Outcomes of Review
Following the review of a research protocol, the DSRB will reach one of the following decisions:
a. Approved
The research proposal is approved as submitted. No changes are required.
b. Conditionally Approved
There are no major problems with the proposal. Issues listed by the DSRB must be addressed before the study can be formally approved. Subjects must not be recruited into the study until final approval has been issued.
c. Tabled for next convened meeting
A proposal may be tabled if there are significant questions raised that need further information from the Principal Investigator. The DSRB decides on the subsequent action required. The Principal Investigator may be asked to submit additional information, may be invited to a subsequent meeting or the proposal might be sent to an Independent Consultant for further review. When additional information has been obtained, the proposal is discussed at the next DSRB meeting.
d. Not Approved
The proposal fails to meet one or more criteria used by the DSRB for approval of research. Disapproval cannot be given through the expedited review and may only be given by majority vote at a DSRB convened meeting.
Appeals to DSRB Decision
If the DSRB determines that a study is not approved, the reasons for the disapproval will be provided in the outcome letter to the Principal Investigator.
The Principal Investigator may appeal against the DSRB decision by responding in writing to the DSRB. This written response should contain the rational for the appeal.
Once the study has been included in the agenda, the Principal Investigator will be notified and will be given the opportunity to attend the meeting and present the information in person.
The DSRB will carefully and fairly evaluate the Principal Investigator’s response in reaching the final decision. If the study is disapproved, the outcome letter will include the reason(s) for the disapproval.
If the Principal Investigator is dissatisfied with the decision, the Principal Investigator may write to the Research Ethics Committee (REC). The REC will then discuss the study and the DSRB’s decision at the next scheduled meeting.
