Research projects in the area of further use that require authorisation

Encrypted and unencrypted data

Research involving further use utilises encrypted or unencrypted health-related data or biological material which, if needed, can be traced back to the donor. Further use of the data for research purposes requires the consent of the person concerned.

Post hoc consent

Since research involving further use utilises pre-existing data or material, the persons involved don’t necessarily know in advance that their material or their data are to be used for research. If no consent has been received, the researcher must contact these persons directly and obtain post hoc consent for further use. Once the researcher has obtained the consent of the persons concerned, he or she may make further use, for research purposes, of the data or biological material.

Proxy consent by ethics committee

If it is not possible for the researcher to contact the persons concerned directly, he or she may apply to the ethics committee for proxy consent. If the proxy consent is received, the researcher may make further use, for research purposes, of the data or biological material.

Procedure in special cases

Projects whose research subjects are deceased persons or embryos/foetuses from abortions do not directly affect living persons. For these types of projects the researcher requires the deceased persons’ consent given during their lifetime or post hoc consent of their next of kin or a trusted person, or, in the case of embryos/foetuses from abortions, the consent of the couple concerned.

Categorisation of research projects in the area of further use

The kofam website provides a categoriser to assist in assigning and categorising research projects. Further information is available here.