DATA ACCESS REQUIREMENTS- DETAILS
For line-level data, procedures and requirements are nearly identical for baseline and longitudinal data, if the data requestor agrees to work with a study team and/or Black Caucus (BC) member throughout the project. Procedures and requirements are slightly different for requestors who wish to work with baseline data but do not wish to work with a study team/BC member throughout the process.
Requesting Data
If working with a Study Team/BC Member throughout the process, the requestor must submit the “HPTN 061 DUA-WORKING WITH 061 OR BC TEAM MEMBER” data use agreement with their application. By signing this agreement, the requestor agrees (among other things) that if they are granted data access, they will receive orientation to the study and the dataset from a study team/BC member, and that they will work with that collaborator throughout the process of producing and reviewing their manuscript, grant proposal or other product. They agree to include a study-team-provided acknowledgement statement in their work, to have their work reviewed through the 061 Publications Committee and HPTN MRC, and to provide the team with updates on what becomes of their work (submitted, published, etc.)
If NOT working with a Study Team/BC Member throughout the process, the requestor must submit the “HPTN 061 DUA-NOT WORKING WITH 061 OR BC TEAM MEMBER” data use agreement with their application. By signing this agreement, the requestor agrees (among other things) that if they are granted data access, they will receive orientation to the study and the dataset from a study team/BC member. However they will not be required to work with a study team or BC member during the process of producing and reviewing their manuscript, grant proposal or other product. They agree to include a study-team-provided acknowledgement statement in their work, and this statement will state that the work is solely the responsibility of the author and not a product of, or endorsed by, the study team or HPTN. Because of this, their work will not receive official 061 team or HPTN MRC review. Requestors agree to provide the team with updates on what becomes of their work (submitted, published, etc.).
Requestors must provide documentation of recent (within 3 years) Human Subjects Protection training with their application. Those who do not have this training will be directed to free training through the CITI Program or from the NIH website at https://phrp.nihtraining.com/users/login.php.
Requestors must submit a completed Data Request Application form. This form collects basic information about the requestor and the nature of the request. It requires the applicant to declare whether they are planning to work with an 061/BC team member longitudinally and to vouch that they have reviewed the list of completed or proposed 061 projects, identifying potential overlap between previously approved work and their proposed project.
Data Request Application Materials will be sent to the HPTN LOC representative, who will initiate review procedures.
Review of Data Requests
Applications confirmed as complete by the LOC will be distributed for review by the HPTN 061 Publications Committee (including BC representation). The study team will provide feedback to the requestor regarding whether the proposal was approved, sent back for revision/clarification or rejected.
Post-Approval Activities
When a requestor receives approval, they will also be assigned a study team/BC member for orientation to the study and dataset. This orientation will include:
- History and context of the HPTN 061 study
- Review of the nature of the 061 study, including design, recruitment methods and sampling limitations/generalizability of study findings
- Discussion of previously-published findings
- Discussion of the requestor’s project, including strengths and limitations with regard to the 061 dataset
After study orientation, the SDMC will provide the requestor with access to the requested dataset. Requestors working with a study team/BC collaborator will work with their collaborator throughout the production of the work. When the work is ready for review by the 061 Publications Team, the requestor will submit to the LOC representative who will organize the review. Manuscripts, abstracts, posters and presentations will require HPTN MRC review, in addition to 061 study team review, before they can be submitted to journals or conferences. Review procedures are spelled out in the HPTN 061 Publications Guidance document and HPTN Manual of Operations. As noted elsewhere, the study team will provide an acknowledgement statement that must be included by the requestor in their work.
Requestors using baseline data who opt NOT to work with a study team/BC collaborator can still request assistance from the team for any questions that arise as they complete their work. However, no formal review by the HPTN study team and no review by the HPTN MRC will take place. These authors will also be required to include in their work an acknowledgement statement, provided by the study team, stating that the work is solely a product of the author and is not a product of the 061 Study Team or HPTN.
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