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Policy No.: 8013
Effective Date: 03/15/12
Revised Date: 07/30/18
Reviewed Date: 07/30/18

Human Tissue Use and Transfer Policy

Policy

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

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.

Transfer means tissue sent outside the Nebraska Medical Center campus organizations.

Use pertains to activities utilizing tissue within the Nebraska Medical Center campus organizations.

Procedures

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.

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 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:

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.

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.

IRB Resources. Refer to the following policies and resources for further information:

i. UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Materials"

ii. UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research"

iii. UNMC IRB Human Biological Material applications

Investigators will be required to contact UNeMed with a request to have UNeMed complete a Material Transfer Agreement (MTA) for any planned tissue transfer. The MTA must be completed and signed by all relevant parties before the transfer can take place.

Use/Transfer for Educational Purposes

Use for UNMC Education

i. Education in this context refers to use by qualified undergraduate or graduate students in the course of the established curriculum for the UNMC, including the Colleges of Medicine, Allied Health, Dentistry, Nursing, Pharmacy and Public Health.

ii. Medical: Tissues obtained during the course of normal clinical practice may be used for educational purposes within the Nebraska Medical Center clinical enterprise in accordance with campus policies (including pathology HGL, MGL and infection control policies) and state or federal law (including the Uniform Anatomical Gift Act).

iii. Dental: In accordance with the UNMC College of Dentistry Infectious Disease Control Policy as revised June 2014, "extracted teeth, oral tissues, or other tissues may be used for educational purposes in the preclinical laboratories". The decontamination of extracted teeth or other tissues for use in the preclinical laboratories is conducted in accordance with Centers for Disease Control recommendations.

Transfer for Medical/Dental Educational Purposes

Transfer of tissue to an accredited educational institution outside UNMC is permitted, provided that the tissues are to be used by qualified undergraduate or graduate students in the course of an established curriculum for the institution to which they are being transferred. A Material Transfer Agreement (or similar written agreement) must be in place documenting the intended use as described above.

Transfer of Tissue to Commercial Entity for Business Purposes

Transfer of Nebraska Medical Center clinical enterprise tissue to an external commercial entity for business purposes is only permitted when such business purposes are consistent with the instructional, scholarship and research objectives of the University of Nebraska. "Business purposes" refers to exchange of tissue for money or other like compensation at cost or beyond the reasonable costs of procurement, storage, processing or shipping of tissue. "Consistent with the instructional, scholarship and research objectives of the University of Nebraska" means that the sale of tissue must support the objectives of the University, including financial support of infrastructure necessary for those goals. For UNMC tissue, the Chancellor, Vice Chancellor for Research, or Senior Vice Chancellor for Academic Affairs shall have the authority to determine if business purposes are consistent with the instructional, scholarship and research objectives of the University of Nebraska. For The Nebraska Medical Center tissue, the Chief of Pathology and the Chief Medical Officer shall have the authority to determine if the business purposes are consistent with organizational objectives. The Medical Director of Anatomic Pathology shall determine if there is sufficient tissue to meet the requests, as applicable.

Material Transfer Agreements (MTAs)

MTAs shall not be required for human tissue transfers for clinical purposes, including second opinions. MTAs shall be used for tissue transfers for education and research, except when the transfer is to a research sponsor pursuant to a sponsored research agreement that incorporates tissue transfer provisions. For further information, see UNeMed Material Transfer.

Export Control

Any shipment of Human Tissue internationally must be reviewed for compliance with export control and related regulations in accordance with UNMC Policy No. 8005, Export Control. To facilitate this evaluation, a Request for Export Controls Review Application should be submitted in advance to the Export Control Compliance Officer as the request takes time to research and process.

Additional Information

• Contact the Chief Compliance Officer
• Contact the Export Control Office
• UNMC Policy No. 8005, Export Control
• Request for Export Controls Review Application
• UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Materials" (available with login on UNMC Research Support System server)
• UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research" (available with login on UNMC Research Support System server)
• UNMC College of Dentistry Infectious Disease Control Policy
• UNeMed Material Transfer
• Nebraska Medicine Policy MS.11, Removal of Specimens
• 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral

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