Protocol Management
Human Research Protections Program
Researchers and Advisors
Post-Approval Actions
Once you have received a protocol determination or approval, you still have ongoing responsibilities to the HRPP during the course of the study. But the level of review and nature of changes will determine whether you need to submit formal paperwork. Read below for more information.
Post-Approval Monitoring (PAM)
Expedited Studies
No Continuing Review Application (CRA) required. The HRPP will email you approximately 2 weeks before your study approval expires to inquire about the status of your study. Please respond promptly, so that we may update our records.
In line with HRPP policy, if you do not respond after three inquiries, the HRPP will administratively close the protocol and end oversight. (Any research activities conducted after that point will represent ongoing non-compliance and be treated as research misconduct.)
Full Board Studies — Continuing Review
According to federal regulations and WWU HRPP policy, you must submit a Continuing Review Application for any full-board study that will continue beyond its one-year approval period. However, if you conclude all data collection and will no longer interact with participants, you may be eligible to have your study downgraded to either Expedited or Exempt status. Email the HRPP for more information.
Out-of-Compliant Studies
You may not engage in any participant interaction or data collection if your protocol approval has expired. Any data collected after protocol expiry may not be retained or used for the study. If your approval has lapsed but you consider your study ongoing, contact the HRPP immediately to discuss next steps for restoring compliance.
Modification Requests
Exempt or Not Human Participant Research Studies
No Modification Request form submission required unless the change(s) could reasonably elevate risk to participants and might need a higher level of review, OR if you have internal or external funding and are altering any incentive payment method or amount.
Email the HRPP with a brief overview of any minor changes and wait for HRPP confirmation before proceeding. Examples:
- Adding or removing key personnel (provide CITI certification to the HRPP before personnel join the study)
- Minor changes in study procedures, instruments, or recruitment methods
- Alterations in HRPP-approved incentive plan (amount, method, etc.)
- Increasing or decreasing enrollment
- Adding logically relevant population groups (excluding minors)
NOTE to Student Researchers: Regardless of review level, students who wish to retain identifiable data and signed consent forms after graduation must first submit a Modification Request to transfer primary investigator status to their faculty advisor. Alumni may then continue to work on research in the capacity of an independent researcher; however, as the formal WWU affiliate, the faculty advisor remains responsible for the conduct of future research with this data, unless the former student enrolls at a new institution and transfers oversight of the project to the new HRPP/IRB.
Expedited and Full-Board Studies
Submit a formal Modification Request and wait for written HRPP confirmation before implementing any changes.
Downgrade to Exempt (DTE)/ Study Closure
Expedited Studies
When you complete all data collection, conclude all interaction with participants, and will now engage in data analysis only, you may request that the HRPP downgrade your study to Exempt status, thereby ending HRPP/IRB oversight and your responsibility to the office. (Some studies involving highly sensitive, identifiable data may not be eligible for DTE.)
For Expedited studies that have not been downgraded to Expedited, you need to submit a Study Closure report to provide a summary of the research protocol, after which the HRPP will formally close the file and end oversight.
Full-Board Studies
Full-Board studies that complete all data collection, conclude all interaction with participants, and do not involve highly sensitive, identifiable data may be eligible to be downgraded to Expedited status, after which formal Continuing Review will no longer be necessary.
For-Full Board studies that have not been downgraded to Expedited, you need to submit a Study Closure report to provide a summary of the research protocol, after which the HRPP will formally close the file and end oversight.
Unanticipated Problems/Adverse Events
For protocols of ALL review levels, carefully read the WWU HRPP Policy on Adverse Event/Unanticipated Problems. If your even/problem meets reportable conditions, you must submit an Adverse Event/Unexpected Problem Report and explain steps to mitigate the event/problem, as well as the potential for recurrence. For minor events/issues, email the HRPP for guidance.
Reporting Concerns or Complaints (including Research Misconduct)
The HRPP takes all concerns regarding WWU-affiliated studies seriously and will promptly investigate any complaints. Study participants and study team members should follow the Office of Research Integrity and Compliance guidance on reporting concerns or complaints regarding any WWU-affiliated research study.