What is the Purpose of the IRB?
The goal of the Pacific University IRB is to assist investigators at Pacific University in their efforts to protect the rights and welfare of individuals who participate in research conducted at or under the auspices of the University, and to ensure Pacific University's compliance with federal regulations regarding the protection of human subjects.
As needed, the IRB will work together with investigators to ensure that both goals noted above are met to our satisfaction. This can be done in the planning phase (i.e., each school/college has an IRB representative who will be happy to work with investigators as they play their proposals) or during the review process (preferably the former). To aide investigators in the planning phase of their research, the IRB has provided investigators with a list of links to the ethical guidelines for several different disciplines (put link here). The IRB urges all investigators to familiarize (or refresh, as the case may be) themselves with the ethical guidelines of their disciplines as they prepare their proposals.
During the review process, the IRB only comments on the scientific merit of the research if the merit is not in balance with the risk posed to potential participants. That is, the IRB does not review the scientific merit of research studies per se; however, the IRB does evaluate the risks to human subjects in light of the potential benefits of the study, which requires a consideration of the scientific merit of the study.
Why do we need an IRB?
The Pacific University IRB is required by federal policy for human subjects' protection -- this federal policy is known as "The Common Rule". The Common Rule requires an institution that is conducting research to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices. The Common Rule was first promulgated by the U.S. Department of Health and Human Services in 1974 and extended to 16 U.S. governmental agencies in 1991.
The Common Rule is based on the ethical principles articulated in The Belmont Report (issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). The three basic principles are:
[1] ensuring that individuals can make informed choices about their participation in research, and protecting those individuals with diminished autonomy;
[2] ensuring that the potential risks of a study are minimal, or are justified by the potential benefits;
[3] ensuring that the selection of research participants is fair, and not based simply on their easy availability, their willingness to participate, or other considerations not directly related to the problem being studied.
For questions about submission requirements and schedule changes, please contact your school's IRB representative, or Tori Eaton, Administrative Assistant for the IRB, 503-352-2112, irb@pacificu.edu