NIH Says Single IRBs Reduce Delays In Multi-Center Studies
By Cyndi Root
National Institutes of Health (NIH) announced in a press release, that it is promoting single IRBs for multi-site studies instead of multiple Institutional Review Boards (IRBs). The federal agency has bridged the gap in the movement to multi-center studies from the single sites common after World War II when IRBs were initially conceived, stating that the draft policy is intended to reduce clinical trial delays. Francis S. Collins, M.D., PhD, Director of the NIH, said, “By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
Institutional Review Boards (IRBs) evaluate the risks and benefits of research activities to participants. They play a role in ethical research, and studies must be approved by the IRB before beginning and while operating. When sponsors moved to multi-center studies, they located IRBs at each site as a default practice. The NIH writes, “Working through IRB review at each site can add delay without increasing the protections for the research participants in the study.”
NIH Draft Policy
To remedy this situation, the NIH has issued a draft policy, which interested parties may comment on until early 2015. The policy proposal is for NIH-funded studies, including those utilizing grants and contracts. Industry sponsors acting autonomously can review Food and Drug Administration (FDA) guidance published in 2006, which they can reasonably expect to be updated in line with the NIH’s policy in the near future as the two agencies work together to streamline guidance and regulations. The Secretary's Advisory Committee on Human Research Protections (SACHRP) issued more recent guidance.
The NIH’s policy for all multi-site studies in the U.S. allows for exceptions if local IRB review is necessary. Those conditions include situations where the local population is better served by a local IRB or in the event that federal, tribal, or state laws make a local IRB necessary. The NIH states that single IRBs will achieve greater efficiency in starting studies and positively impact the NIH’s entire portfolio of clinical research.