What is the role of the Secretariat on Responsible Conduct of Research (SRCR)?
It writes, updates, and explains TCPS 2, helps use it, spots new ethics issues, consults with researchers, and supports the ethics panel.
What is the role of the Panel on Research Ethics (PRE)?
Provides expert, independent advice on TCPS 2, reviews guidance, considers new ethics questions, and serves as advisory body to the Agencies
Who must follow TCPS 2?
All researchers under the auspices of an eligible institution (universities, colleges, research institutes, affiliated hospitals), regardless of funding source.
What makes an institution eligible under TCPS 2?
Signing the Agreement on the Administration of Agency Grants and Awards, committing to Agency policies including TCPS 2.
What is the RCR Framework?
Rules for responsible research. Breaches of TCPS 2 break this framework.
What happens if a researcher breaks TCPS 2?
Can get a warning, lose funding eligibility, or face institutional discipline.
What if ethics and law conflict?
Try to avoid conflicts, ask experts, but law takes precedence.
What is research (TCPS 2)?
Work done to extend knowledge through systematic study.
What is not research?
Exploratory talks, program evaluation, quality reviews, creative work (unless used as research).
Who counts as a research participant?
Anyone giving data, biological materials, or responses relevant to the study.
Who is not a participant?
People giving info in their job (e.g., spokespersons), unless focus is on their personal views.
When is REB review not needed?
Public info with no privacy, observing people in public (no interaction/ID), or secondary use of anonymous info.
Three core principles?
Respect for Persons, Concern for Welfare, Justice.
What is minimal risk research?
Risks no greater than everyday life risks.
What makes consent valid?
Voluntary, informed, ongoing, and before participation.
How can consent be documented?
Written, verbal, or implied (like returning a survey)
Special cases for consent?
Third-party consent + assent if capacity lacking, exceptions for deception/emergencies/public health, secondary use rules.
What is an incidental finding?
An unexpected result that may affect participant welfare (e.g., health discovery)
What is a research directive?
Document where people state preferences for future research if they lose capacity.
What does Justice mean?
Fair distribution of risks and benefits; no unfair exclusion or over-burdening.
Example of unfair exclusion?
Leaving out women, children, elderly, or disabled without valid reason.
What is vulnerability?
When someone has less ability to protect their interests. Needs extra safeguards.
Must researchers share results?
Yes — both positive and negative. Also should share with participants in suitable ways.
What’s privacy vs. confidentiality?
Privacy = freedom from intrusion. Confidentiality = duty to protect info given.
