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

Bioethics Commission Meeting 21: Live from Philadelphia

We are live from Philadelphia, blogging the 21st public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting today, May 27, from 9 a.m. to 4:30 p.m. EDT.

At this meeting, the Bioethics Commission will discuss the role of deliberation and education in bioethics. The Bioethics Commission is exploring the idea of teaching deliberation as a tool to promote ethical literacy.

You may 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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New Educational Module from the Bioethics Commission on Informed Consent in Neuroscience Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on informed consent. The module accompanies the Bioethics Commission’s two-volume report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1) and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The new Gray Matters module adds to the informed consent resources already produced by the Bioethics Commission. Additional materials on informed consent include a background module and four report-specific modules that accompany the Bioethics Commission reports Ethically Impossible: STD Research in Guatemala from 1946 to 1948, Privacy and Progress in Whole Genome Sequencing, Safeguarding Children: Pediatric Medical Countermeasure Research, and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings. Other topics covered by the Bioethics Commission’s educational modules include research design, privacy, community engagement, compensation for research-related injury, and vulnerable populations.

The Informed Consent in Gray Matters module provides a brief introduction to the concept of consent capacity; elaborates an ethical justification for responsibly including individuals with impaired consent capacity in neuroscience research; describes the current regulatory framework regarding human subjects research involving participants with impaired consent capacity; and describes additional ethical safeguards to protect vulnerable populations, including adults with impaired consent capacity.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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

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Engaging Parents and Children Throughout Pediatric Research: A New Report from the Nuffield Council on Bioethics

Today the Nuffield Council on Bioethics (Nuffield Council), an independent bioethics advisory body in the United Kingdom, released Children and Clinical Research: Ethical Issues. The report marks the culmination of a two-year inquiry, during which the Nuffield Council received input from over 500 stakeholders – including the U.S. Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission addressed the ethics of research with children in its March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. In that report, the Bioethics Commission tackled the particularly complex ethical dimensions of conducting clinical trials of medical countermeasures (MCMs) – that is, clinical products and interventions used in response to chemical, biological, radiological, and nuclear terror attacks – with children. Through six recommendations to guide the ethical conduct of pediatric MCM research, the Bioethics Commission sought to navigate the tension between protecting individual children from undue risk in research and protecting all children, to the extent possible, through the fruits of research.

Throughout its analysis in Safeguarding Children, the Bioethics Commission recognized the critical importance of pediatric research to address children’s health needs. It expressed “an unwavering commitment to safeguard all children from unacceptable risks in research and through research that promotes their health and well-being.” (p. 105) The Nuffield Council echoed this commitment at the very outset of its report, “challeng[ing] the idea that clinical research is something from which children need to be protected and essentially excluded,” and articulating a “belief that children will be best protected from ill health, disease and the impacts of disability through a greater commitment to evidence-based care.” (p. vii)

The Bioethics Commission and Nuffield Council also fundamentally agree that pediatric research protections can be strengthened through engagement with trial participants, their families, and other stakeholders. The Bioethics Commission recognized the critical role of community engagement in pediatric MCM research to “build transparent, meaningful, collaborative, and mutually beneficial relationships among those considering or conducting research and the relevant communities.” (p. 79) Several of the Nuffield Council’s recommendations support similar engagement, for example, through the consideration of young persons’ and parents’ views in designing research. As the Nuffield Council’s Director, Hugh Whittall, explained, “by speaking to children and their families, researchers can design studies which are more suited to their needs, and ultimately more acceptable.”

In Safeguarding Children, the Bioethics Commission called for an ongoing conversation about the ethical conduct of pediatric research. Today the Nuffield Council has added its valuable voice to the discussion.

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Bioethics Commission recommends establishing clear requirements for identifying legally authorized representatives for research participation

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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New Education Materials from the Bioethics Commission on Research Design Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on research design. The materials on research design increase the breadth of topics covered by the Bioethics Commission’s educational resources. Previous topics include privacy, community engagement, compensation for research-related injury, informed consent, and vulnerable populations. The new series includes both a background module, and a module to accompany the Bioethics Commission’s Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1).

The Research Design Background module provides a brief introduction to research design; relates research design to guiding ethical principles; describes practical and ethical considerations in research design generally; identifies design components and ethical considerations in randomized controlled trails for biomedical research with human participants specifically; and explains the relevant regulatory requirements and guidelines that promote ethical research design.

The Research Design in Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society module emphasizes the importance of integrating ethics early and explicitly throughout the research endeavor, including in the determination of research design; explains how foundational domains of ethical conduct support ethical research design; and provides examples of approaches to ethics integration in neuroscience research design.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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

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Bioethics Commission Recommends Engaging Stakeholders to Address Stigma Associated with Impaired Consent Capacity

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) explored capacity and the consent process as one of three topics that illustrate some of the ethical and societal tensions that surround rapidly advancing neuroscience research and its applications. When considering and addressing ethical concerns about consent capacity, it is crucial to avoid policies and practices that perpetuate or exacerbate stigma. Equating certain conditions with impaired consent capacity or making unfounded assumptions about individual abilities based on diagnoses can subject individuals to stigmatizing or discriminatory practices, undermining the respect due to those individuals. The Bioethics Commission recognized that one important approach to help neuroscience researchers alleviate stigma is stakeholder engagement, and recommended engaging stakeholders to address stigma associated with impaired consent capacity:

Funders and researchers should engage stakeholders, including members of affected communities, to build understanding of consent capacity and associated diagnoses to mitigate the potential for stigma and discrimination.

