Tag: incidental findings

Bioethics Blogs

Dear Mr. President: It’s Time for Your Bioethics Commission

by Craig Klugman, Ph.D.

Last week, seven Democratic members of the U.S. House Representatives sent a letter to the White House asking President Trump to appoint a director to the Office of Science and Technology Policy (OSTP), position that normally serves as the presidential science advisor. The impetus for writing the letter was a communication from the Deputy National Science Advisor that two hoax reports, that tried to undermine climate change, were circulating through the West Wing as “science.” The Congresspersons state “Where scientific policy is concerned, the White House should make use of the latest, most broadly-supported science…Relying on factual technical and scientific data has helped make America the greatest nation in the world.” Among the signers are a PhD in math and a PhD in physics. They hold that the U.S. faces strong questions that revolve around science, both opportunities and threats, and the need for a scientist who can understand and explain the importance of objective fact to the chief executive is essential.

This article led me to think that the U.S. also faces a lot of issues regarding health and medicine and their impact on society. Consider the task of creating a new health plan, CRISPR/CAS-9, in vitro gametogenesis, the threat of Zika, extra uterine gestational systems, legalized marijuana, digital medicine—pharmaceutical computing for treating disease, head transplants, and DYI science are among the bioethical issues that will effect policy in the coming few years. Thus, it is time for President Trump to call for his Presidential Bioethics Commission.

The last bioethics advisory body ended in January 2017, although many of the staff are still winding down the office and archiving the many reports and papers produced.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ethically Sound Episode 3: Anticipate and Communicate

The third episode of the Bioethics Commission’s podcast series, Ethically Sound is now available. This 10-episode series has been created to bring the diverse body of the Commission’s work to a wide audience. Today’s episode, “Anticipate and Communicate,” focuses on the Commission’s sixth report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings, which addressed how to ethically manage incidental findings—findings that lie outside the aim of a test or procedure—that arise in clinical, research, and direct-to-consumer contexts.

In the report, the Bioethics Commission analyzed the ethical issues related to incidental findings that could arise in clinical, research, and direct-to-consumer settings. During its public meetings, the Commission heard from individuals who have been affected by incidental findings, including Carol Krucoff, a yoga teacher and journalist. Ms. Krucoff spoke before the Commission about the discovery of her brain tumor, which was an incidental finding that resulted from an MRI taken after she fainted during a marathon. Ms. Krucoff opens this podcast by recounting her experience and sharing how the discovery of her incidental finding affected her life. She notes that “advances in imaging technology have made it increasingly common for healthy, asymptomatic people like me to learn of such a disturbing incidental finding.”

The podcast also features Bioethics Commission Member Dr. Christine Grady, Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, who was interviewed by Hillary Wicai Viers, a former Communications Director with the Commission staff. Dr. Grady explains how her background as a researcher and as a nurse informed her understanding of the ethical challenges that incidental findings pose.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Introducing the Bioethics Commission’s New Educational Resource: “Classroom Discussion Guide on Ethics and Incidental Findings”

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new discussion guide titled “Classroom Discussion Guide on Ethics and Incidental Findings.” This guide is designed to facilitate students’ engagement with the ethical issues surrounding incidental and secondary findings. This guide builds on the work of the Bioethics Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts

This guide introduces students of various levels to the ethical issues related to incidental and secondary findings. The guide provides a set of discussion questions to help students understand, evaluate, and reflect on these ethical challenges. The guide also includes three case studies that demonstrate the real-life impact that incidental and secondary findings have had in clinical, research, and direct-to-consumer settings.

This guide is part of a series of classroom discussion guides that have been developed for students at various educational levels, and includes discussion guides on ethical issues related to public health emergencies and neuroscience. We have also developed a series of teaching tools, including topic-based modules, case studies, deliberative scenarios, and empirical research resources. All resources are available for free download, and can be integrated into existing science or ethics curricula, or used to create a new course.

Please stay tuned for forthcoming educational materials, including a new deliberative scenario and teacher companion about incidental findings.

All Bioethics Commission educational materials are free and available at www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Introducing New Primer Series: Spotting and Responding to Hype

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new series of primers on spotting and responding to science hype in the media. The three primers cover hype related to topics in new technology, public health and neuroscience. The primers introduce hype about scientific topics in the media, and provide users with ways to spot hype and evaluate scientific claims in media outlets. The primers draw on topics covered in three of the Commission’s reports: New Directions: The Ethics of Synthetic Biology and Emerging Technologies, Ethics and Ebola: Public Health Planning and Response, and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society.

