Ethics

1. Ethics National Judging Advisory Committee RB � Introduction of team (PGI as �YSF Support Team�) - Purposes of our presentation - Tell you about YSF Canada and its activities - Demonstrate where we believe there is a commonality of mandates - Showcase potential areas of partnership - We will be glad to answer your questions after the presentationRB � Introduction of team (PGI as �YSF Support Team�) - Purposes of our presentation - Tell you about YSF Canada and its activities - Demonstrate where we believe there is a commonality of mandates - Showcase potential areas of partnership - We will be glad to answer your questions after the presentation

2. 2 YSF Ethics:

3. 3 Socrates: 400 BC Rabelais: French Rennaisance � died 1553 AD Dellaire � 2004 ADSocrates: 400 BC Rabelais: French Rennaisance � died 1553 AD Dellaire � 2004 AD

4. 4 Goals To present the information that Regional Science Fair Committees need to understand the ethical issues To define clearly the rules that participants must follow To make it easy for participants to follow the rules

5. 5 Background Regional Science Fairs (RSF) need to ensure that projects comply with YSF rules and regulations Need to get out of the mode of �Backwards Compliance� and surprises at the CWSFs Help us encourage Canada�s young scientists to conduct ethical and sound research

6. 6 National Judging Advisory Committee The National Judging Advisory Committee (NJAC) monitors YSF Canada policies and procedures relating to all aspects of judging and makes recommendations for change to the Executive Director in consultation with the National Science Fair Committee.and makes recommendations for change to the Executive Director in consultation with the National Science Fair Committee.

7. 7 YSF Canada Ethics Committee Responsible for the oversight of human and animal research at RSF and CWSF Reviews challenging projects submitted by RSF Ethics Committees 2 ex officio members: Executive Director, CWSF Chief Judge, member of the National Science Fair Committee2 ex officio members: Executive Director, CWSF Chief Judge, member of the National Science Fair Committee

8. 8 Ethics: What Types of Research? Human Research Ingestion and absorption Psychological risk Physical activities Animal Research Inhumane treatment There are a number of rules that impact on RSF and CWSF projects The ones that we will focus on today are those involving HUMANS and ANIMALS Other rules that we will not cover today include: Hazardous Materials, Apparatus (chemicals, medicines, lasers, microbiologicals) Safety (participants, experimenters, others) Law (injury, damage, civil or criminal actions) Public Relations (participation, sponsorship, volunteers) There are a number of rules that impact on RSF and CWSF projects The ones that we will focus on today are those involving HUMANS and ANIMALS Other rules that we will not cover today include: Hazardous Materials, Apparatus (chemicals, medicines, lasers, microbiologicals) Safety (participants, experimenters, others) Law (injury, damage, civil or criminal actions) Public Relations (participation, sponsorship, volunteers)

9. 9 Regional Science Fair Ethics Committee Each region is expected to set up an Ethics Committee which will become knowledgeable about the rules and ethical issues related to student research CREDIBILITY What happens if you don�t do it? Current state: Phone Calls, emails, notes, �nuisance� Opportunity to further communicate Must be prepared for progressive re-enforcement as part of managing this change. (This is not fun). YSF Canada Policy Manual 3.1.1.3 Regional Science Fair Ethics Committees www.ysf-fsj.ca/Members/pdirectory3.aspx CWSF Participants Guide �Reminder� p49 CREDIBILITY What happens if you don�t do it? Current state: Phone Calls, emails, notes, �nuisance� Opportunity to further communicate Must be prepared for progressive re-enforcement as part of managing this change. (This is not fun). YSF Canada Policy Manual 3.1.1.3 Regional Science Fair Ethics Committees www.ysf-fsj.ca/Members/pdirectory3.aspx CWSF Participants Guide �Reminder� p49

10. 10 Ethics Review Committee A group of adults knowledgeable about regulations concerning experimentation in restricted areas Role is to educate and support Members (1-3 people): Ethics Consultant Veterinarian Health care professional RSF Chief Judge

11. 11 Ethics Review Process * All animal research * All human research Research proposals must be reviewed by the RSF Ethics Committee An Adult and Scientific Supervisor are required

12. 12 Adult Supervisor Required for projects involving human and animal research Parent, teacher or scientist Ensures student understands ethical issues at an appropriate level Ensures YSF rules are followed

