Karen Meagher – 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 Bioethics really is For Every Generation: Vice Chair publishes editorial on K-12 Education https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/07/18/bioethics-really-is-for-every-generation-vice-chair-publishes-editorial-on-k-12-education/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/07/18/bioethics-really-is-for-every-generation-vice-chair-publishes-editorial-on-k-12-education/#respond Mon, 18 Jul 2016 10:00:33 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1874 James Wagner, Vice Chair of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), recently published a commentary in Education Week. In this piece on the Bioethics Commission’s tenth report, Bioethics for Every Generation, Dr. Wagner notes that early ethics education:

“prepare[s] students for the road ahead. Each of us will face crucial bioethical decisions in our lives—how to make difficult treatment choices when diagnosed with an illness, how best to care for a sick or elderly loved one, or whether to adopt new cutting-edge technologies to detect a genetic disorder or attack a neurological disease. Ethics education can help prepare us to tackle these tough questions.”

The Bioethics Commission’s report delineates how ethics education can be tailored for different educational levels and life stages (see Fig. 4, adapted from Bioethics for Every Generation, p. Wagner K2 Companion Blog Adapted Figure 4 Cleared 7.12.16 69). Dr. Wagner highlighted key ways to integrate bioethics education at the primary and secondary levels. The Bioethics Commission’s recommendations at these levels included:

  • Recommendation 4: Implement Foundational Board-Based Ethics Education at all Levels: Educators at all levels, from preschool to postsecondary and professional schools, should integrate ethics education across the curriculum to prepare students for engaging with morally complex questions in a diverse range of subjects. Ethics education should include attention to both the development of moral character and virtue as well as the cultivation of ethical reasoning and decision-making skills that can be deployed in a bioethics context. Methods of ethics education should be evidence-based and grounded in best practices.
  • Recommendation 6: Support Opportunities for Teacher Training in Bioethics Education: Education policymakers, teacher training programs, and other funders should support development of teacher training in ethics education to prepare teachers of all subjects to facilitate constructive bioethical conversations in their classrooms. Teacher training programs should anticipate existing educational inequities and provide teachers and students with equitable access to ethics education, with an aim of preparing all students for the bioethical questions that might arise during the course of their lives.

As Dr. Wagner concludes, Bioethics for Every Generation ties together educational recommendations the Bioethics Commission has made over its tenure: “When we strengthen ethics education for future scientists and clinicians and for every member the public, we will be better equipped to move forward as individuals and as a nation. Our hope is that every generation can “do better” as we face the dynamic future of that awaits us.”

For more information on the Bioethics Commission’s educational materials that accompany their reports, please explore our education page: http://education.

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Bioethics Commission’s New Recommendations Bolster Ethics Education https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/26/bioethics-commissions-new-recommendations-bolster-ethics-education/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/26/bioethics-commissions-new-recommendations-bolster-ethics-education/#respond Thu, 26 May 2016 10:40:00 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1855 The Bioethics Commission has encouraged and supported bioethics education throughout its projects and activities. Our educational materials, related to our reports, are tailored reach a variety of audiences. As the Bioethics Commission nears the end of its tenure, the capstone report Bioethics for Every Generation: Deliberation and Education in Health, Science, and Technology ties together these educational efforts. Among its eight recommendations, Bioethics for Every Generation included three that focus on improving bioethics education going forward.

First, early ethics education should build a foundation of ethical reasoning, literacy, and character formation. A solid basis in ethics will help children grapple with ethical choices far beyond the traditional classroom, such as how to be loyal to a friend or when, if ever, to break a promise. Those who develop curricula for ethics education should use evidence about childhood and adolescent moral development to inform their instruction, selecting questions and topics that are age-appropriate.

Second, in secondary school and higher education, bioethics education should become more targeted, and prepare students for particular ethical challenges that arise in health, science, technology, and engineering. Professionals should explore ethical questions alongside the technical dimensions of their fields, as critical reasoning skills and moral sensitivity help professionals grapple with the distinct ethical dimensions of their work.

Third, teachers and educational administrators need support, including professional development, to provide effective bioethics ethics education. Such efforts are likely to encounter understandable, but surmountable, obstacles. Among these include a hesitancy to engage students in questions of values, especially in matters that are likely to produce disagreement. Professional development can prepare instructors to overcome such obstacles. For example, training can prepare teachers to enlist support and address concerns of administrators and parents and demonstrate how ethics education is rooted in respect, does not seek to indoctrinate students, and cultivates critical thinking.

To assist educators in understanding the intersection of bioethics education and deliberation, Bioethics for Every Generation has an accompanying suite of educational materials, including deliberative scenarios that provide teachers and students with information on how to model deliberation in the classroom. 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.

Bioethics for Every Generation and all other Bioethics Commission reports are free and available at www.bioethics.gov.

