Weaver and Associates Consulting LLC, West Lafayette, IN, USA.
USDA-Agricultural Research Service Beltsville Human Nutrition Research Center, Beltsville, MD, USA.
Adv Nutr. 2021 Feb 1;12(1):21-45. doi: 10.1093/advances/nmaa118.
Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient 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 human nutrition 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 (institutional review boards, data safety and monitoring boards, US FDA); 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.
在人体营养随机对照试验中，培训以确保良好的文件记录实践和遵守法规要求尚未得到足够重视。此外，很难方便地找到组织良好或以与营养方案相关的形式呈现的此类信息。临床营养研究中存在培训和研究监测方面的当前差距，因为培训模块侧重于药物和设备，促进对监测委员会的依赖，并且人体营养研究团队缺乏营养专业知识。此外，由于进食是必需的、持续的且高度个体化的，因此很难将与干预相关的风险与自由生活条件下的进食区分开来。控制喂养试验为获得对所消耗食物的更多实验控制提供了一种选择，但代价是外部有效性降低，并且可能会带来与干预无关的人类行为问题。本文涵盖了在规划和进行营养干预试验时可能遇到的许多预期文件记录和法规要求，并提供了示例和参考文献，这些内容应该对临床营养研究人员、研究资助者和研究机构有用。其中包括临床营养研究监督（机构审查委员会、数据安全和监测委员会、美国 FDA）的定义和指导；参与者安全；标准操作程序；研究人员、工作人员和学生的培训；以及与饮食相关的临床研究开展和文件记录相关的当地文化和报告要求。
