- HRPP Manual *Published updates effective 09/01/2023
The Washington State University (WSU) Human Research Protection Program (HRPP) Policies and Procedures Manual (PPM) complements the WSU Policy “Research Involving Human Subjects” (BPPM 45.50) and details the written procedures, notably those required under 45CFR46.108(3) and 21CFR56.108, that WSU will follow to ensure compliance with applicable regulatory requirements (e.g., HHS, FDA, WAC), ethical principles for the conduct of human participant research (e.g., Belmont report), and to fulfill the commitment WSU has made to the Department of Health and Human Services (HHS) via the WSU Federal wide Assurance (FWA) statement. When reviewing research that is not federally funded, WSU applies equivalent protections to those cited above.
Human research participant protection is a constantly evolving field, as such, sections of the manual require occasional revisions. Changes may not be immediately reflected in the pdf version of the manual, when this is the case changes will be communicated to faculty and staff prior to implementation and will be reflected as soon as practicable in the online version of this manual found on the WSU Institutional Review Board (IRB) web page (irb.wsu.edu). Please contact the IRB/HRPP office with any questions related to policies and procedures.
The review of non-exempt human participant research performed by WSU faculty, staff, students, or volunteers (anyone acting as an agent of WSU) is conducted by the IRB. The IRB is part of the Human Research Protection Program (HRPP) within the Office of Research Assurances (ORA), which provides administrative support to all WSU IRBs. The HRPP conducts pre-reviews to ensure applications are complete, provides support to researchers via consultation and educational outreach, and is responsible for determining if a project requires IRB review or if it is exempt (see 45CFR46.104).
Each IRB is comprised of faculty representatives from various academic disciplines and campuses at WSU as well as staff from various WSU departments who serve as subject matter experts (e.g., Information Technology and Security, Regulatory Compliance, Legal). IRB membership includes but may not be limited to physicians, researchers, scientific members, non-scientific members and community representatives (who are not otherwise affiliated with the University). All WSU IRBs are registered with the Food and Drug Administration (FDA) as required under 21CFR56.106, as well as the Office of Human Research Protections (OHRP) within the HHS.
Effective January 1, 2019, the WSU HRPP transitioned to the revised common rule (2018). All new federally funded research is reviewed under the 2018 requirements. Any ongoing research that was originally reviewed under the pre-2018 requirements will be re-reviewed under the 2018 requirements during continuing review, with the transition date documented. For any project reviewed under the pre-2018 requirements that cannot be transitioned, the basis for not transitioning will be documented during continuing review.