Transcript March 5 HSREB Letter of Information

Research Ethics
Western University
Health Sciences Research Ethics Board
Letter of Information & Consent Process
Grace Kelly
Ethics Officer
[email protected]
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Consent can be withdrawn at any time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. Being
recruited by a boss or supervisor
•
Incentives – eg. Win a prize for participating
in research
•
Capacity – eg. Can the person sign for
themselves?
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
Assent
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, not to be confused with a waiver of 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)
Waiver of Consent
•Used for retrospective studies, NEVER for clinical trials
•Sample size is too big to consent everyone
•Large proportion of individuals have relocated or died
•Creation of privacy risk by linking ID to de-identified data
•Risk of psychological, social or other harm
•Difficulty in contacting individuals
•Participants are being identified
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]