14. Obtaining Approvals for Research

Researchers must obtain approvals prior to conducting their research (i.e. before a participant is enrolled or before data is obtained). Ethics, research impact, and privacy are the three essential reviews required for almost all clinical research projects conducted in Manitoba. For some research projects, additional reviews (e.g., feasibility, legal, other Types of reviews) may be required.

14.1 Research Ethics Review

The majority of research being conducted on humans or research involving access and analysis of health or personal health information data require ethical review and approval PRIOR to the commencement of the study. This means that study participants cannot be approached, recruited or enrolled prior to ethical review and approval. For data intensive research, this means that data cannot be obtained or accessed until a Research Ethics Board (REB) has reviewed the study and has granted approval to conduct the study.

REBs review research projects to ensure that the proposed research considers and safeguards the rights, safety and well-being of study participants. Research Ethics Board review and approval prior to study conduct is a legal requirement found in Canadian legislation, such as the Food and Drugs Act and Regulations (Health Canada) and in the Good Clinical Practice Guidelines (ICH-GCP).

Researchers affiliated with the University of Manitoba or the WRHA are required to submit their proposed research for ethical review to the University of Manitoba REB. Rural Researchers affiliated with the Brandon University are to submit their research projects to the Brandon University REB. Regional Health Authority (RHA) Researchers outside of the WRHA who are not affiliated with the University of Manitoba or Brandon University may be required to submit to a Canadian Central Research Ethics Board (e.g. Western IRB, Central IRB Services). For more information, contact the RHA where the research will occur.

Apply for REB Review:

14.2 Institutional Impact Review

If you are conducting your research from or within a health institution, such as a hospital or community health access centre, your proposed research may require impact review prior to commencement. Impact reviews and approval are required for all WRHA operated and affiliated institutions. Most institutions have a formal submission, review and approval process. Researchers should check with their respective institutions to determine whether an impact review is necessary prior to commencement of their research.

Impact reviews consider what impact the proposed research will have on institutional resources. Impact reviews by data trustees (i.e. Manitoba Family Services, Manitoba Justice, Vital Statistics etc.) also consider how the data is being represented, used, and analyzed and the potential impact operationally, socially and politically of the outcomes of the research.

Impact review by Diagnostic Services of Manitoba (DSM) may be required for research involving human specimen sampling, processing or analysis.

Apply for Institutional Research Impact Review:

If the research will be conducted in a WRHA facility that does not have a Research Review Committee or if the research will be conducted in the community, the researcher must seek and receive approval from the WRHA Research Review Committee.

If the research will be conducted in a facility or community of another health authority, the researcher must seek approval from the appropriate authority as listed below:

14.3 Privacy Review

Privacy review to meet PHIA requirements involving personal health information in relation to research is conducted by the UM REB during review of the study. The REB reviews the study's recruitment process, data security plans and the content of the consent form. Further information can be found at the Application of PHIA in a Research Ethics Context. In some cases an institutional Impact Committee may also review the research project to ensure privacy requirements are being met.

Researchers who are accessing data through the Manitoba Centre for Health Policy (MCHP) are required to obtain approval from the Province of Manitoba via the Health Information Privacy Committee (HIPC). Apply for HIPC privacy review at Health Information Privacy Committee (HIPC)

Researchers desiring access to health or personal health data from medical charts (paper or electronic) or from a WRHA database may require privacy review from either the Institutional Impact Committee where the medical charts are held or the WRHA Research Access and Approval Committee.

For research being conducted in other RHAs in Manitoba, Researchers may be required to submit to a data access granting committee or submit to HIPC.

14.4 Legal Review

Legal review may occur as part of an impact review or may be conducted independently by the institution or the university. Legal reviews typically involve the review and execution of agreements and contracts such as confidentiality disclosure agreements, researcher data use and sharing agreements, and research contractual agreements between the researcher and the industry sponsor or funding agency.

Legal reviews typically address contractual projections for the participants, the researchers, and for the institutions where the research is being conducted. Legal reviews consider indemnification clauses, data ownership, intellectual property protections, and jurisdiction governance should the matter go to court.

In limited circumstances, legal review may also be required of the Participant Information And Consent Form, specifically for studies requiring high risk procedures or interventions or studies involving persons who are vulnerable or at high risk.

In Manitoba, legal review is typically conducted by the Director of Research, the institution’s legal department, or the Office of Research Services (University of Manitoba). Depending on who will be a party within the contract, the Impact Review Committee may also review the contract.

For data researchers, data user and sharing agreements may also require legal review, particularly for those studies that are collaborating with institutions outside of Manitoba. User and sharing agreements provide the boundaries and scope of the data accessed for the purpose of the research, define who will access and review the data, the length of time the data will be accessed, and how the data will be shared and disseminated.

Further information can be obtained from:

14.5 Protocol Review

Protocol review is performed to determine the feasibility of the proposed research. The review may be performed via peer-review, departmental review or by a data trustee like the WRHA Research Access and Approval Committee (WRHA-RAAC) or by a data steward like Manitoba Centre for Health Policy (MCHP).

14.6 Feasibility Review

Feasibility review is performed to determine the feasibility of the proposed research and typically occurs prior to other reviews and may or may not be compulsory (i.e. WRHA-RAAC’s feasibility review is not compulsory prior to any other review where MCHP’s feasibility review is). See Feasibility Assessment for more information.

14.7 Other Types of Reviews

Depending on the population under study, other reviews may be required.

  • For studies involving cancer patients, review and approval from a CancerCare Manitoba Disease Site Group (CCMB-DSG) may be required prior to commencement.
  • Studies involving vulnerable populations such as children, those who are physically or mentally infirm or those who are incarcerated may also require additional ethical or impact review prior to conduct.
  • For projects involving First Nations or Indigenous populations including the Inuit or Metis, review and approval may be required from such organizations as the Assembly of Manitoba Chiefs or the Manitoba Metis Federation.

Researchers conducting research on the above populations should inquire with the Research Ethics Board or the institution where the research is being conducted (i.e. CancerCare MB, St. Amant Centre, Manitoba Justice etc.) as to whether additional reviews and approvals are required.

Research involving a drug or device may require approval from Health Canada through a Clinical Trial Application or Investigational Testing Authorization.