Effective January 19, 2018, however is now delayed until July 2018
Continuing Review will no longer be required for:
- Most studies that qualify for the expedited review process
- Studies (regardless of review path) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involving follow-up clinical data from procedure that subjects undergo as part of clinical care.
REMEMBER: Studies qualifying for expedited review must be of no more than minimal risk and meet one of the OHRP Expedited Review Categories.
Continuing Review of FDA regulated studies still remains in effect.
MCHS Transition Process
For existing expedited studies that were approved prior to January 19, 2018 and for full board studies that no longer involve subject intervention/interaction, the MCHS IRB will evaluate the need for continuing review at the time of the next scheduled continuing review submission.
For new studies approved via expedited review on or after January 19, 2018, the MCHS IRB 's expedited reviewer will determine the need for continuing review. Most expedited studies will not require continuing review. Some reasons for maintaining the continuing review requirements include:
- The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review
- The project involves additional regulatory oversight, such as Conflict of Interest (COI) management
- The research will be conducted at a non Marshfield Clinic Health System site
- An amendment or incident report reveals new findings that require additional oversight
- The investigator has had previous serious non-compliance or a pattern of continuous non-compliance either serious or non-serious.
New MCHS Processes:
For studies which no longer require an IRB Continuing Review report, the study team must still:
- Complete a new MCRI "Status update" form on an annual basis to be provided to the IRB on behalf of the institution's requirements
- Submit amendments on a Change/Update to Original Submission form for project changes per usual regulatory requirements
- Report Unanticipated Problems per usual regulatory requirements
- Terminate the project once it ends, or when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed.
A courtesy email reminder will continue to be sent, reminding investigators that the MCRI Status update form is due. The system email will be sent prior to the anniversary approval date for the study.
Upon receipt of a Change/Update request, the MCHS IRB may re-evaluate its No Continuing review decision for a project depending on the type of change(s) proposed in an amendment/revision request (e.g. protocol change that increases subject risk), or as an outcome of the IRB's review of Unanticipated Problem.