Professional Report

Publication of the American Association for the Advancement of , Scientific Freedom, Responsibility & Law Program in collaboration with the Committee on Scientific Freedom & Responsibility

VOLUME XXI NUMBER 2 SPRING 2008

REAL TIME MACROETHICAL [3]. In short, as put it in a 2003 somewhat higher level, the idea of “social ASSESSMENT editorial, “Welcome to the ethics” has been advanced to cover the ,” to the human earth [4]. important intersection between the Brad Allenby practice of individual ethics and the Brad Allenby is Lincoln Professor of Three important characteristics of the institutional context within which those Engineering and Ethics, Professor of Anthropocene differentiate it from the ethics are to be practiced or, in some Civil and Environmental Engineering, traditional human systems within which cases, undermined [9]. and Professor of Law, at Arizona State existing ethical structures have University. This work is supported in developed. The first is that the earth These ethical structures, generally part by the Lincoln Center for Applied systems characteristics of the bounded by culture and underlain by Ethics at ASU. Anthropocene are neither “human” nor unitary ontologies, are adequate because “natural,” but highly integrated under most circumstances ethical issues It is increasingly apparent that the past composites of both [5]. Second, and arise in systems that don’t extend beyond several centuries have seen a fundamental perhaps most important for ethical these boundaries. Thus, a scientist may change in the relationship of the human analysis, the dynamics of such resolve her ethical dilemma simply by species to the Earth as a whole, in that a Anthropocenic systems include the referring back to the accepted standards principal result of the Industrial reflexivity and, thus, unpredictability of of scientific behavior, or an engineer may Revolution and concomitant human systems. Third, these systems are refer to her professional organization’s demographic, economic and cultural highly interconnected: managing global ethical cannons. Accordingly, although changes is a planet where the dynamics climate change is difficult precisely ethical conflicts are not uncommon, their of most major natural systems are because the climate system is tightly analysis and resolution in general occurs increasingly shaped by human activity coupled to human economic and within a settled cultural and ontological [1]. The climate change debates, for technological systems and their future context. example, reflect not a temporary paths, to powerful cultural and aberration but the fact that for the ideological systems, and to other natural Alternative Ethical Principles foreseeable future climate dynamics will systems such as the carbon and nitrogen continue to be shaped in significant ways The highly complex integrated cycles. In short, the future paths of these by the activities of our species – and that human/natural/built systems that complex adaptive systems (CASs) are the climate system and human economic characterize the anthropogenic Earth do highly uncertain and unpredictable. activity are integrated and co-evolving. not necessarily respect the boundaries

Some note that with synthetic biology the which traditional ethical systems assume, CASs thus pose a challenge to the essence of biodiversity is shifting from a and within which they are valid. This has existing ethical approaches most familiar “naturally evolved” basis to a designed led to efforts to generate alternative to scientists and technologists. These basis, with only dimly perceived ethical precepts. These include approaches include explicit professional implications. Meanwhile, the rate of formulations based on sustainability, ethics, such as those common in technological evolution is accelerating such as the Precautionary Principle so engineering [6], which are in turn only rapidly, a phenomenon that is particularly popular in Europe (as stated in the UN’s part of the overall ethical structure that evident in the literature discussing the World Charter for Nature [10]: “where individuals bring with them. These in implications of converging potential adverse effects are not fully turn can reflect many different ethical nanotechnology, biotechnology, robotics, understood, the activities should not frameworks: duty (Kant), rights, a information and communication proceed.”). Another sustainability utilitarian calculus (Bentham), revealed , and cognitive science fields example is the Aldo Leopold ecoethic: universals (), varying emphases (NBRIC) [2], especially in the area of “A thing is right when it tends to preserve on outcome or intent (the basis of many “,” where the human is the integrity, stability and beauty of the legal systems), and the like [7]; [8]. At a increasingly understood as design space biotic community. It is wrong otherwise” Spring 2008 Professional Ethics Report 1

