human participants

MOST IMPORTANT: You MUST get formal PreApproval by an IRB before you may begin recruiting participants and collecting data. Florida does NOT recognize IRB exemptions for precollegiate research.

• An IRB (Institutional Review Board) is a committee that reviews proposed research projects for ethics and safety. They consider the participants' (and researchers') physical safety, psychological safety, and privacy rights. They ensure that researchers follow appropriate informed consent procedures, data storage, and treat participants ethically.

• If you are conducting your project at an institution with their own IRB (like UCF, Stetson, AdventHealth, Nemours, etc), you may be required to go through their IRB approval. Your professional mentor at that institution can advise you on whether you'd need to do that.

  • If so, we require that their IRB approval lists YOU as one of the investigators and specifically includes YOUR project on the IRB approval letter that you include with your project file. It is NOT enough that your pro mentor has IRB approval for their research. Please remember, though, that a professional institution's IRB may approve research that is beyond the scope of our precollegiate rules; any research outside the bounds of our precollegiate rules may not be entered into the competition, even if it was approved through a university IRB.

  • If you're not going through their IRB, you can go through ours instead! 

• If you are conducting your project anywhere else, please plan to go through our IRB. In Seminole County, we have a county-wide IRB for student research projects, run through our science fair office.

• IMPORTANT: Almost every single project will need at least one round of revisions before the IRB approves it. Use the info below to pre-empt the most common issues! But please factor this into your timeline when planning your project. 

The deadline to submit your project to our IRB for project PreApproval is 10/25/2024. Exception: AP Research students have a separate deadline of 11/22/24 to follow the CollegeBoard course timeline. Earlier submission is STRONGLY encouraged.

Informed Consent Requirements
In Florida, precollegiate researchers MUST ALWAYS obtain informed consent (or minor assent PLUS parent/guardian permission) for human participants research. NO exemptions.

• If your participants include MINORS: 

  • Reminder: The project MUST be reviewed and approved by an IRB BEFORE you begin recruiting participants and collecting data.

  • Use the Sample Informed Consent Form. Fill out all sections (except signatures/dates at the bottom), consistent with what's listed in your Research Plan. 

  • EVERY participant MUST have this form signed by BOTH the minor (fancy term = "minor assent") AND a parent/guardian (parent permission).

    • We strongly recommend you use hard-copy informed consent forms whenever dealing with minor participants. If extenuating circumstances require you to obtain digital informed consents, contact our fair staff for guidance.

    • Parents/guardians MUST be allowed to preview any materials before signing (like your survey questions, or scripts, songs, shows, etc.).

    • AFTER getting both the minor and the parent/guardian to agree (and sign), you may give the participant the survey or otherwise start collecting data on them.

• If your project includes ONLY ADULTS:

  • Reminder: The project MUST be reviewed and approved by an IRB BEFORE you begin recruiting participants and collecting data.

  • Use the Sample Informed Consent Form. Fill out all sections (except signatures/dates at the bottom), consistent with what's listed in your Research Plan.

  • EVERY participant must agree to this by EITHER:

    • Signing the hard-copy form before you give them the survey or otherwise start collecting data on them.
      -OR-

    • If you are giving ADULTS a digital survey, you may incorporate the informed consent to the beginning using the following procedure:

      • (1) It MUST appear as a separate page. In Google Forms, you can do this for FREE using the feature called "sections." Each section is a page, so the first section would be the Informed Consent info, and the next section would start the survey.

      • (2) It MUST include ALL of the same information that is on the Sample Informed Consent Form, including the statement about voluntary participation. In addition, it MUST also include the statement: "There is always the possibility of tampering from an outside source when using the internet for collecting information. While the confidentiality of your responses will be protected once the data are downloaded from the internet, there is always a possibility of hacking or other security breaches that could threaten the confidentiality of your responses. Please know that you are free to decide not to answer any question."
        NOTE: That means you may NOT make any of the questions "required" in your survey program (except the consent question at the beginning).

      • (3) INSTEAD of signing and dating, they MUST check a box that says "I am 18+ and consent to participate." This question should be marked as "required." [Your survey program will log the date and time when they submit.]

      • NOTE: With this method, your earliest signed consent form would be a "Print to PDF" of the first one submitted.

• STORAGE AND DISPOSAL: Your teacher sponsor must store signed informed consent forms for 3 years in a locked cabinet (or if digital, in a password-protected folder). After 3 years, they must be destroyed (shredded or burned, or if digital, deleted with the trash emptied).

  • You will submit the earliest signed consent form with your science fair project file as proof that you followed the required informed consent procedures. Your teacher sponsor will sign a form (the VICF) verifying how many total there were.

  • NOTE: Your teacher sponsor will also need to store the data in a locked cabinet for 3 years then destroy. If your data contain any identifying information (like names, email addresses, phone numbers, addresses, or birth dates), or if you have a "key" to match names to anonymous data, that must be stored in a separate locked cabinet or other password-protected folder with a different password.

Privacy Protection Requirements

• If you can collect your data anonymously, then you MUST. This means that you DON'T know who submitted which survey response.

  • This means you should NOT ask them to write their name on their survey. Nor their birthdate (age is okay, though).

  • If you need to be able to link different responses together (like a before survey and an after survey), you can still do this anonymously! Have them create a participant code like age-sex-petsname (I would be 34-F-bowser). Pro tip: Don't use favorite color--you'd get repeats that would be hard to match up!

  • If you can't collect your data anonymously, then you MUST at least keep it confidential. You may NOT use participant names in your project display, on your graphs, etc. If you need to refer to a particular participant, you should use a code.

• Signed consent forms and project data MUST be stored by your teacher sponsor in a locked cabinet for 3 years then destroyed (shredded or burned). If your data contain any identifying information (or if you have a "key" to match names to codes), it MUST be stored in a separate locked cabinet for 3 years then destroyed.

