A New Keeper at the Gate Predicting the Effect of the Revised Rule 702(A) on Medical Malpractice in North Carolina

Total Page:16

File Type:pdf, Size:1020Kb

A New Keeper at the Gate Predicting the Effect of the Revised Rule 702(A) on Medical Malpractice in North Carolina A New Keeper at the Gate Predicting the Effect of the Revised Rule 702(a) on Medical Malpractice in North Carolina BY MATTHEW D. BALLEW Zaytoun Law Firm, PLLC 3130 Fairhill Drive, Suite 100 Raleigh, NC 27612 Tel: (919) 832-6690 Fax: (919) 831-4793 [email protected] Table of Contents I. Introduction ......................................................................................................................... 2 II. New Rule 702(a) .................................................................................................................. 3 A. Amended Rule 702(a) .............................................................................................................. 3 B. Other provisions of Rule 702 relevant to medical malpractice ............................................... 3 III. Context of the Change ....................................................................................................... 5 A. Goode, Howerton, and the prior N.C. rules governing general admissibility of scientific opinion testimony ........................................................................................................................ 5 B. Crocker, Day, and the most recent N.C. rules governing expert testimony in N.C. medical malpractice cases ........................................................................................................................... 7 C. Daubert and its progeny .......................................................................................................... 9 D. The current FRE 702 and Advisory Committee Notes ........................................................ 11 IV. Predicting the Effects on Medical Malpractice in N.C. ....................................................... 13 A. N.C. federal court cases applying the Daubert standard to medical testimony .................... 13 B. Expert qualification ............................................................................................................... 17 C. Standard of care opinions ..................................................................................................... 19 D. Causation opinions ............................................................................................................... 20 E. Damages opinions .................................................................................................................. 21 F. Differential Diagnosis ............................................................................................................ 21 G. Peer Reviewed Literature ....................................................................................................... 22 H. “Ipse dixit” opinions ............................................................................................................. 23 I. Rule 9(j) ................................................................................................................................... 