Research Ethics Western University NonMedical Research Ethics Board

Research Ethics Western University Non-Medical Research Ethics Board Letter of Information & Consent Process Grace Kelly Ethics Officer grace. kelly@uwo. ca 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 Consent can be withdrawn at any time 3.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 grace. kelly@uwo. ca or Julie Pfeiffer at 519 -661 -2111 ext. 86811 or jpfeiff@uwo. ca