(Allenby continued from page 1) ecoethic, implicitly assume that single Second, macroethical systems must not ontologies are adequate to ethically frame rely on assumptions about outcomes, for (Leopold, quoted in Sagoff, 1996, at 154 CASs in the Anthropocene. But this the future behavior of CASs is highly [11]). They also include over-emphasis critical assumption is mistaken. The uncertain; among other things, this means of particular religious traditions or behavior of these systems at scale is of an that the utilitarian calculus which often worldviews in complex ethical order of complexity that cannot be underlies scientific and technological environments, a situation some have captured by any single worldview [14]; ontologies is inadequate since utility can alleged exists with the Bush [15]. Moreover, the related assumption not be known beforehand. Thus, in Administration’s Council on that decisions about ethics by individuals practice, macroethics will need to rely on [12], or efforts to extend existing ethical or even specific political entities are continued real-time dialog with the systems into broader regimes (e.g., the controlling is questionable: neither the systems in question, rather than one off movement to make individual scientists strong European Union reaction against snapshots. In other words, given the responsible for the behavior of the larger genetically modified organisms (GMOs), inherent unpredictability of these systems, such as biotechnology or nor the Bush Administration’s efforts to systems, RTMA requires that institutions nanotechnology, on which they work, limit federal funding of biomedical and individuals remain engaged with leading some to claim, for example, that in certain areas for religious them as they evolve, as otherwise it will “nanoethics” are necessary to deal with reasons has prevented the rapid advance be difficult to react in real time to system issues raised by nanotechnology [13]). of the relevant science and technology. changes as they implicate ethical - or for that matter design or operational - These efforts are doomed to be Real Time Assessments concerns. unsuccessful because they fail to understand the profound difference in Several years ago, Guston and Sarewitz Thirdly, many of the systems of interest – systems behavior between the usual [16] wrote an influential article about the climate system, carbon cycle, or bounded ethical situation, and the much “real time .” They designed biodiversity, for example – will different ethical demands generated by understood technology as a complex extend long enough so that the cultural CASs. Thus, both the Precautionary phenomenon combining elements of models and assumptions that ethical Principle and the requirement that engineering, , and social systems are built on will themselves individual scientists be responsible for science, demanding an appropriately evolve and change. Thus, RTMA will systems effects require a knowledge of flexible approach. It is increasingly not only focus on process rather than future paths which is simply not possible apparent that a similar approach needs to specific outcome, but it must be able to with CASs: such proposals are thus either be developed to be able to work function in an environment where norms, naïve or backdoor attempts to halt rationally, responsibly and ethically with teleologies and ontologies are understood technological and scientific advance. the CASs that increasingly characterize to be contingent. Ethics at this level of Most other approaches, such as the the anthropogenic world – in short, we flexibility is a new and, for many people, also need a “real time macroethical challenging concept [7] – but it is Editor: Mark S. Frankel assessment” capability, or RTMA. systems structure, not choice, that Deputy Editor: Jennifer L. Sta.Ana imposes these requirements. And again Contributing Authors: Vivian Cheng, RTMA entails several requirements. flexibility is not relativism, for if CASs Jessica Davis, Stephanie Heath, Leslie First, macroethical frameworks must be are uncertain, they also display local Lipsick, Cristina Kapustij able to accept, respect, and work with order. Thus, rules that are contingent mutually exclusive but equally valid when the system is taken as a whole may The Professional Ethics Report is ontologies. This is not a recipe for mere well be valid within bounded subsystems published quarterly by the Scientific relativism, for the systems state, and the that remain locally stable. Freedom, Responsibility and Law Program in collaboration with the Committee on goals of the relevant decisionmakers and Scientific Freedom and Responsibility. designers, will in individual cases rely far For those used to rule-based and more heavily on certain ontologies than simplistic ethical frameworks, developing American Association for the Advancement on others – but at the level of the CAS and relying on RTMA is no doubt of Science, 1200 New York Avenue, NW, itself, multiple ontologies will be challenging. But it is a necessary Washington, DC 20005 (202) 326-6217; engaged. Similarly, as the GMO and response to the complexity of the Fax(202)289-4950; Email: [email protected] stem cell cases indicate, any reasonable anthropogenic Earth which, far from http://www.aaas.org/spp/sfrl/per/newper macroethical system must also be global being hypothetical, is already upon us. Back issues of Professional Ethics Report are in scope, and thus truly multicultural. on-line at [1] Allenby, B. R., 2007a, Earth systems Letters to the Editor: The editors http://www.aaas.org/spp/sfrl/per/archives1.s engineering and management: A welcome comments from our readers. We html manifesto,” Environmental Science & reserve the right to edit and abridge the

letter as space permits. Please address all Technology 41(23):7960-7965. This newsletter may be reproduced [2] Garreau, J.,2004, Radical Evolution correspondence to the deputy editor. without permission as long as proper (New York, Doubleday). acknowledgement is given. [3] Allenby, B. R., 2007b, “From Human to Transhuman: Technology and the

(Allenby continued on page 3) Spring 2008 Professional Ethics Report 2

