title: Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval.
abstract: The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. "Omissions" in documentation (40%) and "better clarity" (24%) accounted for the majority, while "word-smithing" accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging "word-smithing" on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process.
authors.affiliation: a University of Michigan Medical School , Ann Arbor , Michigan , USA.
authors.forename: R Alexander
authors.initials: RA
authors.lastname: Blackwood
authors.forename: Ronald F
authors.initials: RF
authors.lastname: Maio
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Mrdjenovich
authors.forename: Terry M
authors.initials: TM
authors.lastname: VandenBosch
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Gordon
authors.forename: Emily L
authors.initials: EL
authors.lastname: Shipman
authors.forename: Ted A
authors.initials: TA
authors.lastname: Hamilton
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D032962:Consent Forms / Q000941:ethics / Q000331:legislation & jurisprudence*; D004282:Documentation / Q000941:ethics / Q000379:methods*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D014481:United States
keywords: IRB; contingencies; informed consent