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Human Tissue Use and Transfer: Difference between revisions
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Trial Fee Billing Procedures]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[International Research Policy]] | [[Health Care Vendor Interactions]] | [[Internal Audit]] | ||
<br /><br />Policy No.: '''8013'''<br /> | <br /><br />Policy No.: '''8013'''<br /> | ||
Effective Date: '''03/15/2012'''<br /> | Effective Date: '''03/15/2012'''<br /> | ||
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Human tissue obtained through clinical procedures or for research may be used within the Nebraska Medical Center campus or transferred to external organizations consistent with the Nebraska Medical Center campus mission of patient care, teaching, research and outreach. Tissue obtained for clinical and/or research purposes is the property of the Nebraska Medical Center Academic Clinical Enterprise (i.e. UNMC, UNMC Physicians and The Nebraska Medical Center). Use and transfer of human tissue shall take place in accordance with the procedures below to ensure applicable regulatory and ethical standards are met. This policy applies to physical tissue and not to tissue images. | Human tissue obtained through clinical procedures or for research may be used within the Nebraska Medical Center campus or transferred to external organizations consistent with the Nebraska Medical Center campus mission of patient care, teaching, research and outreach. Tissue obtained for clinical and/or research purposes is the property of the Nebraska Medical Center Academic Clinical Enterprise (i.e. UNMC, UNMC Physicians and The Nebraska Medical Center). Use and transfer of human tissue shall take place in accordance with the procedures below to ensure applicable regulatory and ethical standards are met. This policy applies to physical tissue and not to tissue images. | ||
== Definitions == | == Definitions == | ||
''Human tissue'' is tissue, blood products, serum, DNA and other biological materials or specimens that are obtained from (1) patients as a part of their regular clinical care that would otherwise be discarded or archived, or (2) patients or other individuals who have agreed to donate their specimens obtained specifically for research or for deposit into tissue repositories. | ''Human tissue'' is tissue, blood products, serum, DNA and other biological materials or specimens that are obtained from (1) patients as a part of their regular clinical care that would otherwise be discarded or archived, or (2) patients or other individuals who have agreed to donate their specimens obtained specifically for research or for deposit into tissue repositories.<br /> | ||
''Transfer'' means tissue sent outside the Nebraska Medical Center campus organizations. | ''Transfer'' means tissue sent outside the Nebraska Medical Center campus organizations.<br /> | ||
''Use'' pertains to activities utilizing tissue within the Nebraska Medical Center campus organizations. | ''Use'' pertains to activities utilizing tissue within the Nebraska Medical Center campus organizations. | ||
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#* Dental. In accordance with the UNMC College of Dentistry Infection Control Policy as revised June 2011, "extracted teeth or other removed body tissues may be given to the patient from whom they were removed if the patient requests them." | #* Dental. In accordance with the UNMC College of Dentistry Infection Control Policy as revised June 2011, "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. | ||
#: ii. If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in section 493.1242, paragraphs (a)(1) through (a)(7) as specified in the current CLIA regulations. | #::ii. If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in section 493.1242, paragraphs (a)(1) through (a)(7) as specified in the current CLIA regulations. | ||
#'''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 an existing tissue bank may transfer tissue for research purposes to external individuals/organizations utilizing a material transfer agreement (MTA). 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 an existing tissue bank may transfer tissue for research purposes to external individuals/organizations utilizing a material transfer agreement (MTA). 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: | #* 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 of 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. | #* 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 of 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''' | ||