Human Participant Rules

A human participant is a living individual about whom an investigator conducting research obtains (1) data or samples through intervention or interaction with individuals(s) or (2) identifiable private information.

Examples of projects that are considered “human participant research” include:

1. Participants in physical activities (e.g., physical exertion, ingestion of any substance, any medical procedure)

2. Psychological, educational and opinion studies (e.g., surveys, questionnaires, tests)

3. Studies in which the researcher is the subject of the research

4. Testing of student-designed invention, prototype or computer application by human participants other than student researcher or single adult guardian/adult sponsor/QS/DS when the testing requires an adult tester.

5. Data/record review projects that include data that are not de- identified/anonymous (e.g., data set that includes name, birth date, phone number or other identifying variables)

6. Behavioural observations that:

   • • involve any interaction with the observed individual(s) or where the researcher has modified the environment (e.g., post a sign, place an object).

     • occur in non-public or restricted access settings (e.g., day care setting, doctor’s office)

     • involve the recording of personally identifiable information.

Rules

1. Student research involving human participants must be reviewed and approved by the Science Fair Leadership Committee (SFLC) before any interaction (e.g., recruitment, data collection) with human participants may begin. It is the responsibility of the SFLC to evaluate potential physical and/or psychological risks of the project and make a determination about whether the project is appropriate for student research and safe for the student researcher and participants.

2. Participation in research may begin only after research participants have voluntarily given informed consent/assent (in some cases with parental permission). Adult research participants may give their own consent. Research participants under 18 years of age and/or individuals not able to give consent (e.g. developmentally disabled individuals) give their assent, with the parent/guardian providing permission.

The SFLC will determine whether the consent/assent/ parental permission may be a) verbal or implicit or b) must be written.

1. Informed consent requires that the researcher provides complete information to the participant (and where applicable, parents or guardians) about the risks and benefits associated with participation in the research study, which then allows the participants and parents or guardians to make an informed decision about whether or not to participate.

2. Participants must be informed that their participation is voluntary and that they are free to stop participating at any time (i.e., they may participate or decline to participate, with no adverse consequences of non- participation or aborted participation).

3. Informed consent may not involve coercion.

4. When written parental permission is required and the study includes a survey, the survey must be attached to the consent form.

5. The student researcher may request that the SFLC waive the requirement for written informed consent/parental permission in his/her research plan if the project meets specific requirements. See section on waivers for more information about situations in which written parental permission and/or written informed consent can be waived by the SFLC.

3. The research study must be in compliance with all privacy laws when they apply to the project (e.g. the project involves medical information).

4. Students are prohibited from independently diagnosing disease, administering medication, and/or performing medical procedures on human participants.

a. A student may observe and collect data for analysis of medical procedures, medication/treatment efficacy, and diagnosis of illness, only under the direct supervision of a licensed health care provider/professional.

b. This Healthcare provider/professional must be named in the research plan/ protocol approved by the SFLC. The SFLC must also confirm that the student is not violating the appropriate practice act (medical, nursing, pharmacy, etc) of the country.

c. Students are prohibited from providing diagnostic or medical information to participants without direct supervision and involvement of a medical professional. This includes publishing diagnostic apps on public websites or app stores without appropriate approvals.

5. Student researchers may NOT publish or display information in a report that identifies the human participants directly or through identifiers linked to the participants (including photographs) without the written consent of the participant(s).

6. All published instruments that are not in the public domain must be administered, scored and interpreted by a Qualified Scientist as required by the instrument publisher. Any and all use and distribution of the test must be in accordance with the publisher’s requirements, including procurement of legal copies of the instrument.

7. Studies that involve the collection of data via use of the internet (e.g., email, web-based surveys) are allowed, but researchers should be aware that they can pose challenges in collecting anonymous data, obtaining informed consent, and ensuring that participants are of the appropriate age to give informed consent.

a. Studies that involve the use of minors in conducting online surveys must have Informed Consent and the parent/guardian of the minor must provide written parental permission before the survey may be given to the minor. The procedures used to obtain parental permission must be described in the Research Plan.

b. In order to protect the confidentiality of the participants, it is extremely important that IP addresses, as well as the data provided, be safeguarded. Precautions must be delineated in the Research Plan.

For suggestions as to how to comply with 7a and 7b above please speak to the SFLC.

8. After initial SFLC approval, a student with any proposed changes in the Research Plan must repeat the approval process and regain approval before resuming interaction (recruitment, data collection) with human participants.

