Treatment of Human Anatomical Specimens

This policy is intended to ensure the appropriate and ethical treatment, handling, and final disposition of Human Anatomical Specimens used in instruction and research at the University of Wisconsin-Milwaukee.

1. This policy applies to all Human Anatomical Specimens of any origin except as specifically excluded below. 
2. This policy does not apply to:  
   • Archaeological and Cemetery Remains; 
   • Embryos and stem cells; 
   • Blood, tissue, or other materials that were removed while a person was still alive or specimens naturally shed from a living human, such as teeth, hair and nails removed from a person while that person is alive;  
   • Body fluids, such as blood, removed from a Cadaver; and 
   • Specimens used in forensic work. 

Archaeological and Cemetery Remains: Human skeletal remains over 50 years old excavated or removed from an archaeological site and/or cemetery. 

Cadaver: A dead human body. 

Human Anatomical Specimens:  

• For purposes of this policy, “Human Anatomical Specimens” includes Cadavers and portions (including limbs, organs, bones, tissue samples, and other specimens) of Cadavers, except Archaeological and Cemetery Remains and as excluded in Scope Section b above.  
• If there is uncertainty as to whether a specimen constitutes Human Anatomical Specimens for purposes of this Policy, US&A must be consulted. 

NAGPRA: Native American Graves and Repatriation Act, 25 U.S.C. Chapter 32 and 43 CFR Part 10 

Procurement Office: University unit responsible for review and approval of a submitted requisition for issuing a purchase order. 

Specimen Custodian: The individual responsible for the oversight and care of the Human Anatomical Specimens. 

University: The University of Wisconsin – Milwaukee. 

University Premises: Facilities under the control of the University. 

US&A: Office of University Safety & Assurances – the unit responsible for maintaining records of all Human Anatomical Specimens in use on University Premises. 

