Research projects in the area of further use that require authorisation
Research projects in the area of further use work with pre-existing health-related data or biological material which can be traced back to the persons concerned.
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.
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.
The researcher contacts the persons concerned directly to obtain post hoc consent for the further use of their health-related data or biological material.
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.
If it is not possible for the researcher to contact the persons concerned directly, he or she may obtain proxy consent for the further use of the material from the ethics committee.
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.
The kofam website provides a categoriser to assist in assigning and categorising research projects. Further information is available here.