24 V. Conclusion ......................................................................................................................... 24 VI. Appendix .......................................................................................................................... 25 A. Helpful cases and reference material ..................................................................................... 25 B. Post Daubert FRE 702 case annotations from LEXIS relevant to medical malpractice issues ....................................................................................................................... 32 |1 I. Introduction With the enactment of House Bill 542 in June 2011, the General Assembly amended Rule of Evidence 702(a), the general rule governing the admissibility of expert opinion testimony in North Carolina. Prior to this amendment, North Carolina’s Rule 702(a) was essentially identical to the old version of Federal Rule of Evidence 7021, and read simply that “[i]f scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion.” N.C. Gen. Stat. 8C-702(a) (2010). As part of the General Assembly’s latest round of “tort reform” efforts last year, North Carolina Rule 702(a) was revised to bring it in line the current Federal Rule of Evidence 702 (hereinafter “FRE 702”). FRE 702 itself was amended in December 2000 in response to the court’s “gatekeeper” role as articulated in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and its progeny. “The Federal Rules of Evidence Advisory Committee Note to its 2000 amendment of Rule 702 makes it clear that the intent of the amendment was to incorporate the principles set forth in Daubert and its progeny into the Federal Rules of Evidence.” 1-4 Brandis and Broun on North Carolina Evidence § 113 (2012). Some legal scholars believe that because North Carolina’s “Rule 702(a) has been rewritten to mirror FRE. 702 at the time the statute was enacted,” then “this indicates a clear legislative intent to abandon the Howerton standard announced by our Supreme Court2 in favor of the Daubert standard adopted by the United States Supreme Court as [currently] codified in F.R.E. 702.” 1-702 North Carolina Evidence Courtroom Manual (2012). Others take a more cautious approach, saying that “[t]he amendment to the North Carolina rule could have the same effect, thus dramatically changing the approach announced in Howerton. Whether the North Carolina courts will interpret the amendment to put the state on the same path as the federal courts or whether the interpretation will be more in line with Howerton remains to be seen.” 1-4 Brandis and Broun. Although the “extent to which Howerton and its progeny are overturned by the new Rule 702(a) remains to be determined,” it is generally agreed upon that “trial courts will undoubtedly now look to federal caselaw for guidance with respect to the acceptability of scientific methods, at least until North Carolina caselaw is developed in this area.” 1-702 North Carolina Evidence Courtroom Manual. The intent of this manuscript is to predict the effects the revised Rule 702(a) will have on medical malpractice cases in North Carolina. As the plaintiff’s bar well knows, for many years now there have been in place various procedural and evidentiary hurdles to filing and litigating medical malpractice actions in this state. As a result, a large body of case has emerged interpreting and 1 See Sec. III(B), infra, for a discussion of FRE 702 and the landmark amendment in December 2000 in response to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and its progeny. 2 See Sec. III(A), infra, for a discussion of Howerton and the prior law governing admissibility of scientific opinion testimony in North Carolina. |2 applying these technical rules in the North Carolina appellate courts. The challenge of this paper is to forecast which of these preexisting rules will be affected and to what extent. In the end, what follows is merely educated guesswork as we await the inevitable appellate opinions applying the new Rule 702(a). II. New Rule 702 in N.C. A. Amended Rule 702(a) The newly amended North Carolina Rule of Evidence 702(a) reads as follows: Rule 702. Testimony by experts. (a) If scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion, or otherwise, if all of the following apply: (1) The testimony is based upon sufficient facts or data. (2) The testimony is the product of reliable principles and methods. (3) The witness has applied the principles and methods reliably to the facts of the case. The new rule can be broken down into five essential elements, all of which must be established in order for the trial court to deem any expert opinion testimony admissible: (i) the subject matter at issue must be one where “scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact3;” (ii) the proposed expert must be qualified “by knowledge, skill, experience, training, or education” to render an opinion on the subject; (iii) the testimony must be “based upon sufficient facts or data;” (iv) the testimony must be “the product of reliable principles and methods;” and (v) the expert must have “applied the principles methods reliably to the facts of the case.” These elements represent a preliminary set of requirements for the admissibility of all expert opinion testimony, including standard of care, causation and damages opinions in a medical malpractice action. Each will be discussed below. It is critical to remember, however, that these “gatekeeper” requirements will operate in conjunction with the other evidentiary rules governing expert testimony in North Carolina. B. Other provisions of Rule 702 relevant to medical malpractice While the amendments to Rule 702(a) have been considered by many to be a seismic evidentiary shift toward the much-maligned “Daubert standard,” it is easy to overlook the fact that many other provisions of North Carolina Rule 702 will continue to govern the admissibility of 3 It has long been recognized in North Carolina that expert testimony is required in medical malpractice
Recommended publications
  • Using Phenomenography to Study Factors Affecting the Propagation of Invalid Science
