Ethics in HIV Prevention Research Involving LGBT Youth

描述(由申请人提供)：与男性发生性关系的年轻男性(MSM)和变性人女性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女性和变性人男性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，但还没有针对18岁以下的女同性恋者、男同性恋者、双性恋者和变性人青年(LGBTY)的经验建议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启动对18岁以下LGBTY的研究的挑战。对于保护LGBTY的研究权利和福利的适当道德程序，研究人员及其IRBs之间缺乏共识。而且，如果没有经验数据来指导他们的决定，IRBs必须经常依赖主观判断，这可能会导致高估或低估LGBTY参与艾滋病毒预防研究的风险的大小和概率。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LGBTY排除在艾滋病毒预防研究之外。这一不幸的排除使LGBTY无法参与有可能确定适合这一人群发展的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。目前提案的首要目标是让调查人员和机构都能作出基于证据的决策，以负责任地设计和开展涉及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鸿沟：(1)为道德上负责任的决策和IRB应用相关联邦法规(46.102i；46.111.a)提供信息，以评估心理、社会和信息风险收益 LGBTY参与艾滋病毒预防研究。利用焦点小组和调查，我们将生成LGBTY对招募战略、风险行为调查、艾滋病毒/性传播感染和药物使用测试以及生物医学预防试验参与的风险和概率的大小和概率以及预期好处的评估的经验数据。(2)告知道德上负责任的决策和IRB关于允许LGBTY参与艾滋病毒预防研究的监护人许可豁免的法规的实施(46.116d和46.408c)。利用焦点小组和调查，我们将生成LGBTY对监护人许可是否对他们参与风险行为调查、HIV/STI和药物使用测试以及生物医学预防试验的研究是否是一项“实际”或“合理”要求的评估的经验数据。我们将探索这些评估是否根据年轻人的特征(例如，“外向”程度、艾滋病毒风险)而有所不同。(3)：就LGBTY参与艾滋病毒生物医学预防试验的青年同意能力条例(46.116d和46.408c)向伦理负责的决策和IRB的应用提供信息。使用一项假设的艾滋病毒预防试验，我们将产生关于14-17岁LGBT青年与具有成年法律地位的LGBT青年(18-20岁)同意准备情况的经验数据。

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).