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Human Tissue Use and Transfer: Difference between revisions
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Policy No.: '''8013'''<br /> | Policy No.: '''8013'''<br /> | ||
Effective Date: '''03/15/2012'''<br /> | Effective Date: '''03/15/2012'''<br /> | ||
Revised Date: ''' | Revised Date: ''' 07/09/18'''<br /> | ||
Reviewed Date: <br /><br /> | Reviewed Date: '''09/09/18'''<br /><br /> | ||
<big>'''Human Tissue Use and Transfer Policy'''</big> | <big>'''Human Tissue Use and Transfer Policy'''</big> | ||
== Policy == | == Policy == | ||
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===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. | '''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. | '''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." | '''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." | ||
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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 or the | 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 | 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 Material for Future Research" | :i. UNMC Human Research Protection Program Policies & Procedures #7.1, "Banking Human Biological Material for Future Research" | ||
:ii. UNMC Human Research Protection Program Policies & Procedures #7.2, "Human Biological Material Use in Research" | :ii. UNMC Human Research Protection Program Policies & Procedures #7.2, "Human Biological Material Use in Research" | ||
:iii. UNMC IRB Human Biological Material applications | :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. | :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 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 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==== | ||
: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 HGL, MGL and infection control policies) and | :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. | :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/ UNeMed]. | 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]. | ||
===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://www.unmc.edu/academicaffairs/_documents/compliance/ExportControlReviewFormShipping.pdf Request for Export Controls Review Application] should be submitted in advance to the [mailto:mmorien@unmc.edu Export Control Compliance Officer] as the request takes time to research and process. | 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://www.unmc.edu/academicaffairs/_documents/compliance/ExportControlReviewFormShipping.pdf Request for Export Controls Review Application] should be submitted in advance to the [mailto:mmorien@unmc.edu Export Control Compliance Officer] as the request takes time to research and process. | ||
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*[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.2, "Human Biological Material Use in Research"] (available with login on UNMC Research Support System server) | *[https://net.unmc.edu/rss/ UNMC Human Research Protection Program Policies & Procedures #7.2, "Human Biological Material Use in Research"] (available with login on UNMC Research Support System server) | ||
*[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 UNeMed] | *[https://www.unemed.com/services/material-transfer UNeMed Material Transfer] | ||
*[https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS79PFVr3v7p1xWhDuaK2iMmj5IdmTNjZ57upUDClzamVCkQYmITQMO8CfujvSV8W4dVPdNGzO39KuJd2zeg12K8TSy3CGbpEmxgK3fLBvLhli3oPZrjXHZykKj7UZ%2b2AHrBjPTPiRaaz%2bWn%2bSxTV3NKi3zB76fsOrS96vS4t2khnaTA%2bZc%2bUvafFxh5m%2fTRwAL6uMOL%2fRbeX69UkPxHM%2fNT Nebraska Medicine Policy MS.11, Removal of Specimens] | *[https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS79PFVr3v7p1xWhDuaK2iMmj5IdmTNjZ57upUDClzamVCkQYmITQMO8CfujvSV8W4dVPdNGzO39KuJd2zeg12K8TSy3CGbpEmxgK3fLBvLhli3oPZrjXHZykKj7UZ%2b2AHrBjPTPiRaaz%2bWn%2bSxTV3NKi3zB76fsOrS96vS4t2khnaTA%2bZc%2bUvafFxh5m%2fTRwAL6uMOL%2fRbeX69UkPxHM%2fNT Nebraska Medicine Policy MS.11, 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]. | ||