Institutional Review Board (IRB)
California Southern University, as a member of the American InterContinental University System, has a standing committee known as the Institutional Review Board (IRB). This board exists for the protection of human subjects and requires those students and faculty conducting research involving human subjects to submit their research proposals for review prior to data collection. Among others, the charge of the IRB is to ensure adherence to federal, state, and local regulations; as well as established ethical principles including respect for persons, beneficence, and justice, as enunciated by the Belmont Report and recognized by the U.S. Department of Health Sciences.
Respect for Persons. The ethical principle of respect for persons includes the requirement to recognize persons as independent beings capable of voluntarily deciding whether or not to choose to participate in research. The IRB also addresses the issues of safeguarding individuals unable to make informed decisions, such as children or those not competent to understand the benefits or risks resulting from research. The IRB also considers procedures to ensure confidentiality of subjects. In research involving children, federal guidelines mandate the use of parental consent forms and assent forms for the minor.
Beneficence. Beneficence regarding research is concerned with protecting subjects from harm and acting in the best interest of research subjects. In order to prevent harm, the IRB requires researchers to carefully consider and analyze the risks and benefits of their study and then formally address them individually. The IRB Committee then has the responsibility to determine if these potential risks and benefits are clearly spelled out for both the IRB and potential subjects; and whether the research can be approved based upon the listed risks and benefits analysis.
Justice. The ethical principle of justice requires people be treated fairly. Subjects have the right to be aware of the potential risks of research when they are asked to participate. This principle also requires the researcher to consider who or which group will benefit from the proposed research. The researcher needs to ensure that potential risks are not being taken by only one segment of the population for the benefit of another segment of the population.
What Requires IRB Review and Approval?
Any research involving human subjects must be approved by the AIUS IRB prior to data collection. Research is defined as “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46. 102). This includes pilot studies and preliminary studies but does not include surveys that are designed to improve programs (rather than contribute to a body of knowledge). Human subjects are defined as a “living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.”
No member of the CalSouthern community (students, faculty, and staff) may access or collect research data on human subjects without IRB approval.
Failure to submit an application to and receive approval of the IRB prior to commencement of data collection shall constitute a violation of university policy and subject the researcher (student, faculty, or staff) to sanctions ranging from suspension to termination from employment.