UCLA Office of the Human Research Protection Program (OHRPP)
Post Approval Reporting. The Principal Investigator is responsible for submitting to the IRB ongoing reports of events that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research. The types of events and information that may need to be reported to the IRB include, but are not limited to:
- Adverse Events
- Violations, Deviations, and Incidents
- Updated Study Safety Information
An unanticipated problem is an event or outcome that meets the following criteria: 1) unexpected; 2) related or possibly related to participation in the research; and 3) places subjects or others at a greater risk of harm than was previously known or recognized. All unanticipated problems need to be reported to the IRB via webIRB, though not all adverse events, violations, incidents or deviations are unanticipated problems. For examples, please see the guidance document.
UCLA Environment, Health & Safety
Training & Outreach. In-class and online training courses are available to assist you in meeting regulatory training requirements along with videos, publications and other resources to help promote safety on campus.
David Geffen School of Medicine Research Safety
Standard Operating Procedure (SOP) Template Library with Sample Procedures. SOP templates are provided to help research groups update the SOPs required for safety compliance. The templates have sample procedures with the level of detail required to determine the hazard level. Edit the SOP template to reflect your laboratory-specific procedures.
All sections on the SOP template must be completed. Please refer to the corresponding Safety Data Sheet (SDS) from the same manufacturer of the chemical to add important information on the SOPs per the manufacturer's recommendations. All SOPs must be approved and signed by the principal investigator, and then reviewed and signed by the laboratory workers and documented in the Laboratory Safety Manual binder.
If you need to write an SOP for a chemical not listed below, you may customize the universal SOP template. Alternatively, you can customize the chemical-specific SOPs on the UCLA EH&S site to match your laboratory chemical-specific operations. Do not cut and paste contents or certain sections from the SOPs without careful review, as the SOPs in the library must be customized for your specific laboratory operations.