Tenny Zhang – 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 Engaging Stakeholders to Address Stigma Associated with Impaired Consent Capacity https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/05/bioethics-commission-recommends-engaging-stakeholders-to-address-stigma-associated-with-impaired-consent-capacity/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/05/bioethics-commission-recommends-engaging-stakeholders-to-address-stigma-associated-with-impaired-consent-capacity/#respond Tue, 05 May 2015 17:06:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1620 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 Makes Recommendations on Existing and Novel Methods to Maintain and Improve Neural Health https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/01/bioethics-commission-makes-recommendations-on-existing-and-novel-methods-to-maintain-and-improve-neural-health/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/01/bioethics-commission-makes-recommendations-on-existing-and-novel-methods-to-maintain-and-improve-neural-health/#respond Wed, 01 Apr 2015 19:58:11 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1596 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 Makes Recommendations on Research Ethics in Public Health Emergencies https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/03/12/bioethics-commission-makes-recommendations-on-research-ethics-in-public-health-emergencies/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/03/12/bioethics-commission-makes-recommendations-on-research-ethics-in-public-health-emergencies/#respond Thu, 12 Mar 2015 15:46:20 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1584 In its recently published brief, Ethics and Ebola: Public Health Planning and Response, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) considered what lessons might be drawn from U.S. engagement in the global response to the Ebola epidemic. The brief examined two areas of human subjects research ethics that have been particularly controversial in the current Ebola epidemic: clinical trial design and the use of placebos; and the collection, use, and international sharing of biospecimens for research.

Public health emergencies add ethical complexity to the conduct of clinical research and yet the Bioethics Commission recognizes the importance of such research—especially when an emergency presents the best, or only, opportunity to conduct research on potential preventive or therapeutic interventions, as is the case for Ebola. As large clinical trials are planned or already underway in western Africa to investigate experimental Ebola vaccines and therapies, the Commission considered whether it is ethically appropriate to conduct randomized placebo-controlled trials to evaluate these interventions. The Bioethics Commission considered two perspectives on this question, one against and one in support of placebo-controlled trials in the current Ebola epidemic, as well as possible middle grounds, while underscoring ethically relevant aspects of conducting clinical research in the Ebola epidemic that might help to resolve tensions between these two viewpoints, such as the role of different levels of supportive care and responsiveness to the needs of communities in which the research is conducted.

Ultimately the Bioethics Commission recommended that the full range of trial designs that protect and promote the welfare of participants and are capable of yielding credible and reliable data on the safety and effectiveness of the interventions should be considered:

Research during the Ebola epidemic should provide all participants with the best supportive care sustainably available in the community in which the research is conducted. Trial designs should be methodologically rigorous and capable of generating results that are clearly interpretable, acceptable to the host communities and, to the extent possible, minimize delays to completing the research. Properly designed placebo-controlled trials can meet these conditions, and innovative designs, such as adaptive randomization, ought to be considered as a means of addressing these research goals. Research teams should actively engage with affected communities while planning research to determine the trial design that best reflects these ethical and scientific requirements.

The Bioethics Commission also considered the ethical and practical challenges of collecting and sharing biospecimens in the context of a communicable disease outbreak like Ebola. The analysis concluded that researchers and other stakeholders should work to ensure equitable access to the benefits that result from research using shared biospecimens and emphasized the importance of ethical acquisition of samples, informed consent, and strong privacy protections.

The Bioethics Commission recommended that the United States should play a leading role in establishing best practices for sharing the benefits of research using biospecimens:

The U.S. government should ensure that Ebola virus related biospecimens are obtained ethically, including addressing the challenges of obtaining informed consent during a public health emergency and ensuring adequate privacy protections. The U.S. government should also, in collaboration with partners, facilitate access to the benefits that result from related research to the broadest group of persons possible. This can be achieved by engaging in dialogue with global partners and working collaboratively with local scientists whenever possible to develop effective strategies for ensuring equitable distribution of the benefits of research both in the United States and abroad.

