionally, the article itself appears to carry no indication that anything is amiss. When I retrieved the Devor article online on January 3, 2016,132 the article itself featured no indication of any problem. Indeed, when I searched the JSCR site using "erratum" as a keyword, I could find only a list of essentially unlabeled errata.133 It was necessary to open each one, to find the erratum in question. I could not find the Devor article erratum by doing a search using "erratum" and "Crossfit" together as keywords.134
This is distinctly out of step with recognized standards. When a retraction is to be made, it should be systematically publicized. Per the ICMJE, retractions
should not simply be a letter to the editor. Rather, they should be prominently labeled, appear on an electronic or numbered print page that is included in an electronic or a print Table of Contents to ensure proper indexing, and include in their heading the title of the original article. Online, the retraction and original article should be linked in both directions and the retracted article should be clearly labeled as retracted in all its forms (Abstract, full text, PDF). . . . The text of the retraction should explain why the article is being retracted and include a complete citation reference to that article. Retracted articles should remain in the public domain and be clearly labeled as retracted.135
A journal's appropriate response does not stop with a suitably disseminated retraction. Again, per ICMJE:
The validity of previous work by the author of a fraudulent paper cannot be assumed. Editors may ask the author’s institution to assure them of the validity of other work published in their journals, or they may retract it. If this is not done, editors may choose to publish an announcement expressing concern that the validity of previously published work is uncertain.136
Accordingly, NCSA and the editors of JSCR still have a duty to notify OSU. OSU has the right, and the obligation, to pursue scientific misconduct allegations for work done within its institutional walls. These authors may have engaged in other forms of misconduct, or Devor may have failed adequately to supervise other graduate students, as apparently occurred in this case. Additionally, as noted above, OSU may also be required to notify the federal government. If the Devor article's project emanated from a project that received federal funding, then the government has a claim to make its own investigation. Although I have no knowledge one way or another, it is at least possible that some of the equipment used by Smith et al. in this study may have been paid for, partly or entirely, with federal funding. It would be up to OSU to explore
132 This was via the Ovid service to which my institution's library (UTHSC) subscribes. 133 See http://ovidsp.tx.ovid.com.ezproxy.uthsc.edu/sp-3.18.0b/ovidweb.cgi (last accessed 1/3/16). 134 See http://ovidsp.tx.ovid.com.ezproxy.uthsc.edu/sp-3.18.0b/ovidweb.cgi (last accessed 1/3/16). It is possible that the search problem may be a function of Ovid rather than the journal's own software. Still, a "crossfit, erratum" search only produced articles relevant to CrossFit and did not produce the erratum in question. 135 ICMJE Recommendations, III-B, at 7-8. Per the U.S. Office of Research Integrity: "Editors are urged to incorporate the standard for retractions suggested by the ICMJE in their policy on corrections and retractions." Office of Research Integrity. Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. January 2000, at 12. https://ori.hhs.gov/images/ddblock/masm_2000.pdf (accessed December 27, 2015) 136 ICMJE Recommendations, III-B, at 8.
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such questions.
JSCR's failure to publish and publicize an appropriate retraction can create significant adverse consequences. Most broadly, the integrity of scientific research everywhere is impugned when a scientific journal refuses to investigate and then remove corrupted work. Public faith in science is tenuous enough; it does not need to be fueled by editors who refuse to fulfill their responsibilities to uphold its integrity. Unfortunately, even as the number of retractions in the scientific literature has risen ten-fold in the past decade, retracted papers continue to be cited as though valid, even after being withdrawn from the literature.137 This raises the unfortunate spectre that a paper thoroughly contaminated by fabrication and falsification can be cited as thought credible – a danger greatly magnified when there is no clear retraction, nor publicizing thereof.
On a more practical level, CrossFit can be harmed if ordinary readers treat fabricated claims about injuries as though true. In a recent litigation, for instance, plaintiff's counsel provided their expert witness with the Devor study, and the witness relied in part on that article to opine that CrossFit is unreasonably dangerous.138
VII. CONCLUSION
In conclusion, NSCA and its scientific journal, JSCR, should be held to the standards applicable to journals of biomedical science, which is what JSCR claims to be. Those standards are widely accepted, including by the U. S. government's Office of Research Integrity. When measured against applicable standards, the editors of JSCR and their NSCA supervisors failed in several ways. They failed to undertake appropriate procedures for manuscript review, mishandling the peer review process at a number of junctures. They failed to follow widely accepted standards for addressing allegations of scientific misconduct. Finally, they failed to issue and publicize retraction as the only appropriate response to scientific misconduct.
April 1, 2016 ______
E. H. Morreim, JD, PhD Date
137 van Noorden R. The trouble with retractions, 478 Nature 26 (October 6, 2011). 138 Jonas Barrish v Sky's Limit Fitness and CrossFit; expert witness report and testimony provided by Thomas Teter, D.C.; Circuit Court of Jackson County, MO, at Kansas City, Case No. 1316-CV14351.
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APPENDIX I: CURRICULUM VITAE
E. Haavi Morreim, JD, PhD March, 2016
ADDRESS: College of Medicine, UTHSC 8343 Stavanger Cove 956 Court, Suite G212 Cordova, TN 38018 Memphis, TN 38163 (901) 755-7479 (901) 448-5725; 901-448-1291 (fax)
EDUCATION: 2009 J.D., magna cum laude; University of Memphis School of Law, Memphis, TN; admitted Tennessee Bar, 2010 admitted Federal Bar, W.D. TN 2012
1980 Ph.D., University of Virginia, Charlottesville, VA; philosophy; AoS: philosophy of law; dissertation: Freedom and Expression
1972 B.A., St. Olaf College, Northfield, MN; philosophy; Phi Beta Kappa
ACADEMIC APPOINTMENTS: 2009- Professor, Department of Internal Medicine, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.
2013 - Adjunct Professor, Cecil C. Humphreys School of Law, University of Memphis, Memphis, Tennessee.
1993- 2009 Professor, Department of Human Values and Ethics, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.
1998- 2006 Professor (joint appointment), Division of Health Services and Policy Research, Department of Preventive Medicine, College of Medicine, University of Tennessee, Memphis.
1988-1993 Associate Professor, Department of Human Values and Ethics, College of Medicine, University of Tennessee, Memphis, Tennessee.
1984-1988 Assistant Professor, Dept of Human Values & Ethics, College of Medicine, University of Tennessee, Memphis
1982-1984 Assistant Professor of Philosophy in Medicine, School of Medicine, University of Virginia, Charlottesville, VA.
1983 Andrew W. Mellon Visiting Assistant Professor of Humanities and (Jan-May) Medicine, Georgetown University School of Medicine, and Senior Visiting Research Scholar, Kennedy Institute of Ethics, Georgetown University; Washington, D.C.
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1980-1982 Medical Philosopher, Program in Human Biology and Society; University of Virginia School of Medicine; Charlottesville, VA.
PROFESSIONAL CREDENTIALS:
Admitted: Tennessee Bar, 2010 Admitted: Federal Bar, W.D. TN, 2012 Listed: Tennessee Supreme Court Rule-31 Mediator: Civil Mediation Family mediation
PROFESSIONAL MEMBERSHIPS:
American Bar Association Vice-Chair, Task Force on ADR and Conflict Resolution in Health Care Health Law Section (2013 - ) Chair, Health Law ADR Committee Dispute Resolution section (2014 - ) American Health Lawyers Association Vice-Chair, ADR Affinity Group (2013 - ) Tennessee Bar Association Memphis Bar Association American Society of Law, Medicine & Ethics Member, Clinical Leadership Council, SharedHealth (2007 - 2011) Member, Board of Directors, Association of Women Attorneys (2010 - 2014) Member, Board of Directors, International Organization of Medical Colleges (2010 - 2014) Chair, Clinical Affairs Section Chair, Independent Patient Advocacy Council, AbioCor Artificial Heart Trials (2001 - 2005) American Society for Bioethics and Humanities (ASBH) Society for Bioethics Consultation; elected, Board of Directors (1993-1996) Society for Health and Human Values; elected, Executive Council (1992-1995) (SBC and SHHV consolidated into ASBH, 1997)
HONORS
Listed: Policy Experts: Guide to Public Policy Experts (Heritage Foundation) (since 2000); Marquis: Who's Who in America; Who's Who of American Women; Who's Who in Medicine and Health Care; Who's Who in the South and Southwest; Who's Who in American Education. Visiting Scholar, University of Texas Medical Branch, Institute for Medical Humanities, 2002 Health Services Research Fellow, UT Center for Health Services Research, inducted 2004 Residents' Special Recognition Award, University of Tennessee Department of Pediatrics, 2001 Raven Society, University of Virginia, 1979 Phi Beta Kappa, 1971 Phi Kappa Phi, 2009 Golden Apple Award for Principles of Clinical Medicine; awarded by M4 class, March 19, 2016
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COMMITTEES:
Dean's Faculty Advisory Committee, College of Medicine; 1994-present Institutional Review Board, University of Tennessee, Memphis; 1989-1999; 2014 - Research Conflict of Interest (Office of the Vice Chancellor for Research); 2016 - Ethics Committee, LeBonheur Children's Medical Center Ethics Committee, Regional Medical Center at Memphis Board of Editors, IRB: Ethics and Human Research, 2000 - Board of Editors, Journal of Law, Medicine & Ethics Board of Editors, Accountability in Research, 2005-2015 Board of Editors, Organizational Ethics: Healthcare, Business, and Policy 2004 - 2008 Board of Editors, Journal of Medicine and Philosophy, 1992-1998 Editorial Advisory Board, Journal of Medicine and Philosophy, 1998-2000 Editorial Advisory Board, Theoretical Medicine, 1987-1997 Editorial Advisory Board, Philosophy & Medicine series, Kluwer, 1990-2000 Institutional Review Board, University of Tennessee, Memphis; 1989-1999; 2014 - Committee on Infection Control, University of Tennessee, Memphis Manuscript reviewer: Journal of the American Medical Association, Annals of Internal Medicine, Annals of Thoracic Surgery, Journal of Law, Medicine & Ethics, Journal of Clinical Ethics, Hastings Center Report, Journal of Health Politics, Policy and Law, Radiology, Harvard University Press, Oxford University Press Policy reviewer, American College of Physicians-ASIM
PUBLICATIONS: Books:
Morreim EH. Holding Health Care Accountable: Law and the New Medical Marketplace. New York: Oxford University Press, 2001.
Morreim EH. Balancing Act: The New Medical Ethics of Medicine's New Economics. Dordrecht: Kluwer Academic Publishers, 1991. Republished in paperback, Georgetown University Press, 1995.
PUBLICATIONS: Chapters of Books:
Morreim EH. Conflict of Interest. Encyclopedia of Bioethics, 4th Edition, Ed. Bruce Jennings. Vol. 2. 4th ed. Farmington Hills, MI: Macmillan Reference USA, 2014. p 676-683. COPYRIGHT 2014 Gale, Cengage; available at http://go.galegroup.com/ps/retrieve.do?sgHitCountType=None&isETOC=true&inPS=true&prodI d=GVRL&userGroupName=compacc9&resultListType=RELATED_DOCUMENT&searchType =BasicSearchForm&contentSegment=9780028662121&docId=GALE|CX3727400153.
Morreim EH. Quality of Life in Healthcare Allocation. Encyclopedia of Bioethics, 4th Edition, Ed. Bruce Jennings. Vol. 4. 4th ed. Farmington Hills, MI: Macmillan Reference USA, 2014. p1824-1827. COPYRIGHT 2014 Gale, Cengage Learning; available at http://go.galegroup.com/ps/retrieve.do?inPS=true&prodId=GVRL&userGroupName=compacc9 &tabID=&searchType=BasicSearchForm&contentSet=GALE&docId=GALE|CX3727400363
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Morreim EH. American Healthcare: Necessary Components of Ethical Reformation; Proceedings, DeVos Medical Ethics Colloquy; 2012: 15-34, 38-66.
Morreim EH. Limits of science and boundaries of access: Alternative health care. In: Medicine and Social Justice: Essays on the Distribution of Health Care. Rhodes R, Silver A, Battin, MA, editors. Oxford University Press, 2012; 413-432.
Morreim EH. Ethical imperatives of medical errors. Nelson WA, Hofmann PB, eds. Managing Healthcare Ethically: An Executive's Guide. Chicago: Health Administration Press, 2010; 165- 168.
Morreim EH. A matter of obligation: Physicians versus clinical investigators. Cherry MJ, Iltis A, eds. Bioethics: Pluralistic Casuistry. Dordrecht: Springer Publishers, 2007; 149-165.
Morreim EH. Ties without tethers: Bioethics-corporate relations in the AbioCor artificial heart trial. Cohn F, Eckenwiler LA, ets. The Ethics of Bioethics: Examining the Moral Landscape. Baltimore: Johns Hopkins University Press, 2007; 181-190.
Morreim EH. Medical errors: Pinning the blame versus blaming the system. In: Accountability: Patient Safety and Policy Reform. Sharpe VA, ed. Washington DC: Georgetown University Press, 2004; 213-232.
Morreim EH. Conflict of interest. In: Encyclopedia of Bioethics, 3rd edition, Stephen G. Post, ed. New York: Macmillan Reference USA; 2004; 503-508
Morreim EH. Quality of life in health care allocation. In: Encyclopedia of Bioethics, 3rd edition, Stephen G. Post, ed. New York: Macmillan Reference USA; 2004; 1394-1397
Morreim EH. Back to the future: from managed care to patient-managed care. In: The Ethics of Managed Care: Professional Integrity and Patient Rights. Bondeson WB, Jones JW, editors. Dordrecht: Kluwer Academic Publishers, 2002; 139-162.
Morreim EH. Alternative health care: limits of science and boundaries of access. In: Health Care and Social Justice. Rhodes R, Silver A, Battin, MA, editors. New York: Oxford University Press, 2002; 319-344.
Morreim EH. Sticks and carrots and baseball bats: economic and other incentives to modify health behavior. In: Managing Health Behavior: Ethical Dilemmas in Health Promotion and Disease Prevention. Daniel Callahan, editor; Georgetown: Georgetown University Press; 2000; 56-75.
Morreim EH. Saving lives, spending money: shepherding the role of technology. In: Ethical Issues in Health Care on the Frontiers of the Twenty-First Century. Wear S, Bono JJ, Logue G, McEvoy A, editors; Philosophy and Medicine Series; Dordrecht: Kluwer Academic Publishers, 2000; 65-112.
Morreim EH. Coverage of emergency services. In: Ethical Challenges in Managed Care: A Casebook. Gervais KG, Priester R, Vawter DE, Otte KK, Solberg MM, eds. Washington, DC: Georgetown University Press, 1999; 36-41.
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Morreim EH. At the intersection of medicine, law, economics, and ethics: the art of intellectual cross-dressing. In: Perspectives on Philosophy in Medicine. Philosophy and Medicine Series, vol. 50; Carson RA, Burns CR, eds. Dordrecht: Kluwer Academic Publishers, 1997; 299-325.
Morreim EH. Medicine's monopoly: from trust-busting to trust. In: Reading Engelhardt, B Minogue, G Palmer-Fernandez, and JE Reagan eds. Dordrecht: Kluwer Academic Publishers, 1997, pp. 45-75.
Morreim EH. Conflicts of interest for physician entrepreneurs. In: Conflicts of Interest in Clinical Practice and Research, edited by David S. Shimm, Roy G. Spece, and Alan Buchanan; London: Oxford University Press, 1996, pp. 251-285.
Morreim EH. Conflict of interest. In: Encyclopedia of Bioethics, 2nd edition, edited by Warren Thomas Reich; New York: Simon & Schuster MacMillan, 1995; Volume 1, 459-465.
Morreim EH. Quality of life in health care allocation. In: Encyclopedia of Bioethics, 2nd edition, edited by Warren Thomas Reich; New York: Simon & Schuster MacMillan, 1995; Volume 3, 1358-1361.
Morreim EH. Ethical issues in scope of practice. In: Proceedings of the Orthodontic Educational Development Symposium, edited by W.E. Roberts, R.A. White, W.C. McGaghie. St. Louis: American Association of Orthodontists, 1994, 104-112.
Morreim EH. Rationing and the law. In: Rationing America's Medical Care: The Oregon Plan and Beyond. M.A. Strosberg, J.M. Wiener, R. Baker, and I.A. Fein, eds. Washington, D.C.: Brookings Institution, 1992, 159-184.
Morreim EH. Competence: At the intersection of law. Medicine and Philosophy. In: Competency: A study of informal competency determinations in primary care. Cutter MAG, Shelp E, eds. Dordrecht: Kluwer Academic Publishers, 1991: 93-125.
