1. Public Health Ethics and Leadership: Getting it Right! Leslie E. Wolf, J.D., M.P.H. Georgia State University College of Law Center for Law, Health & Society June 22, 2011

2. Outline Historic cases: Tuskegee, Guatemala Lessons from the cases Ethics frameworks Ethics resources Questions/discussion

3. Tuskegee Syphilis Study National archives from the records of the CDC

5. Guatemala Studies Susan Reverby from Wellesley College website

6. Lessons from the studies Long memory for problems Should listen to our (or other’s) gut instincts Need to evaluate our biases Laws only get us so far

7. Long memory for problems

8. Should listen to our (or other’s) gut instinctions TUSKEGEE “I am utterly astounded... that [MDs] allow patients with potentially fatal disease to remain untreated when effective therapy is available.” 1965 MD “This is the first letter of this type we have received. I do not plan to answer this letter.” CDC internal response GUATEMALA “I am...more than a bit, leary [sic] of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be the best or the prisoners for they can give consent.” PHS supervisor

9. Need to evaluate our biases

10. Laws only get us so far

11. So how do we do better? Make ethics an explicit part of decision- making/policy making –Ensures consideration of ethics issues –Provides opportunity for others to provide input –Enhances transparency N.B. an ethicist is not required –But a consultation with an ethics consultant or committee, when one exists, can be helpful

12. What standards do we use? Different ethics frameworks –Clinical, public health, research BUT common foundation principles –Respect for persons –Beneficence –Justice –And more (trust, integrity, ethics of care)

13. Common principles Respect for persons –Autonomous individuals  informed consent –Confidentiality Beneficence –Minimize risks/maximize benefits Justice –Fair treatment; equitable distribution of burden and benefits

14. Limitations of ethics frameworks Principles can and do conflict –That’s why we call them ethical dilemmas Process can help reach consensus –Or at least justify a decision (even if you disagree)

15. Specific questions to consider: Research ethics Is the science justified? Are the risks to participants minimized? Is the study population affected by the condition under study? Will the study population benefit from the study results? What needs to be done to ensure that participants understand the study?

16. Specific questions to consider: Public health Is the intervention necessary and effective? Is it the least restrictive alternative? Which populations will be (most) burdened by the action? Which populations will benefit (most) by the action? Has there been communication with the affected communities?

17. Specific questions to consider: Clinical care (policy) What will patients be told about the policy/proposed action? What populations will be affected by the policy/proposed action? Have patient preferences been taken into account? What processes are in place to assess patient comprehension?

18. Resources Clinical ethics –Professional organizations (e.g., AMA, ANA, APA, etc) –Clinical ethics texts Research ethics –Belmont Report, Code of Federal Regulations –Declaration of Helsinki –OHRP

19. Resources Public health ethics –Public Health Law Society’s Code of Public Health Ethics (http://www.phls.org/home/section/3-26/)http://www.phls.org/home/section/3-26/ –CDC public health ethics http://www.cdc.gov/od/science/integrity/phethics/ Proposed public health ethics consortia

20. Questions? Comments?