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2011 03 15 Ethics - Science Policy Research Science Ethics...

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Unformatted text preview: Science Policy, Research Science Ethics, and Social Responsibility Responsibility Jen McCormick, PhD, MPP Assistant Professor of Biomedical Ethics Divisions of GIM and HCPR Mayo Clinic, Rochester MN National Science Policy 481 (HANeal, JJDuderstadt) JJDuderstadt University of Michigan University 15 March 2011 15 1 Outline • Ethics, Bioethics, Research Ethics • Conducting Research Responsibly • Social Responsibility • Examples • “Civic scientist” • Discussion (?) 2 Terms • Ethics • Bioethics • Research ethics 3 Ethics • “The principles of conduct governing an The individual or a group” individual • Webster’s 9th Collegiate Dictionary • ”....a philosophical structure, which together ..a with empirical fact, will yield a decision will with procedure for moral reasoning…” procedure • Williams, Ethics and the limits of philosophy, p 6 4 Bioethics • “Systematic study of the moral dimensions – of including moral vision, decisions, conduct, and including policies – of the life sciences and health care, policies of employing a variety of ethical methodologies in an interdisciplinary setting” an • Encyclopedia of Bioethics, 1995 • “...combines biological knowledge with a combines knowledge of human value systems, which would knowledge which build a bridge between the sciences and the humanities, help humanity to survive, and sustain and improve the civilized world” and • VR Potter, Perspectives in Biology and VR Medicine, p 127, 1970 Medicine, 5 Research Ethics Research ethics is an incoherent field (insofar as it Research incoherent (insofar can be considered “a field” at all). Its subject at matter necessarily encompasses … • ageless moral truths and recent arbitrary ageless conventions; • minute details of particular actions and the minute broad sweep of public policy; • life-and-death issues and matters just the other death side of simple etiquette. simple -Kenneth Pimple (2002) Research Ethics Educator 6 Research Ethics • Responsible Conduct of Research Responsible Curriculum (RCR) Curriculum • Federal view • Required training for NIH trainees • Recently required training for NSF Recently trainees trainees • America COMPETES Act 7 Responsible Conduct of Research • Data acquisition, management, ownership, Data sharing, etc sharing, • Mentor/trainee responsibilities and Mentor/trainee relationships relationships • Peer-review and process, impartiality, review confidentiality, etc confidentiality, • Collaborative science, sharing materials and Collaborative information, setting ground rules, etc information, 8 Responsible Conduct of Research • Publication practices, assigning credit, proper Publication citations, etc citations, • Research involving animals, treatment of Research animals, guidelines, etc animals, • Human subjects, informed consent, risks and Human benefits, etc benefits, • Research misconduct, fabrication, falsification, Research plagiarism plagiarism • Conflict of interest and commitment 9 10 Responsibility in Conduct • Scientific misconduct • Research misconduct is “fabrication, Research fabrication, falsification, or plagiarism in proposing, falsification, plagiarism performing, or reviewing research, or in reporting research results.” reporting Office of Science and Technology Policy 11 Scientific Misconduct • Fabrication: making up data or results and Fabrication: recording or reporting them recording • Falsification: manipulating research materials, Falsification: equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record record • Plagiarism: the appropriation of another Plagiarism: person's ideas, processes, results, or words without giving appropriate credit without 12 “All honest scientists are victims of All scientists who commit misconduct. Jobs in science, research funds, and journal space are all scarce. Every job occupied, every grant received, and every paper published by someone who engages in misconduct deprives at least one honest scientist of an opportunity to which he or she was entitled.” which Herbert N Arst, Jr, Nature 403:478, 2000 Herbert Arst Jr Nature 13 Conducting Research Responsibly • “The scientific research enterprise is The built on a foundation of trust: trust that the results reported by others are valid and trust that the source of novel ideas will be appropriately acknowledged in the scientific literature.” the • Bruce Alberts and Kenneth Shine Bruce Alberts 14 Data Sharing 15 Data Sharing: Why • [Traditional] culture of science (?) • Collaborative nature of science • “Big Science” in biomedical sciences • Large databases enable this • Facilitating real downstream applications of fundamental discoveries • Social responsibility • Public trust 16 Data Sharing: Emerging Issue • NIH’s data sharing policies • General data sharing rules (=/>$500K/yr) • Since ~ 2003 • GWA study data sharing since 2008 • e.g., dbGaP • Relatively new and emerging • Both DNA and phenotype data • Making data “publically accessible” • Sharing plans are a requirement in applications for federal funding 17 Data Sharing: Some Challenges Data • Negotiations • Informed consent process • iinput from research participants from nput • • whom the data come.... whom “point of no return” future use of data/samples • DNA is a unique identifier • even limited phenotypic data can be! 18 Conflict of Interest 19 Conflict of Interest • Conflict of Interest (COI) • Situation in which an individual’s competing competing obligations or financial interests make it difficult for that individual to fulfill his or her duties for • Individual • Institutional 20 Conflict of Interest • An interesting dilemma.... 