The primers are designed to help members of the public spot and respond to hyped claims in the media, which can often distort, exaggerate or misrepresent scientific information. The primers note that hype is generated from numerous sources, including scientists, communication and public relations professionals, and journalists. Each primer provides users with steps to spot hype as well as respond to hype when they counter such claims in news stories and blog posts. The primers also include examples of hyped claims that were found in news outlets.

The Commission has discussed hype in a number of its reports. In New Directions, the Commission recommended that individuals and deliberative forums should use clear language when communicating scientific information and avoid “sensationalist buzzwords” when describing topics in synthetic biology. The Commission also called for a private organization to fact-check claims that discuss advances in synthetic biology.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Introducing the Bioethics Commission’s User Guide for Medical Educators

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has released a new user guide, designed to help medical educators find useful pedagogical materials related to the Bioethics Commission’s work. The user guide builds on the work our most recent report, Bioethics for Every Generation: Deliberation and Education in Health, Science and Technology.

The user guide provides an overview of the Bioethics Commission’s educational materials that can be used by educators in health professions, including medicine, nursing, and allied health. The guide also explains the application and relevance of these materials to students who are pursuing careers in these disciplines. The user guide directs medical educators to the Bioethics Commission’s materials that can be incorporated into the curricula of courses that discuss incidental findings, community engagement, clinical research, genetics, neuroscience, public health, and biotechnology.

This guide is one in a series of user guides that have been designed for use by professionals and educators in a variety of disciplines, including public health, law, and public policy. User guides are also available for high school and science educators. Though the user guides are designed with a particular audience in mind, they, along with all of the Bioethics Commission’s educational materials, can be used by anyone in any area of study.

The Bioethics Commission will be releasing new educational materials in the near future. Please stay tuned for more information about educational materials relating to science hype in the media and a community engagement module associated with the Commission’s report Ethics and Ebola: Public Health Planning and Response.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Special Issues: Psy Sciences and Healthism by Anna Zogas

In advance of our regular monthly journal round-up, here are two special issues to check out! First, the brand new June 2016 issue of East Asian Science, Technology and Society is titled Transnational Psy Sciences in East and Southeast Asia. Next, a special double issue of Eä – Journal of Medical Humanities & Social Studies of Science and Technology (open access) is titled Healthism & Self-Care: Reconfiguring Body & Life through Science & Technology. Enjoy!

East Asian Science, Technology and Society

Transnational Psy Sciences in East and Southeast Asia

From the 1970s onward, the psy sciences were witness to blustering confrontations from a New Age movement heavily informed by Asian philosophy. Nowadays, yoga practices and mindfulness training have been integrated into mainstream psychotherapy. Nevertheless, such trends toward East-West admixing are in fact not at all new. Through four case studies, this special issue provides empirical data complementing the abundance of new scholarship on the history of psy sciences in East and Southeast Asia.

Making and Mapping Psy Sciences in East and Southeast Asia (open access)
Harry Yi-Jui WuWen-Ji Wang

The rich history of psy disciplines or psy sciences (psychology, psychiatry, psychotherapy, psychoanalysis) in modern society has been subject to different and sometimes conflicting interpretations. Major events, theories, and figures have been recorded and the meaning of their contributions explored to illustrate the ways in which various forms of psychological knowledge become important sources of self-understanding and self-actualization. Insights into the social and cultural history of psy sciences enable us to understand the interconnection between forms of knowledge and the social order to which they relate (Eghigian et al.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

A Tool to Help Address Key Ethical Issues in Research

Guest post by Rebecca H. Li and Holly Fernandez Lynch

One of the most important responsibilities of a clinical project lead at a biotech company or an academic research team is to generate clinical trial protocols. The protocol dictates how a trial will be conducted and details background information on prior research, scientific objectives, study rationale, research methodology and design, participant eligibility criteria, anticipated risks and benefits, how adverse events will be handled, plans for statistical analysis, and other topics. Many protocol authors use as a starting point a “standardised” protocol template from their funder or institution. These templates often provide standard language, and sections for customisation, sometimes with various “pick-and-choose” options based on the nature of the research. They inevitably cover each of the key topics listed above, but often fail to include ethical principles and considerations beyond the regulatory requirement of informed consent. Indeed, the process of protocol writing has traditionally focused on scientific detail, with ethical analysis often left to institutional review boards (IRBs) and research ethics committees (RECs); unfortunately, robust discussion of specific ethical issues is often absent from clinical trial protocols.

