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

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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Two years of Neuroscience Inquiry at the Bioethics Commission

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On March 26, 2015, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the second of its two-volume  response to President Obama’s charge to examine the ethical implications of neuroscience research and its applications.

To commemorate the completion of Gray Matters, the Bioethics Commission has created a Storify to trace its work over the past two years. Highlights include:

Capture Capture2 Capture3 Capture4To view the complete story, click here. If you missed the release-day webinar, an archived recording is available at Bioethics.gov.

 

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Bioethics Commission Makes Recommendations on Existing and Novel Methods to Maintain and Improve Neural Health

In its recently published report, 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) focused on three controversial topics that illustrate some of the ethical and societal tensions that surround rapidly advancing neuroscience research and its applications. One of those topics was cognitive enhancement. The Bioethics Commission expanded the conversation about cognitive enhancement to include all forms of neural modification. It considered not only novel neurotechnologies like brain stimulation devices and brain training tools, but also any methods, behaviors, and conditions that alter the brain and nervous system.

For example, some lifestyle and public health interventions can benefit neural health and might be safer and more effective than novel neural modifiers such as transcranial direct current stimulation (tDCS) devices. The Bioethics Commission’s first recommendation addresses the prioritization of such existing strategies to maintain and improve neural health:

In addition to developing new drugs and devices to maintain and improve neural health, funders should prioritize and support research on existing, low-technology strategies, such as healthy diet, adequate exercise and sleep, lead paint abatement, high-quality educational opportunities, and toxin-free workplaces and housing.

Existing treatments for neurological disorders also are valuable and can be improved. Emerging neural modification interventions have the potential to reduce the burden of neurological disorders on individuals and society. Safe and effective treatments can help improve the lives of millions of individuals living with neurological disorders in the United States. The Bioethics Commission’s second recommendation is to prioritize treatment of neurological disorders:

Funders should prioritize research to treat neurological disorders to improve health and alleviate suffering. This research should consider individual, familial, and public health burdens as well as potential risks, benefits, and long-term effects of specific interventions.

Although the Bioethics recommended prioritizing the study of both traditional and novel interventions for the prevention and treatment of neurological disorders, it also recognized the need for research to better characterize novel neural modification techniques such as stimulant drugs and brain stimulation devices. Limited evidence exists for the benefits and risks of novel neural modifiers and more data is needed on the prevalence of use of these interventions for enhancement purposes. Therefore, the Bioethics Commission’s third recommendation is to study novel neural modifiers to augment or enhance neural functioning:

Funders should support research on the prevalence, benefits, and risks of novel neural modifiers to guide the ethical use of interventions to augment or enhance neural function.

Overall, the Bioethics Commission considered a variety of forms of neural modification and recommended that funders prioritize research on existing, low-technology and public health interventions and treatments for neurological disorders, and support research to better understand novel methods of cognitive enhancement and their use. By broadening the cognitive enhancement conversation to include all forms of neural modification, the Bioethics Commission aims to expand the scope of current dialogue.

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

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Bioethics Commission Releases Final Neuroscience Report as Part of BRAIN Initiative: Focuses on Controversial Topics that Must be Addressed if Neuroscience is to Progress and be Applied Ethically

The Presidential Commission for the Study of Bioethical Issues today released Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the second of its two volume report in response to President Obama’s BRAIN Initiative related charge. The President requested that the Bioethics Commission consider the ethical issues associated with neuroscience research and the application and implications of neuroscience research findings. Gray Matters, Vol. 2takes an in-depth look at three controversial topics at the intersection of neuroscience and society that have captured the public’s attention—cognitive enhancement, consent capacity, and neuroscience within the legal system. In the first volume, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society, released in May 2014, the Bioethics Commission emphasized the importance of integrating ethics and neuroscience early and explicitly throughout the research endeavor. Programs that integrate neuroscience and ethics will be well-positioned to answer new and remaining ethical questions, consider societal implications of neuroscience research, educate the public, and implement policy recommendations. The three topics addressed in Gray Matters, Vol. 2 illustrate the ethical tensions and societal implications of advancing neuroscience and technology, and bring into heightened relief many important ethical considerations.

Contemporary neuroscience research offers us the opportunity to better understand the human brain and support the development of new or more effective diagnostic tools, treatments, preventions, and cures for neurological disorders and psychiatric conditions that affect tens of millions of individuals in the United States, and more than a billion globally. In addition, it has the potential to lead to a deeper understanding of our cognition, emotion, imagination, behavior, memory, learning, and social interactions.

Amid public and scholarly debate surrounding cognitive enhancement, consent capacity, and neuroscience within the legal system, Gray Matters, Vol. 2 seeks to clarify for the public the current scientific landscape, clear a path to productive discourse to navigate difficult issues as they arise, and identify common ground where it exists.

The Bioethics Commission offers 14 recommendations to guide the ethical progress of neuroscience research and its applications. The recommendations call for attention to fundamental ethical concerns regarding, for example, justice and stigmatization of groups and individuals; research to clarify persistent questions and fill gaps in our current state of knowledge; accurate communication about the ethical and practical implications and application of neuroscience research results; clarity around legal requirements and new guidance where needed; and the need to support and advance innovative multidisciplinary research and scholarship at the critically important intersection of neuroscience, ethics, and society.

The report is available at Bioethics.gov. Additional posts about the Bioethics Commission’s recommendations will be highlighted here on blog.Bioethics.gov throughout this spring.

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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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