MODIFY OR RENEW A PROJECT

WHEN DO I MODIFY AN APPROVED PROTOCOL?

Any modification to your research (exempt, expedited, or full board) requires HSC review and approval prior to implementation. Modifications that do not pose any new or additional risks to participants are typically handled via expedited review procedures.  Modifications that are substantive in nature and increase risk to the subjects are reviewed by the full board at a convened HSC meeting. Some examples of modifications are:

  • Adding/removing a study or procedure
  • Adding a new recruitment method or subject population
  • Updating the consent process or form
  • Updating questionnaires, surveys, or interview guides
  • Changing the subject compensation

If you need to modify your protocol, click here for instructions.

WHEN DO I RENEW AN APPROVED PROTOCOL?

Exempt submissions are approved indefinitely and do not need to be renewed. Expedited and full board submissions must be renewed and approved annually prior to its expiration date for ongoing studies to avoid any lapses in protocol approval.

You will receive an email reminder 60, 30, and 14 days before your protocol expires. If you have not submitted a renewal by the protocol’s expiration date, you will receive an expiration notice and all research must cease until the renewal has been approved by the HSC.

Protocols should be renewed when any of the following activities are still ongoing:

  • Subjects are being recruited and/or are enrolled in the study;
  • Interventions or interactions with the subjects are occurring;
  • The research team is obtaining or analyzing identifiable information

If you need to renew your protocol, click here for instructions.

If you are not sure if you can close your protocol, see the guidance on Closing a Project.

CAN I RENEW AN EXPIRED PROTOCOL?

Yes, you have 180 days from the date of expiration to renew an expired protocol. After 180 days, the project will be automatically closed and the UCOP records retention period starts. If you would like to renew a protocol that has expired and been closed, you may base a new protocol off the closed protocol, but it will be reviewed as a new submission.

If you have been conducting research on an expired protocol, cease all activities and contact the HSCimmediately.

CLOSING A PROJECT

DO I NEED TO RENEW MY PROTOCOL IF I HAVE FINISHED DATA COLLECTION?

Whether or not you should close your protocol depends on the state of your data.

In order to close a protocol, all of the following conditions must be met:

  • The research never started and will not be conducted

OR

  • All subject recruitment and enrollment is complete;
  • All subjects records, data, and/or specimens have been obtained;
  • There will be no further interaction or interventions with the subjects;
  • Analysis of identifiable private information (e.g., data, records, specimens, video/audio recordings) is complete; AND
  • Data analysis (if applicable) is limited to anonymous data or data stripped of any identifying information (including codes linking subjects to data).

If you would like to close your protocol, click here for instructions.