Morreim EH. The very low birth weight fetus: Ethical considerations in obstetric management. In: etal Diagnosis and Therapy: Science, Ethics, and Law. Evans M, Fletcher J, Dixler A, Schulman J, eds. Philadelphia: J.B. Lippincott Co, 1989: 233-242.
Morreim EH. Computing the quality of life. In: The price of health: Cost benefit analysis in medicine. Agich G, Begley C. Dordrecht: D. Reidel Pub. Co, 1986: 45-69.
PUBLICATIONS: Journal Articles:
Morreim EH. EMTALA Turns 30: Unconstitutional from Birth. The Health Lawyer 2015; 28(2): 32-42.
Morreim EH. Candor after Adverse Events: Physicians versus the Data Bank. The Hastings Center Report 2015; 45(4): 9-10.
Morreim EH. EMTALA: Medicare's Unconstitutional Condition on Hospitals. The Hastings Constitutional Law Quarterly 2015; 43(1): 61-92.
Morreim EH. Conflict Resolution in the Clinical Setting: A Story Beyond Bioethics Mediation.
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Journal of Law, Medicine & Ethics 2015; 43(4): 843-856.
Morreim EH. Increasing Integration Among Hospitals and Physicians: Increased Need for Conflict Management, and Evolution of the Attorney's Role. ABA Health eSource 2015; 11(9); available at http://www.americanbar.org/publications/aba_health_esource/2014- 2015/may/integration.html.
Morreim EH. Moral Distress and Prospects for Closure. American Journal of Bioethics 2015; 15(1): 38-40.
Morreim EH. Medical Liability and Reporting Malpractice Payments (letter). Journal of the American Medical Association 2015; 313(10): 1058.
Morreim EH. 'Taking' Medical Care from Hospitals. Regulation 2014; 37(4): 46-51.
Morreim EH. Deception for the Patient's Own Good: Of Short-Cuts and Unintended Consequences. Annals of Behavioral Science and Medical Education 2014; 20(2): 35-36.
Morreim EH. Conflict Resolution in Health Care. Connections 2014; 18(1): 28-32.
Morreim EH. By the Numbers: Age-Based Rationing in an HMO. Virtual Mentor. 2014;16:339-347. http://virtualmentor.ama-assn.org/2014/05/ecas2-1405.html .
Morreim EH. In-House Conflict Resolution Processes: Health Lawyers as Problem-Solvers. The Health Lawyer 2014; 25(3): 10-14.
Macklin R, Shepherd L, Dreger A et al. The OHRP and SUPPORT — Another View. (letter) New Engl J Med June 26, 2013 DOI: 10.1056/NEJMc1308015; 368; http://www.nejm.org/doi/full/10.1056/NEJMc1308015
Morreim EH. Dumping the "Anti-Dumping" Law: Why EMTALA is (Largely) Unconstitutional and Why it Matters. University of Minnesota Journal of Law, Science, & Technology 2014; 15(1): 211 - 286.
Morreim EH. Malpractice, Mediation, and Moral Hazard: The Virtues of Dodging the Data Bank. Ohio State Journal on Dispute Resolution 2012; 27(1): 109-178.
Morreim EH. Dodging the Rules, Ruling the Dodgers. American Journal of Bioethics 2012; 12(3): 1-3.
Morreim EH. Mediating Med-Mal Without the Data Bank Reports. American Journal of Mediation; 2011; vol.5: 35-63.
Morreim EH. Moral Hazard: The Pros and Cons of Avoiding Data Bank Reports. Drexel Law Review 2011; 4(1): 265-296.
Morreim EH. Taking a Lesson from the Lawyers: Defining, Addressing Conflicts of Interest. American Journal of Bioethics 2011; 11(1): 33-34.
Morreim EH. The devil in the detail(ing). American Journal of Bioethics 2010; 10(1): 15-17.
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Morreim EH. The dirty little truth: We want them to understand, but not really…. American Journal of Bioethics 2009; 9(2): 9-11.
Morreim EH. High-deductible health plans: Litigation hazards for health insurers. Health Matrix 2008; 18(1): 1-64.
Morreim EH. The sex kitten of bioethics? Research ethics comes of age. (letter) Hastings Center Report 2008; 38(5): 4-5.
Morreim EH. Consumer-defined health plans: Emerging challenges from tort and contract. Journal of Health Law 2006; 39(3): 307-348.
Morreim EH. When research ethics meets business ethics: the AbioCor artificial heart trial. Organizational Ethics: Healthcare, Business, and Policy 2006; 3(1): 40-45.
Morreim EH, Mack MJ, Sade RM. Surgical innovation: Too risky to remain unregulated? Annals of Thoracic Surgery 2006; 82: 1958-1961.
Morreim EH, Webb GE, Gordon HL et al. Innovation in human research protection: The AbioCor artificial heart trial. The American Journal of Bioethics 2006; 6(5): W6-W16.
Morreim EH. High-deductible health plans: New twists on old challenges from tort and contract. Vanderbilt Law Review 2006; 59: 1207-1261.
Morreim EH. End-stage heart disease, high-risk research, and competence to consent: the case of the AbioCor artificial heart. Perspectives in Biology and Medicine 2006; 49(1): 19-34.
Morreim EH. The clinical investigator as fiduciary: Discarding a misguided idea. Journal of Law, Medicine & Ethics 2005; 33(3): 586-598.
Morreim EH. Surgically implanted devices: Ethical challenges in a very different kind of research. Thoracic Surgery Clinics 2005; 15(4): 555-563.
Morreim EH. Civil disobedience: the devil is in the details (letter). Hastings Center Report 2005; 35(4): 4.
Morreim EH. Another kind of end-run: Status upgrades. American Journal of Bioethics 2005; 5(4): 11-12.
Morreim EH. Cardiovascular research and subject advocates. Law and Bioethics Report 2005; 4(3): 4-5.
Morreim EH. Research versus innovation: Real differences. American Journal of Bioethics 2005; 5(1): 42-43.
Morreim EH. Clinical trials litigation: practical realities as seen from the trenches. Accountability in Research 2005; 12(1): 47-64.
Morreim EH. Beyond the lies: Solving the problem. American Journal of Bioethics 2004; 4(4): 61-63.
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Morreim EH. About face: Downplaying the role of the press in facial transplantation research. American Journal of Bioethics; 2004; 4(3): 27-29.
Morreim EH. By any other name: the many iterations of 'patient advocate' in clinical research. IRB: Ethics & Human Research 2004; 26(6): 1-8.
Morreim EH. Litigation in clinical research: Malpractice doctrines versus research realities. Journal of Law, Medicine and Ethics; 2004; 32(3): 474-484.
Morreim EH. High-profile research and the media: the case of the AbioCor artificial heart. Hastings Center Report; 2004: 34(1): 11-24.
Morreim EH. Medical research litigation and malpractice tort doctrines: courts on a learning curve. Houston Journal of Health Law and Policy; 2003; 4(1); 1-86. Excerpts reprinted in: Coleman CH, Dubler NN, Goldner JA, Menikoff JA, eds. The Ethics and Regulation of Research with Human Subjects. Newark: LexisNexis Matthew Bender & Co., Inc.; 2005. Excerpts reprinted in: Coleman CH, Menikoff JA, Goldner JA, Dubler NN, Parasidis E, eds. The Ethics and Regulation of Research with Human Subjects. Newark: LexisNexis Matthew Bender & Co., Inc.; forthcoming 2015.
Morreim EH. Clinical Trials Litigation: Courts in Confusion. Medical Research Law & Policy (BNA) December 17, 2003; 2(24): 908-910
Morreim EH. ERISA Takes a Drubbing: Rush Prudential and its Implications for Health Care. Tort & Insurance Law Journal 2003; 38(3): 933-961.
Morreim EH. A dose of our own medicine: CAM, conventional medicine, and the standards of science. Journal of Law, Medicine & Ethics 2003; 31(2): 222-235.
Morreim EH. Supreme Court rejects preemption in ERISA benefits dispute. Hospital News Letter 2002; 20(1): 1-5.
Morreim EH. Battling for Control of Healthcare Resources. The Independent Review 2002; 7(2): 237-252.
Morreim EH. Defined contribution: from managed care to patient-managed care. Cato Journal 2002; 22(1): 103-120.
Morreim EH. Professionalism and clinical autonomy in the practice of medicine. Mt. Sinai Journal of Medicine 2002; 69(6): 370-77.
Lamm RD, Morreim EH. Health care: A Faustian bargain. Society 2002 (May/June); 39(4): 33- 38.
Morreim EH. Innovation in human research protection: the Independent Patient Advocacy Council. Law and Bioethics Report 2001; 1: 3-5.
Morreim EH. Another ERISA twist: the mysterious case of Pegram and the missing fiduciary. University of Pittsburgh Law Review 2002; 63(2): 235-292.
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Morreim EH. Result-based compensation in health care: a good, but limited, idea. Journal of Law, Medicine & Ethics 2001; 29(2): 174-181.
Morreim EH. The futility of "medical necessity." Regulation 2001; 24(2): 22-26. Reprinted as: Let contracts, not 'necessity,' guide health system. Consumers' Research 2001; 84(12): 18-22
Morreim EH. From the clinics to the courts: the role evidence should play in litigating the standard of care. Journal of Health Politics, Policy and Law 2001; 26(2): 409-427.
Morreim EH. Quality of life: erosions and opportunities under managed care. Journal of Law, Medicine & Ethics 2000; 28: 144-158.
Morreim EH. Confusion in the courts: managed care financial structures and their impact on medical care. Tort & Insurance Law Journal 2000; 35(3): 699-728. reprinted in: Encyclopedia of Health Law & Ethics
Morreim EH. The ethical and legal imperatives of medical errors. Healthcare Executive 2000; 15(4): 56-57. reprinted in: Hofman PB, Nelaon WA, eds. Managing Ethically: An Executive's Guide. Chicago: Health Administration Press, 2001; 141-144.
Morreim EH. Playing doctor: corporate medical practice and medical malpractice. Michigan Journal of Law Reform 1999; 32(4): 939-1040. reprinted in: Shepherd L, Dolgin J. Bioethics and the Law. Cambridge: Aspen Publishers, 2005.
Morreim EH. Beyond the fee-for-service/managed care dichotomy (review of: Wong K. Medicine and the Marketplace). Medical Humanities Review, 2000; 14(1): 42-48.
Morreim EH. Ethical issues in care management: case studies in moral problem-solving. Geriatric Care Management Journal 1999; 9(4): 8-15.
Morreim EH. Assessing quality of care: new twists from managed care. Journal of Clinical Ethics 1999; 10(2): 88-99.
Morreim EH. Bioethics and the press. Journal of Medicine and Philosophy 1999; 24(2): 103- 107.
Morreim EH. Organizational ethics: physician compensation in managed care (case commentary). Lahey Clinic Medical Ethics Newsletter Winter 1999: p.3.
Morreim EH. Revenue streams and clinical discretion. Journal of the American Geriatrics Society 1998; 46(3): 331-337. reprinted in: DeGrazia D, Mappes TA. Biomedical Ethics, 5th ed. New York: McGraw- Hill, 2001
Morreim EH. Benefits decisions in ERISA plans: diminishing deference to fiduciaries, and an emerging problem for PSOs. Tennessee Law Review 1998; 65(2): 511-553.
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excerpts reprinted in: Alan Lieberson, ed. Healthcare Enterprise Liability (supplement). Charlottesville: Lexis Law Publishers, 1997 (supplement: 1999)
Morreim EH. Medicine meets resource limits: Restructuring the legal standard of care. University of Pittsburgh Law Review 1997; 59(1): 1-95.
Morreim EH. The semantics and concepts underlying physician-assisted dying (symposium panel). Cornell Journal of Law and Public Policy. Winter, 1998; 7(2): 294-326.
Morreim EH. Case study analysis on gaming payers' reimbursement rules. In: Mandated use of PA in surgery raises two concerns. Amer Med News 2/23/98, p. 47.
Morreim EH. Bioethics, expertise, and the courts. Journal of Medicine and Philosophy 1997; 22(4): 291-295.
Mirvis DM, Chang C, Morreim EH. Protecting older people while managing their care (editorial); Journal of the American Geriatrics Society 1997; 45(5): 645-646.
Morreim EH. Managed care, ethics, and academic health centers: Maximizing potential, minimizing drawbacks. Academic Medicine 1997; 72(5): pp. 332-340.
Morreim EH. To tell the truth: disclosing the incentives and limits of managed care. American Journal of Managed Care 1997; 3(1): 35-43.
Morreim EH. Moral problem-solving in managed care. Journal of the American College of Dentists 1996; 63(4): 43-48.
Morreim EH. Diverse and perverse incentives in managed care; bringing the patient into alignment. Widener Law Symposium Journal 1995; 1(1): 89-139.
Morreim EH. From advocacy to tenacity: finding the limits" (editorial). Journal of the American Geriatrics Society 1995; 43(10): 1170-72.
Morreim EH. Lifestyles of the risky and infamous: from managed care to managed lives. Hastings Center Report 1995; 25(6): 5-12. reprinted in: Brannigan MC, ed. Health Care Ethics: A Text/Anthology. Mountain View, CA: Mayfield Publishing Company, 8/2000. reprinted in: Parks J, Wilke V. Bioethics in a Changing World. Englewood Cliffs: Prentice Hall, 2010: 163-172. to be reprinted in: Parks J, Wilke V. Bioethics in a changing world, 1e by Jennifer A. Parks and Victoria S. Wike. Englewood Cliffs: Prentice Hall, 2012.
Morreim EH. Moral justice and legal justice in managed care: the ascent of contributive justice. Journal of Law, Medicine, and Ethics 1995; 23(3): 247-265. reprinted in: by Patricia Illingworth P, Parmet W, eds. Ethical Healthcare. New York: Prentice Hall, 2006: 338-356. reprinted in: Nelson J, Nelson H, eds. Meaning and Medicine: A Reader in the Philosophy of Health Care. New York: Routledge, 1998. reprinted in: CEMAR, June 1996, 1(4), pp. 20-24 (part I); CEMAR, September 1996 1(5), pp. 16-29 (Spanish trans. title: Justicia Moral y Justicia Legal en los Sistemas 'Managed Care'. El crecimiento de la Justicia Contributiva.)
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Morreim EH. Futilitarianism, exoticare, and coerced altruism: the ADA meets its limits. Seton Hall Law Review 1995; 25(3): 101-149. reprinted in: Robinson JH, Berry RM, McDonnell K. A Health Law Reader: A Interdisciplinary Reader. Durham: Carolina Academic Press, 1999; 200-214.
Morreim EH. The ethics of incentives in managed care. Trends in Health Care, Law and Ethics 1995; 10(1-2): 56-62. reprinted in Glaser JW, Hamel RP, eds. Three Realms of Managed Care. Kansas City: Sheed & Ward, 1997, pp. 125-133. reprinted in Rosenthal M, Heirich M. Health Policy: Understanding Our Choices from National Reform to Market Force. Boulder: Westview Press, 1998, 289-300.
Morreim EH. Relentless medicine on demand: the wide berth of Baby K. Northwest Ethics Center for Veterans' Health Care (newsletter) April, 1995: 4-5, 9.
Morreim EH. Ethical issues in managed care: economic roots, economic resolutions. Managed Care Medicine 1994; 1(6): 39-43, 52-55.
Morreim EH. Of rescue and responsibility: learning to live with limits. Journal of Medicine and Philosophy 1994; 19(5): 455-470.
Morreim EH. Redefining quality by reassigning responsibility"; American Journal of Law and Medicine 1994; 20(1-2): 79-104.
Morreim EH, Schaffner K. Introduction: Oregon and the limits of health care. Journal of Medicine and Philosophy 1994; 19(4): 301-303.
Morreim EH. Impairments and impediments in patients' decision making: reframing the competence question"; The Journal of Clinical Ethics 1993; 4(4): 294-307.
Morreim EH. Profoundly diminished life: the casualties of coercion. Hastings Center Report 1994; 24(1): 33-42.
Morreim EH. Blessed be the tie that binds? Antitrust perils of physician investment and self- referral. Journal of Legal Medicine 1993; 14(3): 359-412.
Morreim EH. Am I my brother's warden? Responding to the unethical or incompetent colleague. Hastings Center Report 1993; 23 (3): 19-27. reprinted in: Weinberg M, ed. Medical Ethics. Amherst: Prometheus Books, 2000.
Morreim EH. Unholy alliances: physician investment for self-referral”; Radiology 1993; 186(1): 67-72.
Morreim EH. What to do about self-referral prohibition: a rejection that is long overdue. Radiology 1993; 186(1): 79-82.
Morreim EH. Self-referral: The need for a comprehensive regulatory approach: reply" (letter); Radiology 1993; 188: 28-30.
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Morreim EH. Let patients decide where to take their business. Wall Street Journal, December 9, 1992, p. A-24.
