• Above minimal risk submissions are reviewed at full board meetings.
• Minimal risk submissions are reviewed in the order received. 

• 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® (updated fall 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

• Research Ethics Board Standard Operating Procedures (18 February 2022)
• SOP Table of Contents

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 106 USask Addendum
• 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 302 USask Addendum
• 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 404 USask Addendum
• SOP 405 Continuing Review
  • SOP 405 USask Addendum
• SOP 406 Research Completion
• SOP 407 Suspension or Termination of REB Approval

500 Reviews Requiring Special Consideration (501-503)

• SOP 501 REB Review During Publicly Declared Emergencies

600 REB Communication and Notification (601-602)

• SOP 601 Communication Researcher
• SOP 602 Communication Research Participants

700 Informed Consent (701)

• SOP 701 Informed Consent Form Requirements and Documentation

800 Responsibilities of Investigators (801)

• SOP 801 Researcher Qualifications and Responsibilities

900 Quality Management (901-903)

• SOP 901 Quality Assurance Inspections
• SOP 902 External Inspections or Audits
• SOP 903 Noncompliance

—————————–

• Glossary of Terms
• References
• Table of Concordance

Behavioural Application Form:

• Behavioural Application Form
• Understand the lifecycle of your application: Behavioural REB Delegated Review Workflow

Course-Based Research Application Form:

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) places under REB purview pedagogical activities involving human participants that are conducted by students as part of a course: "[The REB's scope] 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.”

The Application for Review of Course-Based Research can be used for courses where students are engaging in research activities solely for pedagogical purposes. This application can NOT be used for thesis or dissertation projects, including at the undergraduate level.

The Application for Review of Course-Based Research allows the Behavioural Research Ethics Board and Biomedical Research Ethics Board to provide REB approval to the course instructor for the general form and content of course-based research activities. The REB then delegates responsibility to the instructor for ensuring that students’ specific processes and project materials adhere to the REB approved application and the TCPS2. 

Please note that the course-based approval is for one year, and can be renewed twice. After three years, a new course-based application form must be submitted for review.

• Course-based Research Application Form

Behavioural Consent Form Templates/Guides:

• Consent Form Template & Guidelines - Individual Participation
• Consent Form Template & Guidelines - Online Survey
• Consent Form Template & Guidelines - Group Activity
• Recruitment Poster Template
• Behavioural Consent Form Templates/Guides for Research Using an Online Videoconferencing Service:
  • Consent Form Template & Guidelines for Individual Interviews by Videoconference
  • Consent Form Template & Guidelines for Group Interviews by Videoconference
• Transcript Release Form Template

Behavioural Amendment Form:

• Behavioural Amendment Form

Behavioural Renewal and Closure Forms:

• Behavioural Closure Form
• Behavioural Renewal Form

Behavioural Protocol Deviation Form:

• Behavioural Protocol Deviation Form

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.
• Safe Research Plan Template
• Safe Research Guidelines

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

Research During the COVID19 Pandemic

Human Ethics applications that include in person data collection may require extra considerations to safeguard the wellbeing of the participants during the pandemic.

• Biomedical Guidance on Consent During COVID-19

The Research Ethics Boards (REB) in the province of Saskatchewan have moved to a policy of full reciprocity. Approval by an REB at University of Saskatchewan, University of Regina, or Saskatchewan Health Authority will be accepted by the REBs at the other two institutions without the need for additional REB review, provided the protocol is identical in its content and activities. Please note that there are criteria for determining which REB is the one that you must seek approval from (it is not necessarily your home institution), so before you begin preparing your REB application, please check in with the staff at your local REB office for guidance. 

For all other Canadian institutions, the USask REBs may provide a Letter of Acknowledgement of the primary institution’s approval, rather than perform a second review. More information is available on knowledge base.

Plese consult the TCPS2 (2022) - Chapter 8 regarding Multi-Jurisdictional research.

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:

1. 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.
2. 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

Questions? Please contact:

• Human Research Ethics Office
  • Susan Jelinski (Director) at ethics.office@usask.ca
  • Tenille Shivak (Research Ethics Administrator) at 306-966-2975 or ethics.office@usask.ca

• Biomedical Ethics
  • Caitlin Prebble (Research Ethics Specialist) at caitlin.prebble@usask.ca
  • Adrian Taylor (Research Ethics Coordinator) at adrian.taylor@usask.ca

• Behavioural Ethics
  • Melanie Bayly (Research Ethics Coordinator) at melanie.bayly@usask.ca
  • Shalini Reymond (Research Ethics Coordinator) at shalini.reymond@usask.ca
  • Hamisi Mwaguni (Research Ethics Coordinator) at hamisi.mwaguni@usask.ca

In order to contact the Biomedical or Behavioural Research Ethics Board Chair, please email ethics.office@usask.ca and it will be directed to the appropriate person immediately. 

