Best practices for applying for human ethics approval Research Day August 31, 2006

2. Best practices for applying for human ethics approvalResearch Day August 31, 2006 Susan Blum, Ph.D. Manager, Ethics Office

3. Research Ethics • Nuremberg Code (1947) • Declaration of Helsinki (1964) • Belmont Report (1979) • Universal Declaration on Bioethics & Human Rights, UNESCO (2005)

4. Required Compliance • TCPS, Ethical Conduct for Research Involving Humans • Tri-Council MOU • U of S Policies & Procedures for Research with Human Subjects

5. Ethics Structure at U of S

6. The Canadian Road Map: Tri-Council Policy Statement

7. Education • On-line tutorial http://pre.ethics.gc.ca/english/index.cfm • Anyone conducting research with human subjects

8. Purpose of Ethics Review

9. Research Requiring Review • Human participants, human remains, cadavers, tissues, biological fluids, embryos or fetuses • Observation of human behaviour in a natural environment • Use of identifiable data • Third-party interviews

10. Research not requiring review • Secondary use of pooled data which cannot be linked to the original subject (de-identified data) • Quality assurance studies, performance reviews or testing within normal educational requirements • Observation of subjects at public meetings or political rallies • Publicly available reports,literature, STATS CAN data

11. Role of the REB

12. Which REB? Biomedical REB Behavioural REB

13. Do I Need Review? • I am only talking to people • It's an anonymous survey; sending it back indicates consent • It was already reviewed at U of Toronto • It is just records from human subjects (chart review; use of data for new purpose) • Research by students for courses/theses • Pilot projects • Research outside University of Saskatchewan

14. Behavioural-REB • Non-invasive interventions & measures interviews, surveys, questionnaires, psychological, social or behavioural interventions, non-invasive physiological measures (e.g. heart rate, blood pressure) • Observation or descriptive research drug, dietary, & exercise protocols that are observational in nature with no intervention • Audio and/or video recording other monitoring

15. Biomedical-REB • Medically invasive procedures invasive interventions, invasive measures (includes administration & testing of drugs • Physical interventions drug, dietary, and exercise protocols that have the potential for adverse events • Surgical procedures biopsies, blood or specimen collection • Permanent charts or records

16. Level of Risk “no greater than…encountered in everyday life” (TCPS)

17. Team Effort

18. Submission to the REBs • Submit all required materials • Guidelines & Templates on website • Copies • Full Board (Above Minimal Risk) • Minimal risk

19. Delegated Review Minimal risk 3-4 wks turnaround Deadlines Beh-REB Wed. @ noon Bio-REB daily Full Board Review AboveMinimal Risk Deadline: 10 working days prior to monthly meeting 3-4 weeks turnaround Expedited Review Minimal risk and subject to certain conditions Types of Review

20. . Responses from the REB Approved • Start your research Notice of Ethical Review • Changes required with consent, recruitment, or methodology • Researcher must submit these changes for review (1 copy required) • 7 working days turnaround for review of resubmission

21. Timeline • Average response time from submission deadline to final approval is 3-4 weeks • Dependent, in part, on how quickly you make your revisions • Build in 1 month

22. Delays caused by • Improper signatures • Insufficient copies • Inappropriate format • Missing documentation • Insufficient information • Hand-written or improperly collated submissions

23. Delays - cont’d • Say too little • Ask for personal info not needed • Write for academics • Grade 8 reading level

24. Consider when • Signed consent is impractical • Organizations or communities need to give consent to perform research within the population • Participants are <18 years of age • Parental consent may be waived • Participant has a dependant relationship with the researchers

25. Consider when • Participant is unable to give consent (i.e. cognitive impairment) • Conducting participant-observation or naturalistic-observation research • Potential for coercion • Possible loss of privacy or anonymity

26. Required Signatures • Researcher(s) – only one principal investigator • Department Head, Dean, Director, or Administrative Head • Student Signature • Contact Person and Mailing Address for Correspondence

27. Amendments • Any changes to the research protocol must be submitted to the REB prior to implementation. • Submit one copy with changes highlighted. • Identify changes in a covering letter. • Amendments can usually be reviewed within 7 working days.

28. Continuing Review • Approval is for 1-year • Project continues beyond 1-year • Status Report Form must be submitted prior to the expiry date • If not submitted: • ethics approval automatically expires • data collected CAN NOT be used • any research funds will be withheld • department head, sponsors will be notified • Study completions and closures need to be reported (submit Status Report Form)

29. Contact http://www.usask.ca/research/ethics_review/ Ethics Office 966-2975