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Use of Human Anatomical Material: Difference between revisions
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updated Anatomical Tissue Request Form https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf to https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf and iEXCEL Anatomical Material Request Form https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf to https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf
(removed double mailto: on Compliance Officer link) |
m (updated Anatomical Tissue Request Form https://www.unmc.edu/academicaffairs/_documents/compliance/AnatomicalTissueRequestForm.pdf to https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf and iEXCEL Anatomical Material Request Form https://www.unmc.edu/academicaffairs/_documents/compliance/iEXCELAnatomicalMaterialRequestForm.pdf to https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf) |
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# 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. | # 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/ | # 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 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 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. | # 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. | ||
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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/ | :::'''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 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 /> | ||
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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/ | :::'''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 /> | ||
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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/ | *[https://www.unmc.edu/iexcel/_documents/anatomical-tissue-request-form.pdf Anatomical Tissue Request Form] | ||
*[https://www.unmc.edu/ | *[https://www.unmc.edu/iexcel/_documents/iexcel-anatomical-material-request-form.pdf iEXCEL Anatomical Material Request Form] | ||
*[https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies] | *[https://net.unmc.edu/rss/ UNMC Guidelines for the Protection of Human Subjects in Research Studies] | ||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||