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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]] | [[International | [[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]]<br /> | ||
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Policy No.:'''8007'''<br /> | Policy No.: '''8007'''<br /> | ||
Effective Date: '''08/10/05'''<br /> | Effective Date: '''08/10/05'''<br /> | ||
Revised Date: ''' | Revised Date: '''07/16/21'''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''07/16/21'''<br /><br /> | ||
<big>'''Appropriate Use of Human Anatomical Material Policy'''</big> | <big>'''Appropriate Use of Human Anatomical Material Policy'''</big><br /><br /> | ||
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== Purpose == | == Purpose == | ||
The purpose of the Appropriate Use of Human Anatomical Material Policy is (1) to establish guidelines to account for all human anatomical material from deceased individuals during initial procurement and use through final disposition; (2) to ensure that use of human anatomical material meets [http://nebraskalegislature.gov/laws/statutes.php?statute=71-4825 Uniform Anatomical Gift Act], [http://www.osha.gov/SLTC/bloodbornepathogens/standards.html OSHA Bloodborne Pathogen Standard], and other state and federal regulatory standards for the safe and ethical treatment of human anatomical material; (3) to ensure proper handling of human anatomical material; and (4) to protect individuals handling or transporting human anatomical material/specimens from potential exposure to blood and/or body fluids. The [mailto:mailto:sarah.glodencarlson@unmc.edu Compliance Officer] of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy. | The purpose of the Appropriate Use of Human Anatomical Material Policy is (1) to establish guidelines to account for all human anatomical material from deceased individuals during initial procurement and use through final disposition; (2) to ensure that use of human anatomical material meets [http://nebraskalegislature.gov/laws/statutes.php?statute=71-4825 Uniform Anatomical Gift Act], [http://www.osha.gov/SLTC/bloodbornepathogens/standards.html OSHA Bloodborne Pathogen Standard], and other state and federal regulatory standards for the safe and ethical treatment of human anatomical material; (3) to ensure proper handling of human anatomical material; and (4) to protect individuals handling or transporting human anatomical material/specimens from potential exposure to blood and/or body fluids. The [mailto:mailto:sarah.glodencarlson@unmc.edu Compliance Officer] of the University of Nebraska Medical Center (UNMC) shall be responsible for implementing and monitoring compliance with this policy. | ||
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== Procedures == | == Procedures == | ||
===Procurement of Human Anatomical Material=== | ===Procurement of Human Anatomical Material=== | ||
# Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from a UNMC Nebraska State Anatomical Board Representative or iEXCEL<sup>SM</sup> | # Faculty, researchers and staff who need human anatomical material for educational or research purposes shall obtain it from a UNMC Nebraska State Anatomical Board Representative or iEXCEL<sup>SM</sup> Advanced Surgical Simulation Supervisor. Other methods for obtaining anatomical material are strictly prohibited. | ||
# Any research involving the use of human anatomical material from a living individual requires IRB approval (i.e. amputation, or some post-mortem uses when consent is obtained while the research subject is living). Refer to the [https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies]and UNMC Policy No. 8013, [[Human Tissue Use and Transfer]]. Research on cadavers does not require IRB approval. The IRB, however, does serve as the privacy board for the institution in the event that the researcher would receive protected health information (HIPAA) about the deceased. Contact the Office of Regulatory Affairs for guidance on how to proceed. | # Any research involving the use of human anatomical material from a living individual requires IRB approval (i.e. amputation, or some post-mortem uses when consent is obtained while the research subject is living). Refer to the [https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies]and UNMC Policy No. 8013, [[Human Tissue Use and Transfer]]. Research on cadavers does not require IRB approval. The IRB, however, does serve as the privacy board for the institution in the event that the researcher would receive protected health information (HIPAA) about the deceased. Contact the Office of Regulatory Affairs for guidance on how to proceed. | ||
# Individuals shall complete an [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL | # Individuals shall complete an [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL Advanced Surgical Simulation Supervisor. | ||
# Requests for human anatomical material will be made to the Nebraska State Anatomical Board. If a requested human anatomical material or human body segment cannot be supplied by the Nebraska Anatomical Board, a UNMC Nebraska State Anatomical Board Representative or iEXCEL | # Requests for human anatomical material will be made to the Nebraska State Anatomical Board. If a requested human anatomical material or human body segment cannot be supplied by the Nebraska Anatomical Board, a UNMC Nebraska State Anatomical Board Representative or iEXCEL