Publications Policy - HIV Vaccine Trials Network

Authorship
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.

For ancillary publications, the lead author is the investigator who proposed and carried out the ancillary study. To submit a manuscript involving HVTN participants or samples, authors must receive written permission from the protocol chair or (in studies involving more than 1 protocol) from the appropriate science committee leadership. If the lead author is not an HVTN member, at least 1 HVTN member (chosen by the chair of the appropriate science committee) serves as network liaison and is included as coauthor. Publication of ancillary studies should not precede core protocol publication, unless agreed to by the protocol chair or chair of the appropriate science committee.

The protocol chair or other protocol team members present data at scientific meetings. Vaccine developers are included as coauthors, if appropriate.

Review
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 support
If the lead author of a publication is not a principal investigator, that author's site PI must approve the publication before submission. Ancillary publications and cross-protocol publications must be approved by the chair of the appropriate science committee. Ancillary publications may also require review by protocol chairs or by protocol teams (including -vaccine developers). Publications by lead authors in HVTN Core must be approved by the author's unit chief, then submitted to the associate director for scientific support.

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 Administrative Assistant with ample time for review according to the guidelines below.

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.

The Protocol Committee Administrative Assistant 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 website.

Deadlines
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 Administrative Assistant. 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 Administrative Assistant. (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 Administrative Assistant:

The Protocol Committee Admin 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 Admin.

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.

Reprint distribution
The publications coordinator distributes reprints of published material at the request of the corresponding author. The request must be in writing and accompanied by the number of copies to be distributed. Unless otherwise requested, distribution will be to all authors, DAIDS representatives, the vaccine developer, and the HVTN Core Operations Center. Additional distributions may be made as directed by the lead author.

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.

Publications Development & Policy