Consent is a concept that applies to many aspects of our daily lives. We encounter situations requiring consent discussions regularly, for example, when we interact with health care professionals who seek our consent to medical procedures, or in our interpersonal relationships when someone wants access to our time or resources, or when we agree to the terms and conditions of that latest app. But what does consent mean when applied to the research setting, and what information needs to be shared in a research consent document and discussion? As described in Chapter 3 of the TCPS2 (2022; the “Policy”) research consent must be:
- informed; individuals must have sufficient information to make a participation decision
- given freely; the decision to participate is voluntary
- ongoing; participants must be made aware of changes in the circumstances of the research that may affect their ongoing decision to take part
- prior; consent to take part, or to have biological materials used, in the research must be given in advance of involvement in the research
Why does research consent matter?
Research consent requirements reflect the Policy’s foundational Respect for Human Dignity, which is expressed through three complementary and interdependent Core Principles:
- Respect for Persons – all humans have intrinsic value and are due respect and consideration; dual moral obligation to respect autonomy and respect developing, impaired, diminished autonomy
- Concern for Welfare – protection of welfare of human participants, promotion of welfare in respect of foreseeable research risk; welfare in this context refers to quality of life in all aspects, including physical, mental, and spiritual health and physical, economic, and social circumstances
- Justice – obligation to treat people fairly (with respect and concern) and equitably (distribution of benefits and burdens of research)
Although all three of these principles are reflected in the consent process, the requirement that consent should be free, prior and ongoing particularly reflects Respect for Persons (autonomy):
"[t]his requirement reflects the commitment that participation in research, including participation through the use of one's data or biological materials, should be a matter of choice and that, to be meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits, both to the participant and to others." (Article 1.1).
How can I ensure consent is informed, free, prior, and ongoing?
The quote above from Article 1.1 of the Policy provides a helpful starting point for ensuring participants have sufficient information to make an informed participation decision, namely “the purpose of the research, what it entails, and its foreseeable risks and potential benefits, both to the participant and to others”. Let’s consider what information is necessary to ensure prospective participants are informed accordingly.
Provide prospective participants with information about the purpose of the research and what it entails, in other words, address the who, what, where, when and why of your research.
- Who: Who is conducting the research? Who is invited to take part?
- What: What will participants be asked to do? What is their responsibility as participants?
- Where, When: Where and when will participants be involved in aspects of the research? How long will their involvement take?
- Why: Why are you conducting the research? What is the goal or aim of the research? How will research findings be used and shared?
Provide participants with information about the foreseeable risks and potential benefits of the research, both to the participant and to others.
- Foreseeable risks include risks related to the possibility of injury, whether physical, emotional or spiritual, during participation in the research
- Foreseeable risks also include those related to the access, management, use and dissemination of data, information and/or biological materials collected from or about participants
- Address the likelihood of each foreseeable risk; note that risks should not be overstated, nor should risks be identified where none are anticipated
- Provide information about risk mitigation strategies being used, as well as information about supports available to participants if they have concerns about, or experience adverse effects from, their participation
- Prospective participants should be made aware of any foreseeable risks related to limits to confidentiality, e.g., duty to report, as well as any limits to their ability to withdraw themselves and/or their data/materials from the research
- Describe the potential benefits to the participant directly, if any, and the potential benefits of the research more broadly
To facilitate participant understanding, consider carefully the "who" being invited to participate as you develop your consent documents.
- Write in a conversational tone, avoiding jargon and overly technical or legalistic language
- Address the participant directly, e.g., “You are invited”, not “the participant is invited"
- Use bullet points to improve readability and graphics/images where possible for complex procedures
- Ensure the language is at a grade 8 reading level for participants from the general adult population; adjust for participant populations that may not have a grade 8 reading level, e.g., young children
The above guidance for Informed Consent describes the best practice for research consent and should be the approach taken whenever possible. In limited cases, researchers may ask the REB for an exception to these requirements, e.g., for secondary use of data.
These alterations to consent requirements are addressed in the Policy in detail.
Where can I find consent resources and support?
To support researchers in developing consent materials that meet TCPS2 requirements, the Research Ethics Office and REB offer a Consent Checklist & Consent Guidance Document. If you have any questions, please reach out to the Research Ethics Office.
