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.

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: irb_reliance@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
    5. If using Advarra, submit the informed consent form(s) to OPHS for prior review. See below for additional guidance.
    *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

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

Andy Parkhurst (Institutions Partnership Manager)
Phone: 360-252-2893
aparkhurstn@wirb.com

OR

Client Care
clientcare@wcgirb.com
Phone: 360-252-2289
https://www.wcgirb.com/contact-us/

Advarra IRB Reliance

UC Berkeley has an existing reliance agreement with Advarra IRB. Advarra IRB may be used for external IRB review of qualifying studies, as described above.

Advarra IRB is a commercial IRB headquartered in Columbia, MD that provides services for academic and non-academic institutions. Advarra IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Advarra IRB Contact for UCB Research

For questions about the IRB submission process, please contact Institutions@advarra.com, Andrew.Saunders@advarra.com, or David.Burnham@advarra.com

When using Advarra’s IRB, insert CPHS consent template language and submit the consent form(s) to CPHS for review/clearance before applying to Advarra for review.

Sterling IRB Reliance

Sterling IRB may be used for external IRB review of qualifying studies, as described above.

Sterling IRB is a commercial IRB headquartered in Atlanta, GA that provides services for academic and non-academic institutions. Sterling IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

While the University of California doesn’t have a master agreement with Sterling IRB, Sterling IRB is a signatory of the SMART IRB agreement, and reliances are set up through SMART IRB’s Letter of Acknowledgement (LOA). OPHS staff will provide further instructions on executing the LOA after the step-by-step guidance referenced above has been completed (note that steps 3 and 4 do not apply when Sterling is used).

 

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