Comments please: framework for editors when requesting patient consent for publication in small cohort studies

The International Rhuematology Editors' Group would like to receive comments from wider specialty communities on their framework below. Please send any comments to Shehnaz Ahmed.

Framework for editors when requesting patient consent for publication in small cohort studies

Created by: Shehnaz Ahmed on behalf of the International Rheumatology Editors’ Group
 

The International Rheumatology Editors’ Group propose a working policy with the aim that all rheumatology or specialty journals adopt the common principles of patient confidentiality and data anonymity for small cohort studies with n<20. We hope that this will provide a common framework not only for editors but also for authors and the academic community in general.

We recognise that this is perhaps a bigger task for this community of editors and input from the wider community of COPE editors will ensure that the outlined policy might be applicable to the wider specialty communities. We recommend that this policy be reviewed annually to adapt to any changes in law.

We welcome comments and suggestions from all participating editors as they will bring their unique view of this topic from their own national experiences and result in a culturally sensitive policy. The only caveat is that this is perhaps more pertinent to medical specialties; however we hope that it will not deter any humanities journals who may have similar issues.

1.     In the case the study comprises a small data set of patients (<1 but fewer than n=20), either from a single cohort or a hospital institutional database, and at least two or more patient identifiers such as age and gender, age of disease onset along with disease characteristics are listed in a table.  The first step is to check whether the paper has ethics approval for this research. Some types of study, such as audits, do not need ethics approval but will need consent. Second, if the paper has ethics approval but no consent for publication then we recommend requesting the following: (a) the authors obtain consent for publication from the patients in the study. (b) If retrospective consent for publication is not possible then to request a letter of exemption from the ethics committee. (c) If neither (a) nor (b) is possible then to assist the authors to anonymise the data further.  It is often a case by case approach and the Editor alone can make this judgement call, but would be advised to seek legal help from their publisher if they are not sure.  You as Editor must feel comfortable in making this decision and you must position yourself from the patients’ perspective.

2.     In the case of a case series with detailed descriptions of patients, case series should be treated in the same manner as a Journal would treat a case report and request authors seek patient consent for publication and not just consent for treatment alone. Deleting detailed description of patients in case series will make the paper clinically irrelevant and hence unpublishable. The only instance that such a paper can be published without consent is when non-publication of such a study may cause greater public harm. We would also suggest seeking legal advice from your publisher before publishing a case series without patient consent for publication.

3.     If the patients have died, the law then states it is best to try and obtain consent from next of kin; however, their data can be published without consent. Authors just need to insert a footnote in the articles about which of the patients have died. In the case of children or juvenile patients even if the child has died, it is best to seek consent from next of kin.

4.     In the case where countries state no ethics approval is required in their country for case studies or series, editors must seek to understand why no ethics approval was needed especially if these are interventional studies. If possible, querying an editorial board member from that region might help shed light. Editors should also ask authors to provide an exemption letter from their institution; however whether to publish or not is dependent on the nature of the study, nature of consent from the patients and whether the authors followed the Helsinki Principle. The editor then has to judge for themselves whether they would be able to defend such a study if questions were to be raised in the future.

5.     Patient registries do not require consent for publication but they do require ethics approval. Editors should ensure that a statement of ethics is included in the study.

Please send any comments to Shehnaz Ahmed.

Deadline for comments: 24 February 2017

 

COPE guidance: Journals' best practices for ensuring consent for publishing medical case reports: 

For more guidance on the general topic of consent for publishing case reports see COPE's recently released document Journals's best practices for ensuring consent for publishing medical case reports.