(Allenby continued from page 2) Human-dominated ecosystems. of underrepresented groups, enhances the Science 286:443-491. infrastructure of research and education,” Reconstruction of the World,” Annual along with other issues addressed in the Templeton Fellow Lecture, Letter. Additional educational materials asu.edu/transhumanism (Arizona In the News on the broader impacts criterion are State University Center for available in the American Chemical and Conflict). HOW RSEARCHERS CAN Society Broader Impacts Showcase. [4] Nature editorial, 2003, Welcome to PROPERLY ADDRESS NSF’S the Anthropocene, Nature 424:709. BRODAER IMPACTS CRITERION Although NSF identifies several ideal [5] Allenby, B. R., 2005, Reconstructing foci, they urge researchers “to be creative Earth (Washington, DC, Island In April 2008, the National Science in their approaches and to discuss ideas Press). Foundation (NSF) published a “Dear with their NSF program officer.” [6] NAE (National Academy of Colleague Letter on Broader Impacts Engineering), 2004, Emerging Proposal Requirements.” The Letter “Dear Colleague Letter on Broader and Ethical Issues in informed researchers about the two Impacts Proposal Requirements” Engineering (Washington, DC, criteria-intellectual merit and broader http://www.nsf.gov/pubs/2008/nsf08044/ National Academy Press). impacts-that apply to research proposal nsf08044.pdf [7] Johnson, M., 1993, Moral evaluations. The letter focused on American Chemical Society Broader Imagination: Implications of broader impacts and ways that it might be Impacts Showcase Cognitive Science for Ethics addressed. http://www.nsf.gov/pubs/2005/nsf0540/n (Chicago, University of Chicago sf0540.jsp Press). The NSF recommended that, “proposers [8] LaFollette, H., 2003, The Oxford should carefully consider ways to *SH Handbook of Practical Ethics incorporate rigorous, meaningful, and (Oxford, Oxford University Press). innovative broader impacts activities that PLAGUED PUBLISHERS’ PLANS [9] Devon, R., 2004, “Towards a social integrate with the research being ON PREVENTING ethics of technology: A research proposed.” They also cautioned prospect,” Techne 8(1):99-115. researchers that, “a simple listing of In response to the many plagiarism [10] UN General Assembly, 1982, outreach activities, or reference to concerns plaguing publishers, CrossRef Resolution on the World Charter for inclusion of research personnel who are will launched new plagiarism detection Nature, Resolution 37/7, Section II, members of underrepresented groups, service, CrossCheck, on June 19th of this para.ii(b). falls short of the rigor required to year. Access to CrossRef will allow [11] Sagoff, M., 1996 (first published satisfactorily address this criteria.” “users from one publisher to link 1988), The Economy of the Earth citations and references to the primary (Cambridge; Cambridge University In response to the many requests from the source material of another publisher, to Press). community, NSF included in its letter the check content and accuracy,” explained [12] Charo, R. A., 2005, in Vision 2033, ways in which one would address the Caroline White of the British Medical (Washington, DC, AAAS), pages 55- broader impacts criteria, offering Journal. 61. questions to address, relevant information [13] Caplan, A. L., 2008, Deciphering to include, and additional links for further According to Geoffrey Bilder, director of nanoethics, Chemical and assistance. strategic initiatives at CrossRef, “the Engineering News 86(13):42-43. As researchers prepare their proposals, system contains 30 million DOIs (digital [14] D. Sarewitz, 2004, How science particular attention to the broader impacts object identifier) for articles, theses, and makes environmental controversies criterion should be given for the Project conference proceedings, 19,000 journals worse, Environmental Science and Summary, the Project Description, and and material dating back to the 1600s.” Policy 7:385-403. the Results of Prior Support section. CrossCheck will work by creating “text [15] Michael, D. N., 1995, Barriers and fingerprints” from small chunks of the bridges to learning in a turbulent Included in the Project Summary, two original document, “which are then human ecology, in Gunderson, L. H., separate statements addressing checked against databases for evidence of C. S. Holling, and S. S. Light, eds. intellectual merit and broader impacts of similar matches,” and an “originality Barriers and Bridges to the Renewal the proposed activity must be presented. report” is produced. The report is then of Ecosystems and Institutions (New The NSF also provided guidance for “interpreted by a human being” to York: Columbia University Press) researchers who must complete a Results identify legitimate matches such as: Pp. 461-488. of Prior Support section of the proposal. references, formulas, and quotes, said Mr. [16] Guston, D. H. and D. Sarewitz, Bilder. 2002, Real-time technology The Project Description must describe assessment, Technology in Society “broader impacts resulting from the The BMJ Publishing Group Ltd., 23(4):93-109. proposed activities,” addressing how well Elsevier, Wiley-Blackwell, Taylor and [17] Science special report. 1997. the activity “advances discovery and understanding, broadens the participation (News continued on page 4)

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(News continued from page 3) In February 2008, SOMO (Stichting CROs in at least 60% of their clinical Onderzoek Multinationale research projects. To the authors, the Francis, and the New England Journal of Ondernemingen, translated as “Centre for prevalent use of CROs is an example of Medicine, the Institute of Electrical and Research on Multinational the ethically murky waters in which Electronics Engineers, IUCr, and the Corporations”) published a report on pharmaceutical companies swim. Association for Computing Machinery “Ethics for Drug Testing in Low and have agreed to participate in the Middle Income Countries: The researchers used the Declaration of CrossCheck pilot. Considerations for European Market Helsinki (“DoH”) as a benchmark of Authorization” by Irene Schipper and ethically appropriate behavior. The