Tag Archives: informed consent

Welcome to the Future: HHS Releases Final Rule to Modernize Protections for Clinical Trial Participants

Photo of Kyle GregoryBy Kyle Gregory and Payal Cramer on Posted in Uncategorized
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. Department of Health and Human Services in collaboration with 15 other federal agencies (the Agencies) issued a Final Rule to update the Common … Continue Reading

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

By Greg Fosheim on Posted in Uncategorized
An overview of stakeholder comments on proposed revisions to informed consent forms and the posting of informed consent forms within 60 days after closure of enrollment On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection … Continue Reading

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

By Greg Fosheim and Payal Cramer on Posted in Uncategorized
An overview of stakeholder comments on the redefinition of “biospecimen” as a “human subject” and the consent requirements for secondary use of these biospecimens. On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for … Continue Reading

It’s About Time (But Not Quite Yet)

Photo of Rob RozierBy Greg Fosheim and Rob Rozier on Posted in Uncategorized
The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an additional 30 days to January 6, 2016.  Only the Department of Health and Human Services (HHS) has received any comments on … Continue Reading

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

Photo of Rob RozierBy Greg Fosheim and Rob Rozier on Posted in Uncategorized
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. But until now, the rules and regulations governing human subjects research (the “Common Rule” at 45 C.F.R. Part … Continue Reading
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