Animal welfare:

• Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules
• Advises the IACUC on the appropriate procedures for safe conduct of animal use involving recombinant DNA
• Conducts joint training programs for research personnel using recombinant DNA

Biosafety/Recombinant and Synthetic DNA Molecules:

• Reviews research involving gene transfer
• Reviews research involving viruses, bacteria, parasites
• Reviews research for compliance with the NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
  • Assessment of facilities, procedures and practices
  • Assessment of training/expertise of personnel
• Ensures that investigator has addressed issues in the NIH Guidelines for Research with recombinant and synthetic DNA molecules
• Facilitates development of and approves a study-specific Human Gene Transfer Research Plan
• Notifies investigator of results of review/approval
• Reviews submitted adverse events
• Refers to IRB, OBA, etc. any concerns regarding conduct of the HGT study and/or adverse events
• Notifies investigator of results of review
• Requires that investigators seek review and approval from the IRB for new, continuing and modified applications involving Human Gene Transfer
• Provide any information requested by the IRB to facilitate review and approval
• Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
• Files annual report with OBA with roster and CVs of members
• Reports problems, violations, accidents/illnesses to the University of Utah and NIH/OBA within 30 days

Conflict of interest: N/A

Data and safety monitoring: N/A

Education and training:

• Conducts joint training with IACUC for research personnel using recombinant DNA in animal studies

Environmental health and safety:

• Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
  • Assessment of containment level required
  • Assessment of facilities, procedures and practices
  • Assessment of training/expertise of personnel
• Notifies investigator of results of review
• Provides any information requested by IACUC, IRB to facilitate review and approval
• Refers issues involving animal or human subjects to IACUC or IRB
• Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
• Chair reports any problems, violations, accidents/illnesses to the University of Utah and NIH/OBA within 30 days

Financial management of research: N/A

Human gene transfer:

• Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
  • Assessment of containment level required
  • Assessment of facilities, procedures and practices
  • Assessment of training/expertise of personnel
• Notifies investigator of results of review
• Provides any information requested by IRB to facilitate review and approval
• Refers issues involving human subjects to IRB
• Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
• Chair reports problems, violations, accidents/illnesses to University of Utah and NIH/OBA within 30 days

Human subjects:

• Reviews research for compliance with NIH Guidelines for Research with recombinant and synthetic DNA molecules which includes:
  • Assessment of containment level required
  • Assessment of facilities, procedures and practices
  • Assessment of training/expertise of personnel
• Notifies investigator of results of review
• Provides any information requested by IRB to facilitate review and approval
• Refers issues involving human subjects to IRB
• Consults with OBA/RAC for experiments not explicitly covered in the Guidelines
• Provides any information requested by IRB to facilitate review and approval

Human tissue samples: N/A

Patents and inventions: N/A

Radiation safety: N/A

Sponsored projects administration:

• Provides assurance of review and approval of any protocol using recombinant DNA

Last updated: 09/09/2004