Comments on Federal Policy for the Protection of Human Subjects

January 6, 2016

The Honorable Sylvia Mathews Burwell
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Re: Federal Policy for the Protection of Human Subjects (HHS-OPHS-2015-0008

The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the U.S. Department of Health and Human Services to the multi-agency September 8, 2015 proposed rule, Federal Policy for the Protection of Human Subjects (the "proposed rule"). 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 largely supports the proposed rule and offers suggestions below for consideration prior to promulgation of a final rule. This proposed rule is of particular interest to the Academy and our members because of members' roles conducting social and behavioral and clinical research, including through 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

The Academy continues to support the proposed move towards approval of multi-site research by a single IRB. 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-documented and manifest challenges in multi-institutional review situations.3 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 practice-based 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

The Academy asks HHS 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.

Informed Consent Requirements

The Academy supports the attempt to refocus informed consents on the subjects' evaluation of risks and benefits. While we question how these regulations will prevent the documents for complex trials from being lengthy, we support the requirement that relevant information be readily accessible and encourage strong guidance on informed consent readability and comprehensibility to overcome this ongoing problem.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 HHS in a final rule to explicitly outline the expectations for local vs. centrally approved consent forms with a focus on readability. We believe the posting requirement for consent forms is valuable and not overly burdensome if integrated into current required registrations such as clinicaltrials.gov.

Excluded/Exempt Categories

The Academy applauds efforts to re-define research categories and further clarify which are eligible for exemption or exclusion. Clarifying that program assessment and clinical quality improvement are excluded reduces burden without negatively impacting human subjects. We also support the use of a standardized decision tool to create exemption decisions. However we believe that allowing investigators to use the tools themselves may erode the public trust in the research infrastructure due to potential conflicts of interest or manipulation by investigators. We believe that individuals who are familiar with the protection of human subjects should be required to work with investigators to operate this new tool. These would likely be institutional IRB staff members but we imagine this process could be conducted more quickly than even expedited IRB review. In addition we believe it may be important for the decision tool to also capture the new excluded categories of research. Because of the trend towards publication of quality improvement projects, one reason for the proliferation of these initiatives in IRB queues is that investigators require a decision of their human subjects status for journal editors. Allowing the decision tool to also create excluded notices could assist in this process.

Conclusion

The Academy sincerely appreciates the ongoing opportunity to offer comments to NIH on the proposed rule. Please contact either Jeanne Blankenship by telephone at 202-775-8277 ext. 1730 or by email at jblankenship@eatright.org or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

Jeanne Blankenship, MS, RDN
Vice President
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, Esq.
Senior Director
Government and 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. 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.