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

Now Available: Set of Primers for Practitioners on Management of Incidental and Secondary Findings

To continue its support of bioethics education, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has developed and posted to Bioethics.gov a new set of primers to inform a variety of practitioners on the ethical management of incidental and secondary findings. This new set of primers includes one for clinicians, one for researchers, and one for direct-to-consumer (DTC) providers. Each primer guides practitioners as they grapple with the issues related to incidental and secondary findings. The primers help practitioners consider the Bioethics Commission’s recommendations in Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Context in an easy to use format.

Each primer begins with a description of incidental and secondary findings, and the types of tests and procedures likely to uncover them. Then, the primers guide practitioners in answering questions about ethical duties with regard to incidental and secondary findings.

For example, the primer for clinicians highlights a clinician’s role in shared decision making and in communicating potential incidental and secondary findings. The researcher primer describes the factors that contribute to an ethical plan for management of incidental and secondary findings, and emphasizes the central role of informed consent. And the DTC primer describes some potential duties to consumers, for example, in developing industry-wide best practices.

The primers also include tables, such as the Bioethics Commission’s taxonomy of findings, and relevant ethical principles and their application to incidental and secondary findings in each context.

The goal of this set of primers is to help practitioners in each context understand the Bioethics Commission’s recommendations, and assist in incorporating those recommendations into their work. Each primer ends with a list of considerations for ethical management of incidental findings in the particular context.

All Bioethics Commission educational materials are available for free use and can be downloaded at Bioethics.gov. In the coming weeks an additional set of primers to accompany Anticipate and Communicate will be posted to Bioethics.gov to guide potential recipients of incidental findings, including patients, research participants, and DTC consumers. The Bioethics Commission welcomes feedback on all of its educational materials at education@bioethics.gov.

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Supporting International Research Ethics and Education – An Inter-American Bioethics Collaboration

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) Executive Director, Lisa M. Lee, Ph.D., M.S., and Associate Director, Michelle Groman, J.D., spoke yesterday at a workshop hosted by University of Miami’s Pan American Bioethics Initiative (PABI) at the Pan American Health Organization (PAHO) headquarters in Washington, D.C. The workshop, “Inter-American Bioethics Collaborations: Prospects and Challenges,” included presentations and discussions led by experts in bioethics, medicine, and philosophy from Latin America and the United States.

The workshop began with a presentation by Sergio Litewka, M.D., M.P.H., project director for PABI, discussing the various projects that the initiative has constructed in Latin American countries including Argentina, Brazil, Columbia, and Peru. PABI, which was established in 1993 and is funded by a grant from the Fogarty International Center of the U.S. National Institutes of Health, aims to foster human subjects protection, research integrity, and the responsible conduct of research in Latin America and the Caribbean. This session also included presentations by PABI Principal Investigators Kenneth Goodman, Ph.D., and Paul Braunschweiger, Ph.D.

The Bioethics Commission’s presentation focused on its international research ethics work and its resources for international research ethics education. Groman discussed the Bioethics Commission’s September 2011 report on the U.S. Public Health Service research in Guatemala, “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, and the Bioethics Commission’s December 2011 report, Moral Science: Protecting Participants in Human Subjects Research. She also described the International Research Panel subcommittee report, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, specifying the impact that the panel had on the Bioethics Commission’s recommendations on community engagement and equivalent protections. Lee spoke about the Bioethics Commission’s creation of accessible educational materials for students in bioethics in both traditional and non-traditional settings. She explained potential uses of the Bioethics Commission’s educational modules and Human Subjects Research Landscape Project – Analysis Dataset. Finally, she discussed how the Bioethics Commission’s A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, available in both English and Spanish, aspires to engage and excite young students about bioethics.

Other sessions included first hand accounts of bioethics education at the university level throughout Latin America, discussion of international research ethics training programs sponsored by the Fogarty International Center, and a presentation on ethics education programs in Costa Rica. Carla Saenz, Ph.D., Bioethics Regional Advisor at PAHO, spoke on PAHO’s Regional Program on Bioethics and discussed challenges in Latin America, including closing the bioethics language gap and the issues with training mid-career professionals in bioethics.

Participants brainstormed ways to enhance and continue conversations about bioethics and the responsible conduct of research in Latin America. Bioethics Commission staff were excited to be part of such an interesting and productive day.

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Bioethics Commission Staff Holds Multidisciplinary Educational Materials Webinar

The Presidential Commission for the Study of Bioethics Issues (Bioethics Commission) recently hosted a webinar entitled “Multidisciplinary Implementation of Bioethics Commission Education Materials.” In the hour-long presentation, three Bioethics Commission staff members (including myself) demonstrated how the Commission’s educational materials can be used in three different settings: a philosophy course, a biology course, and a law school lunch-and-learn.

Research Analyst Misti Ault Anderson opened the session by introducing the Bioethics Commission and its commitment to education throughout its work, and highlighting recommendations that call for education in three of its past reports. In addition, Anderson demonstrated how to access all of the educational materials, which are available for free download and use at Bioethics.gov.

Next, Senior Policy and Research Analyst Karen Meagher demonstrated how to use two of the Bioethics Commission’s modules—Informed Consent Background and Informed Consent in Privacy and Progress—in an existing undergraduate philosophy course. Meagher showed how an existing syllabus could be revised to include lectures and discussion about informed consent in genetic and genomic research.

Then, Anderson demonstrated how to use the same two educational modules in two kinds of undergraduate science classes—an introductory biology class and an upper-level research seminar. She highlighted the versatility of the modules, showing that teachers can adapt the materials to fit the level of the students.

Finally, I demonstrated the use of the same two modules to build a law school lunch-and-learn training session on informed consent for genetic research. I emphasized the importance of teaching ethics to law students and showed that the pedagogical materials are not stand-alone documents; instead, instructors can access additional materials from the Bioethics Commission, including its reports, to design workshops, exercises, and discussion questions.

A robust discussion session followed, with attendees from institutions across the country asking insightful questions. Participants asked about using the modules in other settings, including in secondary school, in a medical pharmacology course, and for clinical research staff orientation. In addition, the panelists answered questions about the importance of the Bioethics Commission’s educational materials and offered tips regarding how to get students and teachers interested in learning about bioethics.

A recording of the session is now available on the Bioethics Commission’s YouTube channel, bioethicsgov. There, you can also find a video of Commission Members discussing the importance of bioethics education, and another webinar hosted by staff on advancing bioethics education. All of the Bioethics Commission’s educational materials are available for free use at http://Bioethics.gov/education.

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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.

 

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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.

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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.

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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. 

 

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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.

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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.

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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.

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About blog.Bioethics.gov

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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