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Long-Awaited Changes to Research Misconduct Rules Have Arrived

On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Health Care Triage: When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives

In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more

Biden Administration Seeks to Establish New US$6.5 Billion Health Research Agency to Target Key Disease Areas

On 9 April 2021, during a weekly economic briefing, President Biden announced his administration’s intent to establish and fund a new regulatory agency, named the Advanced Research Projects Agency for Health (ARPA-H), which...more

COVID-19: Frontline University Perspective on the Pandemic’s Disruption to Ongoing Research, and Public Policy Projections for a...

In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more

Research Community Alert – NIH Finalizes Updated Data Sharing Policy

On 29 October 2020, the National Institutes of Health (NIH) issued its final NIH Policy for Data Management and Sharing (the DMS Policy), which updates and replaces the 2003 NIH Data Sharing Policy. Although the DMS Policy...more

COVID-19: Regulatory Guidance and Flexibilities for the Clinical Research Community

INTRODUCTION - The COVID-19 outbreak has placed an unprecedented burden on the global health care community and caused significant disruption to numerous aspects of operations, including ongoing clinical research programs....more

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