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

New Educational Module on Informed Consent in Safeguarding Children

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the context of pediatric medical countermeasure research. The module integrates material from the Bioethics Commission’s March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research.

The aim of this module is to help teachers and students understand the components of the consent process in the specific context of pediatric medical countermeasure (MCM) research, which investigates interventions to be used for children in the event of a bioterrorism attack. Pediatric MCM research raises complex ethical and regulatory issues. Children cannot ethically or legally give informed consent to participate in research, because their autonomy forms over time and is not fully developed until adulthood. In addition, pediatric MCM research that would take place before a bioterrorism attack occurs (pre-event) is ethically distinct from pediatric MCM research that would take place after an attack (post-event), due to differing risks and potential direct benefits for participants.

The moral and legal equivalent of informed consent in pediatric research involves two components: informed parental permission, and meaningful and developmentally appropriate child assent. In Safeguarding Children the Bioethics Commission’s recommendations emphasize the importance of informed parental permission and meaningful child assent in all pediatric MCM research.

Through discussion questions, scenarios, and exercises this module encourages students to consider the ethical complexities of informed consent in more depth, and offers a timely example and application of the process. The module highlights important differences between pre-event and post-event pediatric MCM research. For example, parents considering enrolling their child in pre-event research need to be well-informed about the lack of any potential direct benefit to their child; and in post-event research, the process of obtaining parental permission might be complicated if parents and children are in different locations.

This module is the latest addition to the Bioethics Commission’s series of modules on informed consent, which includes background material and modules discussing informed consent in the diverse contexts of historical U.S. Public Health Service STD research in Guatemala, whole genome sequencing, and incidental and secondary findings. By introducing students to the ethical nuances of informed consent in pediatric MCM research, this latest module adds a new dimension to the considerable resources the Bioethics Commission has developed on this important topic.

In addition, this module is the first the Bioethics Commission has developed based on its report Safeguarding Children. Future modules from this report, to be released soon, will cover topics including vulnerable populations and compensation for research-related injury.

All Bioethics Commission educational materials are freely available at www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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Presidential Bioethics Commission 101

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed by Congress and charged with identifying fundamental principles for research involving human volunteers. It completed its work and was ended in 1979. That commission is recognized as the first contemporary U.S. bioethics commission and since its formation, bioethics has had a steady but varied presence within the federal government. For a list of U.S. bioethics commissions visit the history page on bioethics.gov. But what is a U.S. bioethics commission?

First and foremost, the key characteristic of each and every U.S. commission, including the current Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), is that it is term limited. Each commission since 1975 has been independently established by Congress or, more often, by the sitting President. The commissions have been established for different purposes – some to examine single issues, like the Advisory Committee on Human Radiation Experiments and others to advise on bioethics writ large. Each commission has been equipped with its own members, staff, and unique name. As a result, there have been a total of seven federal bioethics commissions over the past 40 years. President Obama first established the current Bioethics Commission on November 24, 2009 with Executive Order 13521. Like all federal advisory bodies, his Bioethics Commission must be renewed every two years.   The Executive Order under which the Commission currently operates expires in September 2015. Even if President Obama extends his order and issues an additional continuance for the Commission, due to the nature of federal bioethics commissions it is expected that the Commission, in its current form, will likely complete its term at the close of President Obama’s second term.

Many other countries have standing bioethics commissions. For example, the Nuffield Council on Bioethics (Nuffield) is a permanent bioethics council based in London. Nuffield is an independent body that was established in 1991 to address concerns over the lack of a bioethical governing body in the U.K. Nuffield operates as a permanent standing council with rotating members; temporary subcommittees are established as needed in order to address specific topics and to allow for the inclusion of subject matter experts. Since its formation, the Nuffield Council has continued to maintain its independence and is considered to be a leading international authority on bioethics policy and debate.

There are advantages and disadvantages to having standing bodies like Nuffield versus temporary commissions like ours here in the United States. Jason Schwartz, a historian of medicine at Princeton University and a former staff member for the current U.S. Bioethics Commission, explains that because each U.S. bioethics commission is established by a presidential administration or Congress, they are able to better reflect the values and priorities of the administrations they serve. Appointed members collectively bring broad expertise to the issues they study, while each commission is able to establish a unique identity and approach, independent of those of its predecessors. However, because each new commission effectively starts ‘from scratch,’ this deliberate absence of continuity and institutional memory can also pose challenges as commissions undertake their work.

Schwartz says that these structural features of U.S. bioethics commissions are particularly apparent when multiple commissions have examined topics of perennial interest and concern, such as how to ensure the protection of participants in human subjects research. Overall, fresh perspectives on enduring questions in bioethics can be of great value, he adds, especially in light of the rapid pace of new developments in science and medicine.

As for this Commission, work continues on Gray Matters, Vol. 2, the second installment in its response to President Obama’s neuroscience related request. Its next public meeting is scheduled for August 20, 2014 and will take place in Washington, D.C.

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Safeguarding Children in Emergencies through Ethical Pediatric Research

Tomorrow, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will present its recommendations on pediatric medical countermeasure (MCM) research at the 10th Annual Pediatric Bioethics Conference in Seattle. The conference, hosted by the Treuman Katz Center for Pediatric Bioethics at the Seattle Children’s Hospital, takes place July 18 and 19, 2014; its theme: “New Opportunities, New Challenges: Exploring the Ethical Boundaries of Pediatric Research.”

