Medical research involving food and food supplements
Medical research that involves subjecting individuals to actions or imposing rules of behaviour falls under the Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, or WMO). Nutrition (food/nutritional supplements) may also be the subject of research in this regard. In collaboration with the Dutch Association for Medical Research Ethics Committees (MRECs; Nederlandse Vereniging voor Medisch-Ethische toetsingscommissies, or NVMETC), CCMO has drafted a guideline for the review of research involving food and food supplements that is subject to the requirements of the WMO.
Guideline
The guideline aims to clarify the requirements for food in general and the information to be provided by investigators and sponsors for assessment by a review committee.
Checklist
The guideline comes with a checklist, which provides a concise overview of the information to be supplied for assessment of research involving food.
Decision tree
The decision tree below will help you determine whether your study is a food-related study. Follow the steps in the order shown. If there is any doubt as to whether the the study falls within the scope of research with a medicinal product or food research, you are advised to submit this question to an accredited MREC or CCMO.