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Requests
What do I do first?
At the time of initial inquiry, investigators are asked to provide a summary of the proposed research and to meet with DBBR operations staff (Mary Nesline and Warren Davis) to evaluate feasibility. The following areas are discussed in the feasibility meeting:
- Evaluation of the availability of appropriate banked biospecimens and data to fulfill the study request and/or determination of the need and logistics of additional (study-specific) collection.
- Anticipated time frame for the research.
- Service cost estimate and funding source for the research.
- Protocol development and Material Transfer Agreement (MTA) requirements (if necessary).
Which requests require pre-approval by the relevant Disease Site Research Groups (DSRGs)?
- Requests for aliquots of finite patient material including serum, plasma, red blood cells and buffy coat require DSRG pre-approval.
- Requests for <=1 uL of DNA per subject do not require DSRG pre-approval.
- Requests for healthy control specimens do not require DSRG pre-approval.
What is the DSRG pre-approval process?
DBBR provides the research proposal summary to the appropriate DSRG for prioritization and approval. RPCI CCSG program members with peer reviewed funding are given top priority for requests, followed by newly developing RPCI investigators, then external investigators with federal funding, and lastly, commercial investigators.
Which requests require an Institutional Review Board approved protocol for human subjects research?
- Requests for de-identified specimens and data that were collected under DBBR banking protocol I 03103 "RPCI Data Bank and BioRepository (DBBR)" require an IRB approval prior to release.
- Requests for anonymously collected specimens and data from healthy volunteers, under DBBR banking protocol I 36404 "Anonymous Specimen Collection for Pilot Data" do not require IRB approval prior to release. Because these samples cannot be linked to their donors, they are not considered human. Use of this protocol for collection is limited to small pilot laboratory studies.
