HRPP policies & procedures manual

102: Policy and procedure maintenance

1. Purpose

The purpose of this section is to state the IRB’s commitment to maintain and follow up-to–date policies and procedures that adhere to regulatory mandates and ethical principles.

2. Policy

Following regulations and guidance of Office of Human Research Protections (OHRP), FDA, and WSU policy ensures that the rights and welfare of human participants in research will be overseen and protected in a uniform manner. Written procedures are in place to ensure the highest quality and integrity of the review and oversight of research involving human participants and for the adequate documentation of such oversight.

Standard operating policies and procedures (SOPs) provide the framework for the ethical and scientifically sound conduct of research involving human participants.

3. Specific policies

3.1 Review, revision, approval of policies and procedures

At the minimum, policies will be reviewed by the ORA director annually. Changes to regulations, federal guidelines, or research practice, as well as the policies and procedures of WSU, may require a revision to a previously issued SOP. Any new information identified as being pertinent to the protection of research participants will be disseminated via e-mail and will be available on the website. New information that is considered pertinent to investigators and IRB members will be listed on the IRB website.

3.2 Policy disseminating and training

When new or revised SOPs are reviewed by the IRB and approved by the ORA director, they will be disseminated to the appropriate individuals and departments via WSU Announcements and will be available on the IRB website.

Training will be provided to all IRB members and ORA staff on new or revised policies and/or procedures.

Each new IRB or ORA staff member must review all applicable policies and procedures prior to undertaking any responsibility at the IRB.

4. Applicable regulations and guidelines

45 CFR 46.103(b), .108
21 CFR 56.108(a)(1), (b)(3), .115(6)

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

ORA directorMonitor appropriate sources and contacts for policy updates. Revise
and approve policies, procedures and forms as needed.
IRB coordinatorUpdate the website with revised or new standard operating procedures (SOPs)