Step-by-Step 

Step 1: Determine If Your Project Requires Ethics Review

 Step 2: Determine Which Research Ethics Board Your Project Should Be Reviewed By

 Step 3: Assess The Risk Level Of Your Project (Minimal Risk Or Above Minimal Risk)

 Step 4: Submit An Ethics Application To The Ethics Office

 Step 5: Make The Requested Revisions As Suggested By The Research Ethics Board (If Necessary)

During the Ethics Review Process the REB will often respond to you with suggested revisions or modifications to the research protocol, consent form, recruitment protocol, etc. These revisions will need to be made and submitted for review prior to ethics approval being granted. Revisions must be submitted electronically.

 Step 6: Receive The Certificate Of Approval And Begin The Project

Approval is issued for the protocol and corresponding documents that are described in the application. Changes to any aspect of this protocol (i.e. a change in research method, recruitment of participants, participant population, consenting process, consent form, etc.) require approval from the appropriate REB. An amendment form (Bio) (Beh) must be submitted to ethics.office@usask.ca.

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

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.

All research that involves human participants requires review and approval by a Research Ethics Board (REB) in accordance with the Tri-Council Policy Statement before the research is started.

REB review and approval of the ethical acceptability of research is required prior to the start of recruitment of participants, access to data, or collection of human biological materials.

An Amendment Form must be completed for all revisions to your approved study including changes to research personnel (PI, sub-I, student), sponsor and/or funder, location, questionnaires, consent forms, recruitment material.

Your project is minimal risk if the risk of harm anticipated in the proposed research is not greater, considering probability and magnitude, than that which is ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Risks of daily life mean those risks encountered in the daily lives of the participants of the research, considering their actual life situations, as opposed to the daily life of "all persons" or of "healthy volunteers" as the case may be.

If your study is minimal risk, it will be reviewed via delegated review by the Chair or Vice-Chair of the Research Ethics Board (REB).

If your study is above minimal risk, it will be reviewed by the REB at a full board meeting, and will need to be submitted by the appropriate deadlines:

Biomedical Research Ethics Submission Deadlines

Behavioural Research Ethics Submission Deadlines

The REB requires that a closure form is submitted when the research study is completed.

• Biomedical Closure Form
• Behavioural Closure Form

A study is completed when there is no further contact between the researcher and participants.  This point might come, for example, at the end of data collection when the researcher has no intent of further contact with participants or after data analysis because some follow-up contact with participants may be needed or possible. In some cases, researchers undertake to report back to individuals, or to the community or group from whom they collected data. In these cases, contact with participants would only end once they have reported their findings in accordance with this undertaking. This would occur after data analysis, interpretation of the findings, and/or drafting of the research report.

• Clinical Trials: Once the study has been completely closed by the sponsor, the REB must be notified of the study closure. The submission should include:
  • The PI’s affirmation that participant data collection is completed;
  • Total number of research participants enrolled at the local site;
  • The number of Serious and Unexpected Adverse Events;
  • The date of the study monitor’s final visit;
  • The final disposition/storage of all research related study documents;
  • The final disposition of any electronic data, and;
  • Any other information required by the study sponsor.
•  All Other Studies Enrolling Participants: The PI must notify the REB that the study has been completed. The submission should include:
  • The PI’s affirmation that participant data collection is completed;
  • Total number of research participants enrolled at the U of S local site;
  • The final disposition/storage of all research-related study documents.
  • The final disposition of any electronic data, and
  • Any other information relevant to the REB.
•  Studies Using Secondary Sources of Data Only:
  • The PI must notify the REB that the acquisition of data is complete.
•  US Federally Funded Research Studies:
  • Studies that are funded or supported by the US federal government may not be closed until analysis of all individually identifiable information is completed

Step-by-Step

1. Download the appropriate form to your desktop.
2. Type in your responses, and save a copy and any associated documents.
3. Questions marked with an * are mandatory.
4. Signatures are not required on any forms.
5. Submit the completed form and all associated documents electronically to ethics.office@usask.ca. DO NOT SCAN DOCUMENTS.
6. If submitting a form on behalf of the Principal Investigator (PI), you must copy the PI on the email submission.

