Frequently Asked Questions - REB
Are there any additional REB requirements for studies involving contact with patients (e.g. patient interviews, patient surveys, focus groups, etc.)?
Yes. Beginning March 2011, principal investigators of studies involving contact with patients (e.g. patient interviews, patient surveys, focus groups, etc.) must complete the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) tutorial prior to submission to the Board. Principal investigators of studies involving contact with patients prior to March 2011 are exempt from this requirement.
Are there any additional REB requirements for chart audit studies?
Yes. Beginning March 2011, principal investigators of chart audit studies must complete the McMaster Chart Audit Tutorial prior to submission to the Board. Principal investigators of chart audit studies prior to March 2011 are exempt from this requirement.
Does my study amendment need Full Board review or Delegated review?
Most amendments can be reviewed under the Delegated Review process. Refer to ‚ÄúFull Board Review‚Äù in the ‚ÄúApplication Requesting Amendment of a Previously Approved Project‚Äù form for criteria that designate which type of amendments must receive Full Board review. The Chair (or designate) may at any time put forward a request for approval of an amendment to the Full Board.
How do I submit an amendment of my research?
One copy of all necessary documents must be submitted for either Full Board Review or Delegated Review. Incomplete submissions will not be reviewed and will have to be resubmitted. Amended documents must be submitted in such as way that any changes are clearly identified. Protocol amendments may include a separate document that lists both the original section(s) and the subsequent revision(s) so changes to the original text are easily seen. Submit an amended consent form with the changes underlined or in bold text so that it is easy to see how the original consent form has been altered. The amended consent form should include a footer with an updated version number and/or date. Documents listed in Section 1.12 of the original Research Ethics Application form must be recorded accurately with their complete title and version numbers because this information is included in the amendment box of the certificate. The Amendment Application Form (downloaded from the REB forms page) and attached documents are submitted to the Research Ethics Board, Research and Health Information Services, 2180-23rd Avenue, Regina, SK, S4S 0A5.
Under what conditions do I need to submit a research amendment form?
The principal investigator for a study is responsible for ensuring that amendments are submitted to the REB prior to implementation and for understanding and adhering to the TCPS and other relevant guidelines, including ICH GCP when applicable. In particular, ICH GCP 4.5.2 specifies that: ‚ÄúThe investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment‚Ä¶‚Äù.
When do I need to renew my research study?
At the expiration of one year, please see the Application for Reapproval on the REB Forms page to complete a re-approval of your study. Please note that studies may only be approved/reapproved for a total of five years. After that time, you will be required to submit a new application. In rare cases in which ongoing follow-up is occurring with patients previously enrolled in a clinical trial, an exception may be granted at the discretion of the Chair. For all other types of studies, a new complete application (e.g., application form, signatures, operational approvals, data collection tools, master list, consent form) must be submitted.
How do I report a serious adverse event?
An Adverse Event Report Form is to be submitted with each adverse event report. Please Note: the form must be accompanied by a detailed serious adverse event report describing the actual incident (where applicable). The Adverse Event Report Form should be completed and signed by the principle investigator. For assistance in completing the Adverse Event Report Form, please see the adverse events reporting guide. These documents can be downloaded on the REB Forms page.
Adverse events which occur no more frequently than expected and which are discussed in the consent form, need not be reported unless they result in death.
Reports of local serious adverse events require one copy of the serious adverse event report attached to the completed Adverse Event Report Form. Reports of adverse events which occur at another site of a multi-site study require one copy. The principle investigator must read the report(s) and fill out the Adverse Event Reporting Form accordingly. Submit the original signed copy of the Adverse Event Report Form and copies to the Research Ethics Board, Research and Health Information Services , 2180-23rd Ave., Regina, SK, S4S 0A5.
When should I report an adverse event?
Investigator obligations for reporting adverse events fall under ICH GCP 4.11.1 which states ‚ÄúAll serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g. investigator‚Äôs brochure) identifies as not needing immediate reporting‚Äù. In addition, ‚Äúthe investigator should also comply with the applicable regulatory requirements related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC‚Äù.
What is a serious adverse event?
