The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects, is the common ethical standard for publicly funded research in the United States. Changes to the Common Rule were issued by the Department of Health and Human Services (HHS) in January 2017. Most changes went into effect on January 21, 2019.
Major Regulatory Changes
Continuing review is no longer required for many categories of minimal risk research or for research that is not FDA-regulated where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. In most cases, minimal risk studies no longer require continuing review. The IRB will notify researchers upon initial approval about any post-approval review requirements.
The categories of research that are exempt from IRB review have been expanded and some existing categories have been clarified. Under the revised rule, researchers will still submit all human participant research to the IRB to determine any exemptions.
New elements of consent and a re-organization of the consent document to begin with a concise and focused presentation of the key information that is most likely to assist a potential research subject’s decision to participate or not are required.
Because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable, the UW-Madison will not implement Broad Consent at this time, which includes new exemption categories 7 and 8, which rely on Broad Consent.
Single IRB-of-Record (sIRB)
Most federally funded collaborative research projects located in the US that require IRB oversight will be required to use a single IRB (commercial, academic, or hospital-based) starting January 2020. Research teams should work with the RELIANT team to help identify the appropriate IRB to oversee any federally supported collaborative research.