Michelle Groman – 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 Modernizing Human Subjects Research Protections: A Blog Series on Recent Proposed Revisions to the Common Rule https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/10/modernizing-human-subjects-research-protections-a-blog-series-on-recent-proposed-revisions-to-the-common-rule/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/09/10/modernizing-human-subjects-research-protections-a-blog-series-on-recent-proposed-revisions-to-the-common-rule/#respond Thu, 10 Sep 2015 20:29:47 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1708 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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Engaging Parents and Children Throughout Pediatric Research: A New Report from the Nuffield Council on Bioethics https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/14/engaging-parents-and-children-throughout-pediatric-research-a-new-report-from-the-nuffield-council-on-bioethics/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/14/engaging-parents-and-children-throughout-pediatric-research-a-new-report-from-the-nuffield-council-on-bioethics/#respond Thu, 14 May 2015 15:11:58 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1627 Today the Nuffield Council on Bioethics (Nuffield Council), an independent bioethics advisory body in the United Kingdom, released Children and Clinical Research: Ethical Issues. The report marks the culmination of a two-year inquiry, during which the Nuffield Council received input from over 500 stakeholders – including the U.S. Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission addressed the ethics of research with children in its March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. In that report, the Bioethics Commission tackled the particularly complex ethical dimensions of conducting clinical trials of medical countermeasures (MCMs) – that is, clinical products and interventions used in response to chemical, biological, radiological, and nuclear terror attacks – with children. Through six recommendations to guide the ethical conduct of pediatric MCM research, the Bioethics Commission sought to navigate the tension between protecting individual children from undue risk in research and protecting all children, to the extent possible, through the fruits of research.

Throughout its analysis in Safeguarding Children, the Bioethics Commission recognized the critical importance of pediatric research to address children’s health needs. It expressed “an unwavering commitment to safeguard all children from unacceptable risks in research and through research that promotes their health and well-being.” (p. 105) The Nuffield Council echoed this commitment at the very outset of its report, “challeng[ing] the idea that clinical research is something from which children need to be protected and essentially excluded,” and articulating a “belief that children will be best protected from ill health, disease and the impacts of disability through a greater commitment to evidence-based care.” (p. vii)

The Bioethics Commission and Nuffield Council also fundamentally agree that pediatric research protections can be strengthened through engagement with trial participants, their families, and other stakeholders. The Bioethics Commission recognized the critical role of community engagement in pediatric MCM research to “build transparent, meaningful, collaborative, and mutually beneficial relationships among those considering or conducting research and the relevant communities.” (p. 79) Several of the Nuffield Council’s recommendations support similar engagement, for example, through the consideration of young persons’ and parents’ views in designing research. As the Nuffield Council’s Director, Hugh Whittall, explained, “by speaking to children and their families, researchers can design studies which are more suited to their needs, and ultimately more acceptable.”

In Safeguarding Children, the Bioethics Commission called for an ongoing conversation about the ethical conduct of pediatric research. Today the Nuffield Council has added its valuable voice to the discussion.

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Bioethics Commission Continues to Recognize Value of Empirical Bioethics Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/12/bioethics-commission-continues-to-recognize-value-of-empirical-bioethics-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/12/bioethics-commission-continues-to-recognize-value-of-empirical-bioethics-research/#respond Wed, 12 Mar 2014 17:40:03 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1197 In its recent report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) emphasized once more the importance of empirical research to support sound policy.  Specifically, the Bioethics Commission recommended that federal agencies and other interested parties support research concerning incidental and secondary findings, including types of findings, potential consequences of responding to findings, and stakeholder preferences regarding such findings (Recommendation 3).

The Bioethics Commission has made similar calls for empirical research in past reports.  For example, in Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission recommended that funders of whole genome sequencing research support the evaluation of proposed frameworks for returning research results (Recommendation 3.4).  And, in Moral Science: Protecting Participants in Human Subjects Research, the Bioethics Commission called more broadly for improved accountability through research to determine whether current policies meet their intended goals.  The Bioethics Commission recommended expanded government support of research to assess the effectiveness of human subjects protections and to address other related ethical and social considerations (Recommendation 2).