    ﻣﻘﺎﻟﻪ ﭘﮋوﻫﺸﯽ ﻣﺠﻠﻪ داﻧﺸﮕﺎه ﻋﻠﻮم ﭘﺰﺷﮑﯽ رﻓﺴﻨﺠﺎن دوره 16، اﺳﻔﻨﺪ 1396، -1114 1097 ﺑﻪ ﮐﺎرﮔﯿﺮي روش ﭘﺪﯾﺪار ﻧﮕﺎري ﺑﻪ ﻣﻨﻈﻮر ﺷﻨﺎﺳﺎﯾﯽ ﻋﻮاﻣﻞ ﻣﺆﺛﺮ در اﻧﺘﺸﺎر ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ ﻣﻬﺪي دادﺧﻮاه1، ﻣﺤﻤﺪ ﻟﮕﺰﯾﺎن2، زﻫﺮا ﻫﻤﺖ1 درﯾﺎﻓﺖ ﻣﻘﺎﻟﻪ: 27/6/96 ارﺳﺎل ﻣﻘﺎﻟﻪ ﺑﻪ ﻧﻮﯾﺴﻨﺪه ﺟﻬﺖ اﺻﻼح: 27/8/96 درﯾﺎﻓﺖ اﺻﻼﺣﯿﻪ از ﻧﻮﯾﺴﻨﺪه: 10/11/96 ﭘﺬﯾﺮش ﻣﻘﺎﻟﻪ: 96/11/24 ﭼﮑﯿﺪه زﻣﯿﻨﻪ و ﻫﺪف: ﻫﺪف اﯾﻦ ﭘﮋوﻫﺶ ﺷﻨﺎﺳﺎﯾﯽ ﻋﻮاﻣﻠﯽ اﺳﺖ ﮐﻪ ﺑﺎﻋﺚ اﻧﺘﺸﺎر ﯾﺎﻓﺘﻪﻫﺎي ﻋﻠﻤﯽ ﻧﺎﻣﻌﺘﺒﺮ ﻣﯽﺷﻮﻧﺪ. آﮔﺎﻫﯽ از ﻋﻮاﻣﻞ ﻣﺆﺛﺮ در اﻧﺘﺸﺎر ﯾﺎﻓﺘﻪﻫﺎي ﻋﻠﻤﯽ ﻧﺎﻣﻌﺘﺒﺮ ﺑﻪ ﻣﺤﻘﻘﺎن اﯾﻦ ﻓﺮﺻﺖ را ﻣﯽدﻫﺪ ﺗﺎ ﺑﺎ ﺑﯿﻨﺸﯽ وﺳﯿﻊﺗﺮ و ﺑﻪ ﺻﻮرت آﮔﺎﻫﺎﻧﻪ اﻗﺪام ﺑﻪ اﻧﺘﺨﺎب ﻣﻨﺎﺑﻊ ﭘﮋوﻫﺶ ﺧﻮد ﻧﻤﺎﯾﻨﺪ و ﺑﺪﯾﻦ ﺻﻮرت از اﻧﺘﺸﺎر ﯾﺎﻓﺘﻪﻫﺎي ﻋﻠﻤﯽ ﻧﺎﻣﻌﺘﺒﺮ ﺑﻪ وﺳﯿﻠﮥ ﺧﻮدداري از اﺳﺘﻔﺎده آنﻫﺎ ﺑﻪ ﻋﻨﻮان ﭘﺎﯾﮥ ﭘﮋوﻫﺶ ﺧﻮد ﺟﻠﻮﮔﯿﺮي ﺑﻪ ﻋﻤﻞ آورﻧﺪ. ﻣﻮاد و روش: در اﯾﻦ ﻣﻘﺎﻟﻪ ﺑﺎ اﺳﺘﻔﺎده از روﯾﮑﺮد ﮐﯿﻔﯽ ﭘﺪﯾﺪارﻧﮕﺎري، ﺑﻪ ﮐﺎرﮔﯿﺮي ﻧﻤﻮﻧﻪﮔﯿﺮي ﻫﺪﻓﻤﻨﺪ و اﻧﺠﺎم ﻣﺼﺎﺣﺒﻪ ﺑﺎ 12 ﻧﻔﺮ ﮐﻪ در زﻣﯿﻨﮥ اﻋﺘﺒﺎر ﯾﺎﻓﺘﻪﻫﺎي ﻋﻠﻤﯽ، ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ و ﻣﺒﺎﺣﺚ ﻣﺮﺗﺒﻂ داراي داﻧﺶ و ﺗﺠﺮﺑﻪ ﺑﻮدﻧﺪ، ﻋﻮاﻣﻞ ﻣﺆﺛﺮ در اﻧﺘﺸﺎر ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ ﺷﻨﺎﺳﺎﯾﯽ ﮔﺮدﯾﺪهاﻧﺪ؛ اﺑﺘﺪا ﺑﺎ اﻧﺠﺎم ﻣﺼﺎﺣﺒﻪ و ﮐﺪﮔﺬاري ﻧﻈﺮي 8 ﻃﺒﻘﻪ ﺗﻮﺻﯿﻔﯽ ﻣﺮﺗﺒﻂ ﺑﺎ ﻋﻮاﻣﻞ اﻧﺘﺸﺎر ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ اﺣﺼﺎء ﺷﺪﻧﺪ و ﺳﭙﺲ ﺟﻬﺖ ﺳﻬﻮﻟﺖ در درك ﻧﺘﺎﯾﺞ ﭘﮋوﻫﺶ، ﻋﻮاﻣﻞ ﻣﺆﺛﺮ در اﻧﺘﺸﺎر ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ ﺑﻪ ﺻﻮرت ﻓﺮآﯾﻨﺪي در ﻓﻀﺎي ﻧﺘﯿﺠﻪ اراﺋﻪ ﮔﺮدﯾﺪ. ﯾﺎﻓﺘﻪﻫﺎ: ﻧﺘﺎﯾﺞ اﯾﻦ ﭘﮋوﻫﺶ ﺣﺎﮐﯽ از آن اﺳﺖ ﮐﻪ ﻋﻮاﻣﻞ ﻣﺨﺘﻠﻔﯽ در اﻧﺘﺸﺎر ﯾﺎﻓﺘﻪﻫﺎي ﻋﻠﻤﯽ ﻧﺎﻣﻌﺘﺒﺮ دﺧﯿﻞ ﻫﺴﺘﻨﺪ ﮐﻪ ﺑﺎ در ﻧﻈﺮﮔﯿﺮي ﻓﺮاﯾﻨﺪ اﻧﺘﺸﺎر ﯾﮏ ﯾﺎﻓﺘﮥ ﻋﻠﻤﯽ، ﻋﻮاﻣﻞ ﻣﺆﺛﺮ در اﻧﺘﺸﺎر ﻋﻠﻢ ﻧﺎﻣﻌﺘﺒﺮ را ﻣﯽﺗﻮان در ﺳﻪ ﻣﺤﻮر اﺻﻠﯽ ﺗﻮﻟﯿﺪ، ﻓﺮآﯾﻨﺪ ارزﯾﺎﺑﯽ و اﻧﺘﺸﺎر ﻋﻠﻢ ﺟﺎي داد.
    [Show full text]
  • Download Preprint
    Recommendations from the Reducing the Inadvertent Spread of Retracted Science: Shaping a Research and Implementation Agenda Project Jodi Schneider*, Nathan D. Woods, Randi Proescholdt, Yuanxi Fu, and the RISRS Team July 2021 *Corresponding author: [email protected] and [email protected] Table of Contents EXECUTIVE SUMMARY 3 Recommendations 4 INTRODUCTION 5 RISRS Project Goals and Assumptions 6 Framing the Problem 8 Scope of this Document 9 THE RISRS PROCESS 10 Scoping Literature Review 10 Interviews 11 Workshop, Dissemination, and Implementation 11 LITERATURE REVIEW AND CURRENT AWARENESS 11 Reasons for Retraction 11 Formats and Types of Retraction 13 Field Variation 15 Continued Citation of Retracted Papers: What Went Wrong? 20 Visibility of Retraction Status 24 Inconsistent Retraction Metadata 25 Quality of Retraction Notices 26 Literature Review Conclusions 28 DEFINING PROBLEMS AND OPPORTUNITIES 29 PROBLEMS AND OPPORTUNITIES DESCRIBED BY THE EMPIRICAL LITERATURE ON RETRACTION 29 Problem Themes Described by the Empirical Literature on Retraction 30 Opportunity Themes Described by the Empirical Literature on Retraction 32 Problem Definition Described by the Empirical Literature on Retraction 35 THEMES FROM STAKEHOLDER INTERVIEWS 36 Problem Frameworks based on Stakeholder Interviews 36 Contentious Themes based on Stakeholder Interviews 38 The Purpose of Retraction According to Stakeholder Interviews 38 Changing the Scholarly Record 39 The Harms of Retraction According to Stakeholder Interviews 39 The Character of Reform According to Stakeholder Interviews 40 SYNTHESIZING THE PROBLEMS AND OPPORTUNITIES 41 Aligning Opportunity Pathways 41 Defining the Scale and Scope of the Problem 42 RECOMMENDATIONS 43 1. Develop a Systematic Cross-industry Approach to Ensure the Public Availability of Consistent, Standardized, Interoperable, and Timely Information about Retractions.
    [Show full text]
  • The Influence of Pedagogical Content Knowledge (Pck) for Teaching Macroevolution on Student Outcomes in a General Education Biology Course
    THE INFLUENCE OF PEDAGOGICAL CONTENT KNOWLEDGE (PCK) FOR TEACHING MACROEVOLUTION ON STUDENT OUTCOMES IN A GENERAL EDUCATION BIOLOGY COURSE A Dissertation presented to the Faculty of the Graduate School University of Missouri In Partial Fulfillment of the Requirements for the Degree Doctor of Philosophy by EMILY MARIE WALTER Dr. Patricia J. Friedrichsen, Dissertation Supervisor MAY 2013 The undersigned, appointed by the dean of the Graduate School, Have examined the dissertation entitled THE INFLUENCE OF PEDAGOGICAL CONTENT KNOWLEDGE (PCK) FOR TEACHING MACROEVOLUTION ON STUDENT OUTCOMES IN A GENERAL EDUCATION BIOLOGY COURSE Presented by EMILY MARIE WALTER A candidate for the degree of DOCTOR OF PHILOSOPHY OF LEARNING, TEACHING AND CURRICULUM - EMPHASIS IN SCIENCE EDUCATION And hereby certify that, in their opinion, it is worthy of acceptance. _______________________________________________________________ DR. PATRICIA J. FRIEDRICHSEN, CHAIR _______________________________________________________________ DR. LLOYD BARROW _______________________________________________________________ DR. DEBORAH HANUSCIN _______________________________________________________________ DR. DAVID BERGIN _______________________________________________________________ DR. GERALD SUMMERS DEDICATION This dissertation is dedicated to my daughters Lily and Charlotte and to my husband Clint. Your love, patience, humor, and bear hugs have been wonderful support for me throughout my doctorate program. I am grateful to share this achievement with you. ACKNOWLEDGEMENTS This dissertation is a result of five years of work in the MU Science Education Center. Throughout that time, many people have challenged and supported my thinking. I take the following pages to acknowledge these individuals. Pat Friedrichsen, my advisor. Thank you for believing in me. You never once told me I might not graduate on time. This meant a lot to me, especially in moments of frustration and exhaustion.
    [Show full text]
  • Scientific Misconceptions Among Daubert Gatekeepers: the Need for Reform of Expert Review Procedures
    BEYEA_FMT.DOC 04/23/01 11:45 AM SCIENTIFIC MISCONCEPTIONS AMONG DAUBERT GATEKEEPERS: THE NEED FOR REFORM OF EXPERT REVIEW PROCEDURES JAN BEYEA* AND DANIEL BERGER** I INTRODUCTION The Supreme Court’s opinions in Daubert v. Merrell Dow Pharmaceuticals, Inc.1, General Electric Company v. Joiner2, and Kumho Tire v. Carmichael3 con- tain two inconsistent views of science. In some places, the Court views science as an imperfect “process” for refining theories, whereas in other places, the Court views science as universal knowledge derived through “formal logic.” The latter view, long out of favor with philosophers and historians of science, comports with the current cultural vision of science and is likely to be adopted by district and appeals court judges, without vigorous “education,” or until such time as higher courts recognize that the two views need to be synthesized into a Copyright © 2001 by Jan Beyea and Daniel Berger This article is also available at http://www.law.duke.edu/journals/64LCPBeyea. * Ph.D., Senior Scientist, Consulting in the Public Interest, Lambertville, New Jersey. Dr. Beyea is a regular panel member and reviewer of studies carried out by the National Research Council of the National Academy of Sciences. He can be contacted at [email protected]. ** Member, Berger & Montague, P.C., a firm that specializes in complex litigation and is a leader in the field of class actions, including toxic tort litigation. We thank Jim Cook for helping us gather statistics on Daubert decisions and Debora Fliegel- man for assistance with editing. 1. 509 U.S. 579 (1993). In Daubert, the Court displaced the so-called Frye test of general accept- ability as the guideline for the admission of expert scientific witnesses.
