IRB Lifecycle Guide
The HUA IRB process step by step
Do You Need IRB Review?
This section includes:
- Why IRBs exist and Regulations: OHRP and FDA
- Definitions of "Research" and "Human Subjects"
- Does my study require IRB review? Decision tree
Preparing for Your IRB Application
This section includes:
- HRPP Plan (PDF) and Investigator Manual (PDF)
- Levels of IRB Review and Other Determinations
- Submission Deadlines and Convened IRB Outcomes
- Training, Collaborations, PI Eligibility, NIH Funding
How to Submit an IRB Proposal
This section includes:
- ESTR: Electronic Submission Tracking and Reporting System
What to Expect When You're Expecting Review
This section includes:
- Ancillary Review
- Clarifications Requested
Researcher Responsibilities After Review
This section includes:
- Modifications
- Continuing Review
- RNI - Review of New Information
- ClinicalTrials.gov
Closing Your Study at Harvard
This section includes:
- When the study is completed
- When you are leaving Harvard