When IRBs and RECs convene to review protocols, they are expected to evaluate whether the study will adequately protect enrolled participants. When the protocol fails to address potential ethical concerns explicitly, reviewers are left to speculate: did the investigator consider the concern, but dismiss it as not relevant in this particular context; did the investigator fail to understand the concern; does the investigator have an appropriate plan in place to resolve the concern, but has left it unstated in the protocol?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Fordham RETI Fellows Present at PRIM&R Annual Meeting

Dr. Erin Bonar, Dr. Faith Fletcher, and Dr. Celia B. Fisher at the PRIM&R Annual Meeting 2015. Photo courtesy Dr. Sue Fish

The Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI) was well-represented at the Public Responsibility in Medicine and Research (PRIM&R) Annual Meeting in Boston, November 12-15, with faculty and fellows presenting on their institute-funded research.

RETI Director Dr. Celia B. Fisher and Cohort 4 fellows Dr. Erin Bonar and Dr. Faith Fletcher presented a session entitled, “Enhancing the Responsible Conduct of Adolescent and Young Adult Health Research through Empirical Studies on Research Ethics.”

This session featured presentations describing empirical studies on research ethics issues that can help IRBs evaluate human subjects protections for health research involving adolescents and young adults. The research described draws on the perspectives of adolescents and parents to illuminate opportunities and barriers to the responsible conduct of HIV, drug use, and mental health research.

During this session, Bonar reviewed how mixed-method research (surveys and interviews) can illuminate best practices for assessing risks and benefits and protecting confidentiality in mobile health-based research on drug use and sexual risk among emerging adults. In addition, Fletcher described how empirical data on African American mothers’ and daughters’ attitudes toward adolescent participation in HIV biomedical prevention trials can inform IRB evaluations of research vulnerability. Finally, Fisher outline how to evaluate ethical justifications for requests to waive guardian permission using data from an innovative, web-based, asynchronous focus group methodology that examined ethical barriers and facilitators to lesbian, gay, bisexual and transgender (LGBT) youth participation in HIV prevention medication adherence trials.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Call for Abstracts BIOETHICS: PREPARING FOR THE UNKNOWN

Call for Abstracts

BIOETHICS: PREPARING FOR THE UNKNOWN

March 17-18, 2016; Kalamazoo, Michigan

Overview

The theme of this conference, hosted by Western Michigan University’s Center for the Study of Ethics in Society, highlights uncertainty as a fundamental factor in bioethics.  Invited speakers include Insoo Hyun, associate professor of bioethics and philosophy at Case Western Reserve University, and Richard Sharp, director of the bioethics program at the Mayo Clinic.
Possible topics for submissions include unintended consequences of innovative medical technologies, public health planning for new diseases, incidental findings in clinical research and practice, prevention of medical error, and communication of risk.  Papers on this general theme will be welcomed from a variety of disciplines and perspectives in relation to policy, practice, research, and communication in fields dealing with bioethics.  These fields include, but are not limited to, bioengineering, biology, medicine, nursing, the social sciences and scientific reporting.

Submission guidelines

Submissions will be accepted in the category of formal papers and panel discussions. Submissions are welcome from academic faculty, graduate students, medical students, medical professionals and research teams consisting of any combination of these.
Submissions should be prepared for blind review; please inspect documents and remove personal information before submitting electronically in .doc/.docx or .pdf format to ethicscenter@wmich.edu. Corresponding authors should include names of all authors, as well as their affiliations, and the paper or panel title, on a separate title page. Completed papers or extended abstracts of 500-1,000 words will be considered for paper submissions. For panel discussions, submissions should include an abstract summarizing the overall topic of the panel, as well as separate abstracts for each author’s contribution, for a total of up to 1,000 words.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Bioethics Deliberation and Education in Anticipate and Communicate

Last month, we left off our “Deliberation and Education” series with the blog post “Bioethics Deliberation and Education in Safeguarding Children.” Like previous posts in this series, it examined the role of deliberation and education in the recommendations issued by the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). This fifth post in the series will examine deliberation and education in the Bioethics Commission’s sixth report: Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.

Anticipate and Communicate, released in December 2013, expands upon the Bioethics Commission’s previous report, Privacy and Progress in Whole Genome Sequencing. Recognizing that the ethics of reporting incidental findings to individuals was an important and unsettled issue raised in Privacy and Progress, the Commission chose to examine both incidental and secondary findings further in a later report.

The Bioethics Commission made 17 recommendations, divided into overarching and context-specific recommendations for clinicians, researchers, and direct-to-consumer companies. In its fourth overarching recommendation, the Commission directly recommended education as a part of the ethical management of incidental and secondary findings:

Public and private entities should prepare educational materials to inform all stakeholders—including practitioners, institutional review boards, and potential recipients—about the ethical, practical, and legal considerations raised by incidental and secondary findings.

The Bioethics Commission recognized that education is important for ensuring both that the public is able to make informed decisions and that practitioners are aware of their ethical obligations with regard to incidental findings. With this in mind, the Commission created a series of primers for IRB members, practitioners, and recipients to support the practical application of its recommendations.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.