Journal editors propose detailed disclosure form for authors

It asks about research pay and industry relationships. Some doctors say it goes too far.

By Kevin B. O’Reilly — Posted Nov. 9, 2009

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An influential group of medical journal editors in October announced a new, more probing conflict-of-interest disclosure form that it hopes will become the industry standard. The effort comes in response to criticism that medical journals have failed to properly inform their readers about authors' financial relationships with industry.

The uniform disclosure form, adopted by the International Committee of Medical Journal Editors, asks authors submitting for publication to disclose any payment for the research that generated the article as well as other kinds of industry relationships such as consultancies, honoraria or stock options from the last three years.

The form also asks authors to disclose whether spouses or children have financial relationships with "entities that have an interest in the content of the submitted work." Writers also should provide "any relevant nonfinancial associations or interests" of a personal, political or religious nature "that a reasonable reader would want to know about."

The ICMJE is composed of 12 of the leading journals from around the world, including the New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine and Lancet. Hundreds of journals already follow the committee's uniform requirements for manuscripts submitted to biomedical journals, which lay out conventions on authorship credits, peer review and how to report research results.

Authors who fail to disclose industry relationships often say they misunderstood what they were required to reveal. The new form aims to simplify the process, said JAMA Editor-in-Chief Catherine D. DeAngelis, MD, MPH.

"Authors submit to over 1,500 biomedical journals and everyone has their own author form with different requirements, and it's extremely confusing for authors," Dr. DeAngelis said. "It becomes an incredible problem for editors because every time we have to go back to an author because somebody says they didn't disclose this thing, which they disclosed in a previous publication, they say, 'Well, I didn't know.' A lot of it is legitimate confusion."

The idea, Dr. DeAngelis said, is that authors can update this one form -- available as a four-page, editable pdf -- and send it whenever they submit an article for publication.

By simplifying the disclosure requirements, the new form should take away "the proverbial dog-ate-my-homework excuse," said Merrill Goozner. In 2004, he authored a report for the Center for Science in the Public Interest, an advocacy group, that found 14% of scientific journal articles included unreported financial conflicts. He helped convene a different group of journal editors to come up with a uniform disclosure form. The results of their work are slated for publication in a forthcoming issue of Addiction, the journal of the Society for the Study of Addiction.

Proper punishment?

Goozner lauded the ICMJE form, but said it should be accompanied by harsher penalties for authors who fail to disclose.

"There have been a number of cases over the last couple of years where there were failures to disclose relevant conflicts of interest," said Goozner, who edits Health Tech Review, a weekly paid-subscription newsletter. "The author says, 'Oh, yeah,' and then writes a letter to the editor that gets published -- and that's it. So, the punishment for failing to disclose is having to disclose. That's like saying the penalty for robbing a bank is giving the money back. If that's the case, what's your disincentive from trying to rob the bank?"

ICMJE members said editors can and do take other actions, such as notifying the author's institution and funding source. Some journals also may refuse to consider future work submitted from the nondisclosing author. Dr. DeAngelis said it is up to individual journal editors to decide how to handle failure to disclose.

"We have no right to tell every editor what they should do," she said. She added that "it's embarrassing for any author" to have a follow-up letter published in the journal revealing a financial conflict.

The ICMJE form is undergoing beta-testing and will be finalized at the committee's April 2010 meeting. One element that drew criticism was the requirement that authors disclose nonfinancial conflicts. The premise is that, for example, if an author who writes about the clinical consequences of abortion is ardently anti-abortion, readers deserve to know that.

"Asking people to declare nonfinancial conflicts of interest is likely not to be fruitful," said Jerome P. Kassirer, MD, former editor of NEJM. "You're not going to get useful information, and to me that's the most important thing. It dilutes the importance of these financial conflicts, and I think that's a problem too."

Others objected to the basic premise of the form. J. Michael Gonzalez-Campoy, MD, PhD, is medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology, a private practice near Saint Paul.

Dr. Gonzalez-Campoy said he believes "in disclosure of working relationships that may have bearing on a publication or presentation," but that framing such collaboration as a "conflict of interest" is "guilt by association."

He said the ICMJE form goes too far.

"It is an unwarranted extreme to require spouse, partner or children information," said Dr. Gonzalez-Campoy, a member of the Assn. of Clinical Researchers and Educators, which supports physician-industry collaboration. "It's unbelievable that the religious or political beliefs of an author are a part of this form. What about one's favorite color, or sports team of choice?"

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Revealing financial relationships

The new disclosure form adopted by editors of some of the world's most influential medical journals seeks to make it easier for authors to declare potential conflicts of interest. Among other things, the form asks authors to disclose whether, in the previous three years, they or their institutions had financial relationships "with any entities that have an interest related to the submitted work." The kinds of relationships covered include:

  • Board membership
  • Consultancy
  • Employment
  • Expert testimony
  • Gifts
  • Grants/grants pending
  • Honoraria
  • Payment for manuscript preparation
  • Patents (planned, pending, or issued)
  • Royalties
  • Payment for development of education presentations, including service on speakers' bureaus
  • Stock/stock options
  • Travel/accommodations expenses covered or reimbursed

Source: International Committee of Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest (link)

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External links

International Committee of Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest (link)

"Uniform Format for Disclosure of Competing Interests in ICMJE Journals," Journal of the American Medical Association, Oct. 13 (link)

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