Research is a public trust that must be ethically conducted, trustworthy, and socially responsible if the results are to be valuable.

—University of Minnesota (2003)

Behavioral intervention research by its nature involves human participants; thus, ethical considerations with respect to the involvement and treatment of research participants is a critical issue at all phases of the pipeline and throughout the research process. Because of its importance and owing to many horrific incidents that have occurred with research participants (e.g., The Tuskegee Syphilis Trial), ethical considerations are critical and reflect fundamental principles as to how to conduct behavioral intervention research. Also, ethical conduct in research is increasingly being scrutinized by funding agencies and research institutions, and there is greater oversight.

Many countries have specific ethical standards for the conduct of research. In the United States, there are many guidelines and requirements at the federal, local, and institutional levels, with which investigators must comply when conducting research with human participants. Professional organizations such as the American Psychological Association also have research ethics policies. In fact, most universities/ research institutions have offices/programs dedicated to research ethics that go beyond Institutional Review Boards (IRBs) to include ongoing seminars, training courses, and consultant services to help ensure that the research conducted by investigators within the institution adheres to the highest ethical standards. At all institutions throughout the United States, and consistent with the policy of the National Institutes of Health (NIH), investigators and in fact all members of a research team, including community partners, must complete training and become certified in the ethical conduct of research before they can engage in any type of research with human participants and receive research grant awards. Although these requirements may sometimes seem to be a nuisance or hinder the progress of behavioral intervention research, they are designed to ensure adherence to fundamental ethical behavior. These requirements underscore the importance of carefully considering ethical issues. Such policies, trainings, and procedures help investigators understand pertinent ethical considerations, including, for example, obtaining informed consent from vulnerable populations such as those that may have some cognitive impairment, providing honorariums for study participation yet assuring this is not coercive, or protecting identifiable information of human participants.

Offices of research ethics and related policies and procedures also help investigators manage ethical dilemmas that might arise during the course of a study. For example, a wide range of issues unrelated to the research itself may be encountered such as physical or financial abuse of a participant, or hospitalization or death of a study participant, or home environmental problems (e.g., infestation, a hole in a roof), which impacts the health of participants. Similarly, a member of a research team may learn that a close colleague or another member of the team is violating ethical principles in an attempt to enhance recruitment efforts, or report better outcomes than the data suggest.

The topic of research ethics is complex and much has been written on ethical conduct in research. There is also a specialized discipline devoted to the study of research ethics—bioethics. The topic is dynamic—information and thinking in this area is continually evolving. For example, the widespread use of the Internet as a vehicle for data collection gives rise to new questions about the informed consent process and how use of the Internet impacts on issues related to privacy and confidentiality.

In this chapter, our goal is to provide an overview of the topic and highlight the critical issues that need to be considered in the conduct of behavioral intervention research. We begin with a brief overview of what falls within the umbrella of research ethics and some of the guidelines and requirements surrounding the ethical conduct of research in general. We then discuss in more detail specific aspects of importance to behavioral intervention research such as the informed consent process, IRBs, adverse events (AEs), and the role of Data and Safety Monitoring Boards (DSMBs).

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