title: How IRBs view and make decisions about consent forms.
abstract: IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn't been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how "perfect" forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also "nitpick" these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research.
authors.affiliation: Columbia University, New York, NY 10032, USA. rlk2@columbia.edu
authors.forename: Robert L
authors.initials: RL
authors.lastname: Klitzman
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D032962:Consent Forms / Q000941:ethics*; D003365:Costs and Cost Analysis; D003657:Decision Making; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent