All publications that include HVTN trial data must meet the criteria for authorship, disclosure, scientific integrity, and other requirements of peer-reviewed scientific journals.
For primary protocol publications (reporting on primary and/or secondary objectives of a single trial), the protocol team serves as the writing team, usually with the protocol chair as lead author. The order of authors is at the Protocol Chair's discretion and should reflect the contributions of all who have participated, including site PIs, junior investigators and the vaccine developer(s). For protocol publications reporting results of a phase I trial, a representative from the DAIDS Preclinical Research and Development Branch may also be included as an author. For cross-protocol publications, either the proposing investigator or investigator proposed by leaders of the network or appropriate science committee will serve as the lead author. Additional authors may include other investigators, representatives from DAIDS, SCHARP, HVTN Laboratory Program, and/or site investigators.
The author line of primary protocol publications must conclude with "and the NIAID-funded HIV Vaccine Trials Network". All publications that include HVTN trial data must acknowledge NIAID-funded HIV Vaccine Trials network, specifying the grant number of all entities (Clinical Research Sites, SDMC, Laboratories, etc) contributing to the study, as applicable.
All authors — plus vaccine developers — must sign off on draft manuscripts and abstracts before submitting them to the Protocol Committee. The Protocol Committee does not review abstracts or manuscripts submitted without this sign-off.
Protocol Committee Review
The Protocol Committee is responsible for scientific review of draft manuscripts and abstracts before final submission for journal or conference consideration. The Protocol Committee reviews the author line with the standard criteria for scientific authorship in mind. The lead author should send his/her manuscript or abstract with a completed Publications Submission Form to the Protocol Committee Project Manager (via e-mail using the following link: Protocol Committee Co-Chairs) with ample time for review according to the guidelines below.
Manuscripts are assigned a primary reviewer who is usually a Protocol Committee member. The manuscript and/or HVTN Manuscript Review Form is typically returned to the lead author within 10 business days with major and/or minor comments. The reviewer may stipulate that the suggested changes be made prior to submission. Reviewers may also require that the manuscript be revised and resubmitted for further review. In this case, this process is repeated until no required changes remain. In the case of persistent disagreement between authors and reviewers, final judgment rests with the Scientific Governance Committee chair or the chair of the appropriate science committee.
Abstracts undergo a similar but abbreviated review. They are assigned a primary reviewer who responds to the lead author within 5 business days. There may be required changes, and the reviewer may ask that the abstract be revised and resubmitted. In addition to the primary reviewer, manuscripts and abstracts are circulated to all members of the Protocol Committee for comment. Each submission undergoes a simultaneous Protocol Committee Leadership Review, which focuses on the submission's broad message to assure consistency with the network policy.
The lead author is notified when the review is complete. The lead author should notify the Protocol Committee Project Manager (via e-mail using the following link: Protocol Committee Co-Chairs) when the abstract or manuscript has been submitted and accepted, and send the accepted version for filing.
Proposal to Submit Abstract to Multiple Conferences
If an abstract is submitted to more than one conference, the Protocol Committee asks that:
- The lead author ensure that a duplicate submission is allowable according to conference guidelines;
- For all abstracts containing data from HVTN protocols, approval for a duplicate submission be obtained from Protocol Team leadership of those protocols; and
- A brief rationale for submitting the abstract to another conference be provided to the Protocol Committee Co-Chairs.
When an abstract is submitted to multiple conferences, it does not need to be reviewed by the Protocol Committee multiple times. However, the lead author should notify the Protocol Committee Project Manager (via e-mail using the following link: Protocol Committee Co-Chairs) indicating where the abstract is being submitted and include a copy of the submitted version for the records.