Myklebust, Kjellaug K. http://orcid.org/0000-0003-0233-1711
Bjørkly, Stål
Article History
Received: 12 April 2019
Accepted: 8 August 2019
First Online: 14 August 2019
Ethics approval and consent to participate
: The National Committee for Medical and Health Research Ethics in Norway (NEM) approved the study (reference number 2016/345). According to the Norwegian Act on medical and health research (the Health Research Act), 2008, § 2 and 4, informed consent from the patients must be obtained before personal information from their electronic health record can be used for medical or health research purposes. However, NEM assessed that the Health Research Act was not applicable to the current research project’s aim and research questions. Moreover, NEM appraised the project to have “substantial benefit to society, because the therapeutic interaction between the professional and patient may be improved as a consequence of this research”. NEM considered the inconvenience for the patients to be minimal, and that obtaining patient’s consent could lead to systematical inclusion bias. Thus, NEM approved this study without any demand for patient’s consent provided that all personal identifying information retrieved from the electronic patient journals was removed before copies of the progress notes used in the study were made. The approval was given in accordance with the Norwegian Personal Data Act, 2000, § 23, Exceptions to the right to information.
: Not applicable.
: The authors declare that they have no competing interests.