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

Bioethics Commission Attends ASBH 2015

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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Bioethics Deliberation and Education in Gray Matters

In last week’s continuation of our “Deliberation and Education” series, we discussed the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) in its sixth report: Anticipate and Communicate. This week’s post will examine deliberation and education in the Bioethics Commission’s Gray Matters reports.

As part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative announced in April 2013, President Obama asked the Bioethics Commission to review the ethical issues associated with the conduct and application of neuroscience research advances. Gray Matters is a two volume Commission report on neuroscience and ethics.

In Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1), released in May 2014, the Bioethics Commission focused on the importance of integrating ethics and neuroscience early and explicitly throughout the research endeavor, and called for funding for ethics. In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), released in March 2015, the Commission focused its analysis on three particularly controversial topics that illustrate the ethical tensions and societal implications of advancing neuroscience and technology.

In Gray Matters, Vol. 1, the Bioethics Commission made four recommendations focused on integrating ethics and neuroscience research. In its third recommendation, the Commission directly recommended education as a part of this integration:

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.

During its deliberations, the Bioethics Commission heard from a number of scientists and educators who emphasized the importance of ensuring that researchers understand the role of ethics in good science. The Commission concluded that ethics and science education should be integrated across the curriculum at all levels, not just in graduate school, in order to create a strong, lasting foundation.

In Gray Matters, Vol. 2, the Bioethics Commission focused its analysis on three topics: cognitive enhancement, consent capacity, and neuroscience and the legal system. The Commission made 14 recommendations to guide the ethical progress of neuroscience research and its applications; the recommendations are divided by topic area and including one concluding recommendation. The Commission included education in its tenth recommendation, under neuroscience and the legal system:

Government bodies and professional organizations, including legal societies and nonprofit organizations, should develop, expand, and promote training resources, primers, and other educational tools that explain the application of neuroscience to the legal system for distribution to members of the public, jurors, judges, attorneys, and others.

In addition, education was also included in the Bioethics Commission’s final, overarching recommendation:

The BRAIN Initiative should establish and fund organized, independent, multidisciplinary efforts to support neuroscience and ethics research and education, including the activities recommended in this report.

Education plays a central role in both volumes of Gray Matters. By providing ethics education and information on the advances of neuroscience, we can ensure that ethical neuroscientific advances continue while avoiding hype and misinformation in a rapidly evolving field.

Both volumes of Gray Matters and all other Bioethics Commission reports are available at bioethics.gov.

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Bioethics Deliberation and Education in Anticipate and Communicate

Last month, we left off our “Deliberation and Education” series with the blog post “Bioethics Deliberation and Education in Safeguarding Children.” Like previous posts in this series, it examined the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). This fifth post in the series will examine deliberation and education in the Bioethics Commission’s sixth report: Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

Anticipate and Communicate, released in December 2013, expands upon the Bioethics Commission’s previous report, Privacy and Progress in Whole Genome Sequencing. Recognizing that the ethics of reporting incidental findings to individuals was an important and unsettled issue raised in Privacy and Progress, the Commission chose to examine both incidental and secondary findings further in a later report.

The Bioethics Commission made 17 recommendations, divided into overarching and context-specific recommendations for clinicians, researchers, and direct-to-consumer companies. In its fourth overarching recommendation, the Commission directly recommended education as a part of the ethical management of incidental and secondary findings:

Public and private entities should prepare educational materials to inform all stakeholders—including practitioners, institutional review boards, and potential recipients—about the ethical, practical, and legal considerations raised by incidental and secondary findings.

The Bioethics Commission recognized that education is important for ensuring both that the public is able to make informed decisions and that practitioners are aware of their ethical obligations with regard to incidental findings. With this in mind, the Commission created a series of primers for IRB members, practitioners, and recipients to support the practical application of its recommendations. These primers are only the beginning; there still remain numerous opportunities for a variety of groups, organizations, and professional bodies to assist in educating stakeholders about incidental and secondary findings.

Anticipate and Communicate, the Bioethics Commission’s educational materials, and all other Commission reports are available at bioethics.gov.

