Research Ethics
Starting Ethically:
A Practical Guide to Research in Healthcare for PAs in Canada
Overview
As the Physician Assistant (PA) profession in Canada continues to grow and integrate into academic, clinical, and leadership settings, so too does its role in research and evidence-informed practice. PAs are no longer just clinical practitioners. We are educators, leaders, and researchers. Whether you are conducting a retrospective chart review, initiating a quality improvement (QI) project at your hospital, or contributing to a multi-site trial, you are engaging with research. And with that engagement comes responsibility.
However, the reality is that any activity involving human participants or their data carries certain ethical obligations. Without appropriate safeguards, even well-intentioned projects, can compromise patient privacy and expose those individuals to harm, or undermine the trust our profession has worked to establish.
This goal of this lesson is to help cut through complexity to give you a working understanding of research ethincs in the Canadian context. We will review the Tri-Council Policy Statement (TCPS 2) and explain when Research Ethics Board (REB) review is necessary.
If you plan to present findings of your research or publich your work, whether you are initiating a student capstone project or a PA completing a research paper or QI project, this module will help you understand and apply these principles.
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By the end of this lesson, you will be able to:
Define research ethics and explain its relevance to PA practice in Canada
Identify the three core principles of the TCPS 2 and apply them to research scenarios
Distinguish between research, quality improvement, and program evaluation
Determine when REB review is required for a given project
Describe the role and function of a Research Ethics Board
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TCPS 2 (Tri-Council Policy Statement): Canada’s national policy on the ethical conduct of research involving humans. Developed by CIHR, NSERC, and SSHRC.
CORE-2022 (Course on Research Ethics): A free, online tutorial aligned with TCPS 2, required by many REBs before submitting a research protocol.
CIHR (Canadian Institutes of Health Research): Federal agency supporting health research in Canada. Co-developer of TCPS 2.
NSERC (Natural Sciences and Engineering Research Council): Federal agency supporting science and engineering research in Canada. Co-developer of TCPS 2.
SSHRC (Social Sciences and Humanities Research Council) : Federal agency funding research in the social sciences and humanities. Co-developer of TCPS 2.
REB (Research Ethics Board): A committee that reviews research involving human participants to ensure ethical standards are met.
QI (Quality Improvement): A structured, systematic process to improve health care delivery and outcomes within a specific clinical setting.
PHI (Personal Health Information): Information that identifies an individual and relates to their health, health care history, or payment for health services.
Lesson Outline
Lesson Activities
Additional Resources
What is Research Ethics?
Research ethics is the application of moral reasoning to the design, conduct, and dissemination of research involving human participants. It is a structured approach to answerin gthe questions: “Should we do this research? Who might be harmed? Who benefits? Are we being fair?
At its core, research ethics is about three principles:
Minimizing harm to participants
Respecting autonomy and decision-making capacity
Ensuring fairness in who bears the risks and who receives the benefits.
These principles apply regardless of methodology of your research. Whether its analyzing EMR data, conducting patient interviews or running a randomized control trial (RCT), ethical considerations are embedded in every stage of your project.
Why This Matters for PAs
As PAs, we occupy a unique position in healthcare. we work closely with patients, have access to sensitive data, and increasingly contribute to clinical scholarship. That access comes with accountability.
Even relatively low-risk projects, such as retrospective chart reviews or satisfaction surveys, may raise ethical considerations depending on how data is collected, used, and shared. A common mistake clinicians make is assuming a project is “just QI” or “not really research,” only to discover later that their work requires ethics approval before it can be presented or published.
As our profession expands its scholarly footprint, we have an obligation to uphold rigorous ethical standards. Doing so protects patients, strengthens our credibility, and positions PAs as competent, trustworthy contributors to the research in healthcare.
By developing a foundational understanding of research ethics, you are not only protecting patients and communities, but also strengthening the professionalism, credibility, and future capacity of the PA role in Canada.
The Tri-Council Policy Statement (TCPS 2)
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is Canada’s primary ethical framework for research involving human participants. It is co-authored and maintained by the country’s three federal research funding agencies:
CIHR – Canadian Institutes of Health Research
NSERC – Natural Sciences and Engineering Research Council
SSHRC – Social Sciences and Humanities Research Council
The TCPS 2 outlines both the ethical foundations and practical requirements for researchers across disciplines. Compliance with TCPS 2 is expected at all Canadian universities, healthcare institutions, and affiliated researcher organizations. This is applicable regardless of whether a research project is externally funded. (Government of Canada, 2022).
