Incidental findings – 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 Ethically Sound Episode 10: Charting a Path Forward https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/21/ethically-sound-episode-10-charting-a-path-forward/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/11/21/ethically-sound-episode-10-charting-a-path-forward/#respond Mon, 21 Nov 2016 16:00:01 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2052 The tenth and final episode of the Bioethics Commission’s podcast series, Ethically Sound, is now available. Today’s episode, “Charting a Path previewscreensnapz001Forward,” focuses on the Bioethics Commission’s two most recent public meetings, during which the Bioethics Commission reflected on the impact of past, present, and future of national bioethics advisory bodies.

Since the 1970s, the U.S. has had a succession of national advisory bodies to provide Congress or the President with expert advice on topics related to bioethics. Other countries also benefit from advisory bodies that provide advice about bioethi
cal issues. During its twenty-fifth and twenty-sixth public meetings, the Bioethics Commission heard
from members of past bioethics advisory bodies, representatives of international bioethics bodies, as well as officials who have been advised by such bodies.

The podcast opens with a narrative from Alex Capron, Professor of Law and Medicine at the University of Southern California. Mr. Capron chaired the Biomedical Ethics Advisory Committee from 1987 to 1990, and served on President William J. Clinton’s National Bioethics Advisory Body from 1996 to 2001. Mr. Capron presented before the commission during Meeting 26, and reflected on his experiences with both of these advisory bodies. In the podcast, Mr. Capron recounts a challenging experience he faced while describing the disciplinary backgrounds of bioethics advisory body staff to policymakers unfamiliar with the interdisciplinary nature of bioethics.

The podcast also includes an interview with Bioethics Commission member Dr. Daniel Sulmasy, Kilbride-Clinton Chair in Medicine and Ethics at the University of Chicago. The interview was conducted by Hillary Wicai Viers, a former Communications Director with the Bioethics Commission staff. Dr. Sulmasy discussed the importance of looking to past commissions, the legacy of the current Bioethics Commission, and the pressing ethical issues that we could face in the future. Regarding the importance of looking to past bioethics commissions, Dr. Sulmasy said “The past is applicable because many of the most basic ethical questions are perennial. We may encounter new problems, but the most fundamental questions about human finitude, the meaning of human progress, the role of balancing relief of suffering versus other ethical principles, questions of cost, and justice are always with us.”

Episode 10, and all of the other Ethically Sound episodes, is now available on our website, as well as on our SoundCloud, YouTube and iTunes pages. Listeners can follow the podcast using #EthicallySound or by following us on Twitter @bioethicsgov. Stay tuned for our upcoming educational resource, a set of discussion questions to accompany the Ethically Sound series that can be used in a classroom or seminar setting. We welcome comments and feedback at info@bioethics.gov.

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PRIM&R Conference Update: Research Ethics and Incidental and Secondary Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/12/11/primr-conference-update-research-ethics-and-incidental-and-secondary-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/12/11/primr-conference-update-research-ethics-and-incidental-and-secondary-findings/#respond Thu, 11 Dec 2014 17:28:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1505 Recently, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) facilitated a didactic workshop session at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference. This past Saturday, December 6, Bioethics Commission staff led the workshop IRB Primer: Incidental and Secondary Findings. The presentation provided an overview of the Commission’s recommendations regarding discoveries that lie outside the original aim of a test or procedure, and introduced educational materials to inform and support institutional review board (IRB) members, who often review protocols that include concerns about the ethical management of these findings.

Elizabeth Pike began with a brief introduction to the Bioethics Commission’s report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. She emphasized the Commission’s main message: The ethical management of incidental and secondary findings requires that practitioners in all contexts anticipate and communicate. Practitioners should anticipate the incidental and secondary findings that can arise from a particular test or procedure and communicate how those findings will be managed to a potential recipient. She also noted the role of IRBs in reviewing research, and provided an overview of definitional issues, including what makes findings “incidental” or “secondary,” as well as the types of tests and procedures that commonly produce these findings.

Misti Ault Anderson then discussed the role of researchers. She highlighted various options researchers have to facilitate the ethical management of incidental and secondary findings, including informed consent processes, access to additional expertise, and opportunities to obtain participant preferences and disclose findings in accordance with these wishes.

