Ethics Review Committee/IRB Approval and Journal Policy

The European journal Haematologica has retracted an article http://www.haematologica.org/cgi/content/full/93/7/1103 after the authors revealed that they had not obtained IRB approval. The lead author on the study, Tojo, "admitted that the research was not reviewed by the ethics panel and that only some of the patients had given their written consent." Details are provided in a news article: http://www.asahi.com/english/Herald-asahi/TKY200807120095.html .

This prompts a question to WAME members: Do any journals require that authors provide documentation of informed consent and IRB approval for research, above and beyond requiring that authors attest that they have obtained IRB approval (or met Helsinki requirements) and informed consent?

Margaret A. Winker
President, WAME
Deputy Editor, JAMA
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Whenever we feel there is any question about ethics or IRB review, we ask for direct documentation (and this happens several times a year). However, we do not request it routinely.

Michael Callaham
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Don't you all think that we are all becoming like the FBI?

Martin B Van Der Weyden
Editor, Med J Aust
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With authors regularly carrying out misconduct, how should journal editors act?

Like others who have replied, we generally do not require proof of ethics approval, but we do insist on it when we are worried about an aspect of the consent or approval. We do require documentation of ethics and funding approval for study protocols.

I wonder if the time has come for authors to be required to submit ethics forms attesting to IRB approval and correct consent procedures, just as we already require trial registration for prospective controlled trials, written consent to publish from patients for case reports, author contributions sections, and competing interests declarations. With these in place, and a good plagiarism checker like CrossCheck, medical journals will be somewhat armoured against misconduct.

Matt Hodgkinson
Publishing Editor, BMC-series Journals
BioMed Central
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Thank you for your message. The WAME discussion is quite timely, as we are doing some research here at Obstetrics & Gynecology into institutional review board policies.

To answer your query, at Obstetrics & Gynecology, we do not require that authors provide documentation of informed consent and IRB approval. However, we do require that they submit documentation from the IRB Chair if the study was considered exempt. Our standard paragraph (sent to authors when a revision is requested), is below:

"Obstetrics & Gynecology requires that all original research studies be reviewed by an IRB. Please insert a sentence in the Materials and Methods section stating that approval was obtained, and include the name of the IRB. If this study was not approved by an IRB, please submit a letter from the IRB Chair stating that the study was considered exempt."

Rebecca S Benner
Managing Editor, Obstetrics & Gynecology

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Good question, Martin, on whether we're all becoming like the FBI.

Transparency is a good thing, of course. But do editors have time to read through the ethics approval documentation as well as the paper, plus all the other things we and many other journals already ask for eg, the completed reporting checklist (eg, CONSORT, QUOROM, STROBE), the study protocol, the responses to previous peer reviewers' comments at the journal that just rejected the paper, the other/overlapping papers arising from the study, the details of the interventions and tools used in the study, and so on? If we're not planning to read all these things, is it right and fair to expect them from authors?

Meanwhile, here's the BMJ's approach on ethics approval. We trust authors to report ethics approval honestly and only ask to see documentation when we're concerned. Our policy—pasted below—is mostly about encouraging authors and reviewers to discuss the actual ethics. And we make the point that, just because a study's protocol has been approved by a committee, the study may not have been ethically conducted.

Trish Groves

Deputy editor, BMJ

http://resources.bmj.com/bmj/authors/editorial-policies/guidelines

Ethics approval for papers submitted to the BMJ The editors aim to ensure that all articles published in the BMJ report on work that is morally acceptable. To achieve this, we aim to appraise the ethical aspects of any submitted work that involves human participants, whatever descriptive label is given to that work including research, audit, and sometimes debate. This policy also applies on the very rare occasions that we publish work done with animal participants.

Many people consider that studies referred to as audit do not need any consideration of ethics, whereas all research must be approved by a formally constituted research ethics committee or, in the USA, an institutional review board. But the distinction between audit and research is unclear, and the assumption that audit or analysing previously collected data is never unethical may not be justified. Furthermore, review by an ethics committee cannot necessarily guarantee that work is morally sound.

