research ethics western university non-medical research ethics board letter of information &...

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Research Ethics

Western University

Non-Medical Research Ethics Board

Letter of Information & Consent Process

Grace KellyEthics 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 Consent can be withdrawn at any time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. 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

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.

– 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]