Human Participants

The following rules were developed to protect the welfare of both human participants and the student researcher. Health and well-being is of the highest priority when students conduct research with human participants.

Index

What is Considered a Human Participant Study?
Prohibited Studies
Rules
Documentation and Approval
Exempt Studies

What is Considered a Human Participant Study?

According to Code of Federal Regulation 45, CFR 46, 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.

A few examples of human participant studies include:

• Studies in which the researcher interacts with another human for purposes of their study
• Participants in physical activities
• Studies collecting surveys, questionnaires, tests of any kind
• Student-designed invention, prototype, computer application or product test by anyone other than the student researcher
• Studies in which the researcher is the subject of the research
• Testing of student designed invention, prototype or computer application by human participants other than student researcher
• Data studies that include data that are not de- identified/ anonymous
• Behavioral observations that
  1. involve any interaction with the observed individual(s) or where the researcher has modified the environment (e.g., post a sign, place an object).
  2. occur in non-public or restricted access settings (e.g., day care setting, doctor’s office)
  3. involve the recording of personally identifiable information.

All human participant studies must be reviewed and approved by an Institutional Review Board (IRB) prior to experimentation. An IRB must consist of a minimum of three members including the following:

• An educator (not the teacher that is serving as the Adult Sponsor)
• A school administrator (preferably principal or vice principal)
• A medical or mental health (More details about the composition and duties of an IRB can be found in the Glossary of Terms).

Prohibited Studies

1. Students are prohibited from independently diagnosing any human condition, illness or disease, administering medication, and/or performing medical procedures on human participants.
   1. Students are prohibited from drawing blood or conducting any other medical procedures on anyone except themselves.
   2. Students are prohibited from providing advice, diagnostic or medical information to participants without direct supervision and involvement of a medical professional.
   3. Students are prohibited from publishing diagnostic apps on public websites or app stores without appropriate FDA approvals.
   4. Students are prohibited from disclosing results or data from their study to the human participants.
2. 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) (Public Health Service Act, 42, USC 241 (d)).

Rules

1. Student research involving human participants must be reviewed and approved by an Institutional Review Board (IRB) before any interaction (e.g., recruitment, data collection) with human participants may begin. An IRB will determine any additional supervision required, make any adjustments to the research plan and designate the risk and consent processes required.
2. A consent process is required. Participation in research may begin only after participants have voluntarily given informed consent/assent (and in many cases received parental permission).
   1. Adult research participants may give their own consent.
   2. All human participant studies involving minors (students under 18 years of age) must receive assent from the student participant and written parental permission from a legal guardian.
   3. For studies involving minors, if the study includes a survey, the survey must be attached to the consent form as part of the written parental permission process.
   4. 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.
   5. 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).
   6. Informed consent may not involve coercion.
   7. A student researcher may request that the IRB waive the requirement for written informed consent from adult participants (over the age of 18) if the research involves only minimal risk and anonymous data collection.
3. The research study must be in compliance with all privacy laws (e.g., U.S. Family Educational Rights and Privacy Act (FERPA) and the U.S. Health Insurance Portability and Accountability Act (HIPAA)) when they apply to the project (e.g. the project involves medical information).
4. 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/ This Healthcare provider/professional must be named in the research plan/ protocol approved by the IRB. The IRB must also confirm that the student is not violating the appropriate practice act (medical, nursing, pharmacy, etc) of the state or country in which he/she is conducting the research.
5. 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.
6. Studies that involve recruitment and interaction with human participants online or via the internet are allowed if they adhere to all of the human participant rules above regarding consent processes and restrictions, including obtaining written parental permission for studies involving In order to protect the confidentiality of the participants, it is extremely important that IP addresses, as well as the data provided, be safeguarded.
7. Student-designed invention, prototype, computer application, engineering/design projects and product testing that involve testing of the invention or consumer product by any human participant require attention to the potential risks to the individual(s) testing or trying out the invention/prototype.
   1. IRB review and pre-approval is required when the student- designed invention, prototype, application, etc. is tested by human participants other than the student researcher(s) or a single adult guardian/ adult sponsor/QS/DS when the testing requires an adult tester (such as driving or other age-restricted activities). This includes surveys conducted regarding potential use or opinions of the invention or consumer product by the general public. This is not intended to apply to receiving professional feedback from experts in the field of study prior to experimentation.
   2. Human participants testing of an invention, prototype or project that involves a medical diagnosis or intervention (as defined by the FDA or Medical Practices Act) must adhere to the prohibition of medical procedures (see Prohibited Studies) and be supervised by a health care professional with appropriate credentials and specialization in the area of medical diagnosis or intervention being studied.

