The regulations at 45 CFR § 46.109(e) requires that research projects are reviewed not less than once a year. In order to insure continuity of the research, Investigators must submit their continuation application and materials to the CHS office 60 days before the study expires, if the research is ongoing. Research projects are considered ongoing until analyses of data are complete and file closure has been confirmed in writing by the CHS office.

Investigators are reminded of their responsibility to receive continuing approval automatically through the Harvard IRB Reporting Tool (HIRBERT) database. Reminders (there are 4) start at 75 days prior to the study expiration date and continue until the day the study expires.

The CHS staff person who reviewed the study materials (initial or continuation) previously will be responsible for seeing the continuation through the re-approval process. This staff person will communicate with the Investigator (or personnel designated by the Investigator) any requests for changes or additional documentation needed for a thorough review by the CHS, or CHS member.

The required materials for continuations are listed in the continuation application. The review process for continuations is identical to the processes outlined in the Submission Guidelines.

Updated: 21-Oct-2009