Participation of Humans in Research - Low Risk

Category: 
4. Youth Science Research - Ethics & Safety
Policy Number: 
4.1.1
Policy Section: 
Ethics
Approved by: 
National Judging Committee
Date Approved: 
Mon, Oct 1, 2012
Date Effective: 
Immediately
Date Last Amended: 
Sat, Aug 1, 2015
Date of Next Review: 
Wed, Aug 1, 2018
Contact: 
Chair, National Ethics and Safety Committee

 

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. Low Risk Projects are limited to:

  • Some surveys
  • Some food and drink projects
  • Some caffeinated beverage projects
  • Some absorption through the skin projects
  • Some exercise projects

Section 3.3 below has a detailed discussion of each of these.  A project is not Low Risk just because you think no one will be harmed.  It is a project that fits one of these five criteria.

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.

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 Youth Science Canada policy is followed. The Adult Supervisor is responsible for ensuring that the student's research is eligible for entry into the CWSF and related or other events sponsored by Youth Science Canada. Every project involving the participation of humans or the use of animals requires an Adult Supervisor.

Low Risk Projects

3.1 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.

3.2 Food and Drink Projects

  1. Projects involving the consumption of food or drink are considered Low Risk when they are designed only to assess the characteristics and effects of a common food.  This is defined as"any article manufactured, sold or represented for use as food or drink for human beings".   (Food and Drugs Act (R.S.C., 1985, c. F-27) (Ref. 1)
  2. The foods to be considered are basic or common foods that contain permitted additives not exceeding Recommended Daily Intake (RDI) guidelines normally associated with those foods.
  3. Evaluation of foods in youth (under the age of 19 years) must only involve participants who are not taking prescription medications, to minimize the risk of drug-food interactions.
  4. 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.

3.3 Caffeinated Beverages.

The daily limits of caffeine intake for Science Fair Projects are:

  1. 200 mg caffeine per day for subjects aged 13 and older.
  2. 85 mg caffeine per day for subjects aged 10 to 12.
  3. No Projects involving caffeinated foods or drinks permitted in subjects under 10 years of age.

Caffeine is found in soft drinks, coffee, tea, iced coffee, energy drinks, and many other food and drink products. It is the responsibility of the student researcher and the adult supervisor to ensure that the above daily limits are not exceeded in any Science Fair Project. The Youth Science Canada website contains links and background information on Caffeine that should be referenced before undertaking any project involving caffeinated drinks. Health Canada has expressed concerns about excessive intake of caffeine by Canadians, especially children and youth (Ref. 2). Thus the ingestion of caffeine in Science Fair Projects must be closely monitored and kept within reasonable limits according to Health Canada recommendations.

3.4 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.

3.5 Exercise Testing

All Exercise Testing beyond normal every day activities is considered Significant Risk, and must be carried out under policy 4.1.2.

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 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.

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 or 19 depending on the Province), then the parent or guardian must also sign the Informed Consent Permission Form.

4.5 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 still 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 for these types of projects.

Signed Informed Consent Forms are mandatory in all cases for food and drink projects, because of the risk of allergic reactions unknown to the teacher.

4.6 Informed Consent - Letter of Information

Answers to the questions 1) to 11) must appear in the Letter of Information to ensure that the participants have been properly informed of all appropriate ethical issues:

  1. What are the name(s) of the investigator(s); school; project title; the Adult Supervisor’s name, email address and telephone number.
  2. What is the purpose of this research?
  3. What are the benefits to the participant from participating?
  4. What are the risks to the participant from participating?
  5. What time commitment is required?
  6. 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.
  7. How will the confidentiality of the data be guaranteed?
  8. 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.
  9. How does the participant communicate a decision to withdraw from the study?
  10. How will the results of the research be communicated to the participant?
  11. 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 7 below.

4.7 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 for download from the Youth Science Canada web site, given in Section 7 below.

4.8 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 data must be planned. The date the data 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.

6 Forms

6.1 Form 4.1A - Approval of Low Risk Projects Form – must be submitted to the Regional Science Fair and Canada-Wide Science Fair at registration for any Low Risk project, along with any applicable Letter of Information, Blank Permission Form, and Sample Survey. 

All forms are available from the Ethics web site.

7 References

  1. Definition of Food Accessed 30 June 2015
  2. Health Canada article on Caffeine Accessed 30 June 2015