Projects Involving Human Subjects
To insure the safety of students and other people they may be working with, many fairs require pre-approval of projects involving the interviewing, surveying, or physical testing of other people.
The following summary is intended as a guide to help you determine whether your intended project involving human subjects would be subject to such pre-approval when participating in a fair that follows the Intel International Science and Engineering Fair (ISEF) rules. Often school science fairs and fairs for the primary grades or middle school rely on the teacher's judgment to insure safety, so their rules might be different. For complete information, consult the rules for your local fair, or the ISEF Rules and Guidelines.
Projects Not Requiring Pre-approval
ISEF rules give the following examples of projects that do not require pre-approval:
- Product testing of engineering projects or inventions (NO health hazard, NO personal data collected, and all feedback is in direct reference to the product) do NOT require SRC review, but it is recommended that a Risk Assessment Form be completed
- Data/record review studies (e.g., baseball statistics, crime statistics) in which the data are taken from pre-existing data sets that are publicly available or published and there is no extra data taken from new individuals
- Behavioral observations of unrestricted, public settings (e.g., shopping mall, public park) in which all of the following apply:
- The researcher has no interaction with the individuals being observed,
- The researcher does not manipulate the environment in any way and
- The researcher does not record any personally identifiable data.
- Data that has been collected by a health professional and given to a student to use in which all of these restrictions apply:
- The original data was collected and shared in a manner that complies with all a federal privacy and HIPAA laws.
- The data is devoid of any information that would identify the people the data is based on. All information has been de-identified and rendered anonymous.
Projects Requiring Pre-Approval
For studies involving human subjects (including interviews and surveys), the ISEF rules state that your project must be reviewed and approved by officials from your fair before you start. These officials are called an Institutional Review Board (IRB). The rules also state that you must obtain written permission from each of your human subjects before you test or interview them. This permission is called informed consent.
Waiver of Informed Consent
The IRB may wave the informed consent requirement if the project involves only minimal risk, anonymous data collection, and falls into one of these categories:
- 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.
What to Do About Informed Consent When Using Data from Previous Studies
For some studies involving human subjects, a student may work with data from human subjects that was collected previously. These projects do not involve any interaction with human subjects by the student or data collection from human subjects. These types of studies fall into three categories (1–3, below), with separate rules for each category (Science Service, 2006).
- If the data are not de-identified/anonymous (e.g., a data set that includes patient name, birth date, phone number, or other identifying variables; student gathers data from patient files that include identifiers), the project is considered a human subject project. The project requires IRB review and pre-approval. The student researcher and adult mentors need to be familiar with the relevant privacy laws and be sure to comply with them.
- If the data are in a de-identified/anonymous format, the project does not require IRB pre-approval, but the project must comply with BOTH conditions below:
- The professional providing the data must certify in writing that the data have been appropriately de-identified and are in compliance with all privacy laws, including HIPAA.
- During the final Scientific Review Committee (SRC) review and approval process before the fair, the SRC must ensure that the data were appropriately de-identified by review of the written documentation provided by the supervising professional.
- If the data are publicly available (i.e., in print, or electronic or internet format) the project does not require IRB review or approval. Examples of such projects include examination of statistics from sports teams or individual athletes, or crime statistics.
Informed Consent from Minors
For all other experiments involving human subjects, informed consent is required in writing from each participant. For studies involving children (minors) as subjects, informed consent must be obtained from both the child and the child's parent/guardian. See the ISEF Rules and Guidelines for a discussion of the forms required to obtain pre-approval for your project.