As the Bioethics Commission has explained, “[t]he need for empirical research in bioethics is well established.  Descriptive data can inform and test normative work in bioethics.  It amplifies the force of conceptual bioethics activity . . . by enabling such work to more closely map onto real-world situations and provide concrete solutions and recommendations.”  (Moral Science, p. 54)  Empirical and conceptual bioethics both play important roles in informing one another and strengthening policy development.

Empirical bioethics research is growing, and stakeholders are responding directly to the Bioethics Commission’s recommendations.  For example, on its Office of Science Policy website, the National Institutes of Health lists awards it has funded in support the Moral Science recommendation.  In addition, the Bioethics Commission has made available data to support empirical bioethics scholarship: the Human Subjects Research Landscape Project – Analysis Dataset, comprising project-level data about federally supported human subjects research from 2006-2010, and the Guatemala Subject Data Spreadsheet, which includes information about the 1940s STD research subjects in Guatemala.

The Bioethics Commission is eager to learn about empirical work undertaken in response to its recommendations and additional scholarship based on its publicly available databases.  If you are engaging in such work, please e-mail info@bioethics.gov and let us know.

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Revisiting Research Ethics https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/03/28/revisiting-research-ethics/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/03/28/revisiting-research-ethics/#respond Thu, 28 Mar 2013 20:55:35 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=551 In its most recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) builds on its prior work concerning human subjects research protections. 

In November 2010, President Obama charged the Bioethics Commission to conduct a thorough review of current protections for research participants.  The Bioethics Commission completed its work in December 2011 and, in its report, Moral Science: Protecting Participants in Human Subjects Research, offered fourteen recommendations to improve the current system.  Less than one month later, HHS Secretary Kathleen Sebelius asked the Bioethics Commission “to conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures (MCMs) in children.”  In Safeguarding Children, the Bioethics Commission offered six recommendations in response.

Moral Science concerns human subjects research generally – focusing principally on research governed by the Common Rule (the federal policy that governs research supported by 18 federal departments and agencies), whereas Safeguarding Children concerns a very specific type of research – pediatric MCM research, that is, pediatric testing of FDA-regulated products and interventions used in response to chemical, biological, radiological, and nuclear attacks.  Pediatric MCM research is particularly complex: it involves pediatric research participants who are ethically and legally unable to consent to participate in research, and when conducted before an attack occurs (i.e., pre-event), it involves testing interventions with an unknown likelihood of ever being used.  Pediatric MCM research conducted after an attack (i.e., post-event) poses its own challenges because of the very stressful circumstances under which it would take place.

The Bioethics Commission echoed many of the themes that it initially raised in Moral Science in its consideration of the unique set of ethical concerns associated with pediatric MCM research.  In Safeguarding Children, the Bioethics Commission stressed once more the importance of compensation for research-related injury, community engagement, and transparency and accountability.  Given the particular ethical contours of pediatric MCM research and the need for heightened protections for research involving children, the Bioethics Commission’s Moral Science and Safeguarding Children recommendations in these areas are not identical; they are complementary.  

For example, in Moral Science, the Bioethics Commission’s central recommendation for transparency and accountability called for public access to basic data about federally supported research, specifically project title, investigator, location, and funding data.  In Safeguarding Children, the Bioethics Commission recommended public access of a different sort.  For pre-event pediatric MCM research that is greater than minimal risk, the Bioethics Commission called for, among other things, enhanced transparency by involving the public in the research review process, communicating the rationale for approving or rejecting a protocol, and providing periodic updates on the conduct of research.  As the Bioethics Commission explained, such enhanced transparency is necessary in this context because a group of individual children who do not stand to benefit directly from research will bear research risks for the potential benefit of children as a class.

The common themes in Moral Science and Safeguarding Children are grounded in the foundational principles of respect for persons, beneficence, justice, and democratic deliberation.  Applying these principles to difficult issues in research ethics, the Bioethics Commission continues to elucidate protections that should be in place to protect participants from undue risk in research.

