Case Report Study/Series
As of November 1, HSREB and GREB require all case report studies/series being conducted for the purposes of research to be approved, regardless of sample size. Approval must be received PRIOR to extracting data from the participant chart and/or obtaining consent for the purposes of the case report study/series.
A ‘Case Report Application’ is available in TRAQ for HSREB and will soon be available for GREB. An updated Case Report Guideline and a Case Report Consent Form Template will be available on the ethics website soon. NOTE: The use of the Case Report Consent Form Template is mandatory. If you completed a case report study/series from April 1st, 2023, to Oct 31st, 2023, and have not received REB approval, please submit this application to the REB via TRAQ. You will receive ‘REB clearance’. “REB clearance” is not a formal approval by the REB but serves as a retroactive clearance, which is sufficient to indicate that the REB has viewed this application. You will receive REB approval if you submit a case report study/series conducted after Oct 31, 2023. When you submit to the REB for a case report study/series, please clearly indicate the date the case report study/series was completed or will be completed (i.e., between April 1st, 2023, to Oct 31st, 2023, OR after Nov 1st, 2023).
Missed renewals- new termination rules
On November 10, 2023, a new process will be implemented for late renewals that have not been received by the REB. Applicants will receive two renewal reminders: one month before the REB expiry date and two weeks prior to the REB expiry date. If a renewal event form has not been received within this time, the study will be terminated in the system in accordance with the REO’s new SOPs. Study teams will have 30 days after the termination of a study to reopen the study. The researcher must describe why ethics approval lapsed in order to reopen a study. When a study has been terminated, all study-related activity must cease until ethics approval has been re-obtained. If a researcher has surpassed the 30 days after termination date, the file will not be re-opened and a new application must be submitted in TRAQ, which is subject to a full re-review.
Older applications may require follow up
When an application is submitted in the TRAQ system (i.e., amendment, renewal, etc.), the research ethics office will review the entire application to determine if all necessary information/context is available. If an application/study is older, it may not have all the required elements. The research ethics office will contact the applicant to request further information to be submitted. This may be requested as an amendment, or as a new application. NOTE: if the consent form or participant-facing documentation is five years old and has not been amended within this time, the research ethics office will ask for updated forms or documents.
Foundations of Privacy Research Course
Queen’s now has access to the Foundations of Privacy Research course for research faculty and staff. Through the Network of Networks (n2canada.ca ) – an alliance of Canadian research networks and organizations working to enhance national clinical research capability and capacity for research faculty and staff. This program is dedicated to enhancing your knowledge of the management and security of research-related information. A Queen's NETID is required to access the course information.
TCPS2 2022 CORE Certificate
The newest version of the Tri-Council Policy Statement 2: Course on Research Ethics (TCPS 2: CORE) was officially released at the beginning of last year. To offer the research community adequate opportunity to take the new training, the REB has requested for the TCPS2 2022 CORE certificate completion by April 2024. It is the responsibility of the researcher to ensure that the TCPS2: CORE-2022 certificate has been acquired by the entire study team.
Finding updates on your team changes
A reminder that a communication was sent in October 2022, where it was announced that the research ethics office will no longer be issuing emails when changes are made to study team members, except following changes to the Principal Investigator (which are completed via Amendment). When your ‘Change to Project Team’ Event Form has been processed, the research ethics office will add a comment in the “Shared Comments” of the Change to Project Team Event to indicate that this update to the study team has been processed. That individual will also need a TRAQ profile, and it should be clearly stated that this individual requires access to the team change event form. Only those indicated will be provided with access within TRAQ.