Maneesha Sakhuja – blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Mon, 09 Jan 2017 23:23:29 +0000 en-US hourly 1 Bioethics Commission Recommends Deliberation and Education to Facilitate Civic Engagement with Pressing Bioethical Concerns https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/16/bioethics-commission-recommends-deliberation-and-education-to-facilitate-civic-engagement-with-pressing-bioethical-concerns/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/16/bioethics-commission-recommends-deliberation-and-education-to-facilitate-civic-engagement-with-pressing-bioethical-concerns/#respond Mon, 16 May 2016 14:29:31 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1847 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Bioethics for Every Generation: Deliberation and Education in Health, Science, and Technology . In Bioethics for Every Generation, the Bioethics Commission addresses how bioethics education and democratic deliberation are mutually reinforcing functions that create a virtuous circle that leads to productive civic engagement.

Educators and policymakers should implement bioethics education and deliberative activities to promote values essential to an engaged and civic-minded population. Through its focus on engagement with values and analytical reasoning, ethics education prepares members of communities to discuss not only their individual perspectives and values, but also those of others in the community. In turn, engagement with topics and issues that affect a community can lead to a better understanding of our own values. Civic involvement helps us focus on the kinds of communities we want to create, and on our own ability to contribute through collaborative problem solving. Ethics education and democratic deliberation are mutually reinforcing—in other words, ethics education prepares us to deliberate, and deliberation helps us clarify values and develop a way forward. In this report, the Bioethics Commission recommends that educators and organizers of deliberative activities use deliberation and education when engaging with the ethical dimensions of developments in health, science, and technology.

The Bioethics Commission outlines several examples of how deliberation can enhance education, including various deliberative classroom activities. Additionally, the Commission highlights the Intercollegiate Ethics Bowl, which teaches college students how to engage in ethical reasoning by deliberating in teams about specific cases, including topics in bioethics.

The Bioethics Commission also addresses the important role bioethics advisory commissions play in supporting public bioethics education and engaging in deliberation. Specifically, the Bioethics Commission recommends that future bodies continue to explore, reimagine, and reinvigorate their role in education and democracy, and that they encourage discourse and civic involvement in developing health, science, and technology policy.

This Bioethics Commission has implemented deliberative practices, and made significant contributions to bioethics education, including the development of educational tools that range in scope and format, are intended for many audiences, and are available for free on Bioethics.gov .

 

Bioethics for Every Generation and all other Bioethics Commission reports are free and available at Bioethics.gov .

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New Educational Module from the Bioethics Commission on Research Design in Ethics and Ebola https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/09/new-educational-module-from-the-bioethics-commission-on-research-design-in-ethics-and-ebola/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/09/new-educational-module-from-the-bioethics-commission-on-research-design-in-ethics-and-ebola/#respond Wed, 09 Mar 2016 22:56:42 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1812 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new educational module on research design in the context of a public health emergency. The module integrates material from the Bioethics Commission’s report Ethics and Ebola: Public Health Planning and Response (Ethics and Ebola).

This module serves as a guide for instructors to help students understand key ethical challenges that might arise when conducting clinical research during public health emergencies. The module identifies ethical considerations of various approaches to clinical research during public health emergencies, including randomized controlled trials.

The Research Design in Ethics and Ebola module provides background information on randomized controlled trials and considers the differences between vaccine and treatment trials, the interpretation of what constitutes “best available” supportive care, the necessity of research to be responsive to the host and affected communities, and the importance of designing trials that yield scientifically valid results. Through discussion questions, scenarios, exercises, and illustrative and timely examples, the module guides instructors to help students reflect on ethically relevant concerns that arise in designing research during a public health emergency.

The Bioethics Commission’s topic-based educational modules are grounded in contemporary ethical questions 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 Attends ASBH 2015 https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/11/04/bioethics-commission-attends-asbh-2015/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/11/04/bioethics-commission-attends-asbh-2015/#respond Wed, 04 Nov 2015 17:36:57 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1742 Several staff and members of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) attended the American Society for Bioethics and Humanities (ASBH) annual meeting, held in Houston, Texas October 22-25, 2015. ASBH is a diverse organization of professionals and students engaged in clinical and academic bioethics and the medical humanities. Along with leading multiple sessions on Bioethics Commission work, the Bioethics Commission was pleased to host a booth in the conference exhibition hall. The exhibit featured Bioethics Commission reports, including its most recent reports, Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), and Ethics and Ebola: Public Health Planning and Response. The Bioethics Commission also distributed “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 and Moral Science: Protecting Participants in Human Subjects Research. For others who were unable to attend ASBH, all materials are available for free download at bioethics.gov.