The Bioethics Commission is well versed on the issue, having addressed research with children in its 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. MCM includes federally regulated drugs and products for use in response to chemical, biological, radiological, and nuclear attacks (i.e., “events”). The report, requested in 2012 by former Health and Human Services Secretary Kathleen Sebelius, addresses the ethical considerations of conducting MCM research with children, as well as, more specifically, pediatric anthrax vaccine adsorbed (AVA) research. Safeguarding Children contains a set of recommendations for conducting ethical pediatric MCM research, both before and after a bioterror event, including an ethical framework the Bioethics Commission developed that specifies criteria for national-level review of certain types of pre-event MCM research. Associate Director Michelle Groman, J.D. will present the Bioethics Commission’s analysis and recommendations and discuss how the ethical framework can be applied to pediatric research.

The Bioethics Commission developed its ethical framework to aid the reviewers of proposed pre-event pediatric MCM research that poses greater than minimal risk (but no more than a minor increase over minimal risk) and offers no prospect of direct benefit to participants. Pre-event MCM research involves testing children for a hypothetical condition with an undefined (and perhaps unknowable) likelihood of occurring. The Commission’s framework clarifies review criteria outlined in existing research regulations: (1) does the research present a reasonable opportunity to increase the understanding, prevention, or alleviation of a serious problem that could affect the health or welfare of children; (2) will the research be conducted in accordance with sound ethical principles; and (3) are adequate provisions made for soliciting the permission of parents or guardians and the meaningful assent of children? Before pre-event pediatric MCM research in which there is no prospect of direct benefit can proceed, all three conditions must be met.

The Bioethics Commission’s ethical framework also can inform the conduct of pediatric research beyond MCM research. Many of the framework’s tenets are relevant to national-level review of pediatric research in other contexts; these include criteria for scientific necessity, fair subject selection, and community engagement. Whether in MCM or other research studies, extra care always must be taken when children serve as research participants. The ethical framework outlined in Safeguarding Children is useful guidance that any pediatric researcher could draw upon to ensure that they have addressed key ethical dimensions.

The Seattle Children’s Pediatric Bioethics Conference will be webcast live at http://www.uwtv.org/pediatric/ and PDFs of speaker presentations and biographies will be made available after the sessions. Tune in on July 19 at 10:30 a.m. for the Bioethics Commission presentation “Recommendations from the Presidential Commission for the Study of Bioethical Issues: Safeguarding Children in Emergencies through Ethical Pediatric Research.”

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Multidisciplinary Members and Staff Reflect the Unique Field of Bioethics

At first glance legal scholars, doctors, philosophers, scientists, and engineers may not appear to have much in common; however, members of these professions make up the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). For the past four years, since its first public meeting on July 8, 2010, the Bioethics Commission has been advising President Obama on issues arising from advances in biomedicine and related areas of science and technology. Bioethics is a multidisciplinary field that draws upon many subject areas and disciplines to address ethical questions in health care and biomedical sciences. The field revolves around core principles such as justice, beneficence, autonomy, and democratic deliberation. Different disciplinary perspectives lend various lenses through which to consider these principles, contributing to the richness of the field as a whole and increasing the likelihood that the ethical analysis generated is well-rounded.

Reflecting the multidisciplinary nature of bioethics, Bioethics Commission members include philosophers John Arras, Ph.D., and Christine Grady, R.N., Ph.D.; legal scholars Anita Allen, J.D., Ph.D., and Nita Farahany, J.D., Ph.D.; clinician Barbara Atkinson, M.D.; scientific researcher Raju Kucherlapati, Ph.D.; clinician and philosopher Daniel Sulmasy, M.D., Ph.D.; along with Nelson Michael, M.D., Ph.D., and Stephen Hauser, M.D., who are both clinicians and researchers; Vice-chair James W. Wagner, Ph.D., an engineer; and Commission Chair Amy Gutmann, Ph.D., a political philosopher. Our Member Spotlight series provides an in-depth look at each member of the Commission, highlighting how their professional backgrounds contribute to the commission’s bioethical work, and our video, What a Bioethics Commission Does,further illustrates the interdisciplinary nature of the field.

Just as the variety of the Bioethics Commission members’ backgrounds fosters rich dialogue and collaboration, so too does the multidisciplinary nature of the Commission’s staff, who assist members with research, drafting reports, and planning public meetings. The Commission staff come from law, epidemiology, philosophy, medical anthropology, health sciences, and public health. This diversity in expertise is intentional and helps the Commission tackle the wide variety of issues bioethics addresses. Already the Commission has covered a range of issues including the ethical considerations arising from emerging technologies—such as synthetic biology, whole genome sequencing, and neuroscience—and the protection of scientific research participants. More specifically the Commission has addressed questions such as: should the government conduct pediatric medical countermeasure research; and how should researchers and clinicians prepare for incidental and secondary findings?

Bioethics often examines questions to which there are no easy answers. Commission Members, representing a variety of professional backgrounds, bring a range of legal, moral, scientific, and political perspectives to the issues it considers. With help from a multidisciplinary staff the Bioethics Commission provides well thought out ethical analyses about complex issues.

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What’s Next for the Bioethics Commission?

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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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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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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