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Human Tissue Use and Transfer: Difference between revisions
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== Procedures == | == Procedures == | ||
===Transfer for Clinical Purposes=== | ===Transfer for Clinical Purposes=== | ||
'''Medical.''' The Nebraska Medical Center Pathology Department has responsibility and authority over clinical use of tissue. Tissue may be transferred into and out of the Nebraska Medical Center campus in accordance with The Nebraska Medical Center policy MS.11, "Removal of Specimens". Patients may also request transfer of their tissue to another health care provider for clinical purposes in accordance with Policy MS.11. | |||
All vendors providing pathology services to patients must be approved by The Nebraska Medical Center Board of Directors as recommended by the Medical Staff and as required by Joint Commission, CAP and CLIA standards. Health care providers who wish to utilize a new external pathology vendor must submit a proposal to the Director, Clinical Pathology. | All vendors providing pathology services to patients must be approved by The Nebraska Medical Center Board of Directors as recommended by the Medical Staff and as required by Joint Commission, CAP and CLIA standards. Health care providers who wish to utilize a new external pathology vendor must submit a proposal to the Director, Clinical Pathology. | ||
'''Genetics.''' The UNMC Munroe Meyer Institute Human Genetics Laboratory (HGL) and Molecular Genetics Laboratory (MGL) follow CLIA and Human Genetics Laboratory protocols. The Laboratories refer specimens for testing only to CLIA certified laboratories or laboratories meeting equivalent requirements as determined by the HGL or MGL. All specimens received by the HGL and MGL must have written orders and instructions from the referring laboratory and comply with CLIA and HGL regulations. | |||
'''Dental.''' In accordance with the [https://www.unmc.edu/academicaffairs/_documents/compliance/Infectious_Disease_Control_Policies.pdf UNMC College of Dentistry Infectious Disease Control Policy] as revised June 2014, "extracted teeth or other removed body tissues may be given to the patient from whom they were removed if the patient requests them." | |||
The UNMC Oral Pathology Biopsy Service, in accordance with current CLIA regulations: | The UNMC Oral Pathology Biopsy Service, in accordance with current CLIA regulations: | ||
:i. Refers any specimens for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. | :i. Refers any specimens for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. | ||
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===Use/Transfer for Research Purposes=== | ===Use/Transfer for Research Purposes=== | ||
The UNMC Institutional Review Board (IRB) has responsibility and authority over research use of tissue in the Nebraska Medical Center clinical enterprise. See the resources listed below or contact the IRB to obtain additional guidance in this area. The principal investigator in charge of a tissue bank or other research protocol may transfer tissue for research purposes to external individuals/organizations utilizing a material transfer agreement (MTA). As appropriate, the Medical Director of Anatomical Pathology or the director of the HGL or MGL, depending on the location of the tissue, shall determine if there is sufficient tissue to meet research requests. | The UNMC Institutional Review Board (IRB) has responsibility and authority over research use of tissue in the Nebraska Medical Center clinical enterprise. See the resources listed below or contact the IRB to obtain additional guidance in this area. The principal investigator in charge of a tissue bank or other research protocol may transfer tissue for research purposes to external individuals/organizations utilizing a material transfer agreement (MTA). As appropriate, the Medical Director of Anatomical Pathology or the director of the HGL or MGL, depending on the location of the tissue, shall determine if there is sufficient tissue to meet research requests. | ||
IRB Resources. Refer to the following policies and IRB applications and resources for further information: | |||
:i. UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Material for Future Research" | :i. UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Material for Future Research" | ||
:ii. UNMC IRB Human Biological Material applications and Educational Guides | :ii. UNMC IRB Human Biological Material applications and Educational Guides | ||
Investigators leaving UNMC. Investigators who leave UNMC are prohibited from taking tissue specimens or the resultant data with them unless they have prior written approval from their department chair, college dean, IRB chair (if IRB-regulated) and the Vice Chancellor for Research. Investigators will be required to complete a Material Transfer Agreement (MTA) and submit it to the UneMed office before tissue transfers can take place. The investigator must pay all the costs of transfer, unless the MTA specifies another source of payment. | |||
===Use/Transfer for Educational Purposes=== | ===Use/Transfer for Educational Purposes=== | ||
====Use for UNMC Education==== | ====Use for UNMC Education==== | ||