#  IRB Lifecycle Guide 

 



### **The HUA IRB process step by step**



 

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###    Do You Need IRB Review?  expand\_more  

### [**Do You Need IRB Review?**](/do-you-need-irb-review-and-why "Do You Need IRB Review... and Why?")

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  expand\_more  

### [**Preparing for Your IRB Application**](/you-begin-prepare-your-irb-application "Before You Begin to Prepare Your IRB Application")

This section includes:

- [HRPP Plan (PDF)](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-05/HRP-101%20-%20HUA%20Human%20Research%20Protection%20Program%20Plan.pdf) and [Investigator Manual (PDF)](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-05/HRP-103%20-%20HUA%20Investigator%20Manual.pdf)
- Levels of IRB Review and Other Determinations
- [Submission Deadlines](https://cuhs.harvard.edu/cuhs-committee-deadline-and-meeting-dates) and Convened IRB Outcomes
- [Training](https://cuhs.harvard.edu/required-ethics-training), [Collaborations](https://cuhs.harvard.edu/ins-and-outs-forging-reliance-agreement), [PI Eligibility](https://cuhs.harvard.edu/am-I-PI-eligible), [NIH Funding](https://cuhs.harvard.edu/requirements-all-nih-funded-human-subjects-research)

 

 



###    How to Submit an IRB Proposal  expand\_more  

### [**How to Submit an IRB Proposal**](/so-how-do-you-submit-irb-proposal "So, How Do You Submit An IRB Proposal?")

This section includes:

- [ESTR](https://irb.harvard.edu/): Electronic Submission Tracking and Reporting System

 

 



###    What to Expect When You're Expecting Review  expand\_more  

### [**What to Expect When You're Expecting Review**](/what-expect-when-youre-expecting-irb-review "What To Expect When You're Expecting IRB Review")

This section includes:

- Ancillary Review
- Clarifications Requested

 

 



###    Researcher Responsibilities After Review  expand\_more  

### [**Researcher Responsibilities After Review**](/researcher-responsibilities-after-review "Researcher Responsibilities After Review")

This section includes:

- Modifications
- Continuing Review
- RNI - Review of New Information
- ClinicalTrials.gov

 

 



###    Closing Your Study at Harvard  expand\_more  

### [**Closing Your Study at Harvard**](/when-close-your-study-harvard "When to Close Your Study at Harvard")

This section includes:

- When the study is completed
- When you are leaving Harvard