The National Institutes of Health (NIH) is officially promoting the use of a single IRB for large, multisite clinical trials.
In December 2014, the NIH released a draft guidance outlining its expectations for the use of a central IRB for multisite NIH-funded studies. The institute acknowledged that the research landscape has evolved since the Department of Health and Human Services (HHS) first published its regulations in 1975, when most research was carried out at a single site.1
HHS and Food and Drug Administration (FDA) regulations allow for the use of central IRBs for multisite studies, and the FDA and Office for Human Research Protections (OHRP) have both published guidance for usage. “However, too few institutions involved in multi-site studies are taking advantage of the option,” according to the guidance. Recent research has shown that many IRBs are still hesitant to use the central IRB model, citing barriers such as confusion over IRB responsibilities and lack of trust in other institutions’ reviews.
“Despite enthusiasm for central IRBs, there is confusion about the optimal structure for central IRBs as well as how best to meet regulatory requirements,” according to an NIH statement. “There are questions about the loci of responsibilities and whether the IRB or institutions will bear the blame if adverse events occur.”2
There is no evidence that multiple IRB reviews of the same study enhance human subject protections, according to the guidance. “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 document states.1
Using a central IRB can alleviate redundant, slow reviews, according to the guidance. “Proponents of the single IRB model maintain that review of a multi-site study by the IRB of each participating site involves significant administrative burden in terms of IRB staff and members’ time to perform duplicative reviews,” the guidance states. “When each participating institution’s IRB conducts a review, the process can take many months and significantly delay the initiation of research projects and recruitment of human subjects into research studies. Use of single IRBs in multi-site studies, on the other hand, has been shown to decrease approval times for clinical protocols and may be more cost effective than local IRB review.”1
While the NIH will not outright require the use of central IRB review, it is promoting 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.”1
The guidance will apply to Type 1 and 2 NIH grant applications, contract proposals, and intramural multisite studies submitted for initial review.1 NIH expectations for central IRB use include the following:
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.
Intramural principal investigators and extramural applicants or offerers will be responsible for choosing the IRB of record.1
“Use of the designated single IRB will be a term and condition of award. If the agreed-upon single IRB is a fee-based IRB, these costs will be included in the Notice of Award as a direct cost. Compliance with this Policy will be a term and condition in the Notice of Award and a contract requirement in the Contract Award,” according to the guidance.
The effective date of the draft guidance has not yet been determined. The full text of the draft guidance can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.htm.
- Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. National Institutes of Health. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html#sthash.I3F6X3W4.dpuf
- Clinical Research Policy – IRB Review. NIH.http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-reviewhyperlink.