Professional Ethics Report

Home , Albert Sabin, Jane Goodall

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Publication of the American Association for the Advancement of Science (AAAS), Scientific Responsibility, Human Rights & Law Program, in collaboration with the AAAS Committee on Scientific Freedom & Responsibility

VOLUME XXVI NUMBER 4 FALL 2013

LABORATORIES WITHOUT They were the only model available to (NEAVS), questions the value of all animal CHIMPANZEES explore the routes of infection of HIV, research, including chimpanzee studies as well as viral replication and [14]. Although there are now vaccines for Deborah Runkle dissemination in the body [4]. hepatitis A and B, there is of yet no such • Monoclonal antibodies: Monoclonal preventive measure for hepatitis C, a fact Deborah Runkle is a Program Associate antibodies tested in chimps have been that those working to prohibit chimpanzee with the AAAS Scientific Responsibility, used to treat B-cell non-Hodgkin’s research have hit upon as evidence that Human Rights and Law Program, where lymphoma, rheumatoid arthritis, there is little value in using chimps for this she has lead responsibility for monitoring Crohn’s disease, and ulcerative colitis purpose [15]. This conclusion ignores the issues related to animals in research. [5]. The IOM report discussed below fact that for many years, one could have stated that, “chimpanzee/human concluded that non-human primates were The passion aroused by the use of chimeric monoclonal antibodies…have useless in the search for a polio virus. chimpanzees in research is in inverse proven to be effective in both in vitro Opposition to chimpanzee research among proportion to the actual number of animals and in vivo assays to neutralize the general public “has reached a historic used. That is, relatively few animals, great infectious viruses or to block the action high.” [16] People are accustomed to seeing passion. Chimps have always constituted a of bacterial toxins.” [6] chimps as cute and affectionate babies, not very small proportion of animals in • Ebola: A viral disease with a mortality the 150 pound creatures that male chimps biomedical research [1], but their close rate of up to 90% in humans, it is might become. Further, the pioneering genetic relationship with humans has made estimated to have killed approximately work of Jane Goodall, studying them a particularly valuable resource for a third of the world’s gorillas, as well chimpanzees in their natural habitat, has studying select diseases and behaviors. as many chimpanzees. “[B]y studying caught the imagination of millions who However, it is this very same relationship captive chimpanzees scientists are have watched documentaries, such as that motivates opposition to the chimp as a making progress towards an Ebola “Jane’s Journey,” with Angelina Jolie, or research subject. Testifying before an vaccine that they hope to test in wild PBS’s “Jane’s Wild Chimpanzees,” Institute of Medicine (IOM) hearing, apes and ultimately use to protect apes featuring chimps charmingly named Fifi discussed below, Kevin Kregel, Professor and humans…” [7] and her son Frodo. of Integrative Physiology and Radiation Oncology at the University of Iowa, and a Perhaps more appealing to the general And scientists’ cause isn’t aided with proponent of using chimps, acknowledged public are behavioral studies. Scientists revelations of possible mistreatment of the that “chimpanzees are a special case that have demonstrated that chimps exhibit animals. In 2009, HSUS reported that deserves special scrutiny…”[2] altruism [8]; have impressive memory skills during the course of an undercover [9]; and can solve complex problems [10]. investigation at the New Iberia Research Chimps in Research More controversially, some researchers Center (NIRC) [17], it discovered “routine Although not used often, chimps have claim that chimps have “language” or and unlawful mistreatment of hundreds of “speech.” [11] played an important role in medical chimpanzees and other primates.” [18] On progress: Animal Rights Groups March 3, 2009, ABC’s “Nightline” featured disturbing video that was shot by an HSUS • Vaccines: Chimpanzees, along with Despite the fact that “[h]umankind has investigator who had obtained employment thousands of monkeys were used in to benefited handsomely [12]” from at NIRC [19]. Joseph Savoie, president of identify attenuated strains of the polio knowledge gained through chimp research, the University of Louisiana, issued a virus that would protect humans the opposition to the animal’s use, led by statement saying the university had a against polio, without causing the animal rights groups like the Humane “clearly stated and direct no tolerance disease [3]. Further, research with Society of the United States (HSUS), has policy when the welfare of any animal in chimps led to the development of been strong and often effective [13]. our care is threatened, and we will continue diagnostic tests for hepatitis A, B, and Scientists and others working for animal to strictly enforce that policy.” [20] Two C and for vaccines for hepatitis A and rights groups have debated the value of months after that program aired, pursuant to B. chimpanzees in research on hepatitis and a complaint filed by HSUS, the US • HIV/AIDS: Chimps played an monoclonal antibodies. For example, Jarrod Department of Agriculture announced that important role in the early stages of the Bailey, a geneticist and science advisor for an “inspection revealed evidence of several drive to find a treatment for AIDS. the New England Anti-Vivisection Society issues with the facility’s compliance” with

Fall 2013 Professional Ethics Report 1 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • federal regulations regarding the care of intelligent and social” apes cannot have Protection Act will inhibit medical laboratory animals [21]. their needs met in a research environment advances and the research and that doing so causes the animals to community’s quest to improve human GAPA and Other Legislation “experience harmful stress and suffering.” health through new treatments and Not surprisingly, the concern over chimp GAPA would “prohibit invasive research vaccines.” FASEB also issued an “e- research has led to a variety of and the funding of such research,” action alert” to biomedical scientists, administrative measures regarding their transporting apes for research purposes, urging them to write to their senators use, as well as legislation, proposed or breeding apes for research, and “require the opposing the Act [27]. passed. In 1997, the National Institutes of permanent retirement of federally owned • In April 2010, 171 scientists “from the Health (NIH) announced a moratorium on great apes.” [23] GAPA defined “invasive most renowned universities” wrote to breeding government-owned chimps, and in research” very broadly, so that it included NIH Director Francis Collins 2007 stopped it altogether, citing cost any experimental procedure that could “decrying” the measure, stating that concerns [22]. In 2000, Congress passed, involve pain or distress; the testing of any “human-chimpanzee comparisons are and President Clinton signed, the drug that could be “detrimental to the essential for understanding the unique Chimpanzee Health Improvement, health of a great ape”; research that characteristics of human biology.” [28] Maintenance, and Protection Act (the involved tranquilizing or anesthetizing a • In a letter to members of Congress, the Chimp Act, PL 106-551). The Act great ape; or isolation or other “physical American Physiological Society’s prohibited the euthanasia of chimps, except manipulations” that could be detrimental to president, Joey Granger, “outlined the for humane health reasons; established a an ape’s “psychological well-being.” The importance of the research at risk [29]” federally-funded “retirement” system for Act would have permitted only “close if GAPSCA passed. chimps no longer needed for research; and observation of natural or voluntary The IOM Report required the government to assume part of behavior of a great ape” if that observation the cost of lifetime care for chimps outside would not require the ape to be removed In 2010, NIH announced that it was moving of research settings (chimps can live to be from its social group. 186 chimpanzees from the Alamogordo

