Item 3a: Names, affiliations, and roles of protocol contributors

Example

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“Jennifer Hemingway-Foday1, Alan Tita2, Elwyn Chomba3, Musaku Mwenechanya3, Trecious Mweemba3, Tracy Nolen1, Adrien Lokangaka4,5, … , Richard Derman19, William A Petri20, Marion Koso-Thomas21, Elizabeth McClure1 ,Waldemar A Carlo2

…

1. RTI International, Research Triangle Park, North Carolina, USA

2. The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA

3. University of Zambia, University Teaching Hospital, Lusaka, Zambia

4. University of Kinshasa, Kinshasa, Congo (the Democratic Republic of the)

5. Kinshasa School of Public Health, Kinshasa, Congo (the Democratic Republic of the)   …

19. Office of Global Affairs, Thomas Jefferson University, Philadelphia, Pennsylvania, USA

 20. University of Virginia, Charlottesville, Virginia, USA

 21. Eunice Kennedy Shriver National Institute of Child Health and Human Development,

       Bethesda, Maryland, USA

…

Contributors

AT and WAC conceived of the study and developed the protocol, with input from EMC, TN, JH-F, MK-T and PLH. TN developed the statistical analyses plan. JH-F wrote the first draft of the manuscript and subsequent revisions, with critical feedback from WAC, AT, EMC, MK-T and TN. EC, MMwenechanya, TM, AL, ATK, GL, PLH, AP, PKD, KK, SSG, AK, MMetgud, SS, SST, FE, PN, AS, LF, MMazariegos, SMB, RH, MSS, RG, MB, CB, EAL, OAE, NFK, RD and WAP contributed to the refinement and finalisation of the study protocol and trial implementation. All authors contributed to the preparation of this manuscript and have reviewed and approved the final version [37]. 

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Explanation

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Listing the protocol authors, their affiliations, and their role in the protocol development process provides due recognition, accountability, and transparency. Naming of authors can also help to identify conflicts of interest (Item 7b) and reduce ghost and gift authorship [38-41].

Naming of authors and describing their roles are standard for protocols published in journals such as Trials and BMJ Open, but are less common for unpublished protocols. Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17% respectively reported the names of protocol contributors/authors [9, 10].

Individuals who contribute substantially to protocol development and drafting should be named as authors or listed as contributors. For example, if statisticians or professional medical writers participated in drafting the protocol, then they should be listed. Nonhuman artificial intelligence (i.e., large language models, machine learning) tools do not qualify for authorship, but their use to create content or assist in writing the protocol should be clearly stated, e.g., under acknowledgements or in a methods section [42, 43].

Summary of key elements to address

For each protocol contributor:

• Name

• Affiliation

• Description of contributions, including use of artificial intelligence technologies, if applicable