Why This is Relevant to PAs
Most Canadian REBs require proof of TCPS 2: CORE-2022 certification before they will review your research protocol.
Beyond compliance, understanding TCPS 2 will sharpen your ability to:
Structure ethically sound projects from the outset
Anticipate privacy and consent considerations
Navigate REB submissions with confidence
Engage with participants in ways that uphold their dignity and rights
Core Training Resource
TCPS 2: CORE-2022 Online Tutorial : a free, self-paced module that provides foundational ethics training and is recognized nationally.
The Three Core Principles of Ethical Research
The TCPS 2 is built on three foundational principles: Respect for Persons, Concern for Welfare, and Justice. These are not abstract concepts. They are the criteria your REB will use to evaluate your protocol, consent process, and data management plan.
1. Respect for Persons
This principle recognizes the inherent dignity and autonomy of every individual. It requires that participants are treated as capable decision-makers who can voluntarily choose whether to participate in research that is free from coercion, deception, or undue influence.
In practice, this means:
Obtaining informed consent that is clear, comprehensive, and ongoing
Ensuring participants understand what they are agreeing to, including risks, benefits, and their right to withdraw
Protecting individuals with diminished capacity to consent (e.g. children, individuals with cognitive impairment, or those in dependent relationships) with additional safeguards
Clinical example:
If you're recruiting patients from your own practice for a survey, you must consider whether they might feel pressured to participate because of your existing clinical relationship.
Respect for Persons principle requires you to mitigate that influence, such as having neutral third party conduct the recruitment. instead
2. Concern for Welfare
Welfare encompasses the physical, psychological, emotional, social, and cultural well-being of participants. Researchers must minimize foreseeable harms and maximize potential benefits. This includes protecting privacy, maintaining confidentiality, and designing procedures that reduce participant burden.
In practice, this means:
De-identifying data whenever possible and storing it securely
Providing participants with the right to withdraw at any time without penalty
Anticipating potential distress and offering appropriate supports (e.g., counseling resources for sensitive interview topics)
Ensuring the time and effort required of participants is justified by the value of the research
Clinical example:
In a chart review examining adverse events, Concern for Welfare means ensuring that patient identifiers are removed before analysis, that data is stored on secure, encrypted servers, and that findings are reported in aggregate to prevent re-identification.
3. Justice
Justice requires fairness in both the process and outcomes of research. It demands that no group is unfairly burdened by research participation, and that the benefits of research are equitably distributed. Researchers must be intentional about who is included, who is excluded, and why.
In practice, this means:
Avoiding the exploitation of vulnerable or accessible populations simply because they are convenient
Ensuring recruitment practices are transparent and inclusive
Considering systemic inequities that may affect who participates, and who benefits
Clinical example:
If you're studying a new model of care, the Justice principle requires that you don't limit participation to only high-functioning, low-risk patients while excluding those with complex needs. The intervention should be tested in a population that reflects the diversity of patients who would ultimately receive it.
Applying the Principles in Practice
These three principles are interconnected. A project that respects autonomy but ignores welfare concerns is not ethical. A study that promotes justice but fails to obtain meaningful consent is not defensible. Your job as a PA researcher is to integrate all three principles into every phase of your work—from protocol development to data dissemination.
Before initiating any research or QI project, ask yourself:
Does this project respect the autonomy and dignity of participants?
Have I minimized risks to their welfare and maximized potential benefits?
Am I treating all potential participants fairly, and are the benefits of this research distributed equitably?
If you can't answer "yes" to all three, your protocol needs refinement before you proceed.
PA Research Tip 💡
Before initiating any research or QI project, ask yourself:
Does this project respect the autonomy and dignity of participants?
Have I minimized risks to their welfare and maximized potential benefits?
Am I treating all potential participants fairly, and are the benefits of this research distributed equitably?
If you can't answer "yes" to all three, your protocol needs refinement before you proceed.
What Counts as “Research”?
One of the most common points of confusion among clinicians is the distinction between “research” and “quality improvement” (QI). According to the TCPS 2, research is defined as:
“An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation”
(Government of Canada, 2022, p. 14).
This definition is intentionally broad, encompassing everything from clinical trials and surveys to retrospective chart reviews and educational interventions.The key determinant is intent: if your project is designed to generate generalizable knowledge, that is findings intended to inform practice beyond your immediate setting, it is research.
Does Your Project Count as Research?
Ask yourself:
Am I planning to publish this work or present it at a conference?
