Institutional Review Board
Welcome. In this web site you will learn about the IRB at Pacific, how it runs, and how faculty and students are expected to work with the committee at the outset of a research project involving human subjects. Please take a moment to read this introduction to acquaint yourself with our operating principles.
Who We Are. As decreed by the United States Department of Health and Human Services (DHHS), the purpose of the IRB is to facilitate, verify and document that all human subject research activities associated with Pacific University diligently protect the rights and welfare of the people participating as subjects. We are required to do so: the Pacific IRB is registered with the Office of Human Research Protections in the DHHS and is thus subject to periodic audits 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 involved with human subject research activities to work directly and conscientiously with the IRB:
- Before research activity is initiated
- During research activity if the protocol requires continuing review
- During research activity if the research protocol needs to change
- During research activity if an adverse reaction occurs
- After research activity ends, to close the file
The committee has created templates and formalized procedures to guide you through this.
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 subject research and to approve proposed research. We, and, in some circumstances, other institutional officials can also disapprove, suspend or terminate human subject research activities. 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.
In the pages that follow are detailed instructions on how to work with the IRB in making these determinations and in getting your research activities ready for implementation. We look forward to working with you.
Sincerely,
Erica Kleinknecht, Ph.D & Philip Schot, Ph.D
IRB Co-Chairs, 2006 – present
Links
- Does my project need IRB-approval?
- NIH Ethics Training Certificate
- Submission Guidelines
- Forms
- Glossary of Terms (coming soon)
- Membership Roster
- Ethics Guidelines and Additional Resources
- Review Process Primer (coming soon)
- FAQs (coming soon)
- Purpose-- Why do we need an IRB?