OHRP correspondence on central IRBs
OHRP outlines shift in philosophy
The Office for Human Research Protections (OHRP) in Washington, DC, recently published letters that explain the agency's revised stand on the use of central or external IRBs.
The initial letter was written to OHRP by James T. McDeavitt, MD, senior vice president, of Carolinas Medical Center, Carolinas HealthCare System in Charlotte, NC. It's dated April 13, 2010, and it states, in part:
- "The FDA has held the IRB-of-record, irrespective of the relationship of that IRB with the research institution/site, accountable for compliance with regulations governing IRB activities. The Office of Human Research Protection (OHRP), on the other hand, has held the 'institution' ultimately responsible for IRB activities, and this has led to the concern that an institution using an 'external' IRB would be held regulatorily 'liable' for non-compliance on the part of the independent external IRB. In our vetting process of several external IRBs, we are receiving mixed messages on their interpretations of the current status of the views of OHRP's on this issue."
- "... the signed Federal Wide Assurance (FWA) states that the institution is responsible for ensuring that the 'designated IRB(s) will comply with the Terms of the Federal Wide Assurance for Institutions within the United States and possess appropriate knowledge of the local context in which this Institution's research will be conducted.'"
- "Absent new guidance from OHRP, the existing guidelines thus seem to indicate that OHRP holds the local institution ultimately accountable for IRB oversight. Without any modification of OHRP expectations, the willingness of local IRB's such as ours to be held fully accountable for decisions and actions taken by external IRB's will likely be low and variable."
OHRP Director Jerry Menikoff, MD, JD, responded to McDeavitt with a letter, dated April 30, 2010. It states, in part:
- "As you indicated in your letter, concerns about regulatory liability under the Department of Health and Human Services human subject protection regulations appear to be one of the main reasons inhibiting institutions from exercising the regulatory flexibility that currently permits institutions to rely on the review of an IRB operated by another institution or organization."
- "The ANPRM [advance notice of proposed rulemaking] sought public comment on whether OHRP should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of the HHS regulations for the protection of human subjects."
- "The majority of public comments we received supported this regulatory change, and we are continuing to consider whether to pursue this change in order to further encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate."
- "... As you indicated, we have archived prior guidance documents that suggested OHRP favors local IRB review over review by a non-local IRB, a position that OHRP no longer holds."
- "Also, in our recent compliance evaluations, we have taken into consideration whether a single central IRB external to the institution was responsible for any identified regulatory noncompliance with 45 CFR part 46."
- "An example of how OHRP addresses this issue can be found in a recent compliance determination letter (see http://www.hhs.gov/ohrp/detrm_letrs/YR09/jun09c.pdf, section A(2) regarding the discussion of corrective actions)."
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