Biosafety/Recombinant and Synthetic DNA Molecules

Principal investigator:

  • Obtains all necessary reviews and approvals for project
  • Obtains all necessary training and/or certifications
  • Ensures that project personnel participate in relevant training
  • Requests operational and/or technical support as necessary
  • Ensures completion of University of Utah Registration of Materials Potentially Infections to Humans form, where applicable
  • Ensures registration of research involving the use of materials potentially infectious to humans with the Department of Environmental Health & Safety
  • Determines if proposed research requires review and approval of Institutional Biosafety Committee
    • If review required, submits information requested in the NIH Guidelines for Research with recombinant and synthetic DNA molecules to committee
  • If required, submits Biological Materials Registration Form for proposed research to Institutional Biosafety Committee
  • Is trained in appropriate microbiological, safety and clinical practices
  • Ensures that research staff is trained in appropriate microbiological, safety and clinical practices
  • Reports adverse events to the Institutional Biosafety Committee, IRB, NIH and DSMBs, as required by the policies of those organizations
  • Reports problems, violations and staff accidents/illnesses to Institutional Biosafety Committee as soon as possible but no later than 30 days after occurrence
  • Complies with shipping requirements for recombinant and synthetic DNA molecules

Other research personnel:

  • Obtain all necessary training (e.g. microbiological, safety and clinical practices) and/or certifications
  • Follow required practices and procedures
  • Reports safety, fire, and health hazards, environmental deficiencies, problems, violations, and accidents/injuries and illnesses to the Principal Investigator or designee

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 biosafety and use of recombinant DNA
  • Follow required practices and procedures
  • Promotes University compliance efforts and programs regarding research biosafety and recombinant DNA in department/center, as relevant

Deans office/designee:

  • Promotes University compliance efforts and programs regarding research biosafety and recombinant DNA in college/school

Executive administration:

  • The Vice President for Administrative Services is responsible for matters of policy regarding biosafety and recombinant DNA in research, and for operation of the Institutional Biosafety Committee
  • Promotes University compliance efforts and programs regarding biosafety and recombinant DNA

Conflict of Interest committee: N/A

Environmental Health and Safety, Department:

  • Notifies investigators of responsibility to register research
  • Reviews research for compliance with NIH Guidelines for Research Involving recombinant and synthetic DNA molecules (Institutional Biosafety Committee) and CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) which includes:
    • Assessment of containment level required
    • Procedures and practices
    • Training/expertise of personnel
  • Notifies investigator of results of review
  • Refers issues involving animals to the IACUC, human subjects to the IRB
  • Staff serve as members of Institutional Biosafety Committee

Governmental Accounting and Support Services: N/A

Institutional Animal Care and Use Committee / Animal Resource Center:

  • Biosafety Subcommittee reviews protocols with identified biosafety issues, advises IACUC
  • Requires registration of use of viruses, parasites, bacteria, as appropriate, for all protocols using animals
  • Requires classification of biosafety levels, as appropriate, on submitted protocols
  • Requests advice on appropriate procedures for safe conduct of animal use involving infectious agents and recombinant DNA
  • Requires Insititutional Biosafety Committee review and approval of research using recombinant DNA

Institutional Review Board:

  • Requests counsel on biosafety issues regarding human subjects from Department of Environmental Health & Safety
  • Resolves issues regarding human subjects referred by Department of Environmental Health and Safety
  • Requires Insititutional Biosafety Committee review and approval of research using recombinant DNA

Office of Internal Audit: N/A

Radiological Health, Department: N/A

Institutional Biosafety Committee:

  • Reports problems, violations, accidents/illnesses to the University of Utah and NIH/OBA within 30 days
  • 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

Office of Sponsored Projects:

  • Verifies Institutional Biosafety Committtee review and approval as per agency requirements and University biosafety, recombinant DNA, and environmental health and safety policies
  • Provides assurances of compliance with agency requirements and University policy regarding biosafety and rDNA use

Technology Transfer Office: N/A

Last updated: 09/09/2004