Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?

By WIRB-Copernicus Group
Published: January 2019

In May 2018 the U.S. Food and Drug Administration (FDA) and the U.S. Office for Human Research Protections (OHRP) issued final guidance titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. The 21st Century Cures Act requires the Secretary of the Department of Health and Human Services (HHS) to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations.

To learn more, register for our free white paper Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?

Please enter in your information below. Fields with an * are required.

Please enter a valid email address to receive an email with a link to download the white paper.   

The WIRB-Copernicus Group® (WCG) is the world’s largest and most trusted provider of regulatory and ethical review services for human research.