Morreim EH. The impossibility and the necessity of quality of life research. Bioethics 1992; 6(3): 218-232.
Morreim EH. Whodunit? Causal liability of utilization review for physicians' decisions, patients' outcomes. Law, Medicine and Health Care 1992; 20(1): 40-56.
Morreim EH. Medical ethics and the future of quality of life research. Progress in Cardiovascular Nursing 1992; 7(1): 12-17.
Morreim EH. Access without excess. Journal of Medicine and Philosophy 1992; 17(1): 1-6.
Morreim EH. Book review of: Bole TJ, Bondeson WB, eds. Rights to health care. Ethics 1992; 103(2): 424.
Morreim EH. Economic disclosure and economic advocacy: New duties in the medical standard of care. The Journal of Legal Medicine 1991; 12(3): 275-329.
Morreim EH. Patient-funded research: Paying the piper or protecting the patient? IRB: A Review of Human Subjects Research 1991; 13(3): 1-5.
Morreim EH. Gaming the system: Dodging the rules, ruling the dodgers. Archives of Internal Medicine 1991; 151(3): 443-447.
Morreim EH. Will beneficence produce economic prudence?; book review of Marsh FH, Yarborough M, eds. In: Medicine and Money: A Study of the Role of Beneficence in Health Care Cost Containment. Medical Humanities Review 1991; 5(2): 77-81.
Morreim EH. Physician investment and self-referral: Philosophical analysis of a contentious debate. The Journal of Medicine and Philosophy 1990; 15(4): 425-448.
Morreim EH. The doctor and I: Old roles and new realities. The World and I. 1990; 5(8): 496513.
Morreim EH. Physicians' obligations to patients: Challenges from medicine's changing economics. Biolaw 1989; 1: R:69-R:82.
Morreim EH. The law of nature and the law of the land: Of horses, zebras, and unicorns. The Pharos 1990; 53(2): 2-6.
Morreim EH. The new economics of medicine: special challenges for psychiatry. The Journal of Medicine and Philosophy 1990; 15(1): 97-119.
Morreim EH. Conflicts of interest, continued (letter). Journal of the American Medical Association 1990; 263(9): 1199-1200.
Morreim EH. Stratified scarcity: Redefining the standard of care. Law, Medicine and Health Care 1989; 17(4): 356-367.
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Morreim EH. Conflicts of interest: Profits and problems in physician referral. Journal of the American Medical Association 1989; 262(3): 390-394.
Morreim EH. Insurance rules and the temptation to cheat. Journal of Insurance Medicine 1989; 21(2): 106-108.
Morreim EH. Fiscal scarcity and the inevitability of bedside budget balancing. Archives of Internal Medicine 1989; 149(5): 1012-1015. reprinted in: Ethical Issues in Modern Medicine, 4th edition; JD Arras and B Steinbock, eds. Mountain VIew: Mayfield Publishing Company, 1995, pp. 119-125. reprinted in: Ethical Issues in Modern Medicine, 5th edition; JD Arras and B Steinbock, eds. Mountain VIew: Mayfield Publishing Company, 1998. reprinted in: Ethical Issues in Modern Medicine, 6th edition; B Steinbock, JD Arras, and, AJ London, eds. Boston: McGraw-Hill, 2003; 132-137.
Morreim EH. Cost containment and strains of commitment (letter). Hastings Center Report 1989; 19(5): 47-48.
Morreim EH. Cost containment: Challenging fidelity and justice. Hastings Center Report 1988; 18(6): 20-25.
Morreim EH. The concept of harm reconceived: A different look at wrongful life. Law and Philosophy 1988; 7(1): 3-33.
Morreim EH. Cost containment and the standard of medical care. California Law Review 1987; 75(5): 1719-63.
Morreim EH. Malpractice implications of cost containment. Clinical Report on Aging 1988; 2(2): 1-5.
Morreim EH. A moral examination of medical advertising. Business and Society Review 1988; 64; 4-6.
Morreim EH. Cost constraints as a malpractice defense. Hastings Center Report 1988; 18(1): 5- 10.
Morreim EH. Cost constraints and emergency treatment (letter). Hastings Center Report 1988, 18(5): 51.
Morreim EH. More on clinicians cutting costs (letter). Hastings Center Report 1988; 18(2): 43-4.
Morreim EH. Physicians face new ethical binds. The Wall Street Journal 1987 Sept 24 : 20 (col. 3). Reprinted in: Tennessee Medical Alumnus, Summer, 1988, pp. 9-11.
Morreim EH. Clinicians or committees--Who should cut costs? (letter). Hastings Center Report 1987; 17(2): 45.
Morreim EH. Stratified scarcity and unfair liability. Case Western Reserve Law Review 1986- 86; 36(4): 1033-57.
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Morreim EH. Philosophy lessons from the clinical setting: seven sayings that used to annoy me. Theoretical Medicine 1986; 7(1): 47-63.
Ethical challenges: the DRG crunch (prepared interview). Orthopedic Surgeons' Legal Letter 1986; 9(5): 3-11.
Morreim EH. Cost-containment: Issues of moral conflict and of justice for physicians. Theoretical Medicine 1985; 6(3): 257-279.
Morreim EH. The MD and the DRG. Hastings Center Report 1985; 15(3): 30-38.
Morreim EH. Who shall live? We must choose. Touchstone 1985; 2(1): 8-9. Reprinted in: Kettering Review, Summer, 1985, pp. 56-60. Reprinted also in: Biomedical Ethics: Opposing Viewpoints, Julie Bach, ed.; St. Paul: Greenhaven Press, 1986, pp. 183-188.
Morreim EH. Three concepts of patient competence. Theoretical Medicine 1983; 4(3): 231-251.
Morreim EH. Conception and the concept of harm. Journal of Medicine and Philosophy 1983; 8(2): 137-157.
Morreim EH. The philosopher in the clinical setting. The Pharos 1983; 46(1): 2-6.
Book Review of: Gorovitz S. Doctors' Dilemmas and Veatch R, Levine C, eds. Cases in Bioethics. The New England Journal of Medicine 1982; 307(25); 1588-1589.
The patient's right to privacy (prepared interview). Nursing Life 1982; 2(3): 34-38. Reprinted in Nursing '89 1989; 19(1): 67-69.
PUBLICATIONS: Executive Editorship, Journal Issues:
Morreim EH. Bioethics and the Press. Journal of Medicine and Philosophy 1999; 24(2).
Bioethics and the Courts; editor; Journal of Medicine and Philosophy 1997; 22(4).
Ethical Issues in Managed Care; co-editor, with Michael Henderson; Managed Care Medicine 1(6), November/December, 1994.
Oregon: The Limits of Health Care; co-editor, with Ken Schaffner; Journal of Medicine and Philosophy 19(5), 1994.
Ethics and Alternative Health Care Systems; editor; The Journal of Medicine and Philosophy 17(1), February, 1992.
INVITED LECTURES:
"Success Stories in Mediation"; panelist; Emerging Issues in Healthcare; sponsored by American Bar Association, Health Law Section; San Diego, California; March, 2016.
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"End-of-Life Care: New Strategies for Working with Families Who Aren’t Ready to Let a Terminal Patient Go"; webinar moderator/presenter; American Health Lawyers Association; December, 2015
"Simple Disputes, Complex Sequellae: Resolutions that Work"; full-day workshop/trainer; American University of Beirut Medical Center; Beirut, Lebanon; December 2015.
"To Tell the Truth: How Honesty about Adverse Outcomes Benefits Everyone"; lecture, "Ethics Matters" series; American University of Beirut Medical Center; Beirut, Lebanon; December 2015.
"Disclosing Adverse Outcomes and Errors: Training for Coaches"; full-day workshop/trainer; American University of Beirut Medical Center; Beirut, Lebanon; December 2015.
"Communication and Conflict Resolution: Next Steps"; full-day workshop for administration; International College; Beirut, Lebanon; December 2015.
"Conflict Resolution in the Medical Setting"; lecture; Weil Cornell Medical College; New York, New York; November 2015.
"Toward a Healthy Workplace: The Role of the Organizational Ombuds in the Healthcare Setting"; webinar organizer/moderator; American Bar Association; November 2015.
"Conflict Resolution for the Clinical Setting"; workshop/trainer; American Society of Bioethics and Humanities; Houston, Texas; October 2015.
"Mediation and Conflict Resolution: A Skills Intro"; lecture/workshop; Bioethics Summer Retreat; Tahoe City, Nevada; June, 2015.
"The Growing Need for Conflict Resolution throughout Healthcare"; American Bar Association, Dispute Resolution section's Mid-Atlantic Chapter meeting; Washington, DC; May, 2015.
"Our Shifting Landscape: Routes to a (More) Peaceable Kingdom"; keynote lecture; 25th Annual Kinsman Statewide Conference, "From Health Care to Health"; Portland, Oregon; May, 2015
"Mediating a Difficult Discharge Decision"; panel; American Bar Association Health Law Section, 16th Annual Conference on Emerging Issues in Healthcare Law; March, 2015; Orlando, Florida
"Learning from our Mistakes: A Gift to Patients, Each Other, and Ourselves"; Keynote Lecture; Salim El-Hoss Center for Bioethics and Professionalism Program's 7th Regional Conference, "Medical Malpractice, Errors and Disclosure"; January, 2015; Beirut Lebanon
"Doing Well by Doing Right"; lecture; "Ethics Matters" series; ; January, 2015; Beirut Lebanon
"Conflict Resolution in the School Environment"; workshops and lectre; International College administration and faculty; January, 2015; Beirut Lebanon
"Keeping Track of One's Moral Compass Despite Pressure to Lose it: How a Public University Can Maintain its Integrity"; lecture; Provost's Forum; Sacramento, California; November, 2014
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"Creating a Culture of Excellence and Trustworthiness in Research Universities"; panel presentation; University of California at Davis; Sacramento, California; November, 2014
"Healthcare Employment, Medical Staff & Peer Review"; panel presentation; 2014 Healthcare Dispute Resolution Innovation and Strategy Conference; sponsored by American Arbitration Association; Dallas, Texas; November, 2014.
"Conflict Resolution in the Clinical Setting: Beyond Bioethics Mediation;" keynote lecture; Seventh Annual Pediatric Bioethics Conference; Jacksonville, Florida; November, 2014.
"Conflict Resolution in the Clinical Setting: Beyond Bioethics Mediation;" lecture; ASBH 16th Annual Meeting; San Diego, California; October, 2014.
"Mediation and Arbitration Agreements: New Developments in Health Care"; lecture; Memphis Bar Association, Annual BenchBar Conference; Destin, Florida; May 2014.
"Conflict Engagement in Health Care Settings: Proactive Problem-solving to Avert Divorces, Dis-Integration, and Financial Disasters"; lecture; American Bar Association; Dispute Resolution Section 16th Annual Spring Conference; Miami, Florida; April 2014.
"Deescalating the Drama in Health Care Conflict"; radio broadcast; Texas Conflict Coach Blog Talk Radio Program; February 11, 2014.
"Conflict Resolution and Bioethics Mediation for Health Care Professionals"; 3-day intensive training; University of Arkansas for Medical Sciences; Little Rock, Arkansas; January, 2014.
"Health Care Mediation & Conflict Resolution"; lecture; Tennessee Association of Professional Mediators; Nashville, Tennessee; September, 2013.
"Dispute Resolution in Healthcare Webinar Forum, Part I: Keeping Healthcare Disputes out of Court and the Public Eye"; panelist, webinar; American Health Lawyers Association; September 12, 2013.
"Incidental Findings in the Clinic"; testimony and panel; Presidential Commission for the Study of Bioethical Issues; Washington, D.C.; April 2013.
"Malpractice, Mediation, and Moral Hazard: The Virtues of Dodging the Data Bank"; lecture; Center for Law, Health & Society; Georgia State University College of Law; Atlanta, Georgia; September 2012.
"Medical Malpractice, Mediation and Moral Hazard: The Virtues of Dodging the Data Bank"; poster presentation; ABA Section of Dispute Resolution Spring Conference, sponsored by the American Bar Association; Washington, D.C.; April 2012.
"Gaming the System: Should Doctors Lie to Help their Patients?"; lecture and panel; University of Wisconsin School of Medicine and Public Health; Fourth Annual Bioethics Symposium: "Doctors, Politics and Conscience"; Presented by the Office of the Dean and the Department of Medical History and Bioethics; Madison, WI; April, 2012; https://videos.med.wisc.edu/videos/40419.
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"American Healthcare: Necessary Components of Ethical Reformation"; lecture and panel; DeVos Medical Ethics Colloquy; Grand Rapids, MI; March 2012.
"Prescribing Under the Influence: Ethical Implications of Pharmaceutical Marketing"; lecture; Norton Medical Ethics Symposium, sponsored by Norton Healthcare; Louisville, KY; November 2011.
"Using ADR in Nontraditional Legal Arenas"; lecture and panel; Bench, Bar and Boardroom conference sponsored by Memphis Bar Association; Destin, FL; May 2011.
"Reaching Beyond the Sciences for your Expert: How Historians & Other Humanities Experts Can Help Your Case"; lecture and panel; Bench, Bar and Boardroom conference sponsored by Memphis Bar Association; Destin, FL; May 2011.
"Malpractice, Mediation and Moral Hazard: the Virtues of Dodging the Data Bank"; lecture; conference on "Reforming Medical Liability: Global Perspectives," sponsored by the earle Mack School of Law, Drexel University; Philadelphia, Pennsylvania; April, 2011.
"Malpractice, Mediation, and Moral Hazard: The Virtues of Dodging the Data Bank"; John F. Grant, MD lecture in Health Care Ethics; Loyola University Chicago; Chicago, Illinois; March, 2011.
"Gaming the System: Dodging the Rules, Ruling the Dodgers"; sponsored by Healthcare Financial Management Association, Tennessee Chapter; Nashville, Tennessee; February, 2011.
"How Early Dispute Resolution Beats Litigation for Improving Healthcare: Opening the Mediation Door Wider for Physicians"; lecture; Physicians and Physician Organizations Law Institute; sponsored by American Health Lawyers Association; Las Vegas, Nevada; February, 2011.
"Early Mediation Beats Litigation for Improving Healthcare Quality: Opportunities for Hospitals and Physicians to Collaborate"; lecture; Hospitals and Health Systems Law Institute; sponsored by American Health Lawyers Association; Las Vegas, Nevada; February, 2011.
"Connecting ADR with Quality in Health Care"; lecture; conference on Early Dispute Resolution in Health Care, sponsored by ADR Institute; Memphis, Tennessee; October, 2010
"Medical-Legal Partnerships"; lecture-discussion; 22nd Annual Bioethics Summer Retreat Conference; Key West, Florida; June, 2010.
"Gaming the System: Dodging the Rules, Ruling the Dodgers"; lecture; conference on "Hot Topics in Health Care"; sponsored by Healthcare Fraud Working Group, U.S. Department of Justice, Western District of Tennessee; Memphis, TN; November 2009.
"How Far Shall We Go? Medical Care at the End of Life"; lecture; annual meeting, National Elder Law Attorneys Association; Washington, D.C.; April 2009.
"Conflicts of Interest in Cardiovascular Research"; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Birmingham, AL; April 2009.
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"The Patient/Subject Advocate in Cardiovascular Research ; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Dallas, TX; October 2008.
"Informed Consent: Digging Into the Realities"; lecture for Chief Medical Officer Lecture Series; sponsored by Quintiles Corp.; Research Triangle Park NC; July 2008.
"The Patient/Subject Advocate in Cardiovascular Research ; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Tucson, AZ; May 2008.
"Research versus Practice," lecture; Spring 2008 Clinical Research Compliance Symposium, sponsored by Arkansas Children's Hospital Research Institute; Little Rock, Arkansas; February 2008.
"The Patient/Subject Advocate in Cardiovascular Research ; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Dallas, TX; February 2008.
"What Duties of Care and Caring do Researchers Owe Their Subjects", panel lecture; 2007 Annual Human Research Protection Programs conference, sponsored by Public Responsibility in Medicine & Research (PRIM&R); Boston, Massachusetts; December, 2007.
"Caught in the Cross-Hairs: Litigation in Clinical Research"; lecture; conference on "Human Subject Protection: The Long and Winding Road", sponsored by Schulman Associates IRB; Covington, Kentucky; October 2007.
"The Patient/Subject Advocate in Cardiovascular Research ; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; San Diego, California; October 2007.
"The New Medical Ethics of Medicine's New Economics"; lecture; Forum on "The Cost of Health: Physiopathology of a Business"; sponsored by Universidad Javeriana; Bogota, Colombia; August, 2007.
"When Patients Pay: New Opportunities ... for Litigation"; lecture; Grand Rounds, William Beaumont Hospital; Royal Oak, Michigan, and Troy, Michigan; July, 2007.
