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Use of Human Anatomical Material: Difference between revisions
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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: draft 04/03/24<br /> | ||
Reviewed Date: | Reviewed Date: <br /><br /> | ||
<big>'''Appropriate Use of Human Anatomical Material Policy'''</big><br /><br /> | <big>'''Appropriate Use of Human Anatomical Material Policy'''</big><br /><br /> | ||
== Purpose == | == Purpose == | ||
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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) 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. | # Obtaining Human Anatomical Material | ||
:::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. | ||