Ethics in HIV Prevention Research Involving LGBT Youth

描述（由申请人提供）：年轻男男性行为者（MSM）和变性女性感染艾滋病毒的风险高得惊人，据估计，与女性发生性行为的女性和变性男性感染艾滋病毒的风险至少与异性恋者一样高。然而，尽管有明确的证据表明，18岁以下的女同性恋、男同性恋、双性恋和变性青年（LGBTY）有需要，但没有经验建议的行为或生物医学艾滋病预防计划。在这一人群中缺乏艾滋病预防项目的一个主要原因是对18岁以下的LGBTY进行研究的挑战。研究者和他们的内部审查委员会对于保护LGBTY研究权利和福利的适当伦理程序缺乏共识。而且，由于没有经验数据来指导他们的决策，irb必须经常依赖主观判断，这可能导致对lgbt参与艾滋病毒预防研究的风险程度和可能性的高估或低估。因此，由于预期或实际难以获得IRB的批准，许多研究人员将18岁以下的lgbt排除在艾滋病毒预防研究之外。这种不幸的排斥使LGBTY无法参与有可能确定艾滋病毒行为或生物医学预防干预措施的安全性，有效性和有效性的研究，这些干预措施适合该人群的发展。当前提案的总体目标是为研究人员和irb提供基于证据的决策，以负责任的设计和实施涉及LGBTY的艾滋病毒预防研究。我们建议通过三个具体目标来解决这一知识差距：(1)为道德负责的决策和相关联邦法规的IRB应用提供信息（46.102i； 46.111）。A)对心理、社会和信息风险-收益的评价

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).