National NeuroHIV Tissue Consortium

Data Coordinating Center

SPECIMEN USER AGREEMENTS

## Human Tissue Handling Risks and Safety Precautions Statement

Working with human tissue carries the potential risk of exposure to infectious diseases that may be communicable to other humans. All human brain tissue should be treated as a potential contamination risk for certain diseases and should be handled with extreme care. Infectious agents that have been identified as possible risks include, but may not be limited to, Human Immunodeficiency Virus (HIV-1, HIV-2), Hepatitis-B and Creutzfeldt-Jakob disease. Although a relatively rare disease entity, Creutzfeldt- Jakob disease has been reported to be able to remain infectious for long periods of time in fixed tissue and it may withstand standard autoclave sterilization procedures.

It is recommended that universal precautions be followed when working with human tissues irrespective of the method of tissue preparation. Investigators are encouraged to incorporate double gloving, appropriate protective garments, and face or eye protection when working with tissue. Disposable instruments and/or an effective regimen of appropriate decontamination should be used routinely. All waste material should be considered as a biohazard. Waste should be disposed of according to your institution's policy for handling such material, which may include incineration, autoclaving and burial, or other approved methods. All laboratory staff that will be working with human tissues should be trained in the proper and approved methods of handling of such specimens.

The NNTC collects HIV negative and HIV positive tissue specimens representative of a wide variety of additional diagnoses from across the United States. The NNTC does not guarantee that any of the donors of specimens were not exposed to or infected by potentially transmissible infectious agents. Ultimately, it is the responsibility of the recipient investigator to ensure that proper, safe handling techniques are employed by all laboratory staff in handling human tissue.

### PLEASE READ AND SIGN THE FOLLOWING STATEMENT:

I have read the Human Tissue Handling Risks & Safety Precautions Statement, and I understand the potential safety risk in handling human tissue and acknowledge these safety precautions and recommendations as essential to my safe handling of specimens.

As the Investigator of Record, I accept full responsibility to ensure that proper, safe handling techniques are employed in my laboratory when working with human tissue, and further accept responsibility to train staff in approved and customary safe handling techniques before they work with these tissues.

I understand that NNTC distributes specimens known to have been exposed to or infected with agents such as, but not limited to, HIV (HIV-1, HIV-2), Hepatitis-B or Creutzfeldt-Jakob disease, and I understand that the NNTC is unable to guarantee that any of its tissue donors were not exposed or infected with such agents.

As the Investigator of Record, I accept full responsibility to ensure that all necessary institutional approvals are in place prior to receipt of any NNTC specimens.

Version 9.0 Page 1 of 6 04 June 2024