University of Nebraska Medical Center

Use of Human Anatomical Material: 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 Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]] |[[Electronic Digital Signatures and Records]]<br />
[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]] |[[Electronic Digital Signatures and Records]] | [[Utilizing Generative AI|UNMC AI Use Guidelines]]<br />
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Policy No.: '''8007'''<br />
Policy No.: '''8007'''<br />
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Most research involving the use of human anatomical material from a living individual requires IRB approval. The Office of Regulatory Affairs should be contacted prior to initiating any research using tissue from living individuals. Refer to the [https://net.unmc.edu/rss/auth.php UNMC Guidelines for the Protection of Human Subjects in Research] Studies and UNMC Policy No. 8013, [https://wiki.unmc.edu/index.php/Human_Tissue_Use_and_Transfer Human Tissue Use and Transfer]. Research on whole body donors does not require IRB approval; however, the IRB, does serve as the privacy board for the institution if the researcher would receive protected health information about the deceased.
Most research involving the use of human anatomical material from a living individual requires IRB approval. The Office of Regulatory Affairs should be contacted prior to initiating any research using tissue from living individuals. Refer to the [https://net.unmc.edu/rss/auth.php UNMC Guidelines for the Protection of Human Subjects in Research] Studies and UNMC Policy No. 8013, [https://wiki.unmc.edu/index.php/Human_Tissue_Use_and_Transfer Human Tissue Use and Transfer]. Research on whole body donors does not require IRB approval; however, the IRB, does serve as the privacy board for the institution if the researcher would receive protected health information about the deceased.
==Background==
The Uniform Anatomical Gift Act regulates the donation of dead bodies or parts of bodies for transplantation, education and research. There are three types of anatomical gifts: tissue donation including blood, organ donation and whole body donation. The Nebraska State Anatomical Board, located at UNMC, is responsible for the Body Donation Program for the State of Nebraska. UNMC shall follow guidelines set by the Nebraska State Anatomical Board for the use of human anatomical material.
iEXCEL will obtain human anatomical material, for training sessions (not involving University of Nebraska Medical Center students) through vendors approved by the iEXCEL Human Anatomical Tissue Review Committee and that have signed the [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-policies/iexcel-tissue-procurement-standards-of-practice-agreement.pdf iEXCEL Tissue Procurement Standards of Practice Agreement].<br />
The Occupational Safety and Health Act (OSHA) Bloodborne Pathogen Standard (BBP) specifies precautions that shall be observed to prevent contact with blood or other potentially infectious materials. Precautions include use of personal protective equipment (PPE) and implementing engineering and work practice controls. Staff shall follow BBP standards when handling human anatomical material.
== Definitions ==
== Definitions ==


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Faculty, researchers, and staff who need human anatomical material for educational or research purposes shall obtain it via one of the two ways listed below. All other methods for obtaining human anatomical material are strictly prohibited.
Faculty, researchers, and staff who need human anatomical material for educational or research purposes shall obtain it via one of the two ways listed below. All other methods for obtaining human anatomical material are strictly prohibited.


#The submission of a completed Anatomical Tissue Request Form to a UNMC Nebraska State Anatomical Board Representative.
1.The submission of a completed Anatomical Tissue Request Form to a UNMC Nebraska State Anatomical Board Representative.
#*A UNMC Nebraska State Anatomical Board Representative may obtain human anatomical material from the Nebraska State Anatomical Board.
*A UNMC Nebraska State Anatomical Board Representative may obtain human anatomical material from the Nebraska State Anatomical Board.
#*If the proximity of the research or educational facility requires vehicle transport, human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to a research or educational facility in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation.
*If the proximity of the research or educational facility requires vehicle transport, human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to a research or educational facility in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation.
#* A UNMC Nebraska State Anatomical Board Representative shall maintain a tracking system for the obtained human anatomical material.
* A UNMC Nebraska State Anatomical Board Representative shall maintain a tracking system for the obtained human anatomical material.
#*Disposition will include the return of all human anatomical material obtained to the Nebraska State Anatomical Board.
*Disposition will include the return of all human anatomical material obtained to the Nebraska State Anatomical Board.
#*Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to: procurement and disposition of the human anatomical material, development and maintenance of accounting systems, and inspections and other oversight activities necessary to comply with this policy.
*Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to: procurement and disposition of the human anatomical material, development and maintenance of accounting systems, and inspections and other oversight activities necessary to comply with this policy.
2. The submission of a completed iEXCEL Anatomical Material Request Form to the iEXCEL Advanced Surgical Simulation Manager.  
2. The submission of a completed iEXCEL Anatomical Material Request Form to the iEXCEL Advanced Surgical Simulation Manager.  


