We have a query regarding institutional review board (IRB) approval for a paper in production.
The paper reports on a 2 year follow-up and cost-effectiveness evaluation for a treatment programme. A previously published paper reports on the original evaluation of the treatment programme. The authors have not obtained IRB approval for either body of research.
The initial research was described as a report of outcomes from 5 years of clinical experience with the programme, rather than as a clinical trial, and as such IRB approval was not sought. For the paper currently under consideration, the authors’ original statement in the paper was that “Institutional review board approval was not required as patients were treated with approved diagnostic and therapeutic procedures according to generally accepted standards of care”. We were unable to verify this as a valid reason for exemption from the requirement for IRB approval.
Having found no clear grounds for the exemption on the basis offered, we asked the author to provide a reference or further information regarding this basis for exemption. The author responded that the research was exempt under the following US federal regulation: “Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects”.
Our concerns with this justification are that the data are not publicly available, and that the data include follow-up telephone interviews, which seem in conflict with the requirement that the data should be de-identified, and that indeed the follow-up interview information are new data, not existing data or records.
Question(s) for the COPE Forum
- Is this research publishable in the absence of IRB approval?
The majority of the Forum noted that they would err on the side of caution—if the editor is unable to verify that the study received IRB approval, then they suggest that he should not publish. The Forum advised contacting the authors and informing them of the journal’s decision. The Forum noted that this is a good opportunity to look at the journal’s instructions to authors. The instructions to authors should be very clear about the journal’s policy on IRB approval, and what type of ethical review is required by the journal.
If however, the editor did decide to publish, the Forum would advise publishing an explicit statement within the paper, outlining the ethics approval process and detailing the facts of the case and what the actions of the editor were.
The authors elected to ask a private institutional review board (IRB) to review the study, and the private IRB verified that the study was exempt (retrospective, de-identified data). We obtained a copy of the IRB’s decision and published the paper with an explanation of the exemption.