Managing Regulatory Requirements in Clinical Nutrition Randomize
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Annals of Biological Research

Short Communication - Annals of Biological Research ( 2021) Volume 12, Issue 4

Managing Regulatory Requirements in Clinical Nutrition Randomized Controlled Trials

Connie M. Weaver1*, Naomi K. Fukagawa2, DeAnn Liska3, Richard D. Mattes4, Gregory Matuszek5, Jeri W. Nieves6, Sue A. Shapses7 and Linda G. Snetselaar8
1Department of Food Science, Purdue University, 745 Agriculture Mall Dr, W Lafayette, USA
2Department of Human Nutrition Research, Beltsville Human Nutrition Research Center, Maryland, USA
3Department of Agriculture and Life science, College of Agriculture and Life science, Texas, USA
4Department of Nutrition Science, Purdue University, West Lafayette, USA
5Department of Biostatistics and Data Management, Jean Mayer USDA Human Nutrition Research Center on Aging at, Tufts University, Boston, USA
6Department of Health and Institute of Human Nutrition, Mailman School of Public Health and Institute of Human, Nutrition Columbia University, New York, USA
7Department of Nutritional Sciences, Rutgers University, New BrunswickNew Brunswick, Canada
8Department of Epidemiology, College of Public Health, University of Iowa, Iowa, USA
*Corresponding Author:
Connie M. Weaver, Department of Food Science, Purdue University, 745 Agriculture Mall Dr, W Lafayette, USA, Tel: 765-412-2695, Email:

Received: 04-Apr-2021 Published: 26-Apr-2021


Conducting Randomized, Controlled Trials (RCTs) carries great responsibility and vulnerability to investigators, participants and institutions. Such work is vital because the knowledge gained informs practices and policies that influence population and individual health, growth, economic development, and productivity throughout the lifespan. Nutrition scientists involved in the conduct of RCTs are typically trained to apply for approval of the study protocol by an Institutional Review Board (IRB). But little training occurs on a broader scale of good documentation practices and adherence to regulatory requirements, especially for the unique considerations involved in nutrition research [1]. Clinical nutrition RCTs can entail provision of an entire diet or a single food, beverage, or supplement or administering dietary prescriptions. It can be difficult to distinguish risks associated with normal eating and the actual study intervention. Good documentation and regulation practices are essential for scientific rigor and reproducibility to improve the quality of the evidence base that is then used to form conclusions about how diet can influence health parameters which in turn provides the evidence base that generates dietary guidelines for consumers.

Documentation Unique to Diet Interventions

Requirements for documentation vary with the type of intervention. For studies evaluating the effect on diagnosis, cure, mitigation, treatment, or prevention of disease, an Investigative New Drug application or request for a waiver is required from the U.S. Food and Drug Administration. Diet-related interventions require documentation of safety, efficacy, and integrity (i.e. compliance, fidelity, purity, stability of compounds of interest) of the intervention [2]. Foods with a history of safe use should still be assessed for their risk related to potential allergen city and improper food handling leading to risk of microbiological contamination. A novel food or component may require safety testing before a study in humans can be initiated. Even for an intervention involving dietary counselling, with no product intervention, documentation of the content and process involved are required.

Clinical Nutrition RCT Oversight

The regulatory environment of the institution for the Human Research Protection Program is often visible to the investigator through the IRB, but it is more extensive than one committee [3]. A clinical nutrition research study may involve a Data Safety and Monitoring Board (DSMB) or oversight by the U.S. FDA, U.S. Department of Agriculture (USDA), National Institutes of Health (NIH), Department of Defence, etc. The IRB can approve, deny, or request changes in a protocol. The DSMB is convened for a specific study and is constituted to represent content expertise for the various aspects of that particular study. These groups provide oversight of participant safety by persons who have no conflict of interest with the study. Absence of risk is not a goal as all research has risk. Rather, transparency of risks and benefits for the participant and efforts to mitigate risk by the investigator are key considerations. Stakeholders and institutions with oversight of the trial may conduct site visits or audits with an expectation that all study files, charts, and data should be available for inspection at all times while maintaining appropriate confidentialities.

Standard Operating Procedures (SOPS) and Staff Training

Development of SOPs and rigorous staff training are critical for success of human RCTs. SOPs with specific written instructions should be developed for as many aspects of a study as possible, especially for critical functions, to promote replicability and accountability of that function. Investigators can consider gathering all materials into a single document (or booklet or regulatory binder) to assist with training and successful conduct of the study (such as including a Table of Contents with background, aims, hypotheses, population, design, SOPs, quality control assurances, etc.). This can be especially helpful for multi-site studies. Clinical trial site staff training materials and certification programs are available. For NIH-funded investigators, Good Clinical Practice (GCP) training, Human Subjects Certifications and Conflict of Interest training are required [4].


The environment for conducting research is rapidly changing. All stakeholders in research are increasingly vulnerable to reputation and legal damage in an environment of growing distrust of science, sensationalism by segments of the media and a culture of litigation. New technologies involving Artificial Intelligence (AI) and increased availability of health data through new approaches including electronic records and large data bases have eroded the assumption that a de-identified database can ensure privacy of individual participants. Rather disclosure for transparency will become the goal. Awareness of such vulnerabilities and open dialogue are crucial to a robust research environment.

Financial Support

This project was funded by National Institutes of Health Clinical and Translational Science Awards to Tufts Clinical and Translational Science Institute UL1TR022544, Indiana Clinical and Translational Sciences Institute UL1TR002529, and Penn State Clinical and Translational Science Institute UL1TR002014. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Author Discloures

CMW, NKF, DL, RDM, GM, JWN, SAS and LGS, no conflicts of interest.