Author refusal to sign an ethics form

Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the COPE Forum where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.

Ethics Approval and Consent is required for reporting of human data, especially that which could be attributed or identified to one person. Without this, the submission should be rejected.
 
However, for public databases such as national health surveys, secondary use does not need permission or ethical approval but the provenance and purpose of the data source need to be clearly stated. 
 
In this case of publicly shared CT scans, the authors may cite the data source clearly and explain the data are (presumably) anonymised and patient consent was already originally given for study participation and also public sharing. The authors of the open-source data should have provided information about the approval for collecting AND sharing these data. Usually, such sources should have consent for secondary use of personal data for research.
 
The editors should also ask why the authors are refusing to sign the ethics form. If they are convinced that they do not have to do so because this is a secondary use and covered by the ethics and consent processes in the original study then the editors can make a decision on that basis. If there is a more fundamental objection then the editors may need to probe more fully whether the necessary permissions have been secured for the data to appear on the open source platform, or if there are other factors present which need to be considered.

Related resources

• Secondary analysis of medical records and ethics committee approval COPE Member's case
• Use of secondary data without proper attribution COPE Member's case
• Is ethics committee approval necessary for retrospective clinical studies? COPE Member's case