ASBH provided an opportunity to interact with colleagues from across the bioethics community; many attendees reported using our educational resources in their classrooms. The Bioethics Commission welcomes feedback and likes to hear how its materials are being used—if you have used our materials and are interested in sharing your experience, please email education@bioethics.gov!

The Bioethics Commission staff received many great questions at the exhibit. Here are some of the most frequently asked questions:

What is the Bioethics Commission currently working on?
The Bioethics Commission is working on a project on deliberation and ethics education. The Bioethics Commission stands behind strong democratic deliberation and enhancing ethics education. Throughout its tenure, Bioethics Commission members have modeled productive deliberation about a number of controversial topics. The Bioethics Commission has made a dozen recommendations about enhancing public and bioethics education, and the staff has produced a variety of educational materials based on report topics. This project on deliberation and education will be the Bioethics Commission’s capstone report, and will make recommendations about how these areas can mutually reinforce each other.

How does the Bioethics Commission choose the topics that it works on?
Topics come before the Bioethics Commission in two ways. The Executive Office of the President or a member of the President’s cabinet can ask the Bioethics Commission to study a particular topic or question and recommend an ethical way forward. The Bioethics Commission also can choose a topic based on pressing issues in the field.

How does the Bioethics Commission promote public bioethics?
All Bioethics Commission deliberations occur in public during its quarterly meetings. Anyone who is interested may attend these public meetings, or watch the meeting via live webcast at bioethics.gov. These meetings provide a unique opportunity to witness the live deliberations of a national bioethics commission—public bioethics in action. The Bioethics Commission welcomes input from anyone wishing to provide public comment on any issue before it, and is particularly interested in receiving comments and questions during meetings that are responsive to specific sessions. The Bioethics Commission’s next meeting will be held on November 17, 2015 in Arlington, VA. Written comments are accepted in advance of each meeting; please address written comments by email to info@bioethics.gov.

How does the Bioethics Commission disseminate its work?

As a part of its ongoing goal to educate the public and stakeholders about the Bioethics Commission’s recommendations, members and staff participate in many outreach events each year. In addition to discussing the findings of the Commission’s reports, the staff has produced a variety of educational materials based on report topics with the goal of making ethics accessible to a variety of stakeholders in both traditional and nontraditional education contexts.

What happens to the Bioethics Commission after President Obama’s term is over?
Like all federal advisory bodies, the Bioethics Commission must be renewed every two years. The Executive Order under which the Bioethics Commission currently operates has been extended until September 2017. However, if history repeats itself, it is likely that the Bioethics Commission in its current form will complete its work at the close of President Obama’s term in January 2017. At that time, it is also expected—though not guaranteed—that the next president will establish his or her own bioethics commission.

Thanks to all who stopped by our booth this year!

 

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Modernizing Human Subjects Research Protections: A Plan for Return of Results https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/05/modernizing-human-subjects-research-protections-a-plan-for-return-of-results/#respond Mon, 05 Oct 2015 18:30:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1728 The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes and their relationship to the Bioethics Commission’s work on incidental and secondary findings.

Currently, the Common Rule requires IRBs to find that certain criteria have been met in order to approve research. The NPRM proposes an addition that IRBs should evaluate the appropriateness of a plan for returning individual findings discovered during research, when that plan is submitted as part of the protocol. The proposed rulemaking also addresses the potential challenges of returning individual research findings when it is unclear if the findings are clinically valid or actionable, or when the findings might have psychological or social ramifications.

The Bioethics Commission addressed return of individual research results in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The Bioethics Commission recommended that IRBs review and approve plans for the disclosure and management of incidental findings—a recommendation echoed in the proposed changes to the Common Rule. The Bioethics Commission stressed the importance of this plan, recommending both that researchers develop a plan for managing incidental and secondary findings and that, during the informed consent process, researchers clearly communicate their plan to participants.

The NPRM cites to the Bioethics Commission’s report, recognizing the importance of the issue of return of individual research results, and the challenges highlighted by Anticipate and Communicate. The challenge of incidental findings and returning individual results in a research context is a perennial one for IRBs and researchers, and due to more advanced technologies and faster and deeper data analysis, the issue is growing. Anticipate and Communicate addresses these challenges head-on, and the Bioethics Commission is pleased to see that federal research regulations are evolving to address them as well.

