What is Research Quality Management?
How does the U of M promote Quality Management in Human Research?
How does the U of M Research Quality Management Program support researchers?
How will the Research Quality Management Program help researchers?
How does a researcher participate in the process?
What standards and guidelines are researchers expected to follow?
What guidelines and regulations must be followed if I work in clinical trial research?
How do I contact the Research Quality Management office?
What is Research Quality Management?
The University of Manitoba has established a Research Quality Management program that includes education and oversight specific to the conduct of research with humans. This program is in place to help support the U of M-affiliated research community as it works to protect human research participants while involved in research activities. Processes are in place to provide guidance to researchers and to help facilitate assurances that research conducted at the U of M is done according to recognized standards for the conduct of safe and ethical research. These are steps taken to assure the quality of research conducted with human participants at or in affiliation with the U of M.
How does the U of M promote Research Quality Management?
The program aims to facilitate research educational and provide oversight activities that will collaboratively support an existing strong research environment. By providing on-site research quality management support, the university is making a commitment to its research community and to the public that it will take an active role in the oversight of research approved by and conducted within the U of M.
How does the U of M Research Quality Management Program support Researchers?
The Research Quality Management Office has been in consultation with stakeholders and representatives of health and educational institutions across Canada, actively exploring the types of support and direction that exist elsewhere.
Networking with researchers and other institutions helps to ensure that established and appropriate processes related to the conduct of human research, in place elsewhere, are shared (informally standardized), and as appropriate, adopted by the U of M.
The Research Quality Management program facilitates on-site educational events and practices specific to the ethical and safe conduct of research with humans. It supports the conduct of research oversight activities (including site visits) that could identify potential gaps in safe and ethical conduct of research, and assist, where necessary, researchers and research teams (those new and experienced) in the conduct of their research. The program is in place to help researchers, as needed, revise or establish practices in research that will assist them as they fulfill their responsibilities and obligations as researchers, specifically, as they pertain to the conduct of human research as approved by one of five U of M Research Ethics Boards (REBs).
The program will evolve as it identifies and accommodates researcher needs specific to human ethics research quality management.
How will the Research Quality Management Program help researchers?
The program will provide support to the research community in a number of ways, through collaborative educational and research oversight activities.
A researcher may decide to participate in a volunteer site visit. Researchers are encouraged to invite the Research Quality Manager to visit your research site to discuss your work and review your research practices. This can be arranged at any time that would be convenient for you.
Stakeholders of the program (including researchers) are encouraged to share their expectations of and comments about the program so that it will continue to evolve in a transparent and supportive way, one that is open and appreciative of stakeholder input.
How does a researcher participate in the process?
If you are a researcher who is working with humans in a safe and ethical manner, you are already participating in the process. Researchers are expected to conduct their research in a safe and ethical way, according to regulations and guidelines that govern their conduct.
Researchers are encouraged to take part in educational opportunities facilitated by the Research Quality Management program. These include on-line tutorials specific to research with humans and other educational events that may take place at the university or in collaboration with other affiliated health and research institutions.
What standards and guidelines are researchers expected to follow?
The Research Quality Management program will base its educational and oversight program on the guidelines provided by the Tri-Council Policy Statement (TCPS 2). This is a document that outlines the standards for the conduct of research with humans as expected by the Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. The TCPS 2 provides guidance for researchers working with humans in several areas of human research, through studies involving the humanities, social sciences and health. The TCPS 2 also has recommendations specific to the conduct of research with First Nations, Inuit and Métis peoples and the conduct of clinical trials, among other guidelines.
What guidelines and regulations must be followed if I work in clinical trial research?
Clinical trial research conducted under Health Canada is expected to meet regulations as outlined in Division 5 of the Food and Drug Regulations - Drugs for Clinical Trials Involving Human Subjects. Health Canada regulations incorporate the principles outlined in the ICH Guidelines for Good Clinical Practice.
It might be helpful to review the expectations of Health Canada specific to clinical drug trials by reviewing information found at Health Canada in Clinical Trials Guidance Documents.
Health Canada also provides information specific to site inspection in the form of a Pre-inspection Package. Researchers are invited to contact the Research Quality Management office to obtain further information about this resource.
How do I contact the Research Quality Management office?
You are invited to contact the Human Ethics Research Quality Management office with any questions:
Monica Woods
Manager, Research Quality Assurance
053H Apotex Centre
750 McDermot Avenue
Winnipeg, MB R3E 0T5
Phone: 204-272-3121
Fax: 204-272-3122
monica.woods@ad.umanitoba.ca
Ricardo Soriano
Research Quality Coordinator
053J Apotex Centre
750 McDermot Avenue
Winnipeg, MB R3E 0T5
Phone: 204-789-3698
Fax: 204-272-3122
ricardo.soriano@ad.umanitoba.ca