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Release of Information to the Public 

Ethical and Legal Considerations

Annette Flanagin

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PRINTED FROM AMA MANUAL OF STYLE ONLINE ( © American Medical Association, 2009. All Rights Reserved. Under the terms of the license agreement, an individual user may print out a PDF of a single chapter of a title in AMA Manual of Style Online for personal use (for details see Privacy Policy).  Subscriber: null; date: 09 February 2016

Release of Information to the Public

In many ways, biomedical journals and their editors act as gatekeepers for the release of scientific information to their readers as well as to the public. However, conflicts often arise between journal editors (who have an ethical duty to ensure that the information they publish has been appropriately peer reviewed and assessed for quality) and scientists (who want to disseminate their findings as widely and quickly as possible) and between editors and news reporters (who want to deliver information about new scientific developments to their readers as quickly as possible).19 The announcement of “scientific breakthroughs” at press conferences or through press releases before the data that support the supposed advance have been evaluated and published in a peer-reviewed journal may cause confusion for the public (who may be given misleading or inaccurate information), news media (who may give undue attention to an inaccurate or incomplete claim), journal editors (who may have a policy that discourages publication of data that have already been reported in the press), and investigators (who may forfeit their chance for publication in a reputable peer-reviewed journal by choosing to publish by press conference or through press releases).21-23

Journal editors have developed 2 policies to discourage premature release of information to the public. The first policy, based on the “Ingelfinger rule” (developed in 1969 by Franz Ingelfinger, MD, then editor of the New England Journal of Medicine), is an understanding between authors and editors that a manuscript will be considered for publication on the condition that it has not been submitted or reported elsewhere24 (see also 5.3, Duplicate Publication). The second policy is a news embargo, which is an agreement between journalists and editors that prohibits news coverage of a journal article until it is published (see 5.13.3, Embargo). Although some authors and journalists misunderstand or disagree with the intent of the Ingelfinger rule and the news embargo,25,26 many journals have found that both, if applied consistently and fairly, effectively serve all communities interested in disseminating quality scientific information to the public (with exceptions made in cases of urgent public need for information or to coincide with presentations at scientific meetings).

The International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME) recommend that journals develop and follow policies for orderly, controlled, and consistent release of information to the public, including the use of embargoes.20,27 There are 4 general exceptions to a journal policy that precludes prepublication release of information to the public: presentation of information during scientific or clinical meetings, release of information that is determined to be of urgent public need, testimony before government agencies, and, in rare instances, release of information that is in the public domain.22

Presentation of Information During Scientific or Clinical Meetings.

Presentation of findings during scientific or clinical meetings (via oral presentation or poster presentation) does not preclude consideration of a manuscript reporting the complete findings for publication.20,22,27 Authors may include abstracts of their findings in print and/or online proceedings published for these meetings. However, authors should refrain from disseminating or publishing details in proceedings that are not included in the meeting abstract or presentation. Authors should not include a complete report of their findings (ie, a mansucript that they plan to submit to a journal) or distribute copies of their detailed findings or tables and figures to meeting attendees or journalists. Authors are encouraged to participate in discussion and the usual exchange with meeting attendees during their presentation. Audiocasts and videocasts of meeting presentations also do not preclude consideration of the full manuscript for publication provided these are intended for meeting participants.

Authors may also answer questions from journalists about their meeting presentations, but they should limit their discussion to explaining and clarifying the findings presented during the meeting and should not discuss any related manuscripts under consideration by a journal or accepted but not yet published. In the event that an author is presenting findings at a meeting that are also included in a manuscript that is under consideration or has been accepted by a journal but not yet published, the author should limit her or his remarks to the findings as presented at the meeting. In this case, the author should inform the editor of plans to present the work at a meeting before the meeting occurs and should discuss options with the editor (see also 5.13.3, Embargo, and 5.13.4, Suggestions for Authors Interacting With the News Media). News media coverage (based on these interactions) about manuscripts that are accepted but not yet published or that are under consideration by a journal occurring before the journal embargo is lifted and without prior approval of the editor may be grounds for rejection of the manuscript by some journals.

Authors of papers under consideration by a journal or accepted but not yet published, as well as authors' institutions and funders, should not participate in press conferences before publication of the peer-reviewed article. Thus, authors should not participate in press conferences at meetings separate from their scientific presentation unless they have prior approval from the journal to which the full paper has been submitted.

On occasion, the journal and the author may plan to publish the complete manuscript online before the article appears in print (after peer review and revision) on the same date of the presentation of the findings during a scientific meeting (eg, with a late-breaking trial that is likely to have a practice-changing effect). In these cases, news releases prepared by an author’s institution or funder that summarize information to be published in a journal should be coordinated with the journal (see also 5.13.5, News Releases). Proper planning is needed among all parties (journal, author, and meeting organizer) to ensure that findings are released in an orderly manner that does not confuse journalists or the public.

Release of Information Determined to Be of Urgent Public Need.

Contrary to what many authors and news reporters believe, few findings from scientific and medical research have such significant and urgently important implications for the public that the information should be released to the public before it has been peer reviewed, revised, and published in a journal (online or in print). Calling such circumstances “exceptional,” the ICMJE recommends that public health authorities should make such decisions and should be responsible for disseminating such information to health professionals and the news media.20 However, an editor may recognize the public health urgency of releasing information contained in a manuscript under consideration without prompting from the authors or relevant authorities. In such a case, the editor should ask the author to notify the appropriate authority to consider advance dissemination of the information, and this dissemination should be coordinated between the responsible authority or agency and the journal. In situations in which there is an immediate public health need for the information, there should be no delay in its release even if this release antedates publication in the print journal.28 Journals should expedite the editorial and peer review process and speed the publication process to permit online publication as quickly as possible. If such online publication occurs before print publication of the article, care should be taken that this is conducted in an orderly and consistent manner so as not to confuse journalists and the public.

Testimony Before Government Agencies.

An author’s testimony before a governmental agency or institution (eg, the US Congress or Food and Drug Administration) that includes information not yet published should not preclude consideration of that information in a manuscript under consideration or subsequently submitted for publication.22 Authors and editors should discuss whether consideration and publication of a manuscript with information relevant to such testimony can be expedited to coincide with or be published before the testimony on a case-by-case basis.

Information in the Public Domain.

Reports of important information from national government or international agencies published in print and widely disseminated or published online (eg, an urgent health alert or Web posting from the US National Institutes of Health or the World Health Organization) should be considered selectively for publication in a peer-reviewed journal on a case-by-case basis.22 In such a case, the editor needs to determine if the information would be useful to the journal’s readers, there is demonstrated need for an additional report (eg, additional important details or follow-up information is available), and if the initial alert did not already include the complete report.

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