60 years old). th Primate Facility at Holloman Air Force Having failed in the 110 Congress, GAPA In 2008, Representative Edolphus Towns was re-introduced in 2009 (H.R. 1326) and Base in New Mexico to the Southwest introduced the Great Ape Protection Act again in 2010 (S.3694), but made no National Primate Research Center in San (GAPA) in the House of Representatives legislative progress. In 2011, taking note of Antonio, where they would be used in (H.R. 5852). The Act stated that the “highly the increasing concern over the national hepatitis C research. The chimps had been debt, the bill was re-named the Great Ape housed at Alamogordo under a 10-year- contract between NIH and the military that Protection and Cost Savings Act (GAPSCA) and introduced in both the prohibited biomedical research on the Editor: Mark S. Frankel animals while at the facility but not their Deputy Editor: Rebecca Carlson House (H.R. 1513) and the Senate (S. 810). This time around, the bill was headed for eventual use in research elsewhere. Contributing Authors: Josh Ettinger and Alamogordo had a troubled history; the Kathryn Smith the Senate floor, where it was successfully blocked by Senator Ron Wyden [24]. chimps had been removed from the The Professional Ethics Report (PER) is Coulston Foundation, a New Mexico published quarterly by the Scientific The scientific community was not silent research laboratory that the federal Responsibility, Human Rights & Law during the repeated introductions of the government determined had been abusing Program in collaboration with the legislation. and neglecting the animals [30]. Committee on Scientific Freedom and Responsibility. • In April 2009, the AAAS Board of The NIH announcement did not go Directors issued a statement stating, unnoticed. Along with Jane Goodall and Issues of PER are available online at: “Because of the unique role that animal rights groups, then-Governor Bill http://www.aaas.org/page/professional- studies of chimpanzees play in Richardson expressed “outrage” at the ethics-report-archives assuring continuing medical progress, attempt to transfer the chimps to an active AAAS, 1200 New York Avenue NW AAAS opposes the Great Ape research facility [31]. On the second-to-last Washington, DC 20005 Protection Act….” [25] day of his term, Richardson was notified (Tel) 202-326-6217 (Fax) 202-289-4950 • Also responding to the 2009 iteration, that Francis Collins had decided to “delay” Email: [email protected] the American Society for moving the animals. Consistent with a Pharmacology and Experimental request made by the governor, Collins Therapeutics issued a statement requested the NAS/IOM to “weigh in” on saying, “These non-human primates the use of chimps in medical research [32],

are a critical animal model. and carry out an “in-depth analysis to This newsletter may be reproduced without Eliminating them from research will reassess the scientific need for the permission as long as proper restrict advances in human medicine.” continued use of chimpanzees to accelerate acknowledgement is given. ISSN: 1045- [26] biomedical discoveries.” [33] The IOM 8808 • On September 3, 2010, FASEB formed an ad-hoc committee, which held responded to the Senate version of three 2-day meetings from May-November GAPA via a letter to Senators Maria 2011, several conference calls, and two Letters to the Editor: The editors welcome “information-gathering” sessions [34]. comments from our readers. We reserve the Cantwell, Susan Collins, and Bernard right to edit and abridge the letter as space Sanders (co-sponsors of the permits. Please address all correspondence to legislation) from its president, William the deputy editor. Tallman: “Passage of the Great Ape Runkle continued on page 3

