Michelle Spektor – 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: Nelson Michael https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/12/member-spotlight-nelson-michael/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/12/member-spotlight-nelson-michael/#respond Fri, 12 Jul 2013 14:31:00 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=749 untitled
As a long-time HIV vaccine scientist for the United States Military, Col. Nelson Michael M.D., Ph.D. didn’t find bioethics—bioethics found him.  Originally trained in internal medicine and molecular biology, Michael entered the U.S. Army in 1989 and became the director of the U.S. Military HIV Research Program in 2006, where he oversaw clinical trials including the first HIV vaccine trial to show efficacy—the RV144 HIV vaccine in Thailand.  There, Michael gained on-the-ground expertise in bioethics by dealing with one of its core principles, community engagement, in real time.

“Doing complex clinical trials with experimental vaccines associated with the U.S. Army in Asia and Africa raises a lot of ethical issues, such as how one communicates with the community and develops trust and partnerships,” noted Michael.  “It gave me more experience on the practical side of ethics.”

In Michael’s experience, effective community engagement involved developing relationships with local authorities and community leaders, including the Thai Ministry of Public Health, which administered the 16,000-person trial in two Thai provinces.  He noted that there were divergent opinions in Thailand regarding how community engagement should be done: “Who should be doing that work?  What is the extent of it?  At the end of the trial, there was a rich debate on whether or not we had done all that we could.”

The RV144 HIV vaccine trial in Thailand was ultimately used as a case study in the deliberations of the International Research Panel, a subcommittee of the Bioethics Commission that met three times in 2011 to help inform the Bioethics Commission’s review of current protections for participants involved in human subjects research.  Michael served on that subcommittee.   In addition, his work on the trial in Thailand helped shape the Bioethics Commission’s recommendation about community engagement in Moral Science : Protecting Participants in Human Subjects Research, focusing on the integration of cultural sensitivities through dialogue between researchers and communities.

The Moral Science report resonated with Michael’s practical experiences as a vaccine researcher for the U.S. military, and the Bioethics Commission’s first report, New Directions in Synthetic Biology, drew upon his doctoral studies in molecular biology.  “I always thought that synthetic biology was a derivative of molecular biology,” he said, also noting that many of the main players and ideas in synthetic biology were familiar to him from his academic work.  He found that the ethical issues seemed similar, and considers synthetic biology to be an evolution, rather than a revolution, of the life sciences.

Regarding the scientific work that served as the jumping-off point for the Bioethics Commission’s report on synthetic biology, he said that “at the end of the day, I did not think life was created.”

While always ready to bring his practical experiences in bioethics to the table, Michael noted the importance of not being too quick to look at bioethics only through that lens. “People can be passionate about their experiences, but they may not generalize them,” he said.

Michael said that the best part about the job at the Bioethics Commission is being surrounded by talented colleagues. He emphasized the humility and respect with which they all approach the Bioethics Commission’s work.  “The Commissioners are just wonderful people—they’re bright, enthusiastic, incredibly talented, and they check their egos at the door,” said Michael. “The degree of respect that the Commissioners have for each other is really remarkable.”

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In Safeguarding Children, Commission provides guidance for application of section 407 https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/04/in-safeguarding-children-commission-provides-guidance-for-application-of-section-407/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/04/04/in-safeguarding-children-commission-provides-guidance-for-application-of-section-407/#respond Thu, 04 Apr 2013 15:01:14 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=559 Most pediatric research can be approved by an institutional review board (IRB) if it poses only minimal risk, offers the prospect of direct benefit, or yields vitally important generalizable information about the participants’ condition. When a pediatric research proposal does not fit within these confines, to move forward, it must be elevated to national-level review under section 407 of 45 C.F.R. Part 46. Section 407 regulates pediatric research that poses higher risk to healthy children without the prospect of direct benefit.

Although some types of pediatric medical countermeasure (MCM) research might be approvable by an IRB as minimal risk, higher risk pediatric MCM research might require national-level review. In its report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) provides much needed guidance for national-level review in the MCM context.  

In order to be approved under section 407, the Secretary of Health and Human Services, in consultation with a national review panel, must find that the research (i) presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children; (ii) will be conducted in accordance with sound ethical principles; and (iii) makes adequate provisions for soliciting parental permission and meaningful child assent.

In formulating the recommendation that was adopted as section 407 three decades ago, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) expressed the view in its report, Research Involving Children, that research presenting more than minimal risk to healthy children without the prospect of direct benefit could only be justified if the research is of major significance, if it addresses a grave and serious health problem, and if the expected benefit is significant.

The serious health problem the National Commission had in mind at the time was polio, and its members did not want their recommendations to be so restrictive that they would have prevented important pediatric research on polio vaccines (http://pediatrics.aappublications.org/content/113/6/1783.full). The National Commission also considered that there might be extraordinary situations in which the dangers of not involving children in more than minimal risk research are so great that it would be unethical to exclude them.

Critics of section 407 argue that its application has not conformed to the intent of the National Commission’s original recommendations.  Instead of reserving section 407 for exceptional situations, for example, IRBs might advance protocols for national-level review simply because they cannot be approved under other provisions that govern the majority of pediatric research. This has resulted in a situation where section 407 has sometimes been treated as a “catchall” for research that should be amended to conform to other approval mechanisms or possibly foregone.

Use of section 407 is further complicated by the fact that it fails to specify the “sound ethical principles” that should govern research under its purview and does not explain how to determine what constitutes a “serious problem.”  While this broad language lends national-level reviewers flexibility to take the particulars of each case into account, it has resulted in uncertainty among panels regarding the interpretation and application of these standards.

In order to successfully address ethical issues in pediatric MCM research, the Bioethics Commission needed to address the ambiguities of section 407 and clarify its guidelines. The recommendations in Safeguarding Children stipulate the circumstances in which a research protocol should proceed to national-level review under section 407, defines the terms and standards provided by section 407, and specifies ethical principles that should be used to assess research under section 407.

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Federal Regulations Concerning Pediatric Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/federal-regulations-concerning-pediatric-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/01/14/federal-regulations-concerning-pediatric-research/#respond Mon, 14 Jan 2013 15:34:33 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=502 “Under what conditions is participation of children in research ethically acceptable?”

This was the question the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research faced in 1974 when it began its deliberations on pediatric research.

Its report, Research Involving Children, ultimately became the foundation for pediatric research regulations adopted in 1983.  These regulations, which were codified in Subpart D of 45 CFR Part 46, are at the heart of the Presidential Commission for the Study of Bioethical Issues’ discussions of pediatric medical countermeasures research at Meeting 12 held in Miami, Florida.

Most provisions of 45 CFR Part 46 provide general protections for human subjects research with adults. In formulating the principles that animate Subpart D, the National Commission maintained the view that children, as a separate class, must be given additional protections in the context of research; unlike adults, children cannot provide informed consent to research and therefore constitute a “vulnerable” population. The National Commission developed standards for pediatric research protections intended to both adequately protect children and allow beneficial or important pediatric research to take place.

The regulations of Subpart D provide four ways to determine whether pediatric research is permissible based on the National Commission’s recommendations in Research Involving Children.  The first, described under 45 CFR § 46.404 (referred to as Section 404), permits research with children that presents no greater than minimal risk, or risk equivalent to that which children encounter in their daily lives, as long as adequate measures are taken to solicit informed parental permission and meaningful child assent, and other research protections, such as independent review, are in place.

The second category, Section 405, provides standards for research that presents greater than minimal risk, but is justified by the expected direct benefit to research participants – a benefit at least as favorable as alternative interventions.

Section 406 permits IRBs to approve research that is greater than minimal risk and does not offer direct benefit to participants if the research is likely to yield knowledge about participants’ condition and meets other ethical and regulatory requirements.

Finally, Section 407 regulates research that cannot be approved under 404, 405, or 406, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.  Unlike research approved under sections 404, 405, and 406, research reviewed under this provision cannot be approved by a local institutional review board; rather it must be assessed by a national review panel and can only be approved by the Secretary of Health and Human Services.  This type of review is rare.

Each type of review in Subpart D requires researchers to obtain both parental permission, and child assent, where meaningful before children can participate.

A major part of the current Commission’s deliberations today and tomorrow concerns how to best apply the ethical foundations underlying the regulations in Subpart D to pediatric medical countermeasure research in general and to anthrax vaccine research in particular.

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Executive Director Lisa M. Lee Presents “Privacy and Progress” at Personalized Medicine Conference https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/05/executive-director-lisa-m-lee-presents-privacy-and-progress-at-personalized-medicine-conference/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/05/executive-director-lisa-m-lee-presents-privacy-and-progress-at-personalized-medicine-conference/#respond Wed, 05 Dec 2012 13:04:44 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=473 Presidential Commission for the Study of Bioethical Issues Executive Director Lisa M. Lee, Ph.D., M.S., presented the Commission’s recent report, Privacy and Progress in Whole Genome Sequencing at the 8th Annual Personalized Medicine Conference at the Harvard Medical School in Boston.

