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

The Potential of Neuroscience Research

As the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continues its examination of the ethical issues associated with neuroscience research and the application of neuroscience research findings, it heard from a panel of experts about what neuroscience research might mean for various affected communities.

The diverse panel included representatives of those affected by Alzheimer’s disease, Parkinson’s disease, and mental illness.  Neuroscience research and translation of neuroscience findings into clinical applications could directly impact these three groups.  Engaging affected communities plays a key role in the Bioethics Commission’s deliberations.

Harry Johns, President and CEO of the Alzheimer’s Association, opened the session.  Alzheimer’s disease is the sixth-leading cause of death in the United States. The largest non-profit funder of Alzheimer’s research, the Alzheimer’s Association has awarded over $315 million to more than 2,200 scientists since 1982 to advance understanding of Alzheimer’s and dementia and identify new treatments, preventions and ultimately, a cure.

According to the Alzheimer’s Association, a lack of volunteers for Alzheimer’s clinical trials is one of the greatest obstacles slowing the progress of potential new treatments. The Association’s clinical studies matching service connects individuals with Alzheimer’s, their caregivers, healthy volunteers, and physicians with current studies.

Johns noted that “for many years in our area diminished capacity was perhaps the biggest consideration” regarding participation in clinical trials. And it remains a key concern.

“At the Alzheimer Association we recommend that for people to have an ethically valid approach, that they do not participate in a study decided only by surrogates if they themselves cannot benefit from the treatment that they would receive,” he said

Sohini Chowdhury, Senior Vice President for Research Partnerships at the Michael J. Fox Foundation for Parkinson’s Research spoke next. According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide are living with Parkinson’s disease, yet the causes of Parkinson’s remain unknown. Medications and treatments, including deep brain stimulation, help patients manage the symptoms of Parkinson’s disease, yet no cure exists. Since 2000, the Michael J. Fox Foundation has granted more than $450 million in research and supported efforts to improve recruitment of participants for clinical trials to accelerate the development of new and improved treatments for Parkinson’s.

Chowdhury said many in the Parkinson’s patient community are willing to participate in research that involves disclosing their genetic status or sharing their medical history.

“They accept that there are risks,” she said. “There are tradeoffs for hearing status or for entering medical history into an online database. Our community has by and large chosen to recognize the potential risks and forge ahead,” she said.

Next up was Dr. Gregory Simon, Chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance (DBSA). Depression and bipolar disorder affect more than 21 million Americans, and contribute to 90 percent of the nation’s suicides every year. DBSA was created for and is led by individuals living with mood disorders, and is guided by a scientific advisory board comprised of the leading researchers and clinicians in the field of mood disorders. It provides information and educational resources for individuals, families, caregivers, and clinicians.  Resources include information on wellness programs, treatments, and the latest research on mood disorders.  The organization offers free support groups and online tools to help patients manage their health.

Simon said while he agreed that there are many things about the issues raised by neurological conditions that are similar to those that occur with other afflictions, it’s important to understand there are differences.

“There are a few things about mental health conditions that do stand out,” he said. “These conditions often affect people early in life, they cause long-term disability…and the expression of mental health conditions is remarkably heterogeneous.”

He added that “mental health conditions unfortunately still carry much stigma and discrimination. And also in the mental health area we see well-intentioned paternalism.”

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Considering Ethics of Neurological Research at All Stages of Life

As the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continues examining ethical issues associated with neuroscience research and the application of research findings, the discussion in Atlanta turned to the difficult issues that arise in neurological research conducted at different stages of life.

In his charge to the panel, President Obama noted that it is important to consider “the implications of the discoveries that we expect will flow from studies of the brain” and explore the issues they raise “as they relate to different life stages, from infancy through old age.”

The Bioethics Commission invited four experts to outline concerns that coalesce around various patient groups, pediatric to geriatric.

William D. Graff, M.D., F.A.A.P., F.A.A.N., a professor in the Department of Pediatrics and Neurology at the Yale University School of Medicine, considered ethical issues that need to be considered when the research subject is a child.

He said there is a critical need for research into neurological disorders that can affect infants, children, and adolescents, pointing out that “neurological development is the essence of pediatrics.” But he said that “knowledge gained from pediatric research must be obtained in a way that recognizes the vulnerability of children and respects their best interests.”

David W. Wright, M.D., Associate Professor of Emergency Medicine and Director of Emergency Neurosciences at Emory University School of Medicine, explored issues that arise from research involving adult patients experiencing neurological emergencies, such as traumatic brain injury or stroke.