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Runkle continued from page 2 “potential” exceptions: (1) there might studies with chimps met the IOM be a “limited number” of monoclonal committee’s guidelines, establishing a In its report, the committee acknowledged antibodies already in development that process for assessing future proposed that it had been asked for its “advice on the could require further use of chimps, research projects to determine whether they scientific necessity of the chimpanzee as an and (2) “the committee was evenly are scientifically necessary and consistent animal model for biomedical and split and unable to reach consensus on with the IOM guidelines, and advising on behavioral research,” and that it should not the necessity of the chimpanzee for the the conditions and placement of both base its recommendations on cost or ethical development of a prophylactic currently active and inactive chimps. The considerations [35]. In fact, at its first hepatitis C …vaccine.” working group called for ending many public meeting, Sally Rockey, Deputy • It may not be possible to study ongoing studies, but recommended the Director for Extramural Research at NIH, emerging or reemerging diseases in maintenance of a colony of 50 chimps, specifically ruled out the role of ethics in models other than the chimpanzee and, should they be needed for future emergency the committee’s charge, saying only that if therefore, its use would be permissible. research, as envisioned by the IOM it wasn’t scientifically necessary to use • Because chimps and humans are so committee [42]. chimpanzees in research, it certainly would genetically similar, “[c]omparative Although the IOM committee’s guidelines be unethical to do so. Nevertheless, a genomics research may be necessary included the recommendation that “[t]he bioethicist, Jeffrey Kahn, then Director and for understanding human development, animals used in the proposed research must Professor at the Center for Bioethics, disease mechanisms, and be maintained either in ethologically University of Minnesota, was chosen to susceptibility….” Thus, when studies appropriate physical and social chair the committee. Thus, not surprisingly, are conducted using existing tissue or environments or in natural habitats,” the committee “recognize[d] that any when minimum pain and distress is nowhere did it specify the nature of these assessment of the necessity for using involved in collecting samples from environments. This gap was filled by 10 chimpanzees as an animal model…raises living animals, this research is recommendations in the working group’s ethical issues, and any analysis must take allowed. report, which set forth specifics, for these ethical issues into account.” [36] • When chimpanzee research could example, regarding the size of a chimp’s The committee issued its report on provide “insights to support living space, materials to build nests, and December 15, 2011. The report set forth the understanding of social and behavioral “an enrichment program developed for criteria it used in making recommendations factors that include the development, chimpanzees” that would include “relevant on the continuing need for chimpanzees in prevention, or treatment of disease” opportunities for choice and self- biomedical research: not obtainable through other means, it determination.” These criteria were an would be necessary [39]. attempt to promote “a full range of • The knowledge gained must be behaviors that are natural for the species.” necessary to advance the public’s Thus, although the IOM committee did not [43] health; endorse a ban on research with chimps, it was hard not to interpret the committee’s • There must be no other research model Stakeholders React conclusions as anything but a “watershed by which the knowledge could be Given an opportunity to comment on this obtained, and the research cannot be event” related to the use of chimpanzees in research [40], erecting formidable hurdles report, representatives of both the scientific ethically performed on human and animal rights communities did so. An subjects; and in the way of continuing federally- supported biomedical research, although example of the latter are the comments of • The animals used in the proposed not behavioral research, with chimpanzees. NEAVS and others activist groups that laid research must be maintained either in out in more detail the “exemplary” social ethologically appropriate physical and NIH Reacts and physical requirements of chimps [44]. social environments or in natural Within hours following release of the IOM The American Physiological Society habitats [37]. Report, Francis Collins made the following expressed some of the research In addition to the criterion related to announcement: “I have considered the community’s concerns in its comments, appropriate environments, the committee report carefully and have decided to accept which “urged” NIH to “revisit” the added the following criteria for the IOM committee recommendations.” He recommendations. For example, the society comparative genomics and behavioral added that NIH was “in the process” of cited the working group’s “excessive research: developing plans to implement the reliance on inflexible engineering recommendations and that he had delegated standards” in defining “appropriate” • Studies provide otherwise unattainable the task to a working group of the NIH environments, rather than “performance insight into comparative genomics, Council of Councils. The working group standards” that “would better serve animal normal and abnormal behavior, mental would “consider the size and placement of welfare.” [45] This particular critique was health, emotion, or cognition; and the active and inactive populations of NIH- typical of the concern of scientists familiar • All experiments are performed on owned or –supported chimpanzees” and no with the issue, that is, the environmental acquiescent animals, in a manner that new awards for research involving the requirements were unrealistic, at best, and minimizes pain and distress, and is animals would be granted until the plans more likely unrealizable. Some referred to minimally invasive [38]. were in place [41]. the living space specifications as “condos for chimps,” and even Chimp Haven, the Following are some of the committee’s key Almost a year after its convening (January conclusions and recommendations: “gold standard” of retirement sanctuaries 22, 2013), the Council of Councils accepted would not be able to meet the new • “[M]ost current use of chimpanzees for the working group’s report, which included requirements. Although the working biomedical research is unnecessary…. 28 recommendations, focusing on “The committee allowed two reviewing which currently-funded NIH Runkle continued on page 4

