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IRB Update: Extended Approval

October 30, 2018 - SCI Communications

Based on the changes to the Federal Policy for the Protection of Human Subjects (‘Common Rule’), as of January 21, 2019, minimal risk studies (mainly IRB review type = expedited) do not need to be reviewed annually.

  • There will be no special IRB review type nor unique IRB form type for those minimal risk studies.
  • The expiration date for such studies will be 12/31/2999. In addition, in the approval letter and ICF will have ‘Does not expire’ phrase as an expiration date.
    • Note: Because OnCore is not able to handle an expiration year of 2999, those studies will have an expiration date of 12/31/2099.
  • Stanford’s IRB proactively initiated some IRB revisions to change the expiration date for such studies; this way research team is prevented to submitted an annual continuing review which is no longer needed for those minimal risk studies.
    • Note: Because OnCore’s structure, these IRB revisions need to be entered as ‘Continuing Review ‘ otherwise the new expiration date will not take effect in OnCore.
  • Modifications are still required to be submitted to the IRB.

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