human subjects protection – 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 Looking Back at the Bioethics Commission’s Blog https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2016/12/05/looking-back-at-the-bioethics-commissions-blog/#respond Mon, 05 Dec 2016 16:00:04 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=2125 Throughout its tenure, the Bioethics Commission has maintained an active digital presence to connect with a global audience. A major component of this has been through its blog. This final blog post reflects on the role the blog has played in disseminating the Bioethics Commission’s work.first-blog

Former Bioethics Commission Executive Director Valerie Bonham launched the commission’s blog on November 15, 2010, announcing that the staff would be liveblogging during Meeting Three in Atlanta. From that meeting onward, Bioethics Commission staff continued to blog live from the Bioethics Commission’s meetings, held throughout the country in cities including Washington DC, Philadelphia, Salt Lake City, San Francisco, Chicago, and Boston. Meeting posts highlighted salient points of discussion as they occurred during the public meetings. For example, during Meeting Three, a blog post outlined the members’ deliberations regarding the risks and benefits of synthetic biology. During Meeting Eighteen, which focused on ethical issues in neuroscience, a blog post highlighted some of the discussion about the ethical challenges in neuroscience research. The Bioethics Commission also used blog posts to distill complex topics that arose during meetings. During Meeting Twelve, which focused on pediatric medical countermeasure research, a blog post presented a simplified structure of some of the federal regulations concerning pediatric research.

The commission’s blog also highlighted and explained the impact of the commission’s work. For example, during the commission’s tenure, a notice of proposed rulemaking (NPRM) to revise the Common Rule—the regulations that govern the ethical conduct of federally supported human subjects research—was published in the Federal Register on September 8, 2015. Elements of the commission’s work were included in this notice. In September and October 2015, the Bioethics Commission released a series of blog posts that described some of the relevant inclusions in the NPRM, and explained their significance.

The Bioethics Commission also used the blog to share its outreach activities and initiatives with a broad readership. For example, when Bioethics Commission staff attended the annual meeting of the American Society of Bioethics and Humanities in October 2015, a blog post highlighted the commission’s outreach efforts, and included answers to frequently asked questions that staff members fielded while at the conference. When the Bioethics Commission presented at the White House BRAIN conference, a blog post shared Executive Director Lisa M. Lee’s remarks. On June 8, 2016, Col. Nelson Michael gave an interview with the bioethics news site BioEdge, and the Bioethics Commission staff wrote a two-part blog post on some of the issues Col. Michael raised regarding democratic deliberation and ethics education. Blog posts were also written to describe publications in academic journals by Commission members and staff. A blog post shared a commentary written by Bioethics Commission Vice Ch
air Dr. James Wagner, who wrote about the importance of early ethics education.

During its tenure, the Bioethics Commission produced over 65 educational materials, and used the blog to picture1announce the availability of new educational materials, including user guides, primers, classroom discussion guides, and deliberative scenarios. Blog posts also helped outline how to use the educational materials. Blog posts also highlighted topics including innovations in ethics education, and the importance of civic engagement. The Bioethics Commission also used the blog to announce and promote its podcast series Ethically Sound, a 10-episode series that focuses on some of the ethical issues raised in the commission’s reports.
Readers can access previous blog posts, educational materials, the podcast series Ethically Sound, along with all of the Bioethics Commission’s reports and related materials at bioethics.gov. On behalf of the Bioethics Commission, we thank our readers for their continued interest in the work of the commission.

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New Educational Module from the Bioethics Commission on Vulnerable Populations in Neuroscience Research Now Available https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/07/15/new-educational-module-from-the-bioethics-commission-on-vulnerable-populations-in-neuroscience-research-now-available/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/07/15/new-educational-module-from-the-bioethics-commission-on-vulnerable-populations-in-neuroscience-research-now-available/#respond Wed, 15 Jul 2015 16:39:33 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1667 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted a new educational module on its website, Bioethics.gov. The module on vulnerable populations accompanies the Bioethics Commission’s two-volume report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1) and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). Additional educational materials on vulnerable populations include a background module, as well as report-specific modules that accompany the Bioethics Commission reports: Safeguarding Children: Pediatric Medical Countermeasure Research and “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. Other topics covered by the Bioethics Commission’s educational modules include community engagement, compensation for research-related injury, informed consent, privacy, and research design.

The Vulnerable Populations in Gray Matters module focuses on vulnerability specifically in the context of neuroscience research. The module provides instructors with a description of the ways in which individuals with impaired consent capacity might be vulnerable. It describes circumstances that might make potential participants vulnerable, including desperation and imprisonment, which merit ethical consideration in neuroscience research. It also addresses additional protections researchers can employ to protect potentially vulnerable populations in research, including those with impaired consent capacity.

The educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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.

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New Educational Module from the Bioethics Commission on Informed Consent in Neuroscience Now Available https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/19/new-educational-module-from-the-bioethics-commission-on-informed-consent-in-neuroscience-now-available/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/19/new-educational-module-from-the-bioethics-commission-on-informed-consent-in-neuroscience-now-available/#respond Tue, 19 May 2015 15:55:08 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1629 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new educational module on informed consent. The module accompanies the Bioethics Commission’s two-volume report Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1) and Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The new Gray Matters module adds to the informed consent resources already produced by the Bioethics Commission. Additional materials on informed consent include a background module and four report-specific modules that accompany the Bioethics Commission reports Ethically Impossible: STD Research in Guatemala from 1946 to 1948, Privacy and Progress in Whole Genome Sequencing, Safeguarding Children: Pediatric Medical Countermeasure Research, and Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings. Other topics covered by the Bioethics Commission’s educational modules include research design, privacy, community engagement, compensation for research-related injury, and vulnerable populations.

The Informed Consent in Gray Matters module provides a brief introduction to the concept of consent capacity; elaborates an ethical justification for responsibly including individuals with impaired consent capacity in neuroscience research; describes the current regulatory framework regarding human subjects research involving participants with impaired consent capacity; and describes additional ethical safeguards to protect vulnerable populations, including adults with impaired consent capacity.

All of the educational modules produced by the Bioethics Commission are based on the contemporary ethical issues addressed by the Commission, and are designed to provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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.

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Engaging Parents and Children Throughout Pediatric Research: A New Report from the Nuffield Council on Bioethics https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/14/engaging-parents-and-children-throughout-pediatric-research-a-new-report-from-the-nuffield-council-on-bioethics/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/14/engaging-parents-and-children-throughout-pediatric-research-a-new-report-from-the-nuffield-council-on-bioethics/#respond Thu, 14 May 2015 15:11:58 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1627 Today the Nuffield Council on Bioethics (Nuffield Council), an independent bioethics advisory body in the United Kingdom, released Children and Clinical Research: Ethical Issues. The report marks the culmination of a two-year inquiry, during which the Nuffield Council received input from over 500 stakeholders – including the U.S. Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission addressed the ethics of research with children in its March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research. In that report, the Bioethics Commission tackled the particularly complex ethical dimensions of conducting clinical trials of medical countermeasures (MCMs) – that is, clinical products and interventions used in response to chemical, biological, radiological, and nuclear terror attacks – with children. Through six recommendations to guide the ethical conduct of pediatric MCM research, the Bioethics Commission sought to navigate the tension between protecting individual children from undue risk in research and protecting all children, to the extent possible, through the fruits of research.

Throughout its analysis in Safeguarding Children, the Bioethics Commission recognized the critical importance of pediatric research to address children’s health needs. It expressed “an unwavering commitment to safeguard all children from unacceptable risks in research and through research that promotes their health and well-being.” (p. 105) The Nuffield Council echoed this commitment at the very outset of its report, “challeng[ing] the idea that clinical research is something from which children need to be protected and essentially excluded,” and articulating a “belief that children will be best protected from ill health, disease and the impacts of disability through a greater commitment to evidence-based care.” (p. vii)

The Bioethics Commission and Nuffield Council also fundamentally agree that pediatric research protections can be strengthened through engagement with trial participants, their families, and other stakeholders. The Bioethics Commission recognized the critical role of community engagement in pediatric MCM research to “build transparent, meaningful, collaborative, and mutually beneficial relationships among those considering or conducting research and the relevant communities.” (p. 79) Several of the Nuffield Council’s recommendations support similar engagement, for example, through the consideration of young persons’ and parents’ views in designing research. As the Nuffield Council’s Director, Hugh Whittall, explained, “by speaking to children and their families, researchers can design studies which are more suited to their needs, and ultimately more acceptable.”

In Safeguarding Children, the Bioethics Commission called for an ongoing conversation about the ethical conduct of pediatric research. Today the Nuffield Council has added its valuable voice to the discussion.

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Bioethics Commission recommends establishing clear requirements for identifying legally authorized representatives for research participation https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/13/bioethics-commission-recommends-establishing-clear-requirements-for-identifying-legally-authorized-representatives-for-research-participation/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/13/bioethics-commission-recommends-establishing-clear-requirements-for-identifying-legally-authorized-representatives-for-research-participation/#respond Wed, 13 May 2015 15:42:30 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1625 On March 26 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second volume of its two-volume report on neuroscience and ethics, Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). In Gray Matters, Vol. 2, the Bioethics Commission recognized the challenging tension between the need for rigorous research on debilitating neurological diseases and psychiatric conditions, and the need to protect research participants who might be vulnerable because of impaired consent capacity.

