October 3, 2016
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability
Dear Sir or Madam,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) related to the August 2, 2016 notification of draft guidance, "Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Availability" ("Draft Guidance"). Representing more than 100,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition across the lifecycle.
The Academy supports the draft guidance as an important step in HHS's and FDA's attempts to streamline IRB processes, enhance human subject protection, and reduce regulatory burden.
The varying expectations of IRBs have been well-documented.2 While the NIH's recently issued final policy on single-IRB approval for multi-site studies3 is an important step toward decreasing variation in review accorded to a single study, this Draft Guidance is important in streamlining IRB processes for studies to which the NIH policy does not apply (e.g., non-government funded studies, single site studies).
Perhaps the most critical section of this Draft Guidance is the following: "IRBs should consider making their written procedures available to investigators to ensure investigators are aware of the IRB's requirements, and to facilitate investigator compliance with IRB requirements. Step-by-step operational details in written procedures also help regulators understand how the IRB operates and fulfills its regulatory responsibilities. OHRP and FDA have observed that some IRB written procedures simply reiterate the regulations, which is an approach that does not provide sufficient detail about the IRBs' operations necessary to meet the regulatory requirements for written procedures."
As Bozeman has argued, IRBs are formal (i.e., highly rule-bound) organizations.4 Simply having written procedures is inadequate in our minds; instead, the IRBs must make these explicit in detail and easily available to investigators and the public. Increasing IRB transparency may improve the public's trust in research in addition to decreasing workload for investigators by allowing them to understand IRB procedures up-front, rather than waiting for questions to be answered or proposals being denied. Our Dietetics Practice Based Research Network5 has experienced these challenges in learning about IRB policies only after submitting a protocol rather than prior to submission, and finds that this not only slows down the research approval process but may also have a negative impact on the protection of human subjects by creating protocol variations across sites. Having easy, up-front access to written procedures would allow investigators to harmonize protocols to meet the expectations of all IRBs in advance of protocol submission.
Public display of written procedures would also assist dramatically in the education of new researchers. IRB is often perceived as somewhat of a trial-and-error process, and as researchers accrue experience working with an IRB they learn the standards and expectations of the board. Passing these standards on to new researchers in an informal matter is likely to lead to inaccurate information sharing. A clearly delineated written procedure manual would assist in training new researchers through a formal rather than informal information sharing.
As centralized IRB approval gains acceptance, written procedures for Item 256 will also become critically important. Academy members' experience with cooperative review agreements demonstrates that this is a new and poorly understood area that would benefit from written procedures.
We suggest that this draft guidance emphasize the importance of considering the entire set of rules to which the IRB is beholden, not simply one section of this checklist. For example, the items in Section V(a-b) (regarding IRB composition) are already frequently published; simply ensuring that this is published, however, does not achieve publication of the entire scope of this proposed rule.
Finally, we suggest that HHS and FDA consider creating templates for each of these written procedures that IRBs could adopt if they do not have written procedures already in place. This would be a significant step toward further streamlining of IRB procedures while still allowing modifications for local context.
The Academy sincerely appreciates the opportunity to offer comments regarding the draft guidance for IRBs. Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Green, LA; Lowery, JC; Kowalski, CP; Wyszewianski, L. Impact of Institutional Review Board Practice Variation on Observational Health Services Research. HSR 2006; 41 (1) 214-230.
3 Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. June 21, 2016. Available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html. Accessed October 1, 2016.
4 Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health. 2009;99(9):1549-56.
5 The Dietetics Practice Based Research Network, or DPBRN, conducts, supports, promotes and advocates for practice-based research that answers questions important to dietetics practice. DPBRN members are RDNs who share a common interest in improving patient care through practice-based research or designing research projects that draw from the knowledge and understanding of practicing clinicians. See, DPBRN. Accessed October 1, 2013. Available at http://www.eatrightpro.org/resources/research/projects-tools-and-initiatives/dpbrn
6 See, Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs Draft Guidance; Item 25. Accessed October 1, 2016. Available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM512761.pdf. ("Implementing cooperative IRB review arrangements (including reliance on review by another qualified IRB, joint review, or any similar arrangement to avoid duplication of effort, procedures used to determine which studies qualify for cooperative review, the role of the institution and the institution's IRB in this type of review process, and documenting arrangements in written agreements). NOTE: FDA has guidance specific to using a centralized IRB review process in multicenter clinical trials.") (Internal citations omitted.)