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Roundtable Discussion: Bioethics Advisory Bodies Past, Present, and Future https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/roundtable-discussion-bioethics-advisory-bodies-past-present-and-future/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/roundtable-discussion-bioethics-advisory-bodies-past-present-and-future/#respond Tue, 03 May 2016 19:09:11 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1836 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) closed its reflections on the impact of national bioethics advisory bodies with a roundtable discussion involving Commission members and the day’s presenters.

Amy Gutmann, Ph.D., Chair of the Bioethics Commission, began the session by asking each panelist to articulate an important takeaway from the previous discussions about what the future holds for bioethics advisory bodies. She invited panelists and members to reflect upon what they would recommend to the next bioethics commission, in terms of either topic selection or structure/function.

Highlights from the discussion include:

Jason L. Schwartz, Ph.D., M.B.E., Assistant Professor of Health Policy and the History of Medicine at Yale University School of Public Health, talked about continuity between commissions, and how retaining their names might ensure a smoother transition and better continuity between administrations.

Nandini Kumar M.B.B.S., D.C.P., M.H.SC., Dr. TMA Pai Endowment Chair at Manipal University in India, emphasized the importance of including a member fluent in issues of international research, especially taking place in developing countries.

Tom L. Beauchamp, Ph.D., Professor of Philosophy and Senior Research Scholar at Georgetown University’s Kennedy Institute of Ethics, discussed the role of philosophy and philosophers in the conversations of bioethics advisory bodies.

Ruth Faden, Ph.D., M.P.H., Andreas C. Dracopoulos Director and Philip Franklin Wagley Professor at Johns Hopkins Berman Institute of Bioethics stressed that human rights and health should be emphasized by future bioethics commissions, as opposed to emerging technologies. She also referred to accountability and the importance of signaling independence and authority, helping to ensure that the government responds to recommendations by commissions.

Manuel Ruiz De Chávez, M.D., M.S., F.R.C.P. President of the Mexico National Commission of Bioethics (CONBIOÉTICA) focused on the importance of international cooperation between bioethics bodies.

Patricia King, J.D., Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy at Georgetown Law said applied ethicists play a critical role in the discussions at this level, and emphasized the importance of passing on some of the institutional knowledge gained by this Bioethics Commission to the next one.

The next meeting of the Bioethics Commission, which continues this discussion, is scheduled for August 31 in Philadelphia, PA. For details, go to www.bioethics.gov.

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Additional Reflections on National Bioethics Advisory Bodies https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/additional-reflections-on-national-bioethics-advisory-bodies/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/additional-reflections-on-national-bioethics-advisory-bodies/#respond Tue, 03 May 2016 18:14:52 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1832 The Bioethics Commission continued its discussion on the impact of bioethics advisory bodies, looking to the past to inform future efforts to address social and ethical dimensions of health, science, and technology policy.

In the second panel of the day, the Bioethics Commission heard from a variety of speakers considering the past, present, and future impact of such groups. Presenters included Tom L. Beauchamp, Professor of Philosophy at the Georgetown University Kennedy Institute of Ethics and Ruth Faden, Director of Johns Hopkins Berman Institute of Bioethics. In addition, the commission heard from Manuel Ruiz de Chávez, President of the Mexico National Commission of Bioethics (CONBIOÉTICA) and Patricia King, Professor of Law, Medicine, Ethics, and Public Policy at Georgetown Law.

Beauchamp shared insights gleaned from his time on the staff of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) where he contributed to the delineation of foundational principles for research ethics in the Belmont Report. He discussed the enduring impact of the Belmont Report both in the United States and abroad, while acknowledging its limitations and reflecting on what national bioethics bodies should focus on in the future.

Faden spoke of her experience as chair of the President’s Advisory Committee on Human Radiation Experiments (ACHRE). She described ACHRE’s charge and the nature of the issue that it was facing under the Clinton administration. Faden emphasized the power that a presidential commission has, serving as a “public pulpit to make a tremendous difference.”

Ruiz de Chávez talked about the importance of promoting the message of bioethics to the public, and the role that national bodies can serve in fulfilling that mission. He discussed the importance of an interdisciplinary commission and staff to advise executive, legislative, and judicial branches of government.

King reflected on her experience to two U.S. bioethics committees, as a member of the National Commission and ACHRE. She discussed what made the National Commission successful, including the fact that the federal government was required to respond to each of their recommendations, even if they did not take them up, and the fact that they convened at least once a month for over four years. She also discussed some of the features of the commission that she felt could have been improved, including a lack of sufficient disciplinary diversity, and what the members learned from the challenges that they faced during their tenure.

Stay tuned as panelists from the morning’s session return for a roundtable discussion with the Bioethics Commission.