For these reasons journals have a duty to consider the ethical aspects of both submitted and published work. The BMJ’s policy on these issues has been developed with the help and advice of the BMJ ethics committee and its key elements are explained here.

Editorial appraisal of a study’s ethics is not always easy because the standard format for presenting original papers does not give room to report the ethical aspects of research. We welcome, therefore, detailed explanations of how investigators and authors have considered and justified the ethical and moral basis of their work. If such detail does not easily fit into the manuscript please provide it in the covering letter or upload it as a supplemental file when submitting the article. We will also be pleased to see copies of explanatory information given to participants.

Even if we do not include such detailed information in a final published version, we may make it available to peer reviewers and editorial committees. We already ask peer reviewers to consider and comment on the ethics of submitted work.

Editorial appraisal of ethical issues goes beyond simply deciding whether participants in a study gave informed consent although this is, of course, one very important issue to consider. Editors should judge whether the overall design and conduct of each piece of work is morally justifiable, as summed up by the following questions:

How much does this deviate from current normal (accepted, local) clinical practice?

What is the (additional) burden imposed on the patients (or others)?

What (additional) risks are posed to the patients (or others)?

What benefit might accrue to the patients (or others)?

What are the potential benefits to society (future patients)?

Even when a study has been approved by a research ethics committee or institutional review board, editors may be worried about the ethics of the work. Editors may then ask authors for more detailed information and ask them how they justified the ethical and moral basis of the work. Editors may also ask authors to provide the contact details of the research ethics committee that reviewed the work, so that the journal can request further information and justification from that committee. For studies that have not been reviewed by research ethics committees or institutional review boards editors may ask authors to explain what ethical issues they considered and how they justified their work.

Editors may ask other editorial colleagues to evaluate the ethical aspects of an article, the authors’ comments, and the response of the relevant research ethics committee to the BMJ’s queries about ethics approval. This consultation may be informal, between the BMJ’s editors, or more formal, through seeking the advice of the BMJ’s ethics committee or the Committee on Publication Ethics (COPE). Problems referred to COPE or the BMJ ethics committee will be considered as anonymised summaries of the relevant articles, written by the editors concerned.

What happens when the BMJ considers a study to be unethical? We believe that editors have a duty to take on issues of unethical audit or research, not to seek punishment for the authors, but to prevent unethical practice and to protect patients. If the BMJ, with or without the advice of its ethics committee and/or COPE, considers the work in a submitted article to be ethically unsound the editor may seek further advice or recommend investigation or action. The fact that the article would have been rejected anyway for other scientific or editorial reasons would not prevent the editor from taking such further action on serious ethics problems.

In the first instance the editor would usually contact the head of the department where the work was done to explain the BMJ’s concerns and recommend a local investigation. Secondly, the editor might write to the professional registration body of the paper’s guarantor or principal investigator. For a doctor in the UK, this body would be the General Medical Council.

In rare instances the BMJ might publish an article despite ethics problems in the work it reported. The usual reason would be that work done in one setting might not reach the ethical standard of work done in another setting, because of differing local resources and standards for health care and research. In deciding to publish such an article, we would consider carefully the context of the study and aim to balance the overall benefit to society against the possible harm to the research participants.
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"If we're not planning to read all these things, is it right and fair to expect them from authors?".

Yes! Emphatically, yes!

If we or the reviewers require these details they should be to hand. Authors of a well-conducted, recorded, ethical, and unmanipulated study should be able to sail over all these hurdles. Trust works when you're working with trustworthy people, but we simply don't know which of our authors are saints and which are villains.

In the field of microarrays, there were probably similar grumbles about publicly depositing data and reporting it according to the MIAME standards, but you're a pariah in that field if you don't now meet those standards. No amount of moaning that people don't trust you will change that.

Trish is correct, of course, that form filling and box-ticking by committees is no guarantee of ethical conduct or soundness of the work—it is simply a bare minimum. Some poor sod is always going to have to read and understand the manuscript...

