1. Research Issues Can be both sociological and ethical Excesses in the past have made rules and standards necessary Rules are participant oriented and protective

2. Research Issues vary with the patient populations and potential respondents involved The issues often center around consent, failure of the consent process and the eligibility to consent (protected populations Further issues are centered around what science can do and what science SHOULD do (moral issues)

3. Research Clear differences in the articles between utilitarian and Kantian approaches to the problems Utilitarian—community priority, gives science free rein Kantian—Individual priority, limits science to what can be done with the least harm

4. Research Uses scientific method Scientific method reviewed Science only peripherally values human subjects, not their individual values and value Science to be convincing must be objective Medicine to be convincing must be subjective—value the individual they serve

5. Scientist-physicians Have a dual role Have dual and competing social contracts Physician—duty to the individual patient above all, to save, heal and alleviate suffering Scientist—to objectively find the answers to scientifically styled questions and to advance the communal knowledge base, to find, in medicine, better and safer treatments and causations for disease

6. Excesses Nazi researchers Tuskegee and syphilis Applications of WHO protocol 076 in the developing world Children and surrogate consent AIDS activism and available therapies

7. Randomized Trials New therapy one group Old therapy/standard therapy/no therapy other group Can’t know which person goes into which group Thereby making INDIVIDUALS not the focus of therapy

8. Randomized Trials Advance science because we know 1] that new therapy is better/worse 2] that new therapy is safer/not safer Therapeutic/non-therapeutic Equipoise concept—scientist does not know the outcome and cannot predict the outcome therefore the research can continue

9. Research The issues really come down to practical issues of research clashing with ideals of medical care and medical ethics

10. Example--AZT trials Controversy centers around drug availability, cost and the use of humans who are disadvantaged to determine standards of care Blinded placebo studies

11. Issues Physician has a duty to individual patients welfare Researcher has a duty to find best therapy and to the community of medicine These duties clash “Genuine uncertainty” standard for ethical studies

12. Rights Do poor uneducated [often foreign] people have the right to drugs that can cure them? How is that right legally and ethically crafted? Do you have a right to medical care or to research protocols?

13. Responsibilities and Duties Who has the responsibility for care— doctors? Drug companies? Researchers? What is the fiduciary duty? Does that duty increase with patients who are unable to pay?

14. What is the Standard of care? Legal context In international research, is there a documented higher standard of care for use human subjects? What standard? Local and global viewpoints

15. Local Standard Determined by local conditions Availability of care and drugs locally Genuine uncertainty at a local level Placebo trials acceptable

16. Global Standard Standard of genuine uncertainty measured globally—research crosses borders and humans are humans In most cases if placebo done in developed world then can’t be done in developing world Places duty on humans in developed world for determining the standards for everyone

17. Benefit Arguments Looking at issue from patient viewpoint and researched person viewpoint Why would YOU do the research trial? What would you get out of it? Communal and individual benefits

18. Exploitation Risks Council for International Organizations of Medical Sciences (CIOMS) standards Vulnerable populations No use of developing countries to do trials if can be done in developed country by genuine uncertainty standard Must benefit actual individuals No placebo trials, trials between drugs

19. Vulnerable Populations Groups that cannot consent Groups that have coercion to consent

20. Ethics Involved in every decision we make as doctors Even research “At risk” populations

21. Summary Easy to place risk somewhere else and benefit from it Hard to be truly altruistic when so much money, prestige and medical opportunity is at stake