| BIOSAFETY/RECOMBINANT
DNA |
| |
| 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
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 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 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 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 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 |
