HVTN Publication Policy for Ancillary Studies

(This policy does not necessarily apply to all Ancillary Study investigators. When approving an ancillary study, the HVTN notifies the investigator which publication policy applies (HVTN Publication Policy or HVTN Publication Policy for Ancillary Studies).

For purposes of this policy, "Ancillary Studies" means studies carried out using data and/or material arising from clinical research conducted by the HIV Vaccine Trials Network ("HVTN"). Prior to submission, Ancillary Study manuscripts and abstracts prepared for publication or public presentation ("Publications") must be reviewed by a review committee designated by the Scientific Governance Committee of the HVTN (“HVTN Ancillary Study Committee”). If required by law or contract, third parties (including vaccine developers) may be entitled to review Publications before submission and may have a right to have their investigators considered as authors.

Authorship

In recognition that employees of FHCRC and HVTN investigators will generally play an important role in determining the properties and use of materials and data to be used in an Ancillary Study and interpretation of the findings of the Ancillary Study, the Ancillary Study Principal Investigator shall include appropriate individuals from the FHCRC and/or HVTN investigators in the authorship of publications resulting from the Ancillary Study, in accordance with the generally accepted customs pertaining to authorship.

Review by HVTN Ancillary Study Committee

The HVTN recognizes that Ancillary Study investigators must be permitted to present at symposia, national, or regional professional meetings, and to publish in journals, theses or dissertations, or otherwise, in their sole discretion, the methods and results of such Ancillary Studies. Ancillary Study Principal Investigators shall submit manuscripts and/or abstracts to the HVTN for review, which review shall be completed within thirty (30) days of receipt. Such review shall be conducted to ensure that confidential information is not inadvertently disclosed and to confirm that all other requirements imposed by law or contract have been satisfied. To ensure minimum delays, review by the HVTN may be concurrent with any review required by law or contract to the fullest extent possible.

Attribution

All Ancillary Study publications or presentations must provide attribution to the HVTN and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIAID-NIH").