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How IRBs view and make decisions about consent forms.

Robert L Klitzman¹

¹Columbia University, New York, NY 10032, USA. rlk2@columbia.edu

Journal of Empirical Research on Human Research Ethics : JERHRE

|March 15, 2013

Summary

Institutional Review Boards (IRBs) face challenges in simplifying informed consent forms due to institutional and funder demands. This study reveals underlying tensions in IRB decision-making processes for consent document length and complexity.

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Area of Science:

Bioethics
Clinical Research Administration

Background:

Institutional Review Boards (IRBs) are frequently criticized for lengthy and complex informed consent forms.
The decision-making processes of IRBs regarding the content and length of these forms remain underexplored.

Purpose of the Study:

To investigate how IRBs perceive and make decisions about the length and complexity of informed consent documents.
To identify the challenges and dilemmas IRBs face when reviewing consent forms.

Main Methods:

Qualitative study involving interviews with leaders and members/administrators from 34 IRBs (55% response rate).
Exploration of IRB perspectives on document requirements and decision-making criteria.

Main Results:

IRBs grapple with balancing the need for comprehensive information against the goal of reducing form length and complexity.
Institutional and industry funder requirements often necessitate consent forms serving as legal documents, creating tension.
IRBs may engage in 'nitpicking' that incurs costs without fully realizing the impact.

Conclusions:

The study highlights significant underlying tensions, ambiguities, and subjectivities in IRB decision-making regarding consent forms.
Findings have critical implications for future policy development, practical implementation, educational initiatives, and research practices in human subjects protection.