We have noticed a lot of variety in the way that ethical approval for Case Reports are published in different journals. For example, some state that the study was determined not to require Ethics Committee (EC) or Institutional Review Board (IRB) review especially if it was a retrospective review. Others state that all procedures were carried out in accordance with approved ethical standards, giving the name and reference number of the relevant IRB. Other cases still simply state that patient consent is available and give the name of the institution which has granted approval, and the protocol ID, while a final category provide no statement about ethical approval.
Question for COPE Council:
- Under what circumstances should a journal require the author(s) of a Case Report to provide ethical approval?
- What does COPE advise journal editors to require from authors?
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.
There are two connected aspects to this question: whether ethics approval is required for the study, and whether consent has been given for personal details (potentially including images) to be published.
On ethics approval for case studies, there are many grey areas, though in general, we would encourage always asking for approval by an institutional review board (IRB) when a study is based on human participants. However, some IRBs, institutions or governments do not regard the reporting of single cases arising during normal practice as research, although cases involving efficacy studies or part of a trial would typically be seen as such. Some case studies are published for educational purposes rather than research, and in others, where data were collected as part of routine care, permission might be given by a hospital or research institute rather than an ethics committee. IRBs may apply a patient number cut-off (eg 3 or 5) above which a case series counts as research. Thus a case-by-case approach may be needed, with further dialogue with authors in cases where there is ambiguity. It is also worth noting, however, that IRBs are primarily concerned with the procedures concerning the study design and conduct, rather than how the reporting is carried out.
The key point from a publication ethics point of view is that journals should make their policies clear on when they expect ethics approval, as well as what declarations are needed at submission and in the paper. Examples of some comprehensive case report guidelines can be found at Dove Press (for authors) and at SAGE for editors.
Since it is beyond a journal’s scope to establish different national legal frameworks they might choose simply to ask for a declaration that national or local laws were followed, naming the ethics committee that gave approval, and the reference number if appropriate. This declaration could be a statement that the need for approval was waived, as in one of the cases cited above. Some journals go further and ask for documentation that IRB approval was waived if there are any doubts about this (for example, a project website which gives further details, or a letter from the IRB).
Proof of patient consent for publication is a separate issue, but one to which journals should pay equal attention even if it is decided that informed consent for research does not apply to case reports or case series. COPE has guidelines regarding patient consent in case reports.
It should be noted that these stipulate that journals collect proof that consent was given for any study involving humans (including its publication), no matter the size of the enquiry. Since the legal procedures underpinning patient consent may vary from one country to another journals could consider providing blank forms which follow COPE guidance. Journals should also stipulate that the information provided to the individuals in question has explained what happens if their identifying photographs are published in scientific journals under an open licence. The BMC portfolio has this as an explicit point in their consent for publication policies: authors need to have informed the subject that the publication will be open access and published under CC BY, and be made aware of the consequences.
Fundamentally, while there is no one-size-fits-all answer to the question, journals should have clear policies on what they require under what circumstances. In particular, they should ensure that the ethics statement published within the manuscript is clear both on ethics approval or its waiver, and that the patient provided proper consent for publication according to local laws and regulations.