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IRB GUIDELINE VII
Biosafety Guideline for Handling of Human Blood & Tissue Samples

Numerous projects have been received for review by the human participants Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC) which involve the collection and subsequent analysis of human blood or other body fluids. Some proposals may even involve the use of human tissues. The IRB and IBC require that blood samples be obtained by qualified medical personnel and tissue samples be obtained by qualified medical personnel. The IBC is responsible for ensuring that University laboratory personnel are aware of the potential hazards of handling human blood/tissues and use the proper precautions to protect themselves from bloodborne diseases.

University Policy SY-24 defines human blood and blood products, human body fluids and human tissues as biohazardous materials. If an investigator decides to conduct research involving the aforementioned materials, the following steps must be taken:

  1. Submit a completed IBC Review Transmittal Sheet and supporting documentation to the Institutional Review Board (IRB) for review and approval.
  2. Once the project has been reviewed and approved, the laboratory where blood/tissues will be handled must be inspected by Environmental Health and Safety (EHS) Office.
  3. Contact the EHS for a copy of the "Universal Precautions" which address specific work practices to be followed when working with human blood/tissues.
  4. Arrange for ALL personnel who will handle human blood/tissues to receive training regarding bloodborne pathogens from EHS. Personnel will be offered the opportunity to be vaccinated against Hepatitis B at this time: if they refuse, a declination form must be signed.

If you have additional questions about the use of human blood/tissues, DER infectious waste disposal regulations, or other biosafety-related issues, please contact EHS at 865-6391. For further information concerning this guideline, please contact ORP at 865-1775 located in The 330 Building, Suite 205.

Approved: August 21, 2003