path Risks, Benefits and Inducements Finding the Balance

path Recall: Justice requires that the burdens and benefits of research be equitably distributed The goal: Avoiding Exploitation

path Balancing risks & benefits F Research must present an acceptable balance between risks and benefits F Ethics committees are there to help judge acceptability of risk/benefit ratio F Informed consent process also helps individuals make their own judgment F Health and well-being of participant can never be sacrificed for “research’s sake” or the “greater global good”

path Participant Risks vs. Benefit F RISKS –Biologic –Social/Emotional F From the product –Side effects –Potential harm F From HIV/STI testing F Partner issues F BENEFITS –Improved access to health care F Better prevention –Risk reduction counseling –STD treatment –Condoms F Other –Cash –Sense of social contribution

path Participants’ Perspective Microbicide trial (benefits) Access to medical services, regular health checks considered biggest benefit Counseling about women’s bodies, sexuality, RTIs, and HIV Good relationships with study staff Feeling empowered; improved communication with male partners and children Access to study gel; improved sex due to gel Contributing to a women’s health cause: “One is helped but is also helping others”

path F Qualitative data from Phase II participants in South Africa microbicde trial: HIV testing considered biggest burden Discomfort during pelvic exam Long waiting times at clinic Feeling of loss at end of study Hardly any worries about side effects; happy about close clinical & lab monitoring and good medical care (see benefits) Participants’ Perspective Microbicide trial (burdens)

path Community Burdens and Benefits F Burdens –Possible Stigma –Diversion of local health personnel F Benefits –Improved health infrastructure –Training –Community education on HIV/research –Preferential access to product if it proves effective

path Should participants be compensated for their participation in a study? If so, how much? Who decides? What are the risks of compensating generously?

path Is providing access to ARVs to those who seroconvert in a microbicide trial undue inducement if such treatment is not otherwise available locally?

path Two principles to consider… F (Undue) inducement –Informed consent must be free of coercion. Consent can be undermined by incentives that lead to “undue” pressure” or “undue inducement” to participate F Reciprocal Justice –Someone who benefits from the investment and sacrifice of others owes them proportional recompense

path (Undue) Inducement F Informed consent can be undermined by incentives that lead to “undue” pressure” or “undue inducement” to participate F An inducement may persuade an individual to change his or her mind about entering a research project, but this in itself is not enough to make it inappropriate F An “inducement” becomes inappropriate when it causes a person to assume risks that they would ordinarily view as unacceptable Nuffield Council on Bioethics

path Evaluating acceptability of inducements F Harmfulness: the nature of the potential risks to the participant’s health F Proportionality: whether the inducement is in proportion to the risks and costs of research F Vulnerability: whether prospective participants are especially vulnerable to influence