Matt Hodgkinson
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These statments won't stop authors acting unprofessionally completely (unless carefully written legally). We had a case of an author stating that the article has not been and isn't about to be published elsewhere, and then, 2 months after commissioning and writing it just before we published it, she received money for publishing the identical (word for word!) article in another journal for the same audience. We have no comeback (being honorary and not dealing with original research). Copyright belongs to the authors but this was pretty low.

Vivienne Miller
Diabetes Management Journal, Cardiology in GP, Paediatrics and Child health in GP
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We recently published the following results on your question.

Freeman SR, Lundahl K, Schilling LM, Jensen JD, Dellavalle RP. Human research review committee requirements in medical journals. Clin Invest Med. 2008;31(1):E49-54. http://cimonline.ca/index.php/cim/article/view/3141/1270

PURPOSE: Independent ethical review committees safeguard participants in human research. The purpose of this study was to describe the current ethical guidelines for human research requirements in the Instructions to Authors of the English language medical journals previously studied in 1995.

METHODS: The instructions to authors of English language medicine journals from the Abridged Index Medicus were searched for any policies regarding guidance on the ethical treatment of human subjects in research.

RESULTS: More medical journals require independent ethics committee approval of human research now [84/101 (83%)] than 10 years ago [48/102 (47%) (P < 0.001)], and most journals continue to require
that this disclosure appear in the manuscript [71/84 (85%) vs. then 37/48 (77%) (P=0.29)]. Fewer medical journal instructions to authors provide no ethical guidelines for human research now [8/101 (8%)] than 10 years ago [25/102 (24%) (P< 0.001)]. No journal required submission of the study approval letter or of the approved protocol.

CONCLUSIONS: Although medicine journals increasingly require disclosure statements of independent ethics committee approval for human research, they fail to verify such approval beyond taking authors for their word.

Robert Dellavalle
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There is a lot of variability in the functioning and constitution of ethical review boards that needs to be recognized in this discussion.

I'm a psychologist and all of my research involving human research participants for the past 25 years has followed ethical guidelines and been reviewed  by an external committee. All of them have followed guidelines for research with minors (my primary population) set out by the Society for Research in Child Development, which are more stringent than those bodies. But all the external committees aren't US registered IRBs governed by standard guidelines. I have worked for four smaller colleges (including my present institution). Of those, one had no ethical review committee, and two required departmental review within the psychology department. Of the latter, I was eventually charged with establishing institution-wide policies for review of all research involving human participants and creating a (US) federally registered IRB. Prior to that time, my federally funded research had to be reviewed by a freestanding IRB that we paid to provide oversight (and which provided completely inappropriate oversight, because it was geared to medical research and not to the survey and observational work I was doing). This was less than five years ago (and not at my current institution).

While I was establishing our IRB, I did a lot of research into current practices by other highly regarded and research oriented liberal arts colleges. I found that very few of them—including those that had federally registered IRBs—were conforming to standard practices as one might see them at a research institution. I would also note that—going from research institution to research institution—there is a huge amount of variability in how committees enforce ethical guidelines.

Many disciplines, notably anthropology, also have strong philosophical questions about how IRBs should function within their disciplines.

I also do research in four countries outside the US, all of which have very different models of appropriate 'consent' and ethical practices (we always have it reviewed in both the US and locally, and follow the strictest of policies).

All of which is to say that I think the notion of asking for documentation of 'IRB approval' is somewhat misguided. I think affirmation of a given set of ethical standards and—when questions arise—examination of protocols to assure that those standards were met is much more important and more practical.

Nancy Darling
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I agree that the central issue is whether journals, prior to evaluating a manuscript of a study involving human subjects, should ask authors for documentation that a committee (or any independent reviewer) has evaluated the study protocol for ethical concerns and approved it. Our study (Freeman SR, et al. Clin Invest Med. 2008;31(1):E49-54) showed that most do not.

The independent protocol reviewer(s) need not be a US Institutional Review Board (IRB).

And wouldn't it be nice if all human subject experimental protocols were available in a database like Genbank? Then, anyone could perform a post publication review to see if what authors report in their publication was what they were approved to do. (See Dellavalle RP, et al. Journals should set a new standard in transparency. Nature. 2007;445(7126):364.)

Robert Dellavalle