BRAIN Initiative – 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 Bioethics Commission recommends establishing clear requirements for identifying legally authorized representatives for research participation https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/13/bioethics-commission-recommends-establishing-clear-requirements-for-identifying-legally-authorized-representatives-for-research-participation/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/13/bioethics-commission-recommends-establishing-clear-requirements-for-identifying-legally-authorized-representatives-for-research-participation/#respond Wed, 13 May 2015 15:42:30 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1625 On March 26 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second volume of its two-volume report on neuroscience and ethics, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). In Gray Matters, Vol. 2, the Bioethics Commission recognized the challenging tension between the need for rigorous research on debilitating neurological diseases and psychiatric conditions, and the need to protect research participants who might be vulnerable because of impaired consent capacity.

Neuroscience research offers promise to find ways to prevent, treat, and cure neurological disorders, psychiatric conditions, and brain and nervous system injuries that inflict great individual and societal burden. Clinical research involving affected individuals is necessary to achieve this worthy goal. However, some potential research participants might have impaired capacity to provide fully informed consent before enrolling in research—an important ethical tenet in the protection of research participants. The Common Rule (the federal policy that governs research supported by 18 federal departments and agencies) requires permission from a legally authorized representative (LAR) if research participants cannot provide their voluntary informed consent. However, federal regulations and state laws lack clarity about who can legally serve as an LAR when a prospective research participant lacks consent capacity. This uncertainty can stall important research.

In Gray Matters, Vol. 2 the Bioethics Commission makes four recommendations regarding research involving human participants whose consent capacity might be absent, impaired, fluctuating, or in question. In its ninth recommendation, the Bioethics Commission called for the establishment of clear requirements for identifying LARs for research participation. The Commission recommended that:

State legislatures and federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.

Current laws for designating an LAR to facilitate decisions about medical care vary by state. For example, they differ in describing how LARs should make decisions on behalf of patients in the clinical context and who can serve as an LAR. Very few of these state laws address decisions about enrollment in research.

Within the current legal and regulatory framework, uncertainty and lack of clarity remain regarding ethically acceptable research involving participants with potentially impaired consent capacity. Using an LAR is one important way to facilitate inclusion of participants with impaired consent capacity in research, ensuring the just distribution of the benefits that might accrue to those affected by the disorder under study. Using an LAR also can help protect participants from exploitation, because loved ones or caregivers who have been designated as LARs are often the best proxy for representing participant interests. Federal regulatory bodies could endorse an existing list of who can serve as an LAR—for example, the Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) recommended list—and explicitly permit researchers and institutional review boards to rely on that list. Alternatively, state legislatures that have not already done so could draft their own priority lists for LARs for research, eliminating the need to rely on lists included in laws pertaining to medical treatment. The Bioethics Commission acknowledged that clarity in identifying LARs will promote the ethical conduct of vital research by helping researchers and IRBs remain accountable to a clear set of ethical and legal standards for enrolling participants with impaired consent capacity in research.

Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at Bioethics.gov.

 

 

 

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Bioethics Commission Finalizing Work on Neuroscience https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/06/bioethics-commission-finalizing-work-on-neuroscience/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/06/bioethics-commission-finalizing-work-on-neuroscience/#respond Fri, 06 Feb 2015 15:15:51 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1539 On July 1, 2013, President Obama requested that the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) review the ethical considerations of neuroscience research and its application as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Specifically, the President instructed 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.”

Today, during its public meeting in Washington, D.C., the Bioethics Commission worked to wrap up its work on neuroscience and related ethical issues and to finalize its recommendations to the President.

The Bioethics Commission has held (counting today’s gathering) nine public meetings in five cities — Washington, D.C., Salt Lake City, Atlanta, Philadelphia, and San Francisco — that have focused on neuroscience. They have featured extensive discussions with experts from a wide array of disciplines, including neuroimaging, cognitive neuroscience, neurology, computational neurobiology, nanotechnology, psychiatry, ethics, philosophy, computer science, behavioral health, engineering and law. The Commission also has heard detailed public comments from affected communities, including advocates for patients with Alzheimer’s disease, Parkinson’s disease, depression and bipolar disorders.

