Abstract
The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee (MREC) regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members.
Highlights
BackgroundCurrently, in the Netherlands there are 20 Medical Research Ethics Committees (MRECs), which independently review medical scientific research protocols involving human subjects
According to all respondents, the central responsibility of the MREC is to protect the rights, security and well-being of subjects who participate in medical scientific research
As far as we know, this is the first qualitative study into the roles and responsibilities identified by individual members of a MREC
Summary
BackgroundCurrently, in the Netherlands there are 20 Medical Research Ethics Committees (MRECs), which independently review medical scientific research protocols involving human subjects. In line with Dutch law, MRECs foster valid informed consent and assess whether the risks and burdens for the subjects are proportionate to the expected benefits for the subjects and/or future patient populations. This latter assessment illustrates that MRECs, next to protecting participating subjects, have other responsibilities that relate to the quality and progress of medical science (Hunter 2007; Garrard and Dawson 2005; Guillemin et al 2012). These studies, focussed mainly on the operation of the committee as a whole, and provided only scant information concerning the experience(s) and views of individual committee members on their roles and responsibilities
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