Explanation

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their roles are standard for protocols published in journals such as Trials and BMJ Open, but are less common for unpublished protocols. Reviews of two samples of 108 and 292 unpublished trial protocols from 2016 found that 11% and 17% respectively reported the names of protocol contributors/authors.(9, 10)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