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Sammanfattning

BACKGROUND Medical and health research may yield findings that are of direct clinical significance for project participants. The Council of Europe has stated that information on such findings shall be offered to participants, and that applications to research ethics committees shall include plans for managing such findings. The purpose of the study was to investigate how the management of such findings had been described in research projects that had been granted prior approval by a regional committee for medical and health research ethics (REK). MATERIAL AND METHOD Research projects that were associated with Oslo University Hospital and had a start-up date in 2011 were identified in the database of the regional ethics committee. Copies of the application form submitted to the committee, project protocols, participant information/consent forms and letters of approval were reviewed with regard to information on the management of findings with possible clinical implications. RESULTS Of the 87 projects found in the database, 70 were included in the study. Of these, 57 studies involved direct interaction with humans, whereof 45 with intended use of biological material. In 21 studies, the management of findings with possible clinical implications was described in one or more documents. In all of these projects, the applicant him-/herself had referred to this topic in the initial application. INTERPRETATION The absence of written information on the management of research findings with possible clinical implications is not in conformity with the recommendations issued by the Council of Europe. By introducing a separate item for this in the form to be submitted to the regional ethics committee for application of prior approval, this issue could be made subject to better assessment.

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