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

New Educational Primers to Accompany Anticipate and Communicate

As part of its ongoing effort to support bioethics education, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has developed and posted to Bioethics.gov a new primer to inform institutional review boards (IRBs) and their members on the ethical management of incidental and secondary findings. The Bioethics Commission designed the IRB Primer to aid IRB members as they review research protocols, grapple with the issues related to incidental findings, and help researchers implement the Bioethics Commission’s recommendations in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

Members of the Bioethics Commission discuss the main message of that report in a video recently posted to Bioethicsgov on YouTube:  in short, practitioners—across contexts—should anticipate potential incidental and secondary findings and make a plan for managing them.  In the research context, IRBs play a crucial role in ensuring that researchers have anticipated and planned for incidental findings.

The IRB Primer begins with a set of frequently asked questions, including: What are incidental and secondary findings? What are some tests and procedures that could give rise to incidental and secondary findings? These introductory questions will help IRB members assess whether the protocols they review might encounter issues related to incidental findings.

The primer also includes helpful tables, including the Bioethics Commission’s taxonomy of findings, and a table describing relevant ethical principles and their application to incidental and secondary findings.

The goal of the primer is to help IRBs evaluate whether researchers and institutions have fully prepared for incidental and secondary findings that might arise in their protocols, and whether they have taken relevant considerations into account. It describes a variety of factors that contribute to an ethical plan, including informed consent, expertise, participant preferences, and researcher responsibilities.

All Bioethics Commission educational materials are available for free download at Bioethics.gov.  In the coming weeks, two additional sets of primers to accompany Anticipate and Communicate will be posted to Bioethics.gov: one set to guide practitioners who might discover incidental findings, including clinicians, researchers, and DTC providers; and another set to guide potential recipients of incidental findings, including patients, research participants, and DTC consumers. The Bioethics Commission encourages feedback on the materials at education@bioethics.gov.

 

New Video Highlights the Need for a Plan When it Comes to Incidental Findings

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted its latest video, in which Commission Members discuss their report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

In the three minute piece, Members highlight the essential message of the report on the ethical management of incidental findings across contexts: the importance of practitioners—including clinicians, researchers, and direct-to-consumer (DTC) companies—having a plan to anticipate and manage incidental findings.

Bioethics Commission Member Stephen L. Hauser, M.D., explains that advances in technology have made the issue of incidental findings pressing: “Incidental findings have always been with us, but with modern diagnostic capabilities they are becoming far more important and far more frequent.”

Hauser explains that, in the clinical setting, doctors must deal not only with findings that they have sought out, but also, increasingly, with incidental findings. He points out that incidental findings can occur up to 40% of the time with abdominal scans, and up to 10% of the time with brain scans. Thus, he says doctors should anticipate the types of findings that might arise, and make a plan for their management.

Bioethics Commission Member Christine Grady, R.N., Ph.D, explains the unique role of researchers: “The goal of doing research is to answer questions, it’s not taking care of people in the same way that you might in a clinical setting. On the other hand – they are people,” and certain incidental findings with significance for people’s health might arise throughout the course of research. Grady explains researchers must develop a plan for what to do in such cases.

Similarly, the Bioethics Commission recommended that DTC providers develop a plan for managing incidental findings. Member Anita L. Allen, J.D., Ph.D., explains, “We want these companies to try to anticipate the kinds of questions and issues that relate directly to peoples’ health care that these findings might implicate.”

This cross-contextual review of the ethical management of incidental findings by the Bioethics Commission was one of the first of its kind. As Executive Director Lisa M. Lee, Ph.D., M.S., describes, “They really are the first body that has looked at the idea of incidental findings… regardless of what the context is.”  This video, along with several others, is now available on the Bioethics Commission’s YouTube channel, Bioethicsgov.

In addition, the Bioethics Commission has developed and is providing free pedagogical materials to supplement its reports, including Anticipate and Communicate. Please check out bioethics.gov/education in the coming days for a new primer to help institutional review boards understand the Bioethics Commission’s recommendations regarding how to manage incidental and secondary findings ethically in the research setting.

Bioethics Commission to Host Webinar Demonstrating Educational Modules

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is committed to developing resources to improve bioethics education. On Thursday, April 24, 2014 the Bioethics Commission will hold a public webinar demonstrating and discussing how the educational modules developed by the Commission and based on Commission reports can be applied in a variety of traditional and non-traditional educational settings.

The Bioethics Commission’s topic-based educational modules are designed to be flexible to support multiple approaches and subject areas. During the webinar, participants will see how one of these topics might be taught in three different educational settings: a philosophy course, an undergraduate science course, and a law school lunch-and-learn venue.

