Participation of Humans in Research - Low Risk
1 Introduction
1.1 A Low Risk Project - involves conditions where the risks of harm are not greater or more likely than those encountered in everyday life.
1.2 All other projects involving humans are to be treated as Significant Risk Projects, and must follow Policy 4.1.1.2 Participation of Humans in Research – Significant Risk.
1.3 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.
1.4 It is sufficient to have the adult supervisor assume responsibility for supervision of ethical as well as scientific aspects of a Low Risk Project, and also sign Form 4.1A Human Participants – Low Risk ensuring that the essential elements of ethics review: consent, confidentiality and the right to withdraw are considered.
2 Low Risk Projects
2.1 Surveys of Attitudes and Beliefs, Skill Tests, or Observations of Behaviour
These are generally Low Risk Projects. Be aware however that not all survey/skill testing studies are automatically low risk. For example, a project to measure the Body Mass Index of a class could cause considerable discomfort to students who perceive themselves to be overweight. Skill testing could be a difficult experience for a participant who scores well below the group average. It is the responsibility of the adult supervisor to ensure that participants are not put at risk, either physically or emotionally. Mechanisms such as discussion and debriefing should be used to minimize any remaining risk.
2.2 Food and Drink Projects
- Such projects are designed only to assess the characteristics and effects of a food, defined in part by the Food and Drugs Act (1953) as:
- "any article manufactured, sold or represented for use as food or drink for human beings";
- the foods to be considered are basic foods for which no health benefits are claimed, and contain permitted additives not exceeding Recommended Daily Intake (RDI) guidelines normally associated with those foods.
- Evaluation of foods must only involve participants who are not taking prescription medications, to minimize the risk of drug-food interactions.
2.3 Sports Drinks – Yes
Sports drinks such as Gatorade or Powerade re-hydrate the body. These sports drinks also provide sugars, which the body burns to create energy and replenish electrolytes. Electrolytes maintain salt and potassium balances in the body. Sports drinks are permitted in Science Fair Projects.
2.4 Energy Drinks – No
Health Canada has concerns about the safe use of energy drinks. Thus ingestion of Energy Drinks is not permitted in Science Fair Projects. These products are identified either by a Health Canada Natural Product Number or Exemption Number (NPN or EN), or by a warning on the packaging that the product is "Not recommended for children".
2.5 Absorption through the skin
Projects that involve absorption through the skin must satisfy the rules for a Low Risk project and involve a risk of harm no greater than that encountered in everyday life. Thus a project comparing different ways of removing bacteria using different brands of hand sanitizer is legal. A project that involves putting benzene on the skin is not.
2.6 Natural Health Products – No
The ingestion of licensed Natural Health Products is not permitted in Science Fair Projects. These products are identified by a Health Canada Natural Product Number (NPN), Homeopathic Medicine Number (DIN-HM), or Exemption Number (EN) and are listed in the Health Canada Natural Health Product Database.2
2.7 Medications (prescription and non-prescription)
All medications, even those available without a prescription, are considered drugs. Projects involving drugs are deemed to be Significant Risk projects, and must follow the directions given in Policy 4.1.1.2.
2.8 Alcohol– No
Projects that involve the consumption of Alcohol are not permitted.
2.9 Excercise Testing
All Excercise Testing is considered Significant Risk, and must be carried out under policy 4.1.1.2.
3 Informed Consent
3.1 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.
3.2 If the participant is under the Age of Majority, 18 or 19 depending on the Province, then the parent or guardian must also sign the Informed Consent Form. In the case of activities that are clearly of very low risk such as some surveys, or such as having participants listen to music, Informed Consent may be assumed by the simple act of agreeing to participate. The parents or guardians must be provided beforehand with the Letter of Information, even though their signed informed consent will not be sought. The teacher or other supervising adult is responsible for deciding if signed Informed Consent is required.
3.3 Informed Consent - Letter of Information
Answers to the questions a) to k) must appear in the Letter of Information to ensure that the participants have been properly informed of all appropriate ethical issues:
- What are the name(s) of the investigator(s); school; project title; the Adult Supervisor’s name, email address and telephone number.
- What is the purpose of this research?
- What are the benefits to the participant from participating?
- What are the risks to the participant from participating?
- What time commitment is required?
- No remuneration or reward will be paid. It is the policy of Youth Science Canada that incentives not be offered for participation in projects displayed at either Regional Science Fairs or the Canada Wide Science Fair.
- How will the confidentiality of the data be guaranteed?
- Is the following clearly explained in the Letter of Information? The participant has the right to withdraw at any time for any reason without consequences of any kind.
- How does the participant communicate a decision to withdraw from the study?
- How will the results of the research be communicated to the participant?
- Are there any other issues that need to be included in the Letter of Information?
A sample for Informed Consent - Letter of Information is available for download from the web site of the Youth Science Canada web site, given in Section 6 below.
3.4 Informed Consent – Permission Form
The Informed Consent - Permission Form is a short document that contains:
- The printed name and signature of the Participant.
- The printed name and signature of the person obtaining the Informed Consent.
- A statement that the Participant has received and understood the Informed Consent - Letter of Information.
- The date.
A sample Informed Consent – Permission Form is available for download from the web site of the Youth Science Canada web site, given in Section 6 below.
3.5 Informed Consent Forms signed by the parent or guardian are mandatory for all food and drink projects, because of the risk of allergic reactions unknown to the teacher.
4 Confidentiality
4.1 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 data must be planned. The date the data will be destroyed must be given.
5 Display
5.1 The project display may include pictures of participants only if prior permission has been obtained.
6 Forms
All forms are available from both the Documentation section of the CWSF Registration System, and from the Ethics Committee web site: ethics.youthscience.ca.
- Form 4.1A – Low Risk – Approval
- Informed Consent - Letter of Information – sample
- Informed Consent – Permission Form – sample
Acknowledgements
The development of this policy benefited from the valuable advice of the following:
Carl von Baeyer, Dept of Psychology, University of Saskatchewan. Saskatoon Regional Science Fair
Tom Crawford, Bay Area Science & Engineering Fair
Jeff Hoyle, Dept. of Environmental Sci., Nova Scotia Agricultural College, Truro, NS. Chignecto Central West Regional Science Fair
Bill Ross, Faculty of Medicine, University of Ottawa
Dan Rurak, Child and Family Research Institute, University of British Columbia. Greater Vancouver Regional Science Fair
Louis Silcox, Waterloo-Wellington Science & Engineering Fair
Fred Smith, Faculty of Science, Memorial University Newfoundland. Eastern Newfoundland Regional Science & Technology Fair
Judith Soon, Faculty of Pharmaceutical Sciences, University of British Columbia. Fraser Valley Regional Science Fair
Susan Sykes, Office of Human Research, University of Waterloo
Gerry Ward, Genome Alberta. Calgary Youth Science Fair
Caroline Whippey, PhD Student, University of Western Ontario, London District Science & Technology Fair
Patrick Whippey, Dept. of Physics and Astronomy, University of Western Ontario, London District Science & Technology Fair