study There are, however, several limits in the Francis Weyzig. SOMO is a Dutch non- depends on five DoH provisions: ¶14 system. CrossCheck cannot identify profit research organization that focuses (instructing that research protocols plagiarized images or graphics, nor does on the effects of Multinational Enterprise should include a statement of ethical it feed from a universal database. Only policies and activities on developing considerations), ¶19 (mandating that the CrossRef articles will be assigned a DOI, countries resulting from the population from which the participants so it will not apply to those articles internationalization of business. The come must benefit from the results of the without a digital object identifier. study analyzes phase III clinical trials research), ¶30 (asserting that every trial http://www.crossref.org/crosscheck.html conducted in low- and middle-income participant must have post-trial access to countries using publicly available healthcare), ¶29 (requiring justification *SH information, and focuses on three drugs: for use of a placebo control if safe, Abilify (aripiprazole), Olmetec standard treatment for the condition is NIH’S EFFORTS TO PROTECT (olmesartan medoxomil, also marketed as available), and ¶8 (emphasizing the need DATA Benicar), and Seroquel (quetiapine for caution when participants belong to a fumarate). The report concludes that vulnerable population). On February 23, 2008, a government European authorities are complicit in laptop computer with information on unethically conducted clinical trials by The authors offer Abilify as an example human study subjects was stolen from the drug companies in developing countries. of available public information trunk of an NIH employee’s vehicle. Authorities encourage the “offshoring” of deficiency and regulation enforcement Initially believed to contain only patients’ trials by allowing companies to conduct inadequacy. The study could not locate medical records, it was later found that trials in developing countries that have the original trial protocol, information the computer also had a file with the been rejected by ethics committees in regarding post-trial treatment, or Social Security numbers for Western Europe and by granting justification for the use of a placebo approximately 1200 of the 3000 patients European Union (“EU”) marketing control given to approximately 300 enrolled in the study. Contrary to federal authorization based on these trials. acutely relapsed schizophrenics. policy, the data were not encrypted. The Furthermore, the report criticizes Furthermore, the European Medicines NIH Office of Extramural Research governments and the pharmaceutical Agency (“EMEA”) accepted the results issued a statement on April 11, 2008, on industry for lack of transparency in the of trials despite expressing concerns the importance of protecting electronic general clinical trial process, and calls for regarding the predominant use of and hard copies of federal data. The more publicly available information. vulnerable psychiatric populations in notice recommends not storing sensitive countries where Good Clinical Practice information on portable electronic According to the report, the number of (“GCP”) inspections were not conducted. devices. If using a portable electronic clinical trials conducted in low- and device is unavoidable, it should be middle-income countries has increased The information available for Olmetec encrypted. Password protection should significantly in the last five years because trials was sparser. The drug marketing, also be implemented to control data of lower costs and faster enrollment. developer, and sponsor websites offered access, and the security of the recipient’s Conducting trials in these areas presents little information. Similar to the Abilify systems should be verified when ethical concerns associated with the trials, there was no justification for the transmitting sensitive information. The vulnerable participant population, the use of a placebo and no information original statement can be found at experienced by regarding post-trial access to healthcare, http://grants.nih.gov/grants/guide/notice- medical professionals with relatively low or precautions taken because of the files/NOT-OD-08-066.html. salaries, questionable ethics review vulnerability of the population, which committees, and the lack of regulatory included children as young as one-year *CK enforcement. Contract Research old. The authors consider the possibility Organizations (“CROs”) are of particular of adequate justification for testing a CLINICAL TRIALS IN concern because they are hired by the treatment for hypertension in a vulnerable DEVELOPING NATIONS: ARE pharmaceutical company to perform a group, but stress that companies invite EUROPEAN OFFICIALS broad range of tasks, including locating suspicion when no explanation is offered. ENCOURAGING UNETHICAL research sites, recruiting patients, DRUG TESTING? creating study designs, and working with Unlike for Abilify or Olmetec, a healthcare facilities. In 2002, pharmaceutical companies employed (News continued on page 5)

