Establishing a School Establishing a School Institutional Review BoardInstitutional Review Board

Training ProgramTraining Program

SEFMD SEFMD

(updated 8/04)(updated 8/04)

Institutional Review Board Institutional Review Board (IRB) – definition(IRB) – definition

• A committee of specific A committee of specific composition at an affiliated fair, composition at an affiliated fair, high school or institution that high school or institution that reviews research plans involving reviews research plans involving human subjects to determine human subjects to determine potential physical and/or potential physical and/or psychological risk.psychological risk.

Why is an IRB needed?Why is an IRB needed?

• Required by federal lawRequired by federal law• Required by the International Required by the International

Science and Engineering Fair RulesScience and Engineering Fair Rules• Required to evaluate potential Required to evaluate potential

physical or psychological risk of physical or psychological risk of research involving human subjectsresearch involving human subjects

Composition of the IRBComposition of the IRB

• MinimumMinimum of 3 members of 3 members• Must include:Must include:

a science teacher;a science teacher; a school administrator;a school administrator; a psychologist, psychiatrist, a psychologist, psychiatrist,

medical doctor, medical doctor, physician’s assistant, physician’s assistant, registered nurse, registered nurse, oror licensed licensed social workersocial worker

Composition of the IRBComposition of the IRB(continued)(continued)

• Additional members are recommended.Additional members are recommended.• If the project is behavioral, one of the If the project is behavioral, one of the

members must be a psychologist, members must be a psychologist, psychiatrist, or someone with human psychiatrist, or someone with human behavioral training.behavioral training.

• Neither the Adult Sponsor, the Qualified Neither the Adult Sponsor, the Qualified Scientist, nor the Designated Supervisor Scientist, nor the Designated Supervisor who oversees a specific project is who oversees a specific project is permitted to serve on the IRB reviewing permitted to serve on the IRB reviewing that project.that project.

What does the IRB do?What does the IRB do?

• The IRB reviews and approves ALL The IRB reviews and approves ALL research involving human subjects research involving human subjects BEFORE experimentation begins. (This BEFORE experimentation begins. (This includes surveys, professional tests, includes surveys, professional tests, questionnaires, and studies in which the questionnaires, and studies in which the researcher is the subject of his/her own researcher is the subject of his/her own research.)research.)

• The IRB determines the level of RISK The IRB determines the level of RISK involved in the project.involved in the project.

What paperwork is What paperwork is required by the IRB?required by the IRB?

• Research Plan (1A), including the Research Plan (1A), including the Research Plan AttachmentResearch Plan Attachment

• Approval Form (1B)Approval Form (1B)• Checklist for Adult SponsorChecklist for Adult Sponsor• Copy of surveys, tests, etc., if Copy of surveys, tests, etc., if

applicableapplicable• Human Subjects Form (4)Human Subjects Form (4)

Is any other Is any other paperwork required?paperwork required?

• If If more than minimal more than minimal riskrisk is involved, the is involved, the student also needs student also needs the Qualified the Qualified Scientist Form (2), Scientist Form (2), the Designated the Designated Supervisor Form (3), Supervisor Form (3), and consent from all and consent from all parti-cipants. (Form parti-cipants. (Form 4)4)

• If If minimal riskminimal risk is is involved, consent involved, consent from all parti-cipants from all parti-cipants (Form 4) is (Form 4) is “recommended, but “recommended, but not required.”not required.”

Is any other Is any other paperwork required? paperwork required?

• If research was conducted or equipment If research was conducted or equipment used in an institutional or industrial used in an institutional or industrial setting at any time during the current setting at any time during the current project year, Registered Research project year, Registered Research Institutional/Industrial Setting Form (1C) Institutional/Industrial Setting Form (1C) must be completed.must be completed.

• IRBs exist at federally registered IRBs exist at federally registered institutions, including prisons, and that institutions, including prisons, and that institutional IRB must initially review and institutional IRB must initially review and approve the research.approve the research.

What is RISK?What is RISK?