"Assisting Research Participants in High-Risk, High-Profile Research"; lecture; International Conference on "Public Trust and Research in Humans," sponsored by The Forum for Institutional Review Boards/Research Ethics Boards in Canada and the United State3s (FOCUS); Ottowa, Canada; June, 2007.
"The Patient/Subject Advocate in Cardiovascular Research ; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Seattle, Washington; May 2007.
"Case Studies in Cardiovascular Research"; panel; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; San Francisco, California; February, 2007.
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"Conflicts of Interest in Cardiovascular Research"; lecture; conference on "Social, Ethical and Legal Considerations for Cardiovascular Research", sponsored by project on Cardiovascular Disease Research Ethics [CADRE]; Chicago, Illinois; November, 2006.
"A 'Bubble Boy' and a Heroic Dentist: How Bioethics Met the Media in the 1970s and 1980s"; panel; American Society for Bioethics and Humanities Annual Meeting; Denver, Colorado; October, 2006.
"Consumerism/Cost Pressures/CDHP crisis"; lecture; HRH MCO Roundtable: "Business Trends and the MCO Risk Profile", sponsored by Hilb Rogal & Hobbs; Atlanta, Georgia; July, 2006.
"Conflict of Interest"; lecture; course sponsored by Cardiovascular Disease Research Ethics ("CADRE") Program, funded by National Institutes of Health; Houston, Texas; May, 2006.
"How Consumer-Driven Health Care is Shaping thee Health Care Landscape"; lecture; Law Conference for Health Plans, Insurers, and Providers, sponsored by American Health Lawyers Association and by America's Health Insurance Plans; Amelia Island, Florida; May, 2006.
"The Socioeconomic Ethics of Treating End-Stage Heart Disease"; lecture; annual symposium of the Oregon Chapter of the American College of Cardiology; Portland, Oregon; May, 2006.
"Research Subject Advocacy: A Case Study"; lecture, General Clinical Research Centers national meeting; co-sponsored by Society of Research Subject Advocates; Washington, D.C.; March, 2006.
"Issues in Research Ethics"; guided discussion for Stamford Hospital IRB; sponsored by Stamford Hospital; Stamford, Connecticut; March, 2006.
"'Patient' or 'Subject'? The Ethical Challenge in Clinical Research"; lecture; Research Club, sponsored by Departments of Surgery and Medicine,Stamford Hospital; Stamford, Connecticut; March, 2006.
"Protecing the Patient in Cutting-Edge Research: the AbioCor Artificial Heart Trial"; Nursing Grand Rounds, Stamford Hospital; Stamford, Connecticut; March, 2006.
"Surgical Innovation: Too Dangerous to Remain Unregulated?"; debate and paper presentation; 52nd Annual Meeting, Southern Thoracic Surgical Association; Orlando, Florida; November, 2005.
"On Prozac: Debating the New Technologies of Mind"; Choices and Challenges Series, sponsored by Virginia Tech University; Blacksburg, Virginia; November, 2005.
"Voice of the Customer"; panelist; conference on "Customer Relationship Management for the Bio/Pharmaceutical Industry"; sponsored by Center for Business Intelligence; Princeton, New Jersey; October, 2005.
"HSAs and the Emergence of the Active Patient-Consumer: A Pot Pouri of Potential Pitfalls"; paper presentation; "Law Professor Symposium on Medical Malpractice", sponsored by the Roscoe Pound Institute and Vanderbilt University Law School; Nashville, Tennessee; October, 2005.
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"Research versus Practice"; lecture; conference on "Emerging Issues in Research with Human Subjects", sponsored by National Institute of Environmental Health Sciences; Research Triangle Park, North Carolina; September, 2005.
"How to Mentor Ethical Behavior"; lecture; conference on "Breaking the Barriers of Research: Mentoring and Human Subjects’ Protection," sponsored by University of Arkansas Medical School and Office of Research Compliance; Little Rock, Arkansas; August, 2005.
"The Clinical Investigator as Fiduciary: Discarding a Misguided Idea"; lecture; annual Health Law Teachers conference, sponsored by American Society of Law, Medicine and Ethics; Houston, Texas; June, 2005.
"Ethical Issues in Research with Surgically Implanted Devices"; Charles W. Bodemer Lecture; University of Washington School of Medicine; Seattle, Washington; May, 2005.
"Building a Framework for Maintenance of Licensure"; panel presentation; annual meeting, "Serving the Public: Keeping the Trust," sponsored by Federation of State Medical Boards; Dallas, Texas; May, 2005
"Patient Advocates in High-Risk Studies"; lecture; conference on "Contemporary Issues in Clinical Research," sponsored by Dartmouth-Hitchcock Medical Center; Hanover, New Hampshire; April, 2005.
"Meaningful Informed Consent in End of Life High-Risk Trials--Is it Possible?"; lecture; conference on "Contemporary Issues in Clinical Research," sponsored by Dartmouth-Hitchcock Medical Center; Hanover, New Hampshire; April, 2005.
Visiting Bioethics Scholar, Wake Forest University; lectures on: "Health Savings Accounts: the next (r)evolution in health care financing"; "High-risk research: can dying people be competent to consent?"; "Litigation in clinical research: Malpractice doctrines versus research realities"; "High-profile research and the media: drawing the line between publicity and public information"' "Bonds of loyalty: why the clinical investigator is not, and cannot be, fiduciary to the research subject"; Wake Forest University; Winston-Salem, North Carolina; March, 2005.
"Special Challenges in High-Profile Research"; keynote lecture; conference on "Responsible Research: Competing Interests in Clinical Trials" sponsored by Office of Human Subject Protections, University of Tennessee College of Medicine at Knoxville; Knoxville, Tennessee; February, 2005.
"Special Challenges in High-Profile Research"; keynote lecture; conference on "Responsible Research: Competing Interests in Clinical Trials" sponsored by Office of Human Subject Protections, University of Tennessee College of Medicine at Chattanooga; Chattanooga, Tennessee; February, 2005.
"Privacy and Confidentiality of Information"; Nigel Roberts Lecture in Healthcare Ethics, Preventive Medicine 2005 conference, sponsored by American College of Preventive Medicine and the American College of Medical Quality; Washington, D.C.; February, 2005.
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"Patient Safety: Ethics"; panel lecture; Preventive Medicine 2005 conference, sponsored by American College of Preventive Medicine and the American College of Medical Quality; Washington, D.C.; February, 2005.
"Health Advocates in Research"; workshop lecture; Sarah Lawrence College; Yonkers, New York; January, 2005.
"Influence of Economics on Medical Decisions"; lecture; Medical Ethics Grand Rounds; Texas A&M College of Medicine; College Station, Texas; December, 2004.
"Economics, Ethics, and Medicine"; Medicine and Humanities Consultation; sponsored by Texas A&M College of Medicine; Salado, Texas; December, 2004.
"The Next (R)evolution in Health Care Finances: HSAs"; lecture; Medical Ethics Grand Rounds; Scott and White Medical Center; Temple, Texas; December, 2004.
"Litigation in Clinical Research"; lecture; 2004 Annual IRB Conference, sponsored by Public Responsibility in Medicine & Research (PRIM&R); San Diego, California October, 2004
"Evolving Economics, Ethical and Legal Challenges"; video interview; program series, "Condition Critical: Health Care in the United States"; St. Louis, Missouri; July, 2004
"Law, Health Care, and the Fine Art of Intellectual Cross-Dressing"; commencement address; Masters of Health Law program, Nova Southeastern University; Fort Lauderdale, Florida; July, 2004.
"Devices Ain't Drugs: Protecting Human Subjects in Medical Device Research"; lecture; Annual Bioethics Summer Retreat; Wintergreen, Virginia; June, 2004.
"Litigation in Clinical Trials: Lessons From the Trenches"; lecture; 28th Annual North American Conference and Exhibition, sponsored by Association of Clinical Research Professionals; San Diego, California; May, 2004.
"Investigators' Forum: Legal Challenges in Clinical Research"; lecture; 28th Annual North American Conference and Exhibition, sponsored by Association of Clinical Research Professionals; San Diego, California; May, 2004.
"Tales from the Trenches: Litigation in Clinical Research"; lecture; NorthWest Regional IRB Conference, sponsored by Oregon Health & Science University; Portland, Oregon; May, 2004.
"Artificial Heart Research at the End of Life: Is Anyone Competent to Consent?"; lecture; NorthWest Regional IRB Conference, sponsored by Oregon Health & Science University; Portland, Oregon; May, 2004.
"Who gives consent, patients of others,to participate in high-risk research, such as the AbioCor Artificial Heart?" and "The AbioCor Artificial Heart Project"; lecture; Hermanos Ameijeiras Hospital; Havana, Cuba; April, 2004.
"Anatomy of a Lawsuit: Practical Realities of Clinical Trials Litigation"; lecture; Fourth Annual Medical Research Summit; Baltimore, Maryland; April, 2004.
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"The Role of Patient Advocates in Medical Research"; lecture; Fourth Annual Medical Research Summit; Baltimore, Maryland; April, 2004.
"Protecting the Patient in Cutting-Edge Research: the AbioCor Artificial Heart Trial"; lecture; University of Iowa School of Medicine; sponsored by University of Iowa Human Subjects Office; Iowa City, Iowa; March, 2004.
"The Special Twists of Device Research and Medical Innovation: Lessons from the AbioCor Artificial Heart Trial"; lecture; University of Iowa School of Medicine; sponsored by University of Iowa Human Subjects Office; Iowa City, Iowa; March, 2004.
"Litigation in Clinical Research Trials: Overview and Recommendations"; presentation and testimony; quarterly meeting of Secretary's Advisory Committee on Human Research Protections (SACHRP); Alexandria, Virginia; March, 2004.
"Tennessee Health Care Decisions Act"; testimony for House Judiciary Committee on SB2312; Tennessee State Legislature; Nashville, Tennessee; March, 2004.
"The Futility of Medical Necessity: Ensuring Access by Preserving Affordability"; lecture; Second Annual Policy Orientation Session for the Texas Legislature; sponsored by Texas Public Policy Foundation; Austin, Texas; January, 2004
"Litigation in Clinical Trials"; lecture; conference on Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, sponsored by American Health Lawyers Association; Washington, D.C.; January, 2004
"Patient Advocates in Research: A Case Study from Conception to Litigation and Back"; lecture; Forum on Preventing Liability Risk in Clinical Trials, sponsored by The Center for Business Intelligence; Philadelphia, Pennsylvania; December, 2003
"Practical Lessons for Avoiding/Reducing the Risk of Lawsuits: A Case Study of ABIOMED Litigation"; lecture; 2003 Annual IRB Conference, sponsored by Public Responsibility in Medicine & Research (PRIM&R); Washington, D.C.; December, 2003
"The Research Subject Advocate in High-Risk Clinical Research: Experiences and Insights from the AbioCor Artificial Heart Trial"; lecture; 2003 Annual IRB Conference, sponsored by Public Responsibility in Medicine & Research (PRIM&R); Washington, D.C.; December, 2003
"Medical Devices: A Different Twist on the Ethics and Law of Research Protections"; endowed lecture; Faegre & Benson Lecture Series on Law, Health & the Life Sciences, sponsored by Universith of Minnesota Consortium on Law and Values in Health, Environment & the Life Sciences; Minneapolis, Minnesota; December, 2003
"Caught in the Crosshairs: Emerging Litigation in Clinical Research"; lecture; Bioethics and Public Policy Seminar Series, sponsored by Institution for Social & Polic Studies y, Yale University; New Haven, Connecticut; November, 2003
"Is Secret Science Good for Your Health? Research Subject Privacy Versus the Public’s Right to Know"; lecture; Bioethics and Public Policy Seminar Series, sponsored by Institution for Social & Polic Studies y, Yale University; New Haven, Connecticut; November, 2003
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"Limiting Support in the Severely Disabled Child"; panel discussion; conference on "Advancing the Frontiers of Pediatric Emergency Care in Tennessee", sponsored by Children's Emergency Care Alliance and American Academy of Pediatrics; Memphis, Tennessee; September, 2003
"Ethics and Research with Human Subjects"; lecture; conference on "Blending Clinical Practice and Research: Forging Partnerships in the Rocky Mountain States to Enhance Drug Addiction Treatment"; sponsored by the National Institute on Drug Abuse (NIDA); Denver, Colorado; September, 2003
"I Don't Know What to Do: Futility, Hope, and the Land Between;" Grand Rounds lecture; Karmanos Cancer Institute; Detroit, Michigan; September, 2003
"Incentives to Improve Quality: Caveats and New Opportunities"; lecture; 27th Annual Health Law Teachers Conference, sponsored by American Society of Law, Medicine & Ethics; Wilmington, Delaware; June, 2003
"Beyond Managed Care: Can We Afford to Care for Our Children?"; lecture; conference on "Current Problems in Pediatric Therapy, XXIX; sponsored by University of Oklahoma College of Medicine; Oklahoma City, Oklahoma; April, 2003
"Protecting Subject Privacy and Managing Media"; lecture; sponsored by 27th Annual North American Conference & Exposition, Association of Clinical Research Professionals; Philadelphia, Pennsylvania; April, 2003
"IPAC: Independent Patient Advocacy Council"; lecture; sponsored by 27th Annual North American Conference & Exposition, Association of Clinical Research Professionals; Philadelphia, Pennsylvania; April, 2003
"Consumer-Defined Benefits"; expert testimony, Texas State Health Care Expenditures Committee; Texas House of Representatives; Austin, Texas; April, 2003
"Big Brother Technologies"; panel discussion; Choices and Challenges Forum, sponsored by Virginia Polytechnic University; Blacksburg, Virginia; March, 2003
"Achieving Informed Consent in Innovative Research Trials"; lecture; IRB Grand Rounds, sponsored by Cedars-Sinai Medical Center; Los Angeles, California; March, 2003
"Litigation Involving Human Subjects in Research"; lecture; Third Annual Medical Research Summit; Washington, D.C.; March, 2003
"Snake Oil or Healing Balm?: Alternative Healthcare Meets Conventional Medicine"; lecture; Jacksonville University; Jacksonville, Florida; February, 2003
"Defined Contribution as an Approach to Consumer Empowerment;" lecture; 2003 Legislator Policy Orientation, sponsored by Texas Public Policy Foundation; Austin, Texas; February, 2003
Visiting Scholar, University of Texas Medical Branch, Institute for Medical Humanities; October and November (two months), 2002.
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"When the Pursuit of New Technologies Drives Research: Special Concerns for IRBs on Novel Therapeutics;" plenary panelist; Annual IRB Conference, "Protecting Human Subjects: What's Best, What Works, What Doesn't?", sponsored by Public Responsib iity in Medicine and Research (PRIM&R); San Diego, California; November, 2002.
"Money, Money, Money! IRB Policies on FInancial Incentives, Including FInder's Fees and Bonus Payments"; workshop presentation; Annual IRB Conference, "Protecting Human Subjects: What's Best, What Works, What Doesn't?", sponsored by Public Responsib iity in Medicine and Research (PRIM&R); San Diego, California; November, 2002.
"The Development of New Technologies: When Is Innovative Therapy Research, Does it Become Medical Practice, and When Do Human Subjects Protections Apply?"; workshop presentation; Annual IRB Conference, "Protecting Human Subjects: What's Best, What Works, What Doesn't?", sponsored by Public Responsib iity in Medicine and Research (PRIM&R); San Diego, California; November, 2002.
"On the Cutting Edge: Ethical Issues in Surgery"; lecture; Fifth Annual Meeting, American Society for Bioethics and Humanities; Baltimore, Maryland; October, 2002.
"Medical Ethics for Healthcare Financial Administrators"; conference, "Strange Bedfellows in Strange Times," sponsored by Texas Association for Health Care FInancial Administration, and Healthcare Financial Management Association Association; Austin, Texas; October, 2002.
"Emerging Litigation Issues in Clinical Research"; lecture, sponsored by Institute for Bioethics, Health Policy and Law, University of Louisville; Louisville, Kentucky; September, 2002.
"Informed Consent to Explantation: the AbioCor Artificial Heart Trial"; lecture and panel discussion; conference on "Medical Implant Information, Performance, and Policies", sponsored by NIH, FDA, and NIST; Gaithersburg, Maryland; September, 2002.
"Health Services Regulation: Controlling Quackery and Other Frauds"; lecture; Ninth Annual Pitts Memorial Lectureship on "Alternative Medical Systems: Here to Stay, but on What Terms?" sponsored by the Medical University of South Carolina; Charleston, South Carolina; September, 2002.
"Innovations in Research Ethics: the AbioCor Artificial Heart Trials"; keynote lecture; conference on "Institutional Review Boards: Fulfilling their Mission or Mission Impossible?" sponsored by the University of Cincinatti and Schulman Associates IRB; Cincinnati, Ohio; September, 2002.
