IRB panel members perceptions of their role in the review of scientific methodology: A qualitative study

The IRB's role in the review of scientific methodology of proposed research is a controversial legal topic that remains unclear despite ongoing debate. Code 46.111 of the Code of Federal Regulations Title 45 empowers IRB members to approve research protocols which "are consistent with sound research design and which do not unnecessarily expose subjects to risk." However, reviewers have reported not feeling competent to assess scientific methodologies, and previous research has suggested that protocols with flaws in study design and statistical methodologies have nonetheless been approved. The purpose of this study was to identify IRB members' perceptions of their role in review of scientific methodology. Sixty one primary and secondary protocol reviewers from 7 of the top 25 NIH funded medical university IRB panels participated in semi-structured interviews. Interviews were recorded, transcribed and coded. Themes related to the research aim were identified, catalogued, and treated as qualitative data. Study demographics included: mean age 50.55 years (SD 11.1), 66% male, 82% white, 13% other, 3% Asian. The distribution of attained education was MD 39%, PHD 16%, MD/PHD 12%, JD 2%, MS 16%, RN 2%, BS/BA 12%. Results highlighted discrepant responses, with many reviewers stating it is not their role to ensure scientific rigor. Others suggested that a methodologically flawed design may not produce proposed outcomes, resulting in unethical research and raising an important subject protection issue. The results suggest variations in reviewers' perceptions of their role in assessing scientific methodology exist, and that additional discussions of this issue are warranted.