Quality Improvement Review Process Project Submission Form
          Introduction
          UHN’s Quality Improvement (QI) review process is intended to confirm that projects:
            1. are appropriately classified as QI projects and do not need to be submitted through CAPCR to
              the Research Ethics Board (REB) for review*;
            2. include procedures for obtaining consent from participants (as appropriate); 
            3. meet ethical and legal responsibilities, particularly with respect to the use of personal health
              information (PHI); and
            4. minimize or eliminate risks to the project team, participants, and UHN.  
          Please see the last page of this document for links to relevant UHN policies, standards and forms.
          Key Application Steps for the QI Review Process
          The figure below illustrates the key application steps for the QI Review Committee (QIRC) process at
          UHN. To request a review, a completed QI project submission form and project documents must be
          submitted to QI@uhn.ca.  During project reviews, applicants may receive email correspondence
          from QI@uhn.ca containing clarifying questions and risk mitigation recommendations. The QI office
          may also recommend consultations with other UHN departments such as the UHN Privacy Office,
          UHN Legal Affairs, and UHN Digital Security for additional ethical and legal requirements.  
          Decision notifications are generally administered within four weeks of submission (COVID-19 related
          projects are prioritized). Additional time may be needed for more complex projects. Communication
          with QIRC (QI@uhn.ca) is required as soon as possible should there be any changes in project
          activity or scope that may (a) alter the classification of a project as QI, or (b) introduce new elements
          that require additional review.
           
          Questions & Contact Information 
          For questions about the QI Review process, the QI Form, project changes, or consultation, please 
          contact QI@uhn.ca.
          *Note: Determination by QIRC that a project fall outside the scope of research requiring REB review is based 
          on the Tri‐Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) V.2 (2018) 
          (Articles 2.5, 2.6, and 2.9).
          Form version updated February 25, 2021
                
         Table A:  Differentiating Research and Quality Improvement 
         The following table outlines key considerations when determining if your project should be classified as Quality Improvement or Research. 
                                                       Research                                              Quality Improvement
                                To develop or contribute to generalizable knowledge or     To implement knowledge, assess a process or program 
               Purpose          seek to explore or understand a phenomenon.                as judged by established or accepted standards.
                                Knowledge-seeking independent of routine care and          To provide information for decisions to improve some 
              Rationale         intended to answer a question or test a hypothesis.        aspect of care or service delivery in a particular location.
                                Follows a fixed protocol that generally will remain        Project outline is an adaptive, iterative design; flexible and
                                unchanged throughout the study. Uses precise and           responsive to change throughout project lifecycle. 
               Design           defensible techniques for sampling, data collection and    Includes an aim statement or evaluation questions and 
                                analysis.                                                  measures.
                                Might or might not benefit current participants. Intended  Directly benefits a process, system or program. Might or 
               Benefits         to benefit future participants.                            might not benefit patients. Interventions, services and 
                                                                                           programs are presumed effective, not experimental.
                                Participation must be voluntary because those              Participants continue to engage in routine care, program 
                                participating will be involved in activities which are in  provision, or role performance. There may be an 
             Participant        addition to routine care, program provision, or role       innovation to service or delivery, but it typically applies to 
              Obligation        performance.                                               everyone. There may be additional data gathering. 
                                                                                           Participant consent may be required. 
                                Answer a research question and contributes to              Improve a program, process or system.
              Endpoint          generalizable or transferable knowledge.  
                                Primarily scholars, practitioners, or organizations well   Primarily, the organization, institution, or system that is 
          Primary Audience      beyond the ones comprising the immediate affiliation of    being assessed. Others may have interest in the results 
             for Results        the researcher and/ or participant.                        or process, but are not the primary target audience.
         Form version updated February 25, 2021
                
         Table B: Common Quality Assurance (QA) Activities 
         While there may be an overlap between QI and QA projects, the following table provides some examples of activities that may have a higher 
         likelihood of being QA in nature. Such activities may require only local oversight (e.g., division/department Chief, program medical director, unit 
         manager), as opposed to institutional oversight provided by the QI Review Committee. However, if you plan to disseminate your project outside 
         of UHN (e.g., peer-reviewed publication) or require a formal review of your project, please contact QI@uhn.ca. 
         Activity                                                                   Example
         Ongoing data collection for routine monitoring or tracking of quality      Length of stay information, hospital-acquired infection rates, 
         indicators at the local, program or hospital level                         employee sick time
         Quality assurance or compliance monitoring activities associated           Policy audits, clinical practice guidelines, and SCAMPS 
         with established hospital-wide quality management processes                (standardized clinical assessment and management plans)
         Staff or student performance review processes including those that         Unleashing Peak Performance
         solicit input from colleagues and peers
         Information gathering related to an internal investigation                 Serious patient safety incident reviews, apparent cause analysis,  
                                                                                    privacy audits, outbreaks and patient complaints
         Routine substitutions, replacements or upgrades of hospital                Update to the Alaris pump data set
         products, supplies and equipment
         Straightforward process changes that do not involve surveys or the         Reorganizing supplies or equipment, changing way finding signage, 
         collection/extraction of personal, personal health, or clinical            observations in public areas
         information
         External reviews and accreditation processes                               Accreditation Canada, Ontario Lab Accreditation
         Evaluation data (also known as Kirkpatrick evaluation) collected as a      Routine program evaluation with staff
         routine expectation of training and education design or delivery, 
         unless the training or education is the intervention of the project
         Adapted with acknowledgement from the Hospital for Sick Children
         Form version updated February 25, 2021
                       
              Section A – QI Project Reflective Checklist (highlight appropriate response)
                                                      Question                                             QIRC      REB
                                Is the aim of the project to improve care for the next patient, local       Yes       No
                                operations or efficiency?
                                Is there a precedent for identifying a quality gap or considering a 
                 Purpose        practice change?
                                o literature                                                                Yes       No
                                o consensus statements, or
                                o consensus among clinician team
                                Are the proposed methods incorporating rapid evaluation, feedback           Yes       No
                                and incremental changes (e.g., Plan-Do-Study-Act cycles)?
                                Do the methods include any of the following?
                  Design        o control group or randomization into different intervention groups
                                o fixed protocol or testing a specific hypothesis                            No      Yes
                                o testing treatments that are experimental or outside of current 
                                    standard of care
                                o answering a specific quantitative or qualitative question
                                Is the risk related to the project minimal and no more than usual 
                                care? In other words, participants would not be exposed to risks            Yes       No
                                beyond what a reasonable person might expect in day-to-day 
                   Risk         interactions or routine care?
                                Does the project involve the evaluation of a device, drug or natural 
                                health product that is not currently used as standard of care (i.e. for      No      Yes
                                a use different from the original approval by Health Canada)?
                                Will this project only involve participants (patients, caregivers, 
                                employees, trainees or physicians) who are already seen, cared              Yes       No
               Participants     for, or work in the project setting? 
                                Will this project require participants to be involved outside of a           No      Yes
                                hospital visit or work hours? 
                                Is the project funded externally (outside of UHN) by any of the 
                                following?
                 Funding        o a TRI-council or national funding agency (e.g. CIHR)                       No      Yes
                                o a manufacturer with an interest in the outcome of the project 
                                    relevant to its products
                                o a non-profit foundation or for-profit corporation
                If a number of the responses are in the white boxes, a CAPCR submission for REB review 
                may be required. 
                If all responses are in the grey boxes, a QIRC submission for QI review is likely appropriate.
                If you have questions about project classification, please contact QI@uhn.ca. 
                Form version updated February 25, 2021