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4-Human-Participants.pdf

Human Participants Form for Research Involving Human Subjects

This form is required for all research involving human participants. It must be completed by the Institutional Review Board (IRB) before recruitment or data collection. If research is conducted at a Research-Related Institution (RRI), equivalent RRI IRB documentation is required.

Researcher Information

Student’s Name(s): ____________________

Title of Project: ____________________

Adult Sponsor: ____________________

Phone/Email: ____________________

Checklist for Student Researcher(s)

MUST BE COMPLETED BY STUDENT RESEARCHER(S) IN COLLABORATION WITH THE ADULT SPONSOR/DIRECT SUPERVISOR/QUALIFIED SCIENTIST:

  1. I have submitted my Research Plan/Project Addendum which addresses all areas indicated in the Human Participants Section of the Research Plan/Project Addendum Instructions.
  2. I have attached any surveys or questionnaires I will be using in my project or other documents provided to human participants.
  3. Any published instrument(s) used was/were legally obtained.
  4. I have attached an informed consent that I would use if required by the IRB.
  5. Are you working with a Qualified Scientist?
    Yes
    No
    If yes, attach the Qualified Scientist Form 2.

IRB Review

MUST be completed by the Institutional Review Board (IRB) after review of the research plan. All questions must be answered for the approval to be valid. If not approved, return paperwork to the student with instructions for modifications.

Approved with Full Committee Review (3 signatures required) and the following conditions: (All 6 must be answered)

  1. Risk Level (check one):
    Minimal Risk
    More than Minimal Risk (a risk assessment form 3 is required).
  2. Qualified Scientist (QS) Required (Form 2):
    Yes
    No
  3. Risk Assessment Required (Form 3):
    Yes
    No
  4. Written Minor Assent and written parental permission required for minor participants:
    Yes
    Not applicable (No minors in this study)
  5. Written Informed Consent required for participants 18 years or older:
    Yes
    No
    Not applicable (No participants 18 years or older in this study)
  6. Facility for “protected groups” used, written approval has been obtained:
    Yes
    No

Signatures

Print Name: ____________________ Degree/Professional License: ____________________

Signature: ____________________ Date (prior to experimentation): ____________________ Email: ____________________

Medical or Mental Health Professional: I attest that I have reviewed the student’s project, that the checkboxes above have been completed to indicate the IRB determination and that I agree with the decisions above.

IRB Signatures (All 3 signatures required)

None of these individuals may be the adult sponsor, direct supervisor, qualified scientist or related to the student (conflict of interest).

Print Name: ____________________ Degree/Professional License: ____________________

Signature: ____________________ Date (prior to experimentation): ____________________ Email: ____________________

School Administrator:

Print Name: ____________________ Degree/Professional License: ____________________

Signature: ____________________ Date (prior to experimentation): ____________________ Email: ____________________

Educator: