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

ETHICS AND INFORMED CONSENT FOR HIV CURE RESEARCH david evans project inform. IGNORANCE = FAILURE. Basic Principles of Research Ethics. Belmont Report, Declaration of Helsinki Good Participatory Practices. Respect for persons S elf-determination Beneficence Do no harm

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

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

  2. IGNORANCE =FAILURE

  3. Basic Principles of Research Ethics Belmont Report, Declaration of Helsinki Good Participatory Practices • 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?

  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 consentprocess 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 byparticipating 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 benefitfrom 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)

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