Presenters will draw from the Informed Consent Background and Informed Consent in Privacy and Progress in Whole Genome Sequencing modules, all of which are available at www.bioethics.gov/education. They will demonstrate how these materials can be adapted to fit into science and law curricula and be used to update a syllabus for a course covering philosophical aspects of bioethics.

“The Bioethics Commission is committed to ensuring that future scientists, public health professionals, and health care providers are able to identify ethically challenging situations, to make ethically sound decisions in response to these situations, and to seek and receive the support they need to do so,” said Executive Director Lisa M. Lee, Ph.D., M.S.

The Bioethics Commission continues to develop educational materials that can be incorporated into education and training at all levels. Educational materials are posted to www.bioethics.gov/education as they become available.

For more information and to register for the April 24 webinar visit http://bioethics.gov/node/3454.

Rock Ethics Institute Research Ethics Lecture on Postwar NIH Research Ethos and the Guatemala STD Experiments

“Ethically Impossible” STD Research in Guatemala from 1946 to 1948 details the federally-supported U.S. Public Health Service (PHS) experiments in Guatemala supporting STD prevention in the U.S. Armed Forces after World War II. By the time PHS researchers left in 1948, over 1,300 vulnerable Guatemalan subjects had been intentionally exposed to syphilis, gonorrhea, and/or chancroid through invasive and painful procedures. Over half of these subjects never received any treatment for their potential infections. The research was never published.

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) found that this research violated both contemporaneous and contemporary scientific and ethical research norms; the experiments have been uniformly repudiated by scientists and ethics scholars alike. But public health research is not an individual activity, and the Guatemala STD research is not the product of an individual’s mistakes. The Guatemala STD experiments were recommended for approval by the first National Institutes of Health study section at its first meeting. “Something of an Adventure”: Postwar NIH Research Ethos and the Guatemala STD Experiments takes a closer look at the structured grant system and defined research environment that supported and enabled these experiments over a two-year period.

In 1946, the World War II government contract process for directed research became a grant program with a focus on scientific freedom and the “complete acceptance” of the “integrity and independence of the research worker and his freedom from control, direction, regimentation, and outside interference.” Evaluations of the new grant proposals were left to specialized study sections who evaluated grant applications using the best available scientific expertise, and a small number of preeminent researchers—whose interests and allegiances overlapped—dominated the field of STD research. When the Guatemala STD experiments were recommended for funding by the Syphilis Study Section in 1946, one member of the study section was the principal investigator of the Guatemala protocol and five members and the Executive Secretary either visited the experiments in Guatemala later and/or tried to join in on the work. The push toward scientific freedom coupled with a lack of attention to these serious conflicts of interest at the grant review level did not offer sufficient protection to the subjects of federally funded research at the inauguration of this new peer review structure.

Today, conflict of interest regulations, along with other layers of protections, make the funding of unethical research much less likely. Human subjects regulations and institutional review boards provide layers of protection against unethical research once it is funded. But what is legal and what is ethical do not always have the same scope—sometimes regulations permit an action that is unethical, and sometimes the ethically optimal choice falls outside regulatory boundaries. Even in this regulated age it is impossible to prevent a researcher from ever having to make an ethical assessment. Ethics training is essential to encourage compliance with the spirit, as well as letter, of the law and inform actions in all situations.

Please join me for further discussion (or watch the live stream) at the Penn State Rock Ethics Institute Research Ethics Series on Monday April 7th from 6 pm to 7:30 pm in Foster Auditorium, 102 Paterno Library.

*The findings and conclusions in this blog are those of the author and do not necessarily represent the official position of the Presidential Commission for the Study of Bioethical Issues or the Department of Health and Human Services. 

 

Bioethics Commission Executive Director to Receive Pellegrino Medal

Lisa M. Lee, Ph.D., M.S., Executive Director of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), will receive the Pellegrino Medal for her contributions to health care ethics. The award will be presented April 11 during the 2014 Conference of Samford University’s Healthcare Ethics and Law (HEAL) Institute in Birmingham, Ala.

Established in 2001 by the HEAL Institute, the Pellegrino Medal honors individuals recognized as “leaders for contributions to healthcare ethics in the selfless spirit of Edmund D. Pellegrino.” The medal’s namesake, Edmund Pellegrino, was the first recipient of a lifetime achievement award from the American Society for Bioethics and Humanities and has been called the “father of the American bioethics movement.” Other notable recipients of the medal include Tom L. Beauchamp, James F. Childress, and Bioethics Commission Member Daniel P. Sulmasy.