13. 13 Scientific Supervisor Involved if there is more than trivial risk Often located in University or industrial laboratory setting Usually has professional qualifications May be the Adult Supervisor

14. 14 Ethics Review Process Can use primarily email and phone discussions Communicate Ethics Rules and expectations to teachers, students and parents Be prepared to enforce the rules

15. 15 Challenging Issues RSF Chief Judge refers to YSF Ethics Committee Chair, Dr. Patrick Whippey After seeking appropriate professional advice, the Committee will assist students where possible so that the methodology can meet the ethical rules for animal or human research

16. 16 Human Participation Low Risk Projects Surveys of attitudes and beliefs Skill tests Observations of behaviour 4.1A Approval of Low Risk Projects

17. 17 One Minute Moment Examples of a low risk survey?

18. 18 Human Participation High Risk Projects Everything Else

19. 19 High Risk Projects Approval required before experiments begin Projects often done in a research laboratory Reviewed by RSF Ethics Committee 4.1B Application For Review of Research with Human Participants Involving Significant Risk 4.1C Human & Animal Research Approval

20. 20 One Minute Moment Examples of surveys with significant risk?

21. 21 Informed Consent Is a process Ethics committee in place Points student & supporting adults to ethics web site Reviews the Informed Consent Form Ensures the required elements are present. Monitors compliance by the student & participants

22. 22 Informed Consent Form Low & High Risk projects The right to be informed of risks The right to remain anonymous The right to withdraw: at any time for any reason The right to be informed of the results Informed Consent Form

23. 23 What is a Drug? Health Canada definition: �Drug" includes any substance or mixture of substances manufactured, sold, or represented for use in:(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in humans or animals;(b) Restoring, correcting, or modifying organic functions in human beings or animals; (c) Disinfection in premises food is manufactured, prepared or kept.

24. 24 Questions to ask of Projects  with Human Participation Is the project high or low risk? Is there supervision by an appropriate scientific advisor? Is the student familiar with the ethics web site(s). Does the informed consent form have all the required elements? Is the student familiar with the definition of a drug? Is a drug involved?

25. 25 Non-Vertebrate AnimalsExcept Cephalopods Allowed

26. Vertebrate Animals, (fishes, amphibians, birds, reptiles, mammals) Cephalopods(Octopus, Squid, Cuttle Fish) Allowed only under four conditions Observation only Behavioural experiments Projects conducted in a registered laboratory Studies of embryos 4.1C Human & Animal Research Approval

27. 27 Questions to ask if Animals are involved Is the animal governed by the rules for vertebrates or invertebrates? Is there supervision by an appropriate scientific advisor? Is the student familiar with the ethics web site(s)? Invertebrates � any scientifically legitimate project is allowed. Vertebrates � is it one of the four types of projects allowed?

28. 28 Case Study of Diabetes Angela�s mother is trained as a medical professional. She works in a community health clinic that supports a minority group with a high incidence of diabetes. Angela asked the RSF Ethics Committee for permission to: Take blood pressure Take a blood sample to check the amount of HbA1c (long-term glucose) in the blood (her mother will take the actual sample) Measure weight and waistline, and survey dietary habits of clients Give a dose of the natural herb Gymnema Sylvestre daily to 12 clients for a month to see if it improves blood sugar levels.

29. 29 Questions to be Asked? Is Angela knowledgeable about the rules for Ethical Research that govern such a study? Is this project being supervised by a research professional? Is Gymnema Sylvestre used in this context a drug? Is this being conducted in a vulnerable population? Has it been approved by her school? If this project is selected for CWSF, must it be disqualified?

30. 30 Off-Side Projects Please do not send projects that are in violation of the Ethics Rules to the CWSF, no matter how meritorious

31. 31 Resources YSF Web Site Devoted to Ethics - New: http://www.ldstf.ca/ethics/ YSF Policy Manual � the Official Rules: http://www.ysf.ca/Members/policydirectory.aspx

32. 32 Summary Adopt the YSF Ethics Rules for your Regional Science Fair Form a Regional Science Fair Ethics Committee Developing awareness and understanding of the ethical issues involved with Science Fairs will empower Canada�s young scientists to conduct ethical and sound research

33. 33 Questions?