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

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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New Bioethics Commission Educational Materials and Improved Website Access

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released new educational materials and unveiled a reorganized webpage to facilitate easier access to all of its educational resources.

New materials include Users Guides that provide field-specific directories to Bioethics Commission educational materials, Public Health Case Studies that provide public health professionals and educators with opportunities to explore ethical issues that might arise in the course of their work, and Classroom Discussion Guides that provide prompts and questions that instructors at various educational levels can use to integrate ethics into their classes. These new resources add to a collection of educational materials that the Bioethics Commission has developed and made available to support the integration of bioethics into many disciplines in traditional and nontraditional educational and professional settings.

The Users Guides are designed to help professionals and educators quickly identify the most relevant materials for their needs. Guides are currently available for Researchers, Human Subjects Researchers, Public Health Professionals, Legal Educators, Public Policy Educators, and Science Educators. Future blogs will highlight the new Public Health Case Studies and Classroom Discussion Guides.

The updated education webpage facilitates access to Bioethics Commission educational materials by grouping them by categories. Categories include Users Guides for professionals in various fields, Primers for professionals and the public, Teaching Tools for educators and professional training instructors, and Videos for all audiences.

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: A Blog Series on Recent Proposed Revisions to the Common Rule

Last week, 16 federal departments and agencies released a notice of proposed rulemaking (NPRM) to revise the Common Rule – the regulations that govern the ethical conduct of federally supported human subjects research. This highly anticipated NPRM arrived more than four years after the July 2011 release of an advanced notice of proposed rulemaking (ANPRM) that sparked substantial commentary and debate.

In its 2011 report, Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission analyzed current protections for research participants, concluding that the regulations generally appear to protect people from avoidable harm or unethical treatment, but also offering recommendations for improvement. Indeed, the Bioethics Commission commented directly on the ANPRM in Moral Science (Recommendation 13).

The Bioethics Commission later addressed genetic research in Privacy and Progress in Whole Genome Sequencing; pediatric research in Safeguarding Children: Pediatric Medical Countermeasure Research; incidental findings in research in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts; and research with participants with potentially impaired consent capacity in Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society. Analysis and recommendations relevant to research ethics exist throughout the Bioethics Commission’s work.

The NPRM cites several of the Bioethics Commission’s reports, and acknowledges that “in preparing the NPRM, the deliberations of the [Bioethics Commission] were taken into account.” (NPRM, p. 397) Moreover, the NPRM’s ethical rationale in support of proposed regulatory changes often closely parallels the Bioethics Commission’s analyses of similar issues. Over the next several weeks, we will be highlighting the impact of the Bioethics Commission’s work on the NPRM, and the relationship between the Bioethics Commission’s recommendations and the proposed revisions to the Common Rule in a series on this blog called “Modernizing Human Subjects Research Protections.”

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Bioethics Deliberation and Education in Safeguarding Children

In the most recent post for the “Deliberation and Education” series, we examined the role of deliberation in the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) fourth report Privacy and Progress in Whole Genome Sequencing. While not specifically citing democratic deliberation in its recommendations in Privacy and Progress, the Bioethics Commission actively demonstrated the principle by inviting experts from the public and private sectors to inform their public deliberations on the topic. The fifth post in the series will examine deliberation and education in the Commission’s fifth report: Safeguarding Children: Pediatric Medical Countermeasure Research.

At the request of the Secretary for Health and Human Services, the Bioethics Commission conducted a careful and transparent review of the ethical considerations of conducting medical countermeasure (MCM) research with children.

Safeguarding Children, published in March 2013, is the Bioethics Commission’s response to this request. In this report, the Commission made six recommendations concerning MCM research with children, differentiating between pre-event (before exposure to an agent) and post-event (after exposure) research. The Commission identified four ethical principles to guide their discussion of pediatric research protections: respect for persons, beneficence, justice, and democratic deliberation. The Commission recognized that in research, one example of democratic deliberation is community engagement—the process of including community members in an ongoing public exchange of ideas. Democratic deliberation can also be present in various aspects of institutional research review and approval. The Commission referenced community engagement and democratic deliberation in its recommendations for both pre- and post-event research.

In its fourth recommendation, the Bioethics Commission included community engagement in its recommended ethical framework for national-level review of pre-event research that poses more than minimal risk without a prospect of direct benefit. Through this framework, the Commission sough to specify a rigorous set of conditions necessary to determine whether research is conducted in accordance with “sound ethical principles”—a regulatory requirement for this exceptional type of research.

