Human Gene Transfer (HGT) & Clinical Research
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 University of Virginia's IRB-HSR and the University of Virginia's IBC.
UVA information
UVA required training
Human Gene Transfer Introduction Training is required for persons who may be potentially exposed to the Human Gene Transfer product during the experiment. This module is available online.
NIH information
- Office of Science Policy (OSP) (NIH Guidelines)
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The follwoing can be found in the NIH Guidelines:
- Appendix M that describes HGT research requirements
- Describes HGT research requirements and Guidance for reporting adverse events to OSP
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). Environmental Health & Safety (EHS) at the University of Virginia 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. Epidemiology and Clinical Infectious Diseases (434-924-0327) manages employee safety in these areas
There are five essential elements in promoting employee safety awareness and compliance.
- 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:
- Log-in Medical Center BBP training through NetLearning
- Log-in EHS Research based BBP training
- 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:
- Academic research laboratory ECP found in the Biosafety e-Manual
- Medical Center Red Book ECP
- Create a new ECP with a template
- Medical services to provide post exposure evaluation, medical consultation, and Hepatitis B vaccine must be available. Sources of medical care may include:
- UVA-WorkMed (434-243-0075) for academic employees
- Employee Health at UVA (434-924-2013) for Medical Center employees
- A healthcare provider specifically use for occupational medical needs
- 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:
- UVA Environmental Health & Safety
- UVA Hospital Environmental Services
- Commercial Source such as Sci Med Waste Systems, Inc.
- Shipping Infectious Substances Training (if applicable)
- Training is required to ship human specimens by air
- (log-in) Shipping Infectious Substances Training (IATA/DOT)
- Required training for persons who ship Category A materials. Those who complete training must retain a training certificate (provided by EHS automatically upon completion) confirming that they passed the final exam.
- Category A materials include but are not limited to the following:
- cultures of Hepatitis B virus
- cultures of Mycobacterium tuberculosis
- cultures of Rabies virus
- culture of Coccidioides immitus
- culture of E. coli (verotixgenic strains VTEC, STEC, etc.)
- culture of Shigella dystenteriae type 1
- Variola virus (anything containing or suspected)
- Ebola virus (anything containing or suspected)
- Other Category A materials
- "Shipping Infectious Substances Training (IATA/DOT)" is valid for two years.
- (log-in) Shipping Category B, Dry Ice, and/or Exempt Specimens Training
- Required training for persons who ship ONLY shipping Category B Biological Substances, Dry Ice, and/or Exempt Human (or Animal) Specimens or a combination of these materials (applies to most UVA shippers).
- International shipments and permits are also offered in this module as an optional add-on of the training. Those who complete training must retain a training certificate (provided by EHS automatically upon completion) confirming that they passed the final exam.
- "Shipping Category B, Dry Ice, and/or Exempt Specimens Training" is valid for two years.
- Information for Transporting human specimens by ground
- 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.
