#  Committee on the Use of Human Subjects 

 



 

### Where to Start? Use the IRB Lifecycle Guide 

 

In our continued effort to de-mystify the IRB process for our research community, we have collapsed the many tips, tricks, and resources about the IRB submission process in the IRB Lifecycle Guide. You will find information presented in a sequential fashion – from understanding if and why you need review, to creating your IRB submission, to modifying it, and to closing your IRB submission when leaving Harvard or completing your study.

Included in the Lifecycle Guide are the following topics:

- Do You Need IRB Review... and Why?
- Preparing for Your IRB Application
- How to Submit an IRB Proposal
- What to Expect When You're Expecting Review
- Researcher Responsibilities After Review
- Closing Your Study at Harvard



 [ IRB Lifecycle Guide arrow\_circle\_right ](/irb-lifecycle-guide) 

 



      ![](/sites/g/files/omnuum921/files/styles/hwp_1_1__480x480/public/2024-05/lifecycle%20tree%20seasons-2019523_1280_0.png?itok=D6Ktq3XE) 

 

 

  

 



 

 

 

 

 

The Committee on the Use of Human Subjects (CUHS) serves as the Institutional Review Board for the Cambridge and Allston campuses at Harvard University. Human subjects research at Harvard University is guided by the ethical principles set forth in the [Belmont Report](https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html#) (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at [45 CFR part 46](http:/www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) and the Food and Drug Administration’s regulations at [21 CFR part 50](http:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50) and [21 CFR part 56](http:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1).



 

---

 

##  Resources 

 



 ### Essentials

- [ESTR](https://irb.harvard.edu)
- [Human Research Protection Program Plan](https://cuhs.harvard.edu/hrpp-overview?admin_panel=1)
- [Data Security](https://vpr.harvard.edu/2020/06/26/research-data-management/)
- [GDPR Privacy Disclosure](https://gdpr.harvard.edu/eeaprivacydisclosures)



 

 ### HUA IRB Information

[Newsletter Archive](/irb-newsletter-archive "IRB Newsletter Archive")  
  
[Metrics](/irb-operationsmetrics "IRB Operations/Metrics")  
  
[Become an IRB Member](/become-irb-member "Become an IRB Member") - **No positions available at this time**  
  
[HUA IRB Members Page](https://irbmemberspage.hsites.harvard.edu/)  
  
[Thank an HUA IRB Staff Member](https://harvard.az1.qualtrics.com/jfe/form/SV_5tANIh2vTQixUCG)



 

 ### Schedule an IRB Office Hour

Before scheduling your appointment, please [Find Your IRB Contact](/find-your-departments-irb-contact-person "Find Your IRB Reviewer") by school and department.

[IRB Office Hours -- HKS, HLS, Psychology](/irb-office-hours "IRB Office Hours")

[How to Cancel an Appointment](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-05/Cancel_an_appointment_1.19.2023.pdf) (PDF)



 

 ### Convened HUA IRB Meeting Dates & Application Deadlines

[Convened HUA IRB Meeting Dates & Application Deadlines](/cuhs-committee-deadline-and-meeting-dates "Convened HUA IRB Application Deadlines and Meeting Dates")



 

 ### How To...

In ESTR

- [Submit a New Application (including Exempt studies)](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=3)
- [Submit a Modification](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=52)
- [Submit a Continuing Review](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=52)
- [Submit an External IRB Application](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=19)
- [Close a Study in ESTR](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=58)
- [Go to the ESTR Support site](https://estrsupport.fss.harvard.edu/)



 

 ### NIH Requirements 

[Requirements for all NIH-Funded Human Subjects Research](/requirements-all-nih-funded-human-subjects-research "Requirements for ALL NIH-Funded Human Subjects Research")



 

 ### Quick Links

- [First Time Submitters - Welcome Page](/welcome-human-subjects-research-harvard "Welcome to Human Subjects Research at Harvard")
- [6 Tips for Speeding Up Review of Your Application](/6-tips-speeding-review-your-application-0 "6 Tips for Speeding Up Review of Your Application")
- [Recruiting Study Volunteers from the Harvard Community](/recruiting-study-volunteers-harvard-university-community "Recruiting Volunteers from the Harvard University Community")
- [Documented Consent](/everything-you-wanted-know-about-documented-consent-were-afraid-ask "Everything You Wanted to Know about Documented Consent but were Afraid to Ask")
- [Am I PI Eligible?](/am-I-PI-eligible "Am I PI Eligible?")
- [Helpful Resources](/helpful_resource_links "Helpful Resource Links")
- [FAQ](/faqs "FAQs")
- [Definitions](/definitions-0 "Definitions ")



 

 ### 2025 Federal Research Policy Changes

**OVPR**’s [Updates on 2025 Federal Research Policy Changes](https://research.harvard.edu/research-policies-compliance/2025-federal-policy-changes/) webpage compiles links to Executive Orders, recent University-wide communications, and evolving guidance from federal agencies.

Public Responsibility in Medicine and Research (**PRIM&R**) has developed [a ](https://primr.org/public-policy-resources/)[policy tracker](https://primr.org/public-policy-2/policy-resources/) for government actions that impact our research community as well.



 

  

 

 

 

### Request a training 

 

The HUA IRB has created a new resource for the Harvard University Area research community. Request a group training from the IRB by completing this form!



 [ Request A Training arrow\_circle\_right ](https://harvard.az1.qualtrics.com/jfe/form/SV_3zc8OyNTmO4gjnU) 

 



      ![illustrated tree with pink flowers growing from a rock](/sites/g/files/omnuum921/files/styles/hwp_1_1__480x480/public/2026-03/illustrated%20tree%20with%20pink%20flowers%20growing%20from%20a%20rock%20-%20the-iop-yql9KjF2-SE-unsplash.jpg?itok=Zc9dpAEW)