Ethics in HIV Prevention Research Involving LGBT Youth

描述（由申请人提供）：男男性行为者（MSM）和变性妇女感染艾滋病毒的风险高得惊人，据估计，与女性发生性关系的妇女和变性男子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需要，但没有经验推荐的针对18岁以下女同性恋、男同性恋、双性恋和变性青年（LGBTY）的行为或生物医学艾滋病毒预防计划。在这一人群中缺乏艾滋病毒预防计划的一个主要原因是发起对18岁以下LGBTY的研究的挑战。研究者和他们的IRB对于保护LGBTY研究权利和福利的适当道德程序缺乏共识。而且，在没有经验数据指导决策的情况下，IRB必须经常依赖主观判断，这可能导致对LGBTY参与艾滋病毒预防研究的风险程度和概率的高估或低估。因此，许多研究者将18岁以下的LGBTY排除在艾滋病毒预防研究之外，因为预期或实际难以获得IRB批准。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者和IRB提供有关涉及LGBTY的艾滋病毒预防研究的负责任设计和实施的循证决策信息。我们建议通过三个具体目标来解决这一知识缺口：（1）告知伦理上负责的决策和IRB对相关联邦法规的应用（46.102i; 46.111.a）对心理、社会和信息风险效益的评估 LGBTTY参与艾滋病毒预防研究。使用焦点小组和调查，我们将产生经验数据LGBTY的评估的规模和概率的风险和预期的好处的招聘策略，风险行为调查，艾滋病毒/性病和药物使用测试，和生物医学预防试验的参与。(2)告知伦理上负责的决策和IRB应用允许放弃监护人许可的法规（46.116 d和 46.408c）男女同性恋、双性恋和变性者参与艾滋病毒预防研究。使用焦点小组和调查，我们将产生经验数据LGBTY的评估监护人许可是否是一个“实际”或“合理”的要求，他们参与的研究，涉及风险行为调查，艾滋病毒/性病和药物使用测试，和生物医学预防试验。我们将探讨这些评价是否因青年特征而异（例如，“外化”程度、艾滋病风险）。(3)：告知道德上负责的决策和IRB关于青年同意能力的规定的应用（46.116 d和 46.408c）男女同性恋、双性恋和变性者参与艾滋病毒预防生物医学试验。使用一个假设的艾滋病毒预防试验，我们将产生经验数据的同意准备的LGBT青年的年龄14 - 17相比，LGBT青年与成年法律的地位（18 - 20岁）。

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).