Elizabeth Fenton – 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 Makes Recommendation on Equitable Access to Safe and Effective Neural Modifiers https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/09/bioethics-commission-makes-recommendation-on-equitable-access-to-safe-and-effective-neural-modifiers/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/09/bioethics-commission-makes-recommendation-on-equitable-access-to-safe-and-effective-neural-modifiers/#respond Thu, 09 Apr 2015 15:52:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1608 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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Bioethics Commission Releases Brief on Ebola and Ethics Preparedness for Public Health Emergencies https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/26/bioethics-commission-releases-brief-on-ebola-and-ethics-preparedness-for-public-health-emergencies/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/26/bioethics-commission-releases-brief-on-ebola-and-ethics-preparedness-for-public-health-emergencies/#respond Thu, 26 Feb 2015 13:02:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1575 Today, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released a brief, Ethics and Ebola: Public Health Planning and Response, to the administration and the public on ethical preparedness for public health emergency response, with a focus on the U.S. response to the current Ebola epidemic in western Africa. The brief considers what lessons the U.S. response to the epidemic has for ethics preparedness for future public health emergencies, emphasizing the role of proactive democratic deliberation in developing responses that reflect public values in a pluralistic society and an increasingly interconnected world. The brief also considers two areas of particular controversy: 1) the ethical use of liberty-restricting public health measures, such as quarantine; and 2) the ethical conduct of research during public health emergencies.

In this brief the Bioethics Commission endorsed the ongoing participation of the United States in the global response to the Ebola epidemic for both ethical and prudential reasons. Public health crises like the Ebola epidemic often occur in countries and communities least equipped to manage and control them. The magnitude of suffering caused by these crises, and global inequalities in wealth and power that contribute to them, provide a strong moral imperative grounded in humanitarianism and justice to contribute to response efforts. In addition, given the capacity of infectious diseases to travel easily in an interconnected world, addressing epidemics at their source is justified on prudential grounds. Safeguarding national health security provides a strong pragmatic reason to respond to public health emergencies where they occur, and to support ongoing efforts to strengthen capacity and public health infrastructure in affected areas.

Strong international and U.S. federal public health infrastructures are essential for responding effectively to public health emergencies and their short- and long-term consequences. In Ethics and Ebola the Bioethics Commission recommended that the United States strengthen key elements of its domestic and global health emergency response capabilities, including leadership and global collaboration, and engage actively in effective public education and communication.

Ethics preparedness for emergency response, both at home and abroad, calls for an approach to policy making that prioritizes early public engagement, building consensus, and transparency. A proactive process of democratic deliberation before the onset of a crisis can inform and facilitate the development of public health policies that reflect shared values. However, democratic deliberation can be particularly challenging in the midst of a crisis, when information is changing rapidly, and policies and their implementation might need to be reconsidered. The Bioethics Commission recommended that ethical principles be integrated into public health decision making, and that qualified public health ethics expertise be readily available in an emergency to ensure that decision makers identify and respond to relevant ethical considerations in light of real-time available evidence.

In its next project the Bioethics Commission will consider in more depth the importance of democratic deliberation and public education in bioethics. The U.S. response to the Ebola epidemic in western Africa is a timely reminder of why broader public engagement in the ethical dimensions of health decision making is critical, both now and in anticipation of the future.

The brief is available at Bioethics.gov. Look for additional blog posts about each of the brief’s recommendations to be posted to blog.Bioethics.gov.

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New Educational Module on Informed Consent in Safeguarding Children https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/07/29/new-educational-module-on-informed-consent-in-safeguarding-children/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/07/29/new-educational-module-on-informed-consent-in-safeguarding-children/#respond Tue, 29 Jul 2014 15:37:27 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1362 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the context of pediatric medical countermeasure research. The module integrates material from the Bioethics Commission’s March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research.

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

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

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

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

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

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

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New Educational Module Available on Informed Consent for Anticipate and Communicate https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/20/new-educational-module-available-on-informed-consent-for-anticipate-and-communicate/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/20/new-educational-module-available-on-informed-consent-for-anticipate-and-communicate/#respond Thu, 20 Mar 2014 15:40:56 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1202 The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the management of incidental and secondary findings. The module integrates material from the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (Anticipate and Communicate).

The pedagogical product, now available for use in traditional and non-traditional educational settings, takes users through several scenarios. For example, imagine that a patient in the emergency room has a CT scan to rule out appendicitis. The CT scan shows a nodule on an adrenal gland, and while discharging the patient from the emergency room the physician recommends she follow up with her primary care provider. These nodules are benign ninety-eight percent of the time, but without this information the patient leaves the hospital confused and anxious about the finding.

Incidental findings – results that arise that are outside the original purpose for which a test or procedure was conducted – can create practical, legal, and ethical challenges for both recipients and practitioners. In Anticipate and Communicate the Bioethics Commission recommended that patients, research participants, and consumers should be informed about the likelihood of such findings arising from a particular test or procedure. Open communication between practitioners and individuals in all contexts helps ensure that individuals understand risks and benefits before they consent, and helps practitioners think through the consequences of conducting various tests and procedures.

The aim of the new module on informed consent is to highlight the interplay between informed consent and incidental and secondary findings in the clinical, research, and direct-to-consumer contexts, and the different elements of that process in each context. Real-life examples are used to show why it is critical that patients, research participants, and consumers are informed about the likelihood of any incidental findings arising from a test or procedure, understand the process for managing those findings, and can express preferences about which findings they want to know.

In addition to background information and readings the module provides discussion questions, questions based on real-life scenarios, and exercises, such as designing an informed consent document for research participants. The goal of the module is to help instructors incorporate a new perspective on informed consent into their curricula, and explore the particular ethical challenges raised by incidental and secondary findings.

All Bioethics Commission pedagogical materials are freely available at www.bioethics.gov. The Bioethics Commission encourages feedback on the materials at education@bioethics.gov.

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Public Engagement Past and Present: From Gopher to Website https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/28/public-engagement-past-and-present-from-gopher-to-website/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/28/public-engagement-past-and-present-from-gopher-to-website/#respond Fri, 28 Feb 2014 15:31:02 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1181 February 2014 marks the 20th anniversary of the creation of the Advisory Committee on Human Radiation Experiments (ACHRE) by President Clinton in 1994. To make its work publicly accessible ACHRE created a “gopher,” what we now call a website, the first of its kind for a bioethics commission.

Tasked with reviewing the ethical and scientific standards of U.S. government-sponsored human experiments involving intentional exposure to radiation, ACHRE believed that the subject-matter of its review and the human stories that constituted it imposed a special responsibility to “disseminate as broadly as possible the results of its investigations, the implications of that history for our own time, and its best judgment concerning the rights and responsibilities of those involved.”

ACHRE’s gopher included historical information about the human radiation experiments, fact sheets about radiation, records of other government documents concerning the experiments, meeting transcripts, and the Committee’s Final Report.  Subsequent bioethics commissions followed ACHRE’s lead by using the internet to make their processes and deliberations easily accessible to the public. The website for the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continues in this tradition and contains similar types of information that ACHRE thought it so important to make available, including transcripts, reports, and details about Bioethics Commission members and staff.  But information technology has come a long way since ACHRE’s gopher, and the Bioethics Commission’s website also embraces new mechanisms for keeping the public up-to-date on its activities, such as regular blog posts, Twitter updates, videos featuring interviews with Commission members, and links to educational resources.  These features bring the Bioethics Commission to life and provide new opportunities for public engagement.

Jonathan Moreno, Senior Advisor to the Bioethics Commission and former staff member at ACHRE, had first-hand experience of the development of ACHRE’s gopher: “My first email address was moreno@achre.gov in 1994. ACHRE wanted very much to take advantage of the Internet text platforms of the day (“graphical” interfaces made possible by the Web were still somewhat exotic), because the issues were of great public concern and there were relevant cases scattered throughout the country. It’s very satisfying to see the improvements in public access to commission activities and presentation of commission materials since then.”

As a portal for information, news, education and public engagement, the Bioethics Commission’s website continues the legacy of ACHRE’s gopher and its commitment to accessibility and transparency.

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