ETHICS ANDINFORMED CONSENT

FOR HIV CURE RESEARCH

david evansproject inform

IGNORANCE = FAILURE

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 HelsinkiGood Participatory Practices

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

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

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:

What is INFORMED consent?

Is it ethical to ask people to participate in cure research for

purely altruistic reasons?

…and will they?

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

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

Altruism, part 1Assuming 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%

33%

31%

24%

Motivation Level:

Not at all mo-tivatedSomewhat mo-tivatedMotivatedVery motivated

Altruism, part 2Assuming 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?

19%

36%29%

16%

Willingness to participate:

Not at all willingSomewhat willingWillingVery willing

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.

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

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

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

#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)