• Exercise other than ordinarily encountered Exercise other than ordinarily encountered in daily lifein daily life

• Emotional stress to questioning or activity Emotional stress to questioning or activity or stress resulting from an invasion of or stress resulting from an invasion of privacyprivacy

• Ingestion of and/or physical contact with Ingestion of and/or physical contact with any substanceany substance

• Any student 21 or under doing Any student 21 or under doing experimentation with toxic chemicals, experimentation with toxic chemicals, radiation, or known pathogens and radiation, or known pathogens and carcinogenscarcinogens

What is Risk?What is Risk?(continued)(continued)

• Any member of a risk group (e.g., Any member of a risk group (e.g., anyone with a disease, cardiac disorder, anyone with a disease, cardiac disorder, pregnant women, etc.)pregnant women, etc.)

• Any member of special groups covered Any member of special groups covered by federal regulations (e.g., Native by federal regulations (e.g., Native Americans, prisoners, special needs Americans, prisoners, special needs persons, including the disabled and persons, including the disabled and gifted, children, economically or gifted, children, economically or educationally disadvantaged persons) educationally disadvantaged persons)

Federal Definition of Federal Definition of Minimal RiskMinimal Risk

No more than minimal risk exists when the No more than minimal risk exists when the probability and magnitude of harm or probability and magnitude of harm or discomfort anticipated in the research discomfort anticipated in the research are not greater (in and of themselves) are not greater (in and of themselves) than those ordinarily encountered in than those ordinarily encountered in DAILY LIFE or during performance of DAILY LIFE or during performance of

routine physical or psychological routine physical or psychological examinations or tests.examinations or tests.

When is Informed Consent When is Informed Consent not required for not required for

research subjects under 18?research subjects under 18?

• Research conducted in established Research conducted in established settings:settings:– Involving normal educational practices;Involving normal educational practices;– Research on individual or group behavior or Research on individual or group behavior or

characteristics of individuals, such as studies characteristics of individuals, such as studies of perception, cognition, game theory, or of perception, cognition, game theory, or test development, where the investigator test development, where the investigator does not manipulate subjects’ behavior and does not manipulate subjects’ behavior and the research the research will not involve stress to will not involve stress to subject.subject.

When is Informed Consent When is Informed Consent not required for research not required for research

subjects under 18? (cont’d)subjects under 18? (cont’d)

• Research involving observation of Research involving observation of legal public behavior.legal public behavior.

• Research involving collection or Research involving collection or study of existing publicly available study of existing publicly available data.data.

After receiving the After receiving the paperwork …paperwork …

• IRB reads through all submitted IRB reads through all submitted paperworkpaperwork

• IRB decides level of risk and checks IRB decides level of risk and checks appropriate box (Form 4)appropriate box (Form 4)

• IRB states justification of waiver of IRB states justification of waiver of informed consent, if applicableinformed consent, if applicable

• All IRB members sign and date Form 4 All IRB members sign and date Form 4 and return paperwork to studentand return paperwork to student

STUDENT MAY BEGIN PROJECTSTUDENT MAY BEGIN PROJECT

Questions…Questions…

• Can a student use a different form Can a student use a different form for “informed consent”?for “informed consent”?

NO. The only acceptable NO. The only acceptable alternative forms to the Human alternative forms to the Human Subjects Form (4) are those Subjects Form (4) are those provided by a registered research provided by a registered research institution.institution.

Questions…Questions…(continued)(continued)

• If the student researcher If the student researcher anticipates more than “minimal anticipates more than “minimal risk”, can he/she submit the risk”, can he/she submit the additional required forms to the IRB additional required forms to the IRB priorprior to approval? to approval?

YES!YES!

Questions…Questions…(continued)(continued)

• If a student changes his/her project after If a student changes his/her project after it has been approved by the IRB, does it it has been approved by the IRB, does it need to be approved again?need to be approved again?

YES! Any proposed changes must YES! Any proposed changes must have subsequent IRB approval before have subsequent IRB approval before such changes are made and before such changes are made and before experimentation resumes.experimentation resumes.

Suggested IRB timelineSuggested IRB timeline

• Sept/Oct – establish the school IRB Sept/Oct – establish the school IRB committeecommittee

• Oct/Nov – students submit paperwork to Oct/Nov – students submit paperwork to the school IRB for approval; student the school IRB for approval; student begins actual work on projectbegins actual work on project

• Dec – students submit paperwork to the Dec – students submit paperwork to the SEFMD SRC by SRC deadline for SEFMD SRC by SRC deadline for verification of approvalverification of approval