    [Show full text]
  • Survey of Research Integrity Measures Utilized in Biomedical Research Laboratories
    SURVEY OF RESEARCH INTEGRITY MEASURES UTILIZED IN BIOMEDICAL RESEARCH LABORATORIES LITERATURE REVIEW Prepared by: C. Mulqueen D. Rodbard American Institutes for Research 3333 K Street, NW Washington, DC20007 October 31, 2000 Prepared for: Department of Health and Human Services Office of Research Integrity 5515 Security Lane Rockville, MD 20852 and Program Support Center Division of Acquisitions Management, AOS General Acquisitions Branch Room 5-101, Parklawn Building 5600 Fishers Lane Rockville, MD 20857 Contract No. 282-98-0029 - Task Order No. 25 Survey of Research Integrity Measures Utilized in Biomedical Research Laboratories Table of Contents 1. Overview of Report..................................................................................................... 1 2. Search Methods Utilized ............................................................................................. 1 3. Content Areas.............................................................................................................. 2 3.1 Data Fabrication .............................................................................................. 3 3.2 Data Falsification ............................................................................................ 4 3.3 Plagiarism........................................................................................................ 4 3.4 Data Management............................................................................................ 5 3.5 Supervision and Mentoring ............................................................................
    [Show full text]
  • Daubert and the Quest for Value-Free "Scientific Knowledge" in the Courtroom Alexander Morgan Capron
    CORE Metadata, citation and similar papers at core.ac.uk Provided by University of Richmond University of Richmond Law Review Volume 30 | Issue 1 Article 4 1996 Daubert and the Quest for Value-Free "Scientific Knowledge" in the Courtroom Alexander Morgan Capron Follow this and additional works at: http://scholarship.richmond.edu/lawreview Part of the Evidence Commons Recommended Citation Alexander M. Capron, Daubert and the Quest for Value-Free "Scientific Knowledge" in the Courtroom, 30 U. Rich. L. Rev. 85 (1996). Available at: http://scholarship.richmond.edu/lawreview/vol30/iss1/4 This Article is brought to you for free and open access by the Law School Journals at UR Scholarship Repository. It has been accepted for inclusion in University of Richmond Law Review by an authorized editor of UR Scholarship Repository. For more information, please contact [email protected]. DAUBERT AND THE QUEST FOR VALUE-FREE "SCIENTIFIC KNOWLEDGE" IN THE COURTROOM* Alexander Morgan Capron** In a world that grows more technologically complex every day and in which scientific research continually expands both our understanding of, and our questions about, the operation of the natural and man-made world, it is hardly surprising that sci- ence should show up with increasing frequency in our court- rooms. Science itself is sometimes at issue, for example, in proceedings on allegations of scientific misconduct or in dis- putes over the ownership or patentability of technologies. But more frequently, science enters in aid of resolving a case in which a complex question of causation is at issue. To establish or rebut causation, each side may seek to introduce evidence from expert witnesses.' With crowded dockets, the simpler cas- es are more likely to settle, while more complex ones-especially class actions and mass tort suits-go to trial, which may explain * This article is a revised version of a presentation to a faculty colloquy, February 16, 1995, during a visit as George E.
    [Show full text]
  • Bridge Linking Engineering and Society
    Spring 2017 ENGINEERING ETHICS The BRIDGE LINKING ENGINEERING AND SOCIETY Ethics in Business: Every Employee’s Character and Behavior Count Chad Holliday Protecting Dissent in Organizational Contexts Thomas W. Smith III and Tara L. Hoke Engineering Society Codes of Ethics: A Bird’s-Eye View Arthur E. Schwartz Engineering Codes of Ethics: Legal Protection for Engineers Jeffrey H. Matsuura Beyond Protecting the Public from Risk Robert B. Gilbert How Some Scientists and Engineers Contribute to Environmental Injustice Kristin Shrader-Frechette Ethical Implications of Computational Modeling Kenneth R. Fleischmann and William A. Wallace Addressing Corruption in the Global Engineering/ Construction Industry William P. Henry Can Engineering Ethics Be Taught? Deborah G. Johnson The mission of the National Academy of Engineering is to advance the well-being of the nation by promoting a vibrant engineering profession and by marshalling the expertise and insights of eminent engineers to provide independent advice to the federal government on matters involving engineering and technology. The BRIDGE NATIONAL ACADEMY OF ENGINEERING Gordon R. England, Chair C. D. Mote, Jr., President Corale L. Brierley, Vice President Julia M. Phillips, Home Secretary Ruth A. David, Foreign Secretary Martin B. Sherwin, Treasurer Editor in Chief: Ronald M. Latanision Managing Editor: Cameron H. Fletcher Production Assistant: Penelope Gibbs The Bridge (ISSN 0737-6278) is published quarterly by the National Aca d emy of Engineering, 2101 Constitution Avenue NW, Washington, DC 20418. Periodicals postage paid at Washington, DC. Vol. 47, No. 1, Spring 2017 Postmaster: Send address changes to The Bridge, 2101 Constitution Avenue NW, Washington, DC 20418. Papers are presented in The Bridge on the basis of general interest and time- liness.