He said brain injuries suffered by U.S. military personnel serving in Iraq and Afghanistan, along with increased attention to sports-related brain trauma, has significantly intensified efforts to find better treatments for these conditions.

Wright said the “elephant in the room is the inability to protect the autonomy” of potential research subjects who might be completely incapacitated and unable to provide consent. He noted the tension between the informed consent concerns surrounding this patient population and the urgent need to deal with injuries that are killing 52,000 people each year, the equivalent of crashing 175 747s.

“There is a moral imperative to find new treatments,” he said.

Howard Feldman, M.D., F.R.C.P, Professor of Neurology and Executive Dean of Research on the Faculty of Medicine at the University of British Columbia, focused on geriatric participants, including ethical issues with patients suffering from dementia. He said the burden presented by the growing numbers of people worldwide with dementia, which could double by 2030 and generate up to $1 trillion in health care costs, has made the search for treatment a public health imperative.

Feldman pointed to how obtaining consent from patients suffering from neurologically degenerative disorders is complicated by the fact that the very nature of the condition means the patient’s capacity and awareness is changing over time.

“You could imagine someone starting a program of research with full capacity and then it changes,” he said.

This issue, assessing a particular patient’s capacity to participate in research, is a challenge facing researchers working in neurological research across the life stages. Earlier in the day, John Arras, Ph.D., the Porterfield Professor of Biomedical Ethics and Professor of Philosophy at The University of Virginia, observed that the issue of capacity comes down to the ability or lack of ability to consent.”

Rebecca Dresser, J.D. , Daniel Noyes Kirby Professor of Law, Professor of Ethics in Medicine, Washington University, St. Louis, discussed concerns associated with research involving patients with diminished, changed, or no capacity to consent, and the ethical safeguards that should be in place to protect them. She said dealing with capacity concerns presents researchers with the constant challenge of evaluating just how much the neurological deficit impairs the ability to provide informed consent.

“We don’t want to stereotype people based on a diagnosis. You don’t want to disrespect the autonomy of people still able to make their own choices,” she said. “But on the other hand, you don’t want to fail to protect vulnerable people who cannot understand the decisions before them.”

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Bioethics Commission Continues Discussion about Neuroscience and Ethics

Contemporary neuroscience has begun to make important breakthroughs, and given the complexity of the brain, scientists recognize we must better understand the brain in order to make desired progress.  As researchers learn about the brain and its relation to the mind, fundamental questions arise about what makes us human.  Accompanying ethical considerations must be addressed.

That is why President Obama requested that the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) review the ethical considerations of neuroscience research and its application as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Last month, the Bioethics Commission released the first of two reports in response to this charge: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society.  In that report the Bioethics Commission recommended integrating ethics explicitly and systematically into neuroscience research across the life of a research endeavor.

During this meeting in Atlanta the Bioethics Commission will continue its work in response to President Obama’s charge. It will consider the ethical and societal implications of neuroscience research and its applications more broadly.  The Commission will examine implications that scientists, ethicists, educators, private funders, and the public should be prepared to handle.

“A strongly integrated research and ethics infrastructure—as recommended in our recent report—will be well equipped to address these ethical implications,” said Amy Gutmann, Ph.D., Chair of the Bioethics Commission, as she opened the Commission’s public meeting.

Over the next two days the Bioethics Commission will hear from experts on topics including neuroscience research across life stages – from infancy through old age; data sharing and access in neuroscience; the potential neuroscience research holds for us all, particularly for affected communities like those diagnosed with or at risk for Alzheimer’s, Parkinson’s, or mental illness, for example.

The President asked the Bioethics Commission to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”

The Bioethics Commission has held five previous public meetings on the topic and, in addition to this meeting in Atlanta, has at least one more meeting scheduled for August. The Bioethics Commission’s process is well underway toward developing recommendations to respond to the second part of the President’s request.

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Live from Atlanta

Welcome to the live blog for the seventeenth public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting in Atlanta today, June 9, 2014, from 9 a.m. to 4:15 p.m., ET and tomorrow, June 10, 2014 from 9 a.m. to 12:15 p.m.

At this meeting, the Bioethics Commission will continue its review of the ethical issues associated with neuroscience research and the application of neuroscience research findings, in response to President Obama’s charge.

You can follow the proceedings of the Bioethics Commission’s meeting here at this blog, and on the live webcast at the Bioethics Commission’s website. All transcripts and webcasts will be archived and available following the meeting.

