Olivia Nevitt – blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Mon, 09 Jan 2017 23:23:29 +0000 en-US hourly 1 Member Spotlight: Anita L. Allen https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/05/member-spotlight-anita-l-allen-j-d-ph-d/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/05/member-spotlight-anita-l-allen-j-d-ph-d/#respond Fri, 05 Jul 2013 15:00:01 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=738 anita-allen_portrait

When Dr. Anita Allen moves in to her new office at the University of Pennsylvania, where she has recently been appointed Vice Provost for Faculty, she will bring her 1991 yearbook from Harvard Law School. Allen points out that the yearbook includes a portrait of her, then a visiting law professor, and also of then student leader and graduating law student, Barack Obama. Allen says that she never imagined that 20 years after those pictures were taken, Obama would be President and she would be a member of his Bioethics Commission, the Presidential Commission for the Study of Bioethical Issues.

A graduate of Harvard Law, Allen has been a part of the University of Pennsylvania faculty since 1998. She is currently the Vice Provost for Faculty at the University of Pennsylvania and Henry R. Silverman Professor of Law and Professor of Philosophy.

When Dr. Allen was a graduate student in philosophy at the University of Michigan, she was recruited to be a teaching assistant for a medical humanities course as well as a contemporary moral problems course. The topics covered in the courses, including women’s reproductive health issues and the right to die, fascinated her. She credits these two courses in particular with inspiring her interest in bioethics.  Her doctoral dissertation research brought her into contact with the U.S. Supreme Court’s right to family and personal privacy cases. The issue of privacy became a gateway to her engagement with a host of topics in clinical medicine and health research.

As a member of the Bioethics Commission Allen has had the opportunity to engage in a number of new topics. For example, she says that the science the Bioethics Commission learned about in connection with New Directions: The Ethics of Synthetic Biology and Emerging Technologies was intriguing and that the problems of justice raised by “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 were particularly gripping. In addition, Privacy and Progress in Whole Genome Sequencing was an exciting report for her to be involved with given her interest in privacy law.

Allen says that being a part of the Bioethics Commission has been a highlight of her professional life. She was extremely honored to have been selected to serve the nation in this way under President Obama. “We have taken on questions of incredible complexity and drawn on the resources of top scholars and affected persons to help us in our deliberations— the work has been deeply satisfying.”

 

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What are Medical Countermeasures? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/03/20/what-are-medical-countermeasures/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/03/20/what-are-medical-countermeasures/#respond Wed, 20 Mar 2013 19:55:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=535 The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published a report, Safeguarding Children: Pediatric Medical Countermeasure Research, addressing the ethical considerations in conducting clinical trials of medical countermeasures (MCMs) with children. The Bioethics Commission received its charge for this report from the U.S. Department of Health and Human Services Secretary, Kathleen Sebelius, whose offices is “responsible for developing and stockpiling safe and effective [MCMs] to protect the nation from bioterror attacks.”

What are MCMs?

In its report, the Bioethics Commission considered MCMs to encompass “U.S. Food and Drug Administration (FDA)-regulated products and interventions used to combat the effects of chemical, biological, radiological, or nuclear (CBRN) events,” one of several varied definitions of MCMs.  Because MCMs can include protections for and responses to many different types of events (e.g., disease, outbreaks, natural disasters, terrorist attacks), various government agencies, policy centers, and legislators have specified the term to reflect the focus of their work.

Some organizations define MCMs very broadly, encompassing a variety of causes of harm, including natural disasters and infectious disease outbreaks such as the 2009 H5N1 influenza virus and the SARS outbreak of 2003.  Others broaden the definition in terms of types of responses to harm.  The White House Office of Science and Technology Policy, for example, employs a broad definition of MCMs, which includes “both biologic and pharmaceutical medical countermeasures (e.g. vaccines, antimicrobials, and antibody preparations), non-pharmaceutical medical countermeasures (e.g. ventilators, devices, personal protective equipment such as face masks and gloves), and public health interventions (e.g. contact and transmission interventions, social distancing, and community shielding) to prevent and mitigate the health effects of biological agents,” some of which are FDA-regulated and some of which are not.