Stakeholder engagement can inform research design, including by identifying what to study, improving informed consent processes, and assessing how results might be received and analyzed. It is also an important mechanism to mitigate potential social harms associated with research participation and to cultivate trust among researchers and affected populations. Stakeholder engagement processes are particularly important for research that involves underrepresented and potentially stigmatized groups. Seeking the perspectives of those with, or at risk for, disorders or conditions associated with impaired consent capacity, caregivers, researchers, and community members affected by research can help alleviate stigma and discrimination by providing information about the lived experience of those affected by particular disorders or conditions, and dispelling common assumptions about those disorders or conditions.

Ethical research involving participants with potentially impaired consent capacity requires that investigators acknowledge and learn from the diversity of individual needs and abilities. Stakeholder engagement provides an additional layer of protection for participants, and also can help researchers identify and develop questions and practices tailored to specific affected communities or categories of impairment. Engaging various stakeholder communities enables neuroscience researchers to uphold ethical standards and advance best practices, remain accountable to the communities with which they work, and foster thoughtful and important discussion about the potential for stigma and discrimination.

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

 

 

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Bioethics Commission Recommends Further Research on Consent Capacity and Ethical Protections for Participants

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) provided ethical analysis of three topics, including consent capacity and neuroscience research. More than one billion people globally, including millions of people in the United States, are affected by neurological disorders.[1]

Neuroscience research, including novel neurological interventions, promises new ways of treating, preventing, and understanding these conditions. However, many of these same conditions can impair individuals’ abilities to provide informed consent to participate in neuroscience research. The Bioethics Commission offered several recommendations to address neuroscience research involving individuals who might have impaired consent capacity. In particular, the Bioethics Commission recommended that:

Funders should support research to address knowledge gaps about impaired consent capacity, including the concept of capacity, brain function and decision-making capacity, current policies and practices, and assessment tools.

The Bioethics Commission recognized the progress made in recent decades, leading to better understanding of consent capacity. However, more research is needed to address remaining gaps in our knowledge including analysis of which abilities are most pertinent to understanding consent capacity, how to best assess individuals’ consent capacity, and the effectiveness of additional protections for research participants.

The Bioethics Commission highlighted the crucial role of neuroscientists in implementing this recommendation and disseminating research results. For example, professional societies like the International Neuroethics Society or the Society for Neuroscience might encourage researchers to share current practices, developments, and insights at meetings. In addition, investigators, with the assistance of journal editors, could publish more detailed accounts of ethical protections employed within scientific manuscripts or elsewhere. These efforts can create a collaborative environment in which neuroscientists facilitate and even lead the way in furthering best practices in research.

Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society and all other Bioethics Commission reports are available at Bioethics.gov.

[1] National Institute of Neurological Disorders and Stroke (NINDS). (2014). NINDS Overview. Retrieved February 2, 2015 from http://www.ninds.nih.gov/about_ninds/ninds_overview.htm; BrainFacts.org. (2014). Global Burden of Neurological and Mental Disorders [Webpage]. Retrieved February 17, 2015 from http:// www.brainfacts.org/policymakers/global-burden-of-neurological-and-mental-disorders/.

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Bioethics Commission recommends the responsible inclusion of participants with impaired consent capacity in neuroscience research

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.

To make discoveries about the brain and related neurological disorders that will benefit society, neuroscientists need to conduct research. Well-established ethical guidelines generally require that participants give their fully informed consent before enrolling in research. This might not be possible, however, if an individual cannot give consent because of an impaired capacity to do so. In such cases, U.S. regulations allow a legally authorized representative (LAR) to give permission for participation.

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 sixth recommendation, the Bioethics Commission called for the responsible inclusion of participants with impaired consent capacity. Specifically the Commission recommended that:

Researchers should responsibly include individuals with impaired consent capacity who stand to benefit from neuroscience research. Participation, with ethical safeguards in place, can ensure progress aimed at understanding and ameliorating neurological disorders and psychiatric conditions.

The Bioethics Commission acknowledged the need for additional safeguards to ensure that participants with impaired consent capacity are adequately protected. Numerous national panels over the last four decades have attempted to establish uniform guidelines and safeguards to ensure ethical research with adults who have impaired consent capacity. Despite these efforts no federal regulations specifically address research with this population.