Biomedical post-approval reporting Forms:

Biomedical Protocol Deviation Form

Biomedical Local Unanticipated Problem Form

Biomedical Non-Local Unanticipated Problem Form

Biomedical Additional Reportable Events/Documents Form

Within Saskatchewan

The Research Ethics Boards (REBs) in the province of Saskatchewan have a policy of full reciprocity.  This means that if your application has been approved by one of the following SK REBs; the University of Saskatchewan, the University of Regina, or the Saskatchewan Health Authority, approval will be accepted by the other institution(s) without the need for additional REB review, provided the protocol is identical in its content and activities.

Please note: There are criteria for determining which REB is the one that you must seek approval from (it is not necessarily your home institution). Before you begin preparing your REB application, please check in with the staff at your local Research Ethics Office for guidance.

Other Canadian Institutions

For all other Canadian institutions, the USask REBs may provide a Letter of Acknowledgement of the primary institution’s approval, rather than perform a second review. The acknowledgement serves to confirm that the project meets the REB’s requirements for the ethical conduct of research and can proceed at the University of Saskatchewan. A certificate of Approval is not issued, and the ethical oversight remains at the primary institution. This process is considered when a project meets the following criteria:

1. The project is minimal risk, as defined by the TCPS 2 (2022).
2. The project has been approved by a TCPS2 compliant REB.
3. The project does not require release of personal health information from any trustee, designated archive, or health information custodian and the collection of information is prospective and supported through consent.

The USask Behavioural and Biomedical REBs have additional criteria that must be met when determining whether an external application can be acknowledged.  To request a review of an external application, please send an email the research ethics office (ethics.office@usask.ca), copying the lead Principal Investigator and attaching the following documents (as applicable):

1. Evidence of external REB approval (e.g., a Certificate of Approval)
2. The approved REB application
3. The approved consent form(s)
4. The approved data collection tools (e.g., surveys, questionnaires etc.).
5. The approved recruitment material(s) that will be used to advertise the study at USask.

When the request is received, the Research Ethics Office will arrange for the documents to be reviewed by a Chair or Vice-Chair of the appropriate REB to ensure that the external approval meets the USask REB’s requirements. This review typically takes 2 to 3 weeks. If the reviewer is satisfied, a Letter of Acknowledgement will be issued. Where the reviewer has questions, especially as it relates to provincial HIPA legislation, the REB may request revisions, or that an application be submitted for approval as opposed to acknowledgement.

Human Research Ethics Approval is granted for one year, provided there is no change to the approved protocol or consent process. The initial Certificate of Approval includes the approval period the Research Ethics Board (REB) has assigned to your study. If your research is continuing past the expiry date, completed renewal applications should be submitted to the REB a minimum of 10 but not more than 30 business days prior to the study expiry date (unless special permission has been granted). Renewals that require full board review should be submitted prior to or on the submission deadline date (no later than 11 but not more than 30 business days) for the scheduled REB full board meeting, prior to the study expiry date in order to be added to the meeting agenda. We encourage study teams to submit early in order to ensure their study is re-approved on time.

The REB requires that a renewal form be submitted once per year until all of the data has been collected, all contact with research participants has concluded and the closure of the research has been acknowledged by the REB.

• Biomedical Renewal Form - Prospective
• Biomedical Renewal Form - Secondary Use of Health Data and Biological Materials
• Biomedical Renewal Form - Biobank or Data Registry

• Behavioural Renewal Form

If the research received initial approval via delegated review it may undergo delegated review at the time of renewal. Research that was previously reviewed by the full board may also be reviewed at the time of renewal using delegated review procedures if certain conditions are met.

If a renewal meets the criteria for full board review, the REB will discuss the research at a Full Board meeting and will make a decision regarding the continued approval of the research, as well as any other additional determinations regarding the conduct of the research, as applicable.

If a renewal or closure form is not submitted to the ethics office by the expiry date, a warning notice will be issued to you. After the expiry date, the research is out of compliance, and you must cease all research activities. If the REB approval lapses and you want to continue with the research, you must submit a renewal form within one month of the current expiry date.

Biomedical Research Ethics Submissions Deadlines

Behavioural Research Ethics Submission Deadlines

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