U.S. Documentation and Regulation of Human Nutrition Randomized Controlled Trials

Authors: WEAVER, CONNIE - Weaver And Associates Consulting Llc; Fukagawa, Naomi; LISKA, DEANN - Texas A&M Agrilife; MATTES, RICHARD - Purdue University; MATUSZEK, GREGORY - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; NIEVES, JERI - Columbia University - New York; SHAPSES, SUE - Rutgers University; SNESTELAAR, LINDA - University Of Iowa

Submitted to: Advances in Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 8/28/2020
Publication Date: 11/17/2020
Citation: Weaver, C., Fukagawa, N.K., Liska, D., Mattes, R.D., Matuszek, G., Nieves, J.W., Shapses, S.A., Snestelaar, L.G. 2020. U.S. documentation and regulation of human nutrition randomized controlled trials. Advances in Nutrition. https://doi.org/10.1093/advances/nmaa118.
DOI: https://doi.org/10.1093/advances/nmaa118

Interpretive Summary: Training to ensure good documentation practices and adherence to regulatory requirements in clinical nutrition research has been given too little attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on research teams. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (Institution Review Boards, Data Safety and Monitoring Boards, Food and Drug Administration), participant safety; standard operating procedures; training of investigators, staff and students, and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

Technical Abstract: Training to ensure good documentation practices and adherence to regulatory requirements in clinical nutrition research has been given too little attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on research teams. Additionally, because eating is essential, ongoing and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (Institution Review Boards, Data Safety and Monitoring Boards, Food and Drug Administration), participant safety; standard operating procedures; training of investigators, staff and students, and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.