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Reflections on National Bioethics Advisory Bodies https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/reflections-on-national-bioethics-advisory-bodies/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/reflections-on-national-bioethics-advisory-bodies/#respond Tue, 03 May 2016 15:31:22 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1829 At today’s meeting, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) reflected on its own tenure and that of other bioethics advisory bodies.

In the first panel session of the day, the Bioethics Commission heard from a series of speakers reflecting on the past, present, and future impact of national bioethics advisory bodies. Presenters included Jason Schwartz, Assistant Professor of Health Policy and History of Medicine at Yale University; James Childress, University Professor and John Allen Hollingsworth Professor of Ethics at University of Virginia; Michael Gazzaniga, Director of SAGE Center for the Study of Mind and UC-Santa Barbara; and Nandini Kumar, former Deputy Director of the Indian Council of Medical Research.

Jason Schwartz has written widely on the history of national bioethics advisory bodies, decision making in public policy, and the structure and function of scientific expert advice to government. He addressed the impact of previous national bioethics commissions, highlighting the unique contributions that the current model for acquiring advice on bioethical issues can offer. He noted that bioethics commissions can serve an agenda setting role, identifying pressing issues of the day and bringing them to the fore. For more on this history, including links to previous commissions’ reports, click here.

Childress served as a consultant to the National Bioethics Advisory Commission (NBAC), which outlined ethical principles governing research involving human participants. He was also a member of other bioethics advisory bodies including the Recombinant DNA Advisory Committee and the Biomedical Ethics Advisory Committee. He observed that part of the overall impact of NBAC was to contribute to a public conversation about bioethics. NBAC’s work stimulated public discourse, informed public policy in the United States and abroad, and generated significant media interest in topics in bioethics.

Gazzaniga recalled his time as a member of the President’s Council on Bioethics under President George W. Bush from 2001 to 2009. He noted, “there should always be a bioethics council advising the President,” despite the sometimes controversial nature of the topics that the President’s Council took on. “People change their minds as a result of the public discourse,” he said, emphasizing the important function of diverse bioethics advisory bodies deliberating in public to bring values and facts to light.

Kumar previously collaborated with the Bioethics Commission as a member of the international panel that informed their report Moral Science. She discussed her time as a member of the Indian Council of Medical Research (ICMR) and contemporary bioethical issues arising in India. She stressed the contribution of the ICMR in helping to revise guidelines on many topics in bioethics in India, including informed consent, biobanking, and other important issues.

Following the four presentations, the Bioethics Commission engaged in a lively discussion with the panelists about the topics, structure, and function of Bioethics Commissions and looked towards the future, offering opinions on the best model going forward.

Stay tuned for more of this discussion, continuing in Session 2 at 12:30pm.

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Bioethics Commission Meeting 25: Live from Washington, DC https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/bioethics-commission-meeting-25-live-from-washington-dc/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/05/03/bioethics-commission-meeting-25-live-from-washington-dc/#respond Tue, 03 May 2016 13:25:02 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1823 Welcome to Washington, DC for the 25th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission’s meeting is today, May 3, 2016, from 9 a.m. to 3:15 p.m. ET.

Chair Dr. Amy Gutmann opened up the meeting by summarizing the Bioethics Commission’s forthcoming report focusing on key aspects of their own efforts—on deliberation and education in bioethics. Deliberation is a process that has informed the Bioethics Commission’s practices, including respectfully engaging different viewpoints and striving toward consensus recommendations with transparent and accountable justification. The Bioethics Commission has previously made numerous recommendations to support bioethics education, and developed its own materials to address this need. The new report builds on these efforts, offering new recommendations for advancing bioethics deliberation and education.

At today’s meeting, the Bioethics Commission will begin its discussion of the impact of bioethics advisory bodies past, present, and future. The Bioethics Commission welcomes a variety of esteemed speakers from past U.S and other national bioethics advisory bodies. Panelists will shed light on previous bioethics advisory committees, and how these set the stage for the future of national-level bioethics bodies.

For the full agenda of today’s meeting, click here.

You can follow the proceedings of the Bioethics Commission’s meetings here at this blog, and on the live webcast at the Bioethics Commission’s website. All transcripts and webcasts will be archived and available following the meeting.

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Bioethics Commission Meeting 24: Member Discussion of Future Educational Materials https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-commission-meeting-24-member-discussion-of-future-educational-materials/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/03/03/bioethics-commission-meeting-24-member-discussion-of-future-educational-materials/#respond Thu, 03 Mar 2016 21:02:06 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1809 Member discussion wrapped up the Bioethics Commission’s twenty-fourth meeting. During this session, members considered future plans for their educational materials. Plans include expanding on the over 50 educational tools currently available on the Bioethics Commission website. Members addressed new topics, audiences, and design of the educational resources.

