HHS Delays Common Rule for Another Six Months

Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced it is delaying, again, rollout of the revised Common Rule on the protection of human subjects in clinical trials for six months—until January 21, 2019. HHS is also granting an exception from the existing federal policy for three burden-reducing provisions during the delay period. Industry has been down this road before. The new federal policy was originally scheduled to go into effect on January 19, 2018, but was delayed for six months through a controversial January 17 interim final rule. HHS can argue that it listened to industry, based on input received during a public comment period on the interim final rule in early 2018. Comments were next solicited on a Notice of Proposed Rulemaking (NPRM) to delay the full implementation of the 2018 requirements while permitting the … Continue reading HHS Delays Common Rule for Another Six Months