Neuroscience research offers promise to find ways to prevent, treat, and cure neurological disorders, psychiatric conditions, and brain and nervous system injuries that inflict great individual and societal burden. Clinical research involving affected individuals is necessary to achieve this worthy goal. However, some potential research participants might have impaired capacity to provide fully informed consent before enrolling in research—an important ethical tenet in the protection of research participants. The Common Rule (the federal policy that governs research supported by 18 federal departments and agencies) requires permission from a legally authorized representative (LAR) if research participants cannot provide their voluntary informed consent. However, federal regulations and state laws lack clarity about who can legally serve as an LAR when a prospective research participant lacks consent capacity. This uncertainty can stall important research.

In Gray Matters, Vol. 2 the Bioethics Commission makes four recommendations regarding research involving human participants whose consent capacity might be absent, impaired, fluctuating, or in question. In its ninth recommendation, the Bioethics Commission called for the establishment of clear requirements for identifying LARs for research participation. The Commission recommended that:

State legislatures and 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.

Current laws for designating an LAR to facilitate decisions about medical care vary by state. For example, they differ in describing how LARs should make decisions on behalf of patients in the clinical context and who can serve as an LAR. Very few of these state laws address decisions about enrollment in research.

Within the current legal and regulatory framework, uncertainty and lack of clarity remain regarding ethically acceptable research involving participants with potentially impaired consent capacity. Using an LAR is one important way to facilitate inclusion of participants with impaired consent capacity in research, ensuring the just distribution of the benefits that might accrue to those affected by the disorder under study. Using an LAR also can help protect participants from exploitation, because loved ones or caregivers who have been designated as LARs are often the best proxy for representing participant interests. Federal regulatory bodies could endorse an existing list of who can serve as an LAR—for example, the Secretary’s Advisory Committee on Human Research Protections’ (SACHRP) recommended list—and explicitly permit researchers and institutional review boards to rely on that list. Alternatively, state legislatures that have not already done so could draft their own priority lists for LARs for research, eliminating the need to rely on lists included in laws pertaining to medical treatment. The Bioethics Commission acknowledged that clarity in identifying LARs will promote the ethical conduct of vital research by helping researchers and IRBs remain accountable to a clear set of ethical and legal standards for enrolling participants with impaired consent capacity in research.

Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at Bioethics.gov.

 

 

 

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Bioethics Commission Recommends Engaging Stakeholders to Address Stigma Associated with Impaired Consent Capacity https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/05/bioethics-commission-recommends-engaging-stakeholders-to-address-stigma-associated-with-impaired-consent-capacity/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/05/bioethics-commission-recommends-engaging-stakeholders-to-address-stigma-associated-with-impaired-consent-capacity/#respond Tue, 05 May 2015 17:06:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1620 In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2), the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) explored capacity and the consent process as one of three topics that illustrate some of the ethical and societal tensions that surround rapidly advancing neuroscience research and its applications. When considering and addressing ethical concerns about consent capacity, it is crucial to avoid policies and practices that perpetuate or exacerbate stigma. Equating certain conditions with impaired consent capacity or making unfounded assumptions about individual abilities based on diagnoses can subject individuals to stigmatizing or discriminatory practices, undermining the respect due to those individuals. The Bioethics Commission recognized that one important approach to help neuroscience researchers alleviate stigma is stakeholder engagement, and recommended engaging stakeholders to address stigma associated with impaired consent capacity:

Funders and researchers should engage stakeholders, including members of affected communities, to build understanding of consent capacity and associated diagnoses to mitigate the potential for stigma and discrimination.

Stakeholder engagement can inform research design, including by identifying what to study, improving informed consent processes, and assessing how results might be received and analyzed. It is also an important mechanism to mitigate potential social harms associated with research participation and to cultivate trust among researchers and affected populations. Stakeholder engagement processes are particularly important for research that involves underrepresented and potentially stigmatized groups. Seeking the perspectives of those with, or at risk for, disorders or conditions associated with impaired consent capacity, caregivers, researchers, and community members affected by research can help alleviate stigma and discrimination by providing information about the lived experience of those affected by particular disorders or conditions, and dispelling common assumptions about those disorders or conditions.

Ethical research involving participants with potentially impaired consent capacity requires that investigators acknowledge and learn from the diversity of individual needs and abilities. Stakeholder engagement provides an additional layer of protection for participants, and also can help researchers identify and develop questions and practices tailored to specific affected communities or categories of impairment. Engaging various stakeholder communities enables neuroscience researchers to uphold ethical standards and advance best practices, remain accountable to the communities with which they work, and foster thoughtful and important discussion about the potential for stigma and discrimination.