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Bioethics Commission Recommends Integrating Ethics and Science through Education at All Levels

In Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society(Gray Matters, Vol. 1), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) emphasized the need to integrate ethics throughout the life of neuroscience research and considered various approaches to integration. Early and explicit integration of ethics and neuroscience research enables scientists, ethicists, educators, public and private funders, policymakers, and the public to better recognize and address the ethical and societal implications of neuroscience research and its applications.

One foundational approach to integration is linking science and ethics education at all levels. Early ethics education is critical for preparing future scientists, including neuroscientists, to cultivate ethical reflection and to integrate ethical considerations into their work. Professional development for experienced investigators is equally important, as ethics education is more likely to inform action when it is continually reinforced. Ethics education should occur at many points before, during, and after graduate school.

Integration through education is a two-way process that involves both exposing scientists to ethics and ethicists to science. Ethics programs should also require exposure to scientific methods. For example, students could be required to complete a laboratory science component to enhance their scientific literacy and understanding. Training scientists in ethics and training ethicists in the sciences are both important for effective integration.

The Bioethics Commission recognized several examples of existing efforts to integrate ethics education at the secondary and undergraduate levels in Gray Matters, Vol. 1, and concluded that further development and evaluation of models for integrating ethics and science through all levels of education are needed. The Bioethics Commission also called for educational models to be shared, allowing researchers to evaluate various models and to identify and apply best practices. When successfully implemented, ethics education can effectively prepare future scientists and better engage practicing scientists—including neuroscientists—to integrate ethics into their work.

In Gray Matters, Vol. 1, the Bioethics Commission’s third recommendation addresses integration of ethics and science through education at all levels:

Government agencies and other research funders should initiate and support research that develops innovative models and evaluates existing and new models for integrating ethics and science through education at all levels.

An overarching theme throughout the Bioethics Commission’s reports has been the need for improvement in bioethics education. The Bioethics Commission is actively committed to doing its part to enhance such education, contributing to bioethics pedagogy by creating free and publicly accessible educational modules based on Commission reports; drafting study guides, primers, and other materials that facilitate deeper examination of the Commission’s ethical analyses; and engaging in outreach and teaching opportunities.

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Bioethics Commission Addresses Approaches to Ethics Integration in Neuroscience Research

On May 14 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1). This report on neuroscience and related ethical issues emphasizes the importance of integrating ethics into neuroscience research across the life of a research endeavor. Ethics integration is a process by which scientists and ethicists engage with each other, and often other stakeholders, to understand the social and ethical dimensions of their work, including the relationship between science and the societal context in which it operates.

Gray Matters, Vol. 1 contains four recommendations for integrating ethics into neuroscience research. In its second recommendation, the Bioethics Commission called for evaluating existing and innovative approaches to ethics integration. Specifically the Commission recommended that:

Government agencies and other research funders should initiate and support research that evaluates existing as well as innovative approaches to ethics integration. Institutions and individuals engaged in neuroscience research should take into account the best available evidence for what works when implementing, modifying, or improving systems for ethics integration.

The Bioethics Commission emphasized that institutions and individuals engaged in neuroscience research should learn from collective experience to improve existing systems and inform others about what works and what does not. In addition, they should evaluate innovative approaches to prevent reliance on approaches that are familiar, but potentially outdated, inefficient, or counterproductive. Funders, institutions, and researchers should look to best practices while evaluating existing and new approaches to integration in order to inform innovation, foster improvement, and measure success. Researchers should share widely their findings and conclusions to support more robust and informed ethics integration.

In Gray Matters, Vol. 1, the Bioethics Commission highlighted several implementation strategies for ethics integration into scientific research. One such strategy is ethics integration through research ethics consultation. An example consultation service is the Benchside Ethics Consultation Service (BECS) at Stanford University, which makes ethics advice available through all stages of research to bench scientists, clinical researchers, biotechnology and pharmaceutical companies, institutional review boards, journal editors, and research participants. Evaluating the impact of research ethics consultation services, assessing the quality of their recommendations, and providing best practices for creating and maintaining these services are crucial to their success and the success of future integration efforts. Dr. Mildred Cho described to the Bioethics Commission that evaluation is a priority for the BECS:

“[An] important aspect of this [integration] for us has been trying to think about what it means to have a successful program in research ethics consultation and what is a successful consultation service, which obviously requires definition of what the goals are….You have to really think about what the goals are. Is it engagement in and of itself or are there other products that you would like to see that come out of that?”

She explained that researchers are examining factors such as “whether uptake of the service has increased [and] whether the stage of utilization…has increased.” Other measures of success might include “products such as publications, modifications to research projects, [and] policy changes” as well as “researcher satisfaction and attitudes.”

Executed well, ethics integration is an iterative and reflective process that enhances both scientific and ethical rigor. It assists neuroscientists in recognizing fundamental ethical and social dimensions of the complex phenomena they seek to understand. The Bioethics Commission’s recommendations are intended to strengthen ethics integration infrastructure for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative and neuroscience more broadly, ensuring that this important science will advance the public good.

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Studying the Study Guide: Key Uptake of Educación Ética

Since first recommending ethics education across disciplines in New Directions: The Ethics of Synthetic Biology and Emerging Technologies, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has been committed to the production, dissemination, and encouraging the use of ethics educational resources. Accordingly, the Bioethics Commission is eager to learn of examples of how its educational tools are being used and how they might be improved. At a recent workshop held at the Pan American Health Organization (PAHO), the Bioethics Commission was excited to learn that Carla Saenz, Ph.D., Bioethics Regional Advisor at PAHO, recently distributed the Spanish translation of the Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, Educación Ética: La Guía de Estudio para “Éticamente Imposible” Investigación sobre ETS en Guatemala de 1946 a 1948 to the Investigación ÉTICA network. Upon receipt of the Study Guide, the Investigación ÉTICA network – which comprises over 1,100 ethics review committees and research ethicists in Latin America and the Caribbean – sent Saenz “very appreciative responses for sharing such a training tool.”

“I was particularly interested in the translation of the Study Guide and its further dissemination because I think it meets a specific regional need,” said Saenz. Addressing the challenges in bioethics training in the Latin American region is a topic recently explored by Saenz and several co-authors in a paper published in the Journal of Empirical Research on Human Research Ethics.[1] Saenz et al., concluded that resources for ethics education should be created for all levels and incorporate critical thinking exercises and case studies. Additionally, they argued that making resources available in Spanish is the key to strengthening the analytical skills of individuals working in research ethics in Latin America. Bioethics materials in Spanish are “really crucial to close the gap on bioethics training between Latin America and the English speaking world,” said Saenz.

The Bioethics Commission designed the Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 to assist those who wish to focus on the ethical significance of these experiments. Each section of the Study Guide includes a review of relevant facts, excerpts from documents contemporaneous to the experiments, and a set of further readings. This material will assist readers who wish to explore the record in further detail or prepare for a more informed discussion of research in light of this example of gross ethical violations.

“The Bioethics Commission is very pleased to learn that the Spanish Study Guide is being distributed and used by such a large Spanish speaking network of researchers and ethicists. All feedback on the tools is extremely valuable, and we’re grateful to Dr. Saenz both for sharing the resource with her colleagues and for sharing the story with us,” said Hillary Wicai Viers, Bioethics Commission Communications Director.

Please share your stories about using the Bioethics Commission’s educational tools via education@bioethics.gov.

All of the Bioethics Commission’s education materials are free and available on www.Bioethics.gov.

 

[1] Saenz, C., et al. (2014). Twelve years of Fogarty-funded bioethics training in Latin America and the Caribbean: Achievements and Challenges. Journal of Empirical Research on Human Research Ethics, 9(2), 80-91.

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Integrating Ethics Early and Explicitly Throughout Neuroscience Research

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1). The report is the first of a two-volume response from the Bioethics Commission to President Obama’s July 2013 request. As part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative the President asked the Bioethics Commission to “identify proactively a set of core ethical standards—both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.” The BRAIN Initiative, launched by the President in April 2013, aims to “revolutionize our understanding of the human mind and uncover new ways to treat, prevent, and cure brain disorders like Alzheimer’s, schizophrenia, autism, epilepsy, and traumatic brain injury.”

In Gray Matters, Vol. 1, the Bioethics Commission addressed the need for the integration of ethics and neuroscience across the life of a research endeavor, making four recommendations. The first of these recommendations called for integrating ethics early and explicitly throughout neuroscience research. Specifically the Commission recommended that:

Institutions and individuals engaged in neuroscience research should integrate ethics across the life of a research endeavor, identifying the key ethical questions associated with their research and taking immediate steps to make explicit their systems for addressing those questions. Sufficient resources should be dedicated to support ethics integration.

Approaches to ethics integration discussed by the Bioethics Commission include:

  • Implementing ethics education at all levels;
  • Developing institutional infrastructure to facilitate integration;
  • Researching the ethical, legal, and social implications of scientific research;
  • Providing research ethics consultation services;
  • Engaging with stakeholders; and
  • Including an ethics perspective on the research team.