21 • “My contention is that the most significant My loss in permitting academic scientists to pursue technology transfer, to establish new companies in partnership with the university, to exploit intellectual property of scientific knowledge is that it turns the university into a different type of institution. The greatest losses are not to the academic professions or to the scholarly publication, but rather to the social role played by universities in American life.” Sheldon Krimsky, 2003 Sheldon Krimsky American 22 • “....We stimulate economic growth ..We and development in Michigan and beyond. The University engages in productive partnerships among academe, industry and government to sustain and grow a vigorous and dynamic economy. University students, faculty and staff embody and advance innovative attitudes and entrepreneurial spirit. ...” University University entrepreneurial of Michigan Vision Statement, added 1995 of 23 Is “Disclosure” the Answer? Is 24 http://www.gooznews.com/node/3411 by GoozNews ~ 24 Aug 2010 07:53am by GoozNews 24 /print/3411"/print/3411" /print/3411"/print/3411" According to University of Minnesota bioethicist Carl According Elliott new ..."studies suggest that, far from remedying the bias created by conflicts of interest, disclosure may actually make the bias worse“ (Elliot 2010, White Coat, actually (Elliot Black Hat). As proof, he offered experiments conducted Black ). at Carnegie Mellon University showing that advisors became more brazen about touting strategies that advanced their own financial interests after disclosure. advanced It was as if the advisors had decided: All bets are off now. It I've disclosed my conflicts so now I'm free to say whatever I like. The Carnegie Mellon group summed this finding up nicely when they said: Coming clean means playing dirty. playing 25 • Who ought to disclose? • What should be disclosed? • Why attention to physician-scientists? scientists? All other scientists are conflict free? All 26 Use of Animals in Research 27 Use of Animals in Research • Show care and respect for the Show animals animals • Controversial topic with a wide Controversial variety of opinions and positions variety • Public trust 28 Use of Animals in Research • Various viewpoints of Animal Use • All animal experimentation is All immoral immoral • Minimum experimentation is Minimum acceptable on “lower” animals • Extensive animal experimentation is Extensive moral and necessary moral 29 Use of Animals in Research • Prominence of care and welfare of Prominence animals animals • IIf the privilege to conduct animal research f is to continue, then the goal must be to: is • Minimize the potential for pain and Minimize distress distress • Ensure that there is a serious societal Ensure purpose purpose • Use alternatives whenever possible 30 Use of Animals in Research • The three Rs The Rs • Russell and Burch (1959) proposed Russell three specific strategies: three • Replacement – Non animal alternates eplacement Non used when possible used • Refinement – Procedures to minimize efinement Procedures harm to animals harm • Reduction – Reduce number of animals eduction Reduce used (statistics) used http://altweb.jhsph.edu/publications /humane_exp/het-toc.htm 31 Use of Animals in Research • Laboratory Animal Welfare Act • Originally passed in 1966 • Jurisdiction under the US Department Jurisdiction of Agriculture of • Why not the National Institutes of Why Health? Health? • Establishes Institutional Animal Care Establishes and Use Committee (IACUC) and 32 Use of Animals in Research • Why should we care? • Animals an essential tool for research • Arson attacks on labs • Threats of violent attacks on researchers Threats and families and • Public trust and confidence Contentious and controversial topic 33 Use of Humans in Research 34 Use of Humans in Research Henry K. Beecher, Ethics and Clinical Research 1966; NEJM 24(274) Henry NEJM 35 Use of Humans in Research • The National Commission for the Protection The of Human Subjects of Biomedical and Behavioral Research (The National Commission) - 1974 • Belmont Report (1979) • “Principles” (foundations for rules & (foundations norms) norms) • respect for persons (autonomy) • beneficence • justice 36 Use of Humans in Research • The IRB – Institutional Review Board The • At least one member is from the At local community local • 45 CFR 46 • 21 CFR (for FDA) • The Common Rule 37 Use of Humans in Research • Informed consent .... • what is it? • why have it? • do we rely on it too much? 38 Use of Humans in Research • Emerging Issues....... • Genetic Testing? • Returning Results of Research to Returning Participants? Participants? • Data Sharing (Genotype/Phenotype. Data dbGaP)? dbGaP • Community Consent vs IIndividual Community vs ndividual Consent? Consent? • Stem Cell Research? 