The University's "Institutional Review Board for the Protection of Human Subjects of Research (IRB)" is appointed by the President of the University. The members serve three-year terms and are compensated for the extra work that this committee entails. The Board is bound to abide by the Institutional Assurance of compliance with federal regulations. Each member brings into the commmittee his or her own moral code and ethical standards for behavior. In the course of indoctrination and on-going training, each member accepts and adopts a common set of principles regarding the protection of human subjects.
Members of the Board often disagree among themselves on the severity of risk and the efficacy of benefit, but the tradition remains that the concern of one member is discussed until the majority are satisfied. Each member brings particular strengths to the Board. Members are selected only from among faculty and staff whose independence of judgment is assured, and to represent defined areas and methodologies of research involving human subjects. The larger context is represented by members from the Long Beach regional community.
Following federal standards, the IRB recognizes three types of human subject research proposals, based on the nature and severity of the inherent risk of the research. Two of the categories require review by the IRB. These are the Standard and the Expedited categories. Standard protocol applications are reviewed by the entire IRB, usually in one of their monthly meetings. Expedited protocol applications are reviewed by three-member subcommittees of the IRB. The results of Expedited Reviews are reported, post facto, to the IRB. The third category is "exempt (from IRB review)."
The Standard Category is reserved for research which inherently involves more than minimal risks and where the research subjects themselves are not autonomous, that is, persons not of legal age or persons of legally-recognized diminished capacity to make their own decisions.
The Expedited Category is for research with no more than a minimal inherent risk to human subjects. The campus IRB follows the federal guidelines regarding qualification of applications for the Expedited Review Category.
When there is no inherent risk to human subjects, including no operational risks to the privacy of subjects, the research protocol may be reviewed under the Exempt Category by the administrator, which is the Director, Office of University Research at CSU Long Beach. The IRB is not required to review this kind of research, but the administrator may refer an application to the IRB for either Standard or Expedited Review.
To determine whether or not a proposal is eligible for Exempt Review, faculty and students are urged to use the Interactive Review for Exempt Status program . This program helps identify the characteristics which will qualify or disqualify a human subjects research application for Exempt Review.
There is one class of human subjects research for which the University policy on human subjects research is not applicable. This is the category of class demonstrations which are defined as "in-class projects" or "in-class exercises." Either or both of the following conditions must exist: (1) the research will not be published, (2) the results of the research are known or are not relevant to the exercise. In addition, there must be no inherent risk to humans in the exercise.
The IRB meets on the second Thursday of each month during the academic year. Applications must be deposited in the Office of University Research two weeks prior to the meeting date to accommodate Board member review prior to the meetings. One original and fifteen copies of each application for Standard Review are required. Results of a meeting are usually ready for applicants the Monday following the meeting. The IRB usually requires additional information, changes and modifications to research designs or human subjects handling procedures.
IRB subcommittees for Expedited Review are established ad hoc. One original and five copies are required. It usually takes about two weeks from the time the application is deposited in the Office of University Research until the subcommittee has reported and the results are ready for the applicant.
Exempt (Administrative) Reviews require one original only. It usually takes about three instructional days for the review to be completed and the results prepared for the applicant.
Meetings of the IRB are open and applicants are sometimes invited to attend to discuss their projects. Seating is limited, so persons who wish to observe the procedings must call the Office of University Research for a reservation.
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