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When certification of IRB review is requested: once your human subjects protocol has been approved by the Human Subjects Committee (LBNL's IRB), researchers or their proposal specialists should fill in the certification request form and submit it along with a copy of the grant proposal to the HARC office (MS 26-143; electronic copies ok). The HARC office will perform a side by side review with the protocol and the grant proposal and if it appears that all human use as described in the grant proposal is covered by the human use protocol, then the HARC office will issue a certificate. This certificate is sent to the principal investigator, investigator lead(s) on the protocol, the sponsored project office, and anyone else indicated on the certification request form. The sponsored project office will then send the document to the funding agency as required. The glossary and matrix document contains definitions for terms used in the form, other information, and a matrix which (we hope) deals with every possible permutation of protocol and proposal need for certification. It may be the case that a given grant proposal describes work covered by more than one human use protocol. The regular certification request form contains spaces to list 3 protocols. In rare cases where more than 3 need to be listed, here is a second page of the form to list further protocols. Note that this is a new form and we welcome feedback on ease of use, understandability, etc.Here is the flow chart which gives a over all view of the process. And if you need still further documentation and explanation, here is a guidance document.
Note, if you need the AHU form (also known as the Human Subjects and/or Vertebrate Animal Use in Field Task/Work Proposals form) for a field task or work proposal, you can download the most recent version here. If you need the similar LDRD form you can download the most recent version here
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 x5399, or send email to email@example.com. Note, if you need theAHU form (also known as the Human Subjects and/or Vertebrate Animal Use in Field Task/Work Proposals form) for a field task or work proposal, you can download the 2008-2009 version here. If you need the similar LDRD form you can download the 2009-2011 version here