Research with human tissue

A legal framework is currently not available for the (further) use of human tissue for medical/scientific research. The regulation regarding the medical treatment contract does however contain a stipulation on the use of anonymous human tissue. Section 7:467 of the Dutch Civil Code (Burgerlijk Wetboek) states: ‘Anonymous tissues and parts which have been separated from the body can be used for medical statistics or other medical/scientific research as long as the patient, from who the human tissue originates, has no objections against such research and the research is carried out with the necessary care’. (Non-official translation).

The second paragraph of section 7:467 of the Dutch Civil Code states that the human tissue used in the study, and any data generated from this, may not be traced back to the person. It also states that general information (issued prior to the treatment) and the possibility for the patient to object is sufficient for further use of non-traceable human tissue. (Oral) Information and consent is repeatedly needed for human tissue which can be traced back to an individual (directly identifying or via a code).

COREON (Committee on Regulation of Health Research) has drawn up the Code of Conduct for Health Research (in Dutch). This is a manual for the responsible handling of (personal) data and human tissue in health research.