Human Research Protection​ and the IRB

Human Research Protection Program (HRPP)

Pacific Northwest University (PNWU) is committed to fostering a research environment that prioritizes protection of the rights, dignity, and welfare of individuals who participate in research conducted by our faculty, staff, and students. In order to fulfill this commitment, PNWU has established the Human Research Protections Program (HRPP).

The HRPP is built on foundational ethical principles (i.e., Respect for Persons, Beneficence, and Justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report). These principles guide the review and conduct of all research involving human participants, ensuring that individual autonomy is respected, risks are minimized, and that the benefits of research are equitably distributed. The HRPP additionally adheres to all relevant federal, state, and tribal regulations governing human subjects research.

Mission

The mission of PNWU’s HRPP is to:

• safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected,
• provide guidance and support to the research community in the conduct of research with human subjects,
• assist the research community in ensuring compliance with relevant regulations,
• to provide timely and high- quality education, review and monitoring of human research projects, and
• to facilitate excellence in human subjects research.

Scope

Key components of the HRPP include the Institutional Review Board (IRB), the Office of Scholarly Activity (OSA), the Institutional Official (IO), and all PNWU investigators. However, the HRPP is a collaborative initiative that, at times, is supported by other departments, committees, and individuals across the university, such as:

• the Research Committee,
• Environmental Health and Safety,
• Biosafety,
• Compliance, Ethics, and Integrity Services,
• Technology Services,
• the Office of Integrated Institutional Effectiveness,
• the Registrar,
• Human Resources,
• and many others.

Institutional Review Board (IRB)

At the heart of PNWU’s HRPP is the Institutional Review Board (IRB). The IRB is a fully autonomous administrative committee that reviews all research involving human participants to ensure compliance with ethical and regulatory standards.

Authority

The IRB’s authority is granted by federal regulations, specifically 45 CFR 46 (HHS regulations for the protection of human subjects, also known as the Common Rule), and 21 CFR 50 and 56 (FDA regulations governing research involving investigational drugs and devices). PNWU holds a Federalwide Assurance (FWA #00014453) from the Office for Human Research Protections (OHRP), which describes the principles and guidelines under which PNWU will conduct research involving human subjects. The IRB has the authority to:

• approve, require modifications to secure approval, or disapprove all research activities under PNWU, regardless of where the research is conducted.
• ensure informed consent is obtained and documented in accordance with regulatory standards, or, where appropriate, approve waivers or alterations to these requirements.
• conduct continuing reviews of research projects, assessing the degree of risk involved.
• suspend or terminate approval for research not conducted according to IRB requirements or associated with unexpected serious harm to subjects.
• observe or appoint third-party observers to oversee the conduct of research.
• determine whether data or information gathered without IRB approval, or from research associated with noncompliance, may be published or used for research purposes.

Membership and Meetings

The IRB is composed of a diverse group of members to reflect varying perspectives, including scientists, non-scientists, and community representatives. This diversity ensures comprehensive and thoughtful review of research protocols.

The IRB convenes on the second Thursday of every month to review full board protocols. Research protocols requiring full board review must be submitted at least one month before the scheduled meeting. Final revisions must be completed two weeks prior to the meeting to ensure the protocol is placed on the agenda.

In some cases, review of research that poses minimal risk to participants and fits certain criteria may be conducted outside the full board meetings by a designated reviewer. These reviews are assigned on a rolling basis.

IRB Administration

The IRB is administered by the IRB Administrator within the Office of Scholarly Activity (OSA) in collaboration with the IRB Chair, Vice-Chair, and the Institutional Official. Investigators should work with the IRB Administrator as they prepare their submissions and throughout the course of the research. Please forward any inquiries concerning human research protections and the IRB to research@pnwu.edu. Consultations are also available and can be scheduled using the link below.