The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year.
NIH made the announcement in a notice published to the Federal Register, saying its goal is to "enhance and streamline the IRB review process" for multi-site clinical trials.
Overall, NIH says feedback on the policy was supportive, though some commenters felt the policy is overreaching and suggested that NIH incentivize the use of sIRBs rather than make them mandatory or a condition for funding. Others commenters expressed concern over costs and responsibilities related to the policy and called on NIH to provide additional guidance.
The Move to Single IRBs
Under federal regulations, IRBs are charged with overseeing clinical trials to ensure they are conducted ethically. IRBs are responsible for approving research protocols and informed consent documents before a study can begin.
However, over time, NIH says that changes in the research landscape have made it necessary to make changes to how IRBs handle multi-site trials.
"In 1975, when the [Health and Human Services] HHS regulations for protection of human subjects were first published, most clinical research was conducted primarily at a single institution. Since then, the research landscape has evolved, and many studies are carried out at multiple sites," NIH wrote when it announced the draft policy in December 2014.
According to NIH, while both the Office for Human Research Protections within HHS and the US Food and Drug Administration (FDA) have issued their own guidance, "too few institutions involved in multi-site studies are taking advantage of the option."
Under the final policy, which takes effect on 25 May 2017, NIH will require all multi-site clinical trials it funds to be overseen by an sIRB, unless federal, tribal, or state law, regulation or policy would prohibit doing so.
"Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight," NIH says.
Under the policy, NIH says it is up to the clinical trial applicants to select an sIRB, and will be their responsibility to ensure it is qualified to oversee their trial.
In announcing the final policy, NIH also addressed some of the major concerns it received during the year-long public consultation it held on the draft rule.
While some comments called on NIH to allow for more exceptions to the policy, NIH says it saw no justification for narrowing its scope, but says it will consider granting other exceptions on a case by case basis when a "compelling justification" is given.
Additionally, NIH says it plans to release guidance documents detailing how to comply with the new policy before it takes effect in May 2017. Specifically, NIH says its future guidance will address:
- How costs associated with sIRBs may be charged as direct versus indirect costs
- Considerations in the selection of the sIRB
- The content on the sIRB plan that must be submitted with applications and proposals
- Process for applicants/offerors to submit a request for an exception and process for NIH review of the request for exception
- Roles and responsibilities of the sIRB and participating sites
- Model authorization agreement that lays out the roles and responsibilities of each signatory
- Models for gathering and evaluating information from all the reliant sites about community attitudes and the acceptability of proposed research
- A model communication plan that identifies when and which documents are to be completed and shared with those involved so each may fulfill their responsibilities
Furthermore, NIH says that "additional costs associated with sIRB review may be charged as either direct or indirect costs according to applicable cost principles in the NIH Grants Policy Statement and the FAR 31.202 (Direct Costs) and FAR 31.203 (Indirect Costs)."
NIH also says it does not expect the policy to be implemented without a hitch, owing to the major changes it introduces. However, NIH says it expects any challenges to be "short-lived."
"Once the transition to the new way of operating is made, the benefits of widespread use of sIRBs will outweigh any costs and, ultimately, reduce burdens to the research process," NIH writes.