Below is a summary of some of the key provisions relevant to investigators and research sites included in the recently enacted, bipartisan 21st Century Cures Act, including human subjects protections and the privacy and security of health information used in clinical research. Among other requirements, the Act:
*requires the Department of Health and Human Services (HHS) to harmonize the U.S. Food and Drug Administration (FDA) Human Subjects Regulations with the HHS Human Subject Regulations (the Common Rule), which should help streamline research that falls under both sets of regulations;
*requires the harmonization of financial conflict-of-interest disclosure policies and regulations of research funding agencies, including minimum reporting thresholds, and the implementation of other measures by HHS to reduce administrative burdens on researchers;
*modifies FDA regulations to allow informed consent to be waived or altered for clinical research that “poses no more than minimal risk” and includes “appropriate safeguards” which are required to be promulgated by HHS, bringing the FDA regulations in line with the Common Rule; and
*allows research sites to use central IRBs for all research studies, including those involving medical devices.
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