The Bioethics Commission provided its initial recommendations to President Obama last year in volume one of its Gray Matters report, in which it stressed the importance of integrating ethics early and throughout neuroscience research.

Today’s deliberations will inform the Bioethics Commission’s recommendations for Gray Matters, Volume two, which will focus on three areas: cognitive enhancement and other neural modifications, capacity and the consent process, and neuroscience in the legal system.

Bioethics Commission Chair Amy Gutmann noted that these three areas “illustrate the ethical tensions and societal implications that can arise as neuroscience and technology advance.”

“Our Commission is well situated to clear a path for productive discourse and conduct policy making on these topics,” she added.

The Commission expects Gray Matters, Vol. 2 to be released this spring.

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Back Live for Day 2 of the Bioethics Commission Meeting in D.C. https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/06/back-live-for-day-2-of-the-bioethics-commission-meeting-in-d-c/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/06/back-live-for-day-2-of-the-bioethics-commission-meeting-in-d-c/#respond Fri, 06 Feb 2015 14:07:52 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1536 We are back live and blogging in Washington, D.C. for day 2 of the 20th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission is continuing the discussion initiated at its November meeting in Salt Lake City focusing on issues arising at home and abroad from U.S. engagement in the global response to the current Ebola epidemic. Members today also resume consideration of ethical issues associated with neuroscience research and the application of neuroscience findings, as requested by President Obama.
You can follow the proceedings of the Bioethics Commission’s meeting here at this blog, and on the live webcast. The webcast and transcripts from the meeting will be archived and available following the meeting at www.bioethics.gov.

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The Bioethics Commission’s Neuro Double-Header https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/11/21/the-bioethics-commissions-neuro-double-header/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/11/21/the-bioethics-commissions-neuro-double-header/#respond Fri, 21 Nov 2014 16:14:51 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1495 Since President Obama’s April 2013 launch of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has worked to ensure that ethics is an integral part of the conversation when discussing neuroscience. This past week, the Bioethics Commission was busy discussing its work at two annual neuroscience conferences in the Washington, D.C. area: the International Neuroethics Society (INS) Annual Meeting and the Society for Neuroscience (SfN) Annual Meeting.

Bioethics Commission Member Stephen L. Hauser, M.D., represented the Commission at INS on November 14, where he took part in the panel “The BRAIN Initiative & the Human Brain Project: An Ethical Focus.” Dr. Hauser was joined by fellow panel participants Walter Koroshetz, BRAIN Initiative, and Henry Markram, Human Brain Project, for a discussion on the ethical issues surrounding neuroscience research. Following the panel, each participant gave a brief interview for the University of Cambridge’s podcast The Naked Scientists.

“There are a whole host of issues that the Commission and society at large needs to undertake and tackle. These include such areas as brain privacy, particularly as our imaging tools become more sophisticated; cognitive enhancement; things like personality, sociability, violent impulses, etc.” said Hauser during his podcast interview. “What we need to have is a two-fold mission: first, to communicate clearly the true value of the therapies that we now have available; and second, anticipate and prepare for those that will perhaps be transformational but that are not yet currently available,” he explained. To listen to the full podcast, visit http://bit.ly/1xxVEmu.

The Bioethics Commission then went on to participate in SfN’s Annual Meeting exhibition, visited by more than 31,000 attendees. The exhibition, which took place November 16-19, 2014, allowed the Commission to discuss its role in the BRAIN Initiative and related reports. The Commission promoted the reports Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings, because so many neuroscience researchers often deal with these issues, and Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the Commission’s first of two reports in response to President Obama’s BRAIN Initiative-related request.

It was wonderful to engage with so many neuroscientists eager to discuss ethics over the past week!

