Draft NIH Policy on the Use of a Single IRB for Multi-Site Research
At a time of the year when love is in the air, one thing is for sure: there is not a lot of love from the human research community on NIH’s Policy on the Use of a Single IRB for Multi-Site Research.
At a time of the year when love is in the air, one thing is for sure: there is not a lot of love from the human research community on NIH’s Policy on the Use of a Single IRB for Multi-Site Research. The news hit the wire December 3, 2014, when NIH announced the issuance of a draft policy that promotes a single IRB of record for NIH-funded multi-site research. NIH Director Francis S. Collins, M.D., Ph.D. stated, “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.”
Seems reasonable, right? So why are many discouraged and frustrated with this direction? The answer may be simple: there is an evident lack of working knowledge and appreciation from the IRB community as to how we can actually make this arrangement work. Traditionally there are two type of IRBs: IRBs within the institution, commonly referred to as the “local IRB,” and those IRBs not affiliated with a specific institution, commonly referred to as “independent IRBs.” NIH proposes that individual local IRBs relinquish their oversight for a given study to a single IRB, granting that single IRB oversight for all sites participating in a given study.
When you take a critical function like IRB review and rely on another group to conduct it, as NIH is proposing, there is an inevitable feeling of lack of control. Add to this a scarcity of resources at many organizations to support this type of review, and some who wind up feeling the draft policy creates undue burden with little to no impact on human subject protection. Others support the initiative in its entirety, but the question remains: how do we make it happen?
All of us who take part in human subject protections have a role to play. The question becomes, how does that role change or shift when working with other local IRBs and/or independent IRBs? Consider the following:
1. Seek buy-in from the research team and institutional officials. What they think really matters.
2. Choose the IRB with the most relevant expertise and experience to be the single IRB. The selection may be different based on each type of study.
3. Establish an understanding of what is important to your institution with the selected IRB.
4. Identify what reporting requirements are different and communicate these to investigators (i.e., SAE reporting, COI, and noncompliance).
5. Identify ways to communicate effectively prior to the start-up and during the conduct of the research.
6. Identify a point-of-contact between IRBs that can facilitate and communicate within each IRB.
7. Talk regularly. Do not let small issues pile up to create larger issues.
8. Document your agreement and share terms with key stakeholders.
9. Do not hold back. Share your concerns along the way.
10. Lastly, be transparent. We all have the same goal to protect the rights and welfare of human subjects. Share what you know.
NIH accepted comments on the draft policy until January 29, 2015, and I am sure there was an overwhelming amount of comments. So, while we will continue to debate the pros and cons of relying on a single IRB, ultimately we need to discover a way to work more collaboratively over the different spectrum of IRBs: we all have so much to share and contribute to improving human subject protection, and that’s a mission we can all love.
