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NIH Calls for Changes to Federal Research Oversight Policies

Posted 04 December 2014 | By Alexander Gaffney, RAC

NIH Calls for Changes to Federal Research Oversight Policies

The National Institutes of Health (NIH) is trying to simplify the oversight of complex, multi-center clinical trials through a new policy promoting the use of a single institutional review board in trials it oversees.

Institutional review boards (IRB), sometimes known as ethics committees in foreign countries, are meant to ensure that clinical trial participants are treated safely and fairly in accordance with local, national and international regulations.

Traditionally, IRBs oversaw relatively small, single-center clinical trials. But as the pharmaceutical, biotechnology and medical device industries have grown, this oversight has become somewhat strained. It is now common to have large, multi-site clinical trials with each site overseen by a separate IRB, NIH explains on its website.

NIH now says it wants to promote the use of "central IRBs" (sometimes called the "IRB of record") in the hopes of making clinical trials more efficient and more robust.  Its new draft policy, On the Use of a Single Institutional Review Board for Multi-Site Research, explains that "NIH generally expects all domestic sites of multi-site NIH-funded studies to use a single IRB of record." Foreign sites may—but are not required to—use a central IRB as well.

"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," NIH explains in its policy. The single IRB will be responsible for conducting initial and continuing review of research, while "participating sites" will be responsible for meeting "other regulatory obligations, such as obtaining informed consent."

Some sites will be eligible for exemptions from this rule as long as they can provide NIH with "appropriate justification" showing that a central IRB would be "unable to meet the needs of specific populations" or if local laws require the use of a local IRB.

 

On the Use of a Single Institutional Review Board for Multi-Site Research

NIH Statement


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