2. 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

3. Upcoming Educational Sessions Forms – Initial submission + Post Approval Forms Surveys and Online Research Teachers’ Research with their own Students ROMEO and electronic submissions

4. Today’s Agenda Tri-Council Policy Statement (Chapter 3) Letter of Information Consent Form Assent Alternates for Obtaining Consent Question and Answer Period

5. 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 Consent can be withdrawn at any time 3.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

6. 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

7. 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

8. Letter of Information

13. Consent Form

15. Assent

16. 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.

18. 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)

20. 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 grace.kelly@uwo.ca or Julie Pfeiffer at 519-661-2111 ext. 86811 or jpfeiff@uwo.ca jpfeiff@uwo.ca