Review of social sciences studies involving human subjects
As described in the first theme entitled “The Dutch review system” in this online course, the main purpose of the Dutch Medical Research Involving Human Subjects Act (WMO) is to protect the participants in medical scientific research while ensuring the integrity of the research data.
The scope of the law is therefore limited to medical scientific research involving human subjects. In order to clarify the term “medical scientific research”, the CCMO formulated the definition presented at the start of this theme. For most studies, it is clear whether a study should be considered to involve medical scientific research; however, in some cases this is less obvious.
Research involving human subjects in the social sciences represents a special case with respect to the WMO. Studies in this field are highly diverse in their nature, execution, and aim. Some social sciences studies can be considered medical scientific research that are designed to answer questions related to illness and health in a systematic way.
If such a study will be performed with the intention to obtain new medical knowledge that can also be applied to populations outside of the direct research population, the study would meet criterion 1 of the WMO. However, for other studies in the social and behavioral sciences, it is less clear whether it should be considered medical scientific research.
Unfortunately, it is not possible to specify unambiguously and prospectively which types of social sciences research should be considered WMO studies. Due in part to a major case of scientific fraud case in the social sciences in the Netherlands reported in 2011 (see Nature November 30, 2011), in 2016 the deans of Social Sciences in the Netherlands adopted the “Code of Ethics for Research in the Social and Behavioral Sciences Involving Human Participants”.
This Code calls for all Social Sciences departments at Dutch Universities to install an Ethics Review Committee for assessing any studies in social sciences that do not fall under the scope of the WMO.
Whether a given study falls under the scope of the WMO or not, is determined on a case-by-case basis and is evaluated by accredited MRECs supervised by the CCMO and by the Ethics Review Committees for Social Sciences installed by the Boards of each Dutch University.
For more information, please read the following pdf entitled Research with human subjects? The big gray area begins where the law ends.