ABSTRACT

Medical Ethics Review Committees (METCs) are separate to the clinical ethics committees, and were formally established by the Medical Research Involving Human Subjects Act (WMO). All medical research involving human subjects must be assessed by an ethics committee in advance, and whether it is an METC or the Committee on Research Involving Human Subjects (CCMO) depends on the type of research. The decision made by an METC is legally binding on the researchers, and the WMO prohibits medical research with human subjects unless it has been approved. Six METCs and the CCMO consider that, at least when the identity of the human source is directly or indirectly knowable, the processing of human biological material for genetic research falls within the scope of data protection law. The Manual for the Review of Medical Research also adds that blood and body tissues may not be retained at the end of research without the subject's informed consent.