When the subject is more than just the subject: two case studies of family involvement in human subjects research.

Institutional review boards (IRBs) protect human research subjects by reviewing research to ensure compliance with federal regulations and institutional policies. One of the most important functions of IRBs is to ensure that investigators anticipate, plan for, and minimize risks to subjects. Under certain circumstances, however, participation in research may pose risks to nonsubject family members or other members of a subject's social network. In the context of a research protocol designed to test an intervention to prevent depression among a population of culturally diverse, urban mothers, we present two case studies of unanticipated problems, which demonstrate how nonsubject family members can either impact, or be impacted by, an individual's participation in research. The case studies illustrate the incongruence between federal regulations addressing IRB approval of research-which focus specifically on risks to subjects-and regulations on reporting incidents that occur during the conduct of the research, which extend to risks involving "others" as well. The cases also illustrate how risks to "others" can be accentuated in certain cultures where codependent family structures may increase the role that family members play in an individual's decision to participate in research. The question is raised as to whether this incongruence can inadvertently result in investigators and IRBs under-appreciating the risks that participation in research can pose to nonsubjects.