Has formal ethical approval been granted that satisfies publication criteria?
The issue here is whether formal ethics approval has been granted in order to satisfy publication criteria. By way of some background information, a lot of screening data are collected on many athletes in many sports, both nationally and internationally. Historically, clubs and associations have disclaimers whereby athletes sign consent for their data to be used for audit purposes on the proviso they will not be identified individually. This study appears to do exactly that, except that this is not a retrospective audit, this is an interventional study whereby these players have been subjected to a specific regimen.
In my opinion, there are several issues here.
(A) A blanket proforma that these players were asked to sign does not constitute formal ethics approval for this interventional study.
(B) These players are under age and therefore warrant additional protection.
(C) These players are vying for selection and there is no obvious protection from them being coerced into participation
Whilst new training regimens are being introduced into clubs all the time, if the findings are intended to be disseminated through formal publication, then ethics approval should be sought beforehand. I would be very grateful for the Forum’s opinion on this matter.
The Forum was concerned that the volunteers involved were under age and so coercion may have been a problem. The Forum were unanimous in their view that ethics approval and informed consent should have been sought specifically for the study and that the study should not be published without these. The authors may also have contravened the Declaration of Helsinki, which covers all human trials. The Forum agreed that blanket consent is not sufficient and that the specific treatment needs to be detailed and consent obtained from individual subjects. The ICJME guidelines state that procedures followed should be approved by an ethics committee and be in line with the Helsinki Declaration. There is also a European directive on obtaining ethics approval and informed consent. A suggestion was for the editor to write an editorial in their journal highlighting this problem in general.
The editor wrote to the authors conveying the decision of COPE and they responded that they did after all have approval. The editor requested to see this approval and it was dated after the study had been completed. The editor then wrote to the authors explaining in no uncertain terms that retrospective approval was not acceptable and that he was extremely concerned that throughout the submission process they had failed to demonstrate any insight into research governance. The editor suggested lessons to be drawn for the future and rejected the paper.