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Subcontracted Human Subjects Research (HSR) 

All subcontracts from Berkeley Lab that include HSR are required to include a Human Subjects clause that passes down the DOE Order requirements to the subcontracted organizations. In most cases, the HSC will also need to establish a record of the collaborative work in the HARP System.

Requirements

Please contact the HARC office for assistance in determining what documentation is appropriate for a given situation.  More information on these processes is available in the human subjects research FAQ: 
  1. HSR Training - All individuals engaged in the HSR activities are required to complete CITI training prior to being listed on a protocol, and complete refresher training every 3 years thereafter. Subcontractors may use the institutional license of the Lab rather than purchasing their own access to the CITI program website. 
  2. Obtaining a Federalwide Assurance (FWA) - In most cases, Berkeley Lab prefers to have subcontracted organizations conduct HSR under their own FWA with the Office of Human Research Protection (OHRP). To obtain an FWA, the institution has to complete a simple electronic form describing their efforts to ensure compliance with applicable requirements for the conduct of Human Subjects Research. 
    1. When the Lab's IRB is performing the review of the study, IRB#00006447 should be designated in Section 6 of the submission form.
    2. Once the protocol and FWA are approved, an IRB Authorization Agreement (see below) will need to be signed covering the study under the Lab's oversight.
  3. Cannot Obtain an FWA? - Berkeley Lab may consider extending their own Assurance to cover the individuals conducting the approved study activities. An Individual Investigator Agreement (see below) will need to be signed in these cases, outlining the responsibilities of the study team members when conducting HSR as an agent of the Laboratory.
  4. Adherence to the DOE Order 443.1C and all institutional policies - The DOE reporting requirements are required to be followed by all personnel conducting HSR, not only the PI. Annual check-ins are also required to fulfill reporting requirements to the Dept of Energy Human Subjects Protection Program.
  5. Adherence to the approved protocol - During the study, only approved materials for all participant interactions may be used. Any changes to the approved protocol methods must be submitted to and approved by the HSC prior to implementation.
    1. NOTE: Consent forms are considered research data that must be accessible by the LBNL PI in charge of oversight, and must be retained as DOE-owned research data.

Documents for Reference

  1. Institutional Review Board Authorization Agreement (IRBAA)
  2. Individual Investigator Agreement (IIA)

Berkeley Lab as a Collaborator

When another institution is the prime recipient of funding that is then passed down to the Lab, collaborative HSR is then typically covered under a "Reliance Agreement" between the Lab's IRB and the prime institution's IRB, which sometimes takes the form of the IRBAA above. Negotiation of this reliance can take some time, so be sure to reach out early in the process of receiving subawards. Remember - If the Lab is collaborating, the DOE Requirements apply!

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