Protocol Development Guidance

Do You Need HRPP/IRB Review?

Federal human participant regulations and WWU Policy require that most activities collecting data directly from individuals or accessing their identifiable data need review by the Human Research Protections Program and/or the Institutional Review Board. Projects that don't meet the federal definition of "Research" might not require an HRPP protocol application, while other projects might require some level of consideration, which can be confusing. For detailed information about different review levels and when you should submit, see Review Categories and Timelines, and click on the "Learn More" links for expanded explanations. (Note: We are in the process of developing decision trees to help guide you in this process.) For additional information, see HRPP FAQ: Common Questions. 

The HRPP/IRB cannot provide retroactive approval under any circumstances for research data collected without prior review and approval. So when in doubt, please ask! For help determining whether your planned research or teaching activity requires review, contact the HRPP.

Special Circumstances

🚩 Collaborating with a non-WWU affiliate? Please read the guidance on Ceding or Obtaining WWU HRPP Oversight before taking any steps.

🚩 Grant application requires "IRB approval" before you've developed your project? Please read the guidance on obtaining Developmental Approval.

Important First Steps

• Complete CITI training.
  • Required for all researchers and study team members who will work directly with participants or with identifiable data.
  • Required for faculty advisors of student research submissions.
  • Average completion time: 1.5-3 hours (depending on individual speed). Include all certifications as PDFs with your submission.
• Consult Review Categories and Timelines for which application is most appropriate for your project and the approximate turnaround.
• Use only the most current posted Submission and Post-Approval Forms. Don't store forms to use later.
• Use only current HRPP Consent and Other Templates.
• Review the Tips for a Successful Protocol Submission to avoid common pitfalls and facilitate a smoother review process.
• Use only your WWU email address for submissions and provide materials as individual, attached files (not shared links). (Non-WWU emails risk ending up in the Clutter or Junk folders.)

Key Submission Guidance

Close attention to these critical areas will strengthen your protocol submission for a smoother review process.