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Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity

This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “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.”

The recent notice of proposed rulemaking (NRPM), which proposes revisions to the Common Rule, recognizes this regulatory gap that was highlighted by the Bioethics Commission. It notes that a possible ramification of this gap is that in states without clear laws, enrolling participants with impaired consent capacity could be difficult or impossible. The NPRM proposes a revision to the Common Rule that would permit LAR requirements to meet an accepted common practice standard, such as an established state or local hierarchy. This proposed revision mirrors the Bioethics Commission’s recommendation and its suggestion that federal regulatory bodies could recognize previous efforts on this front, such as the priority list of potential LARs developed in 2009 by the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).

If the NPRM proposed revisions are implemented, new research regulations will reflect the Bioethics Commission’s recommendation for clarity in LAR requirements. Clear requirements for LARs facilitate the responsible inclusion of participants with impaired consent capacity in research, which is necessary to fulfill the promise of research that might one day ameliorate neurological disorders and psychiatric conditions.

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Modernizing Human Subjects Research Protections: A Plan for Return of Results

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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Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research

In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research.

In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when biospecimens are collected for research purposes, their collection and associated analyses is considered human subjects research and are subject to IRB oversight, informed consent, and other protections required by the Common Rule. However, when biospecimens are collected for clinical purposes, but subsequently used for research, that research is not considered human subjects research under the Common Rule if they are stripped of traditional identifiers. The NPRM proposes changing that.

Over the past 3 years, technology has advanced rapidly, such that it is now possible to identify the donors of biospecimens, even when samples are stripped of traditionally recognized identifiers. As a result, the deidentification process no longer sufficiently protects biospecimen donors from privacy and security risks. In Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission urged that informed consent be obtained for any and all genetic research, regardless of where or why the data were obtained. The NPRM echoes this suggestion, by proposing that the use of biospecimens in research, whether obtained in the context of a study, in the clinic, or any other setting, be considered human subjects research under the Common Rule.

The NPRM strikes a balance for this subsequent data use, allowing for broad initial consent for future research when data are collected for a non-research purpose—a path forward that is both practical and ethically sound, as recognized by the Bioethics Commission in Privacy and Progress.

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New Bioethics Commission Classroom Discussion Guides Now Available

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released two Classroom Discussion Guides to help instructors at various educational levels integrate ethics discussions into their courses. The discussion guides explore contemporary issues that have been addressed by the Bioethics Commission.

The classroom discussion guides provide prompts and questions that instructors can use to initiate and guide group discussion about ethical issues relevant to the subject matter being taught. Discussion questions are accompanied by a set of points that might arise in the conversation to help instructors prepare for and guide the discussion as needed.

The Classroom Discussion Guide on Ethics and Public Health Emergencies addresses two ethically relevant topics that the Bioethics Commission considered in its report Ethics and Ebola: Public Health Planning and Response: ethical considerations of implementing quarantine and isolation, and clinical trials for vaccines and treatments during a public health emergency. The Classroom Discussion Guide on Ethics and Neuroscience addresses three topics that have captured the public’s attention, and which relate to the Bioethics Commission’s report Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Those topics are cognitive enhancement, inclusion of dementia patients in neuroscience research, and the use of neuroscience in the courtroom.

These new resources add to a collection of educational materials that the Bioethics Commission has developed to support the integration of bioethics education in many disciplines in traditional and nontraditional educational and professional settings. Additional classroom discussion guides are under development and will be released upon completion.

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

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Modernizing Human Subjects Research Protections: Informed Consent for Genetic Research

This is the third installment of a new blog series—Modernizing Human Subject Research Protections—taking a closer look at the recent notice of proposed rulemaking (NPRM) that suggests revisions to the Common Rule governing federally funded human subjects research. The NPRM draws on the work of the Bioethics Commission, and its ethical underpinnings mirror the analysis used by the Commission in many of its reports.

