Instructions for Submission
Which Research Ethics Board should I apply to?
There is a reciprocity agreement between the Research Ethics Boards of University of Saskatchewan, University of Regina, and the Saskatchewan Health Authority. The Principal Investigator (PI) should submit their study to the institution with which they have a primary affiliation, as it specifically relates to the research for which the ethics review is being conducted. Other details that must be considered are:
- affiliation of the co-investigators and/or research trainees,
- owner or provider of the necessary equipment, services, supplies, and
- where the related grant or contract is held and administered.
The PI should check with their local REB to confirm where they should apply for REB approval.
Application review timelines and submission information
Applications that require full board review (above minimal risk studies) must be received at least 10 business days prior to a scheduled meeting; however, there are instances when applications are required earlier (e.g., due to planned office closures). The REB typically meets at 12:00 p.m. on the second Monday of every month at Wascana Rehabilitation Centre in Regina, SK.
Applications must be complete (including all required signatures) in order to qualify for review at the next meeting of the REB. If you would like to have your application for full board review screened by a member of our office prior to your submission to the REB, it is recommended that you contact ResearchEthics.Regina@saskhealthauthority.ca with a request for screening no later than 2 business days prior to the submission deadline.
For studies reviewed by the full REB, researchers, in most cases, will get a response from the REB in 15 to 20 business days.
Applications that do not require full board review (i.e., minimal risk studies that meet the criteria for delegated review, as outlined in the guidance notes linked in the ethics application form) may be submitted at any time and will be reviewed on an ongoing basis. Researchers can, in most cases, expect to receive a response from the REB 5 to 10 business days after receiving an REB file number.
- REB Member, Submission Deadlines, and Meeting Dates: see below PDF
- Application forms
What to include with the application for research ethics review
- An Application for Research Ethics Review Form signed by the PI and the department head (with guidance notes removed);
- All applicable recruitment materials, consent forms, data collection tools, master lists, investigator brochures, etc.;
- Supporting clinical trial documentation (e.g., Health Canada regulated device or investigational products trials require a No Objection Letter, all clinical trials require a clincaltrials.gov registration number and approvals from other REBs);
- For multijurisdictional studies, REB approvals from other sites must be submitted to the REB;
- McMaster Chart Audit Tutorial (required for study team members accessing Personal Health Information);
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition1 tutorial (required for all study team members conducting prospective studies involving participants);
- Good Clinical Practice (GCP) and “Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects” training (required for all study team members conducting clinical trials);
- Curriculum Vitae (CV) for SHA PIs (for prospective biomedical studies) and also for those PIs proposing to conduct research at SHA for the first time.
- The REB retains the right to request access to any finalized Research contracts.
Upon submission, all documents must be labeled in the footer with the date and version number and submitted electronically to ResearchEthics.Regina@saskhealthauthority.ca
Links for Required Certifications and Training:
SHA has a membership with the Collaborative Institutional Training Initiative program (CITI) which provides free training in Good Clinical Practice (GCP) and Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects. Researchers should use their SHA affiliation when logging into their site: https://about.citiprogram.org/en/homepage/
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Core tutorial takes 3 to 4 hours to complete. Progress can be saved and the course does not have to be completed in a single sitting. It can be accessed at https://tcps2core.ca/welcome
The McMaster Chart Audit tutorial takes approximately 10-15 minutes to complete and can be accessed at https://ethics.mcmaster.ca/chart/
Please note that Researchers are responsible for understanding and following the SHA Research Policies and Procedures as outlined in SHA’s Research Policy and Research Procedure Manual.
Research Ethics Review Fees
Industry-sponsored studies have an initial review fee and an annual renewal fee that covers the ongoing review of amendments and other trial documents.
Once a new industry-sponsored study has a Research Ethics board file number assigned and the Principal Investigator receives an invoice, the study cannot be approved until the invoice is paid.
The review fee for industry-sponsored studies is $4,000. Industry sponsors include for-profit organizations such as pharmaceutical or medical device companies, or agents thereof. The fee covers requests for initial ethical review.
The fee for each annual renewal of industry-sponsored studies is $750.00. This covers the ongoing review of study documents for the approved year. The fee covers:
- amendments and acknowledgements; and
- review of submissions for unanticipated problem reports (UPRs).
All documents sent to the REB office must include the exact title of the research study and the PI's name. A Certificate of Approval is issued once the REB receives payment of the required fee.
Review fees are refunded if research is withdrawn before review by the REB. If the REB has completed their review, and a Notice of Ethical Review (NER) has been issued, the full REB fee is charged.
Waived REB fees
Industry-sponsored studies receiving a grant-in-aid may have their review fees waived. This includes investigator-initiated studies with partial funding or funding from a non-profit agency (e.g., Saskatchewan Health Research Foundation (SHRF) or Canadian Institutes of Health Research (CIHR). Investigator-initiated studies that have minimal industry support such as a supply of drugs or devices, or a very limited amount of funding are exempt from the REB fees. The Chair or a sub-committee of the REB will assess whether the waiver of the review fee is possible if there is discrepancy in relation to whether a study is industry sponsored or not.