An adverse event is any event that is fatal, immediately life threatening, persistently or significantly disabling/incapacitating, requires and/or prolongs inpatient hospitalization or results in a congenital anomaly/birth defect.
How do I conduct research within the former Regina Qu‚ÄôAppelle Health Region if I am not affiliated with the institution?
There are two ways in which you can conduct research: 1) Become a Research Associate. Please contact (306) 766-5573 for application procedures. 2) Conduct your research with a person who is already associated or affiliated with the former RQHR. Please Note: the affiliated person must be a principal investigator of the research.
What needs to be included in the research ethics application?
Applications for ethics approval of research proposals are made by submitting the application form and all other supplementary forms and documents (e.g., master list, consent form, ethics tutorial certificates), along with one copy of the complete research protocol. All signatures requested must be obtained prior to submission to the REB.
Where do I submit my research ethics application?
Please email all electronic submissions to ResearchEthics.Regina@saskhealthauthority.ca. Signature pages may be faxed to (306) 766-5530, attn: REB.
Hard copy signatures and other documents can be submitted in person or by mail/courier to: Research Ethics Board (REB) 2180- 23rd Avenue, Room M-704, Regina, SK, S4S 0A5
Is there an application fee for research ethics review?
The fee for ethics review of industry sponsored studies is $3,500 and applies only to research that receives its funding from an industry sponsor. Please see ‚ÄúREB Application Fee‚Äù for further clarification.
When does my research ethics application need to be submitted to the REB in order to be reviewed at the next meeting?
Ethics applications need to be forwarded to Research and Health Information Services at least 10 working days prior to a scheduled REB meeting before 4pm. The REB meetings are typically held on the second Monday of every month at noon at the Wascana Rehabilitation Centre. These dates are subject to change due to long weekends; please see the meeting schedule for the next REB meeting date.
Who do I contact if I have questions about preparing my research ethics application?
Please contact the Research Administrator at (306) 766-5573.
How many copies of my research ethics application do I need to submit?
You will need to submit one electronic copy of your entire application (e.g., application form, consent forms, questionnaires, master lists, study protocol, investigator brochure, tutorial certificates, CVs) to ResearchEthics@Saskhealthauthority.ca. Please scan or fax all signature pages; typed names in signature lines will not be accepted. For studies requiring full board review, please forward hard copies of all signature pages to the Research Ethics Board, 2180-23rd Avenue, Room M-704, Regina, SK, S4S 0A5.
Does my research ethics application need full board review or is it eligible for delegated review?
The process used to review new applications varies according to the level of risk that the participants could experience as a result of the particular type of research procedure used. Minimal risk studies are eligible for delegated review. Please refer to the Guidance Notes that correspond with the type of application you are submitting for more information.
Where do I find the application for research ethics review?
Go to the Research Ethics Board page and then click on the REB Forms link in the right-hand menu. Click the link to download the correct type of form for the study you are conducting (Biomedical, Behavioural, or Review of Existing Health Data). There are Guidance Notes documents that correspond with each type of application. Be sure to download the form for RQHR Operational Approvals as well, regardless of what type of study you are conducting.
How do I know if I need research ethics approval?
All research which is to be conducted within and/or under the auspices of the former RQHR must be approved by the Research Ethics Board prior to commencement. However, many projects being conducted within the former RQHR fall into a ‚Äúgrey area‚Äù of whether or not they are considered ‚Äúresearch‚Äù as opposed to program evaluation, quality improvement or quality assurance initiatives. If you are uncertain whether your project needs REB approval, please review the REB application form guidance notes to help you decide. If you are still unsure, please contact (306) 766-5573 and ask to speak to the Chair of the REB for further clarification. The project you are conducting probably requires REB approval if:
‚Ä¢ You will be conducting a client survey or imposing any burdens on the patient beyond what would be considered part of their typical client care
‚Ä¢ The project involves a comparison of multiple sites (e. g., with other health regions) or control sites
‚Ä¢ Your project tests an explicit hypothesis or question
‚Ä¢ Your project is receiving external funding, either through a peer-reviewed funding agency (e.g. CIHR, CHSRF) or an industry sponsor
‚Ä¢ You intend to present the findings of the investigation outside of the former RQHR (e.g. an academic conference or professional journal)