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Human Gene Transfer (HGT) & Clinical Research

Human Gene Transfer (HGT)

Human gene transfer is the process of transferring genetic material (DNA or RNA) into a person. At present, human gene transfer is experimental and is being studied to see whether it could treat certain health problems by compensating for defective genes, producing a potentially therapeutic substance, or triggering the immune system to fight disease. Gene transfer is also being studied as a possible treatment for certain infectious diseases, such as AIDS. Gene Transfer experiments require review by the NIH Office of Biotechnology Recombinant DNA Advisory Committee (RAC), the University of Virginia IRB, and the IBC.

More sources of information

University of Virginia Biosafety Manual For Human Gene Therapy template.

Clinical Research

 

Bloodborne Pathogen Guidelines for Academic Personnel Engaged in Clinical Research

 

Certain clinical research activities, due to the location or nature of the research, do not require registration with the Institutional Biosafety Committee (IBC). For example, phlebotomy services associated with clinical research trials may be performed by academic employees either in a patient care setting or area outside of an academic research laboratory. In these instances, it is important that employees are informed of safe work practices, as well as requirements of the OSHA Bloodborne Pathogen regulations (29 CFR 1910.1030). The University of Virginia Office of Environmental Health & Safety (EHS) has created the following guidelines to assist personnel in these areas.

These guidelines are NOT for:

  • Employees who are included or listed on an IBC Inventory & Activity Registration (IAR)
  • Employees who are engaged in clinical research occurring exclusively in a patient care setting, such as the hospital, outpatient clinic, etc. The Hospital Epidemiology & Infection Control Division (924-0327) manages employee safety in these areas

There are five essential elements in promoting employee safety awareness and compliance.

  1. Annual Bloodborne Pathogens (BBP) training is required for employees that have potential exposure to blood or body fluids in the performance of assigned duties. Training may be acquired through the following sources:
    1. Medical Center BBP training through NetLearning
    2. EHS Research based BBP training
  2. Exposure Control Plan (ECP): Personnel must be familiar with a work-specific ECP that includes details about identifying personnel who may be exposed to bloodborne pathogens, compliance with the OSHA BBP standard, information about Hepatitis B vaccination, procedures to follow in case of an exposure to BBP, and methods to communicate hazards. The following ECP sources may apply:
    1. Academic research laboratory ECP found in Appendix A of the Biosafety Manual
    2. Medical Center ECP
    3. Create a new ECP with a template
  3. Medical services to provide post exposure evaluation, medical consultation, and Hepatitis B vaccine must be available. Sources of medical care may include:
    1. UVa-WorkMed (243-0075) for academic employees
    2. Employee Health at UVa (924-2013) for Medical Center employees
    3. A healthcare provider specifically use for occupational medical needs
  4. Regulated Medical Waste Service: Handling and disposal of regulated medical waste (e.g. sharps, etc.) must be compliant with OSHA and Virginia Department of Environmental Quality regulations. Waste must be managed by one of the following groups:
    1. UVa Environmental Health & Safety
    2. UVa Hospital Environmental Services
    3. Commercial Source such as Sci Med Waste Systems, Inc.
  5. Shipping Infectious Substances Training (if applicable)
    1. Training, available online, is required to ship human specimens
    2. Information for Transporting human specimens by ground
    3. Courtesy letter to use whenever you transport Exempt Patient and/or Exempt Animal Specimens
      • NOTE: The Courtesy letter should be used ONLY for human derived materials, including patient specimens. Category B cultures should be shipped by air or packaged as a Category B and transported by trained personnel or a certified courier. Category A shipments may NEVER be transported by ground. More information here.

     

    Contact EHS Biosafety for additional guidance or questions (434-982-4911).