Study Expiration Dates and Extended Approval Criteria

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How Often Is Continuing Review Required?

Extended Approval Policy

Determining Expiration Dates

 

How Often Is Continuing Review Required?

Your approval letter will clarify how long the study is approved — typically 1 or 3 years. The length of time your study is approved may vary based on a) the level of review required, b) the risk level of the study, c) whether the study is subject to federal oversight d) whether your study is funded and e) what sites are involved. You must submit a continuing review before your study expires if you wish to continue the research.

Annual Review Studies: Studies that are greater than minimal risk, are funded, are subject to federal oversight, and/or are being done at certain sites require re-review at least annually [see 45 CFR 46.109(d) (DHHS) and 21 CFR 56.109(d) (FDA)]. Please note that the IRB may require more frequent review for some studies.

Extended Approval Studies: As described below, the IRB will grant approval for up to 3 years for unfunded, minimal risk studies that are not subject to federal oversight.

No Expiration: There are no expiration dates for studies that the IRB certifies as exempt. Continuing review is not required.

Extended Approval Policy

UCSF’s Federalwide Assurance (FWA) allows some flexibility in applying human subjects federal regulations to non-federally supported research. As such, the UCSF HRPP has implemented a procedure for granting approval for up to 3 years for research projects that:

  1. involve no more than minimal risk to participants (as defined by 45 CFR 46.102),
  2. are unfunded and 
  3. are not subject to federal oversight.

Studies NOT Eligible for Extended Approval

Below is a summary of studies that are not eligible for extended approval. 

Studies that are funded

If your study is funded or will be funded by an external sponsor, gift, program, or specific internal or departmental funds, it is not eligible for extended approval.

Important Reminder: If new funding is secured, you must promptly submit a modification to notify the IRB. The IRB will issue a new approval letter with a shortened approval period.

Research subject to federal oversight

The IRB cannot grant extended approval to studies that receive federal support, are implemented at the direction of federal agencies or otherwise are subject to federal oversight. Below are examples of federal oversight.

1. Federal funding, including:

  • Federal sponsorship, directly or indirectly, including federal training and program project grants
  • Student projects when the faculty sponsor uses federal funding for the student’s project
  • Federal no-cost extensions
  • CFAR funding
  • List of agencies using the PHS FCOI regulations

2. Research directed or overseen by a federal agency that has signed on to the Common Rule, including every agency within Department of Health and Human Services

3. Studies subject to FDA oversight

  • Note: Includes device studies exempt from requirements to submit an IDE (e.g., unapproved diagnostic kits) that are still under FDA oversight and FDA-required registries for post-market surveillance

4. Studies seeking or obtaining Certificates of Confidentiality (which are granted by NIH)

5. Studies submitting data to the NIH GWAS data repository

6. Studies where the the UCSF IRB is serving as the IRB of record for an institution that applies the federal standards to all research regardless of source of funding, including:

  • San Francisco VAMC
  • Northern California Institute for Research and Education (NCIRE)
  • Lawrence Berkeley National Laboratory
  • San Francisco Department of Public Health
  • J. David Gladstone Institutes
  • The Jewish Home
  • Institute on Aging
  • Blood Centers of the Pacific
  • Blood Systems Research Institute
  • UC Hastings

Other exceptions and exclusions

  • Studies that involve greater than minimal risk 
  • Studies with contractual obligations or restrictions that preclude eligibility in this policy, e.g., the non-federal sponsor or funder of the research requires an annual review
  • Studies in which UCSF is serving as IRB of record for an institution not mentioned above that requires annual review
  • Studies involving prisoners or parolees as subjects
  • Studies funded by the California Institute for Regenerative Medicine 

We reserve the right to make exceptions to this policy, and inclusion/exclusion of any research project under this procedure will be at the HRPP’s discretion.

Post-approval submission requirements

Studies that are granted an extended approval period will continue to have the same post-approval submission requirements, including the submission of modifications, continuing reviews, adverse events, protocol violations, other safety information and study closeout reports. 

If the study becomes ineligible for an extended approval period because of new funding (or other changes), the IRB will issue a new approval letter with a shortened approval period.

Determining Expiration Dates

At UCSF the approval date is the day when study activities involving human subjects may start; the expiration date is the last day on which activities may continue, unless a new approval is given.

Annual Review Studies: Federal regulations require that (1) except when an expedited review procedure is used, each IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas; and (2) an IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year. The IRB should decide the frequency of continuing review for each study protocol necessary to ensure the continued protection of the rights and welfare of research subjects.

The IRB uses the following formulas to determine the expiration date of initial reviews and continuing reviews for annual review studies:

Initial reviews — full committee review

The expiration date will be 1 year (minus 1 day) from the date the study was last reviewed by the full committee at a convened IRB meeting.

Initial reviews — expedited review

The expiration date will be 1 year (minus 1 day) from the approval date.

Continuing reviews — full committee review

The expiration date will be 1 year (minus 1 day) from the date the continuing review was reviewed by the full committee at a convened IRB meeting.

Continuing reviews — expedited review

The expiration date will be 1 year (minus 1 day) from the approval date.

Extended Approval for Minimal Risk Studies: If the IRB determines that the study poses no more than minimal risk and qualifies for extended approval, the study may be approved for up to 3 years. The IRB uses the following formulas to determine the expiration date of initial reviews and continuing reviews:

Initial reviews

The expiration date will be 3 years (minus 1 day) from the date of approval.

Continuing reviews

​The expiration date will be 3 years (minus 1 day) from the date the continuing review is approved.