Skip to main content

Currently Skimming:

Appendix D: Selected Studies of IRB Operations: Summary Descriptions
Pages 225-234

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 225...
... Sullivan, 1973, "Research on Human Subjects: Problems of Social Control in Medical Experimentation" This is the first known survey of IRBs, conducted in 1969; it included 300 biomedical IRBs, of which 70 percent had existed prior to the 1966 U.S. Public Health Service policy requirements.
From page 226...
... IRBs often modified consent forms, but there were no significant differences in the average readability or completeness scores between the original and modified consent forms. Those agreeing that "the review procedure has improved the quality of scientific research done at this institution—at least to some extent" were 78 percent of IRB biomedical members, 69 percent of biomedical researchers, 62 percent of IRB behavioral and social science members, and 55 percent of behavioral and social science researchers.
From page 227...
... The participating IRBs varied in their judgments, and a substantial number approved the flawed designs. Although there was considerable consistency in objecting to the consent forms, IRBs did not identify specific deficiencies consistently.
From page 228...
... Advisory Committee on Human Radiation Experiments, 1996, "Final Report" Research Proposal Review Project: This project sampled 125 research protocols involving human participants (84 involving ionizing radiation, and 41 not involving radiation) that were approved and funded by the Departments of Health and EIuman Services, Defense, Energy, and Veterans Affairs or by the National Aeronautics and Space Administration between fiscal years 1990 and 1993.
From page 229...
... Bell, James, John Whiton, and Sharon Connelly, 1998, "Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects" This is the most recent major study of IRBs. The study universe was defined as 491 IRBs that in 1995 operated with multiple project assurances under 45 CFR 46 and that had conducted more than 10 initial reviews of human participant research protocols in the previous
From page 230...
... ; · General opinions and ratings relative to adequacy (rating of overall adequacy, effect of initial review on protocols, effect of IRB action versus other influences at the institution, relative effect of different IRB activities, effect on scientific quality, influence of workload on protection adequacy, bias/lack of expertise, investigators' ability to participate in review decisions, relative impact/burden of federal requirements)
From page 231...
... (Questionnaires were kindly provided to panel staff by James Bell Associates.) Panel on Institutional Review Boards, Surveys, and Social Science Research, January 2003, Staff Review of University IRB Websites (unpublished)
From page 232...
... Yes, guidance is appropriate for SEES research 64% Yes, but guidance specifies inappropriate elements 9 Guidance simply repeats Common Rule No guidance is provided 11 17
From page 233...
... Notice of frequency of IRB meetings Estimate of time to allow for review No guidance provided Minimum time for review for those providing time estimates (n = 20) At least 1 week At least 2 weeks At least 3 weeks At least 4 weeks At least 6 weeks Longer than 6 weeks 30 43 26 100 95 85 75 30 20 13.
From page 234...
... Yes, may attend meeting May wait outside meeting to answer questions Meeting time and place listed, but no invitation 9 No 72 15%


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.