Alternatively, the definition can be narrowed, for example, by specifying the type of response used to prevent and mitigate harm (e.g., pharmaceuticals or public health strategies) or limiting the type of events that might cause the harm in question (e.g., natural events or acts of terrorism).  The Bioethics Commission employed its narrow definition in response to Secretary Sebelius’s charge. The Secretary tasked the Bioethics Commission with conducting “a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children” including “the ethical considerations in conducting a pre- and post-event study of AVA PEP [anthrax vaccine absorbed post exposure prophylaxis] in children”—an MCM designed to respond to a terrorism attack. Moreover, Secretary Sebelius specifically referenced “bioterror attacks” in her charge.

The Bioethics Commission adopts a narrow definition for the purposes of this report. The Bioethics Commission’s guidance, however, might be applicable to a wider range of pediatric research.

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What’s next for the Commission? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/02/19/what%e2%80%99s-next-for-the-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/02/19/what%e2%80%99s-next-for-the-commission/#respond Tue, 19 Feb 2013 14:14:34 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=519 The Presidential Commission for the Study of Bioethical Issues published a report on whole genome sequencing, Privacy and Progress in Whole Genome Sequencing, in October 2012. At its January meeting in Miami, Fla. the Commission finalized its work on a report on the ethics of medical countermeasures research with children, which will be released soon.

So, what’s next?

As an advisory body, the Commission takes on timely and pressing bioethical issues.

The Commission’s topics of study come from two sources.

The Executive Office of the President and the executive departments and agencies can ask the Commission to study a particular subject.  The Commission’s report on the Public Health Services’ STD experiments, “Ethically Impossible” STD Research in Guatemala from 1946 to1948, and the Commission’s report on protections for human subjects in research, Moral Science: Protecting Participants in Human Subjects Research, were written as the result of a charge that came directly from the Executive Office of the President.  You can view the official charge here.

Alternatively, the Commission can use its expertise to identify a topic to study based on issues Commission members feel are timely and important, as was the case for the Commission’s recent report Privacy and Progress in Whole Genome Sequencing.  The report’s topic is certainly timely, as the concept of identifiability continues to be explored and debated in the scientific literature as do the issues of access to and use of genomic data.

At the Commission’s meeting in Miami, Commission Chair Amy Gutmann, Ph.D., announced that the Commission will study the ethical implications of incidental findings.  Incidental findings are data gleaned from medical procedures or laboratory tests that were beyond the aims or goals of the particular laboratory test or medical procedure. This topic came out of the research the Commission did for its Privacy and Progress report and is an area that the members agreed deserved more of the Commission’s time and attention.

At the January 2013 meeting, Commission members began to discuss several fields in which incidental findings raise serious ethical questions, such as neurology and genetics, in addition to various settings such as clinical and research. The implications of how incidental findings are handled affect research participants, patients, consumers, and healthcare professionals. The Commission’s bioethical inquiry likely will include the importance of what patients and participants should be told by healthcare professionals not only after a procedure or a test is performed, but before as part of the informed consent process.

Stay tuned for more information regarding the Commission’s next meeting and first discussion of incidental findings, April 30 and May 1, 2013 in Washington, D.C.

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Tom Beauchamp, Ph.D. to address Commission https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/tom-beauchamp-ph-d-to-address-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/tom-beauchamp-ph-d-to-address-commission/#respond Mon, 14 Jan 2013 18:20:32 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=506 Tom Beauchamp, Ph.D., an invited speaker at the 12th meeting of the Presidential Commission for the Study of Bioethical Issues, has been a Senior Research Scholar at the Kennedy Institute of Ethics and a Professor of Philosophy at Georgetown University for more than 30 years.

Beauchamp has earned many accolades in the field of bioethics.  He joins the Commission’s meeting for continued discussion of the issue of pediatric medical countermeasures.

In 1975 he began work as a staff member of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, where he jointly authored the Belmont Report, a formative text in bioethics. The National Commission is generally viewed as the first national bioethics commission.  (For more information about prior bioethics commissions see http://cms/history.)

Beauchamp’s research interests include the ethics of human subjects research, the place of universal principles and rights in biomedical ethics, methods of bioethics, the philosopher David Hume, and business ethics.

Beauchamp received B.A. and M.A. degrees from Southern Methodist University, a B.D. degree from Yale University, and a Ph.D. in Philosophy from Johns Hopkins University.

His 140 plus scholarly publications include: Frontiers of Biomedical Ethics; The Oxford Handbook of Business Ethics; The Oxford Handbook of Ethics and Animals; Principles of Biomedical Ethics; A History and Theory of Informed Consent; The Human Use of Animals; and Philosophical Ethics. He is also an editor of The Clarendon Hume.

