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An industrial chemist conceptualized, first synthesized, characterized and patented a novel drug. They then transferred the synthetic technology (at the 3kg scale) to a CRO for preparation under cGMP conditions, substantially helped in drafting the "clinical trial investigator brochure", and provided advise throughout the trial. Should they be granted coauthorship of the paper reporting the trial?

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To me, the key point in this is the fact that the person participated in formulating the experimental protocol for the trial (assuming that's what "Clinical trial investigator brochure" means). Everything before this has presumably already been reported in other papers, which means citations, not authorship (if it somehow hasn't, then authorship is warranted). Significant participation in the design of an experiment, however, is generally sufficient to warrant authorship, and I see no reason it would be otherwise in the case as presented.

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The ICMJE guidelines says that authors must meet four requirements:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND

Drafting the work or revising it critically for important intellectual content; AND

Final approval of the version to be published; AND

Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Without knowing your field, it sounds like you think you satisfy the first requirement. It doesn't sound like you meet the final three. While I disagree with the guidelines and think hat everyone who meets the first requirement should be given the option to meet the other three, the guidelines do not require that.

This sounds like a situation where you should talk to the lead investigator. Ideally the conversation should have happened early on, but now is better than never.

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    I disagree with this assessment: my understanding is that these guidelines are primarily intended to prevent inappropriate "gift authorship" (e.g., to senior PIs for political purposes or to help get a paper accepted). If you've done #1, then there is no reason the other authors can't easily include you in the rest unless you opt out.
    – jakebeal
    Mar 23, 2015 at 4:40
  • @jakebeal "The following recommendations are intended to ensure that contributors who have made substantive intellectual contributions to a paper are given credit as authors" it sounds to me like the guidelines are to make sure those deserving authorship get it and not to prevent gift authorship. As I said, I agree with your reasoning that if you meet the first criteria, you really should be given the option to meet the rest and the lead author should have to explain why individuals who meet the first criteria did not meet the rest.
    – StrongBad
    Mar 23, 2015 at 9:37

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