What Does the IRB Review?, Research

Below are the elements the IRB looks for when reviewing research. Federal regulations 45 CFR 46.111 and 21 CFR 56.111 outline the requirements for approval of non-exempt human subjects research. To obtain IRB approval, the IRB must have enough information to determine the criteria in each of the sections below are satisfied.

Does Your Research Project Require IRB Review?

What is an IRB?

IRB reliance: An informatics approach - ScienceDirect

IRB Types of Review, Ethical Compliance, Graduate Studies and Research

Activities Requiring IRB Review - Office of Research Support and Compliance

HUMAN SUBJECTS For Researchers U.S. DOE Office of Science (SC)

Levels of IRB Review

Requirements for Institutional Review Board (IRB) Review and HIPAA Waiver Documentation for RIF DUA Request Submissions

New Common Rule, 2019, IRB Blog, Institutional Review Board

IRB Application and Review Process for Research Involving PHI

Frequently Asked Questions (FAQ)

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study, BMC Medical Ethics

Does My Project Need IRB Review?, Research at Brown