Finally, Karen Meagher presented on the ethical considerations pertinent to IRB members when evaluating protocols in which incidental and secondary findings can arise. This overview included relevant ethical principles, such as respect for persons and beneficence, that IRBs can apply when evaluating researchers’ plans for ethical management of incidental and secondary findings. By considering a variety of options, PRIM&R attendees were able to envision multiple ways in which researchers can meet their responsibilities to participants, including different ways to establish clear communication.

In the second part of the session, staff members facilitated small group activities including the analysis of hypothetical research case studies involving large-scale genetic sequencing, testing of biological specimens, and imaging. Small groups considered the case studies, and reported out to the larger group about how researchers might design ethical protocols regarding the management of incidental and secondary findings, generating a lively group discussion. One attendee noted how IRBs also benefit from planning ahead, as thinking through difficult decisions before they arise is preferable to reacting after an incidental or secondary finding has been discovered, when available options might be limited or the timing of decisions more urgent. Session attendees enriched discussion by sharing their own past experiences and insights gained from a wide variety of professional backgrounds in research ethics.

By prompting audience consideration of the ethical issues that arise when considering research that might produce incidental and secondary findings, staff members demonstrated how professionals can make use of Bioethics Commission educational resources in support of important ongoing work in research ethics.

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Bioethics Commission to Offer Presentations at ASBH This Week https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/15/bioethics-commission-to-offer-presentations-at-asbh-this-week/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/15/bioethics-commission-to-offer-presentations-at-asbh-this-week/#respond Wed, 15 Oct 2014 19:16:14 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1452 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is pleased to offer multiple presentations at the American Society for Bioethics and the Humanities (ASBH) Annual Meeting, scheduled for October 16-19 in San Diego, Calif. Over the course of the four day conference Bioethics Commission staff will highlight a number of bioethical issues, including bioethics literacy, incidental findings, and the integration of ethics into neuroscience research.

Executive Director Lisa M. Lee, along with Mildred Solomon, President and CEO of the Hastings Center, will present “Bioethics Literacy across the Lifespan” on October 17 at 10:45 a.m. According to Lee, the talk will focus on more than just ethics education. “Just like bioethics is multidisciplinary, bioethics education is also multidisciplinary. It is not just about a bioethicist teaching a scientist,” said Lee. “Everyone, from organizational leaders to primary school teachers, has a role in ethics education.” The talk comes on the heels of the recent release of the Sept.-Oct. issue of The Hastings Report. The issue, themed “Teaching Bioethics,” is co-sponsored by the Commission and highlights a collection of papers on bioethics education, the Commission’s newly announced project.

On October 16 at 4 p.m., Bioethics Commission Associate Director Michelle Groman, along with representatives of the New York State Task Force on Life and the Law, will lead the panel “Take it or Leave it: the Role of Bioethics Advisory Bodies in Effecting Policy Change.” The panel will use several case studies in order to examine how the features and structure of a bioethics commission, along with the political and social climate, can impact a commission’s influence on changes to policy and law. Jason Schwartz, a former Commission staff member and current research associate and lecturer in bioethics at the Princeton University Center for Human Values, will moderate.

In addition to Lee’s presentation, October 17 will feature a second presentation by Bioethics Commission staff. At 8 a.m., Research Analyst Nicolle K. Strand will present her paper “The Cost of Misinformation: Consumer Remedies for Misleading Genetic Test Results,” examining the potential legal solutions for consumers to respond to misleading genetic test results, and considering questions of compensation.

On October 18 at 11 a.m., Bioethics Commission Associate Director Kayte Spector-Bagdady, Senior Policy and Research Analyst Karen Meagher, and Executive Director Lisa M. Lee will lead the panel “Applying the Ethical Management of Incidental and Secondary Findings in Context,” moderated by Research Analyst Nicolle Strand. The panel will build on the Commission’s recommendations on the management of incidental and secondary findings, discussing staff work from philosophical, public health, and legal perspectives.

