The current training for human research emphasizes drugs and devices while encouraging the dependence on monitoring joints. Human nutrition trials have unique characteristics that must be considered. However, there is a lack of training and surveillance of research in human nutrition studies, and best practices have not developed and collected in one place. In human food studies, it is not easy and drink. Too often, in the training of nutrition scientists and planning and the completion of their research, insufficient consideration is given to the importance of documentation and the need to comply with the regulations imposed by sponsors, institutions and regulatory agencies.
From this perspective, the distinguished professor Emerita Connie Weaver, Nutrition Sciences at the University of Purdue, Indian Sue Shapses and Linda Snetselaar wrote an article on documentation and regulation of human nutrition research. The authors discussed the need to document the intervention of food, diets or supplements, the role of the Institutional Review Board and the Security and Monitoring Board, as well as staff training and monitoring. This document was one of a series of five articles that describe the central principles for the design, behavior and reports of random controlled tests of human nutrition. The five articles were published in Advances in nutrition.
“The dietary guide must be based on the strongest possible evidence base. This article offers best practices to document and comply with regulations. Other articles in the series cover the best practices in the design, realization and analysis of the rigorous human nutrition research, ”said Principal Author, Professor Weaver.
According to the document, the management of random controlled tests (ECA) of human nutrition puts researchers, participants and institutions in a position of great responsibility and vulnerability. Multiple steps must be navigated to protect all guiding parts and principles. Even so, the principles allow researchers to establish whether / how diets can influence food / health relationships when observed.
In addition to the definitions, the authors provided guidance on the supervision of clinical nutrition research with respect to the regulatory joints, the security for the participants, the training for the interested parties and the standard operational procedures; The local culture and reports requirements for the conduct and documentation of the clinical research related to the diet.
Professor Weaver and his colleagues recommended that knowledge and experience evaluate the security and behavior of the population diet included in the study as a relevant experience when research monitoring organisms are understood. In addition, the distinction between the adverse effects of diet -related intervention and non -intervention events (for example, the behavior of the participants) requires attention in the planning, realization and surveillance of studies. Finally, standard operating protocols related to the diet should be included in the training of researchers and personnel. Professor Weaver added: “The development of standard operational protocols helps to meet the documentation requirements and to conduct high quality research.”
The authors have reviewed good documentation procedures and multifaceted regulatory environments with relevant examples for human nutritional. The main approach in this document was in specific situations found in Human Nutritional ECA (with examples), although many of the topics covered in the article apply to several fields of clinical research.
Newspaper reference:
Weaver CM, Fukagawa NK, Liska D, Mattes RD, Matuszek G, Nieves JW, Shapses SA, Snetselaar LG. Perspective: Documentation and regulation of the United States of random controlled tests of human nutrition. ADV NUT 2020, 12 (1) 21-45, DOI: 10.1093, 2021. https://doi.org/10.1093/advances/nmaa118
About the author
Emeritian distinguished professor Connie M. Weaver, Ph.D.
Dr. Weaver is a distinguished emeritus professor of Nutrition Sciences at the University of Purdue, Indiana and CEO of Weaver and Associates Consulting, LLC. He is a chosen member of the National Academies of Sciences, Engineering and Medicine since 2010. He has and minerals. She is one ex officio Member of the ILSI GC Board and an FDA Science Advisory Board, the California Prune Board, the California Board of Herd up, and the Product For Better Health Foundation (PBH). Dr. Weaver is former president of the American Society of Nutritional Sciences. His honors include the Spirit of the Land Grant Award (2013), Herbert Newby McCoy (2012, this award is the most prestigious research honor awarded by the University of Purdue), the Trailblazer Award (2016, an award to recognize “Exceptional leaders”) by the Institute of Food Technology (IFT) and the Academy of Nutrition and Dietetics (Y), and the Prize for Lifetime Achievement by David Kritchevsky (2017, American Nutrition Society). Dr. Weaver was appointed member of the 2005 dietary guideline advisory committee for Americans. Dr. Weaver received a BS and MS from Oregon State University and a PH.D. of the Florida State University in Food Sciences and Human Nutrition.
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