How does the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?

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The FDA regulations require all IRBs to have membership sufficiently qualified to promote respect for the IRB's advice and counsel in safeguarding the rights and welfare of human subjects. IRBs conducting non-local review need to be knowledgeable about the community from which the subjects are drawn to ensure that subject rights will be protected and that the consent process is appropriate for the subject population involved. The IRB should be sensitive to community laws and mores because state and local laws and community attitudes pertaining to research maybe more restrictive than Federal regulations or the prevailing standards of the community where the IRB is located.

IRBs can obtain knowledge of community attitudes with a site visit by a representative of the IRB, by appointing an IRB member from that community, or by having a consultant from the community advise the IRB, either prior to or during the deliberations. If travel is not feasible, participation in the IRB meeting can be by video-conference or conference telephone call, or by using other technologies that allow for real-time conversational interaction between the remote member and the members at the convened location. All IRB members should receive an advance copy of the documents that are to be reviewed at the meeting. The minutes of the meeting, during which non-local research is reviewed, should document the procedures used to assure that community attitudes were adequately taken into consideration.

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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