First, members considered possible future topics, including ethics education and deliberation as modes of engaging with complex, multifaceted, and challenging topics in health and science. Current educational materials align with Bioethics Commission Reports, ranging from their most recent work on Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society to their very first report New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Available educational tools also address topics that cut across Bioethics Commission reports including community engagement, compensation for research-related injury, informed consent, privacy, research design, and vulnerable populations. Members considered expanding the topics addressed in Bioethics Commission case studies.

Commission members also considered potential new audiences, from primary and secondary school students to adults encountering these issues as patients, research participants, caregivers, and consumers. Materials already available are designed for researchers, public health professionals, and various educators–including those who teach law, public policy, and science. Current User Guides, for example, serve as quick reference documents to help professionals and educators identify which materials are most relevant to them.

Lastly, the Bioethics Commission members discussed making the most of educational material delivery method. Materials are available online, and members noted how educational tools that are publicly available in an electronic format can reach a wide audience long after the Commission’s tenure. Bioethics Commission educational materials to date come in a variety of audience-specific formats. Members considered which new formats will round-out the Bioethics Commission suite of educational resources for their diverse stakeholders including students, teachers, health and science professionals, and the wider public.

The session concluded, and the Bioethics Commission and staff will now turn to putting these plans in action. Find out about educational materials as they become available via this blog by email subscription, RSS feed, or following the Bioethics Commission on Twitter! E-mail us your feedback on bioethics education at education@bioethics.gov.

The Commission is scheduled to meet again on May 3, 2016 in Washington, D.C.

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Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/#respond Fri, 09 Oct 2015 15:07:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1730 This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.

In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”

The recent notice of proposed rulemaking (NRPM), which proposes revisions to the Common Rule, recognizes this regulatory gap that was highlighted by the Bioethics Commission. It notes that a possible ramification of this gap is that in states without clear laws, enrolling participants with impaired consent capacity could be difficult or impossible. The NPRM proposes a revision to the Common Rule that would permit LAR requirements to meet an accepted common practice standard, such as an established state or local hierarchy. This proposed revision mirrors the Bioethics Commission’s recommendation and its suggestion that federal regulatory bodies could recognize previous efforts on this front, such as the priority list of potential LARs developed in 2009 by the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).

If the NPRM proposed revisions are implemented, new research regulations will reflect the Bioethics Commission’s recommendation for clarity in LAR requirements. Clear requirements for LARs facilitate the responsible inclusion of participants with impaired consent capacity in research, which is necessary to fulfill the promise of research that might one day ameliorate neurological disorders and psychiatric conditions.

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Bioethics Commission Recommends Further Research on Consent Capacity and Ethical Protections for Participants https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/29/bioethics-commission-recommends-further-research-on-consent-capacity-and-ethical-protections-for-participants/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/29/bioethics-commission-recommends-further-research-on-consent-capacity-and-ethical-protections-for-participants/#respond Wed, 29 Apr 2015 19:23:48 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1618 In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) provided ethical analysis of three topics, including consent capacity and neuroscience research. More than one billion people globally, including millions of people in the United States, are affected by neurological disorders.[1]

Neuroscience research, including novel neurological interventions, promises new ways of treating, preventing, and understanding these conditions. However, many of these same conditions can impair individuals’ abilities to provide informed consent to participate in neuroscience research. The Bioethics Commission offered several recommendations to address neuroscience research involving individuals who might have impaired consent capacity. In particular, the Bioethics Commission recommended that:

Funders should support research to address knowledge gaps about impaired consent capacity, including the concept of capacity, brain function and decision-making capacity, current policies and practices, and assessment tools.

The Bioethics Commission recognized the progress made in recent decades, leading to better understanding of consent capacity. However, more research is needed to address remaining gaps in our knowledge including analysis of which abilities are most pertinent to understanding consent capacity, how to best assess individuals’ consent capacity, and the effectiveness of additional protections for research participants.

The Bioethics Commission highlighted the crucial role of neuroscientists in implementing this recommendation and disseminating research results. For example, professional societies like the International Neuroethics Society or the Society for Neuroscience might encourage researchers to share current practices, developments, and insights at meetings. In addition, investigators, with the assistance of journal editors, could publish more detailed accounts of ethical protections employed within scientific manuscripts or elsewhere. These efforts can create a collaborative environment in which neuroscientists facilitate and even lead the way in furthering best practices in research.

Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society and all other Bioethics Commission reports are available at Bioethics.gov.

[1] National Institute of Neurological Disorders and Stroke (NINDS). (2014). NINDS Overview. Retrieved February 2, 2015 from http://www.ninds.nih.gov/about_ninds/ninds_overview.htm; BrainFacts.org. (2014). Global Burden of Neurological and Mental Disorders [Webpage]. Retrieved February 17, 2015 from http:// www.brainfacts.org/policymakers/global-burden-of-neurological-and-mental-disorders/.

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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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