The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

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 Commission completed its work in December 2011 and, in its report, Moral Science: Protecting Participants in Human Subjects Research, offered fourteen recommendations to improve the current system.  Less than one month later, HHS Secretary Kathleen Sebelius asked the Bioethics Commission “to conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures (MCMs) in children.”  In Safeguarding Children, the Bioethics Commission offered six recommendations in response.

Moral Science concerns human subjects research generally – focusing principally on research governed by the Common Rule (the federal policy that governs research supported by 18 federal departments and agencies), whereas Safeguarding Children concerns a very specific type of research – pediatric MCM research, that is, pediatric testing of FDA-regulated products and interventions used in response to chemical, biological, radiological, and nuclear attacks.  Pediatric MCM research is particularly complex: it involves pediatric research participants who are ethically and legally unable to consent to participate in research, and when conducted before an attack occurs (i.e., pre-event), it involves testing interventions with an unknown likelihood of ever being used.  Pediatric MCM research conducted after an attack (i.e., post-event) poses its own challenges because of the very stressful circumstances under which it would take place.

The Bioethics Commission echoed many of the themes that it initially raised in Moral Science in its consideration of the unique set of ethical concerns associated with pediatric MCM research.  In Safeguarding Children, the Bioethics Commission stressed once more the importance of compensation for research-related injury, community engagement, and transparency and accountability.  Given the particular ethical contours of pediatric MCM research and the need for heightened protections for research involving children, the Bioethics Commission’s Moral Science and Safeguarding Children recommendations in these areas are not identical; they are complementary.  

For example, in Moral Science, the Bioethics Commission’s central recommendation for transparency and accountability called for public access to basic data about federally supported research, specifically project title, investigator, location, and funding data.  In Safeguarding Children, the Bioethics Commission recommended public access of a different sort.  For pre-event pediatric MCM research that is greater than minimal risk, the Bioethics Commission called for, among other things, enhanced transparency by involving the public in the research review process, communicating the rationale for approving or rejecting a protocol, and providing periodic updates on the conduct of research.  As the Bioethics Commission explained, such enhanced transparency is necessary in this context because a group of individual children who do not stand to benefit directly from research will bear research risks for the potential benefit of children as a class.

The common themes in Moral Science and Safeguarding Children are grounded in the foundational principles of respect for persons, beneficence, justice, and democratic deliberation.  Applying these principles to difficult issues in research ethics, the Bioethics Commission continues to elucidate protections that should be in place to protect participants from undue risk in research.

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This is a space for the members and staff of the 2009 -2017 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.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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