Institutional Review Board
NEW RULE! PLEASE READ!
Beginning February 15, 2007, all Investigators and Faculty Advisors need to have documentation submitted that they have completed an online training regarding use of human participants in research. After February 15, your proposal will NOT be reviewed until ALL investigators have completed the training.
Click here to link to the online training.
Please send a hard copy of your NIH Training Certificate when you send the hard copy of your proposal (or the NCI Training Certificate, if you completed training prior to March, 2008)
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.
What is the purpose of the Pacific University IRB?
The goal of the Pacific University IRB is to assist Principal 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.
To meet these goals, the IRB provides Principal Investigators with information about ways to design their research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ensure ongoing protection of human subjects.
The IRB does not review the scientific merit of research studies per se; however, the IRB does evaluate the risks to subjects in light of the potential benefits of the study, which requires a consideration of the scientific merit of the study.