If it isn’t documented, it didn’t happen: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

The current training for human research emphasizes drugs and devices while encouraging reliance on monitoring boards. Human nutrition trials have unique features that should be considered. However, training and research surveillance in human nutrition studies is lacking, and best practices have not been developed and collected in one place. In human feeding studies, it is not easy to distinguish risks associated with interventions from risks related to food consumption in free-living conditions where there is a risk of choking, vomiting, gagging, and so forth in usual eating and drinking activities. Too often, in the training of nutrition scientists and the planning and carrying out of their research, insufficient consideration is given to the importance of documentation and the need to comply with regulations imposed by sponsors, institutions, and regulatory bodies.

From this perspective, Distinguished Professor Emerita Connie Weaver, Nutrition Science at Purdue University, Indiana (also affiliated with Weaver and Associates Consulting LLC) and her colleagues Naomi Fukagawa, DeAnn Liska, Richard Mattes, Gregory Matuszek, Jeri Nieves, Sue Shapses, and Linda Snetselaar authored an article on documentation and regulation of human nutrition research. The authors discussed the need to document the food, diet, or supplement intervention, the role of the Institutional Review Board and Data and Safety and Monitoring Board, as well as staff training and monitoring. This paper was one of a series of five articles that outline core principles for the design, conduct, and reporting of human nutrition randomized controlled trials. All five papers were published in Advances in Nutrition.

“Dietary guidance should be based on the strongest possible evidence base. This article offers best practices for documenting and complying with regulations. Other articles in the series cover best practices in designing, conducting, and analyzing rigorous human nutrition research,” said lead author, Professor Weaver.

According to the paper, managing human nutrition randomized controlled trials (RCTs) puts researchers, participants, and institutions in a position of great responsibility and vulnerability. Multiple steps must be navigated to protect all parties and guiding principles. Still, the principles allow researchers to establish if / how diets can influence food/health relationships when they are observed.

In addition to definitions, the authors provided guidance on oversight of clinical nutrition research regarding regulatory boards, safety for participants, training for stakeholders, and standard operational procedures; local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

Professor Weaver and colleagues recommended that knowledge and experience to evaluate the diet safety and behavior of the population included in the study as relevant expertise when comprising research monitoring bodies. In addition, the distinction between diet-related intervention adverse effects and non-intervention events (for example, participant behavior) requires attention in the planning, carrying out, and surveillance of studies. Finally, diet-related standard operational protocols should be included in researcher and staff training. Professor Weaver added: “Developing standard operating protocols helps meet documentation requirements and perform high-quality research.”

The authors have reviewed good documentation procedures and multi-faceted regulatory environments with examples relevant to human nutrition RCTs. The main focus in this paper was on specific situations encountered in human nutrition RCTs (with examples), although many of the topics covered in the article apply to various fields of clinical research.

Journal Reference:

Weaver CM, Fukagawa NK, Liska D, Mattes RD, Matuszek G, Nieves JW, Shapses SA, Snetselaar LG.  Perspective:  US Documentation and regulation of human nutrition randomized controlled trials.  Adv Nutr  2020, 12 (1) 21-45, doi:10.1093, 2021. https://doi.org/10.1093/advances/nmaa118

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