Beauchamp was presented with Georgetown’s Career Recognition Award in 2003 for distinguished research across an entire career and in 2004, he received the Lifetime Achievement Award from the American Society of Bioethics and Humanities.

He currently holds an NIH Challenge Grant for work on the distinction between research and treatment, as well as a National Science Foundation award to continue his work in animal research ethics.

He joins the meeting today via videoconference to discuss how the Belmont principles apply in assessing whether research with individual children as participants is ethically permissible, as well as the ethical permissibility of balancing research risk and direct benefit to the individual child.

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Dennis Thompson, Ph.D. to address Commission https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/dennis-thompson-ph-d-to-address-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/dennis-thompson-ph-d-to-address-commission/#respond Mon, 14 Jan 2013 17:08:00 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=504 As the Presidential Commission for the Study of Bioethical Issues gathers in Miami to continue its discussion of the development of an ethical framework around the issue of pediatric medical countermeasures, Commission members will hear from additional experts in relevant fields.

This afternoon Dennis F. Thompson, Ph.D., the Alfred North Whitehead Professor of Political Philosophy at Harvard University, and the founding director of the Edmond J. Safra Center for Ethics at Harvard, will address the Commission. At issue: the philosophical grounding for the ethical approach that the Commission is considering for the complex issue of pediatric medical countermeasure research.

The Commission is not the first to ask Thompson to advise on a challenging topic.  He has served as a consultant to the Institute of Medicine on the topic of Conflict of Interest in Medical Research, Education, and Practice, and as advisor to the American Medical Association, the Food and Drug Administration, the U.S. Senate Ethics Committee, as well as the Joint Ethics Committee of the South African Parliament.

Thompson’s work focuses on political philosophy, ethics in government and healthcare, and democratic theory. He received a first class honors degree in philosophy, politics, and economics from Oxford and a doctorate in political science from Harvard University, where he has been teaching since 1986.

The Edmond J. Safra Center for Ethics serves as a university-wide academic center for the study of theoretical and practical ethics across a variety of disciplines. The Center hosts faculty fellows, graduate fellows, and a wide variety public events programming. Thompson led the center for two decades.

Dr. Thompson will be a part of the Commission’s discussion regarding the ethical aspects of pre-event testing of an anthrax vaccine with children and, more broadly, the content of deliberations of the ethical considerations that should guide pre- and post-event medical countermeasure research with children.

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Empowering Patients through Informed Consent https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/11/09/empowering-patients-through-informed-consent/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/11/09/empowering-patients-through-informed-consent/#respond Fri, 09 Nov 2012 15:44:13 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=446 If your doctor recommended that you have your whole genome sequenced, you would likely have a lot of questions, including:

Where will my data be stored? Who will have access to them? Will they be secure?  Can I control who sees the information gathered from my data? How will my information be kept private? Is having this information entirely a good thing for me? What kind of research might my data be used for in the future? Can I be identified from my data? What can happen to me or my family if someone like an insurance company or my employer gets a hold of this information?

Currently, not all of these questions have clear answers, but the Presidential Commission for the Study of Bioethical Issues believes you should be asking them.

While there are legal protections against the misuse of genetic information by employers and health insurers through the Genetic Information Nondiscrimination Act of 2008 (GINA), there are currently no other broad protections against misuse of genetic information and the laws regulating who has access and how this information can be used varies from state to state.  For example, GINA does not apply to long-term care insurance or life insurance.

The recommendations in the Commission’s recent report Privacy and Progress in Whole Genome Sequencing are aimed at protecting the privacy of individuals who have their genomes sequenced and empowering them through informed consent.  To realize the enormous power of whole genome sequencing, the Commission recognizes that many people will have to have their genomes sequenced and share that very personal information with researchers.  To encourage enough people to share in that way, privacy must be ensured.  That responsibility falls on researchers, clinicians, and participants alike.

The Commission proactively argues that individuals consenting to whole genome sequencing ought to be made aware of not only the associated risks and benefits but also how their data will be used and who will have access to the data.

In assessing the advancing field of whole genome sequencing, the Commission recommends protecting and empowering patients through the “evaluation and adoption of a robust and workable informed consent process.”  Informed consent is more than a form to be signed; it is a process that involves an active discussion between patient and clinician or researcher.  Informed consent is a demonstration of respect for persons, the ethical principle that serves as the cornerstone of the Commission’s report.

The Commission recommends that researchers and clinicians create an environment where participants would have answers to their questions and play an active role in deciding how their whole genome sequencing data will be used both at present and in the future.

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