It is the local principal investigator’s (LPI) responsibility to notify the HiREB using the Study Completion Report form when the study has been closed.
The HiREB file may be closed when:
a. There is no further participant involvement; this means all contact with participants has ceased, and
b. All new data collection is complete and there is no further collection, clarification or transfer (including any access to participant medical records) of data, and
c. Any anticipated monitoring of research files or close-out activities by an external party (e.g. sponsor, CRO) have been completed
If all highlighted above criteria have been met, ethics approval is no longer needed – even if the investigator is still doing the data analysis/hasn’t yet published. The key is ensuring that investigator will no longer be needing to access participant medical records (e.g., no outstanding queries or ongoing data cleaning or monitoring) and all sample analysis has been done (if applicable); if these activities are ongoing/may occur then the study must remain open.
Otherwise, once all the criteria are satisfied, the study can be closed – even if investigators are still working on their publications.
Undergraduate or master’s student projects will be automatically terminated by the HiREB after one year from the final approval date if a Study Completion Report, or an Annual Renewal Form is not received within the required timeframe. For more information about student projects, contact Janice Sancan at 905 521-2100 ext 44574 or sancan@hhsc.ca.