Ethical Review Process: Formal sequence of submission process
- Submission of Application
- In designing a research proposal and research design, the Project Lead should use the Research Ethics Checklist to design the research to adhere to Edge’s research ethics policies.
- The Project Lead should complete a Research Ethics Review Form, to evidence its adherence.
- The Project Lead should submit the completed Research Ethics Review Form to the Research Ethics Administrator.
- In instances where an expedited review is required, the Project Lead must contact both the Director of Research and the Research Ethics Committee (REC) Chair at the earliest possible opportunity, providing a clear rationale as to why the time-sensitive nature of the project warrants accelerated consideration.
2. Initial Administrative Review
- The application is received by the Ethics Administrator, who conducts a preliminary assessment:
1) Form Completion: Has every required section of the application form been completed in full? Yes/No
2) Internal Consistency: Do the responses provide coherent answers to the questions posed in each section? Yes/No
- Subsequent actions:
- If the response to both questions is ‘Yes’:
The Research Ethics Review Form shall be forwarded either: - 3A: to the REC for formal review, or
- 3B: directly to the REC Chair for expedited review only where prior agreement has been reached between the Project Lead, the REC Chair, and the Director of Research, and the time-sensitive nature of the project justifies such acceleration.
- If the response to either question is ‘No’:
The form shall be returned to the Project Lead, accompanied by a request for revision. The Ethics Administrator shall provide a brief explanatory note identifying the section(s) requiring amendment or clarification. - If necessary, the application is returned to the Project Lead for revisions and resubmission.
3. A. Research Ethics Committee (REC) Review
- Upon completion of the initial review, the application is forwarded to REC.
- The REC convenes to consider applications as required.
- The standard review period is approximately two weeks from receipt of a completed application to communication of the outcome.
3. B. Requests for Expedited Review
- In cases of urgency, a request for expedited review may obtained by prior agreement between the Project Lead, the REC Chair, and the Director of Research, and the time-sensitive nature of the project justifies such acceleration.
- In such an eventuality, the REC Chair considers or delegated REC member to consider the application independently.
4. A.Communication of Outcome
- Following deliberation, the REC issues a response to the applicant detailing the outcome. There are three potential outcomes:
- Approved; (stage 5)
- Approved with conditions, the conditions of which will be detailed in the REC response and must be fulfilled by the Project Lead within a specified timeframe (stage 4B);
- Not approved, with resubmission required (stage 1)
4. B. Follow-up on Conditional Approvals
- Where approval is granted subject to conditions (e.g. revisions to consent documentation), confirmation that these have been met may be provided via Chair’s action. This permits direct communication between the applicant and the REC Chair (or designated REC member) without requiring a full committee review.
- If conditional approvals are not met following two phases of review, the application can be rejected and resubmission required (stage 1)
5. Final Institutional Approval
- The REC functions in an advisory capacity and makes recommendations to Edge researchers. Once all conditions are fulfilled formal approval with reference number is issued by the REC Chair.
6. Commencement of Research
- Upon receipt of formal approval, the research project may commence.