Finally, on October 19 at 8 a.m., Michelle Groman, Bioethics Commission Associate Director; Debra Matthews, former Bioethics Commission staff member and current Assistant Director for Science Programs at the Berman Institute of Bioethics; and William Casebeer, formerly of the Defense Advanced Research Projects Agency (DARPA), will lead the panel “Integrating Ethics and Neuroscience Research: Recommendations from the Presidential Bioethics Commission and Integration in Practice.” The panel will focus on the Commission’s recommendations for ethics integration throughout neuroscience research, as presented in its most recent report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society. DARPA’s efforts to integrate ethics into neuroscience research, as well as the integration of ethics and science through all levels of education will be discussed.

With a busy schedule, the Bioethics Commission looks forward to an educational and informative meeting. Be sure to stop by our booth in the exhibit hall. See you at ASBH!

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The Bioethics Commission’s Work on Incidental and Secondary Findings and the Applications for Neuroscience https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/08/the-bioethics-commissions-work-on-incidental-and-secondary-findings-and-the-applications-for-neuroscience/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/08/the-bioethics-commissions-work-on-incidental-and-secondary-findings-and-the-applications-for-neuroscience/#respond Wed, 08 Oct 2014 16:39:38 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1446 Today, Senior Policy and Research Analyst Elizabeth Pike will present on behalf of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) at the conference “Emerging Ethical and Legal Challenges in Chronic Neurological Conditions.” The presentation is part of a two-day conference held at the Cleveland Clinic’s Global Center for Health Innovation and at the Cleveland Convention Center. Its goal is to explore dilemmas that arise in outpatient settings relevant to clinicians, ethicists, and public health scholars, and to provide practical ethical frameworks and tools to navigate these dilemmas.

Pike’s presentation will focus on 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. She will discuss how the Commission’s work on incidental and secondary findings can be applied specifically to neuroscience, and will reference two cases first presented at the Commission’s thirteenth public meeting on April 30, 2013. Sarah Hilgenberg and Carol Krucoff, both received incidental findings as a result of neuroimaging, one in a research setting and one in a clinical setting. Their cases help illustrate the practical, legal, and ethical implications of incidental and secondary findings. These implications vary depending on the context in which they arise and demonstrate the importance of preparing for both incidental and secondary findings when engaging in neuroscience clinical care or research.

Attendees at today’s conference include neurologists, neurosurgeons, psychiatrists, lawyers, advance care nurses, physician assistants, ethicists, psychologists, health services specialists and social workers. It is part of the larger “23rd Annual International Epilepsy Symposia” currently taking place in Cleveland, Ohio through October 11, 2014.

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Bioethics Commission Anticipates and Communicates in Webinar on Incidental and Secondary Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/06/bioethics-commission-anticipates-and-communicates-in-webinar-on-incidental-and-secondary-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/10/06/bioethics-commission-anticipates-and-communicates-in-webinar-on-incidental-and-secondary-findings/#respond Mon, 06 Oct 2014 16:10:42 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1443 Two staff members of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) will lead the October 2014 webinar for Public Responsibility in Medicine and Research (PRIM&R). Elizabeth Pike, J.D., L.L.M., Senior Policy and Research Analyst, and Nicolle K. Strand, J.D., M. Bioethics, Research Analyst, will present “Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings” on Tuesday, October 7, 2014 from 1-2:30 p.m. The webinar will focus on helping IRB members and staff interpret 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. The webinar is free and open to both PRIM&R members and nonmembers; those wishing to attend the webinar are encouraged to register early online on the PRIM&R website.

The Bioethics Commission has defined incidental findings as discoveries that lie outside the original aim of a test or procedure; secondary findings are also not the primary target of the testing but, unlike incidental findings, they are actively sought. Anticipate and Communicate contains specific recommendations for the clinical, research, and direct-to-consumer settings as well as broader recommendations for the management of incidental and secondary findings to help anticipate and communicate unanticipated findings from research.

Pike will open the webinar with a summary of the 2013 report’s analysis and recommendations, focusing specifically on the research context. She will highlight the practical, ethical, and legal challenges to managing incidental and secondary findings in research and will discuss the role IRBs can play in implementing the Bioethics Commission’s recommendations.

