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

The Bioethics Commission Recommends Explicit Inclusion of Ethical Perspectives on Scientific Advisory and Review Bodies

It its latest report, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) emphasizes the need to integrate science and ethics in neuroscience. This report is the first part of the Bioethics Commission’s response to President Obama’s charge 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 part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Recent blog posts have outlined the first three recommendations put forth by the Bioethics Commission in Gray Matters, Vol. 1. The first recommendation underscores the importance of integrating ethics early and throughout the life of a research project. The second recommendation highlights the need to evaluate different approaches to science and ethics integration. The third recommendation calls for ethics education at all levels. The final recommendation, discussed in more detail here, addresses inclusion of those with expertise in ethics in scientific governance in neuroscience. Specifically the Commission recommended that “BRAIN Initiative-related scientific advisory and funding review bodies should include substantive participation by persons with relevant expertise in the ethical and societal implications of the neuroscience research under consideration.”

Underlying this recommendation is a vision of science and ethics integration that goes beyond checking off the “ethics box” by avoiding formulaic or strictly regulatory-focused approaches. To achieve this aim, public and private institutions funding neuroscience research should reflect on how important decisions with ethical and social dimensions, as well as the potential to shape the direction of scientific fields—such as those about which research projects to fund—are made. By elucidating the structures and processes involved in decision-making, institutions will be better able to include ethicists in ways that result in substantive participation. The end goal is to strengthen institutional processes, ranging from advisory groups that shape an organization’s overall research portfolio to individual grant review panels, such that ethics integration becomes an ordinary part of how good research is done.

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New Incidental Findings Conversation Series for Patients, Research Participants, and Consumers

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just released a set of educational materials on incidental findings that it developed for patients, research participants, and consumers. In early May, the Bioethics Commission released primers to guide clinicians, researchers, and direct-to-consumer (DTC) companies – health professionals who manage these types of findings. This latest set of primers is addressed to the other party in those relationships – those who might be receiving unanticipated findings – be they patients in a clinical context, participants in a research context, or consumers in a DTC context.

The conversation series primers, available on Bioethics.gov/education, guide potential recipients in preparing for incidental findings across contexts and operationalize the Bioethics Commission’s discussion of incidental and secondary findings in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Context.

To make their recommendations on incidental and secondary findings accessible to a wide range of potential recipients, the Bioethics Commission created this set of primers as a conversation series – a set of tools that can be used to get conversation started between findings managers and potential findings recipients – for example, doctor and patient, or researcher and participant. As they order tests, doctors can provide the patient primer to their patients. Researchers could use the participant primer as they obtain informed consent from study participants. The primers give a description of incidental findings in each context to help potential recipients understand how incidental findings are different from the primary findings they or their practitioners are seeking. Each primer helps potential recipients understand what those findings might be and prepares them to ask the clinician, researcher, or DTC provider relevant and important questions.

The primer for patients describes types of tests that might result in incidental findings, for example, genetic tests, blood or urine tests, and imaging. It provides some questions that patients can ask their clinicians. For example, the primer suggests asking clinicians “what might you find,” “what will you tell me,” “how do you intend to follow up on any incidental findings,” and “what if I don’t want to know certain results?” The primers for research participants and consumers provide similar information on tests that might result in incidental findings and what to ask the research team or the DTC provider.

The primers also include a variety of hypothetical recipient experiences with incidental findings. For example, the research participant primer presents a case in which a participant underwent a brain scan as part of a research study and found out she had a brain abnormality.

The Bioethics Commission supports bioethics education through these and other educational materials based on its reports and recommendations. All materials are available for free download at Bioethics.gov. The Bioethics Commission welcomes feedback on all of its educational materials at education@bioethics.gov.

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Bioethics Commission Wraps up Meeting in Atlanta

In a roundtable discussion to conclude its Atlanta meeting, members of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) and the day’s invited speakers delved deeper into how to respond to President Obama’s charge to 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 discussion by asking for “input on what you think is the single most important issue we need to deal with, whether it be a finding or recommendation in our report.” The following are highlights from the discussion that ensued:

“One of the most important things is consent, given all of the people with a vested interest in getting on with the work and the temptation to be perfunctory about consent and voluntariness. It has to be rigorous and maybe it should be done by third parties. The other issue is the notion of harm (in neuroscience research). It should not be simply physiological harm. We should also think seriously about the potential for psychic harm.” — Robert McGinn, Ph.D., Professor of Management Science and Engineering and Professor of Science, Technology, and Society at Stanford University.

“Most scientists see consideration of ethical issues in some formal sense as an impediment to their work. If you could find a way of turning that around where ethics can support their work, that is really an important thing to do. The incentives right now are misaligned.” — Herbert S. Lin, Ph.D., Chief Scientist, Computer Science and Telecommunications Board at the National Research Council of the National Academies.

“If people who are going to be talking to the press who are doing these neuroscience studies and thinking about exaggerating their findings, if they are exposed to hard data indicating that this news will have a bad effect (on the field), that may just make them think a little bit harder about it.”  — Alfred R. Mele, Ph.D., the William H. and Lucyle T. Werkmeister Professor of Philosophy at Florida State University.