In its 2012 report, Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission examined the ethics of large-scale genetic research, and made recommendations about how to reconcile the drive to compile large data sets with the imperative to protect the security of donors’ data. Privacy and Progress examined the informed consent process in depth, explaining that informed consent can be more difficult to obtain for genetic research than for other kinds of studies. First, rather than presenting a risk of physical harm, genetic research can involve informational and privacy risks that can be harder to quantify. And second, much of the genetic research that is currently conducted uses samples and data that were collected for other purposes, such as during a clinical encounter or previous research.

Despite these challenges, the Commission emphasized the importance of obtaining fully informed consent from all participants. Being asked to provide informed consent about the use of their data, the Commission argued, conveys respect to participants, separate and apart from their interest in preventing the unauthorized use or disclosure of their data. In other words—there is value to informed consent in and of itself, as it respects autonomy and personhood.

The NPRM reiterates this ethical analysis as a justification for strengthening informed consent for research using biospecimens, even when identifying data are not included. In emphasizing the importance of prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample was derived, the NPRM cites to the ethical analysis and recommendations in Privacy and Progress. The Bioethics Commission is pleased that its work has proven useful in the proposed revisions of human subjects research regulations as they evolve to keep pace with modern advances in science and technology.

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Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of the Bioethics Commission’s response to the corresponding advance notice of proposed rulemaking (ANPRM) in 2011.

The July 2011 ANPRM sought public comment on several potential changes to research regulations. In Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission reviewed federal and international protections for participants in human subjects research. As a part of that review, the Bioethics Commission commented on the considerations highlighted by the ANPRM.

The Bioethics Commission has long espoused the principle of regulatory parsimony—calling for only as much oversight as necessary to uphold ethical standards. Applying this principle to human subjects research, the Bioethics Commission asserted that research oversight should be restructured to appropriately calibrate the level and intensity of review with the level of risk posed to participants. Calibrating the intensity of review to the level of risk allows IRBs to give more attention to higher-risk research. The Bioethics Commission supported specific changes to the Common Rule to help foster regulatory parsimony, in particular, regularly updating the list of research categories eligible for accelerated review processes and eliminating follow-up requirements for certain lower-risk studies.

The NPRM proposes several changes that would reduce unnecessary regulation of low-risk research. Under the proposal, several low-risk activities and categories of research would no longer be deemed human subjects research under the Common Rule. Other categories of research would be assigned to accelerated review processes. Further, some studies would no longer be required to undergo annual follow-up review. Together, these changes proposed by the NPRM constitute a move towards a review system that better matches the level of research regulation to the level of risk to participants.

The Bioethics Commission supports the principle of regulatory parsimony, advocating only as much regulation as is necessary to protect participants. The NPRM proposes several changes to the Common Rule that embody the principle of regulatory parsimony. These changes are an important part of modernizing human subjects research protections.

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New Bioethics Commission Public Health Case Studies Now Available

Last week, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released a set of Public Health Case Studies that provides professionals and educators with opportunities to explore ethical issues that might arise in the course of their work or students’ future work. The case studies explore contemporary issues that have been addressed by the Bioethics Commission.

The set includes a background document and two case studies. The Public Health Case Studies Background provides information on the Bioethics Commission’s work on topics relevant to public health researchers and practitioners, a description of the newly available cases, and a list of additional resources to support educators and professionals that use case studies to teach and learn about public health ethics. Case 1 focuses on the ethical use of liberty-restricting public health measures such as quarantine, and uses a scenario in which the reader is asked to assess a situation and advise a local school board on what action to take. Case 2 addresses communication during a public health emergency, and presents a situation in which a local public health department must decide how to handle public communication in the midst of a rapidly evolving public health emergency.

The case studies describe case scenarios, provide a brief analysis of the ethical dimensions of the cases and the Bioethics Commission’s consideration of the topics, and present questions for group discussion about the cases.

Additional public health case studies are under development and will be released upon completion. All Bioethics Commission educational materials are free and available at www.bioethics.gov/education.

The Bioethics Commission encourages feedback on its materials via email to education@bioethics.gov.

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

Learn more about the Presidential Commission for the Study of Bioethical Issues.

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