Am I collecting data systematically to answer a research question?
Could these findings inform clinical practice or policy outside my institution?
If you answered “yes” to any of these, your project likely requires REB review.
Common Examples That Require REB Approval:
Chart reviews intended for publication or presentation
Surveys distributed to patients, families, or healthcare providers
Case series or case reports submitted to journals or conferences
Student capstone or thesis projects involving human participants or identifiable data
Observational studies examining clinical outcomes or practice patterns
Even if a project seems “low-risk” or internal, the intent to disseminate findings externally typically triggers the need for ethics review.
Research vs. QI vs. Program Evaluation
Understanding the differences between research, quality improvement (QI), and program evaluation is essential—because each has different ethical requirements.
Research
Research is a systematic investigation designed to generate generalizable knowledge. It is typically associated with publication, external dissemination, or informing broader clinical practice.
Examples in PA practice:
Evaluating clinical outcomes across multiple sites
Exploring patient experiences with a new model of care
Examining the accuracy of a diagnostic protocol
Ethics requirement: Formal REB review is required.
Quality Improvement (QI)
QI focuses on improving processes, workflows, or outcomes within a specific local context. It is iterative, action-oriented, and typically intended for internal use rather than generalizable conclusions.
Examples in PA practice:
Streamlining discharge processes in a fracture clinic
Reducing wait times for initial assessments
Improving adherence to a clinical pathway
Ethics requirement: REB review is generally not required if the project remains internal and uses existing data. However, if you plan to publish or present your findings, ethics review becomes necessary.
Program Evaluation
Program evaluation assesses the effectiveness or efficiency of a specific healthcare initiative, service, or intervention. This is usually for internal decision-making or accountability purposes.
Examples in PA practice:
Evaluating the impact of a patient education initiative
Assessing a new procedural protocol's feasibility
Measuring satisfaction with a new clinic model
Ethics requirement: REB review is typically not required if the evaluation is conducted using existing data and is not intended for external dissemination. Once findings will be shared publicly, REB review is likely required.
The Grey Zone: When QI Becomes Research
The line between QI and research becomes blurred when you decide to share your findings beyond your institution. A project that begins as internal QI may become research the moment you submit an abstract to a conference or prepare a manuscript for publication.
If you think there’s even a small chance you'll want to publish or present your work later, consult your REB early. Retroactive ethics approval is difficult to obtain.
Research Ethics Board (REB)
A Research Ethics Board (REB) is a multidisciplinary committee mandated to review research involving human participants or human data. The REB's primary role is to ensure that research is ethically sound, scientifically justified, and protective of participants' rights and welfare.
In Canada, REBs operate under institutional authority (e.g., universities, hospitals, health regions), but all must adhere to the principles outlined in TCPS 2. Their function is not to obstruct research. It is to safeguard participants and uphold the integrity of the research process.
What REBs evaluate:
Risk-benefit balance: Does the potential benefit justify the risks?
Informed consent: Is the consent process clear, voluntary, and appropriate?
Recruitment: Are participants being recruited fairly and without coercion?
Privacy and confidentiality: Are data handling procedures robust and secure?
Scientific merit: Is the study well-designed and feasible?
Equity and inclusion: Are participant selection criteria fair and justified?
A Collaborative Relationship
Think of the REB not as a barrier, but as a partner in ethical scholarship. A well-prepared REB submission demonstrates that you have carefully considered the ethical dimensions of your work.
When Is REB Review Required?
The TCPS 2 outlines clear scenarios in which REB approval is mandatory. You must seek REB approval before initiating your project if any of the following apply:
Your project involves:
Human participants (patients, healthcare providers, families, students)
Identifiable human data (EMR records, lab results, imaging, billing data)
Biological specimens (tissue samples, blood, saliva)
Surveys, interviews, focus groups, or observational methods
Dissemination beyond your institution (conference presentations, publications, public reports)
Your project may be exempt if:
The data is completely de-identified and publicly available
The activity is a QI project conducted strictly for internal improvement with no intent to publish
However, exemptions require caution. If you anticipate any possibility of external dissemination, engage with your REB before you begin.
Don’t delay your ethics review planning. REB approval can take anywhere from 2 to 6 weeks (or more). Begin preparing your materials early, especially if working on a time-sensitive student or clinical project.
Preparing an REB Application
Navigating an REB submission can feel daunting, especially for first-time researchers. Fortunately, most Canadian institutions provide templates, checklists, and support services to guide you through the process.
