 |
 |
|
RESEARCH INVESTIGATOR HANDBOOK 3. OBTAINING REGULATORY COMMITTEE APPROVALS
• What does UCSF consider to be radioactive materials? What does UCSF consider to be radioactive materials? Radioactive materials include sources of ionizing radiation as well as any radiolabeled substance or material. Oversight by the Office of Environmental Health and Safety (OEH&S) extends to radiation producing machines and equipment in research. The Radiation Safety Committee (RSC) within the Office of Research establishes the policies and regulations that govern the use of ionizing radiation as well as the technical and safety related aspects of using ionizing radiation at UCSF. Contact your Departmental Safety Advisor (DSA) for initial consultation and guidance for the use of radioactive materials and the authorization application. The Committee meets monthly to review all applications (Schedule). Call 415-476-2198 to speak to the Technical Committees Coordinator. If you have specific technological questions about radiological hazards, please contact the Radiation Safety Officer at 476-5303. What approvals do I need to work with radioactive materials? Approval: You must receive a Radiation Use Authorization (RUA) number from the Radiation Safety Committee before you can order, store or use radioactive materials. To obtain the RUA, your RUA application must document that all personnel using radioactive materials are qualified by training and experience, that your research facilities are adequate to handle the materials safely, and that the proposed use is safe to all concerned. Expiration Date: The RSC approval of your Radiation Use Authorization expires two years from the approval date. Your RUA must be approved for renewal prior to this expiration date. Approximately two months prior to expiration, you will be notified that your RUA will expire. If you use radioactive materials in animal or human research, you must also have IACUC (animals) or CHR (humans) approved protocols before starting your research. The expiration dates of your IACUC or CHR approvals are absolute and you must stop all animal and human research (and radioisotope use) if you do not renew these approvals prior to their expiration dates. Modifications: Submit modification requests to the DSA prior to implementing changes in your research procedures. (Modification Request Form) Additional approvals: If radioisotopes will be given to or applied to animals, you must also have approval from the Institutional Animal Care and Use Committee which reviews all research that involves animals. With the exception of studies that irradiate animals with external beam radiation, you must submit a completed Animal Involvement in the Laboratory Animal Resource Center form with your RSC application. All human subjects research also requires a Committee for Human Research (CHR) approval. Submit a copy of your CHR-approved protocol and consent form with your application. To determine if you will also need Radioactive Drug Research Committee (RDRC) approval, see Working with Radioactive Materials in Humans section in this Guide. What resources and training are available? The OEH&S provides the following services:
Is auditing or monitoring required? Your DSA will conduct quarterly lab safety audits to inspect handling of radioisotopes. If contamination is found, you will be notified immediately and inspected for appropriate clean up. The DSA will also verify that your Geiger counters were calibrated by the OEH&S once a year and that your radioisotope logs and wipe test logs are complete and current. The RSC and the Radiation Safety Officer (RSO) are authorized by the Chancellor to limit or revoke an individual’s authority to use radioactive material or sources of ionizing radiation if such use presents a hazard to individuals or violates health and safety codes. Tips to Speed up the Approval Process
Tips to Prevent Laboratory Problems
Relevant policies and procedures All university polices and regulations for research investigators are described in the Radiation Safety Manual. The RSC will review your research for compliance with these policies; OEH&S will inspect your research project and laboratory for compliance with regulations concerning the safe use of radioactive materials at UCSF. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Page updated: September 2009