In this chapter, we highlight and discuss issues related to the ethical conduct of research that are important to behavioral intervention researchers. Research ethics is a complex and dynamic question, especially for behavioral interventions. The existing regulations and guidelines are somewhat general and can be confusing, as they have been developed primarily for biomedical interventions. They also vary across governments and federal agencies. However, there are basic principles for the conduct of research with human participants that are essential to behavioral intervention research to ensure that the dignity, rights, safety, and well-being of research participants are maintained; the research is conducted in an ethical manner; and the results of the investigations are credible. As discussed in this chapter, important issues to consider are the informed consent process, the role of the IRB and safety monitoring bodies such as the DSMB, and protocols for handling potential AEs and SAEs. PIs need to be aware of existing regulations and guidelines regarding the protection of human subjects and research ethics, and should also be thoroughly familiar with the IRB and polices of their resident institutions. It is especially important now when research methodologies are changing as well as policies, regulations, and the literature in this area.

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