Low risk study with no ethics committee approval
Case text (Anonymised)
A manuscript was submitted to our journal that describes a social media advocacy campaign that was run by an international NGO for the purpose of eliciting public support for a new law in a low-middle income country. The authors are from the NGO and the government department in that country, that together funded and ran the campaign, and also collected and analysed the data used in the manuscript.
Some of the data reported in the manuscript were survey data collected from people who signed the online petition in support of the proposed law. The manuscript provides information that could be useful for others planning similar advocacy campaigns. The data are reported in grouped format (counts and percentages), such that participants are not able to be identified from the results. The nature of the data reported in the manuscript is not of a sensitive nature, and the study would generally be considered a low risk project (answering an online survey about how the participant found out about the campaign and demographics of respondents etc).
The authors state that all respondents agreed to participate in the research. However, the study has not been reviewed or approved by a human research ethics committee.
Question(s) for the COPE Forum
• Would retrospective research ethics committee review be appropriate to consider in this situation?
The majority view from the Forum was that the editor should obtain retrospective ethics approval for the study. However, the Forum noted that it is up to the editor, and it is his judgement call; if the editor is happy with the current position, and common sense tells him that the study is sound, then he should publish.
Although low risk, some of the Forum cautioned that the editor should err on the side of caution as the study involves human subjects, and the advice was to go back to the authors and ask them to obtain ethics approval for the study. If retrospective approval is obtained, the Forum advised a note on the paper saying that retrospective approval was obtained, in the interests of full transparency. A poll of the (8AM) audience revealed that the majority were in favour of going back to the authors and asking them to obtain retrospective ethics approval.
Another view from the Forum was that editors should only seek retrospective review under extraordinary circumstances. As a norm, retrospective approval should not be used for any study that has been completed, unless there are exceptional circumstances (research conducted in a war zone for example). A suggestion was for the authors to provide more specific information on the type of consent that was obtained and for this to be published as an appendix to the paper.
Often the need for approval is different in different countries and this COPE document provides some helpful information. http://publicationethics.org/files/Guidance_for_Editors_Research_Audit_and_Service_Evaluations_v2_0.pdf
The authors were advised by the editor that they needed to address the issue of lack of ethics approval for the study and it was recommended that they seek retrospective ethics approval from an institutional review board. However, the authors resubmitted the manuscript without ethics approval and stated that ethics approval is not required for this type of study (surveys) in the country where the study was conducted. The editor requested they supply further material, such as a letter from the research ethics authority in the country or other official document that confirms this type of study is automatically exempt from requiring ethics approval, and participant information and consent statements.
The journal is waiting on material from the authors to confirm the study meets accepted standards.
Follow up (October 2016):
The authors submitted a response to the journal. Rather than evidence of exemption from ethical approval, they obtained retrospective ethics approval from a relevant institutional review board in the country and provided the certificate. The manuscript has now been accepted.