Research Ethics
Ethics in Action
Addressing Complex Scenarios in PA Research
Overview
Ethical guidelines provide a framework, but they rarely offer a perfect script for the gray zones of real-world research. In practice, ethical challenges surface when roles blur, procedures deviate, or context shifts in ways you did not anticipate. This lesson examines how to apply ethical principles in action when you are navigating tension between the research you hope to conduct, and your clinical role.
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Recognize common ethical dilemmas that arise in clinical and QI research settings
Apply structured reasoning to resolve dual-role (clinician/researcher) and boundary challenges
Identify when additional REB review or consultation may be required mid-project
Manage ethics in multi-site or team-based research, including differing institutional standards
Reflect on your professional responsibilities when ethics and efficiency are in tension
Lesson Outline
Lesson Exercises
Additional Resources
Introduction
Ethics in the Moral Grey Zone
In Lessons 1 and 2, you explored foundational principles and procedural requirements: consent, privacy, research ethics board (REB) approval, data security. But ethical research is not just about compliance. It requires judgment when situations get complicated, especially when they present subtlety without obvious misconduct.
Here are some questions you might face:
What if a patient expresses interest in your study, but their clinical status makes them vulnerable to undue influence?
What if your research partner wants to analyze data beyond the original REB scope?
What if a colleague wants authorship credit but contributed minimally?
These are not hypothetical. They happen regularly in Canadian health research. As a PA (or PA student) navigating both patient care and scholarly work, you may encounter these scenarios. The question is not whether ethical complexity will arise, but whether you are prepared to navigate it thoughtfully.
Scenario 1
The Dual Role Dilemma
Case
You work as a PA in a surgical outpatient clinic. You have developed a short survey for patients post-discharge to assess their pain management experience. You plan to analyze the responses as part of a student research project. You approach patients during their follow-up visits to invite them to participate.
The Ethical Challenge
Can patients truly decline participation when you are also their care provider?
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This is role conflict in action. Your intent as a clinician is to be supportive, but your research invitation may unintentionally exert pressure. Patients might believe their care could be affected by whether they participate.
According to TCPS 2 (Article 3.1), voluntariness requires that consent be free of coercion, whether real or perceived.
The power dynamic in a clinical relationship exists regardless of your intentions.
Patients may feel obligated to participate out of gratitude, concern about disappointing you, or fear that declining might affect their care.
Even if you explicitly state that participation is voluntary, the perception of pressure can persist. You cannot eliminate that dynamic just by acknowledging it.
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Use a third party (administrative staff or a research assistant) to handle recruitment
Script a clear explanation: "Participation is entirely voluntary and will not affect your care in any way"
Document how voluntariness is protected in your REB submission
Consider timing: avoid recruiting patients during moments of vulnerability or when they are making decisions about their care
Ethical integrity depends not just on what you intend, but how your invitation is perceived by participants.
Scenario 2
Drifting Beyond Scope of the REB
Case
Your REB-approved chart review analyzes 200 orthopedic cases to identify post-op infection rates. Midway through, your supervisor suggests you also collect data on re-operation rates and unplanned ED visits. Neither was included in the original protocol.
The Ethical Challenge
Can you collect and analyze this new data without REB amendment?
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No. Even if the data is accessible and the intent seems related, scope creep (expanding a study beyond its approved parameters) requires REB review. According to TCPS 2 and institutional policy, research must remain within the boundaries of approved protocols unless amended and re-reviewed.
This might feel frustrating. The additional data seems directly relevant and easily obtainable. But the REB approval you received was based on a specific scope, specific risks, and specific data handling procedures. Changing that scope without review undermines the integrity of the ethical oversight process. It also puts you at risk if something goes wrong.
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Ethical research is not static. Changes in scope, however minor they seem, may require formal reassessment. Transparency with your REB protects both you and your participants.
Scenario 3
Multi-Site, Multi-Standard
Case
You are involved in a research collaboration between your hospital and a local university. The university REB has approved your protocol, but the hospital research office insists on additional review.
The Ethical Challenge
Are both approvals required? What if they conflict?
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Yes, both are required. When research spans institutions, multi-site ethics review is often necessary, even if one board provides the primary review. Institutional policies, data sharing rules, and privacy expectations may differ, especially between academic and clinical environments.
This can feel redundant and time-consuming. However, each institution has its own obligations to protect participants, maintain data security, and uphold community trust. A university REB may not be familiar with hospital-specific privacy laws or operational constraints. A hospital research office may have different standards for data access or storage than an academic institution. You cannot assume one approval covers both.
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Identify all sites where data will be collected, stored, or accessed
Contact each REB or research office early to confirm their process (delegated review, formal submission, or acknowledgment)
Harmonize consent forms and data protocols to satisfy both entities
Consider using a harmonized review platform (such as Clinical Trials Ontario or PREP) if available
Build extra time into your project timeline for multiple review processes
Approval from one REB does not override institutional obligations elsewhere. Multi-site research requires multi-site accountability. Verify site-specific requirements early in your planning.
Scenario 4
Contribution vs. Authorship
Case
A colleague helped you design your survey questions but was not involved in data collection or analysis. They now ask to be listed as a co-author on your manuscript.
The Ethical Challenge
Does their contribution qualify them for authorship?
