We received an article about ambulatory treatment of deep venous thrombosis. The authors present 121 cases in a prospective manner. Two referees requested ethical committee consent for this trial, but the authors could not present this. The authors insist that low molecular weight heparin is an already proven regimen in the treatment of DVT, and since this is an observational prospective study, ethical committee consent would not be required. They insist that they have heard of several examples of this policy in several journals. What would be your comment?
 

Korhan Taviloglu
Co-editor, Turkish Journal of Trauma & Emergency Surgery Professor of Surgery
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The authors may be right that ethical review may not be required. At the Malawi Medical Journal, an audit generally does not require ethical approval, but there are standing guidelines with our ethical committee on this. If the editor is concerned about ethics, one way is to ask authors that they get approval of manuscript from their IRB. If the IRB has no problem, I would also not have problems. That a procedure is already acceptable in itself does not constitute automatic waiver of IRB review. If I wanted to compare aspirin and acetaminophen in the control of arthritic pain, and there is randomisation or other patient selection processes, I will need IRB review. But if we provide these as part of routine care and then want to assess the differences between the two, IRB approval may not be so required. 

Adamson Muula
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IRB practices are not uniform, so I can't speak in general, but I know that at many universities, the practice is to let the IRB know of anything you do that might be called research. Were this the practice at the authors' university, they would have requested exempt status, and this may well have been granted. On the other hand, the local practice may be different, and the authors may be given the leeway to make the decision themselves. If that is the case, they acted correctly, though you may believe, from your experience, that they made the wrong choice, and you can request IRB clearance (or accept their decision, if you agree). I can tell you that in the USA this would almost certainly have required IRB review because of the so-called HIPAA regulations that are meant to protect a person's private medical information. The issue here would be over use of medical records and protected information, not over direct harm to subjects that might result from the study itself. In any event, I suspect that most journals require some note about interaction with an IRB.

Rich Rothenberg
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I concur with the above comment. In the United States, in order to comply with privacy regulations, IRBs must give approval (usually by expedited review or exemption) for such studies. We require that authors from other countries verify in writing that IRB is not required by the regulations that apply in the countries of origin.

Michael D. Lockshin
Editor-in-Chief, Arthritis & Rheumatism
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I serve on our IRB's Exempt and Expedited Review Committee, which oversees retrospective research (from chart review or clinical databases). The national regulation in the US as promulgated by the Office for Human Research Protections (OHRP) states that any patient data, individual or summarized, that are used in a publication or scientific presentation outside of the institution from which the data come must have approval by an OHRP-certified IRB before the work is done. The only situation in which such data may be used without IRB approval is if it is being used in internal quality improvement or educational activities. The fact that something is "not new" is irrelevant. The data in the venous thrombosis paper described above were obtained in violation of U.S. regulations.

Perhaps the above statements are not the case in the country in which this study originated. We would not publish this work in our journal because, as a US journal, we must follow US rules for the ethical conduct of research. If these investigators were from the US, non–US journals should insist that all research performed by US investigators follow OHRP regulations.

Bill Tierney
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The choice is simple.

For manuscripts reporting research using humans (or animals for that matter), either hold all authors submitting to your journal

A) to the same standard—[ideally, approval by an independent committee with online posting of the approved protocol (See Dellavalle RP, Lundahl K, Freeman SR, Schilling LM. Journals should set a new standard in transparency. Nature. 2007 Jan 25;445(7126):364)]

or

B) hold the authors to whatever standard the laws of their country allows—good luck keeping that straight.

I advocate the former.

Bob Dellavalle
Dermatology Section Editor, UpToDate