Youth Science Foundation Canada

 

Guide for Ethics Review of Human Research

 

DRAFT

 

A) Statement of Ethics Review Requirements The Foundation requires that all research involving human participants conducted as a project competing in the Canada-Wide Science Fair, or an affiliated Regional Science Fair, satisfy ethical and safety rules. This ensures that the welfare and safety of the participants as well as the researchers are considered and protected. The ethics review process should involve the student's supervising teacher, members of a bona fide research institution or hospital practiced in the ethics of human research, or the Ethics, Animal Care and Safety Committee of the Youth Science Foundation Canada. This will provide the researchers with an appreciation of the requirements and safeguards existing in law regarding experimentation in humans.

 

B) Ethics Review The Foundation's Ethics, Animal Care and Safety Committee invites inquiries regarding the ethics of any planned human (or animal) research project . It will assist in the development of an acceptable research design. It will also review all projects entered in the Canada-Wide Science Fair to ensure they are ethically approved and thus eligible for competition.

 

C) Definitions of Human Research, Researcher, Participant. Human research refers to any project which involves the generation of data about persons beyond that which is necessary for the person's well-being. This includes non-invasive methods such as: surveys, interviews, observations of or field work with individuals, administration of psychometric and other tests, examination of records, exercise testing. It may also involve invasive procedures, such as blood sampling, tissue sampling, and insertion of cannulae. A researcher is a student data or information collector, or assistant, involved in research activities involving humans. A participant is a person, who by virtue of his/her participation in a data-generating situation or activity, is a source of primary data, and bears any risks as the research is being carried out.

 

D) The Application Form

The supervising teacher supervises and accepts responsibility for the safe and ethical conduct of the project.

The student researcher(s) will collect the data. All students involved must be listed, even if assisting the principal investigators.

The title of project should describe the focus of the project, and also be succinct .

 

 

Summary of Proposed Research

 

1. The purpose describes the reason for conducting the project, and briefly outlines literature which has shaped the project proposal.

 

2 & 3. The participants who will be involved should be described with respect to age range, sex, numbers required and other identifying characteristics. Special consideration is needed for the involvement of children or other vulnerable participants. Describe the source of the participants and the manner in which they will be recruited. Attach a copy of any covering letter. Studies involving students and/or teachers often requires the explicit permission of Board of Education officials. Researchers are reminded of the potential for certain participant groups to experience or perceive undue pressure to volunteer as research participants, and are to minimize this perception. Members of distinct cultural groups, legally incompetent people and children are examples of special populations which require special effort to ensure that informed consent is being given. Include details of any compensation for participation in the study. It should not be so high as to induce a person to volunteer, or cause a person to continue in a study past the point at which he/she would otherwise stop.

 

4. Describe procedures in detail and in terms which can be understood by reviewers without specialized knowledge of the research area. For invasive procedures, indicate awareness of and willingness to follow universal precautions for proper handling of blood and body fluids. These guidelines are widely available. If invasive procedures are used, give the name and title of the person conducting these procedures, as well as information about his/her training. When materials are to be ingested, give information on dosage, frequency and possible side effects. Drugs, whether prescription or otherwise, are not to be used. Oral or topical applications of test materials are the only acceptable methods of administration. Studies involving exercise testing must include a description of all tests, a copy of the medical screening form used to determine that the potential participants are in good health, and a statement about exclusion criteria. Describe arrangements for medical supervision of the testing. The 1986 American College of Sports Medicine Guidelines for Exercise Testing chart is offered in an appendix as a common guideline. For non-invasive studies, attach a copy of all test materials to the Research Proposal form. Indicate the time required for participation in the study.

 

5 &6. A complete and clear description of all known or anticipated risks and benefits of participation, whether physiological, psychological, economic and/or social in nature. Indicate how risk will be minimized to the extent reasonably possible. In cases of tasks involving psychological risk, indicate preparations to deal with any negative impact attributable to participation in the study. All studies must have some benefit in order to justify their conduct. Thus, a description of known and/or potential benefits to the participants and/or society, is required.

