Individual Investigator Agreements and IRB Authorization Agreements
Please contact the HARC office for assistance in determining which documentation is appropriate for a given situation. More information on these processes is available in the human subjects research FAQ:
1) Single individuals must complete an Individual Investigator Agreement (IIA) for co-signature by LBNL's Institutional Official. Because they are performing responsible tasks on behalf of LBNL and without any other institutional authorization, they must have LBNL guest/affiliate status, an LDAP, take appropriate CITI Training (see Training page), and be listed on the protocol. Once signed by the collaborator or contractor, the Individual Investigator Agreement should be attached to the associated protocol(s) in the HARP system and submitted for review.
2) Individuals associated with corporations, consulting firms, or non-profit or other external entity conducting research on behalf of the Lab must first be described in a protocol filed with the HARP system. The external entity can then file for a Federalwide Assurance of Compliance assigning LBNL as the IRB of record on the Office of Human Research Protections website. Once the FWA has been awarded, the Protocol Lead Investigator and/or a representative of the entity should complete a draft IRB Authorization Agreement using the template (below). The completed draft IRB Authorization Agreement and the contract or statement of work negotiated with between LBNL and the entity is then submitted to [email protected] for forwarding to the institutional Official.
At the discretion of the Human Subjects Committee, the entity may be asked to designate a single individual to serve as Responsible Personnel on the protocol, but will individually assure that each person in their employ working on the research has been appropriately trained. The entity will maintain a separate record of their employees' training and will provide it to the LBNL Human Subjects Committee upon request. Access to CITI training through an affiliation with LBNL (see Training page) may be used to satisfy this requirement.
