Tips for Forms & Projects:
Some studies involving humans are exempt from IRB pre-approval or additional human participant forms. Exempt projects include:
- Testing of a student-designed invention, program, concept, etc. is done only by the student researcher and where the testing does not pose a health or safety hazard. It is recommended that a Risk Assessment Form (3) be completed. (The use of other human participants for this testing is not exempt from IRB review and approval.)
- Data/record review studies in which the data are taken from preexisting data sets taht are publicly available and/or published and do not involve any interaction with humans or the collection of any data from a human participant for the purpose of the student's research project.
- Behavioral observations of unrestricted, public settings in which all of the following apply:
- the researcher has no interaction with the individuals being observed;
- the research does not manipulate the environment in any way; AND
- the researcher does not record any personally identifiable data.
- Projects in which the student receives pre-existing/retrospective data in a de-identified/anonymous format which complies with both of the following conditions:
- the professional providing the data certifies in writing that the data have been appropriately de-identified before being given to the student and are in compliance with all privacy and HIPAA laws AND
- the affiliated fair's SRC ensures that the data were appropriately de-identified by review of the written documentation provided by the supervising adult(s).
All other projects involving human subject participants MUST be reviewed prior to experimentation by a proper IRB.
The Human Subjects Form 4 is the form that is used to gather the IRB approval signatures. Please note that there are several questions that need to be answered by the Student Researcher prior to forwarding it on to the IRB along with the Research Plan, any surveys or questionnaires being used and a copy of the consent form being used.
The Research Plan for a project that uses Human Subjects must include the following:
- Subjects - Describe who will participate in your study (age range, gender, racial/ethnic composition). Identify any vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged).
- Recruitment - Where will you find your subjects? How will they be
- Methods - What will participants be asked to do? Will you use any surveys, questionnaires or tests? What is the frequency and length of time involved for each subject?
- Risks - What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc) to participants? How will you minimize the risks?
- Benefits - List any benefits to society or each participant.
- Protection of Privacy - Will any identifiable information (e.g. names, phone numbers, birth dates, email addresses) be collected? Will data be confidential or anonymous (Confidential means that the information collected will only be accessible to those authorized to have access like the Student Researcher and the Adult Sponsor. Anonymous means that there is absolutely no way that anyone could link a person's participation in the project to the data gathered.)? If anonymous, describe how the data will be collected anonymously. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will the data be stored? Who will have access to the data? What will you do with the data at the end of the study?
- 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.
It is important that the Medical or Mental Health Professional identifies themselves as one of the approved IRB members listed on the form in the box labeled "Degree/Professional License" where they sign. Remember that the type of activities the student researcher is having participants take part in will determine who should review the project. Physical activities should be reviewed by a medical doctor, physician's assistant or registered nurse. Psychological studies should be reviewed by a psychologist, psychiatrist, licensed social worker, or a licensed clinical professional counselor. In rural areas of the state where a medical professional is hard to come by, please contact CSEF SRC for assistance.
Neither the Adult Sponsor, parent(s), Qualified Scientist, nor the Designated Supervisor who oversees a specific project is permitted to serve on the IRB reviewing that project. This eliminates any conflict of interest.
IRB approval is needed BEFORE laboratory/data collection begins.
Students should feel free to either use the Human Informed Consent Form as it is provided by ISEF, or copy all of the following information into a new document:
Purpose of the project: This is where the Student Researcher should explain as simply as possible, why they are doing the project.
If you participate, you will be asked to: Include EVERYTHING you will be asking the subject to do in the study. If you have different tasks for different sets of subjects, then different consent forms must be used for each set of tasks.
Time required for participation: Give a good estimate for how much time the subject should expect to spend participating in your study.
Risks: Remember, there is no such thing as NO RISK. If no risks are anticipated, then use the phrase "NO KNOWN RISKS." Always keep in mind that there are emotional as well as physical risks involved in some studies. This is also where you would describe how you will minimize the possible risks.
Benefits: Give any benefits to the individual participant as well as the benefit to society in general. If there are no benefits, it is perfectly all right to state that there are no benefits for participating in the study except to satisfy the curiosity of the student researcher.
How confidentiality will be maintained: The best procedures are those where absolutely no identifying information is collected along with the data. Another technique is to have a numbered linked list where the data from the participants is given a number and the number is separately identified by name. This would allow the researcher to destroy the numbered list of names as soon as the need for the link is done. It is also best that the Adult Sponsor or Designated Supervisor be in charge of keeping the data.
Read more about ISEF rules regarding Human Subject research. IRB's may use this power point presentation as a training guide on how to review student research projects.