An Institutional Review Board (IRB) is a committee that, according to federal regulations (45-CFR-46), must evaluate the potential physical and/or psychological risk of research involving human subjects. All proposed human research must be reviewed and approved by an IRB before experimentation begins. This includes any surveys or questionnaires to be used in a project.
Federal regulations require local community involvement, therefore an IRB should be established at the school level to evaluate human research projects. An IRB at the school or ISEF Affiliated Fair level must consist of a minimum of three members. In order to eliminate conflict of interest, the Adult Sponsor, parents, the Qualified Scientist, and the Designated Supervisor who oversee a specific project must not serve on the IRB reviewing that project. Additional members are recommended to avoid conflict of interest and to increase the expertise of the committee. This IRB must include:
a) an educator
b) a school administrator (preferably a principal or vice principal)
c) and one of the following who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study: a psychologist, medical doctor, licensed social worker, licensed clinical professional counselor, physician's assistant, doctor of pharmacy or registered nurse.
If the IRB needs an expert as one of its members and one is not in the immediate area, then documented contact with an external expert is appropriate and encouraged. A copy of the correspondence (e.g. email, fax, etc.) should be attached to Form 4 and can be used as the signature of that expert.
IRBs exist at federally registered institutions (e.g., universities, medical centers, NIH, correctional facilities). The institutional IRB must initially review and approve all proposed research conducted at or sponsored, by that institution. The Adult Sponsor/local SRC is responsible for ensuring that the project is appropriate for a pre-college student and adheres to the ISEF rules.
An IRB generally makes the final determination of risk. However, in reviewing projects just prior to a fair, if an SRC judges an IRB's decision as inappropriate, thereby placing human subjects in jeopardy, the SRC may override the IRB's decision and the project may fail to qualify for competition.
IRBs may use this power point to familiarize themselves the rules and regulations regarding Human Subject testing in science fair projects.