Inconsistency and institutional review boards

Area of Science:

• Medical Ethics
• Clinical Research Oversight
• Human Subject Protection

Background:

• Peer review is crucial for safeguarding human subjects in research.
• Institutional Review Boards (IRBs) are tasked with ethical and scientific oversight.
• Previous assessments of IRB effectiveness have yielded varied conclusions.

Purpose of the Study:

• To evaluate the adequacy and consistency of IRB peer review for human subject research.
• To identify inconsistencies in ethical, methodological, and informed-consent standards applied by IRBs.
• To assess the impact of protocol revisions on IRB approval rates.

Main Methods:

• Submitted identical, ethically flawed oncology and anesthesiology research protocols to 32 IRBs.
• Analyzed IRB decisions, stated reasons for nonapproval, and adherence to standards.
• Twenty-two IRBs participated in the comparative review process.

Main Results:

• Consistent nonapproval of the flawed protocols was observed across participating IRBs.
• Significant inconsistencies were found in the rationales provided by IRBs for similar decisions.
• Substantial variability existed in the application of ethical, methodological, and informed-consent standards among IRBs.

Conclusions:

• Current IRB peer review processes exhibit significant inconsistencies in applying ethical and scientific standards.
• Revisions to protocols based on specific IRB objections may not guarantee the approval of scientifically sound or ethically adequate research.
• There is a need for improved standardization and consistency in IRB review to ensure robust human subject protection.