Research and Quality

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The Research Office is committed to improving quality of patient care, health services efficiency and integration through efforts to build and support quality improvement initiatives and scholarly activities. 

Facilitating a focus on quality, the Research Office seeks opportunities where quality improvement and research may intersect. 

Where do Quality Improvement (QI) and Research meet?

  • The tested intervention involves deviation from established practices
  • There are clear, measurable aims and a timeline for achieving them
  • A rigorous design is possible without disrupting normal work unduly
  • Everything possible is done not to sacrifice data quality and completeness
  • Careful attention is paid to ethics
  • Publication is anticipated throughout the work

Both research and quality improvement are systematic investigations that may involve human participants but they differ in important ways. The table below helps to distinguish between research and quality improvement and is adapted from the Children's Hospital of Philadelphia Research Institute.

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 Typically 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 PDSA 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 learnings externally regarding QI results.
Accountability Local Principal Investigator (LPI) with sign off from the appropriate manager, program director and department chief(s)/division head(s). Project lead with sign off from the sponsoring manager, program director and department chief(s)/division head(s).
Ethics Approval Research Ethics Board (REB). Manager and program director. If accessing/looking at individual patient charts, then REB approval is required. See Frequently Asked Questions below.
Publishing Approval for Posters or Articles Manager, program director and department chief(s)/division head(s) approval with data reviewed by Decision Support Team (DST). Manager and program director with data reviewed by Decision Support Team (DST).

Frequently Asked Questions

Staff or students will be accessing/looking at individual patient charts or reports. Do I need REB approval for this?

Yes, even for QI work. If you are accessing individual patient records for the information you need, then you would need to submit a Retrospective Review of Medical Charts & Health Data application because you would be accessing individual level data. In addition, the students or staff accessing this information all have to complete the privacy tutorial that would be listed on the application.

Note: There is no submission deadline for a chart review/database application and the process takes about 7-10 days to process.

If I am obtaining aggregate level data from the Health Records/Decision Support Department. Do I need REB approval for this?

No, with aggregate data you do not need REB review if this is for QI work. With aggregate data, you would be given de-identified information that is grouped and cannot identify individuals.

If you were obtaining de-identified data to perform research, then you would need ethics approval as per the Tri-Council Policy Statement (TCPS).

Can QI studies be published without prior REB approval?

Even though most QI activities are not research, there is much to be learned from sharing descriptions of these non-research activities.

If publishing or presenting QI work is a possibility, then contact the HiREB for an email that provides a waiver of ethics review; as many journals require some evidence of ethics ‘review’ even though QI activity, and such an email satisfies that requirement.

Also at Niagara Health, you are required to get approval from the following before publishing or presenting a poster: manager and program director with data reviewed by Decision Support Team (DST).

Do Case Reports need REB approval?

Case Reports that are written as an interesting phenomenon to the medical community do not require ethics review. This would include a series of three cases or less. More than three cases suggests there is a research question and will require ethics review.

Journals will require the consent of the patient in order to publish your case report.

A case report does not need to be submitted on a chart review application form.

What ethical oversight is appropriate for QI activities that are not research at NH?

The REB provides ethical oversight for human subjects’ research.

The program manager and director is to review QI activities to ensure that the risks to participants are not greater than minimal and that there are appropriate protections for individual’s privacy and confidentiality of their identifiable data. This is true for not only patients but also staff, students and volunteers, as QI activities could affect staff performance/evaluations.

References:

Children's Hospital of Philadelphia Research Institute (2019). Quality Improvement vs Research. Retrieved from https://irb.research.chop.edu/quality-improvement-vs-research

Hamilton integrated Research Ethics Board – HiREB (2019). Quality Improvement. Retrieved from https://hireb.ca/guidelines/quality-assurance/

For information on HIREB process for general research applications, please click here.

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