The Major Journals (JAMA, NEJM, Lancet and BMJ have adopted a “Uniform Format for Disclosure of Competing Interests in ICMJE Journals.”
NEJM also published simultaneously in all International Committee of Medical Journal Editors (ICMJE) journals a new disclosure form that has been adopted by all journals that are members of the ICMJE.
The form now posted on the ICMJE Web site (www.icmje.org/coi_disclosure.pdf) includes instructions to help authors provide the information, and a sample completed form is also available (www.icmje.org/sample_disclosure.pdf). Authors can download the form from the Internet, add the requested information, and save the completed form on their computer. The completed form can then be uploaded to the Web site of the journal that has requested the information.
NEJM hopes that this new form will eliminate the need to reformat disclosure information for specific journals.
One of the major reasons NEJM created such a form is that “at present, many journals ask authors to report relationships with industry by completing a form with information about their financial associations.” After these reports are compiled, each journal then chooses to publish such information either “online or create a summary of the information and publish it with the article in question.”
Since each individual journal practices a different way of publishing such disclosure, at present, there “is currently no uniform vehicle for the disclosure of financial associations.” This causes problems because authors may provide similar information to different journals in multiple formats. The different formats are problematic because the disclosed information can become confusing “as the same individual may report different information to different journals.”
The new form created by NEJM asks authors to disclose four types of information:
1) Their associations with commercial entities that provided support for the work reported in the submitted manuscript (the time frame for disclosure in this section of the form is the life span of the work being reported);
2) Their associations with commercial entities that could be viewed as having an interest in the general area of the submitted manuscript (the time frame for disclosure in this section is the 36 months before submission of the manuscript);
3) Any similar financial associations involving their spouse or their children under 18 years of age; and
4) Nonfinancial associations that may be relevant to the submitted manuscript.
NEJM also clarifies that journals may differ in when they ask for all these (e.g. at the time of initial manuscript submission or at the time of submission), and note that these decisions will be left to the discretion of the journal.
White Noise
One of the questions in the disclosure form has to do with the relationships with industry of your spouse or minor children (not sure under 18) at this point in time what in the world they could be doing with a pharmaceutical or device company.
Another question asked is do you have any relevant nonfinancial associations or interests (personal, professional, political, institutional, religious, or other).
What in the world are these guys thinking. This is an interesting question that brings up the point that there are many interests a person deals with, but does this mean that from now on that editors will have to expose their bias?
The NEJM also recognizes that this new process may take some adjusting for both authors and journals, and that “there may be situations that are not covered by the form, aspects of the instructions that are unclear, or bugs in the programming that they have not yet discovered.” As a result, the new form will be part of a beta testing period from the date of its release (October 13, 2009) until April 10, 2010.
At the end of this period, ICMJE will meet in late April of 2010 and will adapt the form to address concerns identified by users.
Comments during this period about problems that may arise with the form can be sent through the home page of the ICMJE Web site (www.icmje.org).
The attempt of NEJM to create a uniform disclosure form is extremely desirable for patients, providers and industry. Eventually, this uniform approach at transparency will help make disclosure of financial associations of authors of articles published in biomedical journals extremely reliable. Consequently, once the public and providers are able to consistently check the regularity of such information, readers will better understand the relationships between the authors and various commercial entities.
It may be a good idea for the Alliance for Continuing Medical Education to adopt a similar form for their members. But I would perhaps leave out the questions on all the white noise (spouse and minor children, political affiliations…..)