“Speaking as an experimental psychologist and a neuroscientist…I think that we are too ready to trust our gut reaction–and most of the time our gut reaction is good. But when it comes to bioethical issues, which really force us to confront things that our brains were not designed by biology, culture or personal experience to handle, we really have to be willing to put our gut reactions aside and think in a more reflective way about the consequences of different policy choices.” — Joshua D. Greene, Ph.D., the John and Ruth Hazel Associate Professor of Psychology at Harvard University.

“Immediate incentives may be to avoid ethical issues and just get on with narrow science. But one major ethical lapse, especially, but not only, in an emerging science, and it can derail progress for a long time. So being proactive and integrative in ethics makes practical, not just ethical sense, if you are committed as we are as a society to moving scientific progress forward.”  — Amy Gutmann, Ph.D., Chair of the Bioethics Commission.

 

 

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Considering How Neuroscience Could Influence Moral Decisions

Resuming its consideration of ethical issues generated by neuroscience research, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) turned its attention Tuesday morning to the potential implications of what advances in neuroscience might mean for ethics and moral decision-making.

The session featured Joshua D. Greene, Ph.D., the John and Ruth Hazel Associate Professor of Psychology at Harvard University, and Alfred R. Mele, Ph.D., William H. and Lucyle T. Werkmeister Professor of Philosophy at Florida State University

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, asked them to consider “how, if at all, does neuroscience alter or revolutionize, as some have claimed, our understanding of ethics?”

Greene argued from the perspective that neuroscience could affect how we see moral decision-making and could impact law and our notions of responsibility. He referred to studies that show that when people are exposed to research showing the extent to which brain functions are controlled by biological functions, their decisions about moral issues, such as punishment, change.

“If you just expose people to neuroscience information that gives people the idea that we are ultimately physical systems, people become less punitive and less retributive,” he said. More broadly, he thinks such research shows that “understanding that the brain is ultimately a physical system can change who we think we are.”

Mele was skeptical about how much neuroscience research ultimately reveals about moral behavior. He particularly took issue with researchers who present evidence of biological processes occurring in the brain that precede human awareness of a particular decision or action and claim it as proof that humans do not, in fact, have free will.

“What is really being tested in these studies is how good we are at detecting when we first become conscious of an urge or intention. And it may be that that’s not very important,” he said.

Mele added that “we are going to continue to learn a lot of very important useful things about the brain, but when thinking about the implications, we should not exaggerate.”

Greene said he, too, disagrees with those who interpret results from neuroscience research as questioning whether humans have free will to make important choices.

“Those results are over-interpreted,” he said. “The whole idea that the brain decides before you do, I think that stuff is a big mistake.”

Gutmann agreed that it’s important to note the limits to what neuroscience can reveal about human behavior and morals in particular. She summarized that both speakers agreed that “whatever neuroscience discovers about the determination of our actions, it cannot tell us what is right and what is wrong.”

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Live from Atlanta for Day 2

We’re back from Atlanta for day two of 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 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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Roundtable Discussion: Seeking Guidance for Recommendations

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continued its examination of the ethical issues associated with neuroscience research with an in-depth roundtable discussion involving both members and presenters.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, asked “If there was one thing and only one thing that you think is ripe for our recommendation or our recognizing as a finding, what would that one thing be?”

The following are highlights from the discussion that ensued:

“Don’t forget what makes neuroscience different from other health conditions, which is its impact on behavior. If you are going to look at behavior…people with the lived experience need to be at the table.” – Patrick Corrigan, Psy.D, Distinguished Professor of Psychology, Illinois Institute of Technology.

“We could use some help with a more fine-grained and maybe even a more neuroscience-informed understanding of this concept of diminished capacity. What we are thinking about is the capacity to understand risks and benefits….Do I rank risks in the same order of people who have good cognitive capacity?” –  Dr. Gregory Simon, Chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance (DBSA).

“The number one take away for me would be to consult novel models for conducting research on patients with reduced capacity…My concern is to be careful to avoid regulations without evidence of their practical impact.” — David W. Wright, M.D., Associate Professor of Emergency Medicine and Director of Emergency Neurosciences at Emory University School of Medicine.

“I believe the data sharing issue is just huge. If you take the Alzheimer’s Disease Neuroimaging Initiate, all the partners agreed from the outset that sharing would occur. There is now more science published from people who were not originally funded from that work than there is science published by those who were initially funded. We more than doubled the return on that effort.” — Harry Johns, President and CEO of the Alzheimer’s Association.

“Take into account the [differences in] individual patients. There will be individuals capable of consenting to research and capable of having a good experience, and there will be those who initially consent and then decide to drop out, and others who will experience distress and have to be withdrawn. So avoid sweeping statements [about patient capacity].”  — Rebecca Dresser, J.D., Daniel Noyes Kirby Professor of Law, Professor of Ethics in Medicine, Washington University, St. Louis.

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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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About blog.Bioethics.gov

This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

Learn more about the Presidential Commission for the Study of Bioethical Issues.

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