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) that sparked substantial commentary and debate.
In its 2011 report, Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission analyzed current protections for research participants, concluding that the regulations generally appear to protect people from avoidable harm or unethical treatment, but also offering recommendations for improvement. Indeed, the Bioethics Commission commented directly on the ANPRM in Moral Science (Recommendation 13).
The Bioethics Commission later addressed genetic research in Privacy and Progress in Whole Genome Sequencing; pediatric research in Safeguarding Children: Pediatric Medical Countermeasure Research; incidental findings in research in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts; and research with participants with potentially impaired consent capacity in Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Analysis and recommendations relevant to research ethics exist throughout the Bioethics Commission’s work.
The NPRM cites several of the Bioethics Commission’s reports, and acknowledges that “in preparing the NPRM, the deliberations of the [Bioethics Commission] were taken into account.” (NPRM, p. 397) Moreover, the NPRM’s ethical rationale in support of proposed regulatory changes often closely parallels the Bioethics Commission’s analyses of similar issues. Over the next several weeks, we will be highlighting the impact of the Bioethics Commission’s work on the NPRM, and the relationship between the Bioethics Commission’s recommendations and the proposed revisions to the Common Rule in a series on this blog called “Modernizing Human Subjects Research Protections.”