The Bioethics Commission stressed that those involved in research have a responsibility to identify and address the ethical issues that arise throughout the scientific research process. According to the Bioethics Commission, integrating ethics in science should allow for productive dialogue and collaboration between experts in many fields including the social sciences, the life sciences, medicine, law, history, and philosophy, among others. The Bioethics Commission recognized that, in various ways, ethics is already integrated into the scientific enterprise as it is in many human activities. However, the Bioethics Commission emphasized the importance of making implicit ethical judgments explicit, and implementing ethics integration systematically. The Bioethics Commission explained that institutions and individuals might adopt different approaches to integrating ethics and neuroscience research depending on the context in which they act.

Notably, as part of this recommendation, the Bioethics Commission acknowledged that if something is not appropriately funded, it does not get done. Thus it called for dedicating sufficient financial resources, human capital, and expertise to support integrating ethics and neuroscience research.

Integrating ethics early and explicitly will lay the foundation for successful integration of ethics throughout neuroscience research, equipping scientists, ethicists, and the public to handle the societal implications of these scientific advances.

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Using Our Brains: Integrate Ethics Early in Neuroscience Research

In an editorial for the Chronicle of Higher Education, Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) Chair Amy Gutmann, Ph.D., echoes the recommendations of the Bioethics Commission’s new report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society , calling for the explicit integration of ethics and neuroscience:

“Too often in our nation’s past, ethical lapses in research have had tragic consequences and derailed scientific progress…Ethics in science must not come to the fore for the first time after something has gone wrong. The best approach is for all stakeholders in neuroscience research—including scientists, ethicists and concerned citizens—to work together from the start of potentially path-breaking research to anticipate problems and prevent unethical surprises down the road.”

 Read the op-ed.

 

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Bioethics Commission Releases First Neuroscience Report as Part of BRAIN Initiative: Calls for Explicit Integration of Ethics Throughout Neuroscience Research

Earlier today, the Presidential Commission for the Study of Bioethical Issues released its report, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), the first of two reports it will produce in response to President Obama’s charge to consider the ethical issues associated with neuroscience research and the application and implications of neuroscience research findings.  Gray Matters, Vol. 1 examines the integration of ethics into neuroscience research across the research endeavor. Early integration of ethics and neuroscience will help researchers, policymakers, and the public to recognize and address the ethical and societal implications of neuroscience research and its applications, which the Bioethics Commission will consider in more detail in a later report.

In this report, the Bioethics Commission noted that many of the ethical implications that neuroscience researchers and funders will encounter are not unique to the field, but might be expressed in sharper relief in neuroscience.  For instance, there are privacy implications in many types of biomedical research.  In neuroscience, however, privacy concerns can extend beyond medical information to include the privacy of one’s thoughts if, for example, neuroimaging is ever able to make inferences about truth telling or criminal intent, as some predict it might. Identifying and addressing ethical issues early and throughout the research process reduces the likelihood of ethical pitfalls and can assure the public that research will not be impeded by ethical lapses.

The Bioethics Commission wrote that ethics integration entails collaboration between scientists and ethics professionals. Done well, the process of integration is an iterative and reflective process that enhances both scientific and ethical rigor.

Examples of approaches to integrating ethics into science exist already and provide a starting point for institutions, funders, and researchers to build their organizational plans for integrating ethics into neuroscience research. Examples examined by the Bioethics Commission include ethics integration through all levels of education; dedicated institutional infrastructure; direct consideration of ethical, legal, and social implications of research; research ethics consultation; stakeholder engagement; and inclusion of an ethics perspective on the research team.

The Bioethics Commission recommended that institutions and individuals engaged in neuroscience research integrate ethics throughout research, identifying ethical considerations relevant to their research and making explicit their systems for addressing those issues. It emphasized that sufficient resources—including financial resources, human capital, and expertise—should be dedicated to ethics integration.  It also called for evaluation of innovative and existing approaches to ethics integration, and recommended the development and evaluation of new and existing models for integrating ethics and science education at all levels. Finally, the Bioethics Commission recommended the inclusion of professionals with experience in ethics on BRAIN Initiative-related advisory and review bodies, particularly for the major public and private sector partners.

The report is available at Bioethics.gov. Look for additional blog posts about each of the report’s recommendations to be posted to blog.Bioethics.gov.

Next the Bioethics Commission will consider the ethical and societal implications of neuroscience research and its applications more broadly.  The Bioethics Commission will examine implications that stakeholders, including scientists, ethicists, educators, public and private funders, advocacy organizations, and the public should be prepared to handle.  A strongly integrated research and ethics infrastructure—as recommended in Gray Matters, Vol. 1—will be well equipped to address such ethical and societal implications.

The Bioethics Commission plans to have at least two more public meetings on this topic before releasing its next report.

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