Research with human tissue

 Currently a legal framework specifically aimed at the (further) use of human tissue for medical/scientific research is not available. 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 may be used for medical statistical or other medical scientific research as long as the patient whom the human tissue originates from, 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 it, should not be traceable to the person involved. This entails that in the case of further use of non-traceable human tissue general information (issued to the patient prior to the treatment) and the possibility for the patient to object should be sufficient. When human tissue can be traced back to an individual (directly identifying or via a code) (oral) information and consent are always required.

In addition, one of the review frameworks for non-WMO research may be applicable (refer to page 12-13 of the Toetsingskader medisch-wetenschappelijk niet-WMO-plichtig onderzoek, in Dutch). And 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.