How to Complete ISEF Form 4: Human Participants

ISEF Form 4:  Human Participants

 HUMAN PARTICIPANTS FORM

Students planning research involving human participants MUST, before starting any experiments, COMPLY with the rules and guidelines of the California Education Code, Code of Federal Regulations and Public Service Act, HIPAA Regulations and Human Subjects Rules, and the International Science and Engineering Fair (ISEF). In case of conflict, the provisions of the California Education Code take precedence.

 

The following steps must be taken BEFORE any student begins research involving human participants:

 

1. Become familiar with the a) California Education Code, b) Code of Federal Regulations and c) Public Service Act, d) HIPAA Regulations and Human Subject Rules, and e) International Science and Engineering Fair (ISEF) Rules and Guidelines, Human Participants

2. Download, read and complete ISEF Form 4- Human Participants.  Acquire all required signatures. See 3 for signature information.

Filling in the top box: 

Instruction 1. Write a Research Plan for uploading to the SRC which addresses ALL of the following:

  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?
  6. 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?
  7. 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.

Instruction 2. Attach any surveys/questionnaires which are using or other documents provided to human subjects to include in the SRC upload.

Instruction 3.  Attach an Informed Consent Form. Download, design, and make a pdf copy of the Informed Consent Statement used in the experiment to include in the SRC upload. Details are listed below.          

 ISEF Sample Informed Consent Statement

 

Instruction 4.  If you worked with a Qualified Scientist, attach Qualified Scientist Form 2. 

3. Signatures: 

If your school has an Institutional Review Board: For the IRB, three (3) adult signatures are required on the ISEF Human Participants Form 4-- A medical or mental health professional, an educator, and an administrator.  The supervising teacher may NOT sign ISEF Form 4. 

If your school does NOT have an IRB:  Our SRC will serve as your IRB, but with an exception. If the project is done at a school site with students from that site, the administrator at the site where the project is done must sign. The GSDSEF SRC will provide the other 2 signatures.   If your project is not done at a school, or does not involve students, you may send in Form 4 unsigned, but with all other necessary documents.  The GSDSEF SRC will be your IRB.

4. If research is done at an RRI,  a copy of the Institutional Review Board letter from the RRI granting permission to do research must included in the SRC upload.

5. Additional forms/documents may be required depending on location and type of student research and must be included in the SRC upload.

 

ISEF Form 1C: Regulated Research Institution

IRB Letter from the RRI granting permission to do research

ISEF Form 2: Qualified Scientist

ISEF Form 3: Risk Assessment

 

 

Forms and Signatures Required for SRC Upload

  • If research is conducted at a middle or high school:
    • ISEF Form 4 Human Participants Form
      • See 3 above for required signatures. 
    • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research
    • ISEF Form 3 if needed

 

  • If research is conducted at a Regulated Research Institution (RRI):
    • ISEF Human Participants Form
      •  See 3 above for required signatures.
    •  ISEF Form 1C: Regulated Research Institution
    • ISEF Form 2 (Qualified Scientist) 
    • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research
    • Institutional Review Board (IRB) Approval Letter from RRI
    • ISEF Form 3 if needed

 

  • If research is conducted at a middle or high school with scientist training/supervision:   
    • ISEF  Form 4: Human Participants 
      • See 3 above for required signatures. 
    • ISEF Form 2: Qualified Scientist
    • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research.
    • ISEF Form 3 if needed

 

  • If research is conducted at home:
    • ISEF Form 4: Human Participants Form
      • See 3 above for required signatures.
    • If the Parent/Guardian is trained by a Qualified Scientist:  ISEF Form 2
    • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research
    • ISEF Form 3 if needed

 

Submit  ISEF Form 4: Human Participants and any other necessary forms/documents  with the SRC Approval Form to the GSDSEF Scientific Review Committee (SRC) for approval. 

 
Rules, Regulations, and Guidelines Pertaining to Research Involving Humans:

Human Informed Consent Form

All projects with human participants must develop and submit to the GSDSEF SRC Approval process a Human Informed Consent Form.  An informed consent/assent/permission form can be developed in consultation with the Teacher/Advisor, Designated Supervisor, or Qualified Scientist. This form is used to provide information to the research participant (and parent/guardian if participant is under 18) and to document an informed consent (and parent permission as necessary).

The Human Informed Consent Form requires the following information:

  1. Purpose of the project
  2. Comprehensive directions explaining what the participant will have to do
  3. Time required for participation
  4. Potential Risks—Be specific
  5. Benefits for Participation
  6. Statement of Confidentiality and Data Privacy
  7. Contact—Who the participants should contact if they have concerns or questions (Adult Sponsor, Designated Supervisor, or Qualified Scientist email)
  8. Signature of Participant
  9. Signature of Participant’s Parents/Guardians if Participant is a minor.

 

Below is an example of a Human Informed Consent Form that can be used or modified, as needed:

 

International Science and Engineering Fair Rules and Guidelines

The Greater San Diego Science and Engineering Fair (GSDSEF) adheres to and complies with the Safety Rules and Guidelines of the International Science and Engineering Fair (ISEF). Refer to ISEF Rules and Guidelines, Human Participants.

 

Code of Federal Regulations

The Code of Federal Regulations 45 (§) 46.102 defines a human subject as a person from whom an investigator obtains:

                            1) data through intervention or interactions with the person, or

                            2) identifiable personal information.

 

California State Education Code

(California State Education Code 51513) Parents/guardians have the right to deny participation of any minor child in any study involving tests or questionnaires which may be deemed overly personal/intrusive.

 

HIPAA Regulations and Human Subject Rules

The HIPAA Regulations regarding patient records and confidentiality may well affect whether a project is suitable for student development:

 

  • No identifiable personal information may appear in your records or project notebook or on your display.

 

  • All subjects must sign a consent form allowing the student to use data collected and these consent forms must be kept in a sealed envelope but made available if requested.

 

  • A sample blank consent form should be included in the Project Notebook.  If any question exists as to the propriety of the proposed project, the student or teacher must contact: stevegsdsef@gmail.com

 

Public Service Act

It is illegal to publish information identifying human participants (Public Health Service Act, 42 U.S.C., 241(d).  No photographs or any descriptors revealing identity of human subjects will be shared or displayed physically or digitally.