"Defined Contribution: A Major Shift in Health Care's Evolution"; lecture; conference, "Health Care Task Force," sponsored by Texas Conservative Coalition; Austin, Texas; August, 2002
"Innovations in Human Subject Protection: the AbioCor Artificial Heart Trials"; conference on "Protecting Human Subjects: Safety, Welfare, and Privacy," sponsored by OHRP and the Fred Hutchinson Cancer Center; Seattle, Washington; August, 2002.
"Diverging Trends in ERISA and Provider Payment"; lecture; American Health Lawyers Association annual conference; San Francisco, California; July, 2002
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Ethical Issues for Hospital Group Purchasing Organizations; task force, sponsored by Premier, Inc.; Santa Clara, California; June, 2002.
"Emerging Litigation Issues in Clinical Research"; paper; 26th Annual Health Law Teachers Conference, sponsored by American Society of Law, Medicine, & Ethics; Indianapolis, Indiana; June, 2002
"Persistent Challenges and Innovative Solutions to Truthful and Balanced Information for Research Participants"; lecture; Thirteenth Annual Intermountain Medical Ethics Conference, on "Doctoring the Truth: The Challenge of Truth-Telling in Medical Communication"; Salt Lake City, Utah; May, 2002.
"Corporate Ethics in Healthcare: From the Boardroom to the Bedside"; lecture; Darden School of Business, University of Virginia; Charlottesville, VA; April, 2002
"The AbioCor Artificial Heart Trials: At the Frontiers of Research Ethics"; lecture; University of Washington College of Arts and Sciences; Seattle, Washington, February, 2002.
"Creating Your Company's Code of Bioethics: The Why and the How;" lecture; Annual Conference, Business for Social Responsibility; Seattle, Washington; November, 2001.
"Turbulence and Adaptation: Ethics Meets Changing Delivery Structures"; plenary lecture; 2001 Quality Conference, "Health Plan Strategies with Clinical Impact", sponsored by American Association of Health Plans; Chicago, Illinois; October, 2001.
"Medical Necessity Decisionmaking: Future of Preemption and Coverage Implications"; lecture; symposium, "MCO Forum: The Ground is Moving Beneath Us," sponsored by Marsh U.S.A. HealthSpectrum; Chicago, Illinois; July, 2001
"Protecting Peer Review versus Disclosure and Reporting"; lecture; project on "Promoting Patient Safety: An Ethical Basis for Policy Deliberation," sponsored by the Hastings Center; Garrison, New York; July, 2001.
"Ethics in Research: Ideals to Realities"; lecture; forum on "Biotechnology and the Future of Healthcare," sponsored by College of Engineering, Georgia Tech University; Atlanta, Georgia; June, 2001.
"Ethical Issues in Case Management: Studies in Moral Problem-Solving"; 11th Annual Conference and Expo, Case Management Society of America; Nashville, Tennessee; June, 2001.
"Managed Care: Nightmare, Warfare, or Better Care?"; lecture; conference on "The Ethics of Managed Care: Professional Integrity and Patient Rights," sponsored by University of Missouri- Columbia School of Medicine; Kansas City, Missouri; May, 2001.
"The Twisted World of ERISA: The Mysterious Case of Pegram and the Missing Fiduciary"; keynote lecture; Physicians and Physician Organization Law Institute, sponsored by American Health Lawyers Association; Chicago, Illinois; April, 2001.
"Medical Necessity: The Ruse Comes Home to Roost"; lecture; policy forum on "The Politics of Managed Care: Second Opinions, New Options," sponsored by the Cato Institute; Washington, D.C.; April, 2001.
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"Soaring Eagles, Circling Vultures: the Future of Managed Care"; lecture; Biotechnology Ethics and Policy Spring Speaker Series, Georgia Tech University; Atlanta, Georgia; April, 2001.
"How Courts Mangle Managed Care"; lecture; Biotechnology Ethics and Policy Spring Speaker Series, Georgia Tech University; Atlanta, Georgia; April, 2001.
"Medical Errors: Pinning the Blame vs. Blaming the System"; keynote lecture; Speas Colloquium on "Errors and Accountability in Health Care," sponsored by Carolinas Medical Center and Davidson College; Charlotte, North Carolina; March, 2001.
"Healthcare at Risk: Asking and Addressing the Tough Questions"; keynote lecture; 13th Annual National Managed Health Care Congress; Atlanta, Georgia; March, 2001.
"How Does Managed Care Manage Death?"; lecture; 13th Annual National Managed Health Care Congresss; Atlanta, Georgia; March, 2001.
"Promoting Patient Safety: An Ethical Basis for Policy Deliberation"; working group sponsored by Hastings Center; Garrison, New York; February, 2001.
"Prescribing Under the Influence: Gifts to Doctors from Drug Companies, and their Implications for Patient Interests"; lecture; sponsored by the Markkula Center for Applied Ethics; Santa Clara University; Santa Clara, California; February, 2001.
"Confusion in the Courts"; lecture; College of Law; Santa Clara University; Santa Clara, California; February, 2001.
"Reinventing the Human: The Six Million Dollar Body;" panel; 20th Annual Choices and Challenges Forum; Blacksburg, Virginia; November, 2000.
"Professionalism in Medicine"; lecture; conference on "Understanding Professionalism and its Implications for Medical Education;" sponsored by Mount Sinai School of Medicine; New York, New York; November, 2000.
"Should Medical Insurance Coverage Be Dependent Upon a Research Participant's Willingness to Be Randomized?"; lecture; conference on "IRBs: Afloat in a Sea of Change"; sponsored by Public Responsibility in Medicine & Research; San Diego, California; October, 2000.
"Managed Care on Trial: A Moot Court Debate"; annual meeting, American Society of Bioethics and Humanities; Salt Lake City, Utah; October, 2000.
"Confusion in the Courts" ; lecture; conference on Clinical Ethics for Practitioners," sponsored by The Center for Clinital Ethics, Summit Medical Center; Nashville, Tennessee; October, 2000.
"Contributive Justice"; lecture; 12th Annual Medical Ethics Converence, "Ethics, Economics and Justice in Healthcare: Are We Doing the Right Thing?" sponsored by Colorado Springs Osteopathic Fundation; Colorado Springs, Colorado; October, 2000.
"The Ethics of Balancing Cost and Quality: Contract Law, Informed Consent, and RICO"; lecture; American Society of Anesthesiologists, 2000 Annual Meeting; San Franciso, California; October, 2000.
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"The Twisted World of ERISA: Untangling the Quality/Quantity Distinction"; lecture; Tennessee Bar Associaton's 12th Annual Health Law Forum; Nashville, Tennessee; October, 2000.
"Tissue Banking: Market Quirks and Market Solutions"; paper; project on "Ethical Issues in Tissue Banking", sponsored by Musculoskeletal Transplant Foundation et al.; Cleveland, Ohio; October, 2000.
"Ethical Aspects of the Variable Copayment System"; lecture; conference on "Innovations in Health Insurance: Variable Copayment-an Alternative to Risk Contracting", sponsored by the Massachusetts Medical Society; Boston, Massachusetts; September, 2000
"ERISA on the Ropes: Herdrich v. Pegram"; lecture; Twelfth Annual Bioethics Summer Retreat; Monterey, California; June 2000.
"Truth and Consequences: Moving Patients from the Periphery to the Center--a Response"; lecture; conference on "Error in Medicine: A Complex Sorrow", sponsored by University of California, Berkeley; Berkeley, California; May, 2000.
"Organizational Ethics in Healthcare: A Philosophical Perspective"; lecture; Eighth Annual Conference on Medical Ethics and Religion, sponsored by Bayer Learning Center, Duquesne University; Pittsburgh, Pennsylvania; May, 2000.
"Tactics and Politics: Teaching Humanities in the Clinical Setting"; lecture; conference on "The Humanities in Medical Education," sponsored by the University of South Carolina Center for Bioethics; Columbia, South Carolina; April, 2000.
"Alternative Medicine: Passing Fancy or Wave of the Future?" lecture; Second Annual National Undergraduate Bioethics Conference, sponsored by the University of Virginia; Charlottesville, Virginia; March, 2000.
"Ethics: The Delicate Balance Between Public Health and the Individual"; lecture; Prevention 2000, the Seventeenth Annual Meeting of the American College of Preventive Medicine, and the Association of Teachers of Preventive Medicine; Atlanta, Georgia; March, 2000.
"Ethical Issues in Managed Care"; lecture; Symposium on Critical Care and Emergency Medicine, sponsored by University of Tennessee College of Medicine and by University of Arkansas for Medical Sciences; Hot Springs, Arkansas; March, 2000.
"Healthcare Crisis: Who Decides?"; interview; February, 2000; for PBS television documentary, to be aired June 8, 2000.
"Ethical Challenges for OPO Financial Administrators"; lecture, case discussion; Annual Fall Forum, Association of Organ Procurement Organizations; San Antonio, Texas; November, 1999.
"1999 Health Sector Assembly"; delegate; sponsored by AMA, Johnson & Johnson, Pfizer, Amgen, Purdue Pharma; Deer Valley, Utah; October, 1999.
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"Ethics of Managed Care"; lecture; conference on "Ethical Issues in Managed Care: 21st Century Challenges," sponsored by Covenant Health System and Fort Sanders School of Nursing; Knoxville, Tennessee; October, 1999.
"Doctors and Unions"; lecture; conference on "Ethical Issues in Managed Care: 21st Century Challenges," sponsored by Covenant Health System and Fort Sanders School of Nursing; Knoxville, Tennessee; October, 1999.
"Bioethics and the law: ERISA and the Challenges of Managed Care"; lecture; Twenty-First Annual National Association of Women Judges; Conference on "New Faces of Justice"; Miami, Florida; October, 1999.
"Truth or Consequences: Ethical Issues in Emergency Care"; plenary lecture; Emergency Nurses Association Scientific Assembly; Washington DC; October, 1999
"Sticks and Carrots and Baseball Bats: Economic and Other Incentives to Modify Health Behavior"; lecture; annual meeting of Southern California Public Health Association on "Making the Tough Decisions: Ethics in Public Health"; Cerritos, California; September, 1999.
"Quality of Life: Erosions and Opportunities under Managed Care"; lecture; 9th Annual Conference on "Medical Ethics for the 21st Century", sponsored by Michigan State University; East Lansing, Michigan; June, 1999.
"Perspectives on the Regulation of the Practice of Medicine"; lecture; 20th Annual Health Law Teachers Conference, sponsored by the American Society of Law, Medicine, and Ethics; St. Louis, Missouri; June, 1999.
"Managed Care: Directions in the New Millenium"; lecture; conference on "Preparing for the Millenium", TriCare Region Nine conference, sponsored by Naval Postgraduate School; San Diego, California; May, 1999.
"Emerging Issues in Managed Care"; Grand Rounds; Mercy Hospital; Pittsburgh, Pennsylvania; May, 1999.
"Conflicts of Interest"; lecture; conference on "Educating for the Responsible Conduct of Research in the Next Millenium", sponsored by Public Responsibility in Medicine and Research; Bethesda, Maryland; May, 1999.
"Last Chances"; commentator; documentary, broadcast on America's Health Network; Orlando, Florida; May, 1999.
"Ethical Challenges of Managed Care"; lecture; Annual TriCare conference, Central Region; Las Vegas, Nevada; May, 1999
"Ethical Challenges for Financial Administrators: The Cases that Leave You Scratching your Head"; lecture; conference on "R U Making History, or Will U B History?"; Annual Meeting, Texas Association for Healthcare Financial Administration; San Antonio, Texas; April, 1999.
"Managed Care: Cutting Edge or Precipice?"; keynote address; Southern Oregon Review of Medicine conference on "Ethics of Managed Care: Nightmare, Warfare, or Better Care?"; Medford, Oregon; April, 1999.
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"Ask the Family Doctor"; guest appearance on America's Health Network; Orlando, Florida; April, 1999.
"Conflicts of Interest and Medical Professionalism"; panel presentation; conference on "The Ethics of Managed Care," sponsored by University of Arizona Health Sciences Center; Tucson, Arizona; March, 1999.
"Alternative Medicine: What you Don't Know Can Hurt You"; Grand Rounds; Department of Medicine, College of Medicine, University of Tennessee, Chattanooga; Chattanooga, Tennessee; March, 1999.
1998
"Corporations: Playing Doctor?"; lecture; annual meeting, American Society of Bioethics and Humanities; Houston, Texas; November, 1998.
"Sticks and Carrots and Baseball Bats: Economic and Other Incentives to Modify Health Behavior"; lecture; conference on "Health Promotion & Disease Prevention: Ethical and Social Dilemmas," sponsored by the Hastings Center and by Harvard Medical School; Boston, Massachusetts; November, 1998.
"The Ethics of Managing Financial Risk"; lecture; conference on "Ethics and Professionalism in Managed Care", sponsored by National Institutes of Health, and by Center for Ethics in Managed Care, Harvard Medical School; Washington, D.C.; October, 1998.
"Informed Consents and Ethics"; lecture; Bristol-Myers Squibb Oncology Clinical Research Associate/Nurse Conference; Nashville, Tennessee; October, 1998.
"Government Direction of Healthcare Relationships"; lecture; Mechigan Law School Managed Care Symposium, sponsored by the Journal of Law Reform; Ann Arbor, Michigan; October, 1998.
"The Ethics of Structuring Services"; commentary; annual meeting. American Society of Law, Medicine & Ethics; Boston, Massachusetts; October, 1998.
"Can MCOs Play Doctor? New Developments in the Corporate Practice of Medicine"; lecture; conference on "A New National Agenda: Organization Ethics in Health Care," sponsored by School of Medicine and Darden School of Business Administration, University of Virginia; Charlottesville, Virginia; September, 1998.
"Managed Care and Physicians' Loss of Control"; lecture; annual meeting of Colorado Medical Society; Steamboat Springs, Colorado; September, 1998.
"Whodunit? A Case Study in Managed Care"; noon conference lecture; Internal Medicine Department, Cleveland Clinic; Cleveland, Ohio; September, 1998.
"Conflict of Interest and Ethics"; keynote address; conference on "Human Subject Protection: In Search of Excellence", 14th Annual Training Seminar sponsored by Westerin Institutional Review Board; Seattle, Washington; August, 1998.
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"Organizational Issues in Managed Care: Case Study"; lecture; Eighth Annual Conference on Medical Ethics, sponsored by Michigan State University College of Human Medicine; East Lansing, Michigan; June, 1998.
"Conflicts of Interest: Perennial Challenge in Biomedical Research"; lecture; 40th Anniversity Group Meeting, National Surgical Adjuvant Breast and Bowel Project; Washington, DC; June, 1998.
"Assessing Costs and Cost-Effectiveness in Critical Care"; invitational working forum; sponsored by American Thoracic Society; San Diego, California; May, 1998.
"Assessment of Quality in Managed Care: Solving Ethical Problems"; lecture; working conference on "Solving Ethical Problems in Managed Care", sponsored by Sierra Health Foundation; Sacramento, California; May, 1998.
"Provider-Sponsored Organizations: ERISA Iceberg Ahead"; lecture; annual joint meeting, Mesa County Medical Association and Mesa County Bar Association; Grand Junction, Colorado; May, 1998l
"Whatever Happened to John Worthy?: A Case-Study in Managed Care"; lecture; President- Elect's Planning Conference, Colorado Medical Society; Vail, Colorado; May, 1998.
"From Sacred to Profane? The Rise of Alternative Health Care"; keynote address; President- Elect's Planning Conference, Colorado Medical Society; Vail, Colorado; May, 1998.
"Ethics in Managed Care"; lecture; 9th Annual Managed Law Conference on "Forging New Responses to Today's Managed Care", co-sponsored by American Bar Association and by American Association of Health Plans; St. Petersburg, Florida; April, 1998.
"Managed Care: Cutting Edge or Precipice?"; lecture; University of North Carolina, Greensboro series on "Health Care in the U.S.: New Technologies, New Issues"; Greensboro, North Carolina; April, 1998.
"Consumer Rights and Due Process in Health and Disability Plans"; panel presentation; conference on "Enhancing Benefit Protections in the Global Economy while Minimizing Complexities," co-sponsored by American Bar Association and by American Institute of Certified Public Accountants; Lansdowne, Virginia; March, 1998
"The Role of the Academic Investigator in Stroke Clinical Trials--Scientist or Paid Figurehead"; lecture; 23rd International Joint Conference on Stroke and Cerebral Circulation, sponsored by the American Heart Association; Orlando, Florida; February, 1998.
"Case Studies in Managed Care"; lecture; Drake University y School, Mercy College of Health Sciences Nursing School, Mercy Hospital, and the University of Osteopathic Medicine and Health Sciences; Des Moines, Iowa; January, 1998.
