Human Gene Transfer

Principal investigator:

  • Submits protocol for review by rDNA Committee prior to submission to IRB
  • Submits information requested in Appendix M of the NIH Guidelines for Research with recombinant and synthetic DNA molecules
  • Is trained in appropriate microbiological, safety and clinical practices
  • Ensures that all staff are trained in appropriate microbiological, safety and clinical practices
  • Reports adverse events to IRB, Institutional Biosafety Committee, FDA, NIH and DSMBs, as required by the policies of these groups
  • Makes initial determination of biosafety level and other appropriate precautions for the research
  • Reports problems, violations, accidents/illnesses to the Institutional Biosafety Committee
  • Complies with shipping requirements for all substances used in research

Other research personnel:

  • Are trained in appropriate microbiological, safety and clinical practices
  • Report problems, violations, accidents/illnesses to the Principal Investigator

Department/center/project financial officer: N/A

Department chair/center director:

  • Assures that project is in compliance with state, federal, sponsor and University of Utah policies and regulations regarding human gene transfer
  • Promotes University human gene transfer compliance efforts and programs in the school/college

Deans office/designee:

  • Promotes University research grants management compliance efforts and programs in the school/college

Executive administration:

  • Promotes University research grants management compliance efforts and programs
  • The Vice President for Research is responsible for policy regarding human gene transfer

Conflict of Interest committee: N/A

Environmental Health and Safety, Department:

  • Serves as the primary technical resource for the University research community regarding policies, procedures, and regulatory issues in human gene transfer and biosafety
  • Supports the institution research activities that require decontamination, or disposal of potentially hazardous and/or regulated material
  • Provides emergency response assistance to spills or other critical events involving potentially hazardous and/or regulated materials
  • Identifies training resources. In particular, supports the activities and membership of the Institutional Biosafety Committee
  • Conducts special risk assessments and provides recommendations on appropriate practices and facilities to conduct research safely and in compliance with regulatory requirements
  • Provides operational and/or technical support for the University research community
  • Identifies, monitors, and interprets local, state, and federal agency actions related to human gene transfer for implementation within the University research communit

Governmental Accounting and Support Services: N/A

Institutional Animal Care and Use Committee / Animal Resource Center: N/A

Institutional Review Board:

  • Requires Institutional Biosafety Committee review and approval prior to consideration of protocols

Office of Internal Audit: N/A

Radiological Health, Department: N/A

Institutional Biosafety Committee:

  • Reviews research for compliance with 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 Appendix M of 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 Human Gene Transfer study and/or adverse events
  • Notifies investigator of results of review
  • Requires that investigators seek review and approval of IRB for new, continuing and modified applications involving Human Gene Transfer
  • Chair reports problems, violations, accidents/illnesses to University of Utah and NIH/OBA within 30 days
  • Provides any information requested by IRB to facilitate review and approval
  • Consults with OBA/RAC for any experiments not explicitly covered in the Guidelines
  • Files annual report with OBA with roster and CVs of members

Office of Sponsored Projects:

  • Verifies Institutional Biosafety Committee review and approval as per agency requirements and University policies
  • Provides assurances of compliance with agency requirements and University policies regarding human gene transfer

Technology Transfer Office: N/A