This draft guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for institutions and institutional review boards (IRBs) responsible for oversight of human subject research under HHS and FDA regulations.
This draft guidance is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings (also referred to in this guidance as minutes). This draft guidance document describes requirements for minutes and provides recommendations for meeting the regulatory requirements for minutes.
OHRP’s and FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe OHRP’s and FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in OHRP and FDA guidances means that something is recommended or suggested, but not required.