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THE OFFICE OF RESEARCH
RESEARCH INVESTIGATOR HANDBOOK
3. OBTAINING REGULATORY COMMITTEE APPROVALS
3.1 Making sense of the regulations
Whether you are working with radioisotopes,
rodents, recombinant DNA, controlled substances, or applying for
an NIH grant for research funds, there are five common principles
in common for all types of regulatory compliance at UCSF.
The key elements for regulatory
compliance include:
1.
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Education and training:
Most research projects at UCSF require a mandatory training
component;
much of this training is available on line, but hands-on
specialized training is often required. |
| 2. |
Authorization or approval:
Before a research project begins, authorizations or approvals
are needed
from the relevant committees or panels (i.e., Biosafety, Radiation
Safety, Controlled Substance Program, the
Institutional Animal Care and Use Committee, the
Committee on Human Research). |
| 3. |
Expiration dates and renewals:
Most committee approvals are valid for one year or three years
and
require review and renewal at the end of that period. |
| 4. |
Approvals for modifications:
Any changes to an approved authorization or study must
be reviewed and approved before being implemented. |
5.
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Monitoring and auditing:
The Office of Research conducts regular routine not-for-cause
audits and
inspections, as well as for-cause audits of the various research
programs. |
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To work effectively within the university research environment,
you will interact with professional,
academic, and university groups whose regulatory approval and
support are required for a successful research career
at UCSF. These groups include:
Each of
these groups as well as the key points for obtaining regulatory
approvals and authorizations are discussed in this Research Handbook. |
