Ethical issues in HIV/STD prevention research with high risk youth: Providing help, preserving validity

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.