UC Berkeley’s Federalwide Assurance (FWA) allows some flexibility in applying human subjects federal regulations to non-federally supported research. As such, the UCB Human Research Protection Program – as administered by CPHS/OPHS – has implemented a procedure for granting approval of up to ten (10) years for research.


When is a protocol eligible for a 10-year approval?

Protocols that are eligible for 10-year approvals are those that:

  1. involve no more than minimal risk to participants (as defined by 45 CFR 46.102);
  2. are not supported by federal funds;
  3. are not subject to federal oversight;
  4. are not subject to FDA oversight;
  5. are not required to have more frequent review by the funding agency or sponsor;*
  6. are not involve federal personnel or the Department of Veterans Affairs;
  7. are not involve a Certificate of Confidentiality; and
  8. researchers do not have a financial conflict of interest (if unsure, please refer to the Conflict of Interest Committee website).

*The Principal Investigator is responsible for determining whether the funding agency (e.g. foundation) or sponsor requires a 1-year approval. This information should be included within the protocol to facilitate review.


When is a protocol not eligible for a 10-year approval?

The following DO NOT qualify for a 10-year approval period:

  1. research projects that CPHS determines are “greater than minimal risk” studies;
  2. federally funded research, or research with funding from agencies that adhere to federal regulations in their award contracts;*
  3. research involving procedures, devices, or drugs subject to FDA oversight;
  4. research involving federal personnel or the Department of Veterans Affairs;
  5. research involving a Certificate of Confidentiality;
  6. research involving a conflict of interest (COI) for any study personnel;
  7. any industry-sponsored research or studies with other individuals, entities, or institutions to which UCB charges a fee for IRB review; or
  8. any studies where researcher is a paid consultant for the company providing the software being studied for the research.

*The Principal Investigator is responsible for determining whether the funding agency (e.g. foundation) or sponsor requires a 1-year approval. This information should be included within the protocol to facilitate review.


What if my protocol is given a 10-year approval and later becomes ineligible?

If there is a change (e.g., new federal funding) to a protocol that causes it to become ineligible during the course of the 10-year approval, the PI must immediately submit a Continuing Review Application with an amendment to add the federal funding or other relevant addition. The CPHS will then review and issue a new approval letter with a shortened approval period, as appropriate.


What are other expectations?

Amendments: Investigators are still expected to modify and/or update their protocols through an amendment (or through the continuing review process if the protocol becomes ineligible for 10-year approval). This must be done in advance of implementing any change planned to the protocol (e.g., in procedures, design, personnel, subjects, sites, funding, recruitment or data collection materials, consent materials, etc.). It is the investigator’s responsibility to ensure that the protocol at all times accurately reflects the research study.

Reporting requirements: If there is an unanticipated problem involving risks to subjects or others, or a serious adverse event, it must be reported as usual.  Likewise, any deviation from the approved protocol must also be reported.

Monitoring: CPHS/OPHS reserves the right at any time to monitor research processes and/or audit research records (e.g., consent forms) to ensure compliance with the 10-year approval period conditions.

Other limitations: This 10-year approval period will not be available to any collaborating institution or investigator relying on UCB’s review unless verified in writing as acceptable by the other IRB (an email from the relying IRB is sufficient for this purpose).