Ethics approval for audit 3

Case number:
06-17

Case text (Anonymised)

In this case, an international organisation wished to study the use of various regimens for medical termination of pregnancy in a developing world setting where termination of pregnancy is not supported by the state. They have performed an audit and have obtained data which will be of considerable value in other similar settings around the world. However, they are not willing to state the identity or location of the clinics supplying the data because these clinics fear reprisals and may even be shut down. Moreover, their staff might be put at risk (see the recent editorial in the NEJM on this topic). They are prepared to tell us the location of the clinics provided we do not publish it.

Is it acceptable to publish the data in the interests of women’s health without publishing the source of the data or indeed any evidence of local ethics approval for the study (as the clinics are not officially sanctioned there is no formal institutionally affiliated ethics committee)?

Advice: 

The general consensus of the committee was yes, it is acceptable to publish the data without naming the identity or location of the clinics. The editor stressed that it would be possible to name the continent and the type of setting, but for reasons of security the identity of the setting could not be named. The committee felt that such a decision could be legitimately made by the editor. The situation could also be explained to referees if needed. The editor and/or author could act as guarantor for the validity of the data.

Follow up: 

The paper has been accepted and publication will be going ahead. The authors of the paper are willing to tell the editor the names and addresses of the centres involved with the research, but the editor has declined so that there is no risk of giving away their identity inadvertently. However, the authors have agreed to tell the journal in the future if asked.

Year: