Best Practices for Human Ethics Approval Process

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