Scientific Publications: Engaging and Managing Authors

This is the second posting in a three-part series drawn from ICON’s webinar, “Evolving Best Practices for Working with Authors—Authorship and Beyond.”  

“Give credit where credit is due” is good—but insufficient—advice when it comes to attributing authorship of scientific and medical publications. How involved does someone need to be to be listed as an author? What do you do when a participant leaves the company before the work is published? Should professional medical writers be listed as authors? These and other equally tricky questions have been considered by the International Committee of Medical Journal Editors (ICMJE) and by specialists at ICON who support such publication efforts.

Who should qualify as an author?

Generally, there is no shortage of people who wish to author a publication—at least in terms of being cited as an author. In fact, in an informal poll of participants on an ICON webinar, “limiting number of authors” was an oft-mentioned challenge. The guidelines around granting authorship have been formalized by the ICMJE, and are helpful to companies as they sort out what’s appropriate and acceptable in the scientific community.

According to the ICMJE, to qualify for authorship, a person must meet all of the following criteria:

  • Contribute substantially to the conception or design of the work or to the acquisition, analysis or interpretation of data for the work;
  • Draft the work or revise it critically for important intellectual content;
  • Provide final approval of the work prior to publication; and
  • Be accountable for all aspects of the work and its accuracy and integrity.

Some journals or congresses have limits on the number of authors allowed. When that is not the case, the Publication Steering Committee can set an upper limit on the number of authors by publication type. The limit can be tied to the number that can work effectively in a group, the value of certain key opinion leaders (KOLs), and the company personal who supported the trial and the meet authorship criteria.

When nominating authors, a company must, according to ICMJE standards:

  • Invite authors to participate and define the standards for good publication practice
  • Secure written permission from anyone who will be listed as a Clinical Investigator or Scientific Advisor in the work via an author agreement form
  • Provide access to the Clinical Study Report (CSR) and to additional data upon request.

How should we attribute the work of people who don’t meet all four of the authorship criteria?

Contributors whose work does not justify authorship can be acknowledged under a heading such as “Participating Investigators” along with a line about their contribution, such as “Provided care for study patients” or “Participated in the technical editing of the manuscript.”

How should we handle participants who’ve left the company?

As preparing manuscripts for publication or presentation at a congress is usually a lengthy undertaking, it can happen that an internal investigator or author leaves the company prior to submission. The guidelines surrounding authorship in this situation depend upon the particulars.

Former employees should be retained as authors if: 

  • They continue to meet all four of the criteria for authors mentioned above, through to submission
  • They are not now working for a direct competitor to the product (in which case they would have signed a non-compete agreement and not be able to continue to fulfil their author duties)

Former employees whose participation falls short of the authorship criteria should be named as a contributor and their affiliation should be described as “former employee.”

In any event, prior to the employee’s departure, the employee should document his/her involvement and role in the trial and, if appropriate, participation in the publication. If this documentation is not gathered, the lead author or a principal investigator should provide verification as to the former employee’s participation.

How should we compensate authors?

In a word, you shouldn’t. Authors must not be compensated for drafting the publication to avoid even the appearance of bias. In fact, authors are required to sign a disclosure statement attesting to the fact that they did not receive any compensation related to the development of the manuscript, abstract, or poster.

It is permissible, however, to hire editorial support (such as from an agency or a professional medical writer) in preparing the publication. When this is the case:

  • The support must be openly acknowledged and disclosed in the Acknowledgements section
  • The individual or agency providing the support may not be listed as an author
  • All related documentation should be archived in an electronic publication management tool.

Companies do regularly reimburse authors for any travel expenses incurred while attending medical congresses, and many companies consider this a transfer of value that should be made public according to national or international disclosure regulations (for instance according to the US Sunshine Act). Companies are advised to set specific limits on travel, lodging, and meal costs and to communicate their policy to authors in advance. Some companies even insist that authors book their travel through the company’s travel agency to ensure conformance to policy.

For more information on how to manage the manuscript development process, please visit

For details on ICON’s suite of PubsHub tools to streamline and automate your medical communications visit 


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