How to complete the

CERTIFICATION OF COMPLIANCE OF RESEARCH INVOLVING 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. Read and complete the Greater San Diego Science and Engineering Fair: Certification of Compliance of Research Involving Human Participants Form (GSDSEF Research Involving Human Participants Form). Include all required signatures.

 

3. A teacher shall serve as advisor for the project in which case he/she assumes primary responsibility for the project. If there is no teacher, a Designated Supervisor or Adult Sponsor must provide certification that safety guidelines are followed. 

 

4. Design and make a pdf copy of the Human Informed Consent Form used in the experiment. See description below. If necessary for the research: A pdf copy of the questionnaire/survey/ test.

 

5. In addition to the student signature, certain adult signatures may be required on the GSDSEF Research Involving Human Participants Form depending on the location of the student's research. Additional forms may be required by ISEF depending on location of student research.

 

Forms and Signatures Required in addition to the GSDSEF Signature Form: 

• If research is conducted at a middle or high school:
  • GSDSEF Research Involving Human Participants Form
    • Parent/Guardian Signature
    • Teacher/Advisor signature 
  • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research

 

• If research is conducted at a Regulated Research Institution (RRI):
  • GSDSEF Research Involving Human Participants Form
    • Parent/Guardian Signature
    • Teacher/Advisor signature 
  • Supervising scientist signature on the GSDSEF Research Involving Human Participants Form AND 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 from RRI, as necessary 

 

• If research is conducted at a middle or high school with scientist training/supervision:         
  • GSDSEF Research Involving Human Participants Form
    • Parent/Guardian Signature
    • Teacher/Advisor signature 
  • If another adult is trained: Designated Supervisor Signature on the GSDSEF Research Involving Humans Form.
  • Qualified Scientist signature on the GSDSEF Research Involving Human Participants Form AND ISEF Form 2.
  • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research.

 

• If research is conducted at home: The parent/guardian (or other supervising adult) must already be trained in human subjects research or be trained by a Qualified Scientist.
  • GSDSEF Research Involving Human Participants Form
    • Parent/Guardian Signature
    • Teacher/Advisor signature 
  • Parent/Guardian (or supervising adult) signs as Designated Supervisor on the GSDSEF Research Involving Human Participants Form
  • If the Parent/Guardian is trained by a Qualified Scientist: Qualified Scientist signature on the GSDSEF Research Involving Human Participants Form AND ISEF Form 2
  • A pdf copy of the Human Informed Consent Form and, if necessary, the questionnaire/survey/test used in the research

 

LINKS TO FORMS RELATING TO RESEARCH INVOLVING HUMANS:

 

ISEF Form 2  - Qualified Scientist

 

Submit the GSDSEF Research Involving Humans Form and any other additional forms necessary ISEF forms with the SRC Pre-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 Pre-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 are two examples of a Human Informed Consent Form that can be used or modified, as needed:

• Consent Form for Human Subjects (GSDSEF sample)
• Consent Form for Human Subjects (ISEF)

 

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.