Research Ethics Western University Non-Medical Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer

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Presentation transcript:

Research Ethics Western University Non-Medical Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer

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 Consent can be withdrawn at any time 3.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

Children age 0-6 years 12 months (nothing) Children age 7-12 years 12 months (Assent – see sample) Children age 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 ext or or Julie Pfeiffer at ext or