As of summer 2018, UC Berkeley has expanded its use of external IRBs to include commercial IRBs for the review and approval of human subjects research conducted by UCB faculty.

Qualifying Studies

The following types of funded studies may be reviewed by a commercial IRB:

  1. Industry-authored studies,
  2. Industry-funded /sponsored studies,
  3. Industry-funded clinical trial or multisite clinical trial, or
  4. Federally funded multisite clinical trials and other studies where the sponsoring funding agency has specifically authorized payment for IRB review.

Exclusions

The following types of studies do not qualify for commercial IRB review:

  1. Collaborative research projects done in conjunction with other UC institutions or other academic institutions.
  2. Unfunded, PI-sponsored, or UCB department/school-funded research, unless unrestricted funds are used to pay for the commercial IRB expenses.
  3. Research that involves Radiation or Radioactive Drug Research Committee review, as UCB is not licensed to conduct such research.

Step-by-Step Guidance

  1. PI is interested in obtaining commercial IRB review:
    1. PI determines that UCB has an agreement with the commercial IRB in question. (See commercial IRB reliance information below.)
    2. PI completes a Request for Authorization of Services between the commercial IRB and UCB.  
    3. PI completes the Checklist for Financial Conflict of Interest (COI).
    4. PI submits the Request for Authorization (b) with the Checklist (c) to OPHS by email: ophs@berkeley.edu.

  2. PI must complete the below requirements, as applicable, and document them for “clearance” prior to submitting a protocol to the commercial IRB:*
    1. Conflict of Interest Committee review
    2. CLEB (Biosafety) review
    3. Laser Safety review
    4. Execution of final contract through the Industry Alliances Office
    *Other institutional clearance(s) may be necessary depending on the specific details of the project.

  3. Once all institutional requirements are satisfied, a Letter of Clearance to proceed is issued by OPHS to the PI.

  4. The PI, or his/her designee, submits application to the commercial IRB, per their requirements, and includes the Letter of Clearance from OPHS/UCB.

Commercial IRBs with an Existing Review Agreement with UCB

Western IRB (WIRB) Reliance

UC Berkeley has an existing reliance agreement with Western Institutional Review Board (WIRB). WIRB may be used for external IRB review of qualifying studies, as described above.

WIRB is a commercial IRB located in Olympia, Washington that provides services for academic and non-academic institutions. WIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). WIRB is part of the WIRB-Copernicus Group (WCG), which includes Copernicus Group IRB, Aspire IRB, MidLands IRB and New England IRB.

WIRB Contact for UCB Research

Carmen Thompson (Account Manager, Institutions)
Phone: 360-252-2447
cbthompson@wirb.com


Commercial IRBs with UC System Master Agreements

If interested in using either of the IRBs below, contact the Office for Protection for Human Subjects (OPHS) at ophs@berkeley.edu to determine if a specific agreement with UCB is possible.

  • Advarra (formerly operating as Chesapeake IRB and Schulman IRB)
  • Quorum