ASH Comments on NIH Single IRB Policy

On January 28, The American Society of Hematology (ASH) submitted comments on the National Institutes of Health’s (NIH) Draft Policy to promote the use of a single Institutional Review Board (IRB) of record for domestic sites of multi-site clinical studies funded by NIH. The draft NIH policy proposes that all NIH-funded, multi-site studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB. Exceptions to the policy would be allowed if local IRB review is necessary to meet the needs of specific populations or where it is required by federal, state or tribal laws or regulations.

NIH believes that wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio. A number of NIH institutes and centers have been supporting the use of a single IRB in multi-site studies, including the National Cancer Institute’s (NCI) Central Institutional Review Board, which has been in place for the review of NCI-sponsored clinical trials since 1999. Health and Human Services, (HHS) and Food and Drug Administration (FDA) regulations also allow participating institutions to forego the standard use of local IRBs in favor of single review. However, it is common for local IRBs at each institution in a multi-site trial to independently review the research protocol, informed consent documents, and other materials – sometimes resulting in hundreds of reviews for a single study. This process can be lengthy and burdensome, significantly delaying the initiation of clinical studies.

ASH believes that a single IRB for multi-site trials will ease regulatory and administrative burdens and increase the harmonization of these trials. Expecting all institutions participating in a multi-site study to rely on a single designated IRB as a condition of receiving a funding award is a much-needed step toward making the review process more efficient.

There may be exceptional circumstances in which local IRBs are needed, such as when a designated single IRB is unable to meet the needs of specific populations, or where local IRB review is required by federal, tribal, or state regulations. In these cases, the draft policy rightly allows institutions to provide appropriate justifications for an exception. In addition, local IRB review is not prohibited by the draft policy; rather, the individual institution must simply bear the full cost of performing the review. This important distinction will give flexibility and autonomy to individual institutions while promoting a change in the overall culture of IRB use.