Ethics review

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Office of Research Ethics and Integrity

Ethics review

Any research project involving human participants or human biological material which is conducted within the jurisdiction or under the auspices of the University of Ottawa, whether it is funded or not and regardless of where it is conducted, must receive ethics approval from a University Research Ethics Board (REB) prior to the start of the project. REB review and approval is necessary even if the project received prior approval from another REB.

TCPS 2 (2022) - Research Requiring Research Ethics Board Review

Article 2.1

The following requires ethics review and approval by an REB before the research commences. Research involving:

a) living human participants;

b) human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Application

The scope of this Policy is restricted to the review of the ethical conduct of research involving humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human participants.” It includes course-based research activities, the primary purpose of which is pedagogical, because of the possible risks to those recruited to participate in such activities, and the fact that, from their perspective, such activities may appear indistinguishable from those that meet this Policy’s definition of research (Application of Article 6.12).

For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human reproduction include embryos, fetuses, fetal tissues and human reproductive materials.

REB review and approval is necessary even if the project received prior approval from another REB, unless an agreement exists between the said institutions.

Please note that REB review is required in order to work with any human biological material, regardless of how they are obtained (e.g., ethics approval is needed in order to use material obtained via a commercial biobank).

If you are unsure about whether your project requires ethics review, please contact the Office at ethics@uOttawa.ca or 613-562-5387.

Who should submit a request for ethics review?

Faculty members for their own research;
Ph.D. and Master's students (and their supervisor) or students (and their supervisor) preparing honors or fourth year research projects;
Professors who, in the context of their courses, require students to conduct independent research projects (directed studies) requiring the participation of human participants;
Course instructors who include research activities as part of an undergraduate or graduate assignment designed to provide training in research. Responsibility for carrying out a detailed ethical assessment of specific projects lies with those responsible for such courses;
Professors or students making use of secondary data which were originally collected for purposes other than the current research (e.g., school or criminal records, private association archives, company's internal documents).
External researchers (not affiliated with uOttawa) who want to conduct research with uOttawa members or on its campus.

Types of review and timelines

In keeping with a proportionate approach to research ethics review, as per Article 6.12 of the TCPS 2, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (minimal risk review); the higher the level of risk, the higher the level of scrutiny (full REB review).

A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.

Note: The REB Chair, at his or her sole discretion, may refer the ethics submission to full board, minimal risk, or expedited review.

Submission Process

As stated in University Policy 115 (Article 7), the University of Ottawa is committed to:

maintaining the highest standards of integrity in its research activities;
maintaining a research environment that promotes the responsible conduct of research and academic freedom;
fulfilling its responsibilities in upholding applicable legislation for the conduct of Research and the policies, rules, regulations and its contractual agreements with Research Sponsors and with the Agencies.

The University of Ottawa respects the conditions of the Agencies in regards to the review of the research involving humans, including abiding by the most recent version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS.

Any research project involving human participants or human biological material which is conducted within the jurisdiction or under the auspices of the University of Ottawa, whether it is funded or not and regardless of where it is conducted, must therefore receive ethics approval from a University Research Ethics Board (REB) prior to the start of the project.

Completion of the Request Form

Initial review applications (except Course Outline applications) must be completed directly in the eReviews online portal.
Supported browsers for eReviews are Google Chrome and Firefox.
Provide complete information and answer all questions using full sentences.
Avoid technical jargon and explain terms.
Label all appended documents to reflect the content (e.g., "Consent form - Focus groups").
Additional information is available in the eReviews User Guide.
Course outline applications: Initial submissions can be submitted using this FORM; ongoing forms are available HERE. Forms can be submitted via email to ethics@uOttawa.ca.

Submission of the Request Form

The request form must be created in eReviews by the Principal Investigator of the study.
The request form must be duly completed and approved by relevant team members (Principal Investigator and Supervisor, if applicable) by the required submission deadline (see Dates and Timelines).
Applications submitted after the deadline, when applicable, will be delayed and reviewed the following month.
Incomplete request forms will be returned to the researchers. If errors hinder proper understanding of content, documents will be sent back for corrections and the evaluation postponed.

Evaluation of the Request Form

Upon receipt of the request, the content is verified and the level of risk determined. A confirmation of acceptance will be sent via email when the file is assigned for evaluation.
The request is assigned to a Specialist and REB evaluators.
The request is reviewed by the REB evaluators, the REB Chair, and the Specialist.
REB comments and feedback are compiled and sent to the researchers, at which time the researchers have six months to respond.
Researchers must respond to the REB feedback directly in the online request form. In order to submit revised appendices (recruitment texts, consent forms, research instruments, etc.), please delete the original attachment and upload the new revised version, with tracked or highlighted changes.
Once the request is in order, an ethics certificate will be issued and the project may begin.

REB Decisions

Following the submission of a request for ethics approval and its evaluation by the REB, one of the following decisions may be issued:

Approved: The project is approved and an ethics certificate is issued. Recruitment and data collection may begin as outlined in the application. Generally speaking, ethics approval applies for one year. A Renewal must be submitted if recruitment and/or data collection is not yet complete. Throughout the course of the study, any modification to the project must first be approved by the REB before the changes can be implemented.
Approved – Partial: Part of the project is approved (recruitment and data collection may begin for that specific part) but the other part of the project requires additional review and/or documentation, which will need to be addressed further, before approval for the full approval can be issued.
Revisions required: The project requires some clarifications/revisions. The REB will provide the researcher with written feedback outlining its concerns. Ethics approval will be granted and an ethics certificate issued once the feedback has been satisfactorily addressed.
Resubmission required: There are major ethical concerns or the file is deemed incomplete by the REB. The project cannot be approved as submitted and a complete resubmission of the request is required. The REB will provide the researcher with a summary of the concerns, along with an invitation to meet with the REB, its Chair and/or a Specialist to discuss the concerns. Following this meeting, a revised ethics request (including appendices) must be submitted for evaluation by the REB.
Refused: Ethics approval of the project is refused following the ethics review. The REB will provide the researcher with the reasons for the refusal.