More Information about the Institutional Review Board:
Protect the Rights of Participants in Research Studies or Surveys

by Kenneth A. Gruber, Director, Research and Sponsored Programs

The development of a more intense research focus by the faculty at Cal Poly Pomona has led, in recent years, to a considerable increase in the number of research projects involving human subjects. This is especially true in terms of Federally funded research. In fact, this Institution has several Federally funded research projects that meet the NIH designation for a Phase III Clinical Trial (a study done to examine of a biomedical or behavioral intervention to determine efficacy and further evaluate safety). The presence of Federally funded clinical research on campus required that we apply for a Federal Wide Assurance (FWA), which gives us the right/responsibility of having an Institutional Review Board (IRB) to review research protocols before the research can be initiated. In January 2002 Cal Poly Pomona was given its first FWA by the Federal Office for Human Research Protections. Issuance of a FWA mandates that all research involving humans conducted at the recipient institution, not just that funded by a Federal Agency, must be approved by their IRB.

The Cal Poly Pomona IRB has members from both the sciences and humanities, has one outside (of the institution) member, and is chaired by a professional bioethicist. I serve as the Human Protections Administrator for the IRB and sit as an Ex Officio member. The Office of Research and Sponsored Programs staff assists in the daily administration of IRB paperwork (increasingly electronic). There are many different classes of clinical research (under Federal regulations). The vast majority of the research on the campus needs to be reviewed by at least the IRB chair and the IRB administrator to determine if it is "exempt" from regulatory requirements, can under go "expedited" review (the chair and one additional IRB member), or must go through full review.

Research projects conducted in an "educational setting" (i.e., a course) are not typically required to be submitted to the IRB. However, if a classroom project is to be submitted for a public presentation (e.g., a Research Day), the project must undergo review by the Cal Poly Pomona IRB. While such student project presentations are not explicitly addressed in Federal Regulations, IRBs are allowed to formulate regulations for their institution that are more stringent than the existing Federal Regulations. For example, some IRBs have decided that no research on their campus will be exempt from at least an expedited review. Our IRB's position is that student research performed as part of a course, which will be presented publicly with this Institution's name on it, should undergo IRB review.

Save the educational setting situation described above, all other research involving humans, including surveys or any other instrument designed to collect information about humans, must be submitted to the IRB to determine if it is exempt or needs to undergo review.

The Cal Poly Pomona IRB tries to protect the rights of participants in research studies or surveys, while not making the approval process a significant detriment to the conduct of research or information collection. Anyone conducting or planning to conduct a project involving data collection from humans should contact the Office of Research and Sponsored Programs (ext. 2954) to discuss submission of their project to the IRB.

Kenneth A. Gruber, Director
Research and Sponsored Programs
Cal Poly Pomona
(kagruber@csupomona.edu)
909-869-2954