9. After experimentation and before competition, the SFLC will review for compliance with all rules.

SFLC Waiver of Written Informed Consent/Parental Permission

The SFLC may waive the requirement for documentation of written informed consent/assent/parental permission if the research involves only minimal risk and anonymous data collection and if it is one of the following:

1. Research involving normal educational practices

2. Research on individual or group behaviour or characteristics of individuals where the researcher does not manipulate the participants’ behaviour and the study does not involve more than minimal risk.

3. Surveys, questionnaires, or activities that are determined by the SFLC to involve perception, cognition, or game theory, etc. and that do NOT involve gathering personal information, invasion of privacy or potential for emotional distress.

4. Studies involving physical activity where the SFLC determines that no more than minimal risk exists and where the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities.

If there is any uncertainty regarding the appropriateness of waiving written informed consent/assent/parental permission, it is strongly recommended that documentation of written informed consent/assent/parental permission be obtained.

Human Participant Involvement in Student-designed Invention, Prototype, Computer Application, Engineering/Design Projects & Product Testing

Student-designed invention, prototype, computer application and engineering/design projects that involve testing of the invention by any human participant require attention to the potential risks to the individual(s) testing or trying out the invention/prototype.

1. SFLC review and pre-approval is required when the student- designed invention, prototype, application, etc. is tested by human participants. This includes surveys conducted regarding potential use, review of the invention or consumer product and/or opinions regarding the project/product.

2. Human participants testing of an invention, prototype or project that involves a medical diagnosis or intervention must adhere to Rule 4 of the Human Participant Rules regarding prohibition of medical procedures and be supervised by a healthcare professional with appropriate credentials and specialisation in the area of medical diagnosis or intervention being studied.

Exempt Studies (Do Not Require SFLC Pre-approval or Human Participants Paperwork)

Some studies involving humans are exempt from SFLC pre-approval or additional human participant forms. Exempt projects are:

1. Student-designed Invention, Prototype, Computer Applications or Engineering/Design Project in which the student is the only person testing the invention, prototype or computer application and the testing does not pose a health or safety hazard. It is recommended that a Risk Assessment Form be completed. The use of human participants (other than the student researcher him/herself) for this testing always requires SFLC review and approval.

2. Data/record review studies (e.g., baseball statistics, crime statistics) in which the data are taken from preexisting data sets that are publicly available and/or published and do not involve any interaction with humans or the collection of any data from a human participant for the purpose of the student’s research project.

3. Behavioural observations of unrestricted, public settings (e.g., shopping mall, public park) in which all of the following apply:

a. the researcher has no interaction with the individuals being observed

b. the researcher does not manipulate the environment in any way and

c. the researcher does not record any personally identifiable data.

4. Projects in which the student receives pre-existing/retrospective data in a de-identified/anonymous format. SFLC must be consulted to check that this process has been completed in an appropriate way.

Determining the level of risk involved in a study involving human participants.

All human participant projects are considered to have some level of risk.

No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered by a potential participant in everyday life or during performance of routine physical or psychological examinations or tests.

More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality or invasion of privacy is greater than what is typically encountered in everyday life. Most of these studies require documented informed consent or minor assent with the permission of parent or guardian (as applicable).

1. Examples of Greater than Minimal Physical Risk

Exercise other than ordinarily encountered in everyday life

Ingestion, tasting, smelling, or application of a substance. However, ingestion or tasting projects that involve commonly available food or drink will be evaluated by the SFLC which determines risk level based upon the nature of the study and local norms.

Exposure to any potentially hazardous material.

2. Examples of Greater than Minimal Psychological Risk

A research activity (e.g. survey, questionnaire, viewing of stimuli) or experimental condition that could potentially result in emotional stress. Some examples include: answering questions related to personal experiences such as sexual or physical abuse, divorce, depression, anxiety; answering questions that could result in feelings of depression, anxiety, or low self esteem; or viewing violent or distressing video images.

3. Privacy Concerns

The student researcher and SFLC must consider whether an activity could potentially result in negative consequences for the participant due to invasion of privacy or breach of confidentiality. Protecting confidentiality requires measures to ensure that identifiable research data are not disclosed to the public or unauthorised individuals.

Risk level can be reduced by protecting confidentiality or collecting data that is strictly anonymous. This requires the collection of research in such a way that it is impossible to connect research data with the individual who provided the data.

4. Risk Groups

If the research study includes participants from any of the following groups, the SFLC and student research must consider whether the nature of the study requires special protections or accommodations:

• Any member of a group that is naturally at-risk (e.g. pregnant women, developmentally disabled persons, economically or educationally disadvantaged persons, individuals with diseases such as cancer, asthma, diabetes, AIDS, dyslexia, cardiac disorders, psychiatric disorders, learning disorders, etc.)

• Special groups that are protected by laws or guidelines (e.g. children/minors, prisoners, pregnant women.