Western Manitoba Science Fair

637 10th Street, Brandon, Manitoba, Canada

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©2016 BY WESTERN MANITOBA SCIENCE FAIR. PROUDLY CREATED WITH WIX.COM

Participation of Humans in Research- Significant Risk 

If you think your project might be considered Significant Risk please contact us prior to beginning your project. Read through this Policy carefully before beginning your project or filling out any of the forms found at the bottom of this page. Contact us at info@wmsf.com or 204-727-4700.

1. Introduction

1.1 A Significant Risk Project involves conditions where the risk of harm is greater, or is potentially greater, than that encountered in everyday life.  Low Risk projects are defined here.  ALL OTHER PROJECTS are, by definition, Significant Risk Projects.

1.2 All students must submit a Project Summary including a Research Plan to the WMSF committee before starting their experiments. 

2. Definitions

2.1 Human Research refers to any project that involves the generation of data about persons.

2.2 A Student Researcher is one who takes data or collects information or assists in research activities involving humans.

2.3 A Participant is a person who takes part in a project or activity and so is a source of primary data, and bears any risk as the research is being carried out. The Student Researcher may also be a Participant.

2.4 The Adult Supervisor, a parent, teacher, professor, or scientist is responsible for ensuring that the student is aware of the ethical issues involved in the project and provides guidance and advice to ensure that WMSF policy is followed. The Adult Supervisor is responsible for ensuring that the student's research is eligible for entry into the WMSF. Every project involving the participation of humans or the use of animals requires an Adult Supervisor.

3. Significant Risk Projects

3.1 Drugs

Definition of a “drug”: “drug” includes any substance or mixture of substances manufactured, sold, or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in humans or animals,

  2. restoring, correcting, or modifying organic functions in humans beings or animals;

  3. disinfection in premises in which food is manufactured, prepared or kept.

 

Drugs may be used in any experiment exhibited at a Science Fair only if carried out in a Hospital, University, Medical or other similar Laboratory under the direction of a Scientific Supervisor. The study must be approved by the appropriate Scientific Review Committee that reviews the research at the Institution, and this must be documented by a letter that accompanies the entry form to the Western Manitoba Science Fair. No other studies involving the use of Drugs on human participants, as defined above by Federal Regulations, may be exhibited at the Science Fair..

 

3.2 Invasive Procedures and Bodily Tissues

Invasive procedures, such as taking blood or tissue samples, or use of human bodily tissue or other bodily fluids, are permitted in an experiment exhibited at a Science Fair only if carried out in a Hospital, University, Medical or other similar Laboratory under the direction of a Scientific Supervisor. The project must be approved by the appropriate Scientific Review Committee that reviews the research at the Institution, and this must be documented by a letter that accompanies the entry form to the Western Manitoba Science Fair.

3.3 Ingestion Projects - Allowed

  1. Projects involving ingestion of food or drink, defined as consumption through eating or drinking, are considered Significant Risk when they involve:

    1. articles not manufactured, sold or represented as food or drink for human beings;

    2. foods that contain additives exceeding the Recommended Daily Intake (RDI) normally associated with those foods;

    3. foods not considered to be basic, common or everyday foods.

    4. products that are licensed Natural Health Products.  These products are identified by a Health Canada Natural Product Number (NPN) or Exemption Number (EN), and are listed in the Health Canada Natural Health Product Database.

  2. Significant Risk Ingestion projects are allowed only if carried out under professional supervision at a laboratory with its own internal Ethics Review Committee, such as a university or hospital laboratory.

  3. Some provinces have put in place rules that govern ingestion of food by the public, and these take precedence over the rules in this section. Students doing ingestion projects must know the applicable procedures required for the safe handling of food.


3.4 Ingestion Projects - Forbidden

The following ingestion projects are not eligible to participate:

  1. Projects that involve the consumption of alcohol.

  2. Projects that involve the consumption of cannabis.

3.5 Cannabis

It is illegal for anyone under the age of 18 to possess cannabis. Any project that requires a student to possess cannabis is not permitted at a science fair.

 

3.6 Exercise

Projects involving exercise beyond normal everyday activities are considered to be Significant Risk projects. They require a Scientific Supervisor with training in exercise, such as a degree in kinesiology or appropriate coaching qualifications. Exercise testing must follow the Guidelines for Exercise Testing and Prescription, a publication of the American College of Sports Medicine. 

