Ethical issues in HIV/STD prevention research with high risk youth: Providing help, preserving validity
Ethical issues in HIV/STD prevention research with high risk youth: Providing help, preserving validity
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DOI：
10.1080/10508420802066833
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发表时间：
2008-04-01
影响因子：
2
通讯作者：
Macklin, Ruth
中科院分区：
文献类型：
--
作者：
Bauman, Laurie J.;Sclafane, Jamie Heather;Macklin, Ruth
许多针对青少年的预防性干预研究都涉及高危行为，如吸毒、酗酒和无保护性行为。随机对照试验（RCT）是用于测试这些行为干预措施有效性的金标准方法。严格描述的方案之外的干预是禁止的。然而，实施灵活的干预方案存在伦理挑战，特别是当目标人群年轻，经历许多压力事件，生活在资源贫乏的环境中时。青少年谁是在高风险的物质使用或性风险行为往往是在风险的其他问题，如暴露于暴力，性和身体虐待，抑郁症，和无家可归。研究者应该如何以道德上适当的方式处理青少年在预防项目中的心理和社会需求，同时保持RCT结果的有效性？我们已经确定了程序的特点，参与者的特点，与父母的互动，并与青少年的问题，而不是在研究中的道德困境的来源与风险青少年的RCT。根据我们的经验，我们建议每一项行为干预研究都要制定一项伦理协议，其中应包括为参与者提供帮助的规则，为专家提供指导的联系信息，以及处理危及生命情况的紧急程序。此外，研究应该有一个资源手册，培训研究人员在这些伦理问题，并与数据安全和监测委员会或伦理委员会。
Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee.