Integrity and IRB

Research Integrity at PNWU:

The Institutional Review Board is charged with

• Protecting the rights and welfare of human research participants;
• Impartiality when conducting reviews of human subject research;
• Remaining immune from pressure by the institution’s administration, the investigators whose protocols are brought before it, or other professional and non-professional sources

The IRB accomplishes these goals by monitoring research conducted by PNWU students, faculty, staff, and affiliates. Any research or scholarly activity that may involve human subjects must go through the IRB for either determination or approval. 

IRB Authority to review, approve, disapprove and require modifications is given to the PNWU IRB via the Code of Federal Regulations (45 CFR 46), and additional regulations imposed by the Food and Drug Administration (FDA).  PNWU holds a Federal Wide Assurance (FWA00014453) with the Department of Health and Human Services (HHS), which describes the principles and guidelines under which the PNWU IRB must review and approve the conduct of research involving human subjects under the oversight of the Institutional Official.  The PNWU IRB applies the ethical principles embodied in the Common Rule (45 CFR 46) and the Belmont Report with regard to the protection of human research participants.

Determination is the process of deciding if your project involves human subjects. If your project is determined to be research on human subjects, then you will need further approval from the IRB. 

Pacific Northwest University does not allow investigators to make their own determination if their research/scholarly activity involves human subjects.

IRB Applications for Review and Approval or Determinations of Not Human Subject Research are submitted via Mentor IRB (Login Required).

• PNWU Employee or Student Mentor IRB Link: Click here
• External Partners Mentor IRB Link: Click here 

Standard Operating Procedures (SOPs):

The Human Research Protections Program SOPs are now located in the resources folder within Mentor IRB (Login Required).

Membership

The PNWU IRB consists of a minimum of five voting members, including at least one scientific member, one member who is considered a non-scientist, and one community member who is not otherwise affiliated with PNWU. Members are appointed by the University’s authorized institutional official. 

Authority

The Code of Federal Regulations (45 CFR 46), and additional regulations imposed by the Food and Drug Administration (FDA), define the authority of the PNWU IRB. PNWU holds a Federal Wide Assurance (FWA) with the Department of Health and Human Services which describes the principles and guidelines under which PNWU will conduct research involving human subjects.

Additional IRB Information

• Department of Health and Human Services Regulations
• FDA Guidance Documents
• FDA Home Page
• OHRP Guidance Documents
• OHRP Webinar Series on the Common Rule Notice of Proposed Rule Making Sept 2015
• U.S. Dept. of Health and Human Services Guidance on methods of De-identification of PHI in Accordance with the Health Information Portability and Accountability Act (HIPAA) Privacy Rule