The blog of the Presidential Commission for the Study of Bioethical Issues

Posts in category: Human Subjects Protection

Ethically Sound Episode 1: Safeguarding Children

In an effort to share the Bioethics Commission’s work with a wide variety of audiences, we are issuing a new podcast series called “Ethically Sound.” Today’s episode, the first in the series, focuses on the Commission’s report Safeguarding Children: Pediatric Medical Countermeasure Research, which addressed the ethically challenging topic of when and how to test pediatric medical countermeasures for possible bioterrorism agents. When and how, for example, should we test an anthrax vaccine, approved for adults, in children?

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The History of Bioethics Series – National Bioethics Commissions

This is the first post in our “History of Bioethics” series in which we will examine some of the seminal events that shaped the landscape of bioethics and its practice in the world today. This first blog will focus on the creation of the national bioethics advisory bodies in the United States and their different […]

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Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity

This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate […]

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Modernizing Human Subjects Research Protections: A Plan for Return of Results

The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes […]

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Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research

In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research. In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when […]

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Modernizing Human Subjects Research Protections: Informed Consent for Genetic Research

This is the third installment of a new blog series—Modernizing Human Subject Research Protections—taking a closer look at the recent notice of proposed rulemaking (NPRM) that suggests revisions to the Common Rule governing federally funded human subjects research. The NPRM draws on the work of the Bioethics Commission, and its ethical underpinnings mirror the analysis […]

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Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of […]

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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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Update: The Growing Need for a Systematic Approach to Compensation for Research-Related Injuries

(This post also appears on the Penn Wharton Public Policy Initiative) In December 2011, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) released its report Moral Science: Protecting Participants in Human Subjects Research. In it, the Commission responded to a charge from the President to determine if federal regulations and international […]

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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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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

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