Guidance for Reporting Suspensions / Terminations
Suspensions and terminations are defined as:
Suspensions are a temporary halt to all or some research activities pending future action by the Research Ethics Board (REB), a sponsor and/or Principal Investigator (PI).
Terminations are a permanent halt to all or some research activities by the REB, a sponsor and/or PI.
If the research is suspended or terminated for any reason, the PI must promptly notify the HREBA-Cancer Committee of this suspension/termination following the method for submitting a reportable event.
Reports are to include:
- reason(s) for the suspension/termination;
- source of the suspension/termination (i.e., PI, sponsor, REB, or a combination);
- details of the sites response/action to the suspension/termination;
- procedure for promptly notifying participants of the suspension/termination (attach any scripts/letters that are intended for the participants);
- measures in place to ensure appropriate care and follow-up of the participants; and
- additional information that will be provided to the Committee as follow-up.
When a suspension is made the PI must also notify the REB once a decision has been made to resume with the research.
If the research is terminated or a determination is made that the research not continue following a suspension, a closure will need to be submitted as per committee requirements (SOP 406.002) once all items regarding the termination/suspension have been fully addressed.
For more information, please refer to Standard Operating Procedure 407; Suspension or Termination of REB Approval.