Documentation and Approval

1. Student researchers must have a Research Plan that includes all of the standard elements as well as the following areas specific to human participant research:
   1. Participants:
      • Describe age range, gender, racial/ethnic composition of participants.
      • Identify vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged).
   2. Recruitment:
      • Where will you find your participants?
      • How will they be invited to participate?
   3. Methods:
      • What will participants be asked to do?
      • Will you use any surveys, questionnaires or tests? If yes and not your own, how did you obtain? Did it require permissions? If so, explain.
      • What is the frequency and length of time involved for each subject?
   4. Risk Assessment:
      • What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to participants?
      • How will you minimize risks?
      • List any benefits to society or participants.
   5. Protection of Privacy:
      • Will identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected?
      • Will data be confidential/anonymous?
      • If anonymous, describe how the data will be collected.
      • If not anonymous, what procedures are in place for safeguarding confidentiality?
      • Where will data be stored? Who will have access to the data?
      • What will you do with the data after the study?
   6. Informed Consent Process:
      • Describe how you will inform participants about the purpose of the study what they will be asked to do, that their participation is voluntary and they have the right to stop at any time.
      • If participants are minors, explain the process by which written parental permission will be received and a parent will have access to the survey instrument prior to providing permission.
2. Student research involving human participants must be reviewed and approved by an IRB before any interaction (e.g., recruitment, data collection) with human participants may begin. It is the responsibility of the IRB 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.
   1. Projects that are conducted at school, at home or in the community that are not affiliated with a Regulated Research Institution (RRI) must be reviewed and approved by the School IRB before the student may begin recruiting and/or interacting with human participants.
   2. The School IRB (or SRC/IRB from your affiliate fair) must assess the risk and document its determination of risk on Form 4.
   3. Projects that are conducted at an RRI (e.g., university, hospital, medical center, government lab) must have IRB approval from the A copy of the IRB approval for the project must be obtained.
   4. A letter from an adult mentor and/or Qualified Scientist is not sufficient documentation of the RRI IRB review and approval process.
3. When working with a facility for protected groups where participants live or attend programming (e.g. retirement home, daycare, prison, etc.) written approval from the facility must be obtained prior to experimentation, as well as informed consents for the individual participants.
4. The student must comply with all determinations made by the School or RRI IRB before beginning any interaction with human participants (e.g., recruitment, data collection).
   1. If the IRB requires a Qualified Scientist (QS), Form 2 must be completed by the QS before any interaction with human participants. The School IRB will review this completed form before approving the project.
   2. If the IRB requires a Direct Supervisor (DS), Form 3 must be completed before any interaction with human participants. The School IRB will review this completed form before approving the project.
5. After initial IRB 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.
6. After experimentation and before competition, the Affiliated Fair SRC will review for compliance with all rules.
7. The following forms are required for studies involving human participants:
   1. Checklist for Adult Sponsor (1)
   2. Student Checklist (1A)
   3. Research Plan/Project Summary
   4. Approval Form (1B)
   5. Human Participants Form (4) for projects reviewed by school IRB or IRB approval documentation from an RRI
   6. Informed Consents/Parental Permission, when applicable
   7. Copies of any surveys, when applicable
   8. Regulated Research Institution Form (1C), when applicable
   9. Qualified Scientist Form (2), when applicable
   10. Risk Assessment (3) when applicable
8. Risk Assessment Form 3 is required for all projects that involve human participant testing of any project involving student-designed inventions, prototypes or consumer products.

Exempt Studies (Do Not Require IRB Preapproval or Human Participants Paperwork)

Some studies involving humans are exempt from IRB pre- approval or additional human participant forms. Exempt projects for ISEF and affiliated fairs are:

1. Student-designed Invention, Prototype, Computer Applications, Engineering/Design Project or Consumer Product Testing in which the student researcher is the only person testing the invention, prototype, computer application or consumer product and the testing does not pose a health or safety hazard.
   1. The exemption can also apply when the human participant testing is a single adult guardian or Adult  Sponsor/QS/DS when the testing requires an adult tester. (This is instead of the student researcher; not to supplement.)
   2. IRB review and pre-approval is required if the project involves more than the student researcher (or single adult guardian serving as the sole tester) or any introduction of a human variable or factor in the testing of a consumer product/invention/prototype/ application (e.g., amount of sleep, strength or endurance of tester, etc.).
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. Behavioral observations of unrestricted, public settings (e.g., shopping mall, public park) in which all of the following apply:
   1. the researcher has no interaction with the individuals being observed
   2. the researcher does not manipulate the environment in any way and
   3. 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 which complies with both of the following conditions:
   1. the professional providing the data certifies in writing that the data have been appropriately de-identified before being given to the student researcher and are in compliance with all privacy and HIPAA laws, and
   2. the affiliated fair SRC ensures that the data were appropriately de-identified by review of the written documentation provided by the supervising adult(s).