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Research involving the following requires ethics review and approval by a Research Ethics Board (REB) before the research commences:
- living human participants;
- 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;
- secondary use of data, health information, or biological materials.
- Understand requirements and expectations set out in human ethics policies:
- Confirm whether your project requires approval:
Behavioural REB |
Biomedical REB |
| Meeting dates and deadlines | Meeting dates and deadlines (2021,2022) |
| Board members | Board members (REB 1, REB 2) |
| Average Review Time by Month |
- The TCPS 2 Tutorial Course on Research Ethics (CORE)
- Research Ethics Presentation
- The CITI online GCP training is available at no charge to:
- University of Saskatchewan faculty and their research staff
- Staff and students of the University of Saskatchewan
- Saskatoon Health Region and affiliate staff and practitioners
- U.S. federal-wide Assurance Training Modules
- National Institutes of Health Research (NIH) Researcher Training
- McMaster University Chart Review Tutorial
Policies
- University of Saskatchewan Policies and Procedures for Ethics in Human Research
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)
- Procedures for Stewardship of Research Records at the University of Saskatchewan
- Human Ethics Review Fee Policy
Guidelines
- Guidelines for Registering in a Clinical Trials Registry
- Research Participants Funding Requisition Guidelines and Procedures
Standard Operating Procedures
100 General Administration (101-108)
- SOP 101 Authority and Purpose
- SOP 102 Research Requiring REB Review
- SOP 103 Training and Education
- SOP 104 Management of REB Office Personnel
- SOP 105A Conflicts of Interest REB Members and REB Office Personnel
- SOP 105B Conflicts of Interest Researcher
- SOP 105C Conflicts of Interest Organization
- SOP 106 Signatory Authority
- SOP 107 Use and Disclosure of Personal Information
- SOP 108 Standard Operating Procedures Maintenance
200 REB Organization (201-204)
- SOP 201 Composition of the REB
- SOP 202 Management of REB Membership
- SOP 203 Duties of REB members
- SOP 204 REB Office Personnel Serving as REB Members
300 Functions and Operations (301-303)
- SOP 301 REB Submission Requirements and Administrative Review
- SOP 302 REB Meeting Administration
- SOP 303 Document Management
400 Reviews of Research (401-407)
- SOP 401 Delegated Review
- SOP 402 REB Review Decisions
- SOP 403 Initial Review Criteria for REB Approval
- SOP 404 Ongoing REB Review Activities
- SOP 405 Continuing Review
- SOP 406 Research Completion
- SOP 407 Suspension or Termination of REB Approval
500 Reviews Requiring Special Consideration (501-503)
600 REB Communication and Notification (601-602)
700 Informed Consent (701)
800 Responsibilities of Investigators (801)
900 Quality Management (901-903)
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Research During the COVID19 Pandemic
Human Ethics applications that include in person data collection will require extra considerations to safeguard the wellbeing of the participants during the pandemic.
The Behavioural REB is now reviewing and approving some applications that include in person/face to face data collection. In order for the REB to approve in person research activities, please include with your Application a COVID Safety Plan. If your project has already been approved, please submit an Amendment Form with your plan and any updated documents, such as consent forms. It may help to consult the following guidance document and template when drafting your plan.
Behavioural Application Form:- NEW Behavioural Application Form
- Behavioural Form Instructions
- Behavioural REB Delegated Review Workflow
Behavioural Amendment Form:
Behavioural Consent Form Templates/Guides:
- Consent Form Template & Guidelines - Individual Participation
- Consent Form Template & Guidelines - Online Survey
- Consent Form Template & Guidelines - Group Activity
- Transcript Release Form Template
- Recruitment Poster Template
- Consent Form Template & Guidelines for Individual Interviews by Videoconference
- Consent Form Template & Guidelines for Group Interviews by Videoconference
Behavioural Renewal and Closure Forms:
Human Ethics applications that include in person data collection will require extra considerations to safeguard the wellbeing of the participants during the pandemic.
Instructions: Biomedical Form Instructions
Biomedical Application Forms/Guides:
- Above Minimal-Risk Application Checklist
- NEW Biomedical Application - Secondary Use of Health Data
- NEW Biomedical Application - Secondary Use of Biological Materials
- NEW Biomedical Application – Prospective Research
- NEW Biomedical Application – Creation of Biobank and Data Registry
Biomedical Consent Form Templates/Guides:
- Consent Form Template
- Minimal Risk Consent Form
- Tissue Banking and Genetic Consent Form
- Tips for Filling Out Chart Review Forms
Biomedical Renewal and Closure Forms:
- NEW Biomedical Renewal Form – Prospective
- NEW Biomedical Renewal Form - Secondary Use of Health Data and Biological Materials
- NEW Biomedical Renewal Form- Biobank and Data Registry
- NEW Biomedical Closure Form
Biomedical Post-Approval Reporting:
- NEW Biomedical Protocol Deviation Form
- NEW Biomedical Local Unanticipated Problem Form
- NEW Biomedical Non-Local Unanticipated Problem Form
- NEW Biomedical Additional Reportable Events/Documents Form
- NEW Biomedical Amendment Form
All research studies requiring access to Saskatchewan Health Authority resources or patients (including Personal Health Information) must obtain two types of approval prior to commencing:
- Research Ethics Approval
- Operational Approval
Research ethics approval is obtained from one of the Province of Saskatchewan's recognized Research Ethics Board (University of Regina, University of Saskatchewan or the Saskatchewan Health Authority REB). The ethics review ensures that the proposed study is scientifically valid, ethically sound, compliant with legislation, and most importantly, minimizes risk to participants (patients and staff).