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Commission’s “Moral Science” Report Making an Impact https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/11/20/commission%e2%80%99s-moral-science-report-making-an-impact-2/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/11/20/commission%e2%80%99s-moral-science-report-making-an-impact-2/#respond Tue, 20 Nov 2012 17:01:11 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=460 Less than a year after its release, the Commission’s report, Moral Science: Protecting Participants in Human Subjects Research, is having a noteworthy impact in the research community.  Recently, stakeholders have taken concrete steps to implement two of the Commission’s recommendations, namely, those concerning accountability through public access and promoting community engagement.

As part of its thorough review of current research protections in 2011, the Commission sought basic data about government-supported human subjects research from eighteen federal agencies.  The Commission quickly learned, however, that agency systems to track human subjects research vary widely – some agencies could readily provide the requested information, while others took several months to provide sometimes incomplete responses.  Informed by this experience, the Commission recommended that federal agencies make publicly available basic data about human subjects research projects to improve accountability in federally supported research.

In August, the Department of Defense took action toward accomplishing that goal.  The Department announced that it is developing a unified web-based system to track all of its human subjects research projects.  It cited the Commission’s Moral Science report and noted that this new database will help alleviate much of the difficulty the Department faced in preparing its response to the Commission’s data request.  Although this database is currently being designed as an internal system, the Department has left open the possibility of making it public (http://www.forbes.com/sites/katiedrummond/2012/08/13/military-human-studies/).

The Commission also recognized the role of community engagement in furthering the protection and ethical treatment of research participants.  The Commission pointed to the UNAIDS/AVAC Good Participatory Practice Guidelines as a promising framework for community engagement practices.  These guidelines, however, were developed specifically for HIV-prevention research, and the Commission recommended that they be further evaluated and specified to provide a standardized framework applicable to human subjects research more broadly.  One such specification recently occurred.  A working group of the Critical Path to TB Drug Regimens initiative adapted the Good Participatory Practice Guidelines to tuberculosis drug trials (http://cptrinitiative.org/2012/10/01/launch-of-the-good-participatory-practice-guidelines-for-tb-drug-trials/).

We continue to monitor responses to the Moral Science report with interest.  In its final point in the report the Commission recommended that the government respond directly to the Commission’s recommendations, either with changes to the status quo or reasons for maintaining it.

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Commission Calls for Transparency in U.S. Government-Funded Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/11/16/commission-calls-for-transparency-in-u-s-government-funded-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2011/11/16/commission-calls-for-transparency-in-u-s-government-funded-research/#respond Wed, 16 Nov 2011 20:38:09 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=249 As the Presidential Commission for the Study of Bioethical Issues continued its assessment of current protections for human subjects in research at its public meeting in Boston this afternoon, Commission member, Christine Grady, proposed that the Commission recommend improving transparency in U.S. Government-funded research.  Grady said that federal agencies could develop systems – or improve existing systems – to establish a publicly available listing of federally supported human subjects research. The call for such systems is in line with increasing appeals for government transparency and public access to information about research.

The recommendation stems in part from the Commission’s own Landscape Project.  As it worked to define the volume and scope of scientific studies supported by the government, the Commission found information to be incomplete, with no single listing available.  The Commission therefore requested basic data directly from eighteen federal departments and agencies to define the “landscape” of federally supported human subjects research. 

Commission Member, Lonnie Ali, expressed surprise at the lack of publicly available information because this research “involves individuals and people” – surprise echoed by other Commission members as well.

Amy Gutmann, Commission Chair, explained that such a database is not a “magic bullet” in assuring that human subjects are adequately protected from harm or unethical treatment.  But, she continued, although not sufficient, such a database is absolutely necessary to ensure ethical research. Without transparency into what research the federal government is supporting, there cannot be accountability in the conduct of that research. 

Commission Member, Dan Sulmasy, echoed that thought, saying that although a listing of U.S. Government-supported research projects cannot, in and of itself, reveal problematic research, it can provide insight into where to look to further to examine the ethics of research taking place.

The Commission’s final report, with recommendations, will be presented to the President and posted for public view in mid-December.

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