Does your project involve either:
- Data or samples obtained through intervention or interaction with a living individual(s)?
- Identifiable private information obtained about a living individual(s)?
If you answered YES to either of these questions, your project must comply with the ISEF rules for HUMAN PARTICIPANTS. Please read the guidelines below for details about each topic, allowable projects, and any additional forms you may need to complete.
Requirement for Risk Assessment
- What is Risk Assessment?
When conducting research with human participants, the rights and welfare of the participants must be protected. Therefore, prior to conducting research involving human participants, the risks to study participants must be evaluated and minimized. How is the risk of the project determined?
- Project risk levels fall into one of two categories:
- No more than minimal risk: The probability and magnitude of harm or discomfort anticipated are not greater than those encountered in daily life or while performing routine physical or psychological exams or tests.
- More than minimal risk: The possibility of harm is greater than what is typically encountered in daily life. This type of research requires documented informed consent/minor assent/parental permission.
- What are some examples of types of risks?
- Physical Risks:
- Exercise other than ordinarily encountered in daily life
- Ingestion, tasting, smelling, or application of a substance.
- Exposure to any potentially hazardous material
- Psychological Risks: have potential to result in emotional stress, and include:
- Answering questions about personal experiences (sexual, physical/child abuse, divorce, mental health, etc.)
- Answering questions that could result in feelings of depression, anxiety or low self esteem
- Viewing violent or distressing videos
- Negative Consequences Caused by Invasion of Privacy/Breech of Confidentiality
What procedures should be followed to prevent invasion of privacy for the human participants?
- Measures must be taken to ensure that identifiable research data are not disclosed to the public or unauthorized individuals
- Information that identifies the participants directly or through identifiers linked to the participants (including photos) may not be published or displayed without written consent
- Projects involving medical information must comply with privacy laws & HIPAA laws
- Data collection should be truly anonymous data whenever possible
- Risk Groups: Certain groups of human participants are particularly vulnerable and may require additional protection from risks:
- Any member of a group that is “naturally at-risk” (individuals who are pregnant, mentally disabled, economically or educationally disadvantaged, and physically or mentally ill)
- Special groups covered by federal regulations (children/minors, prisoners, pregnant women, and students receiving services on the Individuals with Disabilities Education Act)
Requirement for Informed Consent/Assent
What is Informed Consent/Assent?
Before enrolling any human participants in a study, the researcher must inform the participants (and where applicable, their parents/guardians) about risks and benefits associated with study participation. This allows the participants, parents, or guardians to make an educated decision about whether or not to participate. Potential participants must also be informed that their participation is voluntary and they may leave the study at any time. This process of educating the potential participant is termed Informed Consent/Assent.
- Consent is given by adult (≥ 18 yrs old) research participants
- Assent is given by participants under 18 yrs old or individuals unable to give consent (e.g. mentally disabled) with parent/guardian permission
- Depending on the risks of the study, the local Institutional Review Board will determine if the informed consent process must be documented in writing. If so, a Human Participants Informed Consent Form must be completed for each human participant (see below).
Requirement for Institutional Review Board (IRB) Pre-review and Preapproval:
- What is an Institutional Review Board?
An Institutional Review Board (IRB) is a committee that evaluates the potential physical and/or psychological risks of research involving humans. An IRB at the school or ISEF Affiliated Fair level must consist of a minimum of three members, which must include:
- an educator,
- a school administrator (preferably, a principal or vice principal),
- and one of the following who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study: a medical doctor, physician’s assistant, registered nurse, psychiatrist, psychologist, licensed social worker, or licensed clinical professional counselor.
NOTE: To eliminate conflict of interest, the Adult Sponsor, parents, Qualified Scientist, and Designated Supervisor who oversee a specific project must not serve on the IRB reviewing that project.
- What is “IRB Review and Preapproval”?
An IRB must review and approve all research involving humans BEFOREexperimentation begins. Based on the level of risk associated with the project, the IRB will determine if documentation of written informed consent/assent/parental permission is required.
- Before the student begins recruiting and/or interacting with participants, the student must submit ALL of the following to the IRB for review and pre-approval:
- A Human Participants Form (4) with the top section completed
- Research Plan (with ALL elements of the Human Participants portion of the Research Plan Instructions, #1, completed)
- a sample Human Participants Informed Consent Form(i.e. the form that will be presented to the human participants who are considering participating in the study),
- any surveys to be administered to human participants
- The IRB will determine whether a Qualified Scientist is required to oversee the project (if so, the Qualified Scientist Form (2) must be completed).
