Nick Seaver – 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 Roundtable Discussion: Identifying Priority Ethical Questions in Neuroscience Research and Applications Wed, 20 Aug 2014 21:22:25 +0000 An in-depth roundtable discussion involving both members and presenters wrapped up today’s Washington, D.C. meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

Today’s meeting was in response to President Obama’s request, as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, that the Bioethics Commission review the ethical issues associated with the conduct of neuroscience research and implications of its findings.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, kicked off the session by requesting that panelists, “pick one piece of advice you’d like us to take into account.”

The following are highlights from the discussion that ensued:

“We need to think about… things such as education plans to help physicians and practitioners think through what they’re going to do when they have a young person come in their office and say, ‘Hey, I’d like this cause it would help me get through my test.’…We look at [cognitive enhancement] too narrowly and we need to treat it as a complex issue. ” – Rear Admiral Peter J. Delany, Ph.D., LCSW-C, Director of the Center for Behavioral Health Statistics and Quality at the Substance Abuse and Mental Health Services Administration (SAMHSA).

“I think one might characterize bioethics as the effort to try to prevent that which should not be done and enable that which should be done. Traditionally, I think the emphasis has been much more on the former—preventing that which should not be done. But, particularly within the enhancement arena, I think there is a big opportunity to start playing the second role:  to try to enable that which should be done. By looking for opportunities for things that would be very valuable and seeing what it is that hinders advancement in that area, particularly… regulatory framework [which] might be unsuitable for enhancement medicine.” – Nick Bostrom, Ph.D., Professor in the Faculty of Philosophy, Director of the Future of Humanity Institute, and Director of the Programme on the Impacts of Future Technology at University of Oxford.

“I think it’s a bit unusual in that we have a melding of federal provisions and state provisions… To what extent should we be adding a more federal system that doesn’t look so much to state law [for guidance on informed consent]?” – Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections, U.S. Department of Health and Human Services.

“Giving people 20 page single-spaced consent forms, having research assistants read the 20 page forms to them—both of which are sort of standard practice—doesn’t work well for anybody, but they are going to work less well for [potential research participants with diminished or diminishing capacity to consent]. So this might be an area in which particularly to encourage experimentation on the part of investigators and [internal review boards] to come up with and to support creative ways of conveying information and getting consent from participants.” – Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine & Law; Director of the Division of Psychiatry, Law, and Ethics; Director of the Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics in the Department of Psychiatry at Columbia University.

“I think bad science hurts everyone doing science…  There are a lot of these grandiose hopes for what might be accomplished in the new BRAIN Initiative and DARPA Initiative and again it’s going to have to be iterative step wise. No one is going to get to make the Hail Mary pass just because they throw a lot of money at it. And that it’s not about money, it’s about stepwise progress and science will move at the speed that it does.” – Helen Mayberg, M.D., Professor of Psychiatry, Neurology, And Radiology, and the Dorothy C. Fuqua Chair, Psychiatric Neuroimaging and Therapeutics at Emory University School of Medicine.

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Who Can Consent to Neuroscience Research? Wed, 20 Aug 2014 20:45:18 +0000 In the fourth series of the presentations from today’s public meeting on neuroscience and related ethical issues, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) addressed questions related to the capacity to consent to neuroscience research.

The Bioethics Commission heard from two experts in the field: Jerry Menikoff, M.D., J.D., the Director of the Office for Human Research Protections at the U.S. Department of Health and Human Services; and Paul S. Appelbaum, M.D., the Elizabeth K. Dollard Professor of Psychiatry, Medicine, & Law, and the Director of the Division of Psychiatry, Law, and Ethics in the Department of Psychiatry at the College of Physicians and Surgeons of Columbia University.

Menikoff focused on the guidance provided by the Office of Human Research Protections about research with those with diminished or diminishing capacity—such as those who have advanced Alzheimer’s disease—and their ability to consent to taking part in neuroscience research.

“Generally, a researcher has to obtain a legally effective informed consent of the subject or the subject’s legally authorized representative,” said Menikoff. However, he went on to explain that while the definition does not sound complicated, its implementation can be.

“If you conclude that they did have the capacity and it’s correct, you’re pretty good,” continued Menikoff. “Once you’ve concluded they do not have the capacity, we are now in the area, as you all know, where the rules are very unclear.”

Appelbaum—who is also a research psychiatrist at the New York State Psychiatric Institute and an affiliated faculty member at Columbia Law School, where he directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetic—discussed how to assess decisional capacity in neuroscience research.

“There may be, but is not necessarily going to be, decisional impairment in people with neuropsychiatric illness,” said Appelbaum. “You can screen for incapacity reliably and validly.”

Appelbaum concluded, “Although we very much want to protect incapable subjects from making bad decisions, we need to balance that desire against the real societal interest of having people make their own decisions.”

With today’s discussions, including this session on capacity to consent, the Bioethics Commission is working to address President Obama’s request that it identify core ethical standards to guide neuroscience research and address potential ethical dilemmas arising from the application of neuroscience research.

