Dominic Chiarelli

by Dominic Chiarelli

sIRB–A Fresh Start?

The drama surrounding the revised Common Rule has kept us all on the edges of our seats for over a year. Despite this uncertainty, we know one thing for sure: the requirement for use of a single Institutional Review Board (sIRB) for multi-site research is here to stay.

The sIRB concept has a fresh and innovative feel, but in truth it has been allowed since the inception of the federal regulations, and the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have endorsed it repeatedly. What’s truly new is moving from permitting sIRB to requiring it.

This idea of mandatory sIRB first started with the Common Rule’s Advanced Notice of Proposed Rule Making and, despite some serious reservations, has methodically marched its way across the research landscape until obtaining almost universal adoption—NIH Grants Policy on June 21, 2016; 21st Century Cures Act on December 13, 2017; and the revised Common Rule on January 19, 2017.

We’ve previously covered selection and budgeting and the new accreditation standard for sIRB. In this blog, we consider the opportunities sIRB may present for improving protections and not just speeding approvals.

 

Better Uses for Limited Resources

sIRB makes perfect sense for multi-site research in which the evaluation of a study’s scientific validity, risks, benefits, and informed consent do not require the unique perspective of a local IRB.1 Research meeting this description would typically have the following characteristics:

  • Led by an experienced central coordinating center or industry-sponsor;
  • Subject to FDA review through an Investigational New Drug or Device Exemption; and
  • Focused on prevalent conditions found in otherwise healthy adults.

This is almost exactly the model promoted by the National Cancer Institute and its single IRB—NCI CIRB. The model has had its detractors, especially when roles and responsibilities were not clearly delineated under the prior facilitated review process, but it’s certainly become widely accepted and clearly requires less effort by local IRBs and institutional representatives.2 This is not to say that sIRB absolves local IRBs and institutions of all responsibilities. Quite the opposite.

The hope is that sIRB will allow institutions to dedicate more resources to responsibilities that are likely to be more impactful than IRB review in ensuring the rights, safety, and welfare of research participants. This includes ensuring compliance with state, local, and institutional requirements; vetting the study team’s competency and the site’s suitability for the research; and taking an active role in investigating study-specific incidences that may suggest a serious problem with the research design or conduct.3

Not all research is a good fit for sIRB.  A poor candidate would be research involving a rare disease, sensitive information (e.g., genetics), or a vulnerable population. With such studies, though, a limited review may again provide an opportunity to focus on what may be most impactful for participants. IRBs and institutions unburdened with the normal review process could create and enforce special institutional requirements that exceed regulatory requirements. For example, a robust institutional policy for research involving persons with limited capacity may require use of a validated assessment tool throughout the study, inclusion of a participant advocate in the consent process, and verbal assent. Compliance with these additional protections would be an institutional requirement, similar to how most institutions handle conflicts of interest.4

sIRB should also allow IRBs to pay more attention or perhaps change their approaches to single-site non-traditional clinical trials, which can present significant review challenges.5 Institutions and IRBs often have greater abilities to influence this type of research. An institution and IRB with a reduced study load due to sIRB (in theory) can use existing resources to begin to offer additional services, such as ethics consultations, investigator trainings, protocol development support, or regulatory affairs.

 

Improved Access to New Resources

sIRB should result in a more integrated research landscape that includes institutions and IRBs frequently learning and working together. Information about research and IRB operations, policies, and procedures should become more available—hopefully counteracting the recent trend of non-public forms and policies. The development of stronger connections between institutions will trigger conversations: How do you handle emergency uses? What’s your policy for a short form consent process? These interactions should help institutions and IRBs identify opportunities to improve before significant problems arise and perhaps result in trusted partners who could be relied upon to handle sensitive reviews or circumstances—for example, research in which the institution maintains a conflict of interest or research conducted by an investigator with a poor working relationship with the IRB.

 

Where to start?

sIRB will be required for all NIH studies by January 25, 2018; federally funded studies by January 20, 2020; and, likely, FDA-regulated research by December 19, 2020. The stakeholders most opposed to sIRB throughout have been institutions and IRBs.6 This opposition is understandable. Preparation for sIRB will require an intensive commitment of limited institutional resources. But it will also present a rare opportunity to consider an institution’s human subjects protection program from top to bottom and, hopefully, whether institutional resources can be deployed in new ways with greater impact. I know that we here at Kinetiq have a few ideas about this. Let us know if you’d like to talk.

 


References

1 Notice of Proposed Rule Making for Federal Policy for the Protection of Human Subjects Revised Common Rule, 80 Fed. Reg. 53983 (September 8, 2015).

2 About the CIRB, https://www.ncicirb.org/about-cirb

3 80 Fed. Reg. 53984.

4 Final Rule for Federal Policy for the Protection of Human Subjects Revised Common Rule, 82 Fed. Reg. 7208 (January 19, 2017).

5 Dawn M. Furey, Stuart Horowitz, PhD, Single IRB Review for All Multicenter Clinical Trials, Applied Clinical Trials (September 20, 2017), http://www.appliedclinicaltrialsonline.com/single-irb-review-all-multicenter-clinical-trials

6 80 Fed. Reg. 53983.

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