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Runkle continued from page 3 Director Dan Ashe said that the earlier split “just not feasible” as a legal strategy [61]. designation was designed to permit the NIH The Project’s Wise is undaunted, and plans group’s report stated that “[t]he majority of to fund biomedical studies with captive to appeal the cases to the appropriate New NIH-owned chimpanzees should be chimps, but was “flawed.” [52] FWS York Appellate Divisions, saying the designated for retirement and transferred to justified this action by its determination that “struggle to attain the personhood of such the federal sanctuary system,” the fact is the Endangered Species Act “does not an extraordinarily cognitively complex there was neither enough room in existing allow for captive-held animals to be nonhuman animal as a chimpanzee has sanctuaries for these retired chimps nor the assigned a separate legal status from their barely begun.” [62] funds to maintain them. Further, many of wild counterparts.” [53] If, after a 60-day The Future the chimps in research settings were elderly comment period, the proposal was adopted, and likely not to survive transfer from their “certain activities would require a Building on their success at achieving the current living spaces, not to mention the permit….Permits would be issued only for near-elimination of all biomedical research disruption in existing social groups this scientific [and certain other] purposes….” on chimpanzees, animal rights groups are would entail. [54] reaching for higher goals. Writing in the Hastings Center Report in 2012, Kathleen On June 26, 2013, Collins accepted most of While the National Antivivisection Society Conlee and Andrew Rowan, vice president the working group’s suggestions. pronounced the FWS proposal “welcome,” for animal research issues and chief [55] scientific societies expressed their • Retain but do not breed a small group scientific officer at HSUS, respectively, worries about the implications of the action. of chimpanzees for future research that argued that “[t]he process that culminated Both the American Physiological Society meets the IOM guidelines; in the phasing out of invasive research on and FASEB urged FWS to “expedite the • chimpanzees in the United States in 2011 Provide ethologically appropriate permitting process” [56] for “critical can and should be applied to all other housing facilities, like those that would research aimed at preventing or treating nonhuman primates.” Their reasoning occur in their natural environment; devastating diseases…,” [57] but did not sounds familiar: Research on primates • Establish a panel to review future ask the agency to reconsider its decision. should be halted for “ethical, scientific, and projects that propose using chimps As of this writing, FWS has not issued a economic reasons.” [63] The force of these based on the IOM guidelines, after the final rule. standard NIH review panel had arguments on the public, congress, the approved the research; Chimpanzee Rights executive branch, professional ethicists, and even some scientists should not be • Wind down ongoing projects using On December 2, 2013, the Nonhuman underestimated. chimps that do not meet the IOM Rights Project filed the first of three criteria; and lawsuits in New York State courts on References • Retire the majority of the NIH-owned behalf of four chimpanzees, two of which [1] Only .056 of animal studies funded by the National chimps designated as unnecessary for were used for locomotion research at Stony Institutes of Health, the largest funder of biomedical research [46]. Brook University. The judges were asked to research, used chimps in 2011. “Chimpanzees in Biomedical and Behavioral Research,” The National The animal rights community cheered this grant the animals’ right to “bodily liberty.” Academies Press, 2011, p. 9 (IOM Report). announcement, with Wayne Pacelle, [58] Steven Wise, president of the rights [2] Testimony before the IOM committee “Chimpanzees in organization who has taught animal law at Biomedical and Behavioral Research,” May 26, 2011. president and CEO of HSUS, proclaiming, [3] Albert Sabin, Letter to the Winston-Salem Journal, “This is an historic moment and major several universities, said that chimps March 20, 1992. “possess complex cognitive abilities that [4] E-mail from Nancy Haigwood, Director and Senior turning point for chimpanzees in Scientist, Oregon National Primate Research Center. laboratories.” [47] are so strictly protected when they’re found [5]www.faseb.org/portals/2/PDFs/opa/ChimpanzeesinBiom in human beings.” [59] In support of its edicalResearch_IOM.pdf The only working group recommendation argument, the rights organization submitted [6] IOM Report, p. 37. not adopted was the specification of 1000 [7] William Talman, “The Benefits of Studying affidavits from what Wise termed “nine of Chimpanzees,” Huff Post Science, posted August 6, 2012. feet of living space per chimp (more than in the world’s leading primatologists.” [60] In [8]www.yerkes.emory.edu/about/news/developmental_cog some small urban apartments) on the a live “chat” sponsored by AAAS, Wise nitive_neuroscience/chimpanzees_generous.html. grounds that there was yet no scientific [9] “Young Chimps Top Adult Humans in Numerical emphasized that he was not asking for Memory,” Science Daily, Dec. 9, 2007. consensus on this criterion [48]. This “human rights” for the animals, rather he [10] Menzel, E.W., Savage-Rumbaugh, E.S., and Lawson, modification in housing requirements was seeking “chimpanzee rights,” and that J., “Chimpanzee (Pan troglodytes) Spatial Problem Solving meant that some chimps could continue to with the Use of Mirrors and Televised Equivalents of the animals should be declared persons who Mirrors,” Journal of Cognitive Psychology, Vol 99(2), June be maintained in research facilities [49]. were being unlawfully imprisoned. 1985. [11] George Johnson, “Chimp Talk Debate: Is It Really Fish and Wildlife Service Wise also said he did not expect to be Language,” New York Times, June 6, 1995. successful in any of the three lawsuits, a [12] “Great Ape Debate,” Nature, 474, 252, June 16, 2011. Just weeks before NIH’s final action on [13] HSUS sponsors a “Chimps Deserve Better” campaign, chimpanzee research, the Fish and Wildlife prediction that proved correct. According to with websites soliciting donations, seeking “scientists, Wise, two of the three judges expressed academics & health care professionals” to support the Service (FWS), acting on a petition from cause, and offering the opportunity to take the several organizations – including HSUS, sympathy in their rulings dismissing the “chimpanality quiz.” In 2009, K-12 students were able to the Association of Zoos and Aquariums, suits, with one of them saying “[y]ou make compete in a “Celebrate Chimpanzee” contest, and in 2012, a very good argument.” The third, in whose activists were able to participate in a 5K Freedom Run. and the Jane Goodall Institute [50] – [14] www.neavs.org/about/expert/bailey-jarrod. See, “An proposed to classify all chimps, whether in court the Stony Brook’s chimps case was Assessment of the Use of Chimpanzees in Hepatitis C the wild or in captivity, endangered. This submitted, dismissed the suit hours after it Research, Past, Present and Future, ALTA (Alternatives to was filed, without holding a hearing. Laboratory Animals),” 38(5): 387-418, 2010. would change the status quo, whereby only [15] R.H. Bettauer, “Chimpanzees in Hepatitis C wild chimps were considered endangered, Although a senior litigator for HSUS thinks Research,” Journal of Medical Primatology, 39(1), 9-23. and captive animals were classified as the Nonhuman Rights Project’s arguments threatened [51]. Fish and Wildlife Service are academically impressive, he finds them Runkle continued on page 5