- During the pre-review process, the IRB will determine whether written documentation of consent/assent/parental permission is required. If so, a Human Participants Informed Consent Form must be completed for each human participant.
- If the IRB determines that the project involves minimal risks and meets specific criteria, the IRB may determine that written documentation of informed consent/assent/parental permission is not required. This is termed an “IRB Waiver of Written Informed Consent.”
- After IRB Preapproval has been obtained, any proposed changes to the Research Plan must also be approved by the IRB before the experiment can be resumed.
- What type of studies require IRB Review and Preapproval?
Examples of studies that are considered “human participant research” and require IRB Review and Preapproval include (but are not limited to) the following:
- Subjects participating in physical activities (physical exertion, ingestion of any substance, medical procedures)
- Psychological, educational, and opinion studies (e.g. surveys, questionnaires, tests)
- Studies in which the student 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. posted a sign, placed an object)
- occur in non-public or restricted-access settings (e.g. day care center, doctor’s office)
- involve the recording of personally identifiable information
- 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 identifiable information)
Requirements for Projects Involving Human Participants Conducted at a Federally Regulated Research Institution
Institutional Review Boards (IRBs) exist at federally regulated institutions (e.g., universities, the National Institutes of Health (NIH), correctional facilities). If the project is conducted at regulated research institution, the institution’s IRB must review and approve the project BEFORE experimentation. For these types of projects, a Regulated Research Institution Form (1C) and a Qualified Scientist Form (2) must be completed. In addition, one of the following must be submitted:
- A copy of the research institution’s IRB approval for the entire project (which must include the procedures used in the student’s project)
- An official letter from the IRB attesting to this approval (a letter from mentor is NOT sufficient).
Additional Rules for Specific Types of Research:
- Analysis of medical procedures and administration of medications:
- Must be performed under direct supervision of a qualified professional (who must be named in the IRB-approved protocol).
- Students may NOT administer medications or perform invasive medical procedures
- Standardized tests not in the public domain
- Must be administered, scored, and interpreted by a Qualified Scientist
- Copies of the test instrument must be obtained legally
- Collection of data via the Internet is allowed but must be done in a manner that ensures
- Data collection is anonymous
- Informed consent is obtained
- Participants are of appropriate age to give informed consent
Requirement for Final Scientific Review Committee (SRC) Approval
After completion of project, the local Scientific Review Committee (SRC) must review and approve previously approved projects to ensure students followed the approved Research Plan.
Some studies involving humans may be exempt from IRB preapproval or human participants paperwork provided that the project fulfills the specific criteria outlined below. However, if the project was performed at a regulated research institution and/or in the presence of a Qualified Scientist, the Regulated Research Institution Form 1C and/or the Qualified Scientist Form 2 must still be completed.
If there is any uncertainty regarding whether the project meets the criteria for an Exempt Study, the project should be submitted to the local IRB prior to experimentation. The local IRB will then determine if the study meets the criteria for an IRB-exempt study.
Examples of Exempt Studies include the following:
- Testing of a student designed invention, concept, etc. only if ALL THREE of the following apply:
- Feedback received is a direct reference to the product
- Personal data is not be collected
- Testing does not pose a health hazard
Completion of a Risk Assessment Form (3) is recommended.
- Data/record review studies conducted with pre-existing data sets only if BOTH of the following apply:
- The data set is publically available or published (e.g. baseball statistics)
- There is no interaction with individuals or collection of data from individuals for the purpose of the student’s project
- Behavioral observations of unrestricted, public settings (e.g. mall, park) only if ALL THREE of the following apply:
- The researchers does not interact with the individuals being observed
- The researchers does not manipulate the environment
- The researchers does not record any personally identifiable data
- Projects involving data received in a de-identified/anonymous format only if BOTH of the following apply:
- The professional providing the data must certify in writing that (a) data have been appropriately de-identified and (b) are in compliance with all privacy/HIPAA laws, AND
- After experimentation, the Scientific Review Committee ensures that the data were appropriately de-identified by review of the written documentation provided by the supervising professiona