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Not necessarily. According to the ICMJE (International Committee of Medical Journal Editors) criteria, used by most Canadian medical journals, authorship requires all four of the following:
Substantial contributions to conception or design, data collection, or analysis
Drafting or revising the manuscript critically for important intellectual content
Final approval of the version to be published
Agreement to be accountable for all aspects of the work
All four criteria must be met.
Designing survey questions alone is more appropriately acknowledged in the “Acknowledgments” section rather than as authorship. Authorship implies intellectual responsibility for the entire work, not just one component.
Authorship disputes are common and often uncomfortable. They arise from mismatched expectations, unclear agreements, or evolving contributions over time. These conversations are easier when you discuss authorship criteria openly at the beginning of a project, not when the manuscript is drafted.
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Discuss authorship criteria at the start of the project, not at the end
Revisit authorship agreements before drafting manuscripts, as contributions may have shifted
Document contributions using a tool like the CRediT taxonomy (Contributor Roles Taxonomy)
Be transparent and respectful in conversations about authorship, acknowledging contributions without overstating roles
Transparency in authorship protects relationships and the credibility of your publication. Address expectations early to avoid difficult conversations later.
Addressing other Ethical Pitfalls
Reusing Consent Forms from a Different Project
Ethical Risk: Inappropriate disclosure, invalid or misleading consent
What to Do: Customize consent materials specifically for your study and submit them for REB re-review. Even minor differences in scope or risk require updated consent language.
Using Clinical Data from Your Own Patients for QI
Ethical Risk: Role conflict, unclear boundaries between care and research
What to Do: Confirm whether REB review is required, even for internal projects. If you plan to publish or present findings, REB review is likely necessary.
Storing Participant Data in Google Docs or Personal Cloud Accounts
Ethical Risk: Potential privacy breach, insufficient data security
What to Do: Use institution-approved secure storage systems only (such as encrypted drives or REDCap). Personal cloud accounts do not meet institutional security standards.
Presenting Preliminary Data at a Conference Before REB Approval
Ethical Risk: Breach of approved research protocol
What to Do: Obtain REB approval before collecting or publicly sharing any research data. Preliminary findings still require ethical oversight.
Assuming Verbal Consent is Sufficient Without Documentation
Ethical Risk: No record of informed consent, potential ethics violation
What to Do: Follow REB-approved consent procedures, which typically require written or documented consent unless specifically waived.
Sharing Identifiable Data with Collaborators Without Consent
Ethical Risk: Privacy breach, violation of participant trust
What to Do: Ensure data sharing agreements are in place and approved by the REB before transferring any data. Even de-identified data may require agreements.
What to Do When You’re Not Sure
Ethical uncertainty is not a failure. It’s a signal to pause and reassess. Most institutions and REBs prefer you ask early, rather than fix problems later.
When Facing Ethical Uncertainty:
Contact your REB: Most offer informal consultations or triage pathways for amendments and clarifications. Do not assume you will be judged for asking questions. REBs would rather clarify than clean up a mess.
Talk to your supervisor: If you are a student or co-investigator, confirm scope and roles regularly. Misalignment often happens silently and can be corrected with a quick conversation.
Document decisions: Keep a brief audit trail of ethical decisions and communications (e.g. follow-up emails to confirm changes made during a verbal discussion). This protects you and demonstrates accountability if questions arise later.
Err on the side of respect: If you are unsure whether a practice is acceptable, ask yourself how it would feel from the participant's perspective. Would they trust this process if they knew the full details?
Seek peer input: Discuss your dilemma with colleagues who have research experience. Sometimes an outside perspective helps clarify uncertainty.
Questions to Ask Yourself
Is this fair to participants?
Is this transparent?
Would I feel comfortable explaining this decision to the participant directly?
Would others trust this process if they knew the full details?
Am I making this choice because it is right, or because it is convenient?
If the answer to any of these questions is uncertain, please pause and seek guidance.
Final Thoughts
Real-world research often involves situations not addressed by checklists, especially for PAs balancing dual roles as clinicians and investigators.
Ethical challenges such as recruiting your own patients, modifying protocols mid-study, managing multi-site approvals, and resolving authorship disputes require sound judgment and transparency, not just rule-following. Role conflicts, scope creep, inconsistent institutional policies, and unclear contribution boundaries can undermine trust and research integrity if not addressed proactively.
When unsure, consult your REB early, clarify team roles in advance, and document decisions along the way. Transparency, communication, and thoughtful planning are your strongest tools.
Lesson Summary
Real-world research often involves complex situations not addressed by checklists—especially for PAs balancing dual roles as clinicians and investigators.
Ethical challenges such as recruiting your own patients, modifying protocols mid-study, managing multi-site approvals, and resolving authorship disputes require not only rule-following, but sound judgment and transparency.
Role conflicts, scope creep, inconsistent institutional policies, and unclear contribution boundaries can all undermine trust and research integrity if not addressed proactively.
When unsure, consult your REB early, clarify team roles in advance, and document decisions along the way. Transparency, communication, and thoughtful planning are your strongest tools.
Ethical research is not just about avoiding mistakes—it's about building credibility, fostering trust, and leading responsibly in complex environments.
References
International Committee of Medical Journal Editors. (2022). Defining the role of authors and contributors. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.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
Lesson 3
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.