Publications Development & Policy
HVTN Publication Policy
All HVTN manuscripts and abstracts ("publications") must, before submission, be reviewed by the Protocol Committee. Manuscripts and abstracts published without proper review are not counted in a site's NEC annual review. Vaccine developers have the right to review publications before submission; clinical trials agreements may specify requirements for authorship and review. Ancillary Study Publications may be handled in accordance with the HVTN Ancillary Study Publication Policy. You will be notified, upon approval of your ancillary study, which publication policy applies.
All publications must meet the criteria for authorship, disclosure, scientific integrity, and other requirements of peer-reviewed scientific journals. The author line must conclude with "and the NIAID HIV Vaccine Trials Network," and NIAID funding must be acknowledged, specifying the grant number if applicable. If applicable, the vaccine developer is normally included as a coauthor.
For core protocol publications (reporting on primary and secondary objectives of a single trial), the protocol team serves as the writing team, usually with the protocol chair as lead author. For cross-protocol publications, leaders of the network or appropriate science committee typically appoint the lead author. Additional authors may include other investigators, usually members of the appropriate science committee, and/or site investigators.
The protocol chair or other protocol team members present data at scientific meetings. Vaccine developers are included as coauthors, if appropriate.
HVTN manuscripts and abstracts are reviewed in 3 stages. The first 2 stages are prerequisites of the third.
1. Consensus of authors
All authors-including vaccine developers-must sign off on a publication before submitting it to the Protocol Committee.
The Protocol Committee will not review abstracts or manuscripts submitted without this sign-off.
2. Approval by site principal investigator or HVTN associate director for scientific development
If the lead author of a publication is not a principal investigator, that author's site PI must approve the publication before submission. Cross-protocol publications must be approved by the chair of the appropriate science committee. Publications by lead authors in HVTN Core must be approved by the author's unit chief, then submitted to the associate director for scientific development.
3. Review by Protocol Committee
The Protocol Committee consists of 3 co-chairs, 6 non-US site investigators, 6 US site investigators, 2 clinic
coordinators, a global CAB representative, a SCHARP representative, a Lab Program representative, and 2 DAIDS
representatives. 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 submission
form to the Protocol Committee Scientific Project Coordinator with ample time for review according to the guidelines
Manuscripts are assigned a primary reviewer from the Protocol Committee. The manuscript is returned to the lead
author with major comments (required changes) and minor comments (recommended changes). If there are required
changes, the manuscript must be revised and resubmitted for further review. This process is repeated until no
required changes remain. In case of persistent disagreement between authors and reviewers, final judgment rests
with the Scientific Steering 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 five working days. If there are required changes, the abstract must be revised and resubmitted.
The abstract is also circulated to members of the Protocol Committee for comments.
If an abstract is proposed to be submitted to more than one conference, the Protocol Committee asks that:
In this case, the abstract will not need to be reviewed again by the Protocol Committee.
- The lead author ensure that the submission is allowable according to conference guidelines;
- Approval be obtained from applicable Protocol Team leadership; and
- A brief rationale for submitting the abstract to another conference is provided to the Protocol Committee chairs.
The Protocol Committee Scientific Project Coordinator will notify the lead author when the review is complete. The lead
author should notify the Protocol Committee Administrative Assistant when the abstract or manuscript has been
accepted and send a final version for filing in the HVTN Publications Database and posting on the HVTN members
Only those review comments received on time will be considered. The clock starts when the draft publication
is sent to reviewers by the Protocol Committee Scientific Project Coordinator. The author is notified of receipt
by fax or e-mail.
Time allowed for review is 10 working days for manuscripts, 5 for abstracts. A vaccine developer may be allowed
more time for review (often 20 working days for manuscripts), if specified in the clinical trials agreement.
Submission of abstracts must allow sufficient time for review before conference deadlines. These timelines
also apply to the review processes outlined in subheadings 1 and 2 above.
For manuscripts reporting results of a specific HVTN trial (covering the primary and secondary objectives),
a complete draft must be produced no more than 3 months after the study is unblinded and the data are available.
If this is not done, HVTN leadership may assign a new lead author from the protocol team.
Submission form and tracking
A manuscript/abstract submission form
must accompany any submission to the Protocol Committee. All submissions to the Protocol Committee, at any stage
of review, are made through the Protocol Committee Scientific Project Coordinator. (Earlier reviews, including those by
the vaccine developer, are arranged directly by the writing team.) Manuscripts and abstracts may be submitted in
hard copy or in a commonly used, editable electronic format such as Microsoft Word. Submit manuscripts, abstracts,
or questions to the Protocol Committee Scientific Project Coordinator:
The Protocol Committee Scientific Project Coordinator distributes draft publications for review, and tracks drafts as well as published products.
For tracking purposes, authors must report the final disposition of publications to the Protocol Committee Scientific Project Coordinator.
Participant identification numbers
Participant ID numbers from trials are not to be used in any publications. If ID numbers are needed, the
SDMC will issue new ones.
Publicity and media
Media inquiries and press releases should be referred to the NIAID Office of Communications Reporting
and Public Response (OC/NIAID). The OC/NIAID and VCRB Program Officer should approve any press
releases and responses to inquiries (t. 301-496-5717). Local media activity should be coordinated with the
NIAID Office of Communications.