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(News continued from page 4) INDUSTRY MUST ABSTAIN FROM forms of alcohol help; and (5) INFLUENCING ALCOHOL taken advantage of their research considerable amount of information on RESEARCH, INTERNATIONAL involvement to gain credibility to weaken the Seroquel trials was available, EXPERTS DECLARE opposing research. including trials intended to prove additional uses and improved efficacy of Torn between protecting public health The alcohol industry’s actions affect not new formulations. However, the Dutch and maximizing profits, large only public health, but also the public’s regulatory agency that granted the EU corporations, like the tobacco industry, perception of research in general. marketing authorization has not often choose the latter. The alcoholic Eliminating financial ties between published its assessment report. The beverage industry is no exception, and researchers and alcoholic beverage research protocols for individual studies the first guideline regarding its influence corporations may restore the rectitude of were uniform, but there were notable over alcohol research was recently alcohol research and protect the public’s differences in the types of studies issued, declaring that the alcohol industry health. partially performed in high-income must not fund alcohol research in order to countries and those performed avoid conflict of interest. This A report on this meeting is posted at: exclusively in low- or middle-income conclusion was decided upon by public http://www.add- countries. For example, while placebo health experts, alcohol policy researchers, resources.org/international-expert- trials were conducted worldwide, trials and non-governmental organization meeting-alcohol-research-must-be- for schizophrenia, acute mania, and specialists who met in Dublin, Ireland, on protected-from-industry- elderly individuals were limited to low- May 15 & 16, 2008, for an international influence.4484336-76188.html. or middle-income countries. expert meeting in relation to this issue. Furthermore, a statement of ethical *VC considerations was unavailable. The Alcohol research significantly affects the procedure and the use development of alcohol policy. Research ETHICAL STANDARDS TO of a placebo in schizophrenic populations findings are employed to alert public PROTECT SUBJECTS OF WHOLE- to prove the efficacy of a new policy makers of the harms caused by GENOME RESEARCH formulation need clear explanation alcohol consumption. Furthermore, it because the health of the acutely ill plays an integral role in the development A committee of experts has produced a patients is exacerbated by poverty, of alcohol prevention and alcohol use consensus statement on ethics related to illiteracy, language barriers, and the reduction programs. Funding research research of individual genomes [1] that unequal dominance position between gives the industry unfair control over offers “ethically rigorous and practical doctor and patient. policies that may otherwise negatively guidance for investigators and research impact its profits. ethics boards.” Although numerous The report also addresses a November issues may develop from whole-genome 2007 European Parliamentary meeting Experts from Europe, the United States, research, the committee chose to focus on and provides recommendations, and the South agreed that industry- four specific areas: consent, withdrawal including: (1) there should be no supported research is often biased and from research, return of research results, discrepancy between the ethical criteria directly conflicts with the interest of and public data release. used to approve trials in developed and public health. According to the Alcohol, low- or middle-income countries; (2) Drugs and Development (ADD) report by Informed consent is pivotal to achieving pharmaceutical companies should take Dag Endal, the industry appears to get an ethical research environment when more responsibility and develop research involved in alcohol research only to working with human subjects. methods to replace ethically questionable challenge social policy on the limitation Researching whole-genomes has created protocols; (3) registration of all clinical of alcohol consumption and to deter new obstacles to achieving fully trials in public registries should be legally initiatives for preventing alcohol informed participants. One major hurdle required and include the locations of the problems. The industry directs alcohol is the unpredictability of how the data trials; and (4) trial sponsors should make politics towards its commercial interests gathered will be used in the future. To it possible for external actors to check the while feigning “corporate citizenship.” overcome this and other concerns, the ethical considerations and precautions committee recommends that research taken to protect vulnerable trial subjects. The ADD report asserted that the participants be provided thorough details industry’s obligation to produce regarding potential future use of their Report available at: maximum earnings for its shareholders information as well as the possibility of http://somo.nl/html/paginas/pdf/Ethics_fo pressures it to undermine research that reconsent when a project significantly r_Drug_Testing_feb08_EN.pdf may compromise its profits. In the past, differs from what the person originally the alcohol industry has: (1) assaulted the agreed to. *JD of rival researchers; (2) paid their own scientists to attack Withdrawal from research without conflicting research; (3) attempted to repercussion is another of the discontinue or diminish researchers’ funding; (4) promoted unsuccessful (News continued on page 6)

