Q: Can the study sponsor submit the manuscript to a journal?

Detailed Question -

Our research team has several researchers conducting the study and a medical writer who is actually writing the paper with inputs from and regular checks by the researchers. Can the study sponsor (who has also provided funding for the medical writer) submit the paper to a journal?

1 Answer to this question
Answer:

Many sponsored research studies, especially in the field of medicine, hire the services of a professional medical writer. This is considered legitimate as long as the writing assistance is declared and the contribution of the medical writer is mentioned in the acknowledgments section. However, in most cases, the medical writer is not considered as an author, as he does not make intellectual contributions to the study. The researchers who conduct the study are the authors. The leader of the research team or the person who has made the maximum contribution to the study is usually the lead author or corresponding author.

The lead author or the corresponding author has to submit the manuscript to a journal. Submissions cannot be done by the sponsor, unless the sponsor is also one of the co-authors. In your case, it seems that the sponsor has not made any contribution to the research apart from funding. Hence, I don't think he will be able to submit the paper.

According to the Council of Science Editors' white paper on publication ethics, a sponsor or sponsoring organization is involved only in the following aspects of publication:

  • Publication planning
  • Authorship
  • Process control (content and journal selection)
  • Disclosure of conflicts of interest
  • Access to and provision of data
  • Copyright
  • Clinical trial registration and dissemination of findings

As there is no mention of a sponsor being involved in the submission process, it is clear only an author is allowed to submit a paper.

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