Memo: Research Approved on a Triennial Basis

As a reminder to investigators who have studies that have been approved for a period of three (3) years, a submission of a progress report is required on a triennial basis (every three years) for as long as you are conducting human subjects research. The IRB Office will send a courtesy reminder to you when your progress report is due. In the meantime, please be reminded of the following:

• Amendments: All changes to the study or study documents must be submitted via an Amendment Request Form, and formally approved prior to implementation. New study staff can be added by using a Study Staff Amendment Form (download).
• Reportable Events: Any unanticipated problems (e.g. breach in confidentiality, incarceration of subject, research-related injury), non-compliance (e.g. use of incorrect consent materials, conducting unapproved procedures, over-enrolling subjects), problems or complaints reported by research subjects , suspension or termination of the research, must be reported to the IRB via the Event Report Form (download), within 5 days of the research team becoming aware of the incident. Please find the reporting policies here on the IRB site (download).
• Training: All study staff who are engaged in research need to be listed on the study staff roster and must have up-to-date Human Subjects Protection Training, to be completed every 3 years. Principal Investigators must ensure all current study staff have up to date human subjects protection training.
• Study Closure: If this study has been completed, including analysis of identifiable data, you may submit a Final Report Form (download).

For any questions, please contact the designated IRB Analyst for your department/school, or the IRB office at irb@bu.edu or 617-353-6115.

Thank you,

Charles River Campus IRB

View all posts