Dominic Chiarelli

by Dominic Chiarelli

NIH Boldly Shakes up the IRB Landscape, Part 1

The National Institutes of Health (NIH) has decided it’s time for the trials it funds to match the era in which they are being conducted. Since 1975, the date in which the Department of Health and Human Services (HHS) first published its regulations for the Protection of Human Subjects, clinical trials have become increasingly more complex with advances in medicine and technology.

A Paradigm Shift in the Protection of Human Subjects

Largely gone are the days of a NIH-funded physician-investigator running a clinical trial solely at the academic medical center. Instead, the vast majority of research is now conducted using a nationwide network of principal investigators, all of which must obtain their own ethical review in accordance with 45 CFR part 46.1

The NIH’s new Policy on the Use of a single Institutional Review Board (sIRB) for Multi-Site Research,2 which goes into effect, May 25, 2017, firmly establishes the NIH’s belief that such duplication of effort is not only administratively burdensome in terms of time and effort, but also not substantively superior in terms of the protection of human subjects. What’s unique with this latest move is that the NIH is not recommending a single IRB review, like past guidance from both the Office of Human Research Protections (ORHP) and the U.S. Food and Drug Administration (FDA),3 it will be requiring it.

sIRB Is Not a Typical Review

All applications for NIH funding subject to the sIRB policy will soon need to include a detailed plan for how ethical review will be accomplished across all domestic research sites—essentially who will be selected as the sIRB. This begs the question of what considerations are necessary to choose an appropriately qualified sIRB for any particular study, as presumably a poor choice could affect the ability to win the award.

The NIH has committed to providing further guidance prior to the policy becoming effective, but without any firm timeline. Thankfully, for principal investigators and institutions, the final policy offers many clues regarding what the NIH might expect from a sIRB.

A qualified sIRB first and foremost must meet all the regulatory requirements specified in the HHS regulations. This includes, but is not limited to, having:

  • a Board comprised of members or consultants with the medical expertise and knowledge of local context to understand the research and its suitability within all the communities where the research will be conducted,
  • the legal expertise necessary to ensure Board decisions are consistent with all local or state laws or regulations, and
  • the ability to notify investigators and institutions in writing of its decisions and to maintain all records necessary to its review.4

A qualified sIRB, however, will need to do more than just meet the standard regulatory requirements. It also must be able to:

  • negotiate and execute reliance agreements that clearly delineate roles and responsibilities with each research site,
  • accommodate institution specific standards as they relate to the study materials and conduct (i.e., unique approaches to consent language or to participant’s lacking capacity),
  • vet the principal investigator’s medical licensing and overall qualifications to conduct and supervise the research, and
  • coordinate and facilitate the numerous and disparate exchanges of information and documents critical to the IRB’s continuing oversight.

A follow-up in our next blog will consider some of the issues this new rule poses for any institution with an active human subject protection program.

 

References

1 45 CFR part 46.103.

2 Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, 81 Fed. Reg. 40325 (June 21, 2016).

3 See, FDA’s Guidance for Industry, Using a Centralized IRB Review Process in Multicenter Clinical Trials (March 2006) and OHRP’s Letter, Use of a Centralized IRB (April 30, 2010).

4 45 CFR 46.107; 45 CFR 46.109; 45 CFR 46.115.

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