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Bioethics Commission Recommends Funding Research on the Intersection of Neuroscience and the Legal System https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/06/08/bioethics-commission-recommends-funding-research-on-the-intersection-of-neuroscience-and-the-legal-system/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/06/08/bioethics-commission-recommends-funding-research-on-the-intersection-of-neuroscience-and-the-legal-system/#respond Mon, 08 Jun 2015 16:20:14 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1654 In March of this year 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 volume of its two-part report on ethics and neuroscience. In Gray Matters, Vol. 2, the Bioethics Commission analyzed three topics, including the application of neuroscience to the legal system. Advances in neuroscience might help us achieve more accuracy in decision making, decreased errors in advancing justice, and improved policymaking. However, the application of neuroscience to the legal system also raises concerns about conceptions of free will and mental privacy, among others.

Applications of neuroscience to the legal system include supporting propositions concerning competency to stand trial, mitigation of criminal responsibility, and predicting future dangerousness. The Bioethics Commission recognized the importance of comprehensive information regarding the use of neuroscience evidence in making important legal and policy decisions. The Commission urged organizations and government bodies to publish reports that address the successes, challenges, and limitations of neuroscience’s application to the legal system. Specifically, the Bioethics Commission recommended:

Relevant bodies, such as the National Academies of Science, the U.S. Department of Justice, the National Institute of Justice, and the Social Security Administration, should support comprehensive studies of the use of neuroscience in legal decision making and policy development.

In response to the surge in DNA evidence used in criminal investigations, and in response to evidence obtained by polygraph examinations, various groups produced reports and recommendations that addressed questions about and limitations of these technologies. Similar reports on the application of neuroscience to the legal system should address the potential, limitations, and challenges for the use of neuroscience evidence in the courtroom and neuroimaging techniques for investigative purposes. For example, government agencies that collect and process data on medical claims in administrative legal proceedings, such as the Social Security Administration, could support new studies to improve understanding of pain and disability to facilitate accuracy in claim processing and arbitration.

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 https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/15/bioethics-commission-recommends-creating-guidance-about-use-of-neural-modifiers-to-augment-or-enhance-neural-function/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/15/bioethics-commission-recommends-creating-guidance-about-use-of-neural-modifiers-to-augment-or-enhance-neural-function/#respond Wed, 15 Apr 2015 15:50:44 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1610 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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Using the Least Restrictive Limits in Public Health Emergencies https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/03/05/using-the-least-restrictive-limits-in-public-health-emergencies/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/03/05/using-the-least-restrictive-limits-in-public-health-emergencies/#respond Thu, 05 Mar 2015 15:08:46 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1580 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Ethics and Ebola: Public Health Planning and Response. In this brief, the Bioethics Commission examined U.S. engagement in the global response to the Ebola epidemic with the goals of 1) determining what lessons might be learned from the U.S. response and 2) creating recommendations to support proactive response to public health epidemics.

The Bioethics Commission considered in detail the U.S. public health emergency response with regard to the ethical use of liberty-restricting public health measures that involve monitoring or restricting movement and association, such as quarantine, and the impact of such measures on western African and U.S. health care workers. The Commission’s analysis of the use of restrictive measures highlighted the importance of the principle of least infringement, which holds that the least restrictive measures—grounded in the best available scientific evidence—should be taken to protect the public health and health care workers. Specifically, the Bioethics Commission recommended that:

Governments and public health organizations should employ the least restrictive means necessary—on the basis of the best available scientific evidence—in implementing restrictive public health measures, such as quarantines and travel restrictions, intended to control infectious disease spread. In addition, governments and public health organizations should be prepared to communicate clearly the rationale for such measures and provide ongoing updates to the public about their implementation, with particular attention to the needs of those most directly affected.

The Bioethics Commission stressed the importance of ethical preparedness and planning, with an emphasis on transparency and consensus in decision making through democratic deliberation, a process that fosters public engagement. The Commission emphasized using deliberative democratic processes to provide citizens with sound scientific and ethical justifications for public health policies. Drawing on the principles of least infringement, beneficence and non-maleficence, reciprocity, justice and fairness, and the harm principle—in addition to lessons from the current Ebola epidemic and other public health crises, including HIV/AIDS, SARS, and tuberculosis—the Bioethics Commission concluded that public health officials should implement the least restrictive measures that are effective in controlling disease transmission during a public health emergency.

The brief and all other Bioethics Commission reports are available at Bioethics.gov.

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New Education Materials on Compensation for Research-Related Injury https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/23/new-education-materials-on-compensation-for-research-related-injury/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/23/new-education-materials-on-compensation-for-research-related-injury/#respond Tue, 23 Sep 2014 15:04:34 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1420 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on compensation for research-related injury. The materials on compensation increase the breadth of topics the Bioethics Commission’s educational resources cover; previous topics include community engagement, informed consent, and vulnerable populations. The new series includes a background module and two modules specific to Bioethics Commission reports: Moral Science: Protecting Participants in Human Subjects Research and Safeguarding Children: Pediatric Medical Countermeasure Research.

