2. Research Ethics Western University Health Sciences 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 Consent can be withdrawn at any time 3.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. 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

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, 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)

20. 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 Waiver of Consent

21. 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