Human Participants �

Florida Pre-college �Student Research

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Rules Reminders

1

Human Participants �Project Oversight

Non-involved adults, with appropriate training, verify ethics and rules compliance BEFORE experimentation.

Adult Sponsor and any DS/QS should work with student to ensure ethics and rules compliance before and after.

Adults on Project

IRB

Adults on Project

If risks to participants are more than minimal, will need a DS and/or QS.

• PBRSEF requires ALL projects to complete a Risk Assessment (Form 3), so all projects will have at least a DS.

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Risks can be physical and/or psychological:

• Surveys are generally psychological risks; athletic feats or biometrics are generally physical risks.
• Consider the nature of the task(s) and the intended participants to determine minimal/more than minimal.
• DS/QS must have relevant credentials for the nature of the risks in that project. EX: Athletic Trainer vs School Mental Health Counselor
• Student researchers are NOT permitted to perform invasive medical procedures nor provide diagnoses; that is licensed professionals only!

Constituting Your IRB

(n/a if you’re using the regional committee)

Projects whose risks are mainly psychological.

Every project must have one on the IRB.

Projects whose risks are mainly physical.

Every project must have one on the IRB.

Educator

Mental Health Professional

Medical Professional

Administrator

Project Ethics

Important: Your researchers are minors, and not all topics are appropriate.

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Be sure to teach, model, and practice ethics with your student researchers conducting human participants projects!

• Project Review and PreApproval
• Risk Assessment and Minimization
• Recruitment
• Informed Consent
• Protection of Privacy

Florida is Stricter than ISEF.

• ALL projects require “written” consent [verbal/implicit not allowed].
• ALL projects with minor participants require written parent permission.
• 18+ yo K-12 students count as minors when participants.
• Must provide a copy of the survey / materials for the parent to preview when obtaining permission.
• ISEF online survey consent procedures are the only methods allowed.�Summary:
• Adults? Can embed consent as landing page for survey.
• Minors? Cannot combine.
• All electronic communication must be made through the parent, who passes along info to/from the minor participant.
• We have the added VICF and earliest signed consent form (redacted).
• If both minors and adults are participants, and earliest consent form was by adult, must ALSO include earliest completed by minor.

Is It Human Participants?

Sometimes there is a gray area:

• Prototype testing or asking for opinions (not feelings!) on your design
• NOT humans = researchers on the project are the testers
• NOT humans = ONE adult does the testing because it requires adult for age or safety reason [only ONE of AS/DS/QS/P/G]
• When the researcher is the only participant
• Typically when there is substantial risk to the participant, where IRB review is useful (e.g., how does ___ affect my mile speed).
• This requires some common sense. General risks are already documented on Form 3, and the researcher’s parent/guardian consented on Form 1B. Ask: Does it need an IRB?
• Data studies about humans
• NOT humans = deidentified data provided by professional (need cert letter) or found in public data set

Exp Group

Documenting It

In the “Before Forms”

• ResPlan must include human participants info and biblio citation.
• Form 3 should document any substantial risks to participants.
• Form 4 (student fills out top) shows IRB decisions and approval.
• Informed consent form: either ISEF form, comparable, or embed
• Attachments: A copy of every survey, recruitment email/script, experiment script, media shown to participants (videos, images, song lyrics, etc.) for the IRB to review and every subsequent review!

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Later in the “After Forms”

• If Form 1C is relevant to the project, shouldn’t contradict anything.
• VICF + Earliest signed consent form
• Redact signatures but KEEP DATES SHOWING
• If embedded in an online survey, show earliest submission
• If earliest was adult but also minors, must give earliest + earliest minor