The complete plan for ensuring that research study is conducted ethically begins with the study investigator submitting their research ethics protocol for Research Ethics Committee (REC) review.
Applying For Initial Review Of Your Research
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 well in advance of the planned 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.
Course-Related Research: 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.
Administrative Review And REC Meeting Review
Study submissions are processed for review in the order in which they are received. An administrative review is conducted and the submission is assigned a unique Aurora College REC protocol number. If the study submission meets the requirements of the Aurora College REC and is assigned for REC meeting review, the study investigators receive an invitation to present their project overview during a Aurora College REC meeting.
The study investigator presentation is highly encouraged as it provides a valuable opportunity for investigators to discuss any ethical issues they have identified and answer REC members' questions.
The applicant can expect the response from the REC within two weeks of the meeting date. Depending on the REC’s requests, further clarifications or revisions to the protocol may be required. Communications continue until the protocol is compliant with TCPS – the REC will work with an applicant to develop a protocol that meets the needs of the research inquiry and complies with the ethical standard.
Re-submitting Your Protocol
After your protocol has been reviewed, the REC may request more information to clarify details of your protocol or suggest revisions to bring your protocol into compliance with TCPS. It is important that any edits and addendums to either the form 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 the 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. When the study submission meets all the criteria as per REC requirements, a certificate of ethics approval is issued.
Post Ethics Approval
After the Aurora College REC issues certificate of ethics approval, the study investigator is asked to sign their certificate of ethics approval and return a copy to the REC at firstname.lastname@example.org.
An ethics approval is only the beginning of study investigator’s relationship with the REC. Throughout the life of the study, the study investigator and the REC should maintain communications to ensure that the study investigator 1. Remains in compliance with TCPS, and 2. Maintains a valid approval certificate. The investigator’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.
Please note: The research community in the Northwest Territories is very close and members of the Aurora College REC 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. The study investigators are strongly cautioned to observe the requirements of continuing ethics review.
Renewing A Protocol
Approval certificates are valid for one year from the date of issue. It is the study investigator’s responsibility to apply for renewal in advance of the ethics approval certificate’s expiry date. For studies that will continue into the following year, the study investigator must submit a Renewal Request Form well in advance of the expiry of their approval certificate. The Renewal Request Form can be submitted at any time, as it is reviewed on an ad hoc basis and not at monthly meetings.
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 study investigator is required to submit an Amendment Request Form to the REC for 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 study investigator should complete an Unanticipated Event Form. Unanticipated event forms are subject to review by the REC and may result in revision requests. However, the investigator is not required to await the REC’s approval before acting to resolve the event. When responding to an unanticipated event, a study investigator 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.
Study Completion Report
When all data collection and study-related activities (including access to the participants’ record) are complete and there is no further participant involvement, a request to close the study file should be submitted by submitting a Study Completion Report.