Policies of Operation

Only discarded human tissues may be obtained by the TPHC for research. Surgical procedures are not altered in any way to obtain additional tissue for the TPHC. Authorization must be obtained from a Surgical Pathologist for the release of remaining surgical tissue not needed for diagnosis. Patient confidentiality is strictly maintained through the use of sample code numbers, and patient identifiers are not released to the researchers, with the exception of those individuals having separate IRB-approved Protocols permitting access to this information. Donor information is maintained in a secure area in the event that follow-up data or additional samples are requested. No contact with the donor patient or family members is permitted. In some studies a researcher may have IRB approval to directly interact with patients through a consented protocol; the TPHC is not involved in any way with these interactions. Discarded tissues may be obtained from live-birth babies to any age. No gender, minority, or special class restrictions are placed on the pool of potential donors. Data identifying patients as members of special classes of individuals are not available to the TPHC. No individual groups of people are targeted for tissue collection. Patients are not recruited to be donors. No fetal tissue can be collected, due to federal and state statutes, as well as local ordinances.

Research using human tissues from living individuals is considered human subjects research in accordance with the policies of the U.S. Office of Human Risk Protection (OHRP). Both the HTPF (umbrella facility) and the TPHC comply with federal regulations applying to human subjects research (45 CFR 46, or the "Common Rule"). The UHC Institutional Review Board (IRB) that oversees the HTPF operates under the Federal Wide Assurance of Compliance number 00003937. The HTPF's IRB Protocolcovers both the HTPF and TPHC and is entitled, "Human Tissue Procurement Facility of UHC" (Protocol 01-02-45J). This Protocol is renewed annually. The Protocol includes a waiver of separate informed consent (consent is provided in the general procedure consent form) for discarded tissues, in accordance with UHC and its IRB policy. A waiver of HIPAA authorization was obtained for the service on April 11, 2003.

In order to receive tissues, researchers must fill out a formal HTPF application and provide a copy of their current IRB approval to conduct the work. Researchers will receive tissues after approval of their application by the Principal Investigator and Director of the HTPF.

Quality control is performed on representative sections of tissues collected for research by experienced clinical Surgical Pathologists to confirm that the diagnoses associated with the samples are correct, to ensure that the QC sample results re-confirm clinical data in the Final Pathology Reports (i.e. no cancer cells are found in QC slides when clinicial pathology results are negative), and to determine the suitability of the samples research (e.g., the samples are not excessively necrotic). Exceptions are made for the QC of certain tissues, including normal skin, tonsils and bone, since grossly normal tissues of theses types rarely have pathologic abnormalities.

Researchers have prioritized access to tissues and services, depending on their affiliations with Case/UHCMC, its Comprehensive Cancer Center, or whether they are from an outside organization. Cancer Center members have exclusive use and receive first priority access to the tissues through the TPHC. Non-Cancer researchers affiliated with Case/UHC receive second priority. Tissues not utilized by internal researchers are made available to external researchers. The Principal Investigator and Directory of the HTPF will resolve any conflicts in access between Cancer Center members. In practice, most tissues are generally available in sufficient quantity and frequency to meet the needs of all internal researchers and many researchers not associated with Case/UHCMC.

Histology, immunohistochemistry (IHC) and Laser Capture Microdissection (LCM) services are generally offered on a first come first serve basis, regardless of order size; however, a research assistant may only spend up to 50% of their time on one particular order a day. Surcharges are placed on rush orders. A formal application is not required to obtain Histology, IHC or LCM services, but it is requested that new facility users complete a New Investigator Information Sheet available in the Forms section of this website. All users are required to drop off tissue with an accompanying HCF Record Sheet, which lists the specifics of work to be performed.