In addition to the report, the Bioethics Commission has also released a number of educational materials for practitioners as well as recipients on incidental and secondary findings, and Strand will describe how IRBs can use the educational materials. Specifically, Strand will demonstrate how to use the Bioethics Commission’s IRB primer to conduct training sessions for IRB members to help prepare them as they assess plans on the management of these findings. In addition, Strand will describe a piece designed for research participants from the Bioethics Commission’s “Conversation Series”—a one-page description of incidental findings that might arise in research and how to prepare for them—and will demonstrate how researchers could use this additional resource as a part of the consent process.

Pike and Strand look forward to a robust question and answer session following the presentations.

All educational materials produced by the Bioethics Commission are available for free at http://education.

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New Incidental Findings Conversation Series for Patients, Research Participants, and Consumers https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/13/new-incidental-findings-conversation-series-for-patients-research-participants-and-consumers/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/06/13/new-incidental-findings-conversation-series-for-patients-research-participants-and-consumers/#respond Fri, 13 Jun 2014 14:31:16 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1345 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just released a set of educational materials on incidental findings that it developed for patients, research participants, and consumers. In early May, the Bioethics Commission released primers to guide clinicians, researchers, and direct-to-consumer (DTC) companies – health professionals who manage these types of findings. This latest set of primers is addressed to the other party in those relationships – those who might be receiving unanticipated findings – be they patients in a clinical context, participants in a research context, or consumers in a DTC context.

The conversation series primers, available on Bioethics.gov/education, guide potential recipients in preparing for incidental findings across contexts and operationalize the Bioethics Commission’s discussion of incidental and secondary findings in its December 2013 report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Context.

To make their recommendations on incidental and secondary findings accessible to a wide range of potential recipients, the Bioethics Commission created this set of primers as a conversation series – a set of tools that can be used to get conversation started between findings managers and potential findings recipients – for example, doctor and patient, or researcher and participant. As they order tests, doctors can provide the patient primer to their patients. Researchers could use the participant primer as they obtain informed consent from study participants. The primers give a description of incidental findings in each context to help potential recipients understand how incidental findings are different from the primary findings they or their practitioners are seeking. Each primer helps potential recipients understand what those findings might be and prepares them to ask the clinician, researcher, or DTC provider relevant and important questions.

The primer for patients describes types of tests that might result in incidental findings, for example, genetic tests, blood or urine tests, and imaging. It provides some questions that patients can ask their clinicians. For example, the primer suggests asking clinicians “what might you find,” “what will you tell me,” “how do you intend to follow up on any incidental findings,” and “what if I don’t want to know certain results?” The primers for research participants and consumers provide similar information on tests that might result in incidental findings and what to ask the research team or the DTC provider.

The primers also include a variety of hypothetical recipient experiences with incidental findings. For example, the research participant primer presents a case in which a participant underwent a brain scan as part of a research study and found out she had a brain abnormality.

The Bioethics Commission supports bioethics education through these and other educational materials based on its reports and recommendations. All materials are available for free download at Bioethics.gov. The Bioethics Commission welcomes feedback on all of its educational materials at education@bioethics.gov.

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Now Available: Set of Primers for Practitioners on Management of Incidental and Secondary Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/08/now-available-set-of-primers-for-practitioners-on-management-of-incidental-and-secondary-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/08/now-available-set-of-primers-for-practitioners-on-management-of-incidental-and-secondary-findings/#respond Thu, 08 May 2014 14:25:10 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1287 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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New Educational Primers to Accompany Anticipate and Communicate https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/17/new-educational-primers-to-accompany-anticipate-and-communicate/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/17/new-educational-primers-to-accompany-anticipate-and-communicate/#respond Thu, 17 Apr 2014 14:00:37 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1247 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 https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/15/new-video-highlights-the-need-for-a-plan-when-it-comes-to-incidental-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/15/new-video-highlights-the-need-for-a-plan-when-it-comes-to-incidental-findings/#respond Tue, 15 Apr 2014 14:19:28 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1240 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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New Educational Module Available on Informed Consent for Anticipate and Communicate https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/20/new-educational-module-available-on-informed-consent-for-anticipate-and-communicate/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/20/new-educational-module-available-on-informed-consent-for-anticipate-and-communicate/#respond Thu, 20 Mar 2014 15:40:56 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1202 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.

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