Ethics of HIV-related research involving underage key populations in sub-Saharan Africa

撒哈拉以南非洲地区未成年关键人群的艾滋病毒相关研究的伦理

• 批准号: 10445571
• 负责人: Ashley Lynn Grosso
• 金额: $ 79.36万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10445571
• 关键词: Africa; Africa South of the Sahara; African; Age; Attitude; Botswana; Characteristics; Committee Members; Country; Development; Ethics; Ethics Committees; Exclusion; Focus Groups; Funding; Government; HIV; Health; Individual; Institution; Institutional Review Boards; Intervention; Knowledge; Legal; Minor; Outcome; Parental Consent; Participant; Policies; Population; Readiness; Recommendation; Reporting; Research; Research Ethics Committees; Research Personnel; Review Literature; Risk; Self Efficacy; Sex Behavior; Stigmatization; Surveys; Testing; Therapeutic; Training; Uganda; Universities; Youth; adolescent men who have sex with men; experience; female sex worker; high risk; improved; member; men who have sex with men; multilevel analysis; sex; systematic review; waiver; willingness

Many youth who sell sex and adolescent men who have sex with men in sub-Saharan Africa are at high risk for HIV and other adverse health outcomes. However, these youth are often excluded from studies conducted with key populations in the region due to legal and ethical challenges. For example, the requirement to obtain parental consent for the participation of minors in research is often not safe or practical for youth whose sexual behaviors are stigmatized. This exclusion from research hinders the development and testing of interventions tailored for underage key populations. This project's long-term objective is to identify legal and ethical barriers to conducting HIV research with underage key populations in sub-Saharan Africa in order to inform strategies for overcoming these barriers to implement such research where it is feasible and warranted. The specific aims of this study are: (1) To examine the relationship between legal restrictions related to the participation of minors under the age of 18 in research and the implementation of studies including underage key populations (female sex workers and men who have sex with men) in 48 countries in sub-Saharan Africa. The content of each country's ethical and regulatory guidance on research with minors will be analyzed, and a systematic review of the literature on key populations in Africa will be conducted to determine where and what types of research (e.g., observational or therapeutic) have been conducted with underage key populations. (2) To assess through surveys the knowledge, attitudes and experiences of research ethics committee members and institutional review board members (n=419) in sub-Saharan Africa regarding the review of studies that include underage key populations as participants. We will analyze the country-level, committee-level, and individual- level characteristics associated with willingness to consider approving research with underage key populations. (3) To identify perceived obstacles to conducting research with underage key populations in Africa through surveys of two groups of researchers who have conducted studies with key populations in Africa: those who have a) included underage participants (n=50) and b) excluded underage participants (n=125). Deliberative focus group discussions will also be conducted with researchers and research ethics committee members. Findings will be disseminated to researchers, ethics committee members, and organizations representing youth and key populations in Africa.

在撒哈拉以南非洲，许多卖淫的青年和与男子发生性关系的青少年男子面临着高风险， 艾滋病毒和其他不良健康后果。然而，这些年轻人往往被排除在研究之外， 由于法律的和道德方面的挑战，该地区的主要人口受到影响。例如，要求获得 父母同意未成年人参与研究，对那些性行为严重的青少年来说往往是不安全或不切实际的。 行为被污名化。这种被排除在研究之外的情况阻碍了干预措施的开发和测试 专门为未成年重点人群量身打造。该项目的长期目标是确定法律的和道德障碍 在撒哈拉以南非洲的未成年关键人群中开展艾滋病毒研究， 克服这些障碍，在可行和有保证的情况下开展此类研究。具体目标 本研究的主要内容是：（1）研究与参与有关的法律的限制之间的关系， 未满18周岁的未成年人在研究和实施研究中包括未成年重点人群 （女性性工作者和男男性行为者）在撒哈拉以南非洲的48个国家。的内容 每个国家对未成年人研究的伦理和监管指导将被分析，并系统地 将对关于非洲关键人口的文献进行审查，以确定在何处以及何种类型的 研究（例如，观察性或治疗性）的研究。(2)到 通过调查评估研究伦理委员会成员的知识、态度和经验， 撒哈拉以南非洲的机构审查委员会成员（n=419）关于审查研究，包括 未成年人作为主要参与者。我们将分析国家一级、委员会一级和个人-- 与考虑批准未成年关键人群研究的意愿相关的水平特征。 (3)通过以下方式确定在非洲未成年关键人群中开展研究的已知障碍： 对两组研究人员进行的调查，他们对非洲的关键人群进行了研究： a）包括未成年受试者（n=50）和B）排除未成年受试者（n=125）。协商 研究人员及研究道德委员会成员亦会参与专题小组讨论。 研究结果将分发给研究人员、伦理委员会成员和代表 非洲的青年和关键人群。