Research on humans must be approved by
Rules The following rules were developed to help pre-college student researchers adhere to the federal regulations governing professional scientists and to protect the welfare of both human participants and the student researcher.
Health and well-being is of the highest priority when students conduct research with human participants. According to Code of Federal Regulation 45, CFR 46, a human participant is a living individual about whom an investigator conducting research obtains (1) data or samples through intervention or interaction with individuals(s) or (2) identifiable private information. Examples of projects that are considered “human participant research” include: 1. Student researchers must complete ALL elements of the Human Participants portion of the Research Plan/Project Summary Instructions and evaluate and minimize the physical, psychological and privacy risks to their human participants. See Risk Assessment information on page 11 and the online Risk Assessment
Guide for additional guidance. 2. Student research involving human participants must be reviewed and approved by an Institutional Review Board (IRB) (See page 5) before any interaction (e.g., recruitment, data collection) with human participants may begin. It is the responsibility of the IRB to evaluate potential physical and/or psychological risks of the project and make a determination about whether the project is appropriate for student research and safe for the student
researcher and participants. a. Projects that are conducted at school, at home or in the community that are not affiliated with a Regulated Research Institution (RRI) must be reviewed and approved by the School IRB before the student may begin recruiting and/or interacting with human participants. The School IRB must assess the risk and document its determination of risk on Form 4. b. Projects that are conducted at a Regulated Research Institution (RRI) (e.g., university,
hospital, medical center, government lab) must have IRB approval from the RRI. A copy of the IRB approval for the project must be obtained. A letter from an adult mentor and/or Qualified Scientist is not sufficient documentation of the RRI IRB review and approval process. 3. The student must comply with all determinations made by the School or RRI IRB before beginning any interaction with human participants (e.g., recruitment, data collection). 4. Participation in research may begin only after research participants have voluntarily given informed consent/assent (in some cases with parental permission). Adult research participants may give their own consent. Research participants under 18 years of age and/or individuals not able to give consent (e.g. developmentally disabled individuals) give their assent, with the parent/guardian providing permission. The School IRB will determine whether the
consent/assent/ parental permission may be a) verbal or implicit or b) must be written. See the Risk Assessment information on page 11 and the online Risk Assessment Guide for further explanation of informed consent. 5. The research study must be in compliance with all privacy laws (e.g., U.S. Family Educational Rights and Privacy Act (FERPA) and the U.S. Health Insurance Portability and Accountability Act (HIPAA)) when they apply to the project (e.g. the project involves medical information). 6. Students are prohibited from independently diagnosing disease, administering medication, and/or performing medical procedures on human participants.
7. Student researchers may NOT publish or display information in a report that identifies the human participants directly or through identifiers linked to the participants (including photographs) without the written consent of the participant(s) (Public Health Service Act, 42, USC 241 (d)). 8. All published instruments that are not in the public domain must be administered, scored and interpreted by a Qualified Scientist as required by the instrument publisher. Any and all use and distribution of the test must be in accordance with the publisher’s requirements, including procurement of legal copies of the instrument. 9. Studies that involve the collection of data via use of the internet (e.g., email, web-based surveys) are allowed, but researchers should be aware that they can pose challenges in collecting anonymous data, obtaining informed consent, and ensuring that participants are of the appropriate age to give informed consent.
For suggestions as to how to comply with 9a and 9b above please see the Online Survey Consent Procedures. 10. After initial IRB approval, a student with any proposed changes in the Research Plan must repeat the approval process and regain approval before resuming interaction (recruitment, data collection) with human participants. 11. After experimentation and before competition, the Affiliated Fair SRC will review for compliance with all rules. 12. The following forms are required:
IRB Waiver of Written Informed Consent/Parental PermissionThe IRB may waive the requirement for documentation of written informed consent/assent/parental permission if the research involves only minimal risk and anonymous data collection and if it is one of the following: 1. Research involving normal educational practices 2. Research on individual or group behavior or characteristics of individuals where the researcher does not manipulate the participants’ behavior and the study does not involve more than minimal risk. 3. Surveys, questionnaires, or activities that are determined by the IRB to involve perception, cognition, or game theory, etc. and that do NOT involve gathering personal information, invasion of privacy or potential for emotional distress. 4. Studies involving physical activity where the IRB determines that no more than minimal risk exists and where the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities. If there is any uncertainty regarding the appropriateness of waiving written informed consent/assent/parental permission, it is strongly recommended that documentation of written informed consent/assent/parental permission be obtained. Human Participant Involvement in Student-designed Invention, Prototype, Computer Application, Engineering/Design Projects & Product TestingStudent-designed invention, prototype, computer application and engineering/design projects that involve testing of the invention by any human participant require attention to the potential risks to the individual(s) testing or trying out the invention/prototype.
Exempt Studies (Do Not Require IRB Pre-approval or Human Participants Paperwork)Some studies involving humans are exempt from IRB pre-approval or additional human participant forms. Exempt projects for ISEF and affiliated fairs are:
Human Participant & IRB ResourcesUse this information to determine the level of risk involved in a study involving human participants. All human participant projects are considered to have some level of risk. No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered by a potential participant in everyday life or during performance of routine physical or psychological examinations or tests. More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality or invasion of privacy is greater than what is typically encountered in everyday life. Most of these studies require documented informed consent or minor assent with the permission of parent or guardian (as applicable). 1. Examples of Greater than Minimal Physical Risk
2. Examples of Greater than Minimal Psychological Risk
3. Privacy Concerns
4. Risk Groups
See the online Risk Assessment Guide and Online Survey Consent Procedures for more detailed information on risk assessment. Sources of Information: Human Participants1. Code of Federal Regulation (CFR), Title 45 (Public Welfare), Part 46-Protection of Human Subjects (45CFR46) 2. Dunn, C. M. and Chadwick, G. L., Protecting Study Volunteers in Research, 3rd Edition (2004). Boston, MA: Thomson Centerwatch. ISBN 1-930624-44-1. 3. NIH tutorial, “Protecting Human Research Participants” 4. Belmont Report, April 18, 1979 5. Standards for Educational and Psychological Testing. (1999). Washington, DC: AERA, APA, NCME. 6. American Psychological Association Information for students: 7. Educational and Psychological Testing 8. The Children’s Online Privacy Protection Act of 1998 (COPPA) (15 U.S.C. §§ 6501–6506) Who approves human research?IRB Organization. 1. What is an Institutional Review Board (IRB)? Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.
Does human subject research require IRB approval?Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities.
Which of the following must approve all research involving humans?The IRB must review and approve all research involving live humans before any such research activities may begin.
What are the guidelines for doing research with humans?NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:. Social and clinical value.. Scientific validity.. Fair subject selection.. Favorable risk-benefit ratio.. Independent review.. Informed consent.. Respect for potential and enrolled subjects.. |