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Runkle continued from page 4 http://www.washingtonpost.com/national/health- FDA is particularly concerned about the science/fish-and-wildlife-proposes-endangered-listing-for- chimpanzees/2013/06/11/1f3382f4-d216-11e2-a73e- consequences of the service on the health 2010. A group of scientists representing the National decisions of consumers: false positives or Chimpanzee Resource Consortium issued a sharp rebuttal 826d299ff459-story.html. to this article in a subsequent letter to the editor, 39(5), [51] “U.S. Fish and Wildlife Service Proposes Protection false negatives on disease assessment October 2010. for All Chimpanzees – Captive and Wild – as Endangered,” measures could lead consumers to circumvent http://www.fws.gov/home/newsroom/serviceproposeschim [16] Nature, id. their physicians and make irresponsible [17] NIRC is one of the federal government’s National panzeesNR06112013.html (FWS). Primate Research Centers and is part of the University of [52] Fears, id. choices regarding their personal health. For Louisiana. [53] FWS, id. example, if the results report a false-positive [18]www.humanesociety.org/news/news/2009/03/undercov [54] FWS, id. [55] “U.S. Fish & Wildlife Proposes Listing All for ovarian or breast cancer, it could lead, “a er_investigation_chimpanzee. patient to undergo prophylactic surgery, [19]http://abcnews.go.com/Nightline/story?id=6997869. Chimpanzees as ‘Endangered’,” [20] Id. http://www.navs.org/pages/news/u.s.-fish-wildlife- chemoprevention, intensive screening or other [21]http://www.aphis.usda.gov/newsroom/content/2009/05/ proposes-listing-all-chimpanzees-as-endangered- morbidity inducting actions, while a false #.UtAsa7TyR2k. newiberia.shtml The USDA is the federal agency charged negative could result in a failure to recognize with administering the Animal Welfare Act, governing the [56] http://the- care of laboratory animals. aps.org/mm/SciencePolicy/AnimalResearch/Current- an actual risk that may exist.” Others have [22] Will Dunham, “U.S. Stops Breeding Chimps for Issues/ChimpsandGreatApes/FWSandChimpanzeeResearch also cited privacy concerns over 23andMe’s Research,” http://www.reuters.com/article/2007/05/24/us- .html. handling of personal genetic information [3]. chimpanzees-research-usa-idUSN2438996. Lifetime care [57] Letter from Margaret Offermann, FASEB President to for a chimpanzee can cost $500,000. FWS, www.faseb.org/portals/2/PDFs/opa/8.12.13. According to the FDA’s letter to 23andMe, [58] Michael Mountain, “Lawsuit Filed Today on Behalf of [23] Although great apes include gorillas and orangutans, dated November 22, 2013, the company failed as well as chimps, for all practical purposes, the Act was Chimpanzees Seeking Legal Personhood,” aimed at preventing almost all research involving chimps. http://www.nonhumanrightsproject.org/2013/12/02/lawsuit- to gain the clearance necessary to clinically [24] http://www.the- filed-today-on-behalf-of-chimpanzees-seeking-legal- prove that its product fulfills its marketed aps.org/mm/SciencePolicy/AnimalResearch/Current- personhood/. purposes. “We have become aware that you Issues-ChimpsandGreatApes/Sen-Wyden-on-Chimp- [59] Bernard Vaughan and Daniel Weissner, “New York Research.html. Senator Wyden has a National Primate Lawsuit Seek ‘Legal Personhood’ for Chimpanzees,” have initiated new marketing campaigns, Center in his state. http://www.reuters.com/article/2013/12/02/us-usa- including television commercials that, [25]www.aaas.org/sites/default/files/migrate/uploads/0429b chimpanzees-lawsuit[idUSBRE9B1OUE20131202. together with an increasing list of indications, [60] Brandon Keim, “Judge Rules Chimps Can’t Be Legal oardstatement_on_apes.pdf. show that you plan to expand the PGS’s uses [26] http://www.aspet.org/Page.aspx?id=728. Persons, but Activists Vow to Fight On,” [27]http://opa1.faseb.org/pages/WashingtonUpdate/Sept03 http://www.wired.com/wiredscience/2013/12/chimpanzee- and consumer base without obtaining 10/page2.htm. personhood-claims-denied/. marketing authorization from FDA.” In [28] Jon Cohen, id. [61] Keim, id. response to the FDA, 23andMe’s chief [29] http://www.the- [62] “Chimpanzee Lawsuits Rejected in New York aps.org/mm/SciencePolicy/AnimalResearch/Current- Court,”http://www.natureworldnews/com/articles/5270/201 executive officer, Anne Wojcicki, Issues/ChimpsandGreatApes/Great-Ape-Research- 31211/chimpanzee-lawsuite-rejected-new-york-court.htm. acknowledged the FDA’s directive and Ban.html. [63] Kathleen Conlee and Andrew Rowan, “The Case for announced a suspension of health-analysis Phasing Out Experiments on Primates,” Hastings Center [30] Dan Frosch, “Will Aging Chimps Get to Retire, or tests until receiving further FDA authorization Face Medical Resarch,” The New York Times, Sept. 1, Report, 42, no. 6 (2012). 2010. [1]. The company will continue to provide [31] Id. new customers with ancestry information and [32] “NIH Puts Hold on Move of Alamogordo Chimps, In the News raw genetic data without 23andMe’s Pending NAS Study on Chimp Research,” interpretation of the data. http://blogs.nature.com/news/2011/nih_puts_hold_on_mov e_of_alamo.html. FDA REBUKES PERSONAL GENOME Some observers are critical of the severity of [33] Id. [34] “Chimpanzees in Biomedical and Behavioral SERVICE OVER CONCERNS ABOUT the FDA’s stance on 23andMe. An article Research: Assessing the Necessity,” The National CONSUMER HEALTH DECISIONS published on January 16, 2014 in Nature Academies Press, 2011 (IOM Report), p. 15. argues that the FDA’s actions against [35] Id. at 14. For just 100 dollars, you can have your [36] IOM Report at 14. 23andMe were unwarranted [4]. The authors [37] Id. p. 4. genome decoded, ancestry traced and health concede that 23andMe should be required to [38] Id. p. 33. risks for more than 250 diseases analyzed. So reveal the limits of their tests to consumers; [39] Id. pp. 4-5. states the Personal Genome Service (PGS), however, according to their research, fears [40] Meredith Wadman, “US Chimpanzee Research To Be Curtailed,” http://nature.com/news/us-chimpamzee- 23andMe, which offered this package for 6 over harmful patient health choices are research-to-be-curtailed-1.9663. years until receiving a harsh warning letter unfounded. After surveying 1,051 customers [41] “Statement by NIH Director Dr. Francis Collins on the from the FDA last November. of 23andMe and a similar company, Pathway Institute of Medicine Report Addressing the Scientific Need for the Use of Chimpanzees in Research,” 23andMe is one of the leading companies in Genomics, they found that 58% of consumers http://www.nih.gov/news/health/dec2011/od-15.htm. the emerging industry of direct-to-consumer did nothing with their genome results and out [42] “Council of Councils Working Group on the Use of genome testing services. Consumers send in of the 42% who did make changes to their Chimpanzees in NIH-Supported Research: Report,” health routines, the majority only changed dpcpsi.nih.gov.sites/default/files/FNL_Report_WG_Chimp biological samples via saliva kits and the anzees_0.pdf. (Working Group Report). company then sends back a detailed analysis their diet or exercise frequency. Only 2% of [43] Id. pp. 3-4. the surveyed customers changed their [44]www.releasechimps.org/resources/article/comments- of their genes. 23andMe is the largest company of its kind, boasting a collection of prescription drug use without first consulting on-nih-council-report-on-the-use-of-chimpanzees-in- their physician. research. 250 million data points constructed from the [45] http://www.the- genomes of more than 500,000 customers aps.org/mm/SciencePolicy/AnimalResearch/Current- In contrast, others laud the FDA’s push for who have participated in their service [1]. greater integrity in this industry. The Issues/APS-Urges-NIH-to-Revisit-Chimpanzee- Recommendations.html. The FDA, however, claims the company Washington Post editorial board wrote, [46] “NIH to Reduce Significantly the Use of Chimpanzees “Genetic testing should not become like the in Research,” http://www.nih.gov/news/health/jun2013/od- failed to meet regulatory standards. Despite, 26.htm (NIH Chimp Announcement). “more than 14 face-to-face and teleconference Wild West of the dietary supplement industry [47] Chris Palmer, “NIH to Reduce Significantly the Use of meetings, hundreds of email exchanges, and into which Americans pour billions annually Chimpanzees in Research,” http://www.the- dozens of written communications,” 23andMe even though quality varies massively and scientist.com/?articles.view/articleNo/36208/title/NIH-to- dubious claims go unchecked.” [5] Though Cut-Back-on-Chimpanzee-Research/. has consistently failed to comply with FDA [48] NIH Chimp Annoncement id. guidelines and follow through on clinical the FDA may have had tough words for [49] Palmer, id. [50] Darryl Fears, “Fish and Wildlife Proposes Endangered studies confirming its effectiveness and Listing for Captive Chimpanzees,” adherence to health requirements [2]. The News continued on page 6

