HRPP/IRB Review Process and Protocol Lifecycle

Initial Evaluation and Determination/Approval Process

1. Principal Investigator (PI) submits protocol application, required training certificate(s), and relevant supporting materials to researchintegrity@wwu.edu.
2. HRPP staff ensure the submission is complete and ready for consideration. (Applications missing training certificate(s), incomplete, or on outdated forms will not be processed and will be routed back to the PI.)
3. Exempt and "Not Human Participant Research" Submissions
   1. HRPP Administrator evaluates whether study meets Exemption/NHPR criteria. (If questions arise, HRPP Administrator consults with IRB Chair and/or other IRB members.) If applicable, HRPP Administrator emails revision requirements to PI. If final materials meet revision criteria, HRPP Administrator emails Exempt or NHPR determination to PI.
   2. If study does not meet Exemption/NHPR criteria, protocol is returned to PI to revise and submit an Expedited/Full-Board submission. (PI may opt to make changes to reduce risk and lower review level instead.)
4. Expedited Submissions
   1. For minimal-risk Expedited studies, HRPP Administrator conducts protocol review, notifies PI of any revision requirements, evaluates revised protocol materials (if applicable), and emails Expedited approval to PI.
   2. For higher-risk Expedited studies, HRPP Administrator and 1-2 Institutional Review Board (IRB) members conduct protocol review. HRPP Administrator collates reviewer feedback and notifies PI of any revision requirements. HRPP Administrator (and in some cases, original reviewers) evaluates revised (if applicable) protocol materials. If materials do not meet approval criteria, routed back to PI with feedback. If materials meet approval criteria, HRPP Administrator emails Expedited approval to PI.
5. Full-Board Submissions
   1. HRPP Administrator conducts prereview to identify non-substantive concerns (clarity, consistency, appropriate consent plan). If applicable, the PI will be asked to revise materials promptly before IRB review continues.
   2. Revised protocol routed to full IRB. Two IRB members serve as primary and secondary reviewers for meeting discussion.
   3. Led by IRB Chair, convened IRB discusses protocol. PI (and faculty or staff advisor, if applicable) may attend part of meeting to respond to questions.
   4. HRPP Administrator sends collated IRB feedback to PI for protocol revision (if necessary).
   5. Subsequently revised materials routed to key reviewers for assessment. If revisions do not meet approval criteria, protocol routed back to PI with feedback. (High-risk studies routed to Full Board and may require consideration at subsequent convened meeting.)
   6. If revised protocol meets approval criteria, HRPP Administrator emails Full-Board IRB approval (issued by IRB Chair) to PI.

Protocol Modifications

Modifications involve any changes to an approved protocol or an Exempt-determined protocol. Exempt studies do not require submitting a formal Modification Request Form but do require communication with the HRPP. Expedited and Full-Board studies require a formal Modification request. HRPP/IRB verification is required before proceeding with any study modification. For more detail on Modification processes and requirements, see Protocol Management.

Exempt Studies

1. PI sends a brief overview of intended changes as an email to researchintegrity@wwu.edu.
2. If alterations do not elevate participant risk or require higher level of review, HRPP Administrator notifies PI of permission to implement changes. If alterations elevate participant risk or require higher review level, HRPP Administrator emails PI options or subsequent requirements.

Expedited and Full-Board Studies

1. PI submits a Modification Request form to researchintegrity@wwu.edu.
2. Expedited: If alterations do not elevate participant risk or require higher level of review, HRPP Administrator notifies PI of permission to implement changes. If alterations elevate participant risk or require higher review level, HRPP Administrator consults with original reviewers (if applicable) and emails PI options or subsequent requirements.
3. Full-Board: If alterations do not elevate participant risk or require additional review, HRPP Administrator consults with IRB Chair for approval of modifications. HRPP Administrator notifies PI of approval to implement changes. If alterations elevate participant risk or requires additional review, HRPP Administrator sends Modification Request to Full Board, which may approve modifications via email discussion or may opt to add the Modification Request to the next convened Board agenda. HRPP Administrator will notify PI of any required revisions or IRB approval.

Ongoing Oversight

Post-Approval Monitoring and Continuing Review

• Exempt studies: Not subject to continuing oversight, but to keep HRPP records accurate, HRPP Administrator contacts PI approximately 1 year after determination to inquire about protocol status (continuing or closed).
• Expedited studies: HRPP Administrator contacts PI approximately 2 weeks before protocol expiry to inquire about the protocol status and identify next steps to continue or close the protocol.
• Full-Board studies: PI wishing to work on a protocol beyond the approval expiration must submit Continuing Review Application to researchinegrity@wwu.edu with sufficient time for consideration before protocol approval expires to avoid the study being out of compliance with federal and HRPP policies.

Unanticipated Problems and Adverse Events

As soon as possible, PIs must report any unintended problems or adverse events that arise in conducting a research study. See HRPP policy on Unintended Problems and Adverse Events to determine whether a formal report will be required. Contact researchintegrity@wwu.edu with questions. Research Integrity and Compliance staff will guide you through next steps.

Downgrade and Closure

• Expedited and Full-Board studies: When data collection is complete and any sensitive information has been deidentified, PIs send a "Downgrade to Exempt/Expedited" request to researchintegrity@wwu.edu. The HRPP Administrator updates review level and new oversight, if applicable.
• Expedited and Full-Board studies: When research is completed (data collection and analysis) PIs send a Study Closure Report to researchintegrity@wwu.edu. HRPP Administrator closes the study file.

For more information, see Protocol Management.