Practical Tips for a Strong REB Submission:
Start early. REB review can take 2–8 weeks (or longer). Build this timeline into your project plan.
Complete TCPS 2: CORE-2022 training before submitting. Most REBs require proof of completion.
Review examples. Ask colleagues or supervisors for sample applications—seeing what a complete submission looks like is invaluable.
Be clear and concise. REBs review dozens of applications. Write clearly, avoid jargon, and answer the questions directly.
Attend an ethics workshop. Many institutions offer training sessions or consultation hours. Be sure to take advantage of them.
Prepare your consent forms carefully. This is often where applications get delayed. Ensure your language is accessible, comprehensive, and aligned with TCPS 2 standards.
Common Pitfalls to Avoid:
Waiting until the last minute to submit
Underestimating risks to participants
Using overly technical or vague language in consent forms
Failing to address data storage and security
Assuming your project is "just QI" without confirming with the REB
Don’t delay your ethics review planning. REB approval can take anywhere from 2 to 6 weeks (or more).
Begin preparing your materials early, especially if working on a time-sensitive student or clinical project.
Final Thoughts
Ethical research doesn’t begin with REB submission. It begins with how you conceptualize your project, engage with participants, and handle the knowledge you generate. As PAs increasingly contribute to clinical scholarship, understanding the foundational principles of research ethics is not optional. It is a professional competency.
Whether you're conducting a chart review, launching a student project, or collaborating on a multi-site trial, your work must uphold the principles of Respect for Persons, Concern for Welfare, and Justice. These principles are not just what REBs require. They are what patients and participants deserve.
When ethics guides your work from the start, you build trust, strengthen your scholarship, and contribute to the credibility and maturity of the PA profession in Canada.
Lesson 1 Summary
Research ethics ensures studies involving humans are designed and conducted with respect, fairness, and accountability.
The Tri-Council Policy Statement (TCPS 2) is Canada's national standard, built on three core principles: Respect for Persons, Concern for Welfare, and Justice.
PAs must distinguish between research, QI, and program evaluation. Only research typically requires REB review.
Most projects involving human participants or identifiable data require REB approval. Start early and plan thoroughly.
Ethical research protects participants, builds trust, and strengthens the impact of PA-led scholarship in Canada.
Additional Resources
TCPS 2: CORE-2022 Tutorial:
Free, self-paced online training recognized nationally. Complete this before your first REB submission.Tri-Council Policy Statement:
The complete TCPS 2 reference guide.CIHR Best Practices for Privacy:
Guidance on protecting participant privacy in health research.
References
Alas JK, Godlovitch G, Mohan CM, Jelinski SA, Khan AA. Regulatory Framework for Conducting Clinical Research in Canada. Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques. 2017;44(5):469-474. doi:10.1017/cjn.2016.458
Canadian Institutes of Health Research. (2005). Best practices for protecting privacy in health research. https://cihr-irsc.gc.ca/e/29072.html
Government of Canada. (2022). Tri-Council Policy Statement: Ethical conduct for research involving humans (TCPS 2 - 2022). Secretariat on Responsible Conduct of Research. https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html
Page SA, Nyeboer J. Improving the process of research ethics review. Res Integr Peer Rev. 2017;2:14. Published 2017 Aug 18. doi:10.1186/s41073-017-0038-7
Panel on Research Ethics. (2022). TCPS 2: CORE-2022 – Course on Research Ethics. Secretariat on Responsible Conduct of Research. https://tcps2core.ca/welcome
Lesson 1
Self-Knowledge Quiz
Answer 3 questions to help you check your understanding of key concepts from this lesson. Once you submit, you will receive immediate to help reinforce what you’ve learned.
Self-Reflective Questions
Ethics is not just about compliance. It is about understanding how your choices, assumptions, and position as a researcher can impact others. These questions are designed to help you think critically about your role and responsibilities.
Reflection Prompts:
Power and influence: How might my role or relationship with participants influence their willingness to participate in my project? What steps can I take to reduce that influence and ensure voluntary consent?
Assumptions about risk: What risks might I overlook if I assume my project is “low-risk”? How could those blind spots affect how I handle consent, privacy, or ethics approval?
Navigating grey areas: Research often involves ambiguity. What would I do if a participant felt pressured to say yes? What if I assumed a project was QI and later wanted to publish it?
Fairness and inclusion: Who is included in my research, and who is excluded? Are there systemic barriers or biases influencing my recruitment strategy?