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

Sara Sauder, Rachel Stein Berman, Emily Feinberg, Howard Bauchner, Mary Banks, Michael Silverstein

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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 researchwhich 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.

Original languageEnglish (US)
Pages (from-to)33-38
Number of pages6
JournalJournal of Empirical Research on Human Research Ethics
Volume6
Issue number1
DOIs
StatePublished - Mar 2011
Externally publishedYes

Fingerprint

Research Ethics Committees
Research
family member
regulation
participation
Research Personnel
Organizational Policy
Research Subjects
Risk Management
Social Support
family structure
Mothers
incident
social network
Depression
Population

Keywords

  • Family involvement in research
  • Maternal depression
  • Secondary subjects

ASJC Scopus subject areas

  • Social Psychology
  • Education
  • Communication
  • Law

Cite this

When the subject is more than just the subject : Two case studies of family involvement in human subjects research. / Sauder, Sara; Stein Berman, Rachel; Feinberg, Emily; Bauchner, Howard; Banks, Mary; Silverstein, Michael.

In: Journal of Empirical Research on Human Research Ethics, Vol. 6, No. 1, 03.2011, p. 33-38.

Research output: Contribution to journalArticle

Sauder, Sara ; Stein Berman, Rachel ; Feinberg, Emily ; Bauchner, Howard ; Banks, Mary ; Silverstein, Michael. / When the subject is more than just the subject : Two case studies of family involvement in human subjects research. In: Journal of Empirical Research on Human Research Ethics. 2011 ; Vol. 6, No. 1. pp. 33-38.
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