Informed consent of human subjects

All projects with human subjects — regardless of grade level and relationship to the subjects — must have SRC/IRB review. Institutional review boards (IRBs) work similarly to SRCs but review research involving human subjects. A school’s SRC and IRB may consist of the same people. Approval must be obtained, where necessary, before a student starts any experimentation.

Students must fill out all material requested on the SRC & Informed Consent PreK-8 Form or the appropriate ISEF Forms (9-12). Failure to receive approval before experimentation will result in Failure to Qualify for SARSEF, AZSEF, Broadcom, and ISEF.

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

When informed consent is required

• When the IRB determines that a research study involves physical or psychological activities with more than minimal risk
• When the IRB determines that the project could potentially result in emotional stress to a research subject
• When the IRB determines that the research subjects belong to a risk group and the study does not meet any of the criteria below for a waiver

When informed consent is not required

Documentation of informed consent is required for most research projects. However, the IRB may waive the requirement for documentation of written informed consent if the research involves only minimal risk and anonymous data collection and if it is one of the following:

• Research involving the observation of legal public behavior.
• Research involving collection or study of existing publicly available data or records.
• Research involving normal educational practices.
• Research on individual or group behavior, or characteristics of individuals where the researcher does not manipulate the subjects’ behavior and the study does not involve more than minimal risk.
• Surveys and questionnaires that are determined by the IRB to 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.
• Studies involving physical activity where the IRB 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 (in and of themselves) than those ordinarily encountered in daily life or during performance of routine physical activities.

Research subjects under 18 years of age

If a research subject is under 18 years of age, it is recommended that, in all cases, informed consent be obtained. Both the parent/legal guardian and the school-age research subject must sign Informed Consent Form (for PreK-8 researchers) and HS ISEF Form 4 (Human Subjects and Informed Consent Form) for high school researchers. However, an IRB may decide that informed consent is not required because of the allowable exceptions listed above. When the IRB waives informed consent of research subjects under the age of 18 for studies involving surveys or questionnaires, documentation justifying this waiver must accompany Informed Consent Form PreK-8 or HS ISEF Form 4.

Documenting informed consent

Consent forms should be copied for each participant’s appropriate signatures and kept in your research journal. They should remain confidential, but may be uploaded as SRC approval for competition at the SARSEF Regional Fair.