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Human Subject Considerations

Any study or research proposal involving human subjects must be concerned with establishing and maintaining ethical practices in the recruitment, enrollment, consenting, interviewing, and intervention delivery processes (see Chapter 13). However, in intervention research, there are additional concerns including the possibility of an adverse event from proposed treatments and participant burden. Thus, human subject considerations must take into account potential adverse events from a treatment (including for the control group conditions), and how the investigative team will handle such possibilities. Although most behavioral intervention studies do not report the occurrences of adverse events, precautions must be put into place in case they do occur. Also, as behavioral intervention research involves interacting with people over multiple occasions, it is possible for the research team to encounter any number of issues that are not due to the study itself but that may require action. These issues may include but are not limited to participant hospitalization, falls, death, unsafe home environmental conditions (e.g., home infestations, lack of heat or air conditioning), and financial, emotional, or physical abuse or neglect, to name a few of the common events that may occur. Having a plan in place to ethically respond to each of these challenges (e.g., contacting adult protective services or linking participants to needed home repair services) must be detailed in a human subjects plan. Furthermore, all staff must be trained in how to address or respond to, report, and record such events.

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