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.
This guidance, which was issued in draft form in August 2016, marks another step towards the more complete harmonization of the OHRP and FDA regulations.
With four pages of guidance and a nine-page checklist, the goal of the document is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures including standard operating procedures (SOPs) and policies. The guidance notes that “OHRP and FDA believe that when institutions and IRBs develop and follow clear written procedures, there is an increased likelihood that the rights and welfare of human subjects will be protected.”
People are often surprised to learn that the regulations governing IRBs require only seven specific written procedures.
Download this whitepaper to learn what the few final guidance from FDA and OHRP mean to you.