Do I need an IRB for frozen biological samples?

An investigator DOES NOT need to submit to the IRB to obtain their own individual approval for tissue samples or biological materials from the Pitt Biospecimen Core (PBC), if the tissue has been previously collected and stored currently within the PBC. The PBC maintains its own IRB Protocol for Collection and Disbursement of Human and Biological Materials. Contact the TARPS Project Manager to obtain a copy of the most recent IRB approval letter.

The investigator will be asked to enter into a Biospecimen User Agreement:

  1. Guarantees that no additional data mining will be attempted by the researcher, without obtaining additional IRB approval for such data mining.
  2. The researcher cannot share these materials with other in-house investigators without obtaining additional IRB approval for such sharing.
  3. The researcher cannot share these materials with outside institutions/entities (profit/nonprofit), without obtaining additional IRB approval for such sharing.
  4. The investigator will receive a de-identified version of the pathology report to annotate each sample that has been requested.

When would it be necessary to submit an application to the IRB?

Certain types of biological specimen collection procedures will require separate IRB approval:

  1. The prospective, focused collection of a specific type of residual biological specimen (i.e., biological specimen remaining after clinical pathology assessment has been completed – research needs cannot be met through existing specimens maintained by the PBC).
  2. The removal, from human subjects, of biological specimens solely for research purposes (i.e., the research use of non-residual biological specimens).
  3. The collection, for research use, of biological specimens and/or annotating data to include patient-subject identifiers.
  4. Projects that involve the utilization of pathology paraffin archives.

What is the TUC?

There are institutional Tissue Utilization Committees (TUCs) in place for evaluating biological specimen requests for each major organ system. Each TUC has representation from the clinical, translational, and basic science community involved in clinical care and research for the particular organ system of interest. Each application will be triaged to the appropriate TUC, which will make a recommendation to the PBC within two weeks. If a request is approved, the PBC will provide appropriate biological specimens, and annotating data, in a de-identified manner to the investigators.

What if I require more data than the surgical pathology report can provide?

Contact the Director of UPMC Registry Information Services:

Sharon Winters
Phone: 412-647-6390
Email: winterssb@upmc.edu