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Bioethics Commission Participates in White House BRAIN Conference https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/01/bioethics-commission-participates-in-white-house-brain-conference/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/01/bioethics-commission-participates-in-white-house-brain-conference/#respond Wed, 01 Oct 2014 16:30:59 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1435 At the White House BRAIN Conference yesterday, Lisa M. Lee, Executive Director of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) joined other representatives from federal agencies to discuss the progress and the goals of the BRAIN Initiative.  Her remarks, as part of the panel “Current Activities, Long-Term Goals, and Critical Components for Success,” follow.

Dr. Holdren, colleagues, honored guests:

Thank you for the opportunity to update you on the Bioethics Commission’s progress and role related to this White House Grand Challenge.

We all know that advances in biomedicine, science, and technology come with a range of ethical considerations.

The Bioethics Commission is an independent advisory panel comprising a variety of disciplines including law, philosophy, medicine, science, and engineering. We seek to identify policies and practices that will ensure that scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.

So, we were delighted last year when President Obama asked us to review the ethical considerations associated with neuroscience research as part of the BRAIN Initiative.

Earlier this year, we released the first of two reports in response to his charge. That report: Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society. We’ve heard that word a lot today—”integrative”—and that’s my message here.

In Gray Matters the Commission called for adequate and clearly demarcated funding to achieve its recommendation of integrating ethics explicitly and systematically throughout neuroscience research.

Such integration allows us to incorporate ethical insights into the scientific process and to consider societal implications of neuroscience research from the very beginning.

Ethics integration – early and throughout research – can prevent the need for corrective interventions, and help build public trust in science. Integration prevents intervention.

We have collected public comments from professional organizations, affected communities and individuals and have engaged with the scientific community, all of whom bring to bear a variety of important perspectives on contemporary neuroscience.

We heard from many, including the Salk Institute, the Allen Institute, and the Kavli Foundation, and others.

In our first report, we actually recommended that BRAIN Initiative-related scientific advisory bodies include substantive participation by persons with relevant expertise in the ethical and societal implications of the neuroscience under consideration.

The Commission did not recommend a single model of integration – there are many good options and we reported on several of these. We did highlight DARPA’s exemplary work in this area. DARPA successfully combines several approaches to ethics integration including

  • Consulting with an independent panel of ethics experts,
  • Linking program managers with ethics mentors, and
  • Setting aside funds for ethics consultation.

In short – good science is ethical science. We point to DARPA’s example because we are keenly aware that ethics recommendations can be interpreted as just one more bureaucratic hurdle in the way of scientific discovery.

Clearly, DARPA’s integrated model has not hampered its progress or broken its bank.

Our commission works diligently to make practical recommendations— recommendations that both de-mystify ethics and facilitate good science. We know that so much can be gained from neuroscience research. And I think we all agree that we must ensure it does not come to a screeching halt because of one significant ethical lapse.

Thinking about these issues now and implementing our recommendations in a way that is compatible with your institution or agency can prevent that from happening.

Next, the Bioethics Commission is considering the implications of neuroscience research and its applications more broadly for our second report. We’re thinking about:

  • The ethical issues raised across stages of life – from infancy through old age,
  • And what neuroscience research might mean for various affected communities like those affected by Alzheimer’s disease, Parkinson’s disease, and mental illness.

These types of community engagement play a key role in our deliberations We expect to hold at least one additional public meeting – in November – before concluding our deliberations and making a final set of recommendations.

Since by now you’ve no doubt picked up our theme, that ethics integration – early and throughout research – prevents intervention, I will close simply by saying that, on behalf of the 11 Members of the Bioethics Commission, we are delighted to be a part of this initiative – from its very beginning.

Thank you.

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Neuroscience and Ethics: Integration Not Intervention https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/30/neuroscience-and-ethics-integration-not-intervention-2/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/30/neuroscience-and-ethics-integration-not-intervention-2/#respond Tue, 30 Sep 2014 19:35:22 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1431 We’re pleased to take part in today’s White House BRAIN Conference. Check out our infographic that highlights our recommendations from Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, the first of two reports on neuroscience and related ethical issues.

bioethics_integration

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What’s Next for the Bioethics Commission? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/23/whats-next-for-the-bioethics-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/23/whats-next-for-the-bioethics-commission/#respond Mon, 23 Jun 2014 13:39:04 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1350 As part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative announced in April 2013, President Obama charged the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) to review the ethical issues associated with the conduct and implications of neuroscience research. Specifically 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 recently released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), its first set of recommendations in response to President Obama’s charge. A multiple-part report allows the Commission to respond quickly in the face of a rapidly emerging and evolving field.

