1. Ethics National Judging Advisory Committee

2. Youth Science Canada Sciences jeunesse Canada 2 YSF Ethics: Developing Awareness, Understanding and Compliance Judith Soon & Patrick Whippey

3. Youth Science Canada Sciences jeunesse Canada 3 “We are discussing no small matter, but how we ought to live”. Socrates “Knowledge without conscience spells but the destruction of the soul”. Francois Rabelais “Business in Canada must have a conscience and ethics”. Lt.-Gen. Roméo Dallaire

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

5. Youth Science Canada Sciences jeunesse Canada 5 Background Regional Science Fairs (RSF) need to ensure that projects comply with YSF rules and regulations 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 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 Help us encourage Canada’s young scientists to conduct ethical and sound research

6. Youth Science Canada Sciences jeunesse Canada 6 National Judging Advisory Committee The National Judging Advisory Committee (NJAC) monitors YSF Canada policies and procedures relating to all aspects of judging The National Judging Advisory Committee (NJAC) monitors YSF Canada policies and procedures relating to all aspects of judging

7. Youth Science Canada Sciences jeunesse Canada 7 YSF Canada Ethics Committee Responsible for the oversight of human and animal research at RSF and CWSF Responsible for the oversight of human and animal research at RSF and CWSF Reviews challenging projects submitted by RSF Ethics Committees Reviews challenging projects submitted by RSF Ethics Committees

8. Youth Science Canada Sciences jeunesse Canada 8 Ethics: What Types of Research? Human Research Ingestion and absorption Ingestion and absorption Psychological risk Psychological risk Physical activities Physical activities Animal Research Inhumane treatment Inhumane treatment

9. Youth Science Canada Sciences jeunesse Canada 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 Each region is expected to set up an Ethics Committee which will become knowledgeable about the rules and ethical issues related to student research We propose to change this to required

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

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

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

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

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

15. Youth Science Canada Sciences jeunesse Canada 15 Challenging Issues RSF Chief Judge refers to YSF Ethics Committee Chair, Dr. Patrick Whippey 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 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. Youth Science Canada Sciences jeunesse Canada 16 Human Participation Low Risk Projects Surveys of attitudes and beliefs Surveys of attitudes and beliefs Skill tests Skill tests Observations of behaviour Observations of behaviour 4.1A Approval of Low Risk Projects 4.1A Approval of Low Risk Projects

17. Youth Science Canada Sciences jeunesse Canada 17 One Minute Moment Examples of a low risk survey? Examples of a low risk survey?

18. Youth Science Canada Sciences jeunesse Canada 18 Human Participation High Risk Projects Everything Else Everything Else

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

20. Youth Science Canada Sciences jeunesse Canada 20 One Minute Moment Examples of surveys with significant risk? Examples of surveys with significant risk?

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

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

23. Youth Science Canada Sciences jeunesse Canada 23 What is a Drug? Health Canada definition: 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 “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 disease, disorder, abnormal physical state, or its symptoms, in humans or animals; (b) Restoring, correcting, or modifying organic functions symptoms, in humans or animals; (b) Restoring, correcting, or modifying organic functions in human beings or animals; (c) Disinfection in premises food is manufactured, in human beings or animals; (c) Disinfection in premises food is manufactured, prepared or kept. prepared or kept.

24. Youth Science Canada Sciences jeunesse Canada 24 Questions to ask of Projects with Human Participation 1. 1.Is the project high or low risk? 2. 2.Is there supervision by an appropriate scientific advisor? 3. 3.Is the student familiar with the ethics web site(s). 4. 4.Does the informed consent form have all the required elements? 5. 5.Is the student familiar with the definition of a drug? 6. 6.Is a drug involved?

25. Youth Science Canada Sciences jeunesse Canada 25 Non-Vertebrate Animals Except Cephalopods Allowed

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

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

30. Youth Science Canada Sciences jeunesse Canada 30 Off-Side Projects Please do not send projects that are in violation of the Ethics Rules to the CWSF, Please do not send projects that are in violation of the Ethics Rules to the CWSF, no matter how meritorious no matter how meritorious We get two or three a year that are in clear violation We are raising the bar

31. Youth Science Canada Sciences jeunesse Canada 31 Resources YSF Web Site Devoted to Ethics - New: http://www.ldstf.ca/ethics/ http://www.ldstf.ca/ethics/ http://www.ldstf.ca/ethics/ YSF Policy Manual – the Official Rules: http://www.ysf.ca/Members/policydirectory.aspx http://www.ysf.ca/Members/policydirectory.aspx http://www.ysf.ca/Members/policydirectory.aspx

32. Youth Science Canada Sciences jeunesse Canada 32 Summary Adopt the YSF Ethics Rules for your Regional Science Fair Adopt the YSF Ethics Rules for your Regional Science Fair Form a Regional Science Fair Ethics Committee 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 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. Youth Science Canada Sciences jeunesse Canada 33 Questions?