Advanced Surgical Simulation Supervisor shall assist in obtaining anatomical material from a source approved by the UNMC Nebraska Anatomical Board Representative. A copy of an approved request signed by a UNMC Nebraska State Anatomical Board Representative or iEXCEL Advanced Surgical Simulation Supervisor must accompany any requested human anatomical material. | ||
# All human anatomical material shall be identified by the decedent identification number of origin. Identification tags should not be removed, unless temporary removal is necessary to conduct the test/procedure on the material. If identification tags are temporarily removed, the user shall establish another mechanism to account for the material (i.e. the container in which the material is maintained contains the identifier). The identification numbers shall be reaffixed to the material after the test or procedure is complete. If the recipient further subdivides human anatomical material, identification of parts must be maintained. Additional identification tags are available through the Nebraska Anatomical Board or iEXCEL. | # All human anatomical material shall be identified by the decedent identification number of origin. Identification tags should not be removed, unless temporary removal is necessary to conduct the test/procedure on the material. If identification tags are temporarily removed, the user shall establish another mechanism to account for the material (i.e. the container in which the material is maintained contains the identifier). The identification numbers shall be reaffixed to the material after the test or procedure is complete. If the recipient further subdivides human anatomical material, identification of parts must be maintained. Additional identification tags are available through the Nebraska Anatomical Board or iEXCEL. | ||
# A UNMC Nebraska State Anatomical Board Representative or the iEXCEL | # A UNMC Nebraska State Anatomical Board Representative or the iEXCEL Advanced Surgical Simulation Supervisor shall maintain a tracking system for human anatomical material, documenting the institutional source of the body or body part, fee schedules and charges of all third party providers, decedent identification number, department body or body part was provided to, purpose of the study, storage facility, estimated and actual date of return, authorization for cremation, and plan for final disposition. | ||
# Laboratories using human anatomical material shall maintain an inventory of material received. Inventory logs shall be retained in the department for three years after the return date of the last entry on each sheet. | # Laboratories using human anatomical material shall maintain an inventory of material received. Inventory logs shall be retained in the department for three years after the return date of the last entry on each sheet. | ||
# Costs associated with administration of this policy shall be paid by the requesting party. Costs may include, but are not limited to: procurement and disposition of body parts; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy. | # Costs associated with administration of this policy shall be paid by the requesting party. Costs may include, but are not limited to: procurement and disposition of body parts; development and maintenance of accounting systems; and inspections and other oversight activities necessary to comply with this policy. | ||
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::'''iv.''' Transportation Documentation<br /> | ::'''iv.''' Transportation Documentation<br /> | ||
:::'''a.''' Whole bodies. The delivery person shall hand-carry the [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] or [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form] with the donor numbers listed. Upon delivery, the donor numbers shall be checked against the actual donor identification. Any discrepancies shall be reported immediately to the Nebraska State Anatomical Board or the iEXCEL | :::'''a.''' Whole bodies. The delivery person shall hand-carry the [https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf Anatomical Tissue Request Form] or [https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf iEXCEL Anatomical Material Request Form] with the donor numbers listed. Upon delivery, the donor numbers shall be checked against the actual donor identification. Any discrepancies shall be reported immediately to the Nebraska State Anatomical Board or the iEXCEL Advanced Surgical Simulation Supervisor.<br /> | ||
:::'''b.''' Human Anatomical Material Specimens. The Anatomical Tissue Request Form or iEXCEL Anatomical Material Request Form and an itemized list of package contents shall be placed in a watertight receptacle (i.e. a zippable plastic bag or plastic container). These documents shall be placed in the secondary container. Documentation for transportation of human anatomical material should not be separated from the specimen during the transport process.<br /> | :::'''b.''' Human Anatomical Material Specimens. The Anatomical Tissue Request Form or iEXCEL Anatomical Material Request Form and an itemized list of package contents shall be placed in a watertight receptacle (i.e. a zippable plastic bag or plastic container). These documents shall be placed in the secondary container. Documentation for transportation of human anatomical material should not be separated from the specimen during the transport process.<br /> | ||