A public health emergency can magnify and complicate ethical concerns associated with research, both clinical and non-clinical, and challenge research protections for vulnerable participants. In Ethics and Ebola, the Bioethics Commission navigated these dilemmas by considering practical realities and applying core ethical principles, including beneficence and justice and fairness. It emphasized the importance of broad and inclusive public engagement and democratic deliberation in advance of public health emergencies to anticipate and address the ethical, societal, legal, and practical challenges that emerge in such crises.

Ethics and Ebola: Public Health Planning and Response, and all other Bioethics Commission reports, are available at www.bioethics.gov.

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New Educational Module from the Bioethics Commission on Community Engagement in Synthetic Biology https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/13/new-educational-module-from-the-bioethics-commission-on-community-engagement-in-synthetic-biology/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/02/13/new-educational-module-from-the-bioethics-commission-on-community-engagement-in-synthetic-biology/#respond Fri, 13 Feb 2015 17:41:12 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1570 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on community engagement in the context of synthetic biology. The module integrates material from the Bioethics Commission’s report New Directions: The Ethics of Synthetic Biology and Emerging Technologies (New Directions).

The aim of this module is to help instructors understand how community engagement can impact technological development and application of synthetic biology and other emerging technologies, as well as the importance of democratic deliberation for addressing the use of such technologies. The module identifies guiding ethical principles and describes how they promote engagement with the public and with affected communities.

Through discussion questions, scenarios, and exercises, the module guides instructors to help students consider the differences between public engagement, community engagement, and community-engaged research, and offers a timely example of the engagement process in synthetic biology. Illustrative examples that highlight potential benefits and challenges of community engagement include the production of algal biofuels, use of synthetic chemicals in consumer products, and development of drugs using synthetic biology techniques.

This module is the latest addition to the Bioethics Commission’s series of modules on community engagement, which includes background material and modules discussing community engagement in the contexts of human subjects research protection and privacy in whole genome sequencing. This module is also the first that the Bioethics Commission has developed based on its report New Directions.

All of the Bioethics Commission’s educational modules are based on ethical questions addressed by the 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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Using the Bioethics Commission’s Pedagogical Materials on Informed Consent and Incidental Findings to Engage Students Undergoing Personalized Genetic Testing https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/01/06/using-the-bioethics-commissions-pedagogical-materials-on-informed-consent-and-incidental-findings-to-engage-students-undergoing-personalized-genetic-testing/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/01/06/using-the-bioethics-commissions-pedagogical-materials-on-informed-consent-and-incidental-findings-to-engage-students-undergoing-personalized-genetic-testing/#respond Tue, 06 Jan 2015 15:50:07 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1511 Recently, some U.S. educational institutions have used personalized genetic testing (PGT) as a pedagogical tool for teaching human genetics, allowing students to generate real-world experiences with technology relevant to course content. In a recent article published in the Journal of Microbiology & Biology Education, Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) staff members Tenny Zhang and Misti Ault Anderson assert that PGT also can be an effective tool for incorporating ethics into the biology classroom. Experiencing PGT first-hand represents a chance for students to reflect upon and discuss the many facets of genetic testing, including the interpretation, limitations, and potential impacts on individuals and society.

PGT in the educational setting provides an opportunity to integrate ethical considerations into the science classroom since genetic testing can raise a number of ethical concerns, including ensuring informed consent, protecting privacy, and promoting accessibility, among others. Integrating discussion about ethics into biology courses that offer PGT can help students to make direct and personal connections between the science learned in class and related bioethical challenges, and encourage consideration of the broader ethical implications of genetic testing.

While it has not taken a position on the use of PGT in the classroom itself, the Bioethics Commission has consistently emphasized in its work the need for ethics education across various disciplines, educational levels, and settings. As part of its ongoing effort to support bioethics education, the Bioethics Commission developed educational materials to facilitate ethics integration.

