A 12-year audit of IRB decisions

Area of Science:

• Medical Ethics
• Health Services Research
• Clinical Research Administration

Background:

• Institutional Review Boards (IRBs) are federally mandated committees overseeing human subject research at funded institutions.
• IRBs aim to safeguard participants by minimizing risks and ensuring benefits outweigh potential harms.
• Understanding IRB decision-making is crucial for ethical research conduct and regulatory compliance.

Purpose of the Study:

• To empirically analyze the decision-making processes of an Institutional Review Board (IRB) over a 12-year period (1973-1984).
• To identify common research protocol types, frequently encountered issues, and actions taken by the IRB.
• To assess the consistency of the IRB's decision-making over time.

Main Methods:

• Retrospective analysis of IRB records at Boston City Hospital from 1973 to 1984.
• Categorization of reviewed research protocols based on study type and subject population.
• Documentation and analysis of issues raised, modifications required, and final decisions made by the IRB.

Main Results:

• Characterization of the spectrum of research protocols reviewed during the study period.
• Identification of recurring ethical and methodological challenges addressed by the IRB.
• Assessment of the variability and consistency in IRB review outcomes and actions over twelve years.

Conclusions:

• The study provides empirical data on historical IRB functioning and decision-making patterns.
• Findings can inform current practices and training for Institutional Review Boards (IRBs).
• Understanding past IRB operations aids in strengthening human subject protection in contemporary research.