As of January 29, 2021, under the terms of the Reciprocity Agreement between Saskatchewan's recognized REBs, applications for Research Ethics Board (REB) approval that (1) require SHA Operational Approval and (2) will be conducted at SHA sites outside of Saskatoon and Regina, will require SHA Local Ethics Committee (LEC) review at the applicable sites. This review is meant to provide a local context to the review of the proposed research. The LEC reviews will be processed through the research ethics office and will not require anything further from the researchers. The REBs maintain the right to determine what is and is not included in the Notice of Ethical Review. This will not cause any interruption in the review/approval of research projects. If you have any questions about this process, please contact the Research Ethics Office at ethics.office@usask.ca
Operational Approval provides assurance that the research can be carried out safely by the impacted departments, within their current workload, and when possible, provides a mechanism for the Saskatchewan Health Authority to recapture the direct costs of supporting the research in a manner that is fair and transparent to researchers.
For more information about obtaining Saskatchewan Health Authority Operational Approval for Research, please email ResearchApproval.Regina@saskhealthauthority.ca
For copies of the Operational Approval form, go to http://www.saskhealthauthority.ca/our-organization/our-direction/research/getting-started/operational-approval
NEW* As of May 15, 2020, anyone conducting a chart review will be required to book their time at any hospital in Saskatoon or Regina. Please call the following numbers to schedule your time:
Saskatoon - Aimee Goss, HIMA @ 306-655-1725 or Aimee.Goss@saskhealthauthority.ca
Regina - Nina Lindo, Manager @ 306-766-3747 or Nina.Lindo@saskhealthauthority.ca
How do I submit my ethics application to the USask Research Ethics Boards?
All submissions can be submitted via email at ethics.office@usask.ca.
Does your project require human ethics review and approval?
University of Saskatchewan Research Ethics Boards (REBs) operate in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Second Edition (December 2018) and the University of Saskatchewan Policies and Procedures for Ethics in Human Research (June 2013).
The following list represents a broad overview of the range of research projects or situations that would require review and approval by the REB:
- Research that will be published.
- Projects where participants are from inside or outside the university.
- Research that is funded or unfunded. Funding may be internal or external.
- Research that is conducted by students or faculty.
- Research projects that are conducted inside or outside the institution.
- Information that is collected directly from participants or from existing records not in the public domain.
- Projects that are conducted in person or remotely (e.g., mail, electronic mail, fax, online video conferencing, or telephone).
- Research designs that are observational, experimental, correctional, or descriptive.
- Review is still required even if a similar project has been approved elsewhere.
- Pilot studies or fully developed projects undergo the same review process.
- The primary goal of the research is for teaching or training purposes, or the acquisition of knowledge
To which REB do I submit my application?
The University has established two Research Ethics Boards (REBs), which have defined Terms and Conditions of Appointment for Members and Chairs. The appropriate REB must approve any project involving the use of human participants.
The Biomedical Research Ethics Board (Bio-REB) is responsible for the review of all protocols involving human participants which include:
- medically invasive physical procedures, invasive interventions and invasive measures (includes administration and testing of drugs); physical interventions that have the potential for adverse effects such as drug, exercise and dietary interventions; surgical procedures such as biopsies, the collection of blood or other specimens;
- use of permanent charts or records in accordance with provincial legislation.
The Behavioural Research Ethics Board (Beh-REB) is responsible for the review of all protocols involving human particpants which include:
- non-invasive interventions and measures including interviews, surveys, questionnaires, psychological, social or behavioural interventions, non-invasive physiological measures (e.g. heart rate, blood pressure);
- observation or descriptive research, including drug, dietary, and exercise protocols that are observational in nature with no intervention;
- audio and/or video recording or other monitoring.
The Research Ethics Office may determine that an ethics application is more appropriately reviewed by one REB than the other and reserves the right to move the ethics application to the REB with the most appropriate expertise to conduct the review. In those cases the researcher will be consulted and informed of the transfer. No new submission will be required, but additional information may be requested.
With the increasing numbers of multidisciplinary research projects and the use of mixed methods, research ethics submissions that combine elements of both biomedical and behavioural research are becoming more common. An ethics application using mixed methods will be reviewed by the REB with the best expertise in the methods that may impose the greater risk to a research participant from either a biomedical or behavioral standpoint. Where appropriate, the Biomedical and Behavioural REB may collaborate in the ethics review of the submission.