39 40 Use of Human Embryonic Stem Use Cells in Research Cells • National Academies report • Guidelines for Human Embryonic Guidelines Stem Cell Research, April 2005 Stem • Committee of scientists, ethicists, Committee legal scholars legal • hES Cell Advisory Committee (2006) • Creation of oversight body • Embryonic Stem Cell Research Embryonic Oversight (ESCRO) committee Oversight 41 Use of Human Embryonic Stem Use Cells in Research Cells • 7 July 2009 Federal Regulations • Largely regulations about what can be Largely funded with Federal Research dollars funded • Informed Consent Requirements • Leftover IVF embryos as source of hES Leftover hES cells; no SCNT • National Commission to Review and National Approve Lines Approve 42 Use of Human Embryonic Stem Use Cells in Research Cells • With the development of iPS cell With iPS cell technology (induced pluripotent pluripotent stem) ... do we need hES cells? stem) hES • Will the issue ‘go away’? Will • Are iPS cells ‘ethics-free’? Are iPS cells 43 Misbehaving in Science (?) • Questionable research practices Questionable and research misbehavior and 44 Falsification Fabrication Plagiarism | Misconduct Authorship Data manipulation Data sharing Conflict of interest Mentoring practices Research participants Fiscal responsibility Personal relations Personal ambition | Questionable Research Practices Laws Rules Guidelines Codes | Ideal Modified from N. Steneck, Univ of Michigan 2004 Modified Steneck Univ 45 Conducting Research Responsibly • In general terms, in science the responsible conduct of research is simply good citizenship applied to professional life • Yes! Science is a profession! 46 Conducting Research Responsibly • Code of Ethics for Scientists Sir David King, Chief Scientific Sir Advisor, UK Government, March 2007 Rigor, Respect, and Responsibility Rigor, 47 Social Responsibility • What does this mean? • social responsibility: an ethical or moral an sense that an entity whether it be a government, corporation, organization or individual has an obligation to make decisions and take actions with the welfare and interests of society in mind. This could be "negative“: there is a This there responsibility to refrain from the action/decision, or "positive“: there is a action/decision, there responsibility to pursue the action/decision. action/decision. 48 Application to Science? 49 • ....life sciences have been and will ..life continue to be prone to influences of ‘ethical, religious, social, cultural, ethical, and philosophical beliefs as to the nature of life and our human place in the natural world...’ the • 2003 50 Conducting Research Responsibly • Why is it important? • Trust within the scientific community ... and • Trust of the public and policy makers 51 52 53 54 The public as a partner • Government was spending too little on scientific Government research research • 34%-37% agree 1992-2002 • 38% agree 2004 • 41% agree 2006 • ~37% agree 2008 • "even if it brings no immediate benefits, scientific "even research that advances the frontiers of knowledge is necessary and should be supported by the Federal Government" • 84% agreed with this statement in 2008 55 The public as a partner • Reservations about S&T • "scientific research these days doesn’t pay pay enough attention to the moral values of society.“ society. • 56% agreed in 2008 • "science makes our way of life change too "science fast“ fast • 47% agreed in 2008 • "science is too concerned with theory and "science speculation to be of much use in making concrete government policy decisions that will affect the way we live" • 34% agree in 2006 56 Shared Values • ....of Science/Scientists • Honesty • Accuracy • Efficiency • Objectivity ORI, Intro to the Responsible ORI, Conduct of Research p. 3 Conduct • ...of the Public 57 Responsible Conduct of Research Responsible • Kenneth Pimple, Six Domains of Research Ethics, Science and Engineering Ethics 8, 2002 • Looking beyond the basic regulatory issues Looking • of human subjects research, conflict of interest, scientific misconduct, and use of animals in research animals Considering the various aspects of professional conduct encapsulated by the notion of social responsibility in scientific research 58 Conducting Research Responsibly • Scientific integrity • Relationship between research and Relationship “truth” • Is it true? 59 60 Conducting Research Responsibly • Interactions among scientific community • Social relationships w/in science • Among researchers • Between research participants and Between researchers researchers • Between researchers and Between institutions • Is it fair? 61 Conducting Research Responsibly • Societal impact • Relationship between research and Relationship the common good the • Is it wise? 62 Conducting Research Responsibly • Is it wise? • The agenda of broader societal and The physical world physical • • • • • • • Research priorities Fiscal responsibility Public service “Forbidden” knowledge Access to findings, local and global How research questions are asked How are How research findings are reported How are 63 What are the obligations of What science and scientists? science • What issues in science are the most critical today? • How engaged, or in-tune, with public, especially for social controversies or dilemmas, are scientists? • How engaged with public need/social challenges are we? • Are all receiving benefit? 