Human Tissue Use and Transfer: 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 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 Research Policy]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]]
[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[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 Research Policy]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]]
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Policy No.: '''8013'''<br />
Policy No.: '''8013'''<br />
Effective Date: '''03/15/2012'''<br />
Effective Date: '''03/15/2012'''<br />
Revised Date: ''' 07/09/18'''<br />
Revised Date: ''' 07/19/18'''<br />
Reviewed Date: '''09/09/18'''<br /><br />
Reviewed Date: '''09/19/18'''<br /><br />
<big>'''Human Tissue Use and Transfer Policy'''</big>
<big>'''Human Tissue Use and Transfer Policy'''</big>
== Policy ==
== Policy ==
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== Procedures ==
== Procedures ==
===Transfer for Clinical Purposes===
===Transfer for Clinical Purposes===
'''Medical.''' The Nebraska Medical Center Pathology Department has responsibility and authority over clinical use of tissue. Tissue may be transferred into and out of the Nebraska Medical Center campus in accordance with The Nebraska Medical Center policy MS.11, "Removal of Specimens". Patients may also request transfer of their tissue to another health care provider for clinical purposes in accordance with Policy MS.11.
'''Medical.''' The Nebraska Medical Center Pathology Department has responsibility and authority over clinical use of tissue. Tissue may be transferred into and out of the Nebraska Medical Center campus in accordance with The Nebraska Medical Center policy MS.11, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Removal of Specimens]. Patients may also request transfer of their tissue to another health care provider for clinical purposes in accordance with Policy MS.11.


All vendors providing pathology services to patients must be approved by The Nebraska Medical Center Board of Directors as recommended by the Medical Staff and as required by Joint Commission, CAP and CLIA standards. Health care providers who wish to utilize a new external pathology vendor must submit a proposal to the Director, Clinical Pathology. 
All vendors providing pathology services to patients must be approved by The Nebraska Medical Center Board of Directors as recommended by the Medical Staff and as required by Joint Commission, CAP and CLIA standards. Health care providers who wish to utilize a new external pathology vendor must submit a proposal to the Director, Clinical Pathology. 
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:iii. UNMC IRB Human Biological Material applications
:iii. UNMC IRB Human Biological Material applications
:Investigators will be required to contact [https://www.unemed.com/services/material-transfer UNeMed] with a request to have UNeMed complete a Material Transfer Agreement (MTA) for any planned tissue transfer. The MTA must be completed and signed by all relevant parties before the transfer can take place.
:Investigators will be required to contact [https://www.unemed.com/services/material-transfer UNeMed] with a request to have UNeMed complete a Material Transfer Agreement (MTA) for any planned tissue transfer. The MTA must be completed and signed by all relevant parties before the transfer can take place.
Investigators leaving UNMC. Investigators who leave UNMC are prohibited from taking tissue specimens or the resultant data with them unless they have prior written approval from their department chair, college dean, IRB chair (if IRB-regulated) and the Vice Chancellor for Research. Investigators will be required to complete a MTA and submit it to the UNeMed Office before tissue transfers can take place. The investigator must pay all the costs of transfer, unless the MTA specifies another source of payment.
===Use/Transfer for Educational Purposes===
===Use/Transfer for Educational Purposes===
====Use for UNMC Education====
====Use for UNMC Education====
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==Additional Information==
==Additional Information==
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]
*Contact the [mailto:mmorien@unmc.edu Export Control Compliance Officer]
*Contact the [mailto:kaschmidt@unmc.edu Export Control Compliance Officer]
*UNMC Policy No. 8005, [[Export Control]]
*UNMC Policy No. 8005, [[Export Control]]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ExportControlReviewFormShipping.pdf Request for Export Controls Review Application]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/ExportControlReviewFormShipping.pdf Request for Export Controls Review Application]
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*[https://www.unmc.edu/academicaffairs/_documents/compliance/Infectious_Disease_Control_Policies.pdf UNMC College of Dentistry Infectious Disease Control Policy]
*[https://www.unmc.edu/academicaffairs/_documents/compliance/Infectious_Disease_Control_Policies.pdf UNMC College of Dentistry Infectious Disease Control Policy]
*[https://www.unemed.com/services/material-transfer UNeMed Material Transfer]
*[https://www.unemed.com/services/material-transfer UNeMed Material Transfer]
*[https://secure.compliance360.com/Common/ViewUploadedFile.aspx?PD=PbRt%2bA78MS79PFVr3v7p1xWhDuaK2iMmj5IdmTNjZ57upUDClzamVCkQYmITQMO8CfujvSV8W4dVPdNGzO39KuJd2zeg12K8TSy3CGbpEmxgK3fLBvLhli3oPZrjXHZykKj7UZ%2b2AHrBjPTPiRaaz%2bWn%2bSxTV3NKi3zB76fsOrS96vS4t2khnaTA%2bZc%2bUvafFxh5m%2fTRwAL6uMOL%2fRbeX69UkPxHM%2fNT Nebraska Medicine Policy MS.11, Removal of Specimens]
*Nebraska Medicine Policy MS.11, [http://now.nebraskamed.com/?utm_source=default&utm_medium=ie&utm_campaign=now Removal of Specimens]
*[https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral]
*[https://www.govinfo.gov/app/details/CFR-2017-title42-vol5/CFR-2017-title42-vol5-sec493-1242 42 CFR § 493.1242 - Standard: Specimen submission, handling and referral]


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