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New Rulemaking for Federal Policy for the Protection of Human Subjects


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The Sleeptember team encourages interested parties to weigh in on new rules regarding patients participating in research studies. This is important as new patient-centered research initiatives and Apple ResearchKit studies get underway.

U.S. government departments and agencies propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.