Roy S. Weiner, M.D. Associate Dean for Clinical Research and Training Edward G. Schlieder Chair in Medical Oncology Tulane University Health Sciences
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1 Roy S. Weiner, M.D. Associate Dean for Clinical Research and Training Edward G. Schlieder Chair in Medical Oncology Tulane University Health Sciences Center October 24, 2013
2 MSCR at TULANE 1999 to PRESENT 1K30 HL04521 Masters Programs in College of Medicine Designed for M.D. and Ph.D. prepared candidates 3 tracks MS CR with Mentored Research 2-4 year curriculum MS CRM 32 Credits 1 yr. curriculum MS CRM Executive 32 Credits Distance Learning 1 yr. curriculum plus 6 on-site weekends
3 ETHICS AND PROPER CONDUCT OF RESEARCH Modern Chronology Nuremburg Code Declaration of Helsinki Belmont Report Clinical Trial Volunteers Bill of Rights
4 HELSINKI EVOLVES Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October th WMA General Assembly, Venice, Italy, October st WMA General Assembly, Hong Kong, September th WMA General Assembly, Somerset West, South Africa, October nd WMA General Assembly, Edinburgh, Scotland, October rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification on paragraph 29 added) 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification on Paragraph 30 added) 59 th WMA General Assembly, Seoul, Korea, October 2008
5 A Transformative Opportunity Deadly Medicine, Creating the Master Race at the WW II Museum in New Orleans July 25 to October 15, 2012 Produced by: US Holocaust Memorial Museum; Presented by: National WW II Museum; Sponsored by: Tulane University A. Emphasis on Eugenics and Social Darwinism morphing into Racism B. Good Scientists committing atrocities in pursuit of good Science C. Bad Scientists seizing opportunity to do bad science D. Adoption of advances wrongly discovered
6 COURSE DISCUSSION: Rationale for Regulatory Oversight And Proper Conduct of Human Research Our Violations between 1946 and present: Tuskegee Nicaragua Willowbrook Milgram Humphrey ETC Thus we have recruited internal and external overseers for Clinical Research
7 CLASS DISCUSSION QUESTIONS To What did the Nuremburg Principles Respond? By whom were they articulated? When? Did they REFLECT American Values, or did they DRIVE American Values? What was the Helsinki Code? Why has it evolved? What were the subsequent legal foundations of Bioethics in Medical Research today?
8 CLASS DISCUSSION QUESTIONS, Cont. Compare and contrast Joseph Mengele and Gerhard Rose What differences were there between whimsical, ideological, opportunistic experiments and military sponsored research during the Nazi era?
9 CLASS DISCUSSION QUESTIONS, Cont. Discuss how good, well trained people could perform Unspeakable Atrocities in the name of Science? Is it ethical to use scientific data obtained unethically and immorally? Provide examples.
10 POINTS RAISED by STUDENTS A. Is Deception of study subjects ever warranted? i. From the Milgram s study of Teacher s stress ii. Krugman s description of his hepatitis research at Willowbrook to parents B. Of the ethical principles, can one override others? C. Does greater good matter? D. Justification for Phase I Clinical Trials carefully done (No Therapeutic Benefit Intended) E. Science cannot (should not) self-regulate needs oversight
11 Protocol Development: Practical Application Revisit Nuremberg, Helsinki, Belmont, Bill of Rights Apply biostatistics, epidemiology, business Stress the relationship between good science and Autonomy Beneficence Utility Justice Protection PI Responsibility
12 TOPICS OF (RE)CURRENT INTEREST How do we deal with ill-begotten knowledge? How do we guard against future lapses?
13 CURRENT EVENTS
14 CURRENT EVENTS Wall Street Journal, Saturday, December 1, 2012 page 1! The Hubertus Strughold Award For Outstanding Work in Aviation Medicine of the Space Medicine Association Wall Street Journal, Friday, September 6, 2013 Book-Review Section, Page 1! Stanley Milgram s Shock Experiments Behind the Shock Machine by Gina Perry
15 (RE)CURRENT INTEREST We don t know how to deal with the innovators who worked under the Nazi culture We have learned to live with the innovations: Life jackets and space travel to name only 2 How?
16 ETHICAL CHALLENGES NOW AND IN THE FUTURE - THAT WE CAN ENVISION A. Justice : Equal access to clinical trials Implications for health care delivery systems NSABP P1 13,000 women, 1% African American B. Beneficence i. Phase I Clinical Trials children and elderly ii. Claims on Data (Identification of significant genetic risk on study of bio-banked tissue) iii.evidence based medical decision making i. Selection of references (X Up-to-Date)
17 OVERIDING QUESTIONS What are VALUES? How do we achieve them? Are they Immutable? Are codes enough? To whom do we delegate oversight? IRB Compliance Officer Internal Audit External Audit Peer Review - PARTICIPATE
18 ETHICAL CHALLENGES THAT WE CANNOT ENVISION A. B. C. D. E. F. G.
19 MAINTAIN VIGILANCE Act consistent with our values Teach consistent with our values Accept oversight provide oversight Technology will complicate our ethical lives ACCEPT IT!
20 REMEMBER What keeps me up at night? Worry that we will lose the COMMUNAL SHAME for the atrocities committed in the name of research and public policy. Ken Jacobson, Deputy Director, Anti-defamation League New Orleans, December 2, 2012
21
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