Institutional review boards were established to protect the rights and welfare of human research subjects. Review and approval by an IRB are necessary before human subject research can begin.
Last week, the US Food and Drug Administration (FDA) and the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) finalized a new guidance for written procedures that independent/institutional review boards (IRBs) are expected to follow, reports RAPS1. A draft version of the guidance was formed in 2016 and is now finalized as part of 21stCentury Cures Act requirements.
IRBs are required to follow written procedures for various activities such as: determining that criteria for IRB approval are met, communicating an IRB’s findings and actions to both the investigator and the institution, tracking study approvals, and scheduling continuing review to prevent lapses in IRB approval.2
The new guidelines enable HHS and FDA to harmonize their human subject protection regulations. The guidance provides IRBs, like Pearl, with a checklist of 55 items used to verify their implemented written procedures meet the regulatory requirements.2However, regulations do not specify the format in which procedures must be written. Each individual IRB may establish its own format as long as the 55-item check list is taken into account.
FDA Commissioner Scott Gottlieb believes that FDA’s new guidance will “make the regulatory requirements and guidance for human subject research more consistent” and “enhance the protection of human research subjects and reduce the regulatory burden on the research community”.1
Pearl IRB delivers quick, quality expedited and full board reviews without compromising the thorough analysis required by regulations. We are one of only 21 AAHRPP accredited independent review boards in the United States and are committed to supporting high quality research by strengthening human subject protection programs. To learn more about our IRB services click here.
2https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM512761.pdf