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For research not performed at one of these facilities, the sponsoring research organization (high school, local or affiliated fair, etc..) must appoint an IRB to review & approve any proposed research involving human subjects. A local IRB within a given school community is preferable to regional IRB's. If your school community can not appoint a properly constituted IRB, contact us & we will help with the process
A minimum of three (3) members are required for a school IRB. An IRB must include:
Neither the Adult Sponsor nor the Qualified Scientist who oversees a specific project is permitted to serve on the SRC or IRB reviewing that project. Consequently, neither the Adult Sponsor nor the Qualified Scientist may sign the SRC portion of (1B) Approval Form or the IRB portion of (4B) Human Subjects Form.
It is suggested that each school district have a pool of members to choose from in order to ensure adequate & appropriate representation when a project is behavioral & a psychologist or psychiatrist is required or when the Adult Sponsor or Qualified Scientist is a member of the IRB & cannot review a project.
An IRB generally makes the final determination of risk. However, if an SRC judges an IRB's decision as inappropriate thereby placing human subjects in jeopardy, the SRC may override the IRB's decision.
**It is important to remember that most projects do involve acceptable risks!
All human research projects (including surveys, professional tests, questionnaires, & studies in which the researcher is the subject of her/his own research) are subject to a complete IRB review before experimentation begins. Copies of standardized tests & student-prepared tests, surveys, etc., must be included with the research plan. Examples of innocuous human projects that involve no risk would be projects that involve color reference, eye color, etc. as opposed to invasive questionnaires that probe into personal matters that do involve risk for the subject.
Parents have the right to deny participation in any behavioral study including those using tests or questionnaires. Consent forms for behavioral projects must be informed consent (i.e. projects involving inquires regarding personal insight into a student's feelings, etc. must include self-made or professional questionnaires with the (4B) Informed Consent Form so that parents or guardians are cognizant of the type of questions to be asked. In other words, when a parent or guardian is asked for permission for their child to participate in a project or survey, the parent or guardian must be informed about the types of questions that the child will be asked to answer or the task the child will be asked to perform.)
(4B) Informed Consent Form is strongly recommended for all projects using human subjects & is required for subjects under 18 years of age & for all subjects when acceptable risk is determined by the IRB. A sample of this form must be submitted to the IRB before experimentation begins. The only acceptable alternatives to (4B) Informed Consent Form are those provided by a registered research institution.
Before experimentation, the IRB reviews the student researcher's plan. Any risks must be described in (4AZ) Human Subjects Form & be approved by the IRB. If the IRB requires any protocol changes, the student must incorporate those changes into the research plan before the IRB signs for approval. Any proposed changes by the student after initial IRB approval MUST have subsequent IRB approval before such changes are made.
Pre college student research conducted at federally registered research institutions (e.g. university labs, medical centers, NIH, etc.) MUST be reviewed & approved by that institution's IRB.
After the IRB has approved the research proposal, the student may begin experimentation. Additional review by a local SRC is not required before experimentation.
A student may observe & collect data for analysis of new procedures & medications ONLY under the direct supervision of a licensed professional. Students are prohibited from administering medications to human subjects. The IRB must ascertain that the student is not violating the medical practice act of the state in question.
It is illegal to publish information in a report that identifies the human subjects directly or through identifiers linked to the subjects, including photographs. Names or photographs of human subjects may not be displayed with a project without informed consent. (Public Health Service Act, 42 (U.S.C., 241(d)).