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(News continued from page 5) http://biology.plosjournals.org/perlserv/?r and scholarship. equest=get- cornerstones of ethical human subject document&doi=10.1371%2Fjournal.pbio "Pursuit: I will pursue research. While this right must be upheld .0060073 knowledge and create in whole-genome research, it may be knowledge for the greater more difficult to apply because the nature *CK good, but never to the of this research calls for broad and quick detriment of colleagues, distribution of results, and there may be UNIVERSITY OF TORNOTO supervisors, research no recourse for withdrawal of an PROMOTES MORAL subjects or the international individual’s information. To this end, the RESPONSIBILITY THROUGH community of scholars of committee’s third and fourth GRADUATE STUDENT OATH which I am now a member. recommendations support the individual’s right to withdraw, which In response to increased concerns "By pronouncing this may include destroying tissue samples regarding the social impact of Graduate Student Oath, I and written information. The subject technology, the Institute of Medical affirm my commitment to must also be advised during the original Studies (“IMS”) at the University of professional conduct and to consent process that this right may be Toronto created a graduate student oath abide by the principles of limited due to the nature of the research. to promote professionalism and ethical ethical conduct and research Experiments should be designed with the conduct. IMS instituted the oath to policies as set out by the subject’s ability to withdraw in mind. encourage awareness and discussion of University of Toronto." the social and moral responsibilities of Results from whole-genome experiments biomedical students. The declarations, Visit: may produce a range of information voluntarily recited at the first meeting of http://sandwalk.blogspot.com/20 about individual participants, even if that each new graduate student body, are part 08/06/graduate-student- is not the primary function of the study. of a program aimed at combating oath.html The committee recommends that a academic misconduct. Each student is process be in place to determine what provided a booklet of information and a *JD findings will be shared with the personal copy of the oath. In addition, individual. The individual’s right to students are required to attend a seminar In the Societies know or not know certain information course, which includes material on should be covered in the initial informed scientific misconduct, and complete an NASULGC RESPONDS TO consent process. The results offered to online ethics course. IMS encourages VIOLENCE STEMMING FROM participants should be “scientifically other life science programs to develop ANIMAL TESTING OPPOSITION valid, confirmed, and have significant similar ethics educational programs, implications for the subject’s health and oaths, and faculty–trainee relationships The National Association of State well being.” that address community, professionalism, Universities and Land-Grant Colleges and ethical conduct. (NASULGC) reaffirmed its support for Finally, whole-genome studies rapidly the use of animals in research on 23 May disseminate their data in order to benefit The text of the Institute of Medical 2008. The organization issued a worldwide science. This dissemination Science Graduate Student Oath follows: statement in response to incidents of needs to be carefully balanced with harassment, violence against researchers subjects’ privacy rights. In order to "I, [NAME], have entered and their families, and destruction of achieve this balance the committee the serious pursuit of new facilities at the University of California at recommends policies that consider both knowledge as a member of Los Angeles, University of California at access to information and privacy the community of graduate Berkeley, University of California at interests of participants. Subjects must students at the University of Santa Cruz, and the University of Utah. be thoroughly informed of the Toronto. implications of the release of their data, NASULGC, a higher education and issues regarding the potential impact "I declare the following: association dedicated to supporting on family members and certain excellence in teaching, research, and populations should be weighed. "Pride: I solemnly declare public service, endorses the use of my pride in belonging to the animals to advance medicine and science [1] Caufield T, McGuire AL, Cho M, international community of when it conforms to ethical, legal, and Buchanan JA, Burgess MM, et al. (2008) research scholars. safety regulations because of the benefits Research ethics recommendations for of research: “The use of animals in whole-genome research: Consensus "Integrity: I promise never to scientific research continues to provide statement. PLoS Biol 6(3): e73. allow financial gain, the basis for critical that have competitiveness, or ambition The original article can be found at: cloud my judgment in the conduct of ethical research (Societies continued on page 7)

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(Societies continued from page 6) information about donations and grants to The AAAS presented a morning institutions that support healthcare and roundtable that focused on a hypothetical benefited our country and the global research. Furthermore, sponsorship case study, while FDLI hosted an community. Through research involving declarations must be revised to reflect afternoon session highlighted by Dr. animals, scientists at NASULGC accurately the degree of the company’s Mark McClellan’s keynote address and a institutions have advanced biomedicine, current involvement. Companies that series of speakers on the legal, regulatory human nutrition and health, food employ health professionals as and policy aspects of implementing production, food safety, biodefense, and consultants are expected to require them personalized medicine. animal health and welfare. Scientific to declare this as an interest. research also has provided the basis for Nine speakers participated in the AAAS federal guidelines for the welfare, feeding Several changes to the Code focus on roundtable each representing a different and housing of animals.” However, increased identification of side effects. sector: industry (Finley Austin of NASULGC remains committed to Pharmaceutical companies must