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

In a public meeting held in Washington, D.C. in February, the Bioethics Commission heard from experts about science communication and hype, especially in the field of neuroscience. Science communication about neuroscience and its applications is one topic that the Bioethics Commission will examine more thoroughly in the next report.

And in its most recent meeting, held earlier this month in Atlanta, Ga., the Bioethics Commission discussed additional ethical and societal issues in neuroscience, including protecting privacy in neuroscience data sharing, and the complexities of ensuring autonomy in individuals with diminished capacity, or no capacity, to consent to neuroscience research across all stages of life.

These issues and more will be elaborated upon in Gray Matters, Vol. 2. Join us or tune in to our live webcast of the Bioethics Commission’s 18th meeting in Washington, D.C. in August, to hear more robust discussion of ethical and societal issues in neuroscience.

 

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Discussion Highlights on Ethical Issues Related to Neuroscience https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/discussion-highlights-on-ethical-issues-related-to-neuroscience/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/discussion-highlights-on-ethical-issues-related-to-neuroscience/#respond Wed, 18 Dec 2013 21:48:47 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1072 In a roundtable discussion that ended today’s meeting, Amy Gutmann, Ph.D., President of the University of Pennsylvania and the Chair of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), emphasized that “we have two big buckets here, one is the ethics of neuroscience research, and the other is the potential applications and ethical implications of the research findings themselves.” She asked each of the meeting presenters for their advice on what the Bioethics Commission should recommend as it examines the ethical issues related to neuroscience.

“I’d like to recommend that there be serious financing incentives and accountability to develop ethics scholarship in neuroscience, and to do it in a way that is very mindful…so the scholarship is structured in a way so that it itself is educational.”  – Mildred Z. Solomon, Ed.D. President of the Hastings Center

“[Bioethics] is the only field where everyone seems to think they are qualified…because everyone believes they are ethical…and they believe that’s all that’s needed.” – Paul Root Wolpe, Ph.D. of Emory University

“As a working scientist, there is already a very large regulatory burden on us, and we now in the case of my institution have several people who are full time doing nothing but the paperwork associated with any one experiment. And I would urge you, if you make recommendations, to give some thought to…the regulatory burden.” – Christof Koch, Ph.D. of the Allen Institute for Brain Science

Bioethics Commission members responded:

“I think it’s really important to recognize that ethical considerations do not equate to regulatory burdens.” – Amy Gutmann, Ph.D. President of the University of Pennsylvania and the Chair of the Bioethics Commission

“We know there are scientists that will be ethical failures…How do we prepare for [ethical failure]…how do we disincentivize it? What sort of sanctions should be in place? What sort of protections for research subjects…should be in place? We can’t pretend like it’s not going to happen; it’s going to happen. What do we do about that?” – Anita L. Allen, J.D., Ph.D. Vice Provost for Faculty at the University of Pennsylvania and the Henry R. Silverman Professor of Law and Professor of Philosophy and a member of the Bioethics Commission

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Neuroscience: What’s Going On Around the Globe? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/neuroscience-whats-going-on-around-the-globe/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/neuroscience-whats-going-on-around-the-globe/#respond Wed, 18 Dec 2013 21:13:46 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1069 At today’s meeting examining the ethical issues surrounding neuroscience research and neuroscientific advances, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to neuroscience and bioethical initiatives taking place around the world.

Nikolas Rose, Ph.D. is a member of the European Union’s Human Brain Project’s Social and Ethical Division Steering Committee. He said the Project aims to “simulate the human brain, cell by cell, in a neuromorphic supercomputer.” He told the Bioethics Commission that bioethics has been a central tenet in the Project since its beginning, with funding devoted to social and ethical programs. One of the central themes, Dr. Rose said, was “the idea of responsible research and innovation.”