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News continued from page 5 argument made by POD proponents that their [1]http://oig.hhs.gov/oei/reports/oei-01-11- business model is more cost-effective. 00660.asp

23andMe, it simultaneously took steps to help [2]http://www.finance.senate.gov/newsroom/chairm The report’s findings support criticisms of an/release/?id=3145394a-3184-44d4-a730- the genetics industry grow as well. Last PODs by policymakers, healthcare officials b432d259d034 November, it approved the Illumina and others. Conflicts of interest may cause [3]https://oig.hhs.gov/fraud/docs/alertsandbulletins/ MiSeqDx, an innovative gene sequencing physicians to make decisions that are not in 2013/POD_Special_Fraud_Alert.pdf device which will further reduce the time and the best interest of their patients (whether this [4]http://www.medscape.com/viewarticle/813213 cost of genomic analysis [6]. is done intentionally or unconsciously is *JE [1]http://blog.23andme.com/news/23andme- unclear). When physicians or hospital officials provides-an-update-regarding-fdas-review/ derive personal economic benefits from the COLLABORATIVE RESEARCH [2]http://www.fda.gov/iceci/enforcementactions/wa use of a particular surgical device, they can be GUIDELINES rningletters/2013/ucm376296.htm motivated to place more patients in surgery - [3]http://www.scientificamerican.com/article.cfm?i d=23andme-is-terrifying-but-not-for-reasons- which can be dangerous for patients. When Since 2007, the scientific research community fda&page=2 choosing between medical devices, physicians has held a world conference on research [4]http://www.nature.com/news/regulation-the-fda- may select the particular device in which they integrity to facilitate discussion around is-overcautious-on-consumer-genomics-1.14527 are invested, rather than the most suitable responsible research [1]. After the 2nd World [5]http://www.washingtonpost.com/opinions/a-safe- choice for a patient. Additionally, as a Conference, The Singapore Statement was smart-approach-to-genetic- significant percentage of operations are released and widely distributed on September testing/2013/12/01/2777b988-56e8-11e3-835d- funded by Medicare, unnecessary surgeries 22, 2010 [2]. This was the first global effort to e7173847c7cc_story.html waste taxpayer dollars. issue general research principles and [6]http://www.nejm.org/doi/full/10.1056/NEJMp13 14561?query=featured_home&& Senator Orrin Hatch (R-Utah) was one of responsibilities intended to challenge

several members of Congress to voice his governments, organizations, and researchers *JE to develop more comprehensive standards to concerns over PODs and call for an investigative report by the Department of foster research integrity, both locally and on HHS FINDS THAT PHYSICIAN OWNED Health and Human Services. “My deep-seated an international basis. DISTRIBUTORSHIPS CORRELATE skepticism that physician-owned distributors rd WITH INCREASED SURGERIES In October 2013, emerging from the 3 World operate in the best interest of patients and save Conference, The Montreal Statement was If physicians hold a financial stake in the taxpayers money has been confirmed by this produced as an extension of The Singapore surgical equipment they use, will they non-partisan report,” Hatch said, “The HHS Statement [3]. This Statement offers Inspector General’s finding that hospitals recommend more of their patients to undergo guidelines specifically for cross-boundary surgery? A new report, released on October conduct a greater number of high risk spinal research collaborations rather than just the 24, 2013, by the U.S. Department of Health surgeries when they purchase products from broad topic of integrity applied to all research and Human Services Office of Inspector physician-owned distributors shows why endeavors. The guidelines are divided into vigorous oversight is necessary to protect the General (HHS-OIG), suggests that they will. four sections: General Responsibilities, health and safety of patients.” [2] Management, Relationships, and Outcomes of According to the report, “Spinal Devices Before the report’s publication, HHS-OIG Research [4]. Each one addresses a different Supplied By Physician-Owned Distributors: component essential to collaborative research. Overview of Prevalence and Use,” there was a released a Special Fraud Alert on physician- owned entities in March 2013 [3], in which The general responsibilities section looks at direct correlation between physicians who are the vision and expectations of each individual, financially invested in their surgical devices the HHS-OIG suggests that some PODs may be in violation of the Anti-Kickback Statute - as well as the institutions involved. through Physician Owned Distributorships Management focuses on communication, (PODs) and an increase in the number of a law under the Social Security Act that “makes it a criminal offense to knowingly and leadership, and logistics. Relationships spinal fusion surgeries [1]. PODs are describes roles and how to handle conflicting distributers of medical equipment that willfully offer remuneration to induce, or in return for, referrals of items of services situations in order to maintain effective maintain financial relationships with collaboration. Finally, outcomes of research physicians, hospital administrators or other reimbursable by a Federal health care program.” [1] According to the HHS-OIG, if covers the responsibilities after the research is health professionals. In the case of spinal PODs intentionally encourage greater conducted including publication, surgeries, PODs are often responsible for the dissemination, and response to misconduct. devices implanted into the spine for structural Medicare covered surgeries by offering support including, plates, screws and rods. physicians financial rewards, they are not Additionally, several themes appear within all complying with this statute and may be the sections, emphasizing their overall The report found that one in five spinal fusion prosecuted. importance to the practice of responsible surgeries billed to Medicare used devices While the Inspector General’s report does collaborative research. First, trust and supplied by PODs in Fiscal Year (FY) 2011. agreement show up repeatedly as fundamental In an analysis spanning from FY 2004 validate some of the concerns of POD opponents, the results are limited to a to establishing and upholding strong through FY 2012, spinal surgery rates grew partnerships. Collaborations are all about faster at hospitals after they began purchasing particular type of surgery within a single medical field. There have been similar teamwork, and the job becomes more difficult from PODs than the rate of spinal surgery when trust and agreement are absent. Second, increase for hospitals overall. Increases in the reported cases such as the high profitability of intensity-modulated radiation therapy procedure, assumptions, and transparency are number of spinal surgeries for hospitals also reoccurring concepts. They indicate that supplied by PODs were three times the overall (IMRT), a treatment for prostate cancer done by urologists that receives high Medicare policies and procedures should be determined increase in spinal surgeries for all hospitals in at the commencement of the project and the study (16% increase vs. 5% increase). reimbursement rates [4]; however, broader analysis of PODs will be necessary to clearly communicated to all parties. Third, Furthermore, the cost of spinal fusion authorship and acknowledgment illustrate that surgeries that used POD devices were not accurately gauge their full impacts and guide future regulatory action. lower than the cost of surgeries without POD devices, thus undermining a common News continued on page 7

