January 29, 2015
Sarah Carr Acting Director
Office of Clinical Research and Bioethics Policy
Office of Science Policy
National Institutes of Health
6705 Rockledge Drive, Suite 750
Bethesda, MD 20892
Re: Notice Number NOT-OD-15-026
Dear Ms. Carr:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the National Institutes of Health (NIH) to its December 3, 2014 Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. Representing more than 90,000 registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionist researchers, 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. Every day we work with Americans in all walks of life--from birth through old age—conducting research and providing medical nutrition therapy (MNT)2 and other evidence-based nutrition counseling services that meet the health needs of all citizens.
The Academy strongly supports the Draft NIH Policy on Use of a Single Institutional Review Board (IRB) for Multi-Site Research (the "draft policy"). This draft policy is of particular interest to the Academy and our members because of members' roles conducting multi-site research and the Academy's Dietetics Practice Based Research Network (DPBRN), which has member sites in all 50 states. The DPBRN conducts, supports, promotes, and advocates research in practice-based settings by bringing practitioners and researchers together to identify research that is needed in practice settings, design high-quality research, obtain funding and carry that research out in real-life practice settings.
Challenges with Multiple IRBs
Academy members conducting DPBRN projects have experienced multiple challenges in obtaining both central and local IRB approval. The order in which to seek approval is complicated by the fact that while first seeking the central IRB often seems logical, approval may be conditioned upon prior approval of all local sites. Similarly local sites often condition approval upon prior central approval.
The varying expectations of IRBs have been well-documented3 and manifest challenges in multi-institutional review situations. For example, the DPBRN recently had a low-risk observational study that the central IRB approved, after which one local site IRB requested one set of changes and another participating site requested another set of changes related to the consent process. Not only did this process not protect human subjects, it actually causes a complex situation in which either (1) the central study coordinator must keep track of each individual site's requirements and work with each local investigator to ensure they are followed or (2) further delay is required to attempt to streamline the approved protocols between multiple local sites and central IRB. Many similar challenges of practicebased research IRB approval and a call for central IRB approval have been outlined by Graham et al (2007)4 and Wolf et al (2002).5
Another advantage of central IRB approval may be dealing with the ongoing problem of informed consent readability.6 Refocusing the IRB on protection of human subjects rather than reducing institutional liability could facilitate the removal of overly complicated legal language from many consent forms. Given that many sites have adopted strict consent templates with large blocks of required text, we encourage NIH in its policy to explicitly outline the expectations for local vs. centrally approved consent forms with a focus on readability.
The Academy also encourages NIH to clarify which institutional requirement for human subjects protection training will be followed when central review is conducted. Many sites require Collaborative Institutional Training Initiative (CITI) training for all investigators listed on a protocol, but if a local site with other training requirements were to be reviewed by a central IRB with this requirement, inefficient, duplicative training may take place.
Finally, the Academy questions whether NIH considered establishing a board similar to the National Cancer Institute IRB before developing the draft policy and if so, we encourage NIH it to share its rationale for deciding to establish institutional agreements rather than establishing an NIH IRB.
The Academy sincerely appreciates the ongoing opportunity to offer comments to NIH on the draft policy. Please contact either Jeanne Blankenship by telephone at 202/775-8277, ext. 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 Blakenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, 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 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process. According the Academy's definition, the provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/ re-assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. [Academy of Nutrition and Dietetics. Definition of Terms List. Available at www.eatright.org/scope/. Accessed December, 17 2012.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans. Further, the Academy’s definition of MNT is broader than the definition of MNT in the Social Security Act (42 U.S.C. 1395(vv)(1)).
3 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.
4 Graham, DG; Spano, MS; Manning, B. The IRB Challenge for Practice-based Research: Strategies of the American Academy of Family Physicians National Research Network. JABFM 2007; 20 (2) 181-187.
5 Wolf, LE; Croughan, M; Lo, B. The Challenges of IRB Review and Human Subjects Protections in Practice-Based Research. Med. Care 2002; 40 (6) 521-529.
6 Paasche-Orlow, MK; Taylor, HA; Brancati, FL. Readibility Standards for Informed-Consent Forms as Compared with Actual Readibility. NEJM 2003; 348 (8) 721-726.