Hoffman-La Roche), ethics (Carol refining, reducing, and replacing the use “prominently” state that “adverse events Isaacson Barash from Genetics, Ethics of animals in research, where appropriate. should be reported” and include contact and Policy Consulting), government information for further concerns. The (Greg Downing on behalf of Health and While the NASULGC continues to ABPI is also obliging their companies to Human Services’ Personalized Health support the use of animals in research, it use the black triangle warning system for Care Office), patient/consumer advocacy also encourages open discourse and free high risk drugs. For the first time, (Annette Bar-Cohen representing the expression so long as individuals do not details of all clinical trials on National Breast Cancer Coalition in the resort to harassment, intimidation, or experimental drugs conducted by ABPI District), physician (Dr. Howard P. Levy violence. It wishes to “ensure a safe companies must be made publicly from the McKusick-Nathans Institute of work and learning environment” for all available. These strong suggestions and Genetic Medicine at JHU), legislature members of its community and activities. requirements are made in hopes of (Dr. Kavita Patel representing the Senate ensuring “maximum confidence in the Health, Education, Labor and Pensions Visit: standards set for ethical and responsible Committee), scientific research (Charles http://www.nasulgc.org/NetCommunity/P behavior of companies and staff,” says Rotimi of the NIH Intramural Center for age.aspx?pid=955&srcid=236 Chris Brinsmead, President of the ABPI. Genomics and Health Disparities), law (Grail Sipes from Covington & Burling *JD Brinsmead also stated that ABPI “made LLP), and insurance (Joanne Armstrong further amendments to reflect experience, on behalf of Aetna). Susan Dentzer, 2008 ABPI ADOPTS NEW comments, and suggestions received editor-in-chief of Health Affairs and on- REQUIREMENTS FOR WORKING since the introduction of the 2006 code.” air health analyst for the PBS NewsHour, WITH HEALTH PROFESSIONALS These changes include: more direction moderated the discussion, which AND PATIENT GROUPS about meetings and hospitality; explored the hypothetical stories of four limitations on the supply of samples; women, each diagnosed with breast The Association of the British publications of interim case reports when cancer, in the context of very different Pharmaceutical Industry (ABPI) will put final reports are delayed; and placing financial, medical and personal its newly revised “Code of Practice for advertisements for the outcome of certain circumstances. The scenario presented a the Pharmaceutical Industry” and cases in nursing media in addition to biomarker that could hypothetically “Constitution and Procedure for the medical and pharmaceutical journals. predict the cancer’s recurrence and thus Prescription Medicines Code of Practice better dictate the respective courses of Authority” in effect on July 1, 2008. The The Code is regularly updated every two treatment for the four women. focal point of the amendments is greater to three years. A transition period will pharmaceutical company transparency. continue through October 31, 2008. Dentzer asked the panelists to advise the These alterations are implemented to patients’ physician on how to proceed in adjust to the provisions of the code The 2008 Code is available at: light of the newly found biomarker, and administered by the European Federation http://www.pmcpa.org.uk/files/siteconten personalized medicine more broadly. For of Pharmaceutical Industries and t/ABPI_Code_of_Practice_2008.pdf. example, she asked how employers and Associations (EFPIA). More than 75 insurers ought to provide coverage for prescription medicine-producing *VC treatments based on potentially uncertain companies included in the ABPI will information, what legislation Congress abide by the changes. PANELISTS PONDER USHERING should consider and, ultimately, how IN AN ERA OF PERSONALIZED doctors should educate patients. The In promoting greater transparency, the MEDICINE discussion expanded beyond the case companies will make short descriptions study, as each panelist shared his or her of all their significant support – both On June 20 at its headquarters, AAAS, in unique insight on the larger issues financial and indirect – for patient collaboration with the Food and Drug surrounding personalized medicine. They organizations publicly available. They Law Institute (FDLI), hosted a national are also encouraged to disclose conference on personalized medicine. (Societies continued on page 8)

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(Societies continued from page 7) Award – The Association for Practical and Policy (registration ends June 27th, class Professional Ethics will award the Squire begins July 1st) and a course on Women, Family Foundation Award and a check for Health and the Environment (registration ends explored the complexities of patient th st education, data management, privacy, the $1000 for the best paper submitted on pre- July 25 , class begins August 1 ). Public college ethics. Papers may address pedagogy, lectures and discussion forums will also be true meaning of the term “personalized extracurricular activities, school-based ethics available to students. Visit: medicine,” and other concepts. centers, or collaborative efforts with other http://umt.edu/ethics/programs/EEI.html. centers and the community. Visit: Contact: Dane Scott, Director of the Center Drs. Rotimi and Levy discussed the http://www.squirefoundation.org/news.appe_2 for Ethics, [email protected]; (406) definition of personalized medicine in the 009.html. 243-6632. context of race and ethnicity. Dr. Rotimi Award –Council of Graduate