    [Show full text]
  • Ethics in Agricultural and Applied Economics∗
    Beasts of the Field? Ethics in Agricultural and Applied Economics∗ Anna Josephsona and Jeffrey D. Michlerb aDepartment of Agricultural and Resource Economics, University of Arizona bDepartment of Agricultural and Resource Economics, University of Saskatchewan August 2018 Abstract Ethical issues in scientific research are neither new nor unique to agricultural and applied eco- nomics. Ongoing changes to research practices and recent media attention to the profession have raised new ethical problems, but also created opportunities for new solutions. In this pa- per, we discuss ethical issues facing the field of agricultural and applied economics and propose potential ways in which the profession can address these issues. We divide our discussion into two topics. First are ethical issues that arise during the collection, management and analysis of data. Second are ethical issues faced by researchers as they formulate, fund, and disseminate their research. We pay special attention to issues of data dredging or p-hacking and potential ethical issues arising from interaction with the media. JEL Classification: A11, B41, Q10 Keywords: Ethics, Scientific Misconduct, Research Practice, Research Misconduct, Role of Economists ∗Authors are listed alphabetically. Corresponding author email: jeff[email protected]. While we may name certain universities, individuals, or other parties, we do so only for illustrative purposes. We do not purport to be ethical arbiters of our profession, but we write this paper to promote discussion in the field, not to call out actions of our colleagues. We are particularly grateful to Marc Bellemare, editor, and an anonymous referee for extensive advice. Nicole Ballenger, Chris Barrett, Karen Brooks, Doug Gollin, Tom Hertel, Jayson Lusk, Will Masters, Jill McCluskey, Hope Michelson, Frank Place, Gerald Shively, Peter Slade, Tristan Skolrud, Melinda Smale, and Wally Tyner were all very generous with their time and provided helpful thoughts and comments on earlier drafts of this paper.
    [Show full text]
  • Fundamentals of Clinical Trials
    Fundamentals of Clinical Trials Lawrence M. Friedman • Curt D. Furberg David L. DeMets Fundamentals of Clinical Trials Fourth Edition Lawrence M. Friedman Curt D. Furberg Bethesda, MD Wake Forest University USA School of Medicine [email protected] Winston-Salem, NC USA [email protected] David L. DeMets Department of Biostatistics & Medical Informatics University of Wisconsin Madison, WI USA [email protected] ISBN 978-1-4419-1585-6 e-ISBN 978-1-4419-1586-3 DOI 10.1007/978-1-4419-1586-3 Springer New ork Dordrecht Heidelberg London Library of Congress Control Number: xxxxxxxxxx © Springer Science + Business Media, LLC 2010 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New ork, N 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connec- tion with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Preface The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1].
    [Show full text]
  • What Is the Clinical Trial?
