national ethics & safety committee comité national d’éthique et sécurité

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National Ethics & Safety Committee Comité national d’éthique et sécurité

Judith Soon & Patrick Whippey

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YSF Ethics:

Developing Awareness, Understanding and Compliance

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“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

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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

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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

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National Judging Advisory Committee

The National Judging Advisory Committee (NJAC) monitors YSF Canada policies and procedures relating to all aspects of judging

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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

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Ethics: What Types of Research?

Human Research

• Ingestion and absorption

• Psychological risk

• Physical activities

Animal Research• Inhumane treatment

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Regional Science Fair Ethics Committee

Each region is required to set up an Ethics Committee which will become knowledgeable about the rules and ethical issues related to student research

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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

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Ethics Review Process

• Human Research – Low Risk

– Adult Supervisor required

• Human Research – Significant Risk

• Animal Research – Vertebrates and Cephalopods

– An Adult supervisor and Scientific Supervisor are required

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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

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Scientific Supervisor• Required for

– Human Participation – Significant Risk

– Vertebrate or Cephalopod Animal projects

• Often located in University or industrial laboratory setting

• Usually has professional qualifications

• May be the Adult Supervisor

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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

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Challenging Issues

RSF Chief Judge refers to YSC National Ethics Committee

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

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Human Participation Low Risk Projects

• Surveys of attitudes and beliefs

• Skill tests

• Observations of behaviour

• 4.1A Approval of Low Risk Projects

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Human Participation Significant Risk Projects

Everything Else

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Significant Risk Projects

• Approval required before experiments begin

• Projects often done in a research laboratory

• Research Plan Reviewed by RSF Ethics Committee

• 4.1B Human Participants - Significant Risk Approval

• 4.1C Animal Research Approval

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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

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Informed Consent Form

Low & Significant 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

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What is a Drug?

“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.

Health Canada definition:

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Questions to ask of Projects with Human Participation

1. Is the project Significant or Low risk?2. Is there supervision by an appropriate scientific advisor?3. Is the student familiar with the ethics web site(s).4. Does the informed consent form have all the required

elements?5. Is the student familiar with the definition of a drug?6. Is a drug involved?

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Non-Vertebrate Animals

Allowed

Except Cephalopods

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(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

• Form 4.1C Animal Research Approval

Vertebrate Animals

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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?

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Off-Side Projects

Please do not send projects that are in violation of the Ethics Rules to the CWSF, no matter how meritorious

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Resources

YSF Web Site Devoted to Ethics

http://youthscience.ca/node/835

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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