Was institutional review board approval required?

COPE Ethics Case

In this regular feature, we highlight an ethics dilemma from the searchable cases database operated by COPE, the Committee on Publication Ethics. In 2008, all Elsevier journals were enrolled in COPE so editors would have an alternative information resource when faced with research misconduct. The cases database contains details of, and advice given on, more than 500 cases and is just one of the many services COPE offers.

In this issue, we highlight a case in which a journal seeks clarification on whether institutional review board approval should have been sought for the research featured in a recent submission.

Simply click on the link at the end of the article to find out what the COPE Forum advised.

Case number 14-09 (anonymized)

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: Is this research publishable in the absence of IRB approval?

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