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Human Subjects

Rationale: Federal regulations govern research involving human subjects. The following rules were developed to help student researchers adhere to the Federal regulations and therefore, to protect the student researcher and the rights and welfare of the research subjects.

The use of human subjects in science projects is allowable only under the conditions and rules in the following sections. Science projects that do not follow these conditions and rules are prohibited from participation in the Vermont State Science & Math Fair.

Rules

1. All projects involving human subjects must follow these rules.

Definition: Based upon Code of Federal Regulations 45, the definition of a human subject is a living person from which a researcher obtains (1) data or samples through intervention or interaction, or (2) private information identifiable with that subject

Examples:

Subjects participating in physical activities (e.g. physical exertion, ingestion of any food or other substance, any medical test, measurement or procedure),
Psychological, educational and opinion studies (e.g., surveys, questionnaire, tests)
Studies in which the researcher is the subject of the research
Behavioral 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) in any way.
occur in a non public or restricted access settings (e.g., day care setting, doctor’s office)
involve the recording of personally identifiable information

Data/record review projects that include identifiable data

2. When developing the Research Plan, student researchers must evaluate the physical and/or psychological risks to their human subjects. Only Research Plans posing Minimal Risk to the human subject(s) are permitted without prior approval from VSSMF. A written Risk Assessment for every human subjects experiment must be available for inspection at the fair.

Definition: No more than Minimal Risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in DAILY LIFE for that subject.

Examples: The following are examples of activities that contain more than minimal risk:

· Physical

a. Exercise other than ordinarily encountered in DAILY LIFE by that subject.

b. Ingestion of any substance, including food or supplements that isunusual for that subject, or by unusual methods, such as rapid consumption, or in unusual quantities or at unusual intervals.

c. Exposure to any potentially hazardous materials or conditions.

d. Any activity reasonably associated with injury, discomfort or sickness, including repetitive motion and movement which would reasonably cause motion sickness.

· Psychological

a. Any activity (e.g. survey, questionnaire, viewing of stimuli) or experimental condition that could potentially result in emotional stress.

b. Any activity that violates norms of decency, respect or civility.

3. The documentation of written Informed Consent is required for most human subjects projects. The consent/assent must be written and dated for each human subject, and must be available for inspection at the fair. It is recommended that students use the Informed Consent Form or Human Subjects Consent approved for ISEF to document Informed Consent. Human subjects who have not attained the age of 18 also require consent of a parent/guardian.

Definition: The process of obtaining Informed Consent provides information to the subject (and parents or guardians) about the risks and benefits associated with participation in the research study and allows the subject (and parents or guardians) to make an educated decision about whether or not to participate. Informed consent is an on-going process, not a single event that ends with a signature on a page. It must incorporate procedures that do not involve coercion or deception.

Requirements: The process of obtaining Informed Consent must inform potential subjects (and their parents or guardians)

about the purpose of the study, and
about what they will be asked to do, and
about the risks and benefits associated with participation in the research study so that they can make an educated decision about whether or not to participate, and
that their participation is voluntary and that they may withdraw from the study at any time.

Exception: Documentation of informed consent is not required if the study meets the criteria listed below.

only minimal risk
and anonymous data collection
and if it is one of the following:

a) Research involving normal educational practices

b) Research on individual or group behavior or characteristics of individuals in public places where the researcher is strictly passive and does not manipulate the subjects’ behavior or environment.

c) Surveys and questionnaires that involve perception, cognition, or game theory and do NOT involve gathering personal information, invasion of privacy or potential for emotional distress. If there is any uncertainty regarding the appropriateness of waiving informed consent, it is strongly recommended that informed consent be obtained.

All subjects must still give their consent/assent to participate in the study, even if the documentation of informed consent is not required. Research subjects under 18 years of age or other individuals not able to give consent (e.g. mentally disabled) give their assent, whereas adults give their consent.

4. Students are prohibited from administering medications and performing invasive medical procedures on human subjects. A student may observe and collect data for analysis of medical procedures and medication administration only under the direct supervision of a qualified professional.

5. Student researchers may NOT publish or display information in a report that identifies the human subjects directly or through identifiers linked to the subjects, (including photographs), without specific written consent to use identifyable information and/or photographs.