Protocol Development Guidance

Do You Need HRPP/IRB Review?

Federal human participant regulations and WWU Policy require that most activities that collect data directly from individuals or access their identifiable data for research purposes need some level of review by the Human Research Protections Program and/or the Institutional Review Board.

But whether projects meet formal criteria as "Research," as defined by federal regulations can be confusing, especially for student projects involving surveys or interviews. Several variables factor into whether and when some level of review is necessary. For more specific examples, see the HRPP FAQ: Common Questions section. 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.)

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, please 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.
• Carefully read about Review Categories and Timelines to determine which application is most appropriate for your project and the approximate time from submission to determination/approval. This page will announce any delays that might occur during holidays, University closures, or summer.
• Always use the most current posted Submission and Post-Approval Forms. Don't store forms to use at a later date.
• Use only the 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 to submit all materials as individual, attached files (not shared links). (Non-WWU emails risk ending up unseen in the Clutter or Junk folders.)

Key Submission Guidance

Following the specific guidance below on these critical areas will help strengthen your protocol and result in a smoother review process.