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NIH draft guidance encourages central IRB use

March 18th, 2015

The National Institutes of Health (NIH) has officially given its blessing to the use of central IRBs for large multi-site clinical trials.

In a draft guidance released at the beginning of the month, the NIH promotes the use of a single, central IRB for its multi-site studies, stating that multiple IRB reviews are slow, cumbersome, redundant, and add nothing to human subjects protections. “In fact, the use of single IRBs may lead to enhanced protections for research participants by eliminating the problem of distributed accountability, minimizing institutional conflicts of interest, and refocusing IRB time and resources toward review of other studies,” the guidance notes.

While the NIH will not outright require the use of central IRBs for its multi-site studies, it is encouraging central IRB use in the strongest terms. “NIH generally expects all domestic sites of multi-site NIH-funded studies to use a single IRB of record. The Policy applies to all domestic sites participating in NIH conducted or supported multi-site studies, whether supported through grants, contracts, or the NIH intramural program,” according to the guidance. “All sites participating in a multi-site study will be expected to rely on a single IRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations for the Protection of Human Subjects,” according to the guidance.

Elements of the guidance include:

  • Participating sites will be responsible for obtaining informed consent, reporting unanticipated and adverse events to the central IRB, and overseeing implementation of protocols.
  • The lead site will be responsible for maintaining authorization agreements and will consider local context when necessary.
  • Participating sites are not barred from performing their own IRB review, but that site would be responsible for the cost of the extra review.
  • Exceptions to central IRB use can be made if local review is designated by state, federal, or tribal laws, or if the central IRB cannot meet the needs of a specific study population.
Of course, the idea of central IRBs is nothing new. But there has been a greater push for the use of them in recent years. Reliance on one IRB for review streamlines approval times and reduces cost and staffing hours involved in approving large studies. IRBs around the country are increasingly relying on central IRBs or forming IRB consortia for multi-site studies.

Even so, many IRBs are reluctant to rely on a central IRB – some simply are reluctant to cede control, while others wonder where responsibility will lie in the case of adverse events, or don’t know how to structure authorization agreements. The NIH acknowledged this in its statement, and referred IRBs to guidances from the Food and Drug Administration and the Secretary’s Advisory Committee on Human Research Protections. The NIH is taking public comment on the guidance through Jan. 29, 2015.