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Use of Human Anatomical Material: Difference between revisions
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# 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 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 about the deceased. Contact the Office of Regulatory Affairs for guidance on how to proceed. | ||
# Individuals shall complete an [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL Advanced Surgical Simulation Manager. | # Individuals shall complete an [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] and submit it to a UNMC Nebraska State Anatomical Board Representative or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form] and submit to the iEXCEL Advanced Surgical Simulation Manager. | ||
# 4.1) | # 4.1) Human Anatomical Material obtained from a UNMC Nebraska State Anatomical Board representative: 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 shall assist in obtaining anatomical material from a source unanimously approved by the Human Anatomical Tissue Review Committee. A copy of an approved request signed by a UNMC Nebraska State Anatomical Board Representative must accompany any requested human anatomical material. All requests for sessions at the Davis Global Center including University students will be made directly to the Nebraska State Anatomical Board by faculty lead. If human anatomical material are to be used in the Davis Global Center, transportation to and from the Center shall be arranged by a Nebraska State Anatomical Board member. 4.2) Human anatomical material obtained from the iEXCEL Human Anatomical Tissue Review Committee: Requests for human anatomical material for teaching and training purposes (not involving University students) within the Davis Global Center will be made to iEXCEL through submission of the iEXCEL Anatomical Material Request Form to the iEXCEL Manager, Advanced Surgical Simulation Operations. The iEXCEL Human Anatomical Tissue Review Committee requires completion of a Tissue Procurement Standards of Practice Agreement. 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 scheduled and received by the iEXCEL Manager, Advanced Surgical Simulation Operations and follow a strict receiving process (iEXCEL Surgical Specimen Receipt Flow). | ||
# 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 Advanced Surgical Simulation Manager 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, the department, the 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. | #A UNMC Nebraska State Anatomical Board Representative or the iEXCEL Advanced Surgical Simulation Manager 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, the department, the 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 the 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 the 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. | ||
# Anatomical material shall not be removed from approved campus facilities. | #Anatomical material shall not be removed from approved campus facilities. | ||
# Transporting Human Anatomical Material | #Transporting Human Anatomical Material | ||
::'''i.''' Human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to research laboratories in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation. All human anatomical material obtained from an approved outside source will be delivered directly to the Nebraska State Anatomical Board facility or the Dr. Edwin G. & Dorothy Balbach Davis Global Center. Human anatomical material obtained from iEXCEL Human Anatomical Tissue Review Committee will be scheduled and received by the iEXCEL Manager, Advanced Surgical Simulation Operations and follow a strict receiving process (iEXCEL Surgical Specimen Receipt Flow). | ::'''i.''' Human anatomical material obtained from a UNMC Nebraska State Anatomical Board representative shall be transported to and from the Nebraska State Anatomical Board to research laboratories in a UNMC-owned vehicle. If a UNMC vehicle is not available, the UNMC Anatomical Board Representative may approve alternative transportation. All human anatomical material obtained from an approved outside source will be delivered directly to the Nebraska State Anatomical Board facility or the Dr. Edwin G. & Dorothy Balbach Davis Global Center. Human anatomical material obtained from iEXCEL Human Anatomical Tissue Review Committee will be scheduled and received by the iEXCEL Manager, Advanced Surgical Simulation Operations and follow a strict receiving process (iEXCEL Surgical Specimen Receipt Flow). | ||
::'''ii.''' Anatomical material shall be placed in a primary container with a leak-proof seal that prevents leakage during collection, handling, processing, storage, transport or shipping. The primary container shall then be placed in a secondary leak resistant container that prevents leakage (i.e., a properly sealed zippable plastic bag (like ZIPLOC®, a properly sealed body bag with a minimum 6 mil. thickness or a properly sealed plastic bucket with a screw-on lid, locking lid or a leak-proof lid, disaster bag). The secondary container shall contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom, and sides of the primary container. The secondary container shall have a biohazard label affixed to the container. Frozen specimens, once placed in their secondary container, shall be placed in a cooler with a latchable lid and transported immediately. However, if the specimen is transported on dry ice, a Styrofoam cooler with the lid securely strapped or taped in place, or other container approved by Environmental Health and Safety, shall be used. The outside of the cooler shall be labeled "For Specimens Only" and shall have the biohazard symbol displayed in a prominent place on the container.<br /> | ::'''ii.''' Anatomical material shall be placed in a primary container with a leak-proof seal that prevents leakage during collection, handling, processing, storage, transport or shipping. The primary container shall then be placed in a secondary leak resistant container that prevents leakage (i.e., a properly sealed zippable plastic bag (like ZIPLOC®, a properly sealed body bag with a minimum 6 mil. thickness or a properly sealed plastic bucket with a screw-on lid, locking lid or a leak-proof lid, disaster bag). The secondary container shall contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom, and sides of the primary container. The secondary container shall have a biohazard label affixed to the container. Frozen specimens, once placed in their secondary container, shall be placed in a cooler with a latchable lid and transported immediately. However, if the specimen is transported on dry ice, a Styrofoam cooler with the lid securely strapped or taped in place, or other container approved by Environmental Health and Safety, shall be used. The outside of the cooler shall be labeled "For Specimens Only" and shall have the biohazard symbol displayed in a prominent place on the container.<br /> | ||
::'''iii.'''Whole bodies and/or larger human anatomical material (limbs) shall be placed in a primary container which is tightly closed and prevents leakage during collection, handling, processing, storage, transport or shipping (i.e., large plastic drum with a seal or screw-top lid or a plastic body bag 6 mil. or thicker). Note that if a plastic body bag is used, these bags are considered to be single-use devices. The primary container shall then be placed in a secondary container which shall prevent leakage (i.e. disaster bag, an air tray with a locking or secured lid). The secondary container shall also contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom and sides of the primary container. If an air tray is used for transport, it may be reused so long as no fluids from the body/anatomical material leak onto the box or the box is otherwise damaged. The secondary container shall have a biohazard label affixed to the container in a prominent place. Specimens shall be transported immediately.<br /> | ::'''iii.'''Whole bodies and/or larger human anatomical material (limbs) shall be placed in a primary container which is tightly closed and prevents leakage during collection, handling, processing, storage, transport or shipping (i.e., large plastic drum with a seal or screw-top lid or a plastic body bag 6 mil. or thicker). Note that if a plastic body bag is used, these bags are considered to be single-use devices. The primary container shall then be placed in a secondary container which shall prevent leakage (i.e. disaster bag, an air tray with a locking or secured lid). The secondary container shall also contain absorbent material (i.e., cellulose packing, thick paper towel or cotton wool) which shall be placed around the top, bottom and sides of the primary container. If an air tray is used for transport, it may be reused so long as no fluids from the body/anatomical material leak onto the box or the box is otherwise damaged. The secondary container shall have a biohazard label affixed to the container in a prominent place. Specimens shall be transported immediately.<br /> | ||
::'''iv.''' Transportation Documentation<br /> | ::'''iv.''' Transportation Documentation<br /> | ||
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:::'''a.''' Whole bodies. The delivery person shall hand-carry the [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] or [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.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 Manager.<br /> | :::'''a.''' Whole bodies. The delivery person shall hand-carry the [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] or [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.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 Manager.<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 /> | ||
::'''v.''' Use of Human Anatomical Material<br /> | ::'''v.''' Use of Human Anatomical Material<br /> | ||
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:::'''b.''' Staff shall follow the UNMC bloodborne pathogen standards and utilize standard Universal Precautions when handling human anatomical materials. Staff shall maintain a clean and sanitary work environment. All personnel coming in contact with or being exposed to the anatomical material must be listed on the appropriate anatomical material request form. The anatomical material may not be distributed to or handled by anyone who is not listed on the form. All lightly embalmed and fresh/frozen anatomical materials obtained from an outside source will have the serology results, including but not limited to HIV, hepatitis and NAT testing, sent to the department prior to shipping and accompany the anatomical material delivery. These serology results will be reported to the end-user prior to the use of any materials.<br /> | :::'''b.''' Staff shall follow the UNMC bloodborne pathogen standards and utilize standard Universal Precautions when handling human anatomical materials. Staff shall maintain a clean and sanitary work environment. All personnel coming in contact with or being exposed to the anatomical material must be listed on the appropriate anatomical material request form. The anatomical material may not be distributed to or handled by anyone who is not listed on the form. All lightly embalmed and fresh/frozen anatomical materials obtained from an outside source will have the serology results, including but not limited to HIV, hepatitis and NAT testing, sent to the department prior to shipping and accompany the anatomical material delivery. These serology results will be reported to the end-user prior to the use of any materials.<br /> | ||
:::'''c.''' Human anatomical material shall be secured within research or training facilities when staff are not present. Material shall be stored in the primary leak-proof container when not in use.<br /> | :::'''c.''' Human anatomical material shall be secured within research or training facilities when staff are not present. Material shall be stored in the primary leak-proof container when not in use.<br /> | ||
::'''vi.''' Disposition of Human Anatomical Material<br /> | ::'''vi.''' Disposition of Human Anatomical Material<br /> | ||
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:::'''a.''' All human anatomical material obtained from the Nebraska Anatomical Board shall be returned to the State Anatomical Board after use. All human anatomical material obtained by the State Anatomical Board or iEXCEL, from an outside source will be returned to the outside source or an approved crematorium. An accounting of returned material will be conducted. Any irregularities will be reported to the respective department chair and the Compliance Officer.<br /> | :::'''a.''' All human anatomical material obtained from the Nebraska Anatomical Board shall be returned to the State Anatomical Board after use. All human anatomical material obtained by the State Anatomical Board or iEXCEL, from an outside source will be returned to the outside source or an approved crematorium. An accounting of returned material will be conducted. Any irregularities will be reported to the respective department chair and the Compliance Officer.<br /> | ||
:::'''b.''' Body parts may not be distributed to anyone who is not listed on either an [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form].<br /> | :::'''b.''' Body parts may not be distributed to anyone who is not listed on either an [https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] or an [https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form].<br /> | ||
::'''vii.''' Program Inspection/Reporting Violations<br /> | ::'''vii.''' Program Inspection/Reporting Violations<br /> | ||