About the IRB
As decreed by the United States Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), the purpose of the IRB is to facilitate, verify, and document that all human subjects research associated with Pacific University diligently protect the rights and welfare of the people participating as subjects. We are required to do so by law.
The Pacific IRB is registered with the Office of Human Research Protections (OHRP) in the Department of Health and Human Services and is thus subject to periodic audits by both OHRP and the FDA to verify that we are in compliance with all relevant federal regulations. To uphold this charge, Pacific University policy requires all faculty, students, or staff engaged in human subjects research to work directly and conscientiously with the IRB at the following times:
- before research is initiated
- during research if the protocol requires continuing review
- during research if the research protocol needs to change
- during research if an adverse event occurs
- after research ends in order to close the file
The committee has created templates and formalized procedures to guide you through these processes.
What to Expect
Before research commences, the IRB assesses the potential for risk to the participants of the study. In so doing, the IRB has the sole authority to require revisions for proposed human subjects research and to approve proposed research. We, and, in some circumstances, other institutional officials can also disapprove, suspend, or terminate human subjects research. Please note, however, that the IRB does not comment on the scientific merit of the proposed research design unless the merit is out of balance with the potential risk to participants.
It is important to recognize that not all data gathering and analysis activities using information gleaned from humans fall under IRB jurisdiction (e.g., research instruction that involves the collection and analysis of data gathered from human participants might not constitute research under federal guidelines). However, the determination as to whether your planned activities fall under the federal guidelines for research with human subjects is to be determined by the IRB chair (or one of the co-chairs as the case may be). This practice is consistent with strong recommendations from several federal agencies and is warranted because the IRB is most familiar with the relevant regulations and interpretations thereof.
The resources on this website provide detailed instructions on how to work with the IRB in making these determinations and in getting your research ready for implementation. We look forward to working with you.
Sandra Rogers, PhD, OTR/L