Ethics in HIV Prevention Research Involving LGBT Youth

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DESCRIPTION (provided by applicant): Young men who have sex with men (MSM) and transgender women are at alarmingly high risk for HIV, and the risk among women who have sex with women and transgender men is estimated to be at least as high as that of heterosexuals. However, there are no empirically recommended behavioral or biomedical HIV prevention programs for lesbian, gay, bisexual, and transgender youth (LGBTY) under the age of 18 despite this clear evidence of need. A major reason for the absence of HIV prevention programs in this population is the challenge of initiating research on LGBTY under age 18. There is a lack of consensus among investigators and their IRBs about appropriate ethical procedures for protecting LGBTY's research rights and welfare. And, without empirical data to guide their decisions, IRBs must often rely on subjective judgments that can lead to over- or under-estimation of the magnitude and probability of risks of LGBTY participation in HIV prevention research. Consequently, many investigators have excluded LGBTY under 18 in HIV prevention research because of anticipated or actual difficulties obtaining IRB approval. This unfortunate exclusion prevents LGBTY from participating in research that has the potential to determine the safety, efficacy, and effectiveness of HIV behavioral or biomedical preventive interventions that are developmentally appropriate for this population. The overarching goal of the current proposal is to inform evidence-based decision making by investigators and IRBs alike regarding the responsible design and conduct of HIV prevention research involving LGBTY. We propose to address this knowledge gap with three specific aims: (1) To inform ethically responsible decision making and IRB application of relevant federal regulations (46.102i; 46.111.a) to the evaluation of psychological, social and informational risk-benefits of LGBTY involvement in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of the magnitude and probability of the risks and anticipated benefits of recruitment strategies, risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trial participation. (2) To inform ethically responsible decisio making and IRB application of regulations permitting waivers of guardian permission (46.116d and 46.408c) for LGBTY participation in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of whether guardian permission is or is not a "practical" or a "reasonable" requirement for their participation in studies involvig risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trials. We will explore if these appraisals differ by youth characteristics (e.g., degree of "outness," HIV risk). (3): To inform ethically responsible decision making and IRB application of regulations on youth capacity to consent (46.116d and 46.408c) for LGBTY participation in biomedical HIV prevention trials. Using a hypothetical HIV prevention trial, we will generate empirical data on the consent preparedness of LGBT youths' ages 14 - 17 compared to LGBT youth with adult legal status (18 - 20 years).