1. Informed Consent in Research Why Conduct Research? Research involving humans is premised on a fundamental moral commitment to advancing human welfare, knowledge, and understanding, and to examining cultural dynamics. Tri-Council Code p. i.4

2. Why do we need Research Ethics? 1.) Correct past problems and abuses 2.) Prevent new problems and abuses 3.) Law is not enough

3. Past Abuses? Two major atrocities in the 20th century led to codification of research ethics 1.) Nazi Science 2.) Tuskagee Institute (Alabama)

4. Dr. T. Clark Tuskagee Study (1932-1972) Tuskagee Institute, Macon County, Alabama * 1931 USPHS Survey Results * 399 untreated syphilitic African Americans * "Study in Nature" * Observe natural history of disease

5. Opportunity? "an unusual opportunity to study the untreated syphilitic patient from the beginning of the disease to the death of the infected person" Journal of the American Medical Association 1936

6. Nuremberg Code 1947 (War Trials in Nuremberg) "The voluntary consent of the human subject is absolutely essential" Nuremberg Code 1947 Article 1

7. Declaration of Helsinki 1964 (World Medical Association) * Physician and Treatment Focus Therapy and Research 1.) Distinction between research where aim is 2.) diagnostic or therapeutic for the patient 3.) purely scientific without implying therapeutic value to the person subjected to the research

8. Right to Standard of Care (Declaration of Helsinki Amended in 1996) Every patient including those of a control group, should be assured of the best proven diagnostic and therapeutic method Declaration of Helsinki 1996 II, 3.

9. TPS (Tri-Council Policy Statement) AKA “Tri-Council Code” This joint policy expresses the continuing commitment of the three Councils to the people of Canada, to promote the ethical conduct of research involving human subjects. TPS i.1 - abiding by the Tri-Council Code is a condition for public funding of research (and many universities have similar rules for private funding for its researchers).

10. Ethical Principles of the Tri-Council Code Four Basic Principles (1997) 1.) Respect for Persons 2.) Non-Maleficence 3.) Beneficence 4.) Justice

11. Guiding Ethical Principles (1999) 1.) Human Dignity 2.) Free and Informed Consent 3.) Vulnerable Persons 4.) Privacy and Confidentiality 5.) Justice and Inclusiveness 6.) Balancing Harms and Benefits 7.) Non-Maleficence 8.) Minimizing Harm 9.) Maximizing Benefits

12. To This Point: 1.) We’ve discussed the historical reasons why research ethical codes came to be Q: Now where are we going? A: To contrast the question of consent in the medical context (which we’ve talked about) with consent in the research context

13. Consent * As a patient, your consent must be respected. * As a research subject, your consent must be scrutinized – and can (and in the right cases must) be rejected.

14. * the difference in the two different informed consents is based in rights: * you have the right to medical care * you don’t have the right to be a research subject (it’s your free choice, but not guaranteed to you as an inalienable right).

15. * When you appear in a lab to be a research subject, the researcher’s obligation is to determine if there is any coercion at work in your decision. * the researcher is obligated (according to Freedman) to examine your consent for hidden reasons * If one becomes apparent, the researcher should refuse you. * Your consent to experimentation is not the same as it is for medical treatment.

16. * coercion (expectation of favour - reference for parole, example of good behaviour, coincides with treatment) Vulnerable populations = groups who have structural/systemic vulnerability to the powerful who may want to research using them.

17. Coercion vs. Inducement Coercion = forcibly, against your will inducement = reward, ultimately your choice

18. Coercion – threat of force is almost always not allowed in research participation/recruitment Inducements – are allowed, so long as their not “undue” 1.) something good, a gift, reward, etc 2.) seems irresistible 3.) inducement causes taking of unusual risk 4.) this risk-taking must create unethical or excessively risky situations x

19. “voluntariness”  Can be addressed in the case of coercion or inducement: “would I do this, if I wasn’t going to have this bad thing/harm happen?” “would you participate in the research if it turned out that the inducement was “out?”

20. Kirkwood’s Case Study of Research Ethics: