To protect the scientific integrity of the Division of AIDS (DAIDS) and to ensure optimal use of limited specimens, all proposals requesting access to clinical trial specimens collected from VAX004 must undergo a review and approval process.
To assist in the process, investigators should review the Scientific Priorities developed by a specially convened DAIDS VAX004 Specimen Access Approval Panel.
Ethical and IRB Issues With Stored Samples
Although these specimens were obtained from trial participants who signed informed consents releasing these specimens for research purposes, certain restrictions may apply. The DAIDS VAX004 Specimen Access Approval Panel has reviewed the protections offered by the Common Rule and the Health Information Protection Act Amendments (HIPAA). In general, consent is required for the storage and future use of samples that contain identifiable private information about living individuals. In the case of VAX004, the original consent form was modified to include taking and storing cells for future "testing," but the tests that would be performed were not specified.
In the Panel's opinion, the vast majority of institutional review boards (IRBs) will allow future research if the specimens are de-linked from personal information (i.e., other than male/female, placebo/vaccine, infected/ uninfected). The Panel felt that, in particular, future research on genetic and host factors should be carefully evaluated by the relevant IRB(s). Investigators could also consider seeking a waiver from HIPAA based on minimal risk, efforts to protect identities, the impracticality of reconsenting the volunteers, and the impossibility of doing the desired research without certain information.
Forms and Submission
All investigators seeking access to these DAIDS VAX004 clinical trial specimens or data must complete and submit the following documents:
- DAIDS VAX004 Specimen Access Approval Application (427K)
- DAIDS VAX004 Specimen Material Transfer Agreement (MTA) (31.2K)
If you have any questions, please contact Dr. Jon Warren.