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:
Quick links:
Behavioural REB |
Biomedical REB |
Meeting dates and deadlines 2023 | Meeting dates and deadlines (2023) |
Board members (REB 1, REB 2) |
- The University of Saskatchewan REBs require that all students engaged in research complete the TCPS 2 Tutorial Course on Research Ethics (CORE). Please submit the certificate of completion for all students.
- The University of Saskatchewan REBs require that all students involved in chart review or data abstraction activities also complete the McMaster Chart Review Tutorial. Please submit the certificate of completion for all students.
- 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
- The Fundamentals of OCAP® (update coming 2023)
Policies
- University of Saskatchewan Policies and Procedures for Ethics in Human Research
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)
- 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 Informa
- SOP 108 Standard Operating Procedures Maintenance
- tion
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)
—————————–
Research During the COVID19 Pandemic
Human Ethics applications that include in person activities may require extra considerations to safeguard participants from COVID-19 transmission. This also applies to amendments where the protocol is changing from virtual to in-person research activities.
Please include in your application/amendment form a description of protocols that will be in place to manage the risk of viral transmission. If no such protocols are required or necessary, please indicate that in your application/amendment instead, along with a brief explanation of why the project doesn’t require them. Please consider the following:
- Protocols must meet the minimum requirements for the location of the research activities.
- Where participants will be particularly vulnerable (e.g., due to advanced age or co-morbidities), it may be prudent to have protocols that exceed the requirements at the location.
- It may help to consult the guidance document and template below when drafting your plan.
- Please ensure that your consent material includes a brief description of any protocols you are following, such as masking, screening questions, and a description of how (and for how long) you will store participants’ contact information if you are keeping it for contact tracing.
How to Submit
- Download and complete the appropriate form and submit, with all supporting documents, to ethics.office@usask.ca.
- CC the principal investigator on the submission email.
- Submit any revised documents (i.e., amendment or response to a notice of ethical review) with tracked changes.
- Please note:
- If you have been assigned an Ethics ID# include the # on the submission email and associated forms.
- Scanned forms cannot be accepted.
- The University of Saskatchewan REBs require that all students complete the TCPS2 Tutorial (CORE) and that all students involved in chart review or data abstraction complete the McMaster Chart Review Tutorial. Please submit the certificate(s) of completion for all students.
Questions? Contact us at 306-966-2975 or ethics.office@usask.ca
Behavioural Application Form:
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.
How to Submit
- Download and complete the appropriate form and submit, with all supporting documents, to ethics.office@usask.ca.
- CC the principal investigator on the submission email.
- Submit any revised documents (i.e., amendment or response to a notice of ethical review) with tracked changes.
- Please note:
- If you have been assigned an Ethics ID# include the # on the submission email and associated forms.
- Scanned forms cannot be accepted.
- The University of Saskatchewan REBs require that all students complete the TCPS2 Tutorial (CORE) and that all students involved in chart review or data abstraction complete the McMaster Chart Review Tutorial. Please submit the certificate(s) of completion for all students.
Questions? Contact us at 306-966-2975 or ethics.office@usask.ca
Biomedical Application Forms/Guides:
- Above Minimal-Risk Application Checklist
- Biomedical Application - Secondary Use of Health Data
- Biomedical Application - Secondary Use of Biological Materials
- Biomedical Application – Prospective Research
- Biomedical Application – Creation of Biobank and/or Data Registry
Biomedical Consent Form Templates/Guides:
- NEW - Above Minimal Risk Consent Form Template
- NEW - Minimal Risk Consent Form Template
- Tissue Banking and Genetic Consent Form
- Tips for Filling Out Secondary Use of Health Data Forms
- Recruitment Poster Template
- Telephone Consent Script Template
- Assent Overview
- Assent SOP Sample
Biomedical Renewal and Closure Forms:
- Biomedical Renewal Form – Prospective
- Biomedical Renewal Form - Secondary Use of Health Data and Biological Materials
- Biomedical Renewal Form- Biobank and Data Registry
- Biomedical Closure Form
Biomedical Post-Approval Reporting:
- Biomedical Protocol Deviation Form
- Biomedical Local Unanticipated Problem Form
- Biomedical Non-Local Unanticipated Problem Form
- Biomedical Additional Reportable Events/Documents Form
- Biomedical Amendment Form
Saskatchewan Health Authority (SHA) Operational Approval to Conduct Research: Review and approval of research projects that impact or affects any SHA resources/facility(s). This includes all research projects conducted by SHA employees.
The requirements for obtaining SHA Operational Approval (OA) for research are twofold:
- Assurance of research ethics approval from the appropriate Research Ethics Board (REB) must be provided before OA can be granted. Research ethics approval must be obtained from one of the following Saskatchewan Research Ethics Boards: SHA (located in Regina), University of Regina or University of Saskatchewan. Do not submit your SHA Operational Approval application until AFTER the REB application has been submitted for review to the appropriate REB.
- The Principal Investigator (PI) must complete and submit the SHA Application for Operational Approval to Conduct a Research Study. The purpose of the application is to ensure that research using SHA or affiliated resources or patients occurs with the approval of the appropriate authorities, as well as to ensure that all research occurring within the SHA meets the requirements of the applicable policies, legislation, and guidelines for conducting responsible research. It is essential to determine whether the SHA has the appropriate resources in place to support the research question or hypothesis, that the areas being affected have an opportunity to review the project details and assess their impact, and to ensure that all necessary ethical and operational processes have been completed prior to the commencement of the project.
Research Approval Coordinator Contact Information:
Regina/South: researchapproval.regina@saskhealthauthority.ca , telephone: (306)766-0893
Saskatoon/North: researchapproval.saskatoon@saskhealthauthority.ca, telephone: (306)-655-1442
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 - TCPS 2 (2022) 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 participants 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.