On January 21, 2019, all new federally funded human subjects research studies must comply with the revisions to the U.S. Department of Health and Human Services (DHHS) human subjects research regulations. Where research studies are also Food and Drug Administration (FDA) regulated “clinical investigations,” they must also comply with those regulations. The FDA is working on harmonizing its regulations with the revised version of the DHHS regulations. In addition, all research conducted in Maryland must continue to follow the Common Rule.
Study applications submitted before 2019 should refer to the revised consent documents below.