Research and Evaluation at SSCY

If you have an idea for a research project or program evaluation, the RCC Research Associate can help you. Contact Elizabeth to discuss your project (ehammond@rccinc.ca or (204) 451-5702).

Research projects need approval from the University of Manitoba Research Ethics Board and the SSCY Research and Evaluation Committee. Program evaluations do not need those approvals, but they must be approved by your manager.
Every project is different, but the general steps are:

1. Develop a protocol, which includes:

• introduction to the importance of the topic (including rationale and significance of the project)
• research question and hypothesis
• method and project design
• expected results
• timeline
• budget
• knowledge translation plan (eg. report, poster, paper, presentation, etc.)

2. Apply for and receive funding for the project (if applicable)

• Depending on the source of the funds, this can take several months

3. Apply for and receive approval from the University of Manitoba Research Ethics Board and the SSCY Research and Evaluation Committee (if applicable)

4. Conduct the project

5. Do analysis as required

6. Prepare and do knowledge translation activities

All research projects to be conducted at SSCY Centre must receive approval from the University of Manitoba Research Ethics Board (REB). There are two Boards for different types of projects: a Biomedical REB and a Health REB. In general, projects that involve a drug, device or medical product go to the Biomedical REB, and all other projects go to the Health REB.

Every research project is different, and the exact submission requirements depend on the project. The REB provides a submission checklist that outlines their requirements. In general, an REB submission includes:

• Protocol
• REB Submission Form
• Informed Consent Form and/or Assent Form
• Questionnaires or other instruments (eg. diary) to be completed by participants
• Advertisements
• Budget
• REB CV for the principal investigator
• TCPS Ethics Course certificate for the principal investigator

The REB submission deadline is the first Monday of every month. The REB will review your application and send you a letter outlining any questions or modifications they have. Once you respond to their satisfaction, they will send you a Certificate of Final Approval. If there are minimal issues, you should receive the Certificate in about a month. If there are more substantial issues with your application, this process can take several months.

You must submit an Annual Study Status Report every year that your project is ongoing. When your project is finished you must submit a Final Study Status Report. You must report to the REB if you deviate from the approved protocol or an adverse event occurs.

The REB has created a Researcher Training Manual, which provides helpful information for applying for and conducting a research project.

All REB forms can be found here.

More information about the REB submission requirements can be found here.

More information about the REB can be found here.

The SSCY Research and Evaluation Committee is responsible for reviewing and approving proposals for all research conducted at SSCY Centre (including recruitment and data collection), involving electronic medical records covered by the SSCY Data Sharing Agreement, or that are about the SSCY Network. Research by external researchers and SSCY Network staff (eg. a clinician at SSCY Centre) is approved using the same procedure. All research projects must receive approval from the SSCY Research and Evaluation Committee before any research activities begin.

Submit a completed SSCY Research Access Application Form, signed signature page from the SSCY Research and Program Evaluation Access Guideline, and a copy of the:

• Research protocol
• Participant informed consent form (ICF)
• Participant assent form
• Questionnaires or other materials to be given to participants
• Advertisements to be posted at SSCY Centre or on the SSCY Network website
• Budget
• Current Principal Investigator CV
• REB submission form
• REB certificate of final approval (you may submit to the SSCY Research and Evaluation Committee before final REB approval is received, but access will not be granted until the REB certificate of final approval is submitted)
• Health Canada Letter of No Objection, if applicable
• Clinical Trials Registry number, if applicable

The SSCY Research and Evaluation Committee will review all proposals with an emphasis on issues such as merit of the proposal, alignment with SSCY Network’s mission, vision and values, benefits and risks to the participants, research design, credentials of the researchers, presence of ethical approval, impact on the organization’s resources, and involvement of appropriate SSCY Network partners.

You will be notified in writing regarding the outcome of this review.

Submit a copy of all REB correspondence that results from a major protocol or informed consent/assent change or update to the approval status of the project (including the updated protocol, informed consent form or assent form), all Adverse Event reporting forms, all protocol deviation reporting (minor and major), the REB Annual Study Status Reports and Certificates of Annual Approval, and the Final Study Status Report.

Submit a copy of any report or publication arising from research conducted at the SSCY Centre, with electronic medical records covered by the SSCY Data Sharing Agreement, or about the SSCY Network.

Researchers will be expected to share results appropriately with a variety of stakeholders, which can include SSCY Centre clients, families or therapists, members of the SSCY Network, policy makers, other researchers and interested community members.

You can download our Guideline and forms here:
SSCY Research Access Guideline
SSCY Research Access Application Form
SSCY Research Access Checklist

The REB CV is the CV (curriculum vitae) format the REB requires for research submissions. It is a short CV that outlines your experience relevant to the research project you are submitting for approval. The template can be downloaded from their website.

The TCPS Course on Research Ethics (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) is an online course by the Government of Canada. All principal investigators must complete this course before they will be approved by the REB to conduct a research project. The course is organized into modules that you can do at your own pace, and it should not take longer than three hours in total to complete. Once you complete the course you will receive a certificate, which you must submit to the REB. For more information and to take the course.

The REB CV and the TCPS Ethics Course are required by the REB. Research projects will not receive approval unless these are included in your submission.

Participants in research projects must provide informed consent before they begin any study-related activities. Informed Consent and Assent Forms are the written format for obtaining consent required by the REB. Some exceptions apply; for example, for an anonymous survey project participants would receive a Letter of Invitation explaining the study instead of an Informed Consent Form.

An Informed Consent Form (ICF) is used for participants aged 18 and older, and an Assent Form is used for participants under 18. If a participant is under 18 their legal guardian must also sign an ICF. The forms provide a summary of the study objectives, procedures, risks and benefits.

The REB provides templates for both forms, which can be downloaded from the REB website.

More information can be found here.

Yes, according to the Tri-Council Policy Statement (TCPS), all clinical trials must be registered on ClinicalTrials.gov before they will be approved by the REB. If you do not correctly register your clinical trial you may be prevented from publishing it in a peer-reviewed journal.

What is the definition of a clinical trial?
“Any research study that prospectively assigns human participants or groups of humans to one or more “health-related interventions” to evaluate the effects of health outcomes. “Health-related interventions” include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”

You can download this pamphlet for more information.

You can apply for access to the WRHA Virtual Library here. Once you receive your login credentials you will be able to access the resources available through the WRHA. Access the Library login page here.

You can request a literature search here. The Library will provide you a list of relevant articles with abstracts to review.  You can then either access the articles through the Library online search or request the item here if it is not available online.

You may also access UpToDate, which is an electronic library resource that provides information about a variety of healthcare issues.

More information about the WRHA Virtual Library can be found on their website.