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News continued from page 6 were tied to seed samples discovered in the an explicit discussion about such processes at luggage of several Chinese delegation the beginning of a project. those responsible for the research, funding, members. The accused in both cases are Second, there is increased pressure to author and other contributions must be given currently being prosecuted, some facing published work. As stated in the New York adequate credit for their work and charges that include conspiracy to steal trade Times a few years ago, “to survive accomplishment. secrets. The two cases were made public last professionally, scientists feel the need to December, and it is unclear whether they are In conclusion, The Montreal Statement publish as many papers as possible. And related. advances expectations for collaborative sometimes they cut corners or even commit research across all sectors, disciplines, The corporate facilities from which the misconduct to get there.” [2] Ultimately, the institutions, and nations. Its publication and Chinese men stole seeds are where large standard for getting published is dissemination are intended to make it easier agricultural companies test new technologies. compromising scientific integrity, which not for others to provide the leadership needed to These companies typically invest millions of only affects the science but society’s promote integrity in research on a global dollars into research and development efforts - perception of science. basis, with a common approach to the Monsanto devotes over a billion dollars to The challenges with defining authorship can fundamental elements of responsible research R&D each year alone [3]. The innovations be reconciled by adopting policies or practice. The Montreal and Singapore that result provide these companies with key guidelines. The International Committee of Statements are a reflection of how guidelines competitive advantages in the agricultural Medical Journal Editors (ICMJE) suggests are adapting to changing research practice, market; therefore, companies are seriously that those identified as authors meet all of the significantly advancing the ethical discussion concerned about the security of their research following criteria: play a substantial role in on science, impacting not only the research and manufacturing process. the design of the research and the acquisition community but all those who benefit from the [1]http://www.scmp.com/news/world/article/13800 and analysis of the data; draft, revise and edit knowledge gained through their work. 11/prosecutors-us-midwest-charge-six-chinese-plot- the work; have the authority to make the final [1] http://www.esf.org/ext-ceo-news- steal-seed-corn approval before publishing; and take full singleview/article/world-conference-on-research- [2]http://www.theguardian.com/world/2013/dec/14/ responsibility for all aspects of the work [3]. integrity-to-foster-responsible-research-318.html chinese-scientists-accused-seed-theft [3]http://www.monsanto.com/careers/Pages/researc In addition to accepting responsibility for the [2]http://www.singaporestatement.org/ research, editing, and publication, ICMJE’s [3]http://download.thelancet.com/pdfs/journals/lanc h.aspx criteria also emphasizes that the authors are et/PIIS0140673613621261.pdf *JE [4]http://www.cehd.umn.edu/olpd/MontrealStateme accountable for anyone who contributes to the nt.pdf\ research. They must trust that the work and AUTHORSHIP GUIDELINES REVISED results are correct. This indicates that *KS authorship is more than just a byline. Assigning credit for scientific discoveries, FEDERAL OFFICIALS REVEAL PLOTS research, and analyses has always been a Some non-conventional methods have also TO STEAL PATENTED U.S. problematic endeavor. Timing, collaboration, been established to address authorship. AGRICULTURAL TECHNOLOGY and building upon results that have already Stanford University has a hands-off approach. been obtained are some factors that contribute There are not any specific guidelines because In what reads like a spy thriller, the FBI to the increasingly more difficult task. At the the university does not wish to, “impose recently uncovered two separate plots of end of the day, the credit will go to the names formal mechanisms for determining Chinese individuals attempting to steal included in the byline of a published piece in authorship,” rather they distribute a letter patented seed technology from the United a prominent scientific journal. This reality written by President Donald Kennedy in 1987 States. In one of the cases, several Chinese makes it critically important to establish and revised in 2012, regarding intellectual men - including the chief executive officer of guidelines that clearly distinguish authorship. contribution to all research laboratories to Beijing agricultural company, Kings Nower Scientific journals, laboratories, and academic incite discussion and action [4]. Some Seed - were observed stealing corn from test institutions are encouraged to set policies publishers such as Nature even go as far as fields owned by Monsanto and DuPont regarding authorship, and indeed many requiring author contribution statements to Pioneer in Iowa [1]. After obtaining court already have them in place. The fundamental ensure the role of each author and contributor orders, federal agents installed surveillance purpose of the policies is to remove ambiguity is explicitly stated. These statements “may go devices in their rental car, listened in on their about whether or not a contribution warrants a long way toward resolving authorship issues plans and followed the men through several authorship. These policies do not eliminate all by providing an additional dimension to the states as they collected additional corn confusion and disputes about authorship, but linear author lists of current papers.” [5] The samples. When Kings Nower Seed CEO, Li they are a valuable aid in mitigating them. methods presented here are feasible for these Shaoming, and an associate prepared to fly particular organizations, but they may not back to China, U.S. Customs agents searched There are challenges that make determining work for all. Nevertheless, they inspire the men and found seed samples hidden authorship a less than straight-forward task creative approaches to the ever growing among their belongings. Another member of that are worth noting. First, collaborative problem of authorship to ensure standards are the group, a dual Chinese-Canadian citizen, work is becoming more prevalent in the field being set for the next generation of scientists. was apprehended when attempting to cross the of science. Complex research projects must employ a wide variety of scientists in order to [1]http://www.nytimes.com/2002/11/19/science/afte Canadian border with seed samples hidden r-two-scandals-physics-group-expands-ethics- under his car seat. broaden the depth of knowledge. Because no guidelines.html one is always an expert on every aspect of a [2]http://www.nytimes.com/2012/04/17/science/rise In a separate incident, two Chinese project, “all collaboration should have in -in-scientific-journal-retractions-prompts-calls-for- agricultural scientists working at research place an appropriate process for reviewing reform.html facilities in Kansas were accused of passing and ensuring the accuracy of the reported [3] http://icmje.org/roles_a.html seed samples to a visiting Chinese delegation results, and all co-authors should be aware of [4]http://doresearch.stanford.edu/policies/research- [2]. Yan Wengui and Zhang Weiqiang, this process.” [1] To resolve this issue, senior policy-handbook/conduct-research/academic- working for the United States Department of scientists must be transparent about their authorship