Schools (CGS) Course – UNESCO is hosting an Ethics suggested that personalized medicine proposals from CGS member institutions who Teacher Training Course in Minsk, Belarus on could not be limited to ethnic categories, can to develop institutional models for November 17-21, 2008. The course is but rather should be applied to any expanding and embedding research integrity particularly aimed for the younger generation characteristic, from age to gender or even and responsible conduct of research education of university teachers to expand and improve height, which could aid in identifying programs. Five $50,000 grants will be ethics courses in all Member States of trends in genomic data. On the subject of awarded. Deadline for project proposals: July UNESCO. Deadline: August 1, 2008. Visit: education, Ms. Bar-Cohen spoke about 30, 2008. Visit: http://portal.unesco.org/shs/en/ev.php- the dramatically differing levels of http://www.cgsnet.org/portals/0/pdf/PSI_RFP. URL_ID=11968&URL_DO=DO_TOPIC&U pdf. RL_SECTION=201.html. involvement in their own treatments that breast cancer patients desire even today, Call for Papers – Papers are invited for a Course – PRIM&R and the American Society without the array of options that conference on Ethics in Intelligence and of Law, Medicine and Ethics (ASLME) will knowledge of a biomarker might provide. Immigration held on November 20-22, 2008 sponsor a webinar entitled, Handling at the University of Texas-Pan American in Incidental Findings in Human Subjects She observed that if personalized Edinburg, Texas. Papers should focus on Research: Legal and Ethical Perspectives, on medicine allows patients to know more ethics in fields of intelligence gathering, July 15th from 1:00-2:30 PM. The webinar is about themselves, they deserve the right global security, and immigration. Deadline: designed to help participants respond to to know more about their conditions, September 2008. Contact: [email protected]. questions arising from incidental findings in diagnoses, and treatment options. Her new and complex areas of medical research. Conference – Scientists will discuss their Visit: remarks led others to consider the collaborative experiences, obstacles http://www.primr.org/Conferences.aspx?id=4 potential pitfalls of increasingly complex encountered with international collaborations, 391. roles for doctors as educators and and avenues for collaborative success in the advisers. Dr. Kavita Patel shared her conference, Challenges and Tensions in Fellowship – Teachers and scholars with a experience as a more recent graduate of International Research Collaborations, on PhD in , political theory, theology medical training, which she believed October 2-3, 2008 in Minneapolis, MN. or related discipline, or an advanced degree, prepared her, and increasingly will Organization, funding, cultural expectations, with no more than ten years of academic prepare others, for the new relationships laws, regulations, and graduate and experience, are invited to apply for a Faculty that doctors are likely to have with postdoctoral systems abroad will be Fellowship in Ethics at Harvard University. addressed. Visit: Moral choice in the professions and public life patients in an era of personalized http://www.international.umn.edu/oriconf. will be explored throughout the 2009-2010 medicine. Contact: Dr. Melissa S. Anderson, academic year. Deadline: October 31, 2008. [email protected]; (612) 624-5717. Visit: http://www.ethics.harvard.edu. While several of the panelists differed in Contact: (617) 495-1336. Conference – Scholars from an array of their opinions of the patient and doctor’s disciplines will discuss the impact of 21st Public Consultation – The National respective roles in personalized care, century genetics at an event called, Mendel in Advisory Board for Biosecurity (NSABB) is there was consensus that one or all of the the 21st Century: The Scientific, Social, and asking for public input on July 15, 2008 at the following three actions would be crucial Ethical Impact of Genetics in Our World, on National Institutes of Health (NIH) Campus in first steps toward realizing the potential September 21-23, 2008 at Villanova Bethesda, MD on a proposed framework for of personalized medicine: increased University. Visit: the oversight of dual use research. The funding for basic and biomedical http://www.villanova.edu/events/yearofmende federal government specifically wishes to research, improved data management, l/mendelsymposium/. address the clarity of the criterion proposed by NSABB for identifying dual use research of and protection of patient privacy. As the Conference – On September 15-18, 2008 in concern; institutional oversight push continues toward making St. Louis, MO, PRIM&R is hosting its responsibilities; and approaches to education regional programs: IRB 101sm, IRB personalized medicine an attainable, to enhance awareness of the issue. Register Administrator 101, IBC Basics, and Essentials tangible health tool, AAAS and FDLI at: of IACUC Administration. The programs are will continue to foster conversations http://www.capconcorp.com/meeting/lifescien aimed at educating IRB/HRPP, IACUC, and about the potential and formidable ces2008/. IBC administrators, coordinators, members, challenges that lie ahead. and research staff. Visit: Support From the Following Societies is http://www.primr.org/Conferences.aspx?id=3 Gratefully Acknowledged: *LL 913&ekmensel=297ded8b_327_0_3. American Anthropological Association Course – The 2008 Environmental Ethics Announcements American Psychological Association Announcements Institute at the University of Montana will American Society for Engineering Education offer a course on Environmental Ethics and Spring 2008 Professional Ethics Report 8