“This field calls us and I am honored to be in the company of these bioethics pioneers,” Lee commented upon learning of the award.

“Lisa truly honors Ed Pellegrino’s spirit of expert and selfless devotion to bioethics,” said Amy Gutmann, Ph.D., Chair of the Bioethics Commission.

The author of numerous publications in both science and ethics, Lee has taught graduate-level courses in public health ethics, serves on the editorial board of two health journals, and is the lead editor of Principles and Practice of Public Health Surveillance, 3rd edition (Oxford University Press, 2010). Lee’s current interests include bioethics pedagogy and public health ethics. Before coming to the Bioethics Commission, Lee worked at the Centers for Disease Control and Prevention (CDC) where she led several agency and cross-agency committees working to establish and maintain an environment of scientific integrity and excellence.

Lee earned a Ph.D. in epidemiology from Johns Hopkins University and an M.S. in bioethics from the Alden March Bioethics Institute at Albany Medical College.

How the Bioethics Commission Works and the Importance of Public Input

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just released its fourth video where Commission Members reflect on the question, “How does the Bioethics Commission work?”  In the short piece, Members discuss how and why the Commission engages in public bioethics as it addresses and responds to requests made by President Obama and his Administration.

The video features, among others, Bioethics Commission Member Anita L. Allen, J.D., Ph.D., who explains how the Commission works in public, holding at least four public meetings a year to deliberate on important and often controversial ethical issues facing our society.  Members invite experts from around the country and the world to present their work and opinions.  Over the course of several meetings the Commission publicly deliberates the issue at hand, develops a set of recommendations, and issues a public report. At all stages, public input is vitally important to the process.

“It’s fantastic when we have additional inputs from the public, additional inputs from people who are watching, so there can be a real conversation and a real deliberation, and a real public engaged opportunity for moving the conversation forward,” says Commission Member Nita A. Farahany, J.D., Ph.D., in the piece, now available on the Commission’s YouTube channel, Bioethicsgov.

“We hope to get feedback from the public about what matters to them, the kinds of things they are thinking about and worried about, and then use the public information and the public comments we get to shape our deliberations,” says Bioethics Commission Executive Director Lisa M. Lee, Ph.D., M.S. “That public participation across the spectrum is really important for our best work to be done.”

Currently the Bioethics Commission is requesting public comment on the ethical considerations of neuroscience research and the application of neuroscience research findings. The Bioethics Commission reviews comments submitted from individuals and organizations, and relies on these comments to help shape public deliberations and reports. The deadline for submitting a comment on the ethical considerations of neuroscience is Tuesday, April 1, 2014.

“Through our meetings, we have an opportunity for the public to comment and to ask questions, but also the public takes advantage of our website,” adds Bioethics Commission Vice Chair, James W. Wagner, Ph.D.  Information about how to submit comments is available on our website, www.bioethics,gov. For more information on submitting a comment on the ethical considerations of neuroscience before the April 1 deadline please review the Federal Register Notice.

Bioethics Commission Videos Highlight Members and Their Work

One of the most important functions of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is to work transparently as it deliberates the difficult issues before it. Another important function of the Bioethics Commission is to help educate the nation about bioethics. As a part of this effort the Bioethics Commission has developed several videos, posted to the Commission’s YouTube Channel, that help answer basic questions about the Commission and its work.

Its most recent video, “Challenging Topics for the Bioethics Commission”  – posted this week – highlights some of the topics that the Bioethics Commission has addressed.  None of the ethical questions considered by the Commission are easy, but Members identified several that presented particularly difficult questions. From synthetic biology and emerging technologies to pediatric medical countermeasure research and protecting participants in human subjects research, Members remember the specific challenges they faced while deliberating recommendations on these critical issues. The video underscores the important role the Commission plays in providing guidance on some of the most exigent issues in science, medicine, and technology today.

In “The Role of a Presidential Bioethics Commission,” Members discuss why the Commission is important and how it can be helpful to healthcare providers, scientists, and researchers but also to the general public. “We are living at a time where great advances in biomedicine are just essential to the future of the health of our society and the well-being of people around the world,” Commission Chair, Amy Gutmann, Ph.D., says in the video. “The only way we are going to make those advances is ethically. If we don’t do it ethically, they won’t be advances.”