"Ethical Issues for Medical Students"; lecture; University of Osteopathic Medicine and Health Sciences; Des Moines, Iowa; January, 1998.
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"The Ethics of Managed Care"; lecture; Fifth Annual Pitts Memorial Lectureship on "Issues in Medical Ethics", sponsored by Medical University of South Carolina; Charleston, South Carolina; January, 1998.
1997
"Sticks and Carrots and Baseball Bats: Economic and Other Incentives to Modify Health Behavior"; lecture; conference on "Health Promotion & Disease Prevention: Ethical and Social Dilemmas," sponsored by the Hastings Center and by Stanford University Center for Biomedical Ethics; Los Angeles, California; and San Francisco, California; December, 1997.
"A Primer on Conflicts of Interest and Commitment for the IRB"; lecture; symposium on "Ethical Research in an Ethical Society: Principles, Practicalities, & Politics," sponsored by Public Responsibility in Medicine and Research; Boston, Massachusetts; December, 1997.
"Ethical Issues in Managed Care"; lecture; 9th Annual Professional Symposium on "Diabetes: What's New, What's Now", sponsored by American Diabetes Association; Chattanooga, Tennessee; November, 1997.
"Quality of Life in Health Care: An Endangered Species?" lecture; sponsored by the Center for Applied and Professional Ethics, University of Tennessee, Knoxville; Knoxville, Tennessee; October, 1997.
"Ethical and Philosophical Perspectives on Health Technologies"; lecture and panel presentation; Seventh Regional Symposium on "Resource Allocation Decision-Making for New and Emerging Health Technologies", sponsored by Canadian Coordinating Office for Health Technology Assessment, and the University of Toronto Joint Center for Bioethics; Halifax, Nova Scotia; October, 1997.
"Physician-Assisted Suicide: the Moral Challenges"; lecture; St. Olaf College, Public Lecture Series; Northfield, Minnesota; September, 1997.
"Ethical Dilemmas in Managed Care"; keynote lecture; Hackensack University Medical Center's Fourth Annual BioMedical Ethics Symposium; Hackensasck, New Jersey; September, 1997.
"Professional Survival of Managed Care"; lecture; quarterly meeting, Central Wyoming Physician Organization; Casper, Wyoming; August, 1997.
"Professional Survival of Managed Care"; Grand Rounds, United Medical Center West; Cheyenne, Wyoming; August, 1997.
"Ethical Issues in Managed Care"; lecture; Annual Meeting, American Bar Association; San Francisco, California; August, 1997.
"Beyond the Obvious: Some Emerging Ethical Issues in Health Care's Ongoing (R)evolution"; lecture; 17th Annual Montgomery Dorsey Sumposium, "Health Care in the 21st Century: What Challenges Lie Ahead?"; Vail, Colorado; July, 1997.
"An Introduction to Moral Problem-Solving in Health Care Ethics"; and "Managed Care and the Business of Medicine: Conflicting Moral Paradigms?"; keynote lectures for Seventh Annual
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Conference on Medical Ethics, sponsored by Michigan State University College of Human Medicine; East Lansing, Michigan; June, 1997.
Task Force; Committee on the Medicare Hospice Benefit and End-of-Life Care, sponsored by National Hospice Organization; Washington, D.C.; May, 1997.
"Balancing Act: The New Medical Ethics of Medicine's New Economics"; lecture and case discussion; annual meeting, Tennessee Society of Pathologists; Knoxville, Tennessee; May, 1997.
"Governance for the New Health Care System"; lecture and case discussion; University Health System, Board of Managers Spring Retreat; San Antonio, Texas; May, 1997.
"Ethics and Managed Care: Are They Incompatible?" and "Justice, Right to Health Care, and Rationing: Hard Choices at the Bedside"; two lectures for course, "Introduction to Medical Ethics and Medical Humanities", sponsored by University of Texas Health Science Center at San Antonio; San Antonio, Texas; April, 1997s.
"Ethical Issues in Health Care: Three of the Major Challenges Facing Medicine"; keynote address; conference on Health Care Horizons, sponsored by Medical College of Ohio; Toledo, Ohio; April, 1997.
"Managed Care: Rapid Changes, Emerging Concepts"; keynote address; conference on "Managed Care: Rapid Changes, Emerging Challenges", sponsored by Garden State Association of Diabetes Educators; Jamesburg, New Jersey; April, 1997.
"Managed Care: Nightmare, Warfare, or Better Care?"; lecture; conference on "New Pathways in Diabetes Care", sponsored by American Diabetes Association, Wisconsin Affiliate, Inc.; Madison, Wisconsin; April, 1997.
"Meaning: the Semantics and Concepts Underlying Physician-Assisted Dying"; panel presentation; conference on "Socially-Assisted Dying: Media, Money & Meaning", sponsored by the Rehabilitation Institute of Chicago; Chicago, Illinois; April, 1997.
"Medicine, Money and Morals in Managed Care"; special presentation; 78th Annual Session, American College of Physicians; Philadelphia, Pennsylvania; March, 1997.
"The Managed Care Odyssy"; keynote address; conference on "2001: A Med-Surg Odyssy", sponsored by Central Baptist Hospital; Lexington, Kentucky; March, 1997.
"Institutional Ethics and JCAHO"; lecture; symposium on "The Changing Health Care Environment: Issues for the Future", sponsored by American Society of Law, Medicine & Ethics, and by Vanderbilt University School of Medicine; Nashville, Tennessee; March, 1997.
"Canaries in the Mines: Ethics, Managed Care, and Psychiatry"; Grand Rounds, Department of Psychiatry, Virginia Commonwealth University; Richmond, Virginia; February, 1997.
"Ethical Dilemmas in Managed Care: A Balancing Act"; lecture; Annual Practice Management Course, "Strategies for Success: How Gastroenterologists Can Thrive in Managed Care Today", sponsored by American College of Gastroenterology; Orlando, Florida; February, 1997.
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"Managing Risks, Managing Care"; lecture; Annual Meeting and Science Innovation Exposition on "Engaging Science, Sustaining Society", sponsored by American Academy for the Advancement of Science; Seattle, Washington; February, 1997.
"The Ethical Side of Healthcare Reform"; lecture; meeting of Healthcare Executives Association of Northeast Ohio; Cleveland, Ohio; February, 1997.
"Coercion, Manipulation, and Incentives"; panel presentation; meeting on "Ethical Issues in Health Promotion and Disease Prevention, sponsored by Hastings Center, California Wellness Center, and the Haas Fund. Palo Alto, California; January, 1997.
"Advocacy, Physician Decision-Making, and the Provider-Patient Relationship"; panel presentation; conference on "Ethics, Professionalism, and the Healthcare Revolution", sponsored by the American Association of Health Plans, and by the Center for Bioethics at the Unvirsity of Pennsylvania; Philadelphia, Pennsylvania; January, 1997.
1996
"Technologic Advances and Economic Retreats: Deciding What to Buy in a Tighter Economy"; lecture; University of Toronto Joint Centre for Bioethics; Toronto, Ontario, Canada; December, 1996.
"Saving Lives, Spending Money: Shepherding the Role of New Technology"; lecture; State University of New York at Buffalo School of Medicine's Sesquicentennial Symposium, "Ethics and Values in Health Care and Medicine on the Frontiers of the Twenty-First Century"; November, 1996; Buffalo, New York
"Ethics of Managed Care"; lecture; conference on "Setting Medical Goals: What Should Our Priorities Be?", sponsored by Colorado Springs Osteopathic Foundation; Colorado Springs, Colorado; October, 1996
"Clinical Ethics Regarding Managed Care"; Grand Rounds; Blount County Memorial Hospital; Knoxville, Tennessee; October, 1996
"Managed Care: Nightmare, Warfare, or Better Care?"; keynote address; conference on "Ethical Issues in Managed Care: Economic Roots, Economic Resolutions", sponsored by Bioethics Resource Group of Charlotte, North Carolina; Charlotte, North Carolina; October, 1996
"From Cost Containment to Chaos: Rewriting the Standard of Care"; lecture; conference on "Examining Errors in Healthcare: Developing a Prevention, Education and Research Agenda"; sponsored by American Medical Association, Joint Commission on Accreditation of Healthcare Organizations, American Association for the Advancement of Science, and Annenberg Center for Health Sciences; Rancho Mirage, California; October, 1996
"Issues in Managed Care and Dentistry"; lecture; for Professional Ethics in Dentistry Network, annual meeting of Society for Health and Human Values/Society for Bioethics Consultation; Cleveland, Ohio; October, 1996
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"Revenue Streams and Clinical Discretion"; paper; conference on "The Ethics of Managed Care", sponsored by the American Geriatrics Society, the Hastings Center, and Robert Wood Johnson Foundation; New York, New York; October, 1996
"Professional Survival of Managed Care"; Grand Rounds, United Medical Center West; Cheyenne, Wyoming; October, 1996
"Voluntariness in the Context of Managed Care"; workshop; conference on Comprehensive Care of the Terminally Ill: A Northern California Consensus Development Conference for Guidelines on Aid In Dying; sponsored by Stanford University Center for Biomedical Ethics; Palo Alto, California; September, 1996
"Ethics in Receivables Management"; lecture; annual meeting of APGAM (American Guild of Patient Account Management), on "Business Office Ethics, Hospital Politics, Disaster Planning, Downsizing, and Customer Services ... A Kaleidoscope of Opportunities for Today's Business Office Manager"; Austin, Texas; September, 1996
"Managed Care and Changing Liability Issues"; Grand Rounds, Southwest Washington Medical Center; Vancouver, Washington, September, 1996
"Managed Care and the Integration of New Technologies", lecture; conference on "The Gods Must Be Crazy: Ethics and Managed Care"; sponsored by Southwest Washington Medical Center, Vancouver, Washington; , September, 1996
"A Discussion of Balancing Act"; lecture; East Carolina University School of Medicine; Greenville, North Carolina; September, 1996
"The Decline and Fall of Managed Care as We Know It: Sooner than You Think"; lecture, Perspectives Series; East Carolina University School of Medicine; Greenville, North Carolina; September, 1996.
"Managed Care: Nightmare, Warfare, or Better Care?"; plenary lecture; 23rd Annual Meeting, on "Unmasking the Potential of Diabetes Educators", sponsored by American Association of Diabetes Educators; New Orleans, Louisiana; August, 1996.
"Assisting Death: Prospects and Pitfalls"; keynote address; Fourth Annual Conference of Bioethics Resource Group, Ltd, "Ethics Committees: Catalysts for Consensus?" Charlotte, North Carolina; August, 1996
"Futilitarianism, Exoticare, and Coerced Altruism: the ADA Meets its Limits"; keynote address; Advanced Bioethics Workshop on "The Americans with Disabilities Act: New Challenges for Institutional Ethics Committees", sponsored by the Center for Ethics and Humanities in the Life Sciences, College of Medicine, Michigan State University; East Lansing, Michigan; June, 1996.
"The New Medical Ethics of Medicine's New Economics"; lecture; 161st Annual Meeting of Tennessee Medical Association, "Medicine On-Line"; Knoxville, Tennessee, April, 1996.
"Academic Medical Centers and Managed Care: Ethical Issues at the New Frontier"; lecture for "Workshop for Faculty and Staff of Family Practice Residencies", sponsored by Family Practice Residency Assistance Program; Kansas City, Missouri; March, 1996.
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"New Technologies: Whose Money Are We Spending?"; lecture; Second Annual Health Ethics Conference on "Healthcare Decisions in a Court of Ethics: Infinite Needs, Finite Resources", sponsored by Kansas Health Ethics, Inc., and Witchita State University; Witchita, Kansas; March, 1996.
"Managed Care: Rapid Changes, Emerging Challenges"; Grand Rounds, Mercy Medical Center; Cedar Rapids, Iowa; March, 1996.
"Managed Care: Rapid Changes, Emerging Challenges"; Grand Rounds, Geisinger Health System; Danville, Pennsylvania; March, 1996.
"Reimbursement for New Technological Advances--Ethical, Legal, and Policy Considerations"; keynote address; Inaugural Fulbright & Jaworski Annual Lectureship, Texas Medical Center; Houston, Texas; March, 1996.
"Ethical Standards in Managed Care"; lecture; 1996 National Leadership Conference, sponsored by the American Medical Association; Washington, D.C.; March, 1996.
"Law vs Medicine vs Ethics"; lecture; Community Forum, sponsored by Charleston Area Medical Center; Charleston, West Virginia; February, 1996.
"Law and Medicine in Changing Economic Times"; Grand Rounds lecture; Department of Medicine, Charleston Area Medical Center; Charleston, West Virginia; February, 1996.
"Legal Accountability of Physicians and Health Plans: Compassionate, Proportionate, or Extortionate?"; paper; symposium on "Ethical Issues in Managed Care", sponsored by Cary M. Maguire Center for Ethics and Public Responsibility, Southern Methodist University; Dallas, Texas; February, 1996.
"Ethical issues in managed care"; workshop, Medical Staff Leadership Retreat, sponsored by Southwest Washington Medical Center; Portland, Oregon; January, 1996.
1995
"Freedom of Speech and the Practice of Medicine"; conference director; colloquium sponsored by Liberty Fund, Inc.; Clearwater Beach, Florida; December, 1995.
"Living Within Our Limits: Diverse and Perverse Incentives for Integration"; keynote address; conference on "Ethical Issues of Integration: Learning from the Allina Experience", sponsored by Allina Foundation, Allina Health System, and Abbott Northwestern Hospital; Minneapolis, Minnesota; November, 1995.
"The New Medical Ethics of Medicine's New Economics"; lecture; Third Annual Pitts Memorial Lectureship, on "Ethical Issues of Managed Care"; Charleston, South Carolina; November, 1995.
"Ethical Issues in Managed Care: National Focus"; keynote address; conference on "Ethical Issues in Managed Care", sponsored by Alliance of Hospital Ethics Committees of Dallas-Fort Worth; Irving, Texas; November, 1995.
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"Managed Care: Issues and the Primary Care Professional"; lecture; conference on "Primary Care Perspectives: State of the Are Breast Cancer Diagnosis & Management for the Primary Care Professional", sponsored by the Virginia Breast Cancer Foundation; Williamsburg, Virginia; November, 1995.
"The Clinician and Bedside Rationing: Clinicians' Roles in Making Decisions at the Bedside Based on Economics"; lecture; conference on "Informed Consent in Clinical Settings", sponsored by Center for Bioethics, University of Pennsylvania Medical Center; Philadelphia, Pennsylvania; November, 1995.
"Managed Care and the Frail Elderly: Overview of Ethical Challenges"; lecture; conference on "Managed Care and the Frail Elderly", sponsored by New York Academy of Medicine; New York, New York; November, 1995.
"Managed Care and Beyond"; lecture; symposium on "Doctor/Patient Relationship in Transition... Who Cares?!", sponsored by Trinity Lutheran Hospital; Kansas City, Missouri; October, 1995.
"Resource Allocation in Managed Care", part two; discussant; Hastings Center project, sponsored by Robert Wood Johnson Foundation; Briarcliff Manor, New York; October, 1995.
"Managed Care: Nightmare, Warfare, or Better Care?"; plenary address; Third Annual Managed Care Best Practices Conference, sponsored by the Prudential Insurance Company of America; Los Angeles, California; October, 1995.
"Medicine's Monopoly: From Trust-Busting to Trust"; plenary lecture; conference on "Ethics, Medicine and Health Care: an Appraisal of the Thought of H. Tristram Engelhardt, Jr."; Youngstown, Ohio; September, 1995.
"Ethics in Integration: the Physician/Patient Relation"; keynote address; 70th annual meeting, on "Transition through Trust," sponsored by Colorado Hospital Association; Vail, Colorado; September, 1995.
"Resource Allocation in Managed Care"; discussant; Hastings Center project, sponsored by Robert Wood Johnson Foundation; Briarcliff Manor, New York; September, 1995.
"Managed Care and Academic Medicine: Are Odd Bedfellows Snuggling Up?"; lecture; East Carolina University School of Medicine; Greenville, North Carolina; September, 1995.
"A Discussion of Balancing Act"; lecture; East Carolina University School of Medicine; Greenville, North Carolina; September, 1995.
"How to Solve Your Own Ethical Dilemmas"; lecture; conference on "Toward a Peaceful Death-- Ethical Issues Across the Life Span", sponsored by Tennessee Nurses Association; Nashville, Tennessee; August, 1995.
"Considering Ethical Issues in Managed Health Care: Benefits and Limits, Paradoxes and Possibilities"; lecture; Group Health Association of America, Forty-Fifth Annual Group Health Institute: "Building on a Legacy of Health Care Leadership"; San Diego, California; June, 1995.
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"Managed Care: Nightmare, Warfare, Or Better Care"; lecture; Eighth Annual Symposium of the West Virginia Network of Ethics Committees, "The Ethics of Managed Care"; Morgantown, West Virginia; June, 1995.
