Service evaluation as research in a controversial area of medicine
Case text (Anonymised)
We received an email from a reader relating to the ethics statement in a research article published in 2011. The article presented data collected at a clinic relating to a controversial area in medicine. The ethics statement in the article indicates that, in accordance with regional guidelines, the research ethics committee deemed that the study was a service evaluation and formal ethical review was not required.
Using the reference number cited in the article, the reader obtained the relevant documents from the research ethics committee via a freedom of information request. The reader argued that the documents from the ethics committee related to data that predated what was presented in the article. A review of the documents indicated that this appeared to be the case. In addition, the reader argued that service evaluations should not be presented as research articles as these are two separate things.
The editor of the journal wrote to the author of the article and asked for comment on the issues raised. The author replied that there had been regular contact with the ethics committee as the service period of the clinic was extended, and the ethics committee continued to indicate that the data were being collected as part of a service evaluation and further ethical review was not required. In addition, the data were collected anonymously, which would further exempt the study from requiring formal ethical approval. The ethics committee also provided the authors with a letter indicating that “this letter …may be provided to a journal or other body as evidence that ethical approval is not required under [the regional] research governance arrangements”.
The author indicated that similar requests had been made in the past and that, due to the controversial area of the work, many attempts were being made to retract articles that used the data from the clinic. Attempting to prevent further queries, the author asked the institutional head of research to post a public statement indicating that the work was conducted appropriately and met the highest ethical standards. As requested, the head of research issued a statement on the institutional website in support of the work.
The editor then responded to the reader indicating that the journal was satisfied with the author’s response and the support of the head of research. The reader was not satisfied with the editor’s response and forwarded the details of the case to a high profile blogger who writes extensively on this controversial area of medicine. The blogger then posted a blog criticising both the article and the journal’s handling of the case. The blog was shared widely on social media. From the journal’s perspective, the blog was inaccurate, misrepresentative and damaging to the publisher’s reputation.
Question(s) for the COPE Forum
• Should we allow data collected in service evaluations to be published as research articles? In medical journals, this is often seen as an acceptable exception; however, if research ethics committees are declaring a study "not research", should journals do the same?
• Should the journal have posted a correction on the article to provide a more detailed ethics statement, bearing in mind that anything labelled a "correction" in a controversial area would be misinterpreted as an error in the research by the critics?
• How should journals respond to blog posts that they feel portray them unfairly and are damaging to the publisher's reputation?
The Forum suggested that perhaps the issue is not whether or not the service evaluation is research, but was the evaluation carried out in human subjects (which would require a sound ethics approach) or were the data contained in registries where the patient data were anonymised. It would appear that the latter is the case and that this is a secondary data analysis, but the editor could ask for clarification from the author on the methodology as it needs to be adequately described. Was this a dataset developed out of a research project that had ethics approval for human subjects? If so, the secondary analysis might not need new ethics approval if additional analyses were covered in the initial approval. The methodology is confusing the issue of whether ethics approval was required. The Forum suggested these points need to be clarified before a decision on whether to add a correction on the article or to respond to the blogger.
This issue often arises with audit articles, which is often a term used for service evaluations. There is a contradiction in that journals publish research articles and yet audits or service evaluations are not thought of as research requiring ethics approval. However, it is up to the ethics committees and their procedures to decide what is research for the purposes of ethics approval. Separately, journals need to decide what they can publish so it is the editor’s decision on what to publish in their journal, irrespective of the decision of the ethics committee.
The Forum suggested that the journal may need to provide more information or specific guidelines for authors on what they mean when they say they accept waiving of ethics approval for service evaluations. What is meant by service evaluations?
The Forum agreed that posting a correction may be excessive and perhaps a short editor’s note would be more appropriate. The Forum advised against responding to the blogger and getting into a spiral of communication that could become problematic. A suggestion was to write an editorial on the concepts more broadly and how the journal’s policy is going to evolve in the future regarding secondary research being conducted as service evaluations/audits/quality improvement reporting and what the ethics requirements will be in the future. What are the expectations of the journal for future submissions of service evaluations?
The Forum suggested the editor may wish to consult the SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence) guidelines on how to publish quality improvement studies, which can be found on the Equator Network website (https://www.equator-network.org/reporting-guidelines/squire/).