Application and Review Process
A schematic diagram of the review process is also provided below.
1. The Applicant develops and submits to the REB a complete Application for Ethical Review. A complete application includes:
- CapU REB Application for Ethical Review Form with all questions answered;
- Appendices such as participant recruitment instruments (e.g. posters, scripts, and recruitment letters), consent forms, interview questions/scripts, focus group scripts, and online survey URL, etc.; and
- Copies of certificates of completion for the Tri-council Course on Research Ethics (CORE).
In the case of student research, faculty supervisors are responsible for submitting application by email on behalf of students under their supervision. By submitting an application on behalf of a student, the student supervisor attests that they have read and endorse the application, and are responsible for ensuring that the research is conducted in accordance with the approved ethical protocol.
Incomplete or incoherent applications are not reviewed by the REB, and are returned to the applicant with a request for more information.
2. The REB Chair and/or the Research Ethics Officer completes a Level of Review Assessment to determine whether an application will be reviewed at a monthly Full Board meeting, a subcommittee of the REB, or by a Departmental Review Committee.
The Level of Review Assessment is based upon an assessment of the degree of risk and vulnerability of participants associated with the proposed research. Research involving a higher degree of risk and vulnerability are reviewed at a monthly REB meeting. Applications for projects involving minimal risk to participants are reviewed by a REB subcommittee (a delegated review), or may be reviewed by a Departmental Review Committee in the case of course-based, student research (a departmental review).
3. The application is reviewed by the REB, a REB subcommittee, or by a Departmental Review Committee. All applications are subject to the same standard of review regardless of the level of review. The standard of review is compliance with the Tri-Council Policy Statement on Ethical Conduct for Research involving Humans (TCPS).
4. The REB or Departmental Review Committee issues a written decision. The decision is either: 1) the application is approved as submitted; or 2) the project contravenes TCPS guidance and/or more information is required. In the case of the latter, the decision letter documents the reasons for the decision and suggests ways to bring the project into compliance with the TCPS.
For delegated reviews, REB decision letters are normally issued within two weeks of receiving a complete application. For full board reviews, REB decision letters are normally issued within four weeks.
5. The applicant may resubmit a revised application to the REB, and/or appeal the decision or aspects of the decision to the REB Chair. There are often multiple ways to address a non-compliance issues. The REB endeavors to be flexible and collaborative to bring projects into compliance with the TCPS.
Revised applications that are missing information, or fail to recognize and account for risks and vulnerabilities of participants, sometimes require multiple resubmissions before approved.
6. An approval letter is issued once the REB is satisfied that the proposed research is compliant with the TCPS. Once approved, the application becomes the ethical protocol to which the research must adhere.
Approval is generally granted for one year, although duration of approval may be shorter where warranted. For research that continues past the one year approval, the protocol holder is required to submit to the REB and Application for Continuing Review.