    한국보건정보통계학회지 제36권 제1호 Journal of The Korea Society of Health Informatics and Statistics 2011; 36(1): 1-14 What is the Clinical Trial? Young Jack Lee† LSK Global PS Abstract No drug is a drug until it is proven safe and effective (safety first-emphasis added). All drugs in these days have been approved by government authority after a series of clinical trials. Today, clinical trials have begun in Korea only recently. Nevertheless Korea is fast becoming a popular destination for multinational clinical trials. Korea Food and Drug Administration has defined that clinical trial is any investigation in human subjects to study effects of investigational products. Clinical trial is a process that must strictly abide by rules, regulations and study plans. Clinical trial of new drug candidate has very high chance of failure and thus is very difficult. Finally, clinical trial is scientific experiment within frame of ethics and respect for human rights. Technical core of this last point is statistical principles of minimizing bias and design of experiment. Final product of clinical trials is statistical inference about effects of investigational products in human body. So, answer to “What is the clinical trial?” is “a statistically valid medical inference- making process for medicine.” Keywords: Clinical trial, Statistical principles, Design of experiment, Clinical research [접수일: 2011년 5월 30일, 수정일: 2011년 6월 15일, 게재확정일: 2011년 6월 17일] Ⅰ. Introduction the clinical trial was allowed generally if the drug was being marketed elsewhere in the world, Korea has a short history of the modern day primarily the US, Western Europe and/or Japan. clinical trial.
    [Show full text]
  • Submission to Senate Inquiry
    Submission to Senate Inquiry “The identification of leading practices in ensuring evidence-based regulation of farm practices that impact water quality outcomes in the Great Barrier Reef” Dr. Lachlan Stewart Lachlan Stewart (PhD) is the Principal of Science Audit Service, a consultancy providing advice on the strengths or shortcomings of published scientific work. He holds the following tertiary qualifications: BSc (Mathematics), Class 1 Honours (Earth Science) and PhD (Earth Science), and his contributions to science have been recognised by the inclusion of his biography in Marquis Who’s Who in the World. Most of his career has been spent in the employment of James Cook University (JCU) and the CSIRO. He has held various paid research roles at JCU within the then departments of Physics (Radar Oceanography), Mathematics (Spinor and Tensor research software), Earth Sciences (Cooperative Research Centre Task 1.3.1/2 Sediment Accumulation and Dynamics on the Great Barrier Reef (GBR)), and Civil and Systems Engineering (Crown of Thorn Starfish dispersal modelling) and this experience has given him a very broad base of scientific understanding. Within the CSIRO he was heavily involved in the modelling and monitoring of sediment and nutrient delivery to the GBR lagoon from the Tully and Murray River catchments in North Queensland. In addition, he was also involved in the modelling of sugarcane crop growth and nitrate delivery to ground water under sugarcane cropping in the Burdekin delta. He is an author on 18 scientific papers published in international and national science research journals and numerous reports. Executive Summary Science Quality Assurance Based on my experience in auditing Great Barrier Reef (GBR) related science it is my opinion that there is a marked problem with the standard of quality assurance provided by the peer review process.
    [Show full text]
  • How Can the Integrity of Occupational and Environmental Health Research Be Maintained in the Presence of Conflicting Interests? Xaver Baur1* , Colin L
    Baur et al. Environmental Health (2019) 18:93 https://doi.org/10.1186/s12940-019-0527-x COMMENTARY Open Access How can the integrity of occupational and environmental health research be maintained in the presence of conflicting interests? Xaver Baur1* , Colin L. Soskolne2,3 and Lisa A. Bero4 Abstract Background: The sciences, and especially the research subspecialties of occupational and environmental health, are being misused. The misuse serves to interfere with the advancement of policies that depend on rational evidence needed for policies to protect public health. Methods: We selectively surveyed the independent scientific literature. In addition, the efforts of respected international professional organizations of scientists whose focus is on maintaining and improving public health have been considered. This commentary is unique in assembling not only the factual basis for sounding alarms about significant bias in occupational and environmental health research, but also about the manipulative mechanisms used, and, in turn, the methods needed to keep science honest. Results: Scientific integrity is based on the principle that research is conducted as objectively as possible; it cannot be compromised by special interests whose primary goals are neither to seek truth nor to protect human health. Evidence demonstrates a significant risk of bias in research reports sponsored by financial interests. Practices of corporate malfeasance include the orchestrated contamination of editorial boards of peer-reviewed scientific journals with industry
    [Show full text]