HUMAN GENE TRANSFER |
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| 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 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
|
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| Other research personnel:
|
- Are trained in appropriate microbiological, safety and
clinical practices
- Report problems, violations, accidents/illnesses to the
Principal Investigator
|
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| Department/center/project
financial officer: N/A |
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| 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
|
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| 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
|
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| 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
|
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| 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 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 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
|
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| 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
|
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| Technology Transfer
Office: N/A |
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