Post REB Approval
Ongoing ethical responsibilities
After receiving ethical approval for the conduct of research involving humans, there are several ongoing responsibilities that researchers must meet to remain in compliance with university and Tri-Council policies. The following information outlines what you need to know about the responsibilities of researchers [DOC - 39 kB] after gaining REB approval.
Annual and final reports
Research Ethics Board approval is effective for up to 12 months at a time (as per TCPS article 6.14). Researchers are responsible for the following reporting requirements subsequent to the initial letter of approval from a Research Ethics Board:
a) Submission of an Annual Report [DOC] for research extending past the most recent effective date of Research Ethics Board approval. After initial Research Ethics Board approval of a research study, the lead researcher is responsible to ensure continuing REB approval of the research for the duration of the study while it involves research participants. Additional review and approval for a subsequent period (or periods) is up to 12 months at a time.
b) Submission of a Final Report [DOC]. When the researcher is confident that no further involvement of participants will occur (and data collection is complete), the final report may be submitted to Research Ethics. Approved data analysis and writing may be ongoing. In determining whether or not it is appropriate to end REB oversight of the research, researchers should consider issues such as the extent of any remaining risk to participants, the status of any commitments or agreements made to participants, for example, with respect to reporting findings and/or the relative likelihood of future unanticipated events, material incidental findings, or new information. Where there is none, submission of a final report is appropriate and this report will close the Research Ethics file for this project.
No research requiring Research Ethics Board approval may be conducted in the absence of such approval. Research requiring REB approval that is conducted without REB approval, including continuing approval, may constitute disregard for University research-related policies and regulations under the Dalhousie University Scholarly Misconduct Policy.
- Submit the completed Annual/Final Report Form to Research Ethics, Dalhousie University, by email at firstname.lastname@example.org at least 21 days prior to the expiry date of your current Research Ethics Board approval.
- Enter subject line: REB# (8-digit number), Last name, Annual (or final) Report.
- Student researchers must copy their supervisor(s) in the cc. line of the Annual / Final Report email.
RESPONSE FROM THE REB
Your report will be reviewed and any follow-up inquiries will be directed to you. You must respond to inquiries as part of the continuing review process.
Annual reports will be reviewed and may be approved for up to an additional 12 months at a time; you will receive an annual renewal letter of approval from the Board that will include your new REB approval expiry date.
Final reports will be reviewed and acknowledged in writing.
PLEASE NOTE: Amendment requests must be submitted as a single electronic MS Word or PDF document. This includes the amendment request form, the cover letter, and the full amended application with changes highlighted.
When changes must be made to a research study in order to complete the work that was described in an approved research ethics submission, such changes must be proposed to the Research Ethics Board for ethical review and approval prior to making these changes. This is done by making an amendment request. If you are addressing a new research question or the changes represent a continuation of the study in a new direction, or with a different study population, then this is considered to be a new project requiring a new submission. Pilot studies are reviewed independently from the larger studies that are derived from them.
To make an amendment request:
1. Complete the amendment request form [DOC - 22 kB] and append associated documentation. In most cases, this includes: a cover letter explaining the proposed changes and the reasons for them, highlighted changes embedded in the latest approved version of the research ethics submission and highlighting any new research instruments, recruitment material, consent forms, etc. You should also include all approved documentation; the amendment request submission should reflect the full scope of your approved project, with proposed changes highlighted only.
2. Submit the amendment request documentation in a single electronic file (Word or PDF) to Research Ethics by email at email@example.com
a) Enter subject line: REB# (8-digit REB file number), Last name, Amendment request.
b) The email submission must come from the lead researcher (PI).
c) Student researchers must copy their supervisor in the cc. line of the email.
3. Amendment requests may be submitted at any time (noting that no ethical reviews are conducted in August).
4. Amendment requests will be reviewed by the Research Ethics Board, normally within 4 weeks of receipt. If the REB requests revisions or clarifications, these must be completed and re-submitted for additional ethical review prior to REB approval. Proposed changes may not be implemented until you receive notification of REB approval by email.