research ethics western university non-medical research ethics board letter of information &...
TRANSCRIPT
Research Ethics
Western University
Non-Medical Research Ethics Board
Letter of Information & Consent Process
Grace KellyEthics Officer
www.uwo.ca/research/ethics
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
•Assent
•Alternates for Obtaining Consent
•Question and Answer Period
Tri-Council Policy Statement 2
Chapter 3
1. Consent shall be given voluntarily
2. Consent can be withdrawn at any time
3. *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
Assent
• 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 forms).
• In all these cases parents MUST give consent also. A child cannot participate based on their Assent only.
Alternate Procedures for Obtaining Consent
Certain types of research require alternate processes for seeking
consent.
– 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 disclosure)
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]
or
Julie Pfeiffer at 519-661-2111 ext. 86811 or [email protected]