Protections might include robust initial and ongoing assessment of consent capacity; methods to improve informed consent processes to accommodate participants’ needs, for example, including audiovisual means and paced verbal instructions; methods to respect participant assent and dissent when consent capacity is partial or in question; and clear parameters and procedures for obtaining the permission of an LAR when a participant lacks consent capacity. In addition, use of research advance directives (a set of written instructions articulated by an individual to appoint a proxy and direct their involvement in future research) and stakeholder engagement can provide protection.

Neuroscience research is a principal means of promoting progress and benefiting populations affected by neurological disorders and psychiatric conditions, including those associated with impaired consent capacity. Substantial progress in understanding many of these disorders has been possible because of the advances in research, yet more needs to be done. The Bioethics Commission’s recommendations are intended to promote vital neuroscience research while protecting those with impaired consent capacity.

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

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Bioethics Commission Recommends Creating Guidance About Use of Neural Modifiers to Augment or Enhance Neural Function

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). This is the second volume in its two-part response to President Obama’s July 2013 Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative-related 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.”

Gray Matters, Vol. 2 addresses some of the ethical and societal implications of neuroscience research and its applications. For example, the Bioethics Commission thoughtfully considered ethical concerns that can accompany the development and use of new techniques and technologies to modify human neural functioning including cognitive enhancers. These “neural modifiers” include any methods, behaviors, and conditions that alter the brain and nervous system including novel technologies. Neural modifiers can serve three goals, including (1) maintaining or improving neural health or cognitive function within typical or statistically normal ranges, (2) treating neurological disorders, and (3) expanding or augmenting neural function above typical or statistically normal ranges.

The Bioethics Commission learned that clinicians often receive requests to prescribe medications for cognitive enhancement, a form of neural modification, and determined that clinicians should have access to detailed professional guidelines to help manage patient requests ethically. This guidance is especially important with regard to children and adolescent patients. Specifically, the Bioethics Commission recommended:

Professional organizations and other expert groups should develop guidance for clinicians, employers, parents, educators, and patients about the use of neural modifiers and their potential risks and benefits. Medical professional organizations should develop guidelines to assist clinicians in responding to requests for prescriptions for interventions to expand or augment neural function. Clinicians should not prescribe medications that have uncertain or unproven benefits and risks to augment neural function in children and adolescents who do not have neurological disorders.

Guidance documents from professional organizations can support the decision-making process for a diverse group of stakeholders, including clinicians, employers, parents, educators, and professional organizations in fields such as aviation, medicine, and the military that are associated with on-the-job use of brain and nervous system enhancement interventions. Guidelines should include relevant information about the ethical concerns related to the prescription and use of neural modifiers, including just distribution and access, risks and benefits, coercion and autonomy, and respect for human dignity.

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

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Bioethics Commission Makes Recommendation on Equitable Access to Safe and Effective Neural Modifiers

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. In this report the Bioethics Commission considered in depth ethical concerns raised by the development and use of novel forms of neural modification, including those designed to enhance cognition.

The Bioethics Commission described three goals of neural modification, including (1) maintaining or improving neural health and cognitive function within the range of typical or statistically normal human functioning, (2) treating neurological disorders, and (3) expanding or augmenting neural function. Although the third goal is sometimes associated with the pursuit of radical human enhancements, such as unyielding stamina or perfect recall, more realistically, expanding or augmenting neural function is associated with modest cognitive enhancement.

Novel forms of cognitive enhancement, such as the use of prescription stimulant drugs, are ethically controversial, and only limited evidence exists regarding their benefits and risks. In addition to recommending greater support for research on the prevalence, benefits, and risks of novel neural modifiers, the Bioethics Commission identified an area of particular ethical concern: the potential for cognitive enhancements to exacerbate existing inequalities between advantaged and disadvantaged groups, if they are available only to those who are already advantaged (for example by wealth, or social capital). However, the equitable distribution of cognitive enhancements could promote justice. Some evidence suggests that individuals with lower levels of baseline cognitive functioning experience a greater improvement from cognitive enhancements than those at a higher baseline level. If these results are borne out by future research, cognitive enhancement could be used to reduce inequities, for example, by reducing gaps in educational attainment.

The Bioethics Commission argued that limiting access to effective forms of cognitive enhancement to those who already enjoy greater access to other social goods would be unjust. It emphasized that the collective pursuit of neural modifications might help to close gaps in opportunity that are related to neural function and promote societal benefits of cognitive enhancement that might be lost if access is limited only to a privileged few. Specifically, the Bioethics Commission recommended that:

Policymakers and other stakeholders should ensure that access to beneficial, safe, effective, and morally acceptable novel neural modifiers to augment or enhance neural function is equitable so as not to compound or exacerbate social and economic inequities.

The Bioethics Commission emphasized the importance of assessing enhancement interventions to determine their potential to affect existing social and economic disparities. The ethical acceptability of these interventions will be determined in part by whether access to them is distributed so as to promote justice and fairness rather than create new, or exacerbate old forms of injustice.

Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society and all other Bioethics Commission reports are available at Bioethics.gov.

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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.

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