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Identifying the Ethical Considerations in Neuroscience Research, Clinical Innovations and Applications Wed, 20 Aug 2014 20:22:51 +0000 As it continued today’s meeting on neuroscience, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention to potential clinical applications and innovations that may stem from neuroscience research. President Obama asked the Bioethics Commission to consider the ethical issues associated with neuroscience as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.

This panel included Steven L. Small, Ph.D., M.D., the Stanley van den Noort Professor and Chair of the Department of Neurology, Professor of Neurobiology and Behavior, Professor of Cognitive Sciences, and Director of the Neuroscience Imaging Center at the University of California, Irvine; Paul J. Ford, Ph.D., the Director of the NeuroEthics Program and Education Director for the Department of Bioethics at the Cleveland Clinic and Associate Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; and Helen Mayberg, M.D., a Professor of Psychiatry, Neurology, and Radiology and the Dorothy C. Fuqua Chair of Psychiatric Neuroimaging and Therapeutics at the Emory University School of Medicine.

Small offered an overview of the current science and began by highlighting the emergence of high performance computing that can crunch vast amounts of data, demonstrating the advances currently being made in the field. Small then identified areas he believes should become research priorities including brain circuit analysis, a field with the potential to help patients with epilepsy or those who have suffered a stroke or spinal cord injury; personalized medicine based on biomarkers or anticipating how an individual’s brain might react to a treatment; brain circuit alterations, using both invasive and non-invasive technologies; and brain computer interfaces. With these various technologies, Small listed several ethical concerns that must be considered, including irreversible changes, new understandings of data, and how these tools and the results they could produce might be used.

Ford turned the conversation to research participation, emphasizing a need to identify the factors that allow researchers to ethically select participants in scientific studies on clinical neuroscience innovations.  Specifically, Ford argued for ethical guidelines to allow for the inclusion of vulnerable patients in research, especially those who might benefit from participation. Ford also emphasized that in this type of research it is essential to view patients as collaborators. For example, he described research on Parkinson’s disease and deep brain stimulation in which a research participant asked for less control over an implanted neurological device than what researchers initially had assumed.  “If we hadn’t asked, we wouldn’t have known,” Ford reflected.

Mayberg concluded this panel’s presentations with “Research Design Considerations for Studies Using Invasive Brain Devices.”  She explored ways to ensure that research using invasive brain technologies was both ethical and scientifically rigorous.

“With brain imaging we have more information than we want,” said Mayberg. “And we are trying to reduce down the necessary and sufficient amount so that we can think about why we might want to invade the brain and tune it in some way, where we might do that, how we might do that, and who we might do that to.”

Additionally, Mayberg spoke about the need to be able to refine human subjects research that uses neurological implants, noting that a key step is identifying at what point researchers should end the study rather than continue to revise and iterate. “The question is how to know the difference. You need a framework to go in either direction.”

Up next, the Bioethics Commission discussed the issue of capacity to consent to research.

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Direct-to-Consumer Neurotechnology: Ethical Applications Today and Tomorrow Wed, 20 Aug 2014 17:45:59 +0000 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) heard this morning from a panel of experts representing the neurotechnology sector and regulatory agencies on the ethical considerations in direct-to-consumer (DTC) sales of neurotechnologies. The Bioethics Commission is reviewing the ethical issues associated with the application of neuroscience research in response to President Obama’s request as part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.

Starting off the conversation, John Reppas, M.D., Ph.D., the Director of Public Policy at the Neurotechnology Industry Organization, discussed the current state of the DTC neurotechnology market. Breaking direct-to-consumer neurotechnologies into two categories, Reppas discussed technologies that measure data and have back-end technologies to analyze data, as well as devices that send artificially generated signals into the brain or body.

“Measurement devices are considered quite safe,” said Reppas. “For this product class, the major real-world concern would center on data privacy and ownership, as well as how that data ends up being presented back to the consumer,” said Reppas.

For products that aim to change ongoing brain function to produce specific behaviors, like relaxation or more efficient learning, Reppas said that “the ethical imperative is to make sure that these products don’t have unanticipated long-term effects on user behavior or health.”

On the question of how these technologies should be regulated, Reppas argued that the neurotechnology sector has been safe and use of these technologies often changes once they’ve reached the market.

Carlos Peña, Ph.D., M.S., the Director of the Division of Neurological and Physical Medicine Devices in the Office of Device Evaluation at the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA) focused on the steps that the FDA takes to regulate new products, including past efforts to regulate neurological devices such as deep brain stimulators, neurodiagnostic devices, and therapeutic devices for migraines.

Picking up the conversation of FDA regulation, Freddie Ann Hoffman, M.D., CEO of the consulting firm, HeteroGeneity LLC and Former Deputy Director of the Medicine Staff in the Office of the Commissioner at the U.S. FDA, shared her expertise on past FDA regulatory requirements, specifically with regard to the Dietary and Supplement Health and Education Act. Hoffman focused primarily on the regulatory standards that exist for dietary supplements and drugs to help establish the framework into which neurotechnologies must fit.

“There are specific legal assumptions that surround these two categories,” explained Hoffman. “Dietary supplements are intended to supplement the diet of healthy, normal individuals for which no risk is really tolerable, versus drugs which are intended for use by a population for which the benefit has been proven to outweigh the risks.”