 

7. Participants must give Informed consent to participate in any science fair project before it begins, and this is normally obtained in writing. Parental approval is required for the participation of minors as research subjects. Details which must appear in the consent letter to ensure the participants have been properly informed and thus given free consent, without pressure to participate include:

 

* name(s) of investigator(s) * school, supervising teacher, telephone number

* description of the procedures * description of risks and benefits from participating

* details of time commitment * details of any plan to recontact participants

* details of remuneration * plans to ensure confidentiality of data

* details about their right to withdraw at any time without fear of reprisal;

* information about how to communicate* statement that the project has been reviewed and received ethics approval from whatever authority was consulted

 

There may be circumstances under which written informed consent cannot be reasonably collected. For surveys, consent may be assumed by the completion of the survey. In these circumstances a detailed explanatory letter should accompany the questionnaire, and provide identical information as listed above.

 

8. The confidentiality and anonymity of all participants must be maintained. Use coded systems of references; no identifying information may be used. Also, appropriate safeguards for storage and access to data, or destruction of data, must be planned.

 

9. Feedback of the findings to the participants, their parents and/or teachers should be part of the plan. If deception is used, provide details about the nature of the deception and why it's needed. Participants in such a study must receive adequate and immediate debriefing at the end of their participation. This debriefing, provided orally and as a written handout, should tell why the deception was required, offer the opportunity to answer any questions and then seek their written consent to use all information obtained from them.

 

Sample letters of consent, parent permission letters and pre-exercise medical screening forms are included as appendices.

 

Appreciation and acknowledgment for assistance in the development of these guidelines goes to Dr. Susan Sykes, Office of Human Research at the University of Waterloo, Dr. Carl L. von Baeyer, Professor of Psychology at the University of Saskatchewan, and Dr. Bill Ross, Faculty of Medicine at the University of Ottawa.

 

 

Youth Science Foundation Canada

 

DRAFT

 

Application For Review of Research with Human Participants

 

Students may use this form, or type an application of 1 to 3 pages with the same headings. Answer the questions in their numbered order, including the question number with each answer.

 

Supervising Teacher __________________ telephone ____________________

 

School _____________________Regional Science Fair ____________________

 

Student Researcher(s)

Name ___________________________ ________________________________

 

Address _________________________ ________________________________

 

Telephone _______________________ ________________________________

 

Title of Project _______________________________________________________

 

Summary of Proposed Research 1. Briefly describe the purpose of this project.

 

 

 

 

 

 

Participants

2. Who, and what number of participants will be involved in this project?

 

3. How will the participants be recruited for this project? (Attach a copy of any recruitment notice or letter.)

 

 

 

 

 

Procedure

4. Briefly outline what the participants will be expected to do. (e.g. surveys, interviews,tests etc.) Attach a copy of test materials, surveys, questionnaires or interview questions to be used.

 

 

 

Estimate of Risks and Benefits to Participants

5. What are the potential risks to the participants in this project (physical, psychological, emotional)?

 

6. What are the potential benefits to this project (e.g. to the participants, to society)?

 

 

 

 

Informed Consent

7. Will informed consent of the participants be obtained in writing? If not, explain why.

Attach a copy of the information consent form to be used.

 

 

 

Confidentiality

8. How will you ensure anonymity of the participants and confidentiality of their data?

 

 

 

Feedback

9. Describe the plans to provide the participants feedback or a summary of the study.

 

 

 

I have read the YSF Canada Guidelines for Research with Human Subjects and agree to comply with the Guidelines. Further, I agree to notify YSF Canada of any changes to this project.

 

Signature of Student Researcher ______________________Date : _______________

 

Signature of Student Researcher ______________________Date: ________________

 

Signature of Supervising Teacher _____________________Date: _________________

 

Ethics Review Committee Comments:

 

 

 

 

 

AMERICAN COLLEGE OF SPORTS MEDICINE

GUIDELINES FOR EXERCISE TESTING

 

The American College of Sports Medicine: Guideline for Exercise Stress Testing and Prescription, 3rd ed. Lea and Febiger, 1985