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QRTI Newsline --- Wednesday September 8, 2010

Do We Need to Audit IRBs?

By Phyllis B. Kent

Do We Need to Audit Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs)?

Historically, sponsors rarely audited IRBs. Sponsors relied on institutional oversight, accrediting agencies and federal regulations to assure that IRBs were in compliance. Even with the shift toward Independent Ethic Committees, most sponsors do not routinely audit Institutional Review Boards or Ethics Committees. So, why should we start auditing them now? After all, FDA does routine inspections, as well as, Office for Human Research Protection (OHRP) oversight.

Can we rely on government oversight?

FDA audits less than 200 IRBs a year while OHRP has a list of over 3600 domestic IRBs on their web page. OHRP conducts their routine evaluations by reviewing mailed documents and telephone interviews and some on-site visits. The government oversight is not very strong when compared to the numbers of IRBs operating domestically.

Are sponsors responsible for IRB oversight?

Investigators are required to assure adequate IRB review of their IND studies by section 312.53 (vii) of the Code of Federal Regulations (CFR). In addition, section 312.66 indicates that, "An investigator shall assure that an IRB that complies with the requirements set forth in Part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study." Sponsors must ensure that the investigation is conducted in accordance with the regulations under parts 312.50 and 312.53(c). Sponsors are required to conduct ongoing review to assure the investigator's regulatory compliance under section 312.56. Since sponsors must oversee the study and the investigator, the IRB compliance becomes part of the sponsor's responsibility. In addition, sponsors select and pay for the Independent Ethic Committee reviews, thereby taking on the ownership of assuring compliance of the IRBs.

Isn't monitoring of the IRB approvals enough?

Sponsor oversight of the IRB has traditionally been addressed through the monitoring of the IRB approval of the study, investigator and informed consent. Monitors routinely collect these approvals, as well as the approval of any changes made. In addition, sponsors collect documentation that the IRB is properly constituted and that there are no conflicts of interest.

So why are we expanding coverage to IRB audits?

Sponsors have continually increased the use of contract IRBs or Independent Ethics Committees over the last 10 years in order to expedite the approval process in multicenter trials. In some cases, hospitals themselves are contracting the IRB review due to the increasing workload for local IRBs and the need to comply with regulations for an ever-changing board.

Auditing IRBs is consistent with the sponsor evaluation of contract services (CROs and other vendors) used in clinical research. Most sponsors have formal programs to evaluate and qualify all clinical research vendors at least every two years. Certainly, contract IRBs should not be omitted from the vendor qualification program. This is especially true when one IRB may be responsible for review of all sites on a protocol or all studies in a submission. A look back at the IRB shutdowns by FDA for non-compliance indicates that this is not prudent.

Considering that the government audits only a small portion of the IRBs in operation, sponsors cannot assume that FDA or OHRP will detect all of the problems. Sponsors cannot afford to jeopardize their studies or the welfare of subjects because of IRB non-compliance. Auditing IRBs makes good business sense, is consistent with internal vendor audit procedures and assures that ethical considerations have been properly applied to the clinical studies.