The Bioethics Commission’s topic-based modules, which are designed to be flexible to support multiple approaches to implementation and can be adapted into existing curricula in various educational settings, can provide a helpful resource to instructors using PGT in classrooms. Report-specific modules about informed consent in the context of whole genome sequencing (Informed Consent in Privacy and Progress) and incidental findings (Informed Consent in Anticipate and Communicate) are relevant to PGT and might help encourage students to consider the ethical complexities of genetic testing. The Conversation Series primer on incidental findings for consumers helps them to understand what incidental findings might arise in the direct-to-consumer (DTC) context and prepares them to ask the DTC provider relevant and important questions.

The full article by Zhang and Anderson, “Personalized Genetic Testing as a Tool for Integrating Ethics Instruction into Biology Courses,” can be read here.

For more information on all of the Bioethics Commission’s educational efforts, please watch the video, Promoting and Providing Materials for Bioethics Education, here.

All Bioethics Commission pedagogical materials are publicly accessible at www.bioethics.gov.

The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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Bioethics Commission Recommends Integrating Ethics and Science through Education at All Levels https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/03/bioethics-commission-recommends-integrating-ethics-and-science-through-education-at-all-levels/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/03/bioethics-commission-recommends-integrating-ethics-and-science-through-education-at-all-levels/#respond Tue, 03 Jun 2014 17:21:23 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1310 In Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) emphasized the need to integrate ethics throughout the life of neuroscience research and considered various approaches to integration. Early and explicit integration of ethics and neuroscience research enables scientists, ethicists, educators, public and private funders, policymakers, and the public to better recognize and address the ethical and societal implications of neuroscience research and its applications.

One foundational approach to integration is linking science and ethics education at all levels. Early ethics education is critical for preparing future scientists, including neuroscientists, to cultivate ethical reflection and to integrate ethical considerations into their work. Professional development for experienced investigators is equally important, as ethics education is more likely to inform action when it is continually reinforced. Ethics education should occur at many points before, during, and after graduate school.

Integration through education is a two-way process that involves both exposing scientists to ethics and ethicists to science. Ethics programs should also require exposure to scientific methods. For example, students could be required to complete a laboratory science component to enhance their scientific literacy and understanding. Training scientists in ethics and training ethicists in the sciences are both important for effective integration.

The Bioethics Commission recognized several examples of existing efforts to integrate ethics education at the secondary and undergraduate levels in Gray Matters, Vol. 1, and concluded that further development and evaluation of models for integrating ethics and science through all levels of education are needed. The Bioethics Commission also called for educational models to be shared, allowing researchers to evaluate various models and to identify and apply best practices. When successfully implemented, ethics education can effectively prepare future scientists and better engage practicing scientists—including neuroscientists—to integrate ethics into their work.

In Gray Matters, Vol. 1, the Bioethics Commission’s third recommendation addresses integration of ethics and science through education at all levels:

Government agencies and other research funders should initiate and support research that develops innovative models and evaluates existing and new models for integrating ethics and science through education at all levels.

An overarching theme throughout the Bioethics Commission’s reports has been the need for improvement in bioethics education. The Bioethics Commission is actively committed to doing its part to enhance such education, contributing to bioethics pedagogy by creating free and publicly accessible educational modules based on Commission reports; drafting study guides, primers, and other materials that facilitate deeper examination of the Commission’s ethical analyses; and engaging in outreach and teaching opportunities.

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Bioethics Commission Staff Presents “Pediatric Medical Countermeasure Research” at PRIM&R Advancing Ethical Research Conference in Boston https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/06/bioethics-commission-staff-presents-pediatric-medical-countermeasure-research-at-primr-advancing-ethical-research-conference-in-boston/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/06/bioethics-commission-staff-presents-pediatric-medical-countermeasure-research-at-primr-advancing-ethical-research-conference-in-boston/#respond Wed, 06 Nov 2013 16:05:05 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1027 Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) Executive Director Lisa M. Lee, Ph.D, M.S., and Associate Director Michelle Groman, J.D., will be speaking at PRIM&R’s (Public Responsibility in Medicine and Research) 2013 Advancing Ethical Research Conference, which takes place Nov. 7-9 in Boston, Mass. Their session, “Pediatric Medical Countermeasure (MCM) Research: Enumerating Ethical Considerations to Aid with Policy Decisions,” will be moderated by Jeremy Sugarman, M.D., M.P.H, M.A., of the Berman Institute of Bioethics at Johns Hopkins University.