The Bioethics Commission determined that community engagement would be particularly important in a post-event scenario, when it’s necessary to educate the public about research, allow them to inform the researchers about their concerns, and encourage the public to utilize the results of the research. The Commission recommended that, for post-event research:

… Institutional review boards must also ensure that…provisions are made to engage communities throughout the course of research.

Both recommendations described here reflect the Bioethics Commission’s emphasis on the importance of democratic deliberation and its practical implementation. By engaging the community throughout the research process—be it pre- or post-event—researchers can ensure that the public remains aware of what is occurring, while the community can guarantee that its voices and concerns are being heard.

Safeguarding Children and all other Bioethics Commission reports are available at bioethics.gov.

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Roundtable: Brainstorming Ideas on Education and Deliberation

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) closed its discussion of democratic deliberation and bioethics education with a roundtable discussion involving Bioethics Commission members and presenters.

Amy Gutmann, chair of the Bioethics Commission, kicked off the session by asking the panelists to share their thoughts on how the Bioethics Commission could strengthen bioethics education and deliberation about important bioethical issues.

The following are highlights from the discussion:

Sir Roland Jackson, the Executive Chair of Sciencewise, commented that including diverse and expert voices is critical for good deliberation. “If you’re trying to encourage a deliberative process among the people who have the power and influence that matter, you need a wider group to deliberate,” he said.

Marion Danis, from the Department of Bioethics at the National Institutes of Health, noted that the citizenry would benefit from engaging with policymakers and lawmakers on a consistent basis, as opposed to strictly during election season. She asked the Bioethics Commission to “find a way to get governmental and organizational leaders to be more respectful of the efforts people have put in, and not just listen to people when they are trying to get elected.”

Florence Evans, a participant in a deliberative polling exercise, told the Bioethics Commission that, during her participation in What’s Next, California, the purpose of the deliberation was never made completely clear. She emphasized that for deliberation to be successful, participants need to understand the purpose of the exercise, and be able to answer the question: “to what end?”

Lisa M. Lee, Executive Director of the Bioethics Commission, emphasized the importance of starting ethics education from an early age. As she noted, ethical literacy is important for all of us in many contexts, because “all of us need skills to help us resolve ethical issues whether we are a plumber, physician, scientist or a surrogate decision maker.”

Seth Mnookin, Associate Director of the MIT Graduate Program in Science Writing, commented that for patients, honest, frank discussions with health care workers are a primary tool to aid medical decision-making. He urged similar face-to-face interaction between citizens and experts, noting, “Since we’re not about to have geneticists and chemists and physicists go out en masse and engage people one-on-one, I wonder if there is some way to take advantage of the fact that there is a very good ratio of citizen interactions with people who have a lot of scientific and medical training.”

Like Dr. Lee, Sue Knight, Curriculum Author of Primary Ethics Limited in Australia also emphasized the importance of starting ethics education early, noting, “education for ethical deliberation has to involve education in the processes of ethical reasoning.”

Robert Ladenson, Emeritus Faculty Associate at the Center for the Study of Ethics in the Professions at the Illinois Institute of Technology, encouraged the Bioethics Commission to focus on how deliberation and education can complement and strengthen one another, and emphasized that “it’s going to be very important in pursuing both of these efforts not to lose sight of the other.”

Carol Ripple, Associate Director for Education Research and Engagement at the Duke University Social Science Research Institute, urged the Bioethics Commission to “encourage the idea of really identifying core competencies through education and through deliberation that you’re really looking to develop among  a particular audience and purpose.”

Raymond De Vries, Professor of Learning Health Science at the University of Michigan, noted that it is important for the Bioethics Commission to include a sociological perspective that understands the “structural, historical, social situation that explains where we are.”

John Gastil, Head and Professor of Communication Arts and Sciences and Political Science at Pennsylvania State University, asked that the Bioethics Commission prioritize a limited set of ideas and recommendations in its report and resist the urge to embrace a wide array of issues. “You are swimming in ideas,” he said. “I can’t imagine how great the temptation must be to go into all of these different places.”

That concludes the 22nd meeting of the Bioethics Commission. The Bioethics Commission is scheduled to meet again on November 17th in Washington, D.C. For details, go to www.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.

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