The goal of instituting single IRB review is a noble one—by decreasing duplicative regulatory work it stands to reason that you'll increase scientific and medical breakthroughs as ideas move from bench to bedside faster. However, the mandate for single IRB review has created a host of logistical complications for many IRBs, and whether the process actually saves time or increases it is still up for debate. Hopefully the challenges we face around this issue are only growing pains; as more institutions develop standardized processes and work together to share best practices, it will facilitate a more collaborative smoother process going forward.
PRIM&R recently hosted a full-day preconference session at the 2018 Advancing Ethical Research Conference (AER18) discussing the challenges and strategies for successfully implementing single IRB review. While the concept of single IRB review is not new, it was historically done at an institution’s discretion depending on the type of research, the expertise of the institution, and the relationship between the reviewing and relying sites. On January 25, 2018, the choice was taken away when single IRB review became mandated for all NIH newly funded research, as well as for competitive and continuing renewal for existing grants. On January 20, 2020, the requirement for single IRB review will be further extended to cover all federally funded studies as part of the Common Rule revisions.
The challenges with single IRB review are many. For one thing, it requires that investigators talk with their IRBs sooner—during the grant writing process—as opposed to waiting until they receive funding, which increases IRB work for studies that may never come to fruition.
Meanwhile, studies relying on a single IRB can range from two-site studies to studies with 50 or more sites across the country. And there may be variances in research procedures across sites that have to be accounted for. For example, standard of care practices may vary, affecting both the risks of a study (e.g. local familiarity with a procedure such as intubating a high-risk population) and the alternatives for treatment if a subject declines participation. So, in many cases, the IRB must do a general review of the overall study, as well as consider the risks and benefits at individual sites and ensure appropriate site-specific consent forms.
Of course, the single IRB mandate is not without benefit. One such benefit is that IRBs are becoming more collaborative through discussions around finalizing authorization agreements, identifying local site context issues, and finding solutions when problems arise. The mandate has, however, made internal processing of studies much more complex. IRBs must now expand their knowledge to incorporate local law and local context issues from around the nation. New issues arise, such as delegation of responsibilities locally vs. to the reviewing site, and unknown compliance history of relying PIs. And, unlike commercial IRBs, many site-specific IRBs are struggling to implement the infrastructure to review multi-center research.
While relying on a single IRB initially sounds easy from an investigator perspective, many investigators are now coming to terms with the additional burden of being the main study investigator and being responsible for coordinating the documentation and communication between sites. Relying investigators must learn new submission systems and adhere to the reviewing IRBs policies. Reviewing IRBs, in turn, must ensure their policies are flexible enough to cover external relying sites. And, crafting authorization agreements and indemnification documents may take months, delaying study initiation.
But, tools are popping up to help. SMART IRB, for example, can reduce turn-around time by establishing a set agreement that many institutions (over 500 to date!) can sign onto. Additionally, individual sites, like CHOP, are developing submission tools, like an external portal, to reduce PI burden and improve efficiency by allowing direct communication between relying investigators and the IRB. Many sites are also sharing templates and guidance on best practices related to single IRB review.
Conferences like PRIM&R’s are an important venue for institutions to get together to discuss these challenges and find solutions. Many scenarios were discussed at the AER18 preconference session, including:
- Single IRB review requests when some sites are private practices without an FWA
- When to consider an exception request to the NIH single IRB policy
- Competitive renewal for huge multi-site studies that have been active for many years
- Concerns when a problematic PI requests to rely on an outside site
- Concerns when the reviewing IRB review does not align with local interpretation of the regulations
- Challenges when the main PI changes institutions and has to switch the Reviewing IRB to the new institution
- Decisions related to charging (or not) for single IRB review
- Scenarios where relying and reviewing IRBs have different local policies (e.g. assent forms, short forms, who can obtain consent (MD or staff))
- Incidents of non-compliance at local sites & reporting
- Amendments to Reviewing sites that may trigger local site ancillary concerns (e.g. changes for pharmacy)
What challenges has your institution faced in relation to single IRB review? Do you have any tips or best practices to share? Continue the dialogue in the comments below.
Heather Cathrall, MBE, CIP, is the Assistant Director of the Children's Hospital of Philadelphia Institutional Review Board. She has a Master's degree in Bioethics from the University of Pennsylvania and Bachelor's degrees in Cognitive Science and Psychology from the University of California, Berkeley. She has worked for the Children's Hospital of Philadelphia IRB for over 13 years and was a research coordinator prior to her IRB work.
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
And with the mandated single IRB, any community input role that was envisioned in the original creation of individual IRBs has vanished. The only “community” with input under the single IRB may be that of the lead institution’s community. And even that has been heavily discounted with the replacement of what was formerly known as a “community representative” by what is now an “unaffiliated member”.
This kind of change flies in the face of sanctimonious calls by and for investigators’ to work more closely with subjects in order to incorporate their interests and buy-in.