He emphasized five streams of the E.U.’s Human Brain Project:

  • First, a foresight lab to anticipate neuroscientific developments and work out scenarios of what would happen if certain developments came to fruition.
  • Second, a conceptual and philosophical analysis of what a simulation of the human brain would entail.
  • Third, a public dialogue with stakeholders. “Everything suggests that the more open, transparent, and dialogic the researchers are,” Dr. Rose said, “…the better it should be.”
  • Fourth, the Human Brain Project encourages ethical reflection among the researchers.
  • Finally, the Human Brain Project is concerned with governance and regulation of the Project as it moves forward.

Jonathan Montgomery, LL.M., Chair of the Nuffield Council on Bioethics spoke about a recent Nuffield Report on Bioethics, which made recommendations relevant to neuroscience. He said that the Council was able to identify three main virtues: inventiveness, humility, and responsibility. Within these tenets, the Council addressed a series of ethical challenges, including investigations into hype and research culture; engaging younger students in bioethical thinking; registries and data collection; and working with ethics research panels on difficult issues such as sham surgery.

The Bioethics Commission also heard from Stefano Simplici, Ph.D., of the International Bioethics Committee, United Nations Educational, Scientific, and Cultural Organization about the issues of discrimination and stigma in bioethics. Dr. Simplici emphasized that “the lottery of social and biological life should not be grounds for disadvantages or advantages.” He expressed concerns about advances in neuroscience that might affect criminal law, in particular the concept of “mens rea,” or guilty mind, the idea of criminal intent.

The Human Brain Project’s Dr. Rose responded to Dr. Simplici’s concern: “A lot of what happens in new and emerging technologies, especially from the ethical point of view,” he said, “is highly speculative and overestimates what the neuroscience can actually do.”

The Bioethics Commission will take this international work into account as it considers how best to integrate ethics into neuroscience research.

 

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How Some Private Sector Representatives Address Ethical Issues https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/how-some-private-sector-representatives-address-ethical-issues/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/12/18/how-some-private-sector-representatives-address-ethical-issues/#respond Wed, 18 Dec 2013 19:55:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1063 The second session in today’s meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) brought together representatives from the private sector to discuss how they identify and address ethical issues in neuroscience research.  The question before the panel: ‘How does your institute currently address ethical issues related to neuroscience research?’

Terrence J. Sejnowski, Ph.D. of the Salk Institute of Biological Sciences, noted that working with a group of human patients changed how he thought of the ethical issues surrounding neuroscience research. “Somehow when you start tinkering with the brain,” he said, “people get more concerned because it’s tinkering with who you are.” It is not like other biomedical research, he said. For example, Dr. Sejnowski said, “The liver can’t think, or if it does, it doesn’t talk.” He noted that now is “the right time to start thinking about this.”

Christof Koch, Ph.D. of the Allen Institute for Brain Science also expressed a sense of ethical responsibility. “Your active brain is who you are,” he said. “We have responsibility to our own science directly, a responsibility to our field, and to society at large.” When asked directly about whether ethical issues have affected how the Allen Institute conducts its research, Dr. Koch noted that due to ethical concerns regarding privacy, the Allen Institute has not put the genomic sequencing information online for its human brain maps. He recognized that the ethical issues absolutely have to be clarified. Dr. Koch spoke of new work that produces ‘organoids’ in a petri dish. The layers of cells show organization and some show electrical activity. The ethical implications of this work needs to be understood, Dr. Koch said, because neuroscience advances may mean that “we need to begin to think about sentience in a dish.”

Anita L. Allen, J.D., Ph.D. Vice Provost for Faculty at the University of Pennsylvania and the Henry R. Silverman Professor of Law and Professor of Philosophy and a member of the Bioethics Commission noted, “we care about controlling or interfering with the brain because it is the substrate of the mind.“ Today’s discussions on addressing and identifying ethical issues in neuroscience, will inform the Bioethics Commission as it moves forward with the request from President Obama related to the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

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