The number of studies an IRB reviews has increased, and the size of the package of review materials sent to IRB members is becoming formidable. Must the IRB send the full package to all IRB members?

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The IRB system was designed to foster open discussion and debate at convened meetings of the full IRB membership. While it is preferable for every IRB member to have personal copies of all study materials, each member must be provided with sufficient information to be able to actively and constructively participate. Some institutions have developed a "primary reviewer" system to promote a thorough review. Under this system, studies are assigned to one or more IRB members for a full review of all materials. Then, at the convened IRB meeting the study is presented by the primary reviewer(s) and, after discussion by IRB members, a vote for an action is taken.

The "primary reviewer" procedure is acceptable to the FDA if each member receives, at a minimum, a copy of consent documents and a summary of the protocol in sufficient detail to determine the appropriateness of the study-specific statements in the consent documents. In addition, the complete documentation should be available to all members for their review, both before and at the meeting. The materials for review should be received by the membership sufficiently in advance of the meeting to allow for adequate review of the materials.

Some IRBs are also exploring the use of electronic submissions and computer access for IRB members. Whatever system the IRB develops and uses, it must ensure that each study receives an adequate review and that the rights and welfare of the subjects are protected.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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