Frequently Asked Questions

 FAQs

1) How can Research and Performance Support help me conduct research?
2) How do I request Research and Performance Support Services?
3) How do I know if I need research ethics approval?
4) If I have received research ethics approval from my university, do I still need to apply for research ethics approval from the RQHR?
5) Where do I find the application for research ethics review?
6) Does my research ethics application need full board review or is it eligible for expedited review?
7) How many copies of my research ethics application do I need to submit?
8) Who do I contact if I have questions about preparing my research ethics application?
9) When does my research ethics application need to be submitted to the REB in order to be reviewed at the next meeting?
10) Is there an application fee for research ethics review?
11) Where do I submit my research ethics application?
12) What needs to be included in the research ethics application?
13) How do I conduct research within the Regina Qu'Appelle Health Region if I am not affiliated with the RQHR?
14) What is a serious adverse event?
15) When should I report an adverse event?
16) How do I report a serious adverse event?
17) When do I need to renew my research study?
18) Under what conditions do I need to submit a research amendment form?
19) How do I submit an amendment of my research?
20) Does my study amendment need Full Board review or Expedited Review?


1) Q. How can Research and Performance Support help me conduct research?

     A. We can help you design or select research measures, create statistical databases, design research methodologies, analyze and summarize data, understand the statistical content of articles, provide on-site instruction in topics such as research ethics, introductory statistics, or quality assurance, as well as assist in the preparation of grant applications and project budget estimations.

2) Q. How do I request Research and Performance Support services?

     A. Requests for research services can be made by submitting a "Request for Research Consultation Form" to RPSConsultations@rqhealth.ca.

For requests related to utilization services, please submit a completed "Request for Utilization Consultation Form" to RPSUtilization@rqhealth.ca.

3) Q. How do I know if I need research ethics approval?

     A. All research which is to be conducted within and/or under the auspices of the RQHR must be approved by the Research Ethics Board (REB) prior to commencement. However, many projects being conducted within the RQHR fall into a "grey area" of whether or not they are considered "research" as opposed to program evaluation, quality improvement or quality assurance initiatives. If you are uncertain if your project needs REB approval, please review the following guidelines to help you decide. If you are still unsure, please contact (306) 766-5451 for further clarification.
     The project you are conducting probably requires REB approval if:

• 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
• The project involves a comparison of multiple sites (e.g. with other health regions) or control sites
• Your project tests an explicit hypothesis or question
• Your project is receiving external funding, either through a peer-reviewed funding agency (e.g. CIHR, CHSRF) or an industry sponsor
• You intend to present the findings of the investigation outside of the RQHR (e.g. an academic conference or professional journal)

4) Q. If I have received research ethics approval from my university, do I still need to apply for research ethics approval from the RQHR?

      A. Yes, any research being conducted within the Regina Qu'Appelle Health Region needs ethics approval from the RQHR Research Ethics Board.

5) Q. Where do I find the application for research ethics review?

      A. Click "Application for Research Ethics Review" to download a copy of the application form and see "REB-Guidance Notes" for additional information for completing your application.

6) Q. Does my research ethics application need full board review or is it eligible for expedited review?

      A. The process used to review new applications varies according to the level of risk (i.e. is proportionate to the level of risk) that the subjects could experience as a result of the particular type of research procedure used. Minimal risk studies are eligible for expedited review. Please see "REB- Guidance Notes, Section 1.9" for further clarification.

7) Q. How many copies of my research ethics application do I need to submit?

      A. If your research requires Full Board review you will need to submit 1 original and 19 copies of your application. If your research qualifies for expedited review you will need 1 original and 2 copies of your application.

8) Q. Who do I contact if I have questions about preparing my research ethics application?

      A. Please contact Research and Performance Support at (306) 766-5451.

9) Q. When does my research ethics application need to be submitted to the REB in order to be reviewed at the next meeting?

      A. Ethics applications need to be forwarded to Research and Performance Support at least 10 working days prior to a scheduled REB meeting before 4pm. The REB meetings are 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 full "meeting schedule" for the next REB meeting date.

10) Q. Is there an application fee for research ethics review?

         A. The fee for ethics review of industry sponsored studies is $1000.00 and applies only to research that receives its funding from an industry sponsor. Please see "REB Application Fee" for further clarification.

11) Q. Where do I submit my research ethics application?

        A.    In person or by mail/courier to:
             Research Ethics Board (REB)
             Research and Performance Support
             2180- 23rd Ave, Regina, SK, S4S 0A5

12) Q. What needs to be included in the research ethics application?

        A. Applications for ethics approval of research proposals is made by submitting the application form and all other attached forms, along with three copies of the complete research protocol. All signatures requested must be obtained prior to submission to the REB.

13) Q. How do I conduct research within the Regina Qu'Appelle Health Region if I am not affiliated with the RQHR?
       
        A. There are two ways in which you can conduct research:
1) Become a Research Associate of the RQHR, please contact (306) 766-5451 for application procedures
2) Conduct your research with a person who is already associated or affiliated with the RQHR. Please Note: the affiliated person must be a principle investigator of the research.

14) Q. What is a serious adverse event?

        A. 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.

15) Q. When should I report an adverse event?

        A. Investigator obligations for reporting adverse events fall under ICH GCP 4.11.1 which states "All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g. investigator's brochure) identifies as not needing immediate reporting". In addition, "the 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".

16) Q. How do I report a serious adverse event?

        A. 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. 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 19 copies 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 1 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 Performance Support, 2180-23rd Ave., Regina, SK, S4S 0A5.

17) Q. When do I need to renew my research study?

        A. At the expiration of one year, please see the application for annual re-approval of a previously approved project form to complete a re-approval of your study.

18) Q. Under what conditions do I need to submit a research amendment form?

        A. The principle 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: "The 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...".

19) Q. How do I submit an amendment of my research?

        A. All necessary documents must be submitted with the correct number of copies required for either Full Board Review (19) or Expedited Review (1). 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 and attached documents (all copies) are submitted to the Research Ethics Board, Research and Performance Support, 2180-23rd Ave., Regina SK S4S 0A5.

20) Q. Does my study amendment need Full Board review or Expedited review?

        A. Most amendments can be reviewed under the Expedited Review process. Refer to "Full Board Review" in the "Application Requesting Amendment of a Previously Approved Project" 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.