As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more
Last week, the U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) made the announcement many academic institutions, legal professionals, and observers in the research community had long been...more
On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” ...more
Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more
10/5/2017
/ 21st Century Cures Act ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
Meeting Minutes ,
Office for Human Research Protections (OHRP) ,
Regulatory Oversight ,
Regulatory Reform ,
Research and Development ,
The Common Rule
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
2/13/2017
/ 21st Century Cures Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRB ,
NPRM ,
Scientific Research ,
The Common Rule