"Managed Care: Last Train Leaving the Station, or Are We on the Wrong Track?"; lecture; 24th Annual Membership Meeting, New York State Society of Internal Medicine; Lenox, Massachusetts, June, 1995.
"Managed Care: Cutting Edge or Precipice?"; lecture; Mercy Medical Center; Cedar Rapids, Iowa; May, 1995.
"Trusteeship in the Managed Care Era"; lecture; board of trustees, ethics committee, Mercy Medical Center; Cedar Rapids, Iowa; May, 1995.
"A Facelift for Marcus Welby: the Physician-Patient Relationship in a Changing Medical Environment"; Jared Haft Goldstein Memorial Lecture; Duke University; Durham, North Carolina; May, 1995.
"Managed Care: Cutting Edge or Precipice?"; lecture; sponsored by Duke University Medical Center; Durham, North Carolina; May, 1995.
"New Issues for Ethics Committees Under Managed Care"; lecture; Duke University Medical Center Hospital Ethics Committee; Durham, North Carolina; May, 1995.
"The Ethics Committee Under Managed Care: Policeman, Ombudsman, or Salesman"; lecture; conference on "Health Care in Transition: the Evolving Role of Ethics Committees", sponsored by Georgia Ethics Committee Consortium; Atlanta, Georgia; May, 1995.
"Ethical Choices, Cost and Quality Outcomes: Can We Have Both?"; keynote address; conference on "Pharmacist's Role in Achieving Quality Outcomes: How Do We Get There From Here?", sponsored by New Jersey Society of Hospital Pharmacists; East Brunswick, New Jersey; April, 1995.
"Bedside Budget Balancing: Permitted? Forbidden? Required?"; keynote address; conference on "Not my Child! Resource Allocation in Individual Case Decision-making," sponsored by Minneapolis Children's Medical Center and St. Paul Children's Hospital; St. Paul, Minnesota; April, 1995.
"Resource Allocation, Public Policy and Futility: A Modest Proposal Arising out of the Baby K Case"; lecture; conference on "Not my Child! Resource Allocation in Individual Case Decision- making," sponsored by Minneapolis Children's Medical Center and St. Paul Children's Hospital; St. Paul, Minnesota; April, 1995.
"Ethical Principles as Practiced in Home Care"; lecture; Annual Spring Conference, Tennessee Association for Home Care; Nashville, Tennessee; April, 1995.
"Ethical Issues in Integrated Delivery, Managed Care"; lecture; annual meeting, Trustee Institute, sponsored by North Carolina Hospital Association; Myrtle Beach, South Carolina; April, 1995.
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"Ethical Treatment and Ethical Training of Students: Two Sides of the Same Coin"; lecture; Southern Regional Meeting, AAMC ( Association of American Medical Colleges), Organization of Student Representatives; Richmond, Virginia; April, 1995.
"Ethical Issues in Managed Care"; lecture; conference on "Managed Care: Its Permutations, Its Quality, Its Ethics, Its Costs, Its Politics," sponsored by University of Michigan Forum on Health Policy; Ann Arbor, Michigan; April, 1995.
"Research in the Managed Care Era and its Moral Dilemmas"; lecture, at 44th Annual Scientific Session, sponsored by the American College of Cardiology; New Orleans, Louisiana; March, 1995.
"Ethics of Healthcare Reform"; lecture; "1995 Workshop for Faculty and Staff of Family Practice Residency Programs", sponsored by Residency Assistance Program; Kansas City, Missouri; March, 1995.
"Managed Care and Geriatrics: Challenges for Practitioners"; lecture; and "Ethics, Economics and Managed Care"; panel; conference on "Advances in Geriatrics VII: Biopsychosocial Aspects of Aging", sponsored by Miami Area Geriatric Education Center; Miami, Florida; March, 1995.
"Diverse and Perverse Incentives in Managed Care, or: Will the Last One Out of the Artesian Well Please Put on the Lid"; paper; conference on "The Doctor and the Patient in the New Health Care Economy," sponsored by Widener University School of Law; Wilmington, Delaware; March, 1995.
"At the Intersection of Medicine, Law, Economics, and Ethics"; paper; William Bennett Bean Sumposium on Philosophy and Medicine, sponsored by Institute for the Medical Humanities, University of Texas Medical Branch at Galveston; Galveston, Texas; February, 1995.
"Ethical Issues for Psychiatry in Managed Care"; lecture; conference on "Psychotherapy in Psychiatry--What Does the Future Hold?", sponsored by American College of Psychiatrists; Acapulco, Mexico; February, 1995.
"Medical Seminar at Sea: Issues in Medical Ethics"; 20-hour continuing medical education course, sponsored by National Osteopathic Foundation; western Caribbean (Norwegian Cruise Lines' M/S Dreamward); January/February, 1995.
"Health Care--Strategic Trends"; grand rounds, Penrose Hospital; Colorado Springs, Colorado; November, 1994.
"Medical Futility: Prescription for Coercion?"; grand rounds, Department of Internal Medicine, University of Colorado School of Medicine; Denver, Colorado; November, 1994.
"Where Medicine and Money are Going in the Next Century"; lecture; annual staff meeting, Memorial Hospital; Colorado Springs, Colorado; November, 1994.
"Futility as Discrimination"; paper; symposium on "Medical Futility", sponsored by Seton Hall School of Law; Newark, New Jersey; November, 1994.
"Balancing Act: Case Management and Employee Rights"; lecture; Hastings Center project on "Emerging Values in Corporate Health Benefits"; Briarcliff Manor, New York; October, 1994.
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"Relentless Medicine and the High Cost of Dying"; lecture; Merit Care Medical Center; Fargo, North Dakota; October, 1994.
"The New Health Care Market: Changing Collegial Relationships Among Physicians"; lecture; Merit Care Medical Center; Fargo, North Dakota; October, 1994.
"Ethics of Managed Care"; lecture; Medical Association of Georgia, Medical Staff Section, conference on "Managed care 94: Practical Strategies for Securing Your Future"; Amelia Island, Georgia; October, 1994.
"Controlling Costs"; lecture; "Appalachian Health Care Reform: Enhancing Quality and Accessibility", sponsored by College of Medicine, East Tennessee State University; Johnson City, Tennessee; October, 1994.
"Who Really Pays the Piper: Payers, Physicians, or Patients?"; lecture; seventh annual Speas Colloquium, sponsored by University of North Carolina, Carolinas Medical Center, and Davidson College; Davidson, North Carolina; October, 1994.
"Power in Bioethics"; paper respondent; annual meeting, Society for Bioethics Consultation; Pittsburgh, Pennsylvania; October, 1994.
"The Effect of Health Care Reform on Patients"; lecture; conference on "Clinical Practice after Health Care Reform: Access and Allocation Issues"; sponsored by Roanoke Memorial Hospitals, Carilion Health System; Roanoke, Virginia; September, 1994.
"Permanently Unconscious Patients: The Need for Medical, Legal, and Public Policies"; panel discussant; symposium sponsored by the Rockefeller Foundation, the Greenwall Foundation, University of Texas System Chancellor's Office, the Park Ridge Center, and the Institute for Medical Humanities; Bellagio, Italy; August, 1994.
"Rationing and Whistleblowing--A Texas Case"; panel presentation; Sixth Annual Bioethics Retreat; Bar Harbor, Maine; June, 1994.
"Managed Care: Nightmare, Warfare, or Better Care?"; lecture; Knoxville Academy of Medicine; Knoxville, Tennessee; June, 1994.
"Medical Ethics and Resource Management: Confronting the Issues in a Changing Health Care Environment"; lecture; 44th Annual Group Health Institute meeting on "Navigating Reform: HMOs and Managed Care in a Time of Transition"; sponsored by Group Health Association of America; Miami, Florida; June, 1994.
"Paths to a Level Playing Field: The Ethics of Health Casre Competition"; lecture; symposium on "The Ethics of Health Care Reform", sponsored by American Association of Bioethics; Washington, D.C.; May, 1994.
"Relentless Medicine on Demand: The Wide Berth of Baby K"; lecture; Portland Veterans Administration Hospital, Portland, Oregon; May, 1994.
"Relentless Medicine on Demand: The Wide Berth of Baby K"; lecture; Veterans Administration Hospital, Seattle, Washington; May, 1994.
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"Ethical Concerns in Scope of Practice"; Orthodontic Educational Development Symposium: "Redefining Orthodontic Education: Predoctoral and Continuing Dental Education", sponsored by American Association of Orthodontists; Orlando, Florida; April, 1994
"Financial Incentives to Limit Care"; audio tape; audio tape series on "Doctors' Resource Service: Ethics in Managed Care", sponsored by American Medical Association; April, 1994.
"Reforming the Malpractice Laws for Entitlement Limited Health Plans"; lecture; Forum on Health Care Rationing: Entitlements, Economics and Health Care Practices"; sponsored by University of Kentucky, Chandler Medical Center; Lexington, Kentucky; April, 1994.
"Quality of Life at the End of Life"; panel presentation; sponsored by Choices and Challenges Series, Virginia Tech University; Blacksburg, Virginia; March, 1994.
"Health System Reform: Threat to Physician/Patient Relationship"; lecture; 1994 National Leadership Conference, sponsored by American Medical Association; San Francisco, California; February, 1994.
"Lifestyles of the Risky and Infamous: Must We Always Rescue the Irresponsible Patient?"; Mesa County Medical Society; Grand Junction, Colorado; February, 1994.
"Scope of Practice: Changing in the Face of Health Reform"; lecture; Visiting Professor in Medicine and Medical Ethics; Center for Medical Ethics, University of Pittsburgh; Pittsburgh, Pennsylvania; December, 1993.
"Lifestyles of the Risky and Infamous: Must the Physician Always Rescue the Irresponsible Patient?" Grand Rounds, Department of Internal Medicine; School of Medicine, University of Pittsburgh; Pittsburgh, Pennsylvania; December, 1993.
"When Families Say 'Everything' and Physicians Say 'Stop'"; Lecture, "Ethics For Lunch" Series; Visiting Professor in Medicine and Medical Ethics; Center for Medical Ethics, University of Pittsburgh; Pittsburgh, Pennsylvania; December, 1993.
"Limits of Access and Costs: The Implications of National Healthcare Reform for Pharmacists", sponsored by American Society of Hospital Pharmacists; Atlanta, Georgia; December, 1993.
"Ethical Concerns in Health Care Reform"; lecture; Hospital Trustees' Association Fifteenth Conference and Annual Meeting, sponsored by Hospital Association of Pennsylvania; Hershey, Pennsylvania; October, 1993.
"Case Studies in Health Reform"; panel discussion; Department of Humanities; Penn State College of Medicine; Hershey, Pennsylvania; October, 1993.
"Liberty and Responsibility in the Practice of Medicine"; conference director; colloquium sponsored by Liberty Fund, Inc.; Key Biscayne, Florida; October, 1993.
"Interpretation and the Case Method"; commentary; 7th Annual Meeting, Society for Bioethics Consultation"; Cleveland, Ohio; September, 1993.
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"Ethical Issues in Managed Care for Psychiatry"; lecture; joint meeting of Council on Psychiatry and Law, and Commission on Judicial Action; Fall Component Meetings, American Psychiatric Association; Washington, D.C.; September, 1993.
"Confidentiality in Medicine"; commentary; Medicine and Humanities Consultation, sponsored by Texas A&M University College of Medicine; Saledo, Texas; September, 1993
"Demands for Futile Life-Support: When Families and Physicians Collide", and "Autonomy, Competence, and Consent: Borderline Cases"; lectures; Seattle Veterans Administration Medical Center; Seattle, Washington; August, 1993.
"Ethics, Law and Public Policy"; "Autonomy and Consent"; "Costs and Clinical Decisions" "Concepts of Physicians' and Patients' Responsibilities in Medical Care"; lectures; Summer Seminar in Health Care Ethics, sponsored by University of Washington School of Medicine; Seattle, Washington; August, 1993.
"Who is Responsible? How Law and Medicine Look at Physician Responsibility"; lecture; "Health and Human Values" Lecture Series, sponsored by Union College Office of Graduate and Continuing Studies, and Albany Medical Center; Schenectady, New York; July, 1993.
"Medical Ethics in the Clinical Setting"; four lectures; Summer Program on Health and Human Values, sponsored by Union College and Albany Medical Center; Schenectady, New York; July, 1993.
"Threats and Opportunities: the Ethics of Medicine's New Economics"; lecture; "Cardiovascular and Pulmonary Conference: From the Office to the ICU--II", sponsored by Swedish Medical Center; Snowmass, Colorado; July, 1993.
"Physicians, Patients, and the New Medical Economics: Incentives or Perversions?"; lecture; 5th Annual Bioethics Retreat; Taos, New Mexico; June, 1993.
"The Quest for Science and Knowledge"; "Problems with the Quest and Managing Uncertainty"; lectures; Governor's School for Science; Knoxville, Tennessee; June, 1993.
"Research, Legal, and Ethical Dimensions of Physician Self-Referral"; panel lecture; symposium sponsored by National Health Policy Forum; Washington, D.C.; May, 1993.
"The Moral Management of Diminished Competence"; paper; symposium on "Human Nature and Health Care for Free and Responsible Individuals", sponsored by Liberty Fund; Houston, Texas; May, 1993.
"Of Torts and Charts: Where Lies Patient Responsibility in Medicine and in Law?"; lecture; combined meeting of Mesa County Medical Society and Mesa County Bar Association; Grand Junction, Colorado; May, 1993.
"National Health Care Reform: Hopes and Hazards"; lecture; medical staff meeting, St. Mary's Hospital; Grand Junction, Colorado; May, 1993.
"Ethical Considerations in Forming a National Health Care Agenda"; lecture; seminar sponsored by Northwest Area Council of Health Care Social Workers; Jackson, Tennessee; April, 1993.
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"Lung Transplantation Workship II"; workshop presentation; sponsored by American Thoracic Society, Health Care Policy and Clinical Practice Committee; Bethesda, Maryland; March, 1993.
"Health Care Reform"; workshop; Annual Retreat, Evangelical Health Systems Board of Directors; Chicago, Illinois; February, 1993.
"Ethical Perspectives on the Use of High-Cost Drugs"; lecture; session on "Clinical, Legal, and Ethical Perspectives on the Use of High-Cost Drugs”; Midyear Clinical Meeting, American Society of Hospital Pharmacists; Orlando, Florida; December, 1992.
"Ethical Dilemmas in Radiologic Practice: A Dialogue"; panel; Seventy-Eighth Scientific Assembly and Annual Meeting, Radiological Society of North America; Chicago, Illinois; December, 1992.
"The Physician Entrepreneur"; lecture; Annual Meeting, Society for Health and Human Values; Memphis, Tennessee; November, 1992.
"The New Medical Ethics of Medicine's New Economics"; panel; Annual Meeting, Society for Health and Human Values; Memphis, Tennessee; November, 1992.
"The Ethics of Health Care Reform"; lecture; Annual Medical Staff Meeting, McKey Medical Center; Loveland, Colorado; November, 1992.
"The Ethical Considerations of Forming a National Health Care Plan"; lecture; annual meeting, Tennessee Society of Health Care Social Workers, sponsored by Tennessee Hospital Association; Nashville, Tennessee; November, 1992.
"Ethical Dilemmas in Nursing"; lecture; Professional Issues Conference: How to Meet Professional and Personal Health Care Challenges, sponsored by Federation of Nurses/UFT; New York City, New York; October, 1992.
"RBRVS--What Values Drive It?"; lecture; Thirteenth Annual Human Values Forum in Medical Ethics, sponsored by Lutheran General Hospital and the Park Ridge Center; Chicago, Illinois; October, 1992.
"Ethical Challenges of Managed Care"; lecture and workshop; Fall Convention, Virginia Psychological Association; Richmond, Virginia; October, 1992.
"Physicians and Incentive Systems: Facing the Issues"; lecture; General Membership Meeting, Marion-Polk County Medical Society; Salem, Oregon; September, 1992.
"Healthcare Reform: The American Way"; lecture; 5th Annual Speas Medical Colloquium in Medical Ethics; Charlotte, North Carolina; September, 1992.
"The Ethics of Health Care Reform"; keynote address; General Membership Meeting, Colorado Medical Society; Copper Mountain, Colorado; September, 1992.
"Limitations of Medical Care: Ethical Decision Making"; lecture; General Membership Meeting, Colorado Medical Society; Copper Mountain, Colorado; September, 1992.
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"Physicians' Investment and Self-Referral"; lecture; Albany Medical Center, Medical Ethics Grand Rounds; Albany, New York; August, 1992.
"Medical Ethics in the Clinical Setting"; four lectures; Summer Program on Health and Human Values, sponsored by Union College and Albany Medical Center; Schenectady, New York, and Albany, New York; August, 1992.
