An article that has been published in our journal has subsequently been found to have serious ethical issues. The authors did not seek the correct ethics approval from their institution before conducting the research (which involves human subjects). They also did not obtain informed consent from the research participants prior to publication.
The article in question is a case study of an educational programme which involves student volunteers. The 'human subjects' in this case are the students who participated in the programme. Although individuals are not named in the paper, the names of the student 'teams' are provided and these could be used to identify individuals through other online materials relating to the educational programme.
A few weeks after this article was published, the journal was contacted by a participant in the study who made a number of allegations against the authors:
1. Consent: the allegation is that consent from the students on the programme was not obtained to publish findings with respect to the programme in a research paper.
2. Factual inaccuracies: the student alleged that there were a number of inaccurate criticisms of their contribution to the research project, which could potentially damage their future career.
This person submitted a simultaneous complaint to the Office for the Protection of Human Subjects (OPHS) of the university where the research was conducted. After investigation, the OPHS ruled that the authors should have sought formal review and approval for the research before undertaking it. They were issued them with a 'formal reprimand', although no further action was taken.
The journal will almost certainly have to redact at least part of the article (in addition to issuing a retraction notice) in the interests of protecting the identity of the participants. It is not possible to retrospectively anonymise the information.
Question for COPE Council
- What are recommended best practices for dealing with material that has to be redacted for legal/ethical reasons?
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.
We would suggest first consulting the legal department of the publisher about the redaction question. It may not be possible to redact the material sufficiently to completely avoid identification of any students. The journal is also responsible here for a lax peer review process (by not questioning the need for ethical permissions) and for failing to consider the consequences of publishing potentially identifiable information about human subjects (even if they had given their consent). Given that the reprimand was 'formal' and the case was reviewed by an institutional OPHS, we would consider that reprimand sufficient cause to retract the article. Failing to obtain ethics approval before undertaking the research as well as failure to obtain informed consent from the participants in the research are serious concerns for research involving human subjects, and are also grounds for retraction.
Redaction is not an issue that has come before COPE previously, but if it is possible to anonymise any identifying information that should be done. However it is likely an unsatisfactory solution because archived copies of the original article, even after retraction, will still be available. An erratum is not sufficient—we would suggest retracting the article.
The journal should examine how this happened in terms of the journal’s own policies and procedures. The journal should consider reviewing their instructions to reviewers so that in the future ethical aspects are looked at with more diligence. In-house procedures could also be considered in order for research ethics to be properly assessed during the early phases of submission. The journal should consider drawing up a standard form if they do not have one already which asks authors to check that their research had ethical approval. Most institutional review board approval would guarantee that informed consent is part of the ethics approval criteria.