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The IRB is not a privileging body

Credentialing Resource Center Connection, April 28, 2003

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Dear Credentialing Colleague:

The process through which physicians and other practitioners are granted clinical privileges and the process used to approve medical research in a hospital (i.e., the Institutional Review Board [IRB]) are two separate processes.

Remember, in a hospital, "no one works without a ticket." Such a ticket may be clinical privileges, a job description, or an agreement (e.g., a scope of practice).

IRB approval of a research protocol may or may not qualify as an appropriate ticket. It certainly may qualify if your policies and procedures cite it as an appropriate way of granting permission to practice. However, such a policy would require the department chair, credentials committee, medical executive committee (MEC), and the board to enter the research approval business in collaboration with the IRB, which probably isn't a wise move.

It would be more advisable for the IRB to begin its review of proposed research by asking the following question: "Has the researcher(s) been granted the clinical privileges needed to carry out this research?" For example, if the IRB is asked to review and approve research regarding the use of carotid stents, it must ask, "Has this physician been granted privileges for carotid stent placement?" If not, it should not approve the research protocol.

Remember, the IRB is not a privileging body. Physicians performing experimental procedures should request appropriate privileges via the medical staff mechanism if the procedure involves equipment or technology that is new to the institution, potentially hazardous, or requires new skills or training; is litigation-prone or subject to the privileging process at other facilities; or is deemed necessary by the department chair, credentials committee, or MEC.

On the other hand, privileges probably aren't needed if the activity calls for the practitioner's existing knowledge or skills (e.g., use of a drug or device for which a simple literature review provides adequate knowledge). By following these guidelines, most IRB requests will not require the granting of additional privileges.

That's all for this week. Thanks to Carol Cairns, CMSC, CPCS, president of PRO-CON; Beverly Pybus, CMSC, president of The Beverly Group; and Rick Sheff, MD, vice president of consulting and education for The Greeley Company, a division of HCPro, Inc., for their assistance with this week's letter.

All the best,

Hugh Greeley

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