 

3.7 Permitted Exceptions - subject to approval

Subject to approval by the WMSF committee prior to starting the project, the topics listed in this section may be considered permitted exceptions to the rules above.

  1. Tests on saliva, sweat, tears and urine.

  2. Taking of cheek swabs.

  3. Projects investigating antiperspirant, mouthwash, sunscreen or toothpaste.

  4. Blood testing data collected using personal glucose monitors commonly available at pharmacies.

4. Informed Consent

 

4.1 Human participants must be assured that they are safe, that they are treated with respect and dignity, and that the information they provide will be kept confidential. These ethical safeguards are primarily the responsibility of the science fair student researchers and their supervisors.  The process of providing this information is called "Informed Consent".

4.2 The Adult Supervisor is responsible for supervision of ethical as well as scientific aspects of a Significant Risk Project, and also must sign Form PHSR (forms are at the bottom of this page) ensuring that the essential elements of ethics review: consent, confidentiality and the right to withdraw are considered.

 

4.3 Participants must give informed consent BEFORE taking part in any science fair project. The project and their participation in it have to be explained to children in words they will understand. It must also be explained to children that they do not have to participate unless they want to, even if their parents have approved. Agreement to participate (assent) must be documented for each participant. Children over 9 years can be invited to indicate their assent by co-signing the same form their parent signed. Younger children can provide assent orally but the researcher must document it.

 

4.4  If the participant is under the age of majority (18), then the parent or guardian must also sign the Informed Consent Permission Form.

 

4.5 If the participant is over the age of majority (18) but not able to consent for themselves, the participant's legal guardian must sign the consent form. Assent of the participant must also be documented.

 

4.6 Informed Consent - Letter of Information

The following points must be covered in the Letter of Information to ensure that the participants have been properly informed of all appropriate ethical issues:

  1. The name(s) of the researcher(s), school, project title, the Adult Supervisor’s name, email address and telephone number.

  2. The purpose of this research

  3. The benefits to the participant from participating

  4. The risks to the participant from participating

  5. What time commitment is required

  6. No remuneration or reward will be paid for participation in projects displayed at the Western Manitoba Science Fair.

  7. How will the confidentiality of the participants' personal data be guaranteed; and state that the participants' personal data will be shredded/deleted after the science fair. 

  8. Clearly explain that the participant has the right to withdraw at any time for any reason without consequences of any kind.

  9. How will the results of the research be communicated to the participant

  10. State that the project been approved by the WMSF committee for participation in the Western Manitoba Science Fair

  11. Any other issues that need to be included in the Letter of Information

 

4.8 Informed Consent – Permission Form

 

The Informed Consent - Permission Form is a short document that contains:

  1. The printed name and signature of the Participant.

  2. The printed name and signature of the person obtaining the Informed Consent.

  3. The signature of a parent or guardian.

  4. A statement that the Participant has received and understood the Informed Consent - Letter of Information.

  5. The date.

 

A sample Informed Consent – Permission Form is available in the Forms section below.

 

4.9 Confidentiality

The confidentiality and anonymity of all participants must be maintained. Use coded systems of references; no identifying information may be used. Appropriate safeguards for storage and access to information must be planned. The date the participants' personal information will be destroyed must be given. 

 

5 Display

 

The project display may include pictures of participants only if prior permission has been obtained in writing. Projects dealing with forensic science topics must preserve the anonymity of any human victims, and project displays must avoid graphic images.

 

6 Forms

These are the forms that are required for a project that falls under the above Policy: 

1. Informed Consent. BEFORE humans participate in a project, they must give their informed consent.

  • Informed Consent - Letter of Information - blank Use it to explain your project. Give one to every participant to keep. Submit a copy with your WMSF entry form and bring a copy to the science fair. 

  • Informed Consent – Permission Form Every participant must sign one. The Adult Supervisor must store them securely. These must be shredded after the science fair season is over. Submit a blank copy with your WMSF entry form and bring a blank copy to the science fair.

 

2. Adult Supervisor Certification of Compliance of Significant Risk Projects: 

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