De vertrouwelijkheid van gegevens bij medisch-wetenschappelijk onderzoek met mensen

– The bill on Medical-Scientific Studies of Humans states that researchers should protect the privacy of test subjects to the extent possible. The right to privacy is also laid down in the Data Protection Act and the Medical Contract Act.

Data gathered in the context of medical-scientific studies of humans should relate to the problem to be investigated, as set forth in the protocol. They must have been obtained legitimately – with the test subject's permission – and must as a matter of principle not be used for any other purpose than the study as a part of which they have been obtained. The data should be protected adequately, e.g. by encoding, and may be placed at other people's disposal only after permission from the test subject.

Once research data have been processed in such a way that they can no longer reveal the test subject's identity, the latter's right to inspect them is cancelled. Furthermore, the test subject cannot assert his power of destruction regarding any parts of his file relating to the study. He must be so informed beforehand.

Study results should be published in such a way that they cannot reveal individual identities.

Every study protocol should include an ‘information section’ on the confidentiality of the data. It might be considered to draw up a code of behaviour regarding protection of privacy in medical-scientific studies of humans.