The Nov. 7 session, scheduled from 10:30-11:45 a.m., will outline the ethical principles that guided the Bioethics Commission’s deliberations on pediatric MCM research and review the recommendations made in the Bioethics Commission’s March 2013 report, Safeguarding Children: Pediatric Medical Countermeasure Research. The session will be aimed primarily at human subjects research professionals who face ethical issues in a practical way, according to Groman. “It is important that those who confront research ethics issues daily are part of this conversation about pediatric medical countermeasure research,” she said.

Safeguarding Children was released in response to a request from Department of Health and Human Services Secretary Kathleen Sebelius, who asked the Bioethics Commission to study the question of anthrax vaccine trials with children after receiving a recommendation from another federal committee that such research be initiated, pending ethical review. In addition to reaching its conclusion about pediatric anthrax vaccine trials, the Bioethics Commission considered more generally the ethics of research on pediatric MCMs. “Pediatric MCM research is a particularly challenging case study that forces us to look more closely at current pediatric research regulations, and the ethics behind the policy,” Groman said.

In addition to communicating the Bioethics Commission’s process of deliberation in work towards Safeguarding Children and summarizing the report’s key conclusions, Groman hopes the session will demonstrate how the Bioethics Commission can offer a unique perspective on how advisory bodies might aid in making difficult policy decisions. “The Bioethics Commission brings together many individuals with diverse expertise, not only through its members but also through the many stakeholders who speak at Bioethics Commission meetings or submit written comments,” she said. “Open discussions help develop informed policy. That is certainly what happened with Safeguarding Children.

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Bioethics Commission Staff Presents “Pediatric Medical Countermeasure Research” at APHA in Boston https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/01/staff-and-bioethics-commission-member-to-present-on-pediatric-medical-countermeasure-research-at-14th-annual-meeting-and-exposition-of-the-apha-in-boston/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/01/staff-and-bioethics-commission-member-to-present-on-pediatric-medical-countermeasure-research-at-14th-annual-meeting-and-exposition-of-the-apha-in-boston/#respond Fri, 01 Nov 2013 18:14:09 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1017 Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) Executive Director Lisa M. Lee, Ph.D, M.S., Associate Director Michelle Groman, J.D., and Commission Member Christine Grady, R.N., Ph.D will be speaking at the 141st Annual Meeting and Exposition of the American Public Health Association (APHA), which takes place Nov. 2-6, in Boston, Mass. Their panel session, “Enumerating Ethical Considerations of Medical Countermeasure Research With Children,” will be moderated by Bioethics Commission Associate Director Kayte Spector-Bagdady, J.D., M.Bioethics.

The Nov. 4 session, scheduled from 4:30-6 p.m., will provide an overview of the ethical grounding of the Bioethics Commission’s review of pediatric medical countermeasure (MCM) research and describe the ethically distinct considerations of conducting such research before and after the occurrence of a terrorist attack. The Bioethics Commission released its recommendations on pediatric MCM research in its March 2013 report, Safeguarding Children: Pediatric Medical Countermeasure Research. Groman, who oversaw staff work on the report, says the APHA session will be aimed primarily at public health professionals. “In examining pediatric medical countermeasure research, the Bioethics Commission recognized both a duty to protect research participants and a duty to protect all children during an emergency, to the extent possible. We are talking about research ethics, but this is also clearly a public health ethics issue,” she said. “By engaging more people in the conversation on this topic, the Bioethics Commission is furthering its work.”

Safeguarding Children was released in response to a request from Department of Health and Human Services Secretary Kathleen Sebelius, who asked the Bioethics Commission to study the question of anthrax vaccine trials with children after receiving a recommendation from another federal committee that such research be initiated, pending ethical review. In addition to reaching its conclusion about pediatric anthrax vaccine trials, the Bioethics Commission considered more generally the ethics of research on pediatric MCMs.

 

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