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

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 (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 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56


Resources

2025 Federal Research Policy Changes

OVPR’s Updates on 2025 Federal Research 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 policy tracker 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!

illustrated tree with pink flowers growing from a rock

New! IRB-led Trainings - IRB 101 and IRB 102 Now Available


The HUA IRB is offering new voluntary IRB-led training sessions to the HUA research community!

IRB 101 - Learn about human subjects research and when you should submit to the HUA IRB: an introductory hour-long session that covers the fundamentals of human subjects research protection, ethical guidelines (Belmont Report), and considerations for when IRB review is required. 

IRB 102 -  Learn about how to submit to the HUA IRB: an introductory hour-long session that provides a brief refresher on key definitions from the regulations and an overview of how to submit to the HUA IRB following the steps outlined in our IRB Lifecycle Guide. 

Seal_2
SmartIRB logo