Research Ethics
Western University
Non-Medical Research Ethics Board
Letter of Information & Consent Process
Grace Kelly
Ethics Officer
[email protected]
Upcoming Educational Sessions
• Forms – Initial submission + Post Approval Forms
• Surveys and Online Research
• Teachers’ Research with their own Students
• ROMEO and electronic submissions
Today’s Agenda
•Tri-Council Policy Statement (Chapter 3)
•Letter of Information
•Consent Form
•Alternates for Obtaining Consent
•Question and Answer Period
Tri-Council Policy Statement 2
Chapter 3
Consent shall be given voluntarily
Consent can be withdrawn at any time
*If a participant withdraws consent, the
participant can also request the withdrawal of
their data or human biological materials
Tri-Council Policy Statement 2
Chapter 3
Undue Influence & Coercion - eg. Teachers’
research with their own students
Incentives – eg. Win a prize for participating
in research
Capacity – eg. Can the person sign for
themselves? Also, cross cultural research to
some extent.
Presentation Title Here
Tri-Council Policy Statement 2
Chapter 3
• Consent shall be informed – eg. Consent Process
• Consent shall be an ongoing process – eg. Check in
• Consent shall precede collection of, or access to,
research data – i.e. you cannot do ANYTHING with
the participant until consent is obtained
• Consent shall be documented – eg. Verbal consent
Letter of Information
Consent Form
• Children age 0-6 years 12 months (nothing)
• Children age 7-12 years 12 months (Assent – see sample)
• Children age 13-17 years 12 months (Assent using the same
letter that their parent will read but sign separate consent
• In all these cases parents MUST give consent also. A child
cannot participate based on their Assent only.
Alternate Procedures for Obtaining
Certain types of research require alternate processes for seeking
– Written Consent (Letter of Information + Consent to sign)
– Explicit Consent (Letter of Information + Completion of Survey)
– Explicit Verbal Consent (Telephone Script + Agree to Interview)
You still need a Letter of Information or script for ALL of these forms
of consent.
Subjects must be told exactly what is going to happen to them (full
Question & Answer Period
Thank you!
We are always here to help.
If you have any questions please contact
Grace Kelly at 519-661-2111 ext. 84692 or
[email protected]
Julie Pfeiffer at 519-661-2111 ext. 86811 or
[email protected]

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