The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...more
On April 20, 2018, as anticipated, 17 federal departments and agencies (the “Agencies”) issued a notice of proposed rulemaking (“2018 NPRM”) in which the Agencies propose a six-month delay to the general compliance date for...more
On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. Final revisions were published on January 19,...more
In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more
The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more
On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S....more
On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more
Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more
The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more
On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more
On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more