In a third piece posted to YouTube Gutmann explains, “One of the things we do as a Commission is make recommendations to the government, but another thing we are doing is actually putting our resources into developing educational materials that every high school and every university in this country can use.” The video, “Promoting and Providing Materials for Bioethics Education” elaborates on this commitment as Members discuss the specific educational materials that the Commission has developed promoting bioethics education in traditional and nontraditional settings. “These [ethical] questions are not simple ones for isolated people working in ivory towers,” explains Member Daniel Sulmasy, M.D., Ph.D. “They are for everybody, which is why the Commission’s efforts at education are so important.”

“In addition to the Commission’s report-based education modules that we have developed, the videos themselves are another tool that we hope educators and students will use in any and all settings where they might have need to explore who this Commission is, what it does, and how its Members arrive at the recommendations they make as they offer non-binding advice to the Administration and the country as a whole,” said Hillary Wicai Viers, Commission Communications Director.

The Bioethics Commission is working on additional videos. One upcoming piece to be released later this week explores how this Bioethics Commission works – through a public process called democratic deliberation.

For these videos and more please check the Bioethics YouTube Channel and follow us on twitter, @bioethicsgov.

Bioethics Commission Seeks Feedback on Educational Materials

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is seeking feedback on its educational materials as a means of quantifying progress in response to its recommendations on improving and supporting bioethics education.  The Bioethics Commission is interested in how the materials are being used to further bioethics education, what materials are most helpful, and suggestions for how they might be improved.

The Bioethics Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. Many of its reports incorporate the overarching theme, and include recommendations, about the need for improvement in bioethics education for scientific and medical profes­sionals, among others.

The Bioethics Commission is committed to seeing its recommendations implemented.  Providing easily accessible and free materials based on the Bioethics Commission’s own analysis is an effort to help meet these recommendations. Given the multidisciplinary nature of science and research, bioethics education should be available to a wide variety of disciplines at the undergraduate, graduate, and professional levels.

To that end, the Bioethics Commission has developed novel educational materials to support bioethics education in many disciplines in traditional and nontraditional educational and professional settings. These include topic-based modules, Bioethics Commission report-specific materials, and datasets generated in the course of the Bioethics Commission’s work that support empirical bioethics education and scholarship. All Bioethics Commission educational materials are free and available for download from bioethics.gov/education.

If you have used the Bioethics Commission educational materials as a reference in preparation for teaching; as presentation material in a class or training course; as a resource for discussion questions, case studies, problem based learning scenarios, or exercises; as a source of data for teaching empirical research methods; or in another way, please share your experience, comments, and feedback by contacting education@bioethics.gov.

For more information on the Bioethics Commission educational modules, please join us for a webinar entitled “Multidisciplinary Implementation of Bioethics Commission Educational Materials” on Thursday April 24, 2014 at 12:00 p.m. EST.

New Educational Module Available on Informed Consent for Anticipate and Communicate

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the management of incidental and secondary findings. The module integrates material from the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (Anticipate and Communicate).

The pedagogical product, now available for use in traditional and non-traditional educational settings, takes users through several scenarios. For example, imagine that a patient in the emergency room has a CT scan to rule out appendicitis. The CT scan shows a nodule on an adrenal gland, and while discharging the patient from the emergency room the physician recommends she follow up with her primary care provider. These nodules are benign ninety-eight percent of the time, but without this information the patient leaves the hospital confused and anxious about the finding.

Incidental findings – results that arise that are outside the original purpose for which a test or procedure was conducted – can create practical, legal, and ethical challenges for both recipients and practitioners. In Anticipate and Communicate the Bioethics Commission recommended that patients, research participants, and consumers should be informed about the likelihood of such findings arising from a particular test or procedure. Open communication between practitioners and individuals in all contexts helps ensure that individuals understand risks and benefits before they consent, and helps practitioners think through the consequences of conducting various tests and procedures.

The aim of the new module on informed consent is to highlight the interplay between informed consent and incidental and secondary findings in the clinical, research, and direct-to-consumer contexts, and the different elements of that process in each context. Real-life examples are used to show why it is critical that patients, research participants, and consumers are informed about the likelihood of any incidental findings arising from a test or procedure, understand the process for managing those findings, and can express preferences about which findings they want to know.

In addition to background information and readings the module provides discussion questions, questions based on real-life scenarios, and exercises, such as designing an informed consent document for research participants. The goal of the module is to help instructors incorporate a new perspective on informed consent into their curricula, and explore the particular ethical challenges raised by incidental and secondary findings.

All Bioethics Commission pedagogical materials are freely available at www.bioethics.gov. The Bioethics Commission encourages feedback on the materials at education@bioethics.gov.

Bioethics Commission Continues to Recognize Value of Empirical Bioethics Research

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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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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