  • Digital version: ...stored in a password-protected computer folder for 3 years then deleted and the trash emptied. If your data contain identifying information (or a "key"), it must be stored in a separate password-protected computer folder with a different password for 3 years then deleted and the trash emptied.

Safety, Risks, and Ethics
Research is about answering the unknown! The unknown will always have an element of risk, and as a researcher you must think through what those risks are and how to manage them:

• You are NOT allowed to state that your project has no risks. If appropriate, you ARE allowed to state that your project has "minimal risk of physical / psychological discomfort."

• If your project has substantial risks:

  • Physical risks: Are your participants doing athletic feats? Drinking, eating, or tasting something (STRONGLY discouraged)? These present real risks--injury, allergic reaction, etc. You will need to document that you understand the likely risks and basic safety precautions. The IRB may also require you to have a professional at your research location while you're collecting data, in case an emergency arises (a "Qualified Scientist" / they'll complete Form 2).

    • NOTE: If you are asking people to do anything athletic for the purposes of your project, you will need to have a medical professional on site in case of emergency. Usually, your school's athletic trainer is the one to decide whether they're comfortable being that person. But if you happen to get a medical professional to agree, then it doesn't have to be the athletic trainer.

  • Psychological risks: Could any of the survey questions make participants uncomfortable? Or any part of your script/media? You will need to document that you understand the likely risks. If your research involves sensitive topics, or participants at higher risk of psychological harm, the IRB will likely require your project to be overseen by a mental health professional (a "Qualified Scientist" / they'll complete Form 2). You can ask your school's Licensed Mental Health Counselor for advice!

    • NOTE: Not all topics are appropriate for precollegiate student research. Particularly sensitive topics may not be approved by our IRB; however, in this case, we're happy to recommend other ways of learning about these topics. For example, surveying teens diagnosed with depression is likely not going to be approved, but you could absolutely survey mental health professionals instead about their experience / professional opinion about those topics!

      • REMEMBER: It's stated in the rules, too, but please remember that precollegiate student researchers are NOT allowed to ask participants to admit to anything illegal (or anything that is a violation of major rules like academic cheating).

    • IMPORTANT: An IRB will always request changes to survey questions (or other project elements) if they could be reworded in a way that poses less psychological risks! For example, in the classic Trolley Ethics Scenario, the question "Who do you think should be sacrificed and why?" is unnecessarily psychologically risky; instead it could be, "Which option do you think is more ethical, and which ethical philosophy is behind that option?"

• You must also be sure that you are treating your participants with dignity at all times, and that you don't set your participants up to do something that would get them in trouble (legal, school, etc) or to intentionally bias their beliefs/opinions.

• For science and engineering fair purposes, you are NOT allowed to provide incentives for students to participate, nor consequences if they don't. It CANNOT be a grade in class--not even extra credit. You may NOT even give them candy for participating. Basically, nothing more than the words "thank you."

Documentation for Human Participants Projects

• Research Plan 

  • You'll answer the subject-specific items for human participants research. See the sections above to help with this, and READ the notes in the question prompts!

  • Your procedure should ALSO include the steps for obtaining consent at the beginning, and for storage/disposal at the end.

  • Your bibliography MUST include a source about protecting human participants, chosen from the list on ISEF Rulebook. [The NIH PHRP tutorial is the best, but it's no longer free. The most common free options are the CFR or the Belmont Report.] Make this source #3 in your bibliography (after the ISEF rules and SSEF rules) so our reviewers are sure to find it!

• Form 1A special note: the "Actual Start Date" should be left blank until you collect your first signed informed consent form. Then fill in the "Actual Start Date" to match the date that consent form was signed. This MUST be AFTER IRB approval (the date will appear on Form 1B, based on the signature dates on Form 4).

  • NOTE: If you are still collecting data when you submit your project to apply to the fair, leave the "Actual End Date" BLANK.

  • Special, special note: If your project is an engineering design project, and the human participants part is only testing the protoype / surveying testers, you have two start dates on 1A. Fill in the date you started building your prototype as the "Actual Start Date" and then hand-write near that "Human Testing Start Date: _____" to clearly show the two.

• Form 3

  • If your project has physical risks to the participants (or to you), make sure they're listed here, too. Make sure to include a safety source in question #5 (or more than one) to address the risk(s). For example, with athletics, it should be a guide about that sport/event and how to do it properly / reduce the risk of injury. 

  • If your project has only psychological risks, those are what you'll list here. The safety source in #5 would be the same source you chose from the list in the ISEF rulebook about protecting human participants.

• Form 4 

  • Fill out the top only. This page is really just for IRB signatures. If you're not sure about the "Qualified Scientist," you can just leave that question blank.

  • ATTACHMENTS: YOU MUST ATTACH TO FORM 4 A FULL COPY OF YOUR PARTICIPANT PACKET. This must include your Sample Informed Consent Form (NOT signed/dated at the bottom) AND a copy of any surveys, scripts, media, or anything else that you will show/give to your participants!

• AFTER FORMS: VICF- When submitting your project for the regional fair, do NOT include all of your signed consent forms. Instead, submit ONLY the earliest ONE (redact the signatures but KEEP THE DATES SHOWING) and the VICF where your teacher sponsor confirms how many signed consent forms you collected.

  • NOTE: If you are still collecting data when you submit your project to apply to the fair, fill out the VICF accurately at the time of submission. Date it accurately, around when you're submitting it. Then on fair day, you can drop off an updated VICF to our "paperwork updates" box, with a new, accurate date. This way, if you advance to higher-level competitions, we know which version is more recent (based on the dates!). 

• Coming soon: sample paperwork file (annotated with instructions) and sample project file