Continuous protocol approval is required. At the time of initial review, a study is granted an approval period. The person listed as Principal Investigator (PI) is responsible for seeking and maintaining approval prior to continuing human subject research activities beyond the expiration date. If human subject research activities have concluded, the PI must properly close the study with RCS using the Study Closure Application.
To request continued approval and secure continued approval prior to the expiration date, the PI must provide the required materials in a timely manner. RCS requires requests for continuation be submitted at least 45 days in advance of the study’s expiration date.
Continued approval will need to be requested as follows:
- Exempt – Studies previously determined to qualify for exemption, must submit a Progress Report Application and a revised project end date will need to be provided. RCS will review the study to verify the study’s progress and determine that the study continues to qualify for exemption; a revised expiration date will be issued.
- Expedited and Full Review – Studies previously determined to require expedited or full review, must submit a Continuing Review Application. The IRB must conduct a continuing review of the project annually, at minimum, and determine that all approval criteria specified in the federal regulations continue to be satisfied. If all criteria are satisfied, the IRB will issue continued approval with a new expiration date.
The Progress Report Form and Continuing Review Application include a submission checklist on the back page to guide researchers in identifying previously approved protocol materials required for submission.
Requests for continuous protocol approval must be reviewed separately from other proposed changes to previously approved research (i.e., amendments). If you would like to request changes, a separate amendment submission will need to be prepared. See the Amendment Review page for instructions on preparing an amendment submission.
For more information on the review process, approval periods, and average review times, see the Protocol Lifecycle: Review Processes and Requirements page.
For more information on preparing a Study Closure Application, see the Closing a Protocol page.