Establishing a School Institutional Review Board Training Program SEFMD (updated 8/04)

Institutional Review Board (IRB) – definition A committee of specific composition at an affiliated fair, high school or institution that reviews research plans involving human subjects to determine potential physical and/or psychological risk.A committee of specific composition at an affiliated fair, high school or institution that reviews research plans involving human subjects to determine potential physical and/or psychological risk.

Why is an IRB needed? Required by federal lawRequired by federal law Required by the International Science and Engineering Fair RulesRequired by the International Science and Engineering Fair Rules Required to evaluate potential physical or psychological risk of research involving human subjectsRequired to evaluate potential physical or psychological risk of research involving human subjects

Composition of the IRB Minimum of 3 membersMinimum of 3 members Must include:Must include: a science teacher; a school administrator; a school administrator; a psychologist, psychiatrist, medical doctor, physician’s assistant, registered nurse, or licensed social worker a psychologist, psychiatrist, medical doctor, physician’s assistant, registered nurse, or licensed social worker

Composition of the IRB (continued) Additional members are recommended.Additional members are recommended. If the project is behavioral, one of the members must be a psychologist, psychiatrist, or someone with human behavioral training.If the project is behavioral, one of the members must be a psychologist, psychiatrist, or someone with human behavioral training. Neither the Adult Sponsor, the Qualified Scientist, nor the Designated Supervisor who oversees a specific project is permitted to serve on the IRB reviewing that project.Neither the Adult Sponsor, the Qualified Scientist, nor the Designated Supervisor who oversees a specific project is permitted to serve on the IRB reviewing that project.

What does the IRB do? The IRB reviews and approves ALL research involving human subjects BEFORE experimentation begins. (This includes surveys, professional tests, questionnaires, and studies in which the researcher is the subject of his/her own research.)The IRB reviews and approves ALL research involving human subjects BEFORE experimentation begins. (This includes surveys, professional tests, questionnaires, and studies in which the researcher is the subject of his/her own research.) The IRB determines the level of RISK involved in the project.The IRB determines the level of RISK involved in the project.

What paperwork is required by the IRB? Research Plan (1A), including the Research Plan AttachmentResearch Plan (1A), including the Research Plan Attachment Approval Form (1B)Approval Form (1B) Checklist for Adult SponsorChecklist for Adult Sponsor Copy of surveys, tests, etc., if applicableCopy of surveys, tests, etc., if applicable Human Subjects Form (4)Human Subjects Form (4)

Is any other paperwork required? If more than minimal risk is involved, the student also needs the Qualified Scientist Form (2), the Designated Supervisor Form (3), and consent from all parti- cipants. (Form 4)If more than minimal risk is involved, the student also needs the Qualified Scientist Form (2), the Designated Supervisor Form (3), and consent from all parti- cipants. (Form 4) If minimal risk is involved, consent from all parti- cipants (Form 4) is “recommended, but not required.”

Is any other paperwork required? If research was conducted or equipment used in an institutional or industrial setting at any time during the current project year, Registered Research Institutional/Industrial Setting Form (1C) must be completed.If research was conducted or equipment used in an institutional or industrial setting at any time during the current project year, Registered Research Institutional/Industrial Setting Form (1C) must be completed. IRBs exist at federally registered institutions, including prisons, and that institutional IRB must initially review and approve the research.IRBs exist at federally registered institutions, including prisons, and that institutional IRB must initially review and approve the research.

What is RISK? Exercise other than ordinarily encountered in daily lifeExercise other than ordinarily encountered in daily life Emotional stress to questioning or activity or stress resulting from an invasion of privacyEmotional stress to questioning or activity or stress resulting from an invasion of privacy Ingestion of and/or physical contact with any substanceIngestion of and/or physical contact with any substance Any student 21 or under doing experimentation with toxic chemicals, radiation, or known pathogens and carcinogensAny student 21 or under doing experimentation with toxic chemicals, radiation, or known pathogens and carcinogens

What is Risk? (continued) Any member of a risk group (e.g., anyone with a disease, cardiac disorder, pregnant women, etc.)Any member of a risk group (e.g., anyone with a disease, cardiac disorder, pregnant women, etc.) Any member of special groups covered by federal regulations (e.g., Native Americans, prisoners, special needs persons, including the disabled and gifted, children, economically or educationally disadvantaged persons)Any member of special groups covered by federal regulations (e.g., Native Americans, prisoners, special needs persons, including the disabled and gifted, children, economically or educationally disadvantaged persons)

Federal Definition of Minimal 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 in DAILY LIFE or during performance of routine physical or psychological examinations or tests.

When is Informed Consent not required for research subjects under 18? Research conducted in established settings:Research conducted in established settings: –Involving normal educational practices; –Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subject.

When is Informed Consent not required for research subjects under 18? (cont’d) Research involving observation of legal public behavior.Research involving observation of legal public behavior. Research involving collection or study of existing publicly available data.Research involving collection or study of existing publicly available data.

After receiving the paperwork … IRB reads through all submitted paperworkIRB reads through all submitted paperwork IRB decides level of risk and checks appropriate box (Form 4)IRB decides level of risk and checks appropriate box (Form 4) IRB states justification of waiver of informed consent, if applicableIRB states justification of waiver of informed consent, if applicable All IRB members sign and date Form 4 and return paperwork to studentAll IRB members sign and date Form 4 and return paperwork to student STUDENT MAY BEGIN PROJECT

Questions… Can a student use a different form for “informed consent”?Can a student use a different form for “informed consent”? NO. The only acceptable alternative forms to the Human Subjects Form (4) are those provided by a registered research institution.

Questions… (continued) If the student researcher anticipates more than “minimal risk”, can he/she submit the additional required forms to the IRB prior to approval?If the student researcher anticipates more than “minimal risk”, can he/she submit the additional required forms to the IRB prior to approval?YES!

Questions… (continued) If a student changes his/her project after it has been approved by the IRB, does it need to be approved again?If a student changes his/her project after it has been approved by the IRB, does it need to be approved again? YES! Any proposed changes must have subsequent IRB approval before such changes are made and before experimentation resumes.

Suggested IRB timeline Sept/Oct – establish the school IRB committeeSept/Oct – establish the school IRB committee Oct/Nov – students submit paperwork to the school IRB for approval; student begins actual work on projectOct/Nov – students submit paperwork to the school IRB for approval; student begins actual work on project Dec – students submit paperwork to the SEFMD SRC by SRC deadline for verification of approvalDec – students submit paperwork to the SEFMD SRC by SRC deadline for verification of approval