Commercial Institutional Review Board (IRB) Review
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.
The following types of funded studies may be reviewed by a commercial IRB:
- Industry-authored studies,
- Industry-funded /sponsored studies,
- Industry-funded clinical trial or multisite clinical trial, or
- Federally funded multisite clinical trials and other studies where the sponsoring funding agency has specifically authorized payment for IRB review.
The following types of studies do not qualify for commercial IRB review:
- Collaborative research projects done in conjunction with other UC institutions or other academic institutions.
- Unfunded, PI-sponsored, or UCB department/school-funded research, unless unrestricted funds are used to pay for the commercial IRB expenses.
- Research that involves Radiation or Radioactive Drug Research Committee review, as UCB is not licensed to conduct such research.
- PI is interested in obtaining commercial IRB review:
- PI determines that UCB has an agreement with the commercial IRB in question. (See commercial IRB reliance information below.)
- PI completes a Request for Authorization of Services between the commercial IRB and UCB.
- PI completes the Checklist for Financial Conflict of Interest (COI).
- PI submits the Request for Authorization (b) with the Checklist (c) to OPHS by email: firstname.lastname@example.org.
- PI must complete the below requirements, as applicable, and document them for “clearance” prior to submitting a protocol to the commercial IRB:*
- Conflict of Interest Committee review
- CLEB (Biosafety) review
- Laser Safety review
- Execution of final contract through the Industry Alliances Office
- Once all institutional requirements are satisfied, a Letter of Clearance to proceed is issued by OPHS to the PI.
- 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
WCG IRB Reliance
UC Berkeley has an existing reliance agreement with WCG IRB. WCG IRB may be used for external IRB review of qualifying studies, as described above.
WCG IRB is a commercial IRB located in Washington State that provides services for academic and non-academic institutions. WCG IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
WCG IRB Contact for UCB Research
Carmen Thompson (Account Manager, Institutions)
Commercial IRBs with UC System Master Agreements
If interested in using the IRB below, contact the Office for Protection for Human Subjects (OPHS) at email@example.com to determine if a specific agreement with UCB is possible.