Research projects ethics evaluation process
Submission of research projects
Applications for ethics approval must be accompanied by three (3) copies plus the original of the following document:
- The Research Ethics Boards Application Form, duly completed, signed and dated and, for applications submitted by students, the signature of the supervising professor;
And accompanied by four (4) copies of the following documents:
- Other relevant documents, including the recruitment text, the consent form, measures, and, where applicable, approvals from other ethics boards and thesis committees, debriefing procedures, and other relevant documentation.
Applications submitted to the Protocol officer for ethics in research on the first 3 business days of the month will be examined by the REBs during that same month. An incomplete or unsigned ethics application will be returned to the investigator.
Within three days following the first working day of the month, the Protocol officer distributes the ethics applications to the members of the appropriate REB.
Evaluation of research projects
- The Protocol officer will assess the content of each ethics application. The Protocol officer may communicate with an investigator to clarify certain issues raised by the application, modify certain parts of the ethics application or invite the investigator to the REB meeting.
- The Protocol officer will send the ethics applications to all the REB's members and will assign each application to two particular voting members for detailed evaluation.
- During the third week of each month (except the month of July), the members of each REB will meet for half a day to assess the ethical aspect of the ethics applications submitted that month.
- The members of the REBs may extend deadlines or meet a second time during any given month to accommodate certain circumstances or to absorb a larger volume of ethics applications.
- At the REB's meeting, the two evaluators briefly explain the project, review its ethical aspects and, when required, point out areas requiring changes. The other members of the REB may then ask questions to the evaluators. The investigator may also be invited to take part in the discussion at that point.
- Once the discussion has ended, the investigator is asked to leave the room so that the members of the REB can make a decision on the research project and classify the project under one of the categories of approval.
Report to the investigators
- For projects of Category Ia: The Protocol officer will inform, by email or a certificate of ethics approval signed by the Chair of the appropriate REB, the investigator of the REB's decision.
- For projects falling under other categories:
- Before or on the last working day of the month, the Protocol officer will inform, by a letter signed by the Chair of the appropriate REB, the investigator of the REB's decision and reasons and, where required, of the recommended changes, or of the request for additional documentation in order to obtain ethics approval.
- The REB may grant preliminary approval for research projects falling under Category Ib.
- The REB may also approve research projects under Category II once all of the Board's requirements have been met. Such decisions must be ratified at the next meeting.