THE OFFICE OF RESEARCH

NEW INVESTIGATORS: A QUICK GUIDE TO STARTING YOUR RESEARCH AT UCSF

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Obtaining Regulatory Committee Approvals - Other Topics:
| What is Research Online? | Working with Biologicals | Working with Chemicals | Working with Radioactive Materials | Working with Radioactive Materials in Humans | Working with Controlled Substances at UCSF | Working with Animals | Involving Human Subjects in Research | Serving on the Committees | Working with UCSF's Affiliates |

OBTAINING REGULATORY COMMITTEE APPROVALS

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.	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.	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:

•	Your Home department,
•	Office of Research,
•	Office of Academic Affairs,
•	VC Finance and Accounting,
•	Materiel Management, and
•	Capital Projects and Facilities Management

Each of these groups as well as the key points for obtaining regulatory approvals and authorizations are discussed in the following Quick Guide.