IRB Lifecycle Guide

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
  • ClinicalTrials.gov

Closing Your Study at Harvard

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