Human Tissue Use and Transfer: Difference between revisions
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Policy No.: '''8013'''<br /> | Policy No.: '''8013'''<br /> | ||
Effective Date: '''03/15/12'''<br /> | Effective Date: '''03/15/12'''<br /> | ||
Revised Date: ''' | Revised Date: ''' 09/21/21'''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''09/21/21'''<br /><br /> | ||
<big>'''Human Tissue Use and Transfer Policy'''</big> | <big>'''Human Tissue Use and Transfer Policy'''</big> | ||
== 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. | 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 | '''''Human tissue''''' is tissue, blood products, serum, DNA and other biological materials or specimens that are obtained from patients.<br /> | ||
'''''Transfer''''' means tissue sent outside the Nebraska Medical Center campus organizations.<br /> | '''''Transfer''''' means tissue sent outside the Nebraska Medical Center campus organizations.<br /> | ||
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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. | ||
'''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 December 2020, "extracted teeth or other removed body tissues may be given to the patient from whom they were removed if the patient requests them and are not subject to OSHA Bloodborne Pathogens Standard." | '''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 December 2020, "extracted teeth or other removed body tissues may be given to the patient from whom they were removed if the patient requests them and are not subject to OSHA Bloodborne Pathogens Standard." | ||
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: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 [https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 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 [https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 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 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 | 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 shall determine if there is sufficient tissue to meet research requests. | ||
IRB Resources. Refer to the following policies and resources for further information: | IRB Resources. Refer to the following policies and resources for further information: | ||
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:ii. UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research" | :ii. UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research" | ||
:iii. UNMC IRB Human Biological Material applications | :iii. UNMC IRB Human Biological Material applications | ||
Investigators will be required to contact [https://www.unemed.com/services/material-transfer 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. | Investigators will be required to contact [https://www.unemed.com/services/material-transfer UNeMed] and Sponsored Programs Administration (SPA) with a request to have UNeMed or SPA 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/Transfer for Educational Purposes=== | ||
====Use for UNMC Education==== | ====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. | :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 | :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 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. | :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 for Medical/Dental Educational Purposes==== | ||
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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. | 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)=== | ===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 [https://www.unemed.com/services/material-transfer UNeMed Material Transfer]. | 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. Researchers should reach out to both UNeMed and SPA with any questions at the outset of an MTA. For further information, see [https://www.unemed.com/services/material-transfer UNeMed Material Transfer]. | ||
===Export Control=== | ===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 [https://info.unmc.edu/safety/ehs-docs/export/Export_Control_Review_Form_UNMC_UNO_2019.pdf Request for Export Controls Review Application] must be submitted in advance to the [mailto:exportcontrol@unmc.edu Export Control Compliance Office], as the request takes time to research and process. Forms and other information are available at the [https://www.unmc.edu/academicaffairs/compliance/areas/export-control/Export-Shipping.html Transporting & Shipping Internationally website]. | 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 [https://info.unmc.edu/safety/ehs-docs/export/Export_Control_Review_Form_UNMC_UNO_2019.pdf Request for Export Controls Review Application] must be submitted in advance to the [mailto:exportcontrol@unmc.edu Export Control Compliance Office], as the request takes time to research and process. Forms and other information are available at the [https://www.unmc.edu/academicaffairs/compliance/areas/export-control/Export-Shipping.html Transporting & Shipping Internationally website]. | ||
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*[https://info.unmc.edu/safety/Export-Shipping.html International shipping information] | *[https://info.unmc.edu/safety/Export-Shipping.html International shipping information] | ||
*[https://info.unmc.edu/safety/ehs-docs/export/Export_Control_Review_Form_UNMC_UNO_2019.pdf Request for Export Controls Review Application] | *[https://info.unmc.edu/safety/ehs-docs/export/Export_Control_Review_Form_UNMC_UNO_2019.pdf Request for Export Controls Review Application] | ||
*[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Materials"] | *[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Materials"] | ||
*[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research"] | *[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research"] | ||
*[https://www.unmc.edu/academicaffairs/_documents/compliance/Infectious_Disease_Control_Policies.pdf UNMC College of Dentistry Infectious Disease Control Policy] | *[https://www.unmc.edu/academicaffairs/_documents/compliance/Infectious_Disease_Control_Policies.pdf UNMC College of Dentistry Infectious Disease Control Policy] | ||
*[https://www.unemed.com/services/material-transfer UNeMed Material Transfer] | *[https://www.unemed.com/services/material-transfer UNeMed Material Transfer] | ||
* | *Policy MS.11, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Removal of Specimens] | ||
*[https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral] | *[https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral] | ||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||
Revision as of 12:49, September 21, 2021
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Policy No.: 8013
Effective Date: 03/15/12
Revised Date: 09/21/21
Reviewed Date: 09/21/21
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 patients.
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.
Dental. In accordance with the UNMC College of Dentistry Infectious Disease Control Policy as revised December 2020, "extracted teeth or other removed body tissues may be given to the patient from whom they were removed if the patient requests them and are not subject to OSHA Bloodborne Pathogens Standard."
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 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 and Sponsored Programs Administration (SPA) with a request to have UNeMed or SPA 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 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. Researchers should reach out to both UNeMed and SPA with any questions at the outset of an MTA. 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 must be submitted in advance to the Export Control Compliance Office, as the request takes time to research and process. Forms and other information are available at the Transporting & Shipping Internationally website.
Additional Information
- Contact the Chief Compliance Officer
- Contact the Export Control Office
- UNMC Policy No. 8005, Export Control
- International shipping information
- Request for Export Controls Review Application
- UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Materials"
- UNMC Human Research Protection Program Policies & Procedures #7.2, "Use of Human Biological Material in Research"
- UNMC College of Dentistry Infectious Disease Control Policy
- UNeMed Material Transfer
- Policy MS.11, Removal of Specimens
- 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral
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