All HVTN manuscripts and abstracts ("publications") must be reviewed by the Protocol Committee prior to submission. Vaccine developers have the right to review publications before submission; clinical trials agreements may specify requirements for authorship and review. Ancillary Study publications are handled in accordance with the HVTN Publication Policy for Ancillary Studies. You will be notified, upon approval of your ancillary study, which publication policy applies (HVTN Publication Policy or HVTN Publication Policy for Ancillary Studies).
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. In addition, all publications must include a disclaimer such as “the content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.” For abstracts, include the disclaimer in the poster or in the PowerPoint presentation.
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:
1. The lead author ensure that a duplicate submission is allowable according to conference guidelines;
2. For all abstracts containing data from HVTN protocols, approval for a duplicate submission be obtained from Protocol Team leadership of those protocols; and
3. 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.
Manuscripts are reviewed by the Protocol Committee within 10 business days, and abstracts within 5 business days. If vaccine developer sign-off has not been obtained, more time may be allowed for review depending on what is specified and agreed to in the Clinical Trials Agreement. Submission of abstracts must allow sufficient time for review before conference deadlines.
Writing teams have 3 months from the time the study is unblinded and the data are available to produce a complete draft of primary manuscripts (covering the primary and secondary objectives of a specific HVTN trial). If this is not done, the HVTN Executive Management Team (EMT) may assign a new lead author from the Protocol Team. Updates on manuscript development are provided to the EMT quarterly.
E-mail: Protocol Committee Chair
Participant identification numbers
Participant ID numbers from trials are not to be used in any publications. If ID numbers are needed, the SDMC issues publication ID numbers.