1. Guiding Principles 
   1. Human Anatomical Specimens must be treated with the utmost respect and care at all times. The body of a human donor is a valuable gift. It should be considered a rare privilege to work with Human Anatomical Specimens. 
   2. When working with Human Anatomical Specimens, respectful recognition of the individual and their donation is encouraged to honor the gift body donors made to help advance scientific education and research. 
   3. When possible, alternate methods of instruction and research should be employed that do not require the use of Human Anatomical Specimens, such as models or digital resources. Human Anatomical Specimens should be used only when there is no comparable substitute available. 
   4. Human Anatomical Specimens subject to NAGPRA may not be accepted without Chancellor approval. Such remains are subject to UW System Administrative Policy 645 and UWM SAAP 14-08: Native American Graves Protection and Repatriation Act (NAGPRA) Compliance, and related University policies and procedures. Upon identifying Human Anatomical Specimens as potentially subject to NAGPRA, research on such specimens must immediately cease, and applicable NAGPRA policies must be followed. 
2. Oversight and Responsible Parties 
   1. Campus wide – US&A will have centralized oversight of all Human Anatomical Specimens on campus, including the following responsibilities: 
      1. Maintain central documentation of all Human Anatomical Specimens in use on University Premises. 
      2. Ensure individuals and units procuring Human Anatomical Specimens have the appropriate approvals from their Dean, Associate Dean, and Department Chair, when applicable, or such parties’ designees, and that a properly trained Specimen Custodian is identified. 
      3. Periodically inspect any spaces where Human Anatomical Specimens are used or stored to confirm compliance with policy, applicable rules, and protocols. 
   2. Department and laboratory 
      1. All Human Anatomical Specimens must be assigned a Specimen Custodian who will have primary responsibility for care, oversight, and compliance with policy, rules, and protocols, including security and appropriate handling. This individual will accept direct responsibility for reporting the acquisition and disposition of Human Anatomical Specimens to US&A.  
   3. Backup and succession 
      1. Each Specimen Custodian must have at least one designated backup with knowledge of the Human Anatomical Specimens under the Specimen Custodian’s oversight and all policies and procedures related thereto. This individual must be sufficiently trained to perform the role of Specimen Custodian as needed.  
3. Acquisition 
   1. Human Anatomical Specimens may only be obtained from ethical sources which, at minimum, obtained prior consent from the donor, their next of kin, or an individual holding power of attorney or similar authority over their affairs.  
      1. Human Anatomical Specimens may only be acquired from ethically operated body donor programs. The source organization must have clear methods for ethically accepting body donations and should provide cadavers for research or educational purposes only. 
      2. Human Anatomical Specimens purchased from third parties may only be acquired from entities that acquire such materials in a legal and ethical manner and can establish the provenance of such materials upon request to demonstrate such appropriate acquisition. This acquisition process should confirm that NAGPRA does not apply to such specimens.  
      3. Determinations regarding the propriety of a particular source require the requestor to collect the appropriate documentation, then consult with US&A, Procurement, the Office of Legal Affairs, and other units as appropriate. US&A may create and maintain a pre-approved list of known ethical sources based on such consultations; however, such list must be regularly reviewed to confirm continued ethical practices. 
   2. All purchases of Human Anatomical Specimens must be completed via the University Procurement Office to ensure appropriate procurement and tracking procedures are followed. Human Anatomical Specimens may not be purchased using P-Card or Direct Payments. The requestor must notify US&A upon initiation of a purchase. 
   3. Upon proposed donation of Human Anatomical Specimens, the Specimen Custodian must notify US&A in advance of processing and accepting the donation. The proposed donation must be vetted and processed through the University’s procedure for accepting non-monetary gifts-in-kind, and US&A, in consultation with other campus departments as needed (e.g. Procurement, Legal Affairs, Risk Management, etc.), will determine if additional approvals or documentation are needed on a case-by-case basis. 
   4. Human Anatomical Specimens may not be acquired or accepted without utilizing the protocols described above. 
4. Security, Maintenance, and Handling 
   1. Any unit maintaining Human Anatomical Specimens shall maintain rules and procedures for the care and use of such specimens.  
   2. For the duration of the presence of Human Anatomical Specimens on University Premises, the applicable Specimen Custodian shall be responsible for maintaining all documentation described herein. 
   3. Human Anatomical Specimens shall be stored in conditions that are actively managed and monitored to ensure the applicable maintenance and security requirements are met. 
   4. Human Anatomical Specimens may only be displayed with the consent of the Specimen Custodian. Prior to granting such consent, the Specimen Custodian must consider: 
      1. Any legal restrictions or cultural sensitivities prohibiting such display; and 
      2. Sensitivities of potential audiences, including consideration of how to prepare visitors to view such remains and warnings or alternatives for those who do not wish to view these. 
   5. Human Anatomical Specimens must be transported in a respectful and discreet manner. The space should be well prepared to receive the specimen. All appropriate security measures, laboratory equipment, and written procedures should be in place before the specimen arrives. Transport between rooms or buildings should be minimized. 
   6. Human Anatomical Specimens must be kept in limited access, secure spaces at all times. No photography is permitted except for specific research or educational purposes, with permission of the Specimen Custodian, and only if not prohibited by applicable law, cultural sensitivities, or contractual obligations. 
   7. Guests and visitors must have a specific scientific or educational purpose for entering the space to view the Human Anatomical Specimens, and such access must have prior authorization from the Specimen Custodian. 
   8. All tissue and materials from a single human must be kept together with proper labeling. Tissue may not be discarded without the prior authorization of the Specimen Custodian and US&A. 
   9. Before authorizing the loan of Human Anatomical Specimens to any other institution, the Specimen Custodian must consult with US&A and the Office of Legal Affairs and acquire sufficient documentation to ensure the borrower will satisfy the applicable legal, contractual, ethical, and practical obligations of holding such Human Anatomical Specimens. 
   10. Training and Compliance 
   11. Individuals accepting Human Anatomical Specimens must have sufficient training and experience, as determined by their department and College and approved by US&A, to handle the specimen safely and respectfully.  
   12. Clear guidelines and procedures for handling Human Anatomical Specimens must be readily accessible at all times in the areas where such materials are stored and utilized. 
   13. Individuals handling Human Anatomical Specimens must comply with all applicable regulations and policies governing laboratory safety, hazardous chemicals, hazardous waste, and biohazardous materials on campus. 
5. Documentation 
   1. The Specimen Custodian shall collect and maintain the following documentation for all Human Anatomical Specimens utilized on University Premises: 
      1. Requestor name, contact information, course/program, and purpose for requested use; 
      2. Backup person name and contact information; 
      3. Donor ID number if applicable; 
      4. Provenance; 
      5. Date of arrival on campus, if known. For existing collections, the best approximate arrival date if the exact date is unknown; 
      6. All laboratory and storage locations on campus where the Human Anatomical Specimens will be used and stored, along with the physical security measures in place for each location; 
      7. A copy of any contractual obligations or terms associated with the procurement; 
      8. Invoice / receipt and PO number, if applicable; 
      9. Disposition plan, including date or triggering event and manner of return or other disposition; and 
      10. For any continuously retained materials, appropriate documentation of the supplier’s agreement to this retention.  
   2. The Specimen Custodian must provide copies of the above-required documentation to US&A including providing updated documentation within five business days of any such revisions.  
   3. US&A will maintain the above-referenced documentation in a central online repository. 
   4. Documentation referred to in Section 6 must be retained for the maximum period required by applicable records schedules and, at minimum, for as long as the University holds the Human Anatomical Specimens. 
6. Existing Holdings 
   1. US&A shall periodically, in its discretion: 
      1. Require University units to conduct surveys and outreach within their units to determine any Human Anatomical Specimens holdings; and 
      2. Require University units utilizing Human Anatomical Specimens to confirm continuing compliance with this policy. 
   2. Human Anatomical Specimens acquired prior to implementation of this policy must be assigned a Specimen Custodian within ten (10) business days after the longer of i) the effective date of this policy, and ii) the discovery of such holdings. Such Human Anatomical Specimens remain subject to all provisions of this policy, and the Specimen Custodian shall, in consultation with US&A, oversee implementation of the necessary steps to achieve such compliance. Documentation of existing holdings shall rely on the best information available based on a comprehensive review by the Specimen Custodian and applicable unit.   
   3. Continued maintenance of Human Anatomical Specimens in a unit requires the unanimous approval of the unit’s Dean, Associate Dean, and Department Chair, when applicable, or such parties’ designees, and US&A. In the absence of such approvals, disposition must be pursued. 
7. Disposition 
   1. The following methods of disposition are appropriate for Human Anatomical Specimens: 
      1. Return to the body donor program from which the specimen was acquired; 
      2. Transfer to another approved Specimen Custodian, after approval by US&A;  
      3. Transfer to an external organization, after approval by US&A, Legal Affairs, and in accordance with any applicable regulations and policies governing such transfer. 
   2. US&A must be notified of the disposition and provided copies of any records documenting the return or transfer.  
8. Consequences of Non-Compliance 
   1. Failure to comply with this policy may result in the following: 
      1. Denial of future requests to acquire, maintain, or utilize Human Anatomical Specimens, including requirements to divest existing specimens; 
      2. Disciplinary action, including termination of employment; and 
      3. Criminal referrals.