Wrapping up the panelist’s presentations, Deven McGraw, J.D., M.P.H., LL.M., focused on privacy issues. McGraw is a partner at Manatt, Phelps & Phillips, LLP and Former Director of the Health Privacy Project at the Center for Democracy and Technology. Discussing existing regulations to protect privacy, McGraw explained that DTC neurotechnology is not clearly regulated under the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

“HIPAA generally is not going to apply in the context of DTC technology; it has very limited coverage,” said McGraw. “The DTC space is collecting a lot of health data…and is not going to be covered. Most medical devices are not covered, as well.”

McGraw went on to explain where there is currently authority to regulate these types of devices within the Federal Trade Commission (FTC). “It isn’t the case that this is a completely unregulated space. The data and the use of it are regulated to some extent by the FTC,” said McGraw. “The FTC has authority to prevent and seek redress for unfair acts or practices. They have very broad authority and they’ve used it to penalize some consumer-facing for-profit companies for failing to abide by a privacy policy.”

However, McGraw explained, “[the FTC] doesn’t set a comprehensive set of guardrails and rules on the data being collected on these devices.”

Following lunch, the Bioethics Commission will return to hear about clinical innovations through neuroscience research.

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Considering the Ethical Implications of Cognitive Enhancement Wed, 20 Aug 2014 15:22:48 +0000 As part of the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, President Obama asked the Presidential Commission for the Study of Bioethical Issues (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.” As the Bioethics Commission resumes its consideration of these ethical issues, it turned this morning to the ethical implications of cognitive enhancement specifically.

The session featured Peter Reiner, V.M.D., Ph.D., from the University of British Columbia’s National Core for Neuroethics, Kinsmen Laboratory of Neurological Research, and Brain Research Centre; Rear Admiral Peter J. Delany, Ph.D., LCSW-C, Director of the Center for Behavioral Health Statistics and Quality at the Substance Abuse and Mental Health Services Administration (SAMHSA); Adrian Raine, Ph.D., the Richard Perry University Professor of Criminology, Psychiatry, and Psychology at the University of Pennsylvania; and Nick Bostrom, Ph.D. a professor in the Faculty of Philosophy at the University of Oxford and founding Director of the Future of Humanity Institute.

Starting off the conversation with a presentation titled, “Cognitive Enhancement Past, Present and Future,” Reiner discussed the definition of cognitive enhancement. In doing so, he explained both the historic understanding and looked forward to how this definition is evolving.

“Cognitive enhancement is more complicated than it seems at first blush,” explained Reiner. “We’re already well on our way to enhancing ourselves with all sorts of drugs, devices and more.”

“I’d submit as we move forward we need to give a fair hearing to the public’s enthusiasms and fears, their utilitarian dreams and their visions for societal harmony for these are the norms to which our policies should hew,” Reiner concluded.

Delany, who oversees a SAMHSA program to collect, analyze, and disseminate critical public health data on substance abuse, mental illness, and related disorders, spoke briefly about how common cognitive enhancement is today, and how we might be able to reliably track both the prevalence of cognitive enhancement and results—both potential benefits and harmful outcomes.

Focusing on prescription drugs like Adderall and Ritalin, Delany explained that data show that people—especially college age students—who use cognitive enhancements also have increased use of other substances such as alcohol, marijuana or cocaine.

Raine later moved the discussion to the potential implications of nutrition as a cognitive enhancer and the possible use of nutritional supplements to alter behavior.

Citing extensive correlational studies about consumption of Omega-3 and a reduction in anti-social behaviors, Raine raised several ethical questions about the use of natural compounds, like fish oil, as a cognitive enhancer.

“To what extent is Omega-3 really different to drugs, medication?” asked Raine. “Our bodies don’t produce Omega-3. Yes, it’s natural, but in some ways it’s nothing short of a drug.”

“We wouldn’t give drugs to sedate prisoners. We wouldn’t give drugs to children to reduce their anti-social and aggressive behaviors. So why would we give Omega-3 to reduce such behaviors that aren’t wanted in society?” asked Raine.

Rounding out the morning’s first session, Bostrom addressed concerns in ensuring fair and equal access to cognitive enhancements, especially given the potential benefits both on an individual level and a societal level.

“There are already large inequalities in cognitive capacities—partly biological, partly because different people have different amounts of education, and so forth,” said Bostrom. “One question that one can ask about a hypothetical new cognitive enhancement intervention is whether it would increase or decrease that. That might partly depend on the system we have to access [the enhancement].”

Up next in this busy day, the Bioethics Commission will consider questions around direct-to-consumer neurotechnology.

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Live from Washington Wed, 20 Aug 2014 13:00:59 +0000 Welcome to the live blog for the eighteenth public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting in Washington, D.C. today, August 20, 2014, from 9 a.m. to 5 p.m., ET.

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 request.

Issues to be discussed include:

  • Cognitive enhancement
  • Direct-to-consumer neurotechnology
  • Clinical innovation through neuroscience research
  • Capacity to consent to research

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.