The “Compensation Background” module describes the goals of compensating individuals for research-related injury; provides ethical justification for compensation; discusses practical considerations, including informed consent and cost and feasibility; presents past U.S. historical context and advisory committee recommendations on compensation; and identifies current U.S. and international approaches to compensation. The module presents various models of compensation including insurance, personal insurance, specialty courts, and compensation funds.

The “Compensation in Moral Science: Protecting Participants in Human Subjects Research” module presents the Bioethics Commission’s examination of treatment and compensation for research-related injury. The module explains the ethical principles that support, and addresses challenges associated with, providing treatment or compensation for research-related injuries. The module describes international requirements and guidance concerning treatment or compensation for research-related injury; leads instructors through different models for compensating participants for research-related injuries and some of the strengths and weaknesses of each; and addresses the difference between compensation for research-related injury and reparations for past unethical research.

The “Compensation in Safeguarding Children: Pediatric Medical Countermeasure Research” module focuses on compensation for research-related injury in the context of pediatric medical countermeasure (MCM) research. The module outlines the ethical principles that support providing treatment or compensation for research-related injuries that arise from pediatric MCM research; describes the different arguments for treating or compensating injured adults and injured pediatric research participants; and addresses the various ways injured pediatric MCM research participants can seek treatment or compensation and the strengths and limitations of these approaches.

All of the learning modules are based on ethical questions addressed by the Bioethics Commission and 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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New Incidental Findings Conversation Series for Patients, Research Participants, and Consumers https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/13/new-incidental-findings-conversation-series-for-patients-research-participants-and-consumers/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/13/new-incidental-findings-conversation-series-for-patients-research-participants-and-consumers/#respond Fri, 13 Jun 2014 14:31:16 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1345 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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Integrating Ethics Early and Explicitly Throughout Neuroscience Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/20/integrating-ethics-early-and-explicitly-throughout-neuroscience-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/20/integrating-ethics-early-and-explicitly-throughout-neuroscience-research/#respond Tue, 20 May 2014 17:30:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1299 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) recently released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1). The report is the first of a two-volume response from the Bioethics Commission to President Obama’s July 2013 request. As part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative 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 BRAIN Initiative, launched by the President in April 2013, aims to “revolutionize our understanding of the human mind and uncover new ways to treat, prevent, and cure brain disorders like Alzheimer’s, schizophrenia, autism, epilepsy, and traumatic brain injury.”

In Gray Matters, Vol. 1, the Bioethics Commission addressed the need for the integration of ethics and neuroscience across the life of a research endeavor, making four recommendations. The first of these recommendations called for integrating ethics early and explicitly throughout neuroscience research. Specifically the Commission recommended that:

Institutions and individuals engaged in neuroscience research should integrate ethics across the life of a research endeavor, identifying the key ethical questions associated with their research and taking immediate steps to make explicit their systems for addressing those questions. Sufficient resources should be dedicated to support ethics integration.

Approaches to ethics integration discussed by the Bioethics Commission include:

  • Implementing ethics education at all levels;
  • Developing institutional infrastructure to facilitate integration;
  • Researching the ethical, legal, and social implications of scientific research;
  • Providing research ethics consultation services;
  • Engaging with stakeholders; and
  • Including an ethics perspective on the research team.

The Bioethics Commission stressed that those involved in research have a responsibility to identify and address the ethical issues that arise throughout the scientific research process. According to the Bioethics Commission, integrating ethics in science should allow for productive dialogue and collaboration between experts in many fields including the social sciences, the life sciences, medicine, law, history, and philosophy, among others. The Bioethics Commission recognized that, in various ways, ethics is already integrated into the scientific enterprise as it is in many human activities. However, the Bioethics Commission emphasized the importance of making implicit ethical judgments explicit, and implementing ethics integration systematically. The Bioethics Commission explained that institutions and individuals might adopt different approaches to integrating ethics and neuroscience research depending on the context in which they act.

Notably, as part of this recommendation, the Bioethics Commission acknowledged that if something is not appropriately funded, it does not get done. Thus it called for dedicating sufficient financial resources, human capital, and expertise to support integrating ethics and neuroscience research.

Integrating ethics early and explicitly will lay the foundation for successful integration of ethics throughout neuroscience research, equipping scientists, ethicists, and the public to handle the societal implications of these scientific advances.

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