Certifications
When certification of IRB review is requested: once your human subjects protocol has been approved by the Human Subjects Committee (LBNL's IRB), researchers should login to the eSRA grants program and find their grant proposal, then use the 'submit CRF' (certification request form) activity for the HSC (or IRB). This will prompt you to identify the protocol(s) associated with this research. Staff in the HARC office will receive an email from eSRA that a grant proposal is waiting certification and will then go in and review the materials. Once the HARC staff member has performed a side by side review confirming that the human subjects work described in the proposal is covered by the Human Subjects Committee approved human subjects protocol, the staff member will certify the proposal for human subjects use in eSRA.
Federal Wide Authorization or FWA
LBNL's Federal Wide Assurance (FWA) number from the US Dept. of Health and Human Services is 00006253. The document itself may be downloaded here. Our Office of Human Research Protections (OHRP) IRB number is 00006447. Studies that are done at other sites, such as UCB or UCSF may be covered by a memorandum of understanding between the UC system campuses, and in most cases only the host institution's Institutional Review Board will review a human subjects protocol and deal with grant certification issues. If you have any questions about this, please call the HARC office at x6005, or send email to [email protected].
