1. ETHICS AND INFORMED CONSENT FOR HIV CURE RESEARCH david evans project inform ETHICS AND INFORMED CONSENT FOR HIV CURE RESEARCH david evans project inform

2. IGNORANCE = FAILURE

3. Basic Principles of Research Ethics Respect for persons – Self-determination Beneficence – Do no harm – Maximize benefits and minimize risks Justice – Will benefits accrue to the participant equally? Study Design – Will the study give a definitive answer? Belmont Report, Declaration of Helsinki Good Participatory Practices

4. What about HIV cure research? Some studies offer no chance for direct medical benefit (proof of concept). Others have higher risks Basic concepts are difficult to describe in plain language Proving someone is “cured” could be quite difficult – need for very long follow-up Some studies must be done in very healthy HIV-positive people

5. How to compensate for ethical challenges? Recruitment must be ethical and must not overemphasize benefits (even inadvertently). Use the “c”word carefully. Must find the proper balance between reasonable compensation and coercion Must ensure that individuals who participate are fully informed and knowledgeable of the risks and benefits

6. Is the current informed consent process up to snuff? Many participants don’t fully read the forms Participant comprehension after standard consents (form + study nurse visit) is inadequate Participant recall at later time points drops off (should we continually reeducate?) Participants under-estimate the harms/risks and overestimate the benefits when self-interest or compensation is high Research suggests that:

7. What is INFORMED consent?

8. Is it ethical to ask people to participate in cure research for purely altruistic reasons? …and will they?

9. Survey Details Fielded on surveymonkey.com between 12/6/2011 and 1/20/2012 with over 2,100 respondents. Participants were asked to read a primer on cure research and research risks before responding. Participants recruited through popular HIV websites, blogs, list-serves, email lists and online forums. Designed by group of activists with input from HIV researchers

10. Survey Demographics 83% male, 16% female, 1% trans (MTF) 73% white, 10% black, 10% Latino, 2% API, 1%, American Indian, 4% other 65% were over 40, most HIV+ for >10 years Highly educated, but very low income 94% on ARV therapy 35% had previously been in a clinical trial

11. Altruism, part 1 Assuming that entering a study might pose health problems and other risks, how much would the chance to benefit others by participating in the study motivate you to join the study?

12. Altruism, part 2 Assuming that entering a study might pose health problems and other risks, if you were aware that you would probably not benefit from a new drug or procedure…but that your participation… might advance the field of HIV research, how willing would you be to participate?

13. Associations with altruism Race/ethnicity: African Americans (26%) and Latinos (12%) more willing to participate for altruistic reasons. Age: Oldest participants (60+ yrs) 37% less likely to be willing/very willing to participate for altruistic reasons than youngest (16 to 25yrs). HIV Knowledge: Least knowledgeable 29% less likely to be willing/very willing to participate for altruistic reasons. Income: Highest earners 33% less likely likely to be willing/very willing than lowest earners. Current CD4: Those with CD4>500 were 23% less likely to be willing/very willing than CD4<50.

14. No Associations or Weak Associations With Altruism Gender identity Education Feelings about ARVs Regimen Status Nadir CD4 Time since diagnosis Previous experience with clinical research

15. Survey Shortcomings No statistical projections during the design, so unable to determine statistical significance No way to ensure that participants read or fully understood the primer No way to to measure variable effects of specific incentives and disincentives Very difficult to recruit females and people of color with an online survey of this methodology Difficult to measure altruism in the absence of self-interest

16. Seeking funding for a new project Partnership with the Legacy Project Online and in person surveys – targets for participation by race, ethnicity and gender Corrects for short-comings of previous survey Expanded to learn about multiple variables affecting willingness to participate Will hopefully lead to a new educational tool to increase readiness and ability to participate in cure research as fully-informed subjects

17. #fail to #winning Learn about research ethics Learn about informed consents If on ACTG – focus on these issues with your colleagues Join a community advisory board (CAB) Join an institutional review board (IRB)