NOTICE: Aurora College Research Ethics Committee Guidance and New Procedure During COVID-19 Pandemic
The Aurora College Research Ethics Committee (REC) recognizes that the ongoing COVID-19 pandemic poses an extraordinary and serious safety and public health threat to our communities. The REC will continue to operate normally as much as possible; however, some changes are necessary. Please also note that there may be delays in responding to e-mails and processing reviews at this time due to a high volume of requests. Your continued patience and cooperation is appreciated.
Effective immediately, the Aurora College REC will now require that investigators eliminate all personal contact, in-person data collection, or site visits with study participants. This also means that research involving physical assessments or the in-person use of equipment or devices must be suspended.
In-person participant interactions should, if feasible, be replaced with telephone, video conference or other digital communication. In doing so, researchers should be mindful of the nature of their protocol and any additional risk that may arise from switching from in-person to virtual communication, including risks to privacy. Revised participant consents or consent addendums may be required (e.g. to update privacy considerations for the use of different communication channels).
The REC will only provisionally approve research that complies with TCPS but does not comply with recommendations and orders made by the Chief Public Health Officer of the Northwest Territories (CPHO), including physical/social-distancing recommendations. These protocols will be moved to approval when CPHO announces that physical/social-distancing measures are relaxed and the REC agrees that participants will not be at risk from COVID-19.
Principal investigators are responsible for applying for their initial research ethics review and for observing the requirements of continuing ethics review. Throughout the life of the study, the PI and REC should maintain communications to ensure the PI:
- remains in compliance with TCPS, and
- maintains a valid approval certificate. The PI’s relationship with the REC ends with an end-of-study report that confirms the close of the protocol and completion of the study. There can be serious repercussions for PIs who fail to observe their responsibilities to the research ethics process.
Applying for initial review of your research
The complete plan for ensuring a study is conducted ethically is called your research ethics protocol. If your study is new and your protocol is being reviewed by the REC for the first time, complete a Research Ethics Review Application Form and submit to email@example.com at least 8-12 weeks in advance of the research start date. Be sure to attach all study documents, including consent forms, interview guides, survey questions, recruitment posters, etc. Resources are available to guide applicants in completing their research ethics protocol.
Re-submitting your protocol
After your protocol has been reviewed, the REC may request more information to clarify details of your protocol or request revisions to bring your protocol into compliance with TCPS. It is important that any edits and addendums to either the forms or the study documents be emboldened, CAPITALIZED or otherwise clearly highlighted to ensure the committee can clearly see where changes have been made. If for any reason you are unable to highlight changes within the application using any of these methods, please submit a document addressing each comment with a page reference to the changes made in the revised application form. Failure to adequately indicate changes throughout the revised application form may result in the committee’s refusal to review until this request has been met. For feedback that does not require edits to your application, you may include your comments via email or in a letter.
For Aurora College instructors or Aurora College students requesting approval to conduct research as part of their course requirements, please submit a Course-Related Research Review Application Form. Please see the resources available to assist you in the completion of your submission.
Continuing Ethics Review
An ethics approval is only the beginning of the PI’s relationship with the REC. After a protocol has been approved, the PI is asked to sign their certificate of ethics approval and return a copy to the REC at firstname.lastname@example.org. Throughout the life of the study, a PI is responsible for communicating to the REC when they wish to make changes to their protocol, when they encounter an unanticipated event, or when they need to renew their approval annually.
The research community in the Northwest Territories is very close and members of the research ethics committee live and work in communities throughout the territory. The REC is often notified about research taking place in NWT communities and is obligated to investigate any public inquiries into or allegations directed at studies under REC purview. PIs are strongly cautioned to observe the requirements of continuing ethics review.
Submitting an Amendment
Research protocols often change as a result of changing circumstances in the field, changes to the research team, as a result of findings or community requests, and for many other reasons. When the need for a change to a study’s ethics protocol is identified, the principal investigator is required to submit an Amendment Request Form for REC review and approval in advance of implementing the change. Be sure to include any study documents that need to be revised as a result of the change in protocol. Amendments can be submitted at any time, as they are reviewed on an ad hoc basis but may be re-directed to a monthly meeting in the event of a major amendment.
Notifying the REC of an unanticipated event
In the event that research activities or changing circumstances in the field cause an unanticipated change to the research ethics protocol or that a response to an event is required immediately to ensure the protection of participants, the PI should complete an Unanticipated Event Form. Unanticipated event forms are subject to review by the REC and may result in revision requests, however, the PI is not required to await the REC’s approval before acting to resolve the event. When responding to an unanticipated event, a PI is responsible for consulting TCPS to ensure they are acting in compliance with TCPS. Unanticipated event forms can be submitted at any time, as they are reviewed on an ad hoc basis and not at monthly meetings.
Renewing a protocol
Approval certificates are valid for one year from the date of issue. It is the PI’s responsibility to apply for renewal in advance of the certificate’s expiry date. For studies that will continue into the following year, PI’s must submit a Renewal Request Form at least 8 weeks in advance of the expiry of their approval certificate. Renewals can be submitted at any time, as they are reviewed on an ad hoc basis and not at monthly meetings.
All new submissions must be submitted for review at a monthly meeting. For guidance on other types of submissions, please see the guidance above
|REC Meeting Date|
September 9, 2020
|September 23, 2020|
October 15, 2020
|October 28, 2020|
|November 11, 2020||November 25, 2020|
|January 13, 2021||January 27, 2021|
|February 10, 2021||February 24, 2021|
|March 10, 2021||March 24, 2021|
|April 14, 2021||April 28, 2021|
|May 12, 2021||May 26, 2021|
|June 9, 2021||June 23, 2021|
The Aurora College REC takes an annual summer recess. No review activity will take place during July and August. PIs planning summer research must submit well before summer recess to ensure that all revisions are complete and approval is granted before committee members leave for summer.
For more information, please contact:
Manager, Research Ethics & Regional Programs
50 Conibear Cres
Fort Smith, NT