The NHKI guiding principles of knowledge generation, knowledge mobilization and capacity building all rely on research and quality improvement (QI) to transform healthcare. As such, we acknowledge the important intersection between research and QI. We also offer the following guidance to help support investigators in differentiating between the two and identifying when a project needs to be submitted for review by a research ethics board.
Research | QI | |
Primary purpose | Designed to develop or contribute to generalizable knowledge. | Designed to implement knowledge, assess a process or program as judged by established/accepted standards. |
Starting point | Knowledge seeking is independent of routine care and intended to answer a question or test a hypothesis. | Knowledge seeking is integral to ongoing management system for delivering healthcare. |
Audience | Usually the external scientific community. | Mainly internal to the organization or local in nature. |
Participation | Commonly optional (a waiver of consent may be granted). | Often not optional; participating in the evaluation of QI can be optional. |
Risk/Burden to participants | Can be substantial and therefore rigorous mitigation strategies are required. | Probable, but often minimal to moderate thus requiring less rigorous mitigation strategies. |
Design/Methods | Follows a rigid protocol that remains unchanged throughout the research. | Adaptive, iterative design (e.g., Plan-Do-Study-Act cycle). |
Endpoint | Answer a research question. | Improve a program, process or system. |
Sharing results | Part of generating new knowledge that engages critical appraisal through presentation and/or publication. | Primary goal is to improve local healthcare delivery and secondary goal is to share QI learnings and results externally. |
Accountability | Local principal investigator (LPI) with sign-offs from impacted departments as outlined in the Research Impact Assessment Policy and Procedure. | Project lead with sign off from the program director and department chief(s)/ head of service. |
Ethics approval | Research Ethics Board (REB). | Program Director and Department Chief/Head of Service. If accessing/looking at individual patient charts, then REB approval may be required. Complete the Research-QI screening tool. |
Publishing approval for posters or articles | Program director and department chief/head of service with data reviewed by Enterprise Analytics*. | Program director and department chief/head of service with data reviewed by Enterprise Analytics. |
*Clinical trials and qualitative research are exempt from needing Enterprise Analytics to review data prior to publication.
Both research and QI are systematic investigations that may involve human participants but they differ in important ways. The guide above helps to distinguish between research and QI, and is adapted from the Children's Hospital of Philadelphia Research Institute.
Complete the Research-QI screening tool adapted from the McGill University Health Centre.
Niagara Health ensures that all research is performed ethically, and in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
Niagara Health has centralized ethics review for clinical research and clinical trials under the Hamilton Integrated Research Ethics Board (HiREB). HiREB is also one of Clinical Trials Ontario (CTO) qualified review boards. CTO offers a streamlined ethics review process for multi-centre research studies that allows for a single ethics review rather than multiple reviews at different institutions’ research ethics boards (REBs).
HiREB is a jointly constituted board of Hamilton Health Sciences, McMaster University’s Faculty of Health Sciences, St. Joseph’s Healthcare Hamilton and Niagara Health.
The mandate of HiREB is to safeguard the rights, safety, and well-being of all research participants. HiREB reviews and approves research projects that meet acceptable ethical and scientific standards and for which adequate facilities and resources are available. HIREB also provides advice on the ethical, scientific and technical aspects of planning research.
All research projects involving Niagara Health, McMaster University, St. Joseph’s Healthcare Hamilton and Hamilton Health Sciences physicians, staff (including staff acting as investigators outside the Institution), students (i.e., research within the institution or using institutional resources), or patients, must obtain ethics approval before research can begin.
Visit HiREB for additional information, or to submit an application.