**The iEXCEL Advanced Surgical Simulation Manager will obtain human anatomical material from sources approved by the iEXCEL Human Anatomical Tissue Review Committee. The iEXCEL Human Anatomical Tissue Review Committee requires a Tissue Procurement Standards of Practice Agreement from each approved source for tissue.
* The iEXCEL Advanced Surgical Simulation Manager will obtain human anatomical material from sources approved by the iEXCEL Human Anatomical Tissue Review Committee. The iEXCEL Human Anatomical Tissue Review Committee requires a Tissue Procurement Standards of Practice Agreement from each approved source for tissue.
** A copy of an approved request, signed by the iEXCEL Manager of Advanced Simulation Operations, must accompany any requested human anatomical material.
 
** All human anatomical material will be ordered and received by the iEXCEL Manager, Advanced Surgical Simulation Operations as described on the iEXCEL Surgical Specimen Receipt Flow. All human anatomical material obtained will be delivered directly to the Dr. Edwin G. & Dorothy Balbach Davis Global Center. All human anatomical material will be confirmed and itemized when received. Any discrepancies shall be reported immediately to the iEXCEL Advanced Surgical Simulation Manager and the tissue supplier.
* A copy of an approved request, signed by the iEXCEL Manager of Advanced Simulation Operations, must accompany any requested human anatomical material.
** The iEXCEL Advanced Surgical Simulation Manager shall maintain a tracking system for human anatomical material, documenting the institutional source of the whole body or human body segment(s), fee schedules and charges of all third-party providers, decedent identification number, the department the anatomical material was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition.
* All human anatomical material will be ordered and received by the iEXCEL Manager, Advanced Surgical Simulation Operations as described on the iEXCEL Surgical Specimen Receipt Flow. All human anatomical material obtained will be delivered directly to the Dr. Edwin G. & Dorothy Balbach Davis Global Center. All human anatomical material will be confirmed and itemized when received. Any discrepancies shall be reported immediately to the iEXCEL Advanced Surgical Simulation Manager and the tissue supplier.
** Disposition of all human anatomical will include the use of a local crematorium approved by the iEXCEL Human Anatomical Tissue Review Committee. Accounting and return of cremated human anatomical material, to the institutional source of the human anatomical material, will be conducted by the iEXCEL Advanced Surgical Simulation Manager.
* The iEXCEL Advanced Surgical Simulation Manager shall maintain a tracking system for human anatomical material, documenting the institutional source of the whole body or human body segment(s), fee schedules and charges of all third-party providers, decedent identification number, the department the anatomical material was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition.
** Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to procurement and disposition of the human anatomical material; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy.
* Disposition of all human anatomical will include the use of a local crematorium approved by the iEXCEL Human Anatomical Tissue Review Committee. Accounting and return of cremated human anatomical material, to the institutional source of the human anatomical material, will be conducted by the iEXCEL Advanced Surgical Simulation Manager.
* Costs associated with the administration of this policy shall be paid by the requesting party. Costs may include but are not limited to procurement and disposition of the human anatomical material; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy.


===Transportation of Human Anatomical Material===
===Transportation of Human Anatomical Material===
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==Additional information==
==Additional Information==
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], 402-559-9576 or 402-559-6767
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer], 402-559-9576 or 402-559-6767
*[https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form]  
*[https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form]  
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