The conference, held November 28-29, is organized by Harvard Medical School, Harvard Business School, and Partners HealthCare Center for Personalized Genetic Medicine – a research organization that aims to integrate genetics and genomics into patient care.  Each year, the meeting convenes hundreds of presenters and attendees from government, academia and the private sector to discuss recent developments in personalized medicine and its broader applications in policy and health outcomes. 

Lee discussed the findings and recommendations of the Privacy and Progress report during an ethics session titled Ethical Aspects of Whole Genome Sequencing.  The report, which deals with the ethical considerations of privacy and whole genome sequencing, concludes that while whole genome sequencing serves to advance personalized medicine and public health, ethical guidelines are needed for its use in clinical and research contexts to respect and secure individual interests in privacy. In short, to ensure the kind of progress whole genome sequencing promises, privacy must be protected.

Robert Green, M.D., M.P.H., an Associate Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital and the Associate Director for Research at Partners HealthCare Center for Personalized Genetic Medicine, also presented during the session.

Both Lee and Green fielded questions that concerned the ownership of whole genome sequence data and the handling of data in medical records.  Lee and Green noted that ethical conversations on these topics may be more concerned with transparency, access and use of data rather than ownership.

Lee also discussed whether genomic data security should be considered a public good that is shared across the biotechnology industry, or if it can be variable across companies in order to maintain a competitive edge.  Lee reiterated the Commission’s view that public trust depends on the maintenance of data security and its view that security best practices be shared across industry to maximize public trust.

“Many of the participants had read the Commission’s Privacy and Progress report,” noted Lee after the conference. “It was heartening to hear the robust ethics discussion at this intensely scientific meeting.”

Commission Member Raju Kucherlapati, Ph.D. chaired the meeting’s organizing committee and delivered opening and closing remarks, as well as a presentation, during the conference.

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Commission Member Anita Allen Presents “Privacy and Progress” at Cold Spring Harbor Laboratory Meeting https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/04/commission-member-anita-allen-presents-privacy-and-progress-at-cold-spring-harbor-laboratory-meeting/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/04/commission-member-anita-allen-presents-privacy-and-progress-at-cold-spring-harbor-laboratory-meeting/#respond Tue, 04 Dec 2012 19:50:03 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=469 Presidential Commission for the Study of Bioethical Issues Member Anita Allen, J.D., Ph.D., presented the Commission’s most recent report, Privacy and Progress in Whole Genome Sequencing, to a key audience of clinicians and scientists whose work involves the very technology the report addresses.

Allen’s presentation was part of an Ethics Panel at the Cold Spring Harbor Laboratories Personal Genomes and Medical Genomics Meeting, held November 14 – 17 in Cold Spring Harbor, N.Y.  Founded in 1890, the Cold Spring Harbor Laboratory is a world leader in molecular biology and genetics research and has been home to eight Nobel laureates over the course of its history.

Allen’s four-person panel presented and discussed ethical considerations in whole genome and single and multiple gene sequencing.  Approximately 100 genomicists, geneticists, graduate students and post-docs affiliated with Cold Spring Harbor and other institutions around the world attended the discussion.

In addition to reviewing the key findings and recommendations of the report, Allen fielded questions and comments from attendees.  Many of the clinicians raised questions about diagnosis, informed consent and the delivery of whole genome sequence results in the context of patient care, while many of the researchers raised questions about incidental findings and barriers to genomic data collection. 

“Everyone seemed to want specific guidance on ethical matters,” noted Allen after the meeting.

The entire panel fielded questions about the use of historical genetic samples, granting consent by opting-out versus opting-in to contributing samples to genetic research, whether biological materials are considered property, and genetic exceptionalism – the notion that genetic information should be considered differently from other types of medical information. 

The meeting convened members of the field to present and explore the biological foundations, broader applications, and current state of personal genomics.  The program included presentations by scientists and physicians, and a keynote speech by Retta Beery, whose personal story of how genome sequencing led to a correct diagnosis and treatment for her children’s rare genetic disorder was included in the Commission’s Privacy and Progress report.

The meeting’s ethics panel, on which Allen participated, also included Dr. Arthur Beaudet of the Baylor College of Medicine, Dr. Jacques Beckmann of the University of Lausanne in Switzerland, and Dr. Gholson Lyon of the Cold Spring Harbor Laboratory, who shared a story of his work in Privacy and Progress.

In addition to her work for the Commission, Allen is the Henry R. Silverman Professor of Law and Professor of Philosophy at the University of Pennsylvania.

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