James Aluri – 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 Democratic Deliberation in Bioethics for Every Generation https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/19/democratic-deliberation-in-bioethics-for-every-generation/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/19/democratic-deliberation-in-bioethics-for-every-generation/#respond Thu, 19 May 2016 10:00:06 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1852 On May 12, 2016 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) issued its tenth report Bioethics for Every Generation: Deliberation and Education in Health, Science, and Technology. In the first section, the report addresses how a pluralistic, democratic society can make policy decisions about complex topics in the realm of bioethics—which involves deeply held values regarding health, bodies, identities, and life and death—using democratic deliberation.

In an era in which complex topics often become mired in polarized debate, the Bioethics Commission’s recommendations for democratic deliberation provide a method for constructive public engagement. Democratic deliberation, characterized by mutual respect and reason-giving, offers a way to find acceptable solutions to complex policy challenges in bioethics. During its tenure, the Bioethics Commission has demonstrated the effectiveness of democratic deliberation by using this method to analyze and make policy recommendations about a variety of challenging bioethical topics.

Three of the eight recommendations that the Bioethics Commission made in Bioethics for Every Generation are about democratic deliberation. First, the Commission recommended that stakeholders in the democratic process inform bioethics policy decisions with democratic deliberation. Examples of stakeholders include government officials, health plans, researchers, and members of the public who are trying to set policies about health, science, and technology with important ethical dimensions. Democratic deliberation can promote understanding, mutual respect, and greater legitimacy for the resulting policy outcomes, even when the issues under discussion seem intractable at the outset.

Second, the Bioethics Commission recommended that organizers of deliberative activities conduct deliberative activities in ways conducive to mutual respect and reason-giving among participants in accordance with best practices. Reason-giving, a central tenet of deliberative practice, entails providing reasons that are accessible to all parties and using facts that are acknowledged by others. In addition, the Commission recommended that organizers design the deliberations to influence policy decisions. For example, if organizers anticipate a policy decision on a topic, they could convene deliberations about that topic and present the results to inform involved policymakers. Empirical research on deliberative activities should guide organizers as they design further parameters and principles of deliberative activities.

Third, the Bioethics Commission recommended that scholars and organizers of democratic deliberation conduct additional research on the effectiveness of deliberative methods to further the practical contribution of deliberation in bioethics. Empirical research serves as an evidence base on which to ground deliberative activities. Further research that evaluates different deliberative processes and outcomes will strengthen this foundation. Such research will require careful consideration of what constitutes success.

These three recommendations work to strengthen the value, process, and empirical foundations of democratic deliberation. Together, they encapsulate the Bioethics Commission’s commitment to democratic deliberation as the most effective way to solve complex problems in bioethics.

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

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Bioethics Commission Meeting 24: The Bioethics Commission Educational Materials https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-commission-meeting-24-the-bioethics-commission-educational-materials/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-commission-meeting-24-the-bioethics-commission-educational-materials/#respond Thu, 03 Mar 2016 20:03:46 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1805 In the first session of its twenty-fourth meeting, the Bioethics Commission reviewed its current portfolio of educational materials and assessed how it might be expanded to reach new audiences. The Bioethics Commission heard from Elizabeth Pike, J.D., LL.M., a Senior Policy and Research Analyst at the Presidential Commission for the Study of Bioethical Issues; Maneesha Sakhuja, M.H.S., a Research Analyst at the Presidential Commission for the Study of Bioethical Issues; and Steven Kessler, M.S., an Instructor of Biological Sciences at the City College of San Francisco.

Pike described different kinds of educational materials. She explained how primers, for example, are intended to help specific audiences understand and implement the Commission’s recommendations in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. She also introduced the topic-based modules, noting how instructors can tailor the addition of cutting-edge topics in health, science, and technology to their classroom to stimulate students’ thinking about their impacts on society. Modules also allow instructors to choose among various activities including discussion questions, problem-based learning, and exercises based on optional additional resources.

Sakhuja continued the discussion by more closely diving into the public health case studies. These case exercises present a detailed description of a case based on real-life public health events, describe relevant analysis from the Bioethics Commission’s deliberations, and prompt engaged discussion. For example, the Communicating During a Public Health Emergency case situates readers in the role of a public information officer in a city health department after learning of a confirmed case of Ebola in a nearby hospital. The case then presents readers with relevant analysis from the Bioethics Commission and asks readers to answer questions about how to proceed with communicating to the public. Sakhuja also unveiled a forthcoming educational material format—deliberative scenarios—slated to be released in Spring 2016. The deliberative scenarios will help high school and college students develop deliberative skills in the classroom by practicing forming a consensus and proposing a course of action by incorporating a variety of perspectives. Each scenario is accompanied with a teacher’s companion to help guide and support the deliberation.

Wrapping up the panel, Kessler informed the Bioethics Commission about his use of the discussion guides in biology classes at the City College of San Francisco. The discussion guides were designed to be appropriate for teachers without expertise in ethics and intended to start conversations about bioethics in a way that was accessible to high school and college students.

The Bioethics Commission will continue the meeting with a member discussion about the educational materials.

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Bioethics Committee Meeting 24: Live Teleconference https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-committee-meeting-24-live-teleconference/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-committee-meeting-24-live-teleconference/#respond Thu, 03 Mar 2016 19:02:41 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1800 Welcome to the twenty-fourth public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting today, March 3, 2016, from 2 p.m. to 4 p.m. EST via teleconference.

At today’s meeting, the Bioethics Commission members will discuss the Commission’s educational materials, present and future. These materials embody the Commission’s commitment to ethics education and are freely accessible at bioethics.gov. The Bioethics Commission will welcome and hear from presenters who have been involved with the development and use of these materials.

For the full agenda of today’s meeting, click here.

Today’s teleconference is open to the public by calling 1-888-769-8756 and entering passcode 8934813 when prompted. Additionally, you can follow the highlights here on the blog. Audio recordings and transcripts will be archived and available following the meeting.

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Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/23/modernizing-human-subjects-research-protection-applying-the-principle-of-regulatory-parsimony/#comments Wed, 23 Sep 2015 15:10:12 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1719 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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