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.