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Modernizing Human Subjects Research Protections: A Blog Series on Recent Proposed Revisions to the Common Rule
Last week, 16 federal departments and agencies released a notice of proposed rulemaking (NPRM) to revise the Common Rule – the regulations that govern the ethical conduct of federally supported human subjects research. This highly anticipated NPRM arrived more than four years after the July 2011 release of an advanced notice of proposed rulemaking (ANPRM) […]
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Engaging Parents and Children Throughout Pediatric Research: A New Report from the Nuffield Council on Bioethics
Today the Nuffield Council on Bioethics (Nuffield Council), an independent bioethics advisory body in the United Kingdom, released Children and Clinical Research: Ethical Issues. The report marks the culmination of a two-year inquiry, during which the Nuffield Council received input from over 500 stakeholders – including the U.S. Presidential Commission for the Study of Bioethical […]
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Bioethics Commission Continues to Recognize Value of Empirical Bioethics Research
In its recent report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) emphasized once more the importance of empirical research to support sound policy. Specifically, the Bioethics Commission recommended that federal agencies and other interested […]
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Revisiting Research Ethics
In its most recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) builds on its prior work concerning human subjects research protections. In November 2010, President Obama charged the Bioethics Commission to conduct a thorough review of current protections for research participants. The Bioethics […]
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Commission’s “Moral Science” Report Making an Impact
Less than a year after its release, the Commission’s report, Moral Science: Protecting Participants in Human Subjects Research, is having a noteworthy impact in the research community. Recently, stakeholders have taken concrete steps to implement two of the Commission’s recommendations, namely, those concerning accountability through public access and promoting community engagement. As part of its […]
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Commission Calls for Transparency in U.S. Government-Funded Research
As the Presidential Commission for the Study of Bioethical Issues continued its assessment of current protections for human subjects in research at its public meeting in Boston this afternoon, Commission member, Christine Grady, proposed that the Commission recommend improving transparency in U.S. Government-funded research. Grady said that federal agencies could develop systems – or improve […]