"The New Medical Ethics of Medicine's News Economics: Allocation of Resources in the 1990s"; lecture; First Annual Aspen Conference on Medical Ethics: "Update on Current Medical Ethics Issues for the Clinician”, sponsored by the Given Institute of the University of Colorado; Aspen, Colorado; July, 1992.
"Health Care Costs Out of Control? Ethical Implications for the Diseased, the Dying, and the Living"; panel; Given Institute of the University of Colorado; Aspen, Colorado; July, 1992.
"Understanding the Nuts and Bolds of the Patient Self-Determination Act"; lecture; Northwest Area Council of Health Care Social Workers; Jackson, Tennessee; July, 1992.
"Philosophy of Science"; four lectures for Academy for Teachers of Science and Mathematics; Knoxville, Tennessee; July, 1992.
"Political Correctness in Bioethics: Is There Such a Thing?"; panel presentation; Fourth Annual Bioethics Retreat; Jackson Hole, Wyoming; June, 1992.
"The Quest for Science and Knowledge"; "Problems with the Quest and Managing Uncertainty"; two lectures on philosophy of science; Governor's School for Science; Knoxville, Tennessee; June, 1992.
"Physicians and Conflicts of Interest"; lecture, sponsored by Department of Philosophy, University of Minnesota, Morris; Morris, Minnesota; May, 1992.
"Decision Making at the End of Life"; lecture, sponsored by Department of Philosophy, University of Minnesota, Morris; Morris, Minnesota; May, 1992.
"A Time to Live and a Time to Die: Decisions to Abate Life Support for Incompetent Patients"; lecture, 1992 Neuro Critical Care Symposium, sponsored by Blodgett Memorial Medical Center; Grand Rapids, Michigan; May, 1992.
"The New Medical Ethics of Medicine's New Economics"; lecture, 1992 Neuro Critical Care Symposium, sponsored by Blodgett Memorial Medical Center; Grand Rapids, Michigan; May, 1992.
"Deciding Cases"; panel sponsored by American Philosophical Association Committee on Philosophy and Medicine; Central Division Meeting, Americal Philosophical Association; Louisville, Kentucky; April, 1992.
"When the Child Says No, Then What?"; lecture; Fourth Annual AMEDD Clinical Investigation Postgraduate Short Course, sponsored by U.S. Army Health Care Studies; San Antonio, Texas; April, 1992.
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"Self-Referral: Economic Realities, Ethical and Legal Constraints"; lecture; Grand Rounds, Department of Internal Medicine, Carolinas Medical Center; Charlotte, North Carolina; February, 1992.
"Should Your Doctor or Family Decide the Moment of Your Death?"; lecture; sponsored by Medical Humanities Program; Davidson College; Davidson, North Carolina; February, 1992.
"Biomedical Ethics Relating to Health Insurance, High Technology, Experimental Procedures, and Reimbursement Issues"; panel discussion; 18th Annual Midwinter Meeting, Tort and Insurance Practice Section, American Bar Association; Palm Beach, Florida; January, 1992.
"Liberty and Responsibility: Psychiatry in the Twenty-First Century"; conference director; colloquium sponsored by Liberty Fund, Inc.; Key Biscayne, Florida; January, 1992.
"Between a Rock and a Hard Place: Case Studies in Ethics"; lecture; annual meeting, Tennessee Society of Healthcare Social Workers"; Nashville, Tennessee; November, 1991.
"A Million Dollar Death: Does Anyone Have the Right?"; lecture; conference "Life-Sustaining Treatment: Whose Choice Is It?”, sponsored by Boone Hospital Center; Columbia, Missouri; October, 1991.
"The New Medical Ethics of Medicine's New Economics” lecture; conference "Medical Ethics for the 90's: An Intensive Skill Building Workshop", sponsored by Michigan State University; East Lansing, Michigan; August, 1991.
"Speak for Yourself in Advance: Decisions for Incompetent Patients at the End of Life"; lecture; conference "Medical Ethics for the 90's: An Intensive Skill Building Workshop", sponsored by Michigan State University; East Lansing, Michigan; August, 1991.
"Philosophy of Science"; four lectures for Academy for Teachers of Science and Mathematics; Knoxville, Tennessee; July, 1991
"The Use of Humanities to Teach Bioethics"; panel presentation; Third Annual Bioethics Retreat; Nantucket, Massachusetts; June, 1991.
"Facts, Values, and Reasoning"; lecture; Governor's School for International Relations; Memphis, Tennessee; June, 1991
"The Quest for Science and Knowledge"; "Problems with the Quest"; and "Managing Uncertainty"; three lectures on philosophy of science; Governor's School for Science; Knoxville, Tennessee; June, 1991.
"Rationing and the Law"; lecture; conference on "Rationing America's Medical Care: Opening Pandora's Box?”, sponsored by The Brookings Institution; Washington, D.C.; May, 1991.
"Setting Priorities for America's Health"; lecture; symposium on "Am I My Brother's Keeper? Who Lives? Who Dies? Who Pays?”, sponsored by Chattanooga Area Healthcare Coalition; Chattanooga, Tennessee; April, 1991.
"Ethical Considerations in Prescription Drug Advertising"; lecture; Thirty-sixth Annual Ohio Pharmaceutical Seminar: "Issues in Pharmaceutical Promotion”; Columbus, Ohio; April, 1991.
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"Direct-to-Patient Marketing: Vulnerable Patient or Sovereign Consumer?"; lecture; The 11th Annual Symposium on Health Care Marketing, sponsored by the Academy for Health Services Marketing; Las Vegas, Nevada; March, 1991.
"Ethical Questions Don't End at the Chaplain's Office: Understanding the Nuts and Bolts of the Patient Self-Determination Act"; lecture; annual meeting, Protestant Health and Human Services Assembly; Miami, Florida; March, 1991.
"Ethical Issues"; lecture; conference on "Scientific Conference on Quality of Life in Cardiovascular Disease", sponsored by the American Heart Association; Santa Fe, New Mexico; March, 1991.
"The New Economics of Medicine"; quarterly staff meeting, Dyersberg Methodist Hospital; Dyersberg, Tennessee; November, 1990.
"Enriching the Lives of the Elderly: Responsibilities of Grantmaking Foundations"; three lectures; annual retreat, The H.W. Durham Foundation; Heber Springs, Arkansas; October, 1990.
"Ethical Dilemmas in Nursing"; lecture; Professional Issues Conference on "Health Care Challenges and How to Meet Them"; sponsored by Federation of Nurses/UFT; New York, New York; October, 1990.
"Fiscal Scarcity and the Inevitability of Bedside Budget Balancing"; keynote address, "Cost of Care" conference; Erlanger Medical Center; Chattanooga, Tennessee; October, 1990.
"Medicine, Money and Morality: Walking the Tightrope Between Patients and Payers"; lecture, "Cost of Care" conference; Erlanger Medical Center; Chattanooga, Tennessee; October, 1990.
"Who Dunit? Utilization Review and Its Causal Responsibility for Doctors' Decisions and Patients' Outcomes"; paper; annual meeting, American Society of Law and Medicine; Cambridge, Massachusetts; October, 1990.
"Ethical Issues in Treating Adolescents: HMO Capitation Incentives and Adolescent Mental Health"; plenary lecture; fall meeting of American Society for Adolescent Psychiatry; Minneapolis, Minnesota; October, 1990.
"The State of Graduate Education in Bioethics"; panel presentation; Second Annual Summer Bioethics Retreat; Lutsen, Minnesota; June, 1990.
"Gaming the System: Dodging the Rules and Ruling the Dodgers"; lecture; Center for Applied and Professional Ethics, University of Tennessee; Knoxville, Tennessee; June, 1991.
"The Quest for Science and Knowledge"; "Problems with the Quest"; and "Managing Uncertainty"; three lectures on philosophy of science; Governor's School for Science; Knoxville, Tennessee; June, 1990
"Physicians as Entrepeneurs: Self-Referrals and Safe Harbors"; lecture; 1990 Health Law Teachers Conference, sponsored by American Society of Law and Medicine; Cleveland, Ohio; June, 1990.
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"Ethics and the Health Professional: How to Make Rational Decisions in an Irrational Environment"; lecture; 1990 Professional Issues Conference, "Meeting the Challenge: Making Changes", sponsored by Federation of Nurses and Health Care Professionals; Washington, D.C.; May, 1990.
"Who Dun It? The Role of Utilization Review in Causing Doctors' Decisions and Patients' Outcomes"; lecture; Midwest Utilization Review Conference, sponsored by Blue Cross and Blue Shield; Nashville, Tennessee; May, 1990.
"Physician as Gatekeeper: A Professional Contradiction?'; George M. Boyer, M.D. and M. McKendree Boyer, M.D. Memorial Lecture; annual meeting, Maryland Medical and Chirurgical Society; Ellicott City, Maryland; May, 1990.
"Patient Autonomy: A Pernicious Idea"; lecture; "Conversations in Bioethics", sponsored by Case Western Reserve University School of Medicine, Center for Bioethics; Cleveland, Ohio; April, 1990.
"Medicine, Money and Morality: How Economics is Changing the Face of Medicine"; lecture; Pre-Med Club, Kent State University; Kent, Ohio; April, 1990.
"Facts, Fallacies and Philosophy"; panel presentation; presented at conference, "Food Fights: Deciding How to Decide about Diet and Disease", sponsored by Virginia Tech University, Center for Programs in the Humanities; Blacksburg, Virginia; April, 1990.
"Conflicts of Interest in Medicine: Problems and Possible Solutions"; panel presentation; The Medical Center Hour, sponsored by University of Virginia School of Medicine; Charlottesville, Virginia; March, 1990.
"The Future of the Doctor-Patient Relationship"; task force; sponsored by the Hastings Center; Briarcliff Manor, New York; February, 1990.
"Medical Ethics and the Health Professional"; lecture; sponsored by Vermont Federation of Nurses and Health Professionals; Burlington, Vermont; January, 1990.
"Physician Investment and Self-Referral: Conflicts of Interest"; address; presented at annual meeting, Maryland Orthopedic Society; Baltimore, Maryland; December, 1989.
"Gaming the System"; address; presented at Medical Staff Quarterly Meeting, St. Joseph Hospital; Townson, Maryland; December, 1989.
"Ethical Considerations in Forming a National Health Plan"; seminar; presented for Task Force on the Future of Health Care, sponsored by Federation of Nurses and Health Professionals; Washington, D.C.; December, 1989.
"Stratified Scarcity: Physicians Caught Between Ethical Obligations and Economic Realities"; lecture; presented at conference, "Economics and Health Care: Rich and Poor Medicine", sponsored by Holland Community Hospital; Holland, Michigan; November, 1989.
"The Abortion Debate: Issues and Fallacies"; lecture; presented at Davidson College; Davidson, North Carolina; November, 1989.
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"Health Care and the Environment: Possibilities and Conflicts in the Humanities Tradition"; lecture; presented at 1989 meeting, National Conference of State Humanities Councils; Nashville, Tennessee; October, 1989.
"A Layman's Guide to the Changing Economics and Ethics of Medicine"; lecture; Nashville Young Women's Christian Association; Nashville, Tennessee; October, 1989.
"The Real World of Physician Referrals and Conflicts of Interest"; paper; presented at annual meeting, Idaho Medical Association; Sun Valley, Idaho; July, 1989.
"The Quest for Science and Knowledge"; "Problems with the Quest"; and "Managing Uncertainty"; three lectures on philosophy of science presented at Governor's School for Science; Knoxville, Tennessee; June, 1989.
"Dodging the Rules and Ruling the Dodgers"; lecture; presented at "The Cost of Caring: Ethics and Prospective Payment", sponsored by Creighton University Center for Health Policy and Ethics; Omaha, Nebraska; May, 1989.
"Gaming the System: Rationing and the Temptation to Cheat"; paper; presented at "Health Care for an Aging Society", sponsored by University of Arkansas for Medical Sciences, Division of Humanities; Little Rock, Arkansas; May, 1989.
"Care and Cost: Economic Realities and Economic Disclosure"; keynote lecture; presented at "Institutional Ethics Committees and Allocating Scarce Resources", sponsored by Medical Ethics Resource Network of Michigan; Grand Rapids, Michigan; April, 1989.
"The Allocation of Scarce Resources: Should Ethics Committees Have a Role?"; panel presentation; "Institutional Ethics Committees and Allocating Scarce Resources", sponsored by Medical Ethics Resource Network of Michigan; Grand Rapids, Michigan; April, 1989.
"Conflicts of Interest"; paper; presented at Hastings Center, Briarcliff Manor, New York; March, 1989.
"Who Pays for New Drugs and Devices?"; paper; presented at "Workshop on Bioethical Considerations in Research with Human Subjects", sponsored by University of Alabama at Birmingham; Birmingham, Alabama; March, 1989.
"Conflicts of Interest"; panel discussion on "Physicians' Journal Update"; Lifetime Medical Television Network; New York, New York; February, 1989.
"The Ethics and Legalities of Conflicts of Interest"; paper; 1989 State Legislation Meeting, sponsored by the American Medical Association; Key Biscayne, Florida; January, 1989.
"Should Physicians Discuss the Cost Constraints of Treatment with Patients?"; lecture, "Ethical Problems in the Health Sciences" series, sponsored by Program in Biomedical Ethics, College of Medicine, University of Iowa; Iowa City, Iowa; December, 1988.
"Philosophy at the Bedside: Practical Ethics in Medicine"; public lecture, Davidson College; Davidson, North Carolina; December, 1988.
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"Testing for HIV 'On the Sly'"; panel presentation in "The Moral Responsibilities of Health Care Professionals to Care for HIV Infected Individuals"; annual meeting, Society for Health and Human Values; Chicago, Illinois; November, 1988.
"A New Kind of Informed Consent"; paper; annual meeting, American Society of Law and Medicine; Boston, Massachusetts, October, 1988.
"Rationing of Care: What Does It Mean for the Clinician?"; lecture, presented at symposium, "Select Issues in Geriatrics", sponsored by Huffington Center on Aging, Baylor University College of Medicine; Houston, Texas; October, 1988.
"A Preliminary Overview of Challenges to the Traditional Health Care Ethic"; lecture for task force on A New Ethic for a Changing Health Care Environment, sponsored by Center for Biomedical Ethics, University of Minnesota; Minneapolis, Minnesota; July, 1988.
"Moral Problem-Solving in Medicine: Economic Exigencies"; lecture for Faculty Bioethics Seminar Group, sponsored by Center for Biomedical Ethics, University of Minnesota, Minneapolis, Minnesota; July, 1988.
"The Quest for Certainty"; "Problems with the Quest"; and "Managing Uncertainty": three lectures on philosophy of science; Governor's School for Science; Knoxville, Tennessee; June, 1988.
"Medical Ethics and the Role of QL Theory and Research"; invited address for "Workshop on Quality of Life and Cardiovascular Disease", sponsored by National Heart, Lung and Blood Institute and Bowman Gray College of Medicine, Winston-Salem, North Carolina; June, 1988.
"Economics and Informed Consent"; lecture, sponsored by Institute for Health Policy Education and Research; School of Public Health, University of Texas Health Science Center, Houston, Texas; April, 1988.
"Being Immoral to Be Moral: Dodging the Cost-Cutters to Serve the Patient"; lecture in Fourth Annual Series, Rush University Lectures in Health Care Ethics; Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois; March, 1988.
"Risk Management in an Era of Cost Containment"; video interview, sponsored by the Institute of Risk Management Studies, Berkeley, California; February, 1988.
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APPENDIX II Documents Relied On
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3. July 16, 2015 Deposition of Keith Cinea and related deposition exhibits.
4. October 23, 2015 Deposition of Keith Cinea and related deposition exhibits.
5. July 17, 2015 Deposition of Travis Triplett and related deposition exhibits.
6. October 20, 2015 Deposition of Allan Sommer and related deposition exhibits.
7. CrossFit, Inc. Complaint.
8. The National Strength and Condition Association’s (“NSCA”) Answer to CrossFit, Inc.’s Complaint.
9. The NSCA’s responses to CrossFit, Inc. Special Interrogatories (Set One).
10. SEALED declarations of the allegedly injured participants from the Devor Study.
11. JSCR’s Instructions for Authors, Online Submission and Review System; available at http://edmgr.ovid.com/jscr/accounts/ifauth.htm (last accessed 12/31/15).
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14. July 15, 2015 Deposition of William Kraemer.
15. William Broad, Nicholas Wade, Betrayers of the Truth: Fraud and Deceit in the Halls of Science. New York: Simon and Schuster, 1982.
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30. Robert McNutt, Arthur Evans, Robert Fletcher, Suzanne Fletcher, The effects of blinding on the quality of peer review. JAMA 1990; 263: 1371-76.
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