Two Important Updates From The US Department of Health And Human Services
ClinicalTrials.gov Requirement Announcement
The effective date to comply with Clinical Trials Reporting Final Rule is January 18th. If you are an Investigator doing interventional research at Rutgers University, you may have to register/update your research study. The Final Rule broadens the range of studies that must be registered, requires submission of additional registration and summary results information, and sets forth legal consequences for non-compliance. Responsible parties have 90 days to comply. Read more
here
.
Federal Policy for the Protection of Human Subjects - UPDATED REGULATIONS
The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule to update regulations that safeguard individuals who participate in research. The new rule is intended to strengthen protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. The regulations were published in the federal register as of January 19, 2017. Read the new rule
here.
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