64 • Science can tell us (public) how it Science works ... and can predict consequences of particular actions consequences • The public must assess and evaluate The the science in the context of societal values and preferences values • Scientists can help • Lockshin, 2007 65 The Responsibility of Scientists as Citizens 66 Social Responsibility in Science • Manhattan Project • Despite the vision and the farseeing wisdom of Despite our wartime heads of state, the physicists felt a peculiarly intimate responsibility for suggesting, for supporting, and in the end, in large measure, for achieving, the realization of atomic weapons. for Nor can we forget that these weapons, as they Nor were in fact used, dramatized so mercilessly the inhumanity and evil of modern war. In some sort of crude sense which no vulgarity, no humor, no overstatement can quite extinguish, the physicists have known sin; and this is a knowledge which they cannot lose. — J. Robert Oppenheimer, Director of Manhattan J. Project (1947) [emphasis added] [emphasis 67 Social Responsibility in Science • Manhattan Project • The Bulletin of the Atomic Scientists • Emergency Committee of Atomic Emergency Scientist Scientist • Pugwash Conferences on Science and Conferences World Affairs World • JASON JASON 68 • Linus Pauling • Nobel Prizes in Chemistry and Peace • Maurice Wilkins • .....developed a negative view about ...developed nuclear weapons and vowed to work in... "another branch of science, one with more positive applications" 69 • Robert Oppenheimer • Squaring the conscience ... “....technically ..technically Squaring sweet ... you go ahead and do it and argue what to do about it only after you have had your technical success...” had 70 Social Responsibility in Science • Recombinant DNA (rDNA) • Self-imposed moratorium (1974) • Scientists regulating themselves From MIT Archives: Maxine Singer, Sydney Brenner, Norton Zinder, and Paul Berg at Asilomar February 1975 71 Social Responsibility in Science • Asilomar 1975 • IInternational Congress on Recombinant nternational • • • • DNA Molecules Evaluate potential safety hazards Concerns of the public Scientists regulating themselves Recombinant DNA Advisory Committee Recombinant (RAC) (RAC) • Federal level • Approves protocols 72 Social Responsibility in Science • The public response • Cambridge MA city council meeting • Cambridge Experimental Review • Board Other cities follow this example • Response of scientists? 73 Self-regulation?? 74 “There are no important risks that scientists alone can assess. Scientists can make a great contribution, but they can’t decide alone.” ~ Harold Shapiro, President Emeritus, Princeton University and the University of Michigan at the 25th Anniversary of Asilomar 75 Social Responsibility in Science • Jon Beckwith • “IIf the goal of scientific training is f to help scientists to be more critical thinkers, then preparing them to be engaged in looking critically at the social implications of their science can only aid in achieving that goal.” (Nature achieving Nature Biotech 23, 2005) Biotech 76 Social Responsibility in Science • Albert Einstein • “Concern for man himself and his fate Concern must always form the chief interest of all technical endeavors, concern for the great unsolved problems of the organization of labor and the distribution of good – in order that the in creations of our mind shall be a blessing and not a curse to mankind. Never forget this in the midst of your diagrams and equations” (California diagrams (California Institute of Technology, 1931) Institute 77 Social Responsibility in Science • Neal Lane • civic scientists: “scientists step scientists beyond their campuses, laboratories, ministries, and institutes and into the center of their communities to engage in active dialogue with their fellow citizens” dialogue (National Academy of Sciences, 24 (National September 1996) September 78 Social Responsibility in Science • Gil Omenn Gil Omenn • “We need to engage people who are We mistrustful of new technologies and openly address the questions they raise. We need to engage people who do not use, understand, teach, or even accept the scientific ways of thinking, observing, and experimenting that we [scientific community] value highly. We should be willing to hear and consider the criticisms and different ways of thinking.” (Then and (Then president-elect of AAAS, December 2004) president 79 “To preserve the public trust in research, To the scientific community must go beyond a culture of compliance—it must beyond it strive for a culture of conscience—one strive one in which we do the right thing not because we are required to, but because it is the right thing to do…” it --Greg Koski, Outgoing Director, Office of Greg Koski Outgoing Human Research Protection (OHRP), 2002 Human 80 Social Responsibility in Science • Consider scientific societal obligations • Pause for moral reflection • Aim to improve social welfare 81 Social responsibility in science is Social perhaps just another way to remind us as scientists to reflect on our day to day activities and how concepts of professionalism can be important aspects of our activities as researchers... to remind ourselves of the principle of social justice and fair distribution/access ... 82 Social Responsibility in Science • Neal Lane’ “civic scientists” • Stepping beyond their natural Stepping comfort zones – out side of the out laboratories and ivory towers, to participate in your community, engaging in active dialogue with their fellow citizens, both listening and talking, and building relationships of mutual respect mutual 83 • Love mercy • Walk humbly • Do justice • Jon Tilburt, MD, MPH Jon Tilburt 84 • Thank you for listening! • [email protected] 85 86 ...
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