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Assessing research protocols

Repository tissue is collected and stored for the purpose of providing it to researchers. Not all tissue will likely be used for research. Presumably much of the tissue will be used for research, and in these cases, should it matter to a repository or to medical center/tissue collection site who the end-users are and what their research protocols are?

Responsible repositories typically review all applications by end-users to determine appropriate use and users of tissue. Some repositories have ethical advisory boards that review atypical applications. Others have internal IRBs or use regional IRBs. Review procedures may also be conducted when there is competitive applications for scarce tissue. It is important for medical centers whose staff remove tissue from patients and function as stewards of the tissue, at least before it is transferred to a repository, to evaluate the type and quality of the application review at the repository. Typically, repositories will have their own IRB or use a regional IRB to assess research protocols.

Responsible tissue collection sites (medical centers) that receive some portion of the tissue collected on site may consider establishing their own internal application review process in order to fairly distribute repository tissue to internal or local researchers. The objective of the review should be the fair distribution of a scarce resource. The quality of the research protocol will presumably be reviewed by peers and by the IRB.