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.                        

IRB LIFECYCLE GUIDE

Do You Need IRB Review?

Question MarkThis 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

PencilThis section includes:

How to Submit an IRB Proposal

DownloadThis section includes:
  • ESTR: Electronic Submission Tracking and Reporting System

What to Expect When You're Expecting Review

WristwatchThis section includes:
  • Ancillary Review
  • Clarifications Requested

Researcher Responsibilities After Review

ID BadgeThis section includes:
  • Modifications
  • Continuing Review
  • RNI - Review of New Information

Closing Your Study at Harvard

Check MarkThis section includes:
  • When the study is completed
  • When you are leaving Harvard

 

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