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, psychiatrist, medical doctor, licensed social worker, licensed clinical professional counselor, physician's assistant 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 IRBs decision as inappropriate,
thereby placing human subjects in jeopardy, the SRC may override the
IRBs 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.