Agriculture and an American expectations and policies. They should initiate biopharmaceutical company respectively, News continued on page 8

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News continued from page 7 Fellowship - The Poynter Center announces the opportunity for a non-stipendiary fellowship at [5]http://www.nature.com/nchembio/journal/v5/n10 Announcements the Center in academic year 2015. The Fellow /full/nchembio.f.13.html will be expected to work on a significant Book Series - Emerging Technologies, Ethics research project in ethics and public life, broadly *KS and International Affairs is a new book series construed, and to participate in the Center’s edited by Jai Galliott, Avery Plaw and Katina scheduled seminars, lectures, and symposia. Michael. The series examines the crucial ethical, Additional information is available here: Resources legal and public policy questions arising from or http://poynter.indiana.edu/research/fellowships/. exacerbated by the design, development and Applications are due February 3, 2014 and eventual adoption of new technologies across all should be sent to Glenda Murray at: PRACTICAL GUIDANCE ON SCIENCE related fields, from education and engineering to [email protected]. AND ENGINEERING ETHICS medicine and military affairs. Further details of EDUCATION FOR INSTRUCTORS AND the series can be found at: Video Contest - In celebration of its upcoming ADMINISTRATORS www.ashgate.com/ET. 50th anniversary, the National Academy of Engineering is launching the Engineering for The National Academy of Engineering's Call for Papers - The Science Communication You (E4U) Video Contest to show how Center for Engineering, Ethics, and Society Project at Iowa State University is seeking paper engineering creations serve the welfare of (CEES), in collaboration with the National submissions for a special volume on ‘Science humanity and the needs of society. The NAE is Center for Professional and Research Ethics at Communication Ethics: State of the Art.’ offering a $25,000 prize to the most inspiring 1-2 Submissions are open to scholars in all minute video focused anywhere between 1964 the University of Illinois at Urbana- disciplines who are able to connect their analyses and 2064. The contest will run from Nov. 1, Champaign, has released proceedings from a to broader issues of theory in considering 2013, to March 31, 2014. Learn more at: workshop on Practical Guidance on Science problems such as these: What are the underlying www.e4uvideocontest.org. and Engineering Ethics Education for goals of science communication? What are the Instructors and Administrators. It is the boundaries of appropriate advocacy and Workshop - The Poynter Center will host a summary of a workshop convened in promotion? What ethical obligations do workshop for research faculty and administrators December 2012 to consider best practices for scientists have to communicate to broader on ‘Promoting Research Integrity’ on February ethics education programs in science and publics? What ethical requirements should 27, 2014. The workshop will be held in engineering. The workshop focused on three govern discussions of risks, benefits, “facts,” and Jacksonville, Florida and will focus on key areas: goals and objectives for ethics uncertainties? Papers should be submitted by reconsidering approaches to promoting research instruction, instructional assessment, and October 15, 2014 to Susanna Priest at: integrity and dealing with research misconduct institutional and research cultures. Leading [email protected]. and questionable research practices. More experts summarized and presented papers on information is available here: current research knowledge in those areas. Call for Papers - The Hastings Center Report http://poynter.indiana.edu/teaching-research- The papers and workshop also included and the Presidential Commission for the Study of ethics/workshop-details/. discussion of guidance checklists for Bioethical Issues seek papers for a special report instructors and administrators. This report on teaching bioethics. Papers are invited on the Workshop - AAAS will host a special workshop following broad topics: assessing the state of on responsible professional practices in a presents the edited papers and a summary of bioethics education, incorporating professional, changing research environment in conjunction the discussions at the workshop. It is available clinical, research, and public health ethics with its Annual Meeting in Chicago, IL on for free at: education into medical and STEM education at February 13, 2014. The workshop, which http://www.nae.edu/Projects/CEES/70909/883 secondary, undergraduate, and graduate levels, requires pre-registration and an additional fee of 12.aspx methods for bioethics instruction, and best $25.00, will focus on integrating research ethics practices in bioethics education. The deadline for education into the research environment. The PRESIDENTIAL BIOETHICS submission is March 10, 2014. Manuscripts workshop is designed to assist research faculty in COMMISSION RELEASES REPORT ON should be submitted to creating concrete, discipline-specific strategies to INCIDENTAL FINDINGS [email protected]. For more incorporate research ethics education into the information, go to: http://goo.gl/kOcZ01. context of the research environment, whether it On December 12, 2013 the Presidential be a lab or field work. The workshop is Commission for the Study of Bioethical Issues Conference - Trainer-of-Trainers Conference- grounded in a recognition that many research released a new report titled “Anticipate and Educating Scientists in Research Ethics for the ethics issues are relevant to the practice and Communicate: Ethical Management of 21st Century. Scheduled for June 8-11, 2014 in application of science, from developing Incidental and Secondary Findings in the Annapolis, MD, this conference is designed to hypotheses and designing a protocol, to data Clinical, Research, and Direct-to-Consumer prepare university faculty and scientific society management and analysis, to reporting findings Contexts.” According to the Commission’s leaders to establish or improve instruction in and advising others on the uses of the work, and research ethics. Participants will learn that integrating ethics instruction in the context press release, the report offers an “ethical interactive approaches for providing instruction of performing those various stages of research analysis and recommendations for clinicians, aimed at both novice and experienced instructors can be an effective strategy for educating future researchers, and direct-to-consumer testing in research ethics. The conference is open to researchers. Participants will be introduced to companies on how to manage the increasingly individuals in all research-oriented fields who rationales, content, approaches, tools, and common issue of incidental and secondary will be providing training in research ethics, resources to give them the means to develop and findings.” [1] For more information and to including other trainers. Registration is limited to implement research ethics education in their read the official report, see: 40 participants, who are selected competitively. research environment. For more information, http://bioethics.gov/node/3183 Applications will be accepted on a rolling basis see: http://www.aaas.org/event/workshop- until all positions are filled. Limited financial responsible-professional-practices assistance is available. Contact: Dr. Beth A. Fischer at [email protected] or visit www.skillassist.org.

Fall 2013 Professional Ethics Report 8