PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. We hope these posts open conversations among research ethics oversight professionals at all points in their careers.
In January 2018, the new single IRB (sIRB) requirement for National Institutes of Health (NIH)-funded multi-site studies will go into effect. NIH’s goal for this mandate is to reduce administrative burden that does not actively contribute to protection of human subjects. The NIH posits that this policy will also result in opportunities for enhanced oversight by the reviewing IRB.
Under the current federal regulations, IRBs participating in cooperative projects can defer oversight to a reviewing IRB on a case-by-case basis. The new directive mandates the use of a single IRB for any NIH-funded study where a single protocol is being implemented at two or more sites. I hold that while reliance on a single IRB can be productive, its required use will pose many logistical challenges and could result in reduced institutional participation in large-scale research projects and diminished oversight for human subjects research.
To begin, the sIRB mandate will impact a large proportion of the research community: according to PRIM&R’s 2015 IRB Workload and Salary Survey, 83% of respondents surveyed review NIH-funded research. And though some of the impacted institutions may enter into reliance agreements on a regular basis, many do not currently have the infrastructure or staff resources to manage large-scale multisite studies;among these same respondents, 48% said their IRBs operate with two full time equivalent staff members or fewer.
Further, this policy will significantly change the volume and nature of the work required of the reviewing IRB. In addition to focusing on human subjects protections, single IRBs will now be responsible for serving as a communications hub for all participating sites and investigators throughout the lifespan of the project. The sIRB will not only need to determine how review decisions will be communicated to all collaborating sites and their investigators, and how reportable events and local issues should be communicated to the single IRB and to all participating sites, but also establish a system by which this communication can take place.
The sIRB requirement also downplays the time-consuming, complicated, and costly nature of the work that goes into developing a reliance agreement, which includes vetting and developing relationships with institutions, creating legally binding memoranda of understanding among the collaborating sites, and systemically managing submissions and disseminating information. Yet the mandate will require institutions to develop these collaborative infrastructure and communication systems without the benefit of the additional time, staff, or resources that a massive coordination effort on this scale typically requires.
Despite its intended purpose to streamline IRB review, this mandate will not reduce the need for relying sites to conduct their own IRB review. Rather, the sIRB policy will change the nature of the work that is required at the local sites. Each participating site will still need to complete local-context reviews and inform the sIRB of any site-specific issues that should be considered in the protocol review, such as special population knowledge, state law, and institutional policy. Even after the study has been approved, local IRBs will have continued oversight work, such as tracking and communicating reportable events to the sIRB, and supervising any resulting management plans implemented by the sIRB.
The sIRB mandate will not only increase administrative burden at the IRB level, it will also create additional, time-sensitive work for the researchers at the participating sites. Per the mandate, the funding applicant (i.e., the principal investigator) is responsible for determining which involved IRB is qualified to serve as the sIRB, and designating this IRB in their funding proposal to the NIH. As such, before they can apply for funding, investigators will need to have their protocol finalized to the extent that IRBs can see which sites are involved, and what activities are taking place at each site, so that the sites can determine which IRB has the qualifications and the staff resources to serve as the sIRB. So, investigators will need to allow time for the sIRB selection process to take place when considering their NIH funding deadlines.
While the sIRB mandate is designed to increase review efficiency, I predict that it will not reduce, but rather, will spread out administrative burden during the review process, as well as add additional administrative burden around the sIRB selection process. Sites that are already set up to conduct large scale reviews may be able to adapt to the sIRB mandate with ease, but those that do not currently have the staff or infrastructure to oversee multisite studies will find themselves needing to reinvent the wheel with each multisite study for which their investigators are seeking NIH funding.
Further, the requirement that the sIRB be designated before funding can be awarded may hinder the ability of investigators to obtain NIH funding, if none of the participating sites are able to step into the sIRB responsibilities or if collaborating sites fail to select the sIRB in time for the investigators to submit their funding proposals.
Finally, if the site selected to step into the sIRB role lacks the resources to effectively manage multisite reviews, or if the system of communication established between the collaborating sites fails, the sIRB mandate might open up oversight gaps that could result in diminished protections for human subjects.
Sarah Luery, MA, CIP, is an IRB Administrator at the University of Southern California.
I completely concur with Sarah’s thinking. If bigger were simpler like a Ford assembly plant that manufactures many cars at the same site and can simplify procedures then her argument could be wrong. But often bigger is not better meaning many sites become more complicated and so safety could more easily become more compromised and more costly.