Participant Perspectives: Risk and Respect

1. Participant Perspectives: Risk and Respect Wylie Burke MD PhD Department of Bioethics and Humanities University of Washington Seattle, WA

2. Protection of participants as rationale for research oversight e.g., role of the Office for Human Research Protections (OHRP): “provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).”

3. Beecher’s 1966 report of research abuses -- 22 examples including Injection of cancer cells into human participants without their knowledge, to study cancer immunology Deliberate infection of institutionalized children with hepatitis, to study natural history of infection US Public Health Syphilis Study (Tuskegee) Beecher H. NEJM 1966;74:1354-60 Federal regulations - a response to disclosure of research abuses

4. “Informational harm” • Primary risk of large data repositories and biobanks linked to health/other data • Stems from unauthorized release of personal information • Revealing clinical status • Revealing personal information deemed sensitive or stigmatizing

5. OHRP guidance (2004, 2008):Coded Private Information and Specimens “Under certain limited conditions, research involving only coded private information or specimens is not human subjects research.” 45 CFR 46.102 Definitions: (f) Human subject means a living individual about whom an investigator conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

6. Were the Havasupai harmed? • ASU researchers engaged tribe in research on diabetes, approved by the tribal authorities • DNA samples stored; over time shared for research on schizophrenia, genetic inbreeding and population migration. ‘Tribal attorney Robert Rosette says he’s been a part of mediation meetings in which ASU officials have told him, “There’s no broken bones – you haven’t been harmed.”’ Bommersbach. Phoenix Magazine, Nov 2008

7. Views of the Havasupai “They lied to me… I trusted them, and that was broken.” “I wanted to better the tribe…Then I found they were using our blood for all these different things. To me, personally, it was raping me of my blood. It was using my blood for their own goals.” Bommersbach. Phoenix Magazine, Nov 2008

8. “I think that [a federal data repository] is good in that data collection is tedious and expensive and a drain, and especially if public money is going into that, you don’t want people gathering the same data over and over again” -- BUT before submitting data- “Ask for permission and if you give your permission, then yes. But without asking, I don’t think so.” Trinidad et al. GIM 2010;12(8):486-95 Focus groups on data-sharing at an urban HMO

9. Research updates “I think that [researchers] should find a way of letting people know what’s been found out. I mean, you donated time and energy and thought.” Return of results General expectation that clinically meaningful results should (and would) be returned. Trinidad et al. GIM 2010;12(8):486-95 Other views of HMO members

10. Indicators of participants’ stake in the research process • Wanting to be sure research is pursued with benefit in mind • Valuing information about how how their samples are used • Assuming they will be provided with information of direct personal benefit

11. HMO member views on risks Speaker 1: “As soon as there’s a database, and it’s on a computer, sooner or later there is a thing where bank records all of a sudden get lost, or somebody steals them, or somebody hacks them…And it’s bank records or it’s hospital records, and this happens several times a year…” Speaker 2: “However, having said that, and knowing that this happens, we don’t stop using banks!” Trinidad et al. GIM 2010;12(8):486-95

12. Moving from risk to respect • Who is at the table when key decisions are made? • Consent procedures • Data storage • Data use • Reporting of results • How are participants informed at different stages of the research process? • How are individual preferences honored?

13. One element of proposed new rules for human participant research “..the allowable current practice of telling the subjects, during the initial research consent, that the data they are providing will be used for one purpose, and then after stripping identifiers, allowing it to be used for a new purpose to which the subjects never consented, would not be allowed.” http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

14. Concept of collaborative stewardship • Mutual recognition among stakeholders • Listening to each other’s voices • Dialogue • Sustained engagement • Accept and work through conflicts • Negotiate accommodation • “What touches all should be agreed to by all” (James Tully) Wylie A, Promise and perils of an ethic of stewardship, in Embedding Ethics, EdsMeskell & Pels 2005

15. Moving beyond informed consent • Acknowledge the essential role of the public in research • Funding • Participation • Develop strategies to keep participants informed • Engage participants and the general public in research governance

16. Acknowledgements University of Washington Kelly Edwards, Malia Fullerton, Dana Gold, Rose James, Gail Jarvik, Susan Trinidad, Helene Starks, Group Health Research Institute EvetteLudman, Eric Larson Oregon Health & Science University Nancy Press Northwest Indian College William Freeman