Reducing Health Disparities and Enhancing the Responsible Conduct of Research Involving LGBT Youth
Reducing Health Disparities and Enhancing the Responsible Conduct of Research Involving LGBT Youth
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DOI：
10.1002/hast.367
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发表时间：
2014-09-01
影响因子：
3.3
通讯作者：
Mustanski, Brian
中科院分区：
文献类型：
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作者：
Fisher, Celia B.;Mustanski, Brian
尽管显然需要针对18岁以下LGBT人群成员的自杀、药物滥用和性健康的循证行为或生物医学预防或治疗方案，但由于研究知识有限，此类方案很少存在。管理人类受试者保护的法规中的模棱两可，以及机构审查委员会(IRB)对法规语言的相关解释不一致，是缺乏严格的临床试验证据来支持治疗选择和预防方法以减少这一人群的健康差距的关键原因。鉴于自杀、药物滥用、艾滋病毒和性传播感染研究的社会敏感性，特别是LGBT研究，在缺乏经验数据指导其决定的情况下，IRBs必须经常依赖于最小风险的主观判断，这可能导致高估LGBT青年参与临床试验可能产生的心理、社会和信息伤害的程度和可能性。此外，与其他青少年相比，家庭不知道自己的性取向或性别认同或因性取向或性别认同而受害的LGBT青少年可能不愿参与需要监护人许可的研究。这反过来又加剧了招聘和无偏见抽样的问题。然而，许多IRBs不愿适用联邦法规，允许在显然不“可行”或“合理”要求监护人许可的情况下放弃这种许可。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患者排除在健康干预研究提案之外。这种情况与当前关注年轻人参与试验的权利的伦理论述相冲突，这些试验将保护他们免受发展中未经检验的、不适当和不安全的治疗。在这篇文章中，我们描述了为LGBT青年提供安全和公平的健康研究机会的这些障碍和建议。
Although there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence to support treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research.