Gray Matters, Vol. 2 and all other Bioethics Commission reports are available at www.bioethics.gov.

 

 

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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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New Education Materials on Compensation for Research-Related Injury https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/23/new-education-materials-on-compensation-for-research-related-injury/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/23/new-education-materials-on-compensation-for-research-related-injury/#respond Tue, 23 Sep 2014 15:04:34 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1420 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on compensation for research-related injury. The materials on compensation increase the breadth of topics the Bioethics Commission’s educational resources cover; previous topics include community engagement, informed consent, and vulnerable populations. The new series includes a background module and two modules specific to Bioethics Commission reports: Moral Science: Protecting Participants in Human Subjects Research and Safeguarding Children: Pediatric Medical Countermeasure Research.

The “Compensation Background” module describes the goals of compensating individuals for research-related injury; provides ethical justification for compensation; discusses practical considerations, including informed consent and cost and feasibility; presents past U.S. historical context and advisory committee recommendations on compensation; and identifies current U.S. and international approaches to compensation. The module presents various models of compensation including insurance, personal insurance, specialty courts, and compensation funds.

The “Compensation in Moral Science: Protecting Participants in Human Subjects Research” module presents the Bioethics Commission’s examination of treatment and compensation for research-related injury. The module explains the ethical principles that support, and addresses challenges associated with, providing treatment or compensation for research-related injuries. The module describes international requirements and guidance concerning treatment or compensation for research-related injury; leads instructors through different models for compensating participants for research-related injuries and some of the strengths and weaknesses of each; and addresses the difference between compensation for research-related injury and reparations for past unethical research.

The “Compensation in Safeguarding Children: Pediatric Medical Countermeasure Research” module focuses on compensation for research-related injury in the context of pediatric medical countermeasure (MCM) research. The module outlines the ethical principles that support providing treatment or compensation for research-related injuries that arise from pediatric MCM research; describes the different arguments for treating or compensating injured adults and injured pediatric research participants; and addresses the various ways injured pediatric MCM research participants can seek treatment or compensation and the strengths and limitations of these approaches.

All of the learning modules are based on ethical questions addressed by the Bioethics Commission and provide instructors with foundational information, ethical analysis, discussion questions, problem-based learning scenarios, exercises, and additional resources to support ethics education and the integration of bioethical analysis into coursework across disciplines.

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.

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New Educational Modules on Vulnerable Populations https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/05/new-educational-modules-on-vulnerable-populations/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/09/05/new-educational-modules-on-vulnerable-populations/#respond Fri, 05 Sep 2014 16:00:35 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1405 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted a new series of educational modules on vulnerable populations on its website, Bioethics.gov. These include a background module on vulnerable populations, as well as report-specific modules on vulnerable populations in two Bioethics Commission Reports: Safeguarding Children: Pediatric Medical Countermeasure Research and “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948.

The “Vulnerable Populations Background” module describes vulnerability and how the term “vulnerable populations” is traditionally defined; provides historical examples of research that exploited vulnerable populations; explores ethical principles applicable to research with vulnerable populations; and identifies various codes of conduct, guidelines, and regulations that shaped human subjects research protections generally, and protections for research with vulnerable populations specifically. To illustrate the history of human subjects research and the emergence of special protections for vulnerable populations, the module also includes a timeline of notable research and related events.

The “Vulnerable Populations in Safeguarding Children: Pediatric Medical Countermeasure Research” module focuses on children as a vulnerable population generally, and on pediatric medical countermeasure (MCM) research specifically. This module provides instructors with an explanation of the ways that children are vulnerable; current regulations for protecting children in pediatric research, including the Bioethics Commission’s ethical framework to guide national-level review of pediatric MCM research when appropriate; as well as scientific, practical, and ethical challenges of conducting MCM research with children.

The third module highlights the Bioethics Commission’s analysis on vulnerable populations in “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948.” The experiments in Guatemala involved the intentional exposure of vulnerable populations—prisoners, soldiers, psychiatric patients, and commercial sex workers—to sexually transmitted diseases without their consent. For guided readings and discussion questions about vulnerable populations in the U.S. Public Health Service STD research studies in Guatemala, the module refers instructors to A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.

All of the vulnerable populations modules are based on the contemporary issues addressed by the Bioethics Commission and aim to provide instructors with foundational information, ethical reasoning, applications, questions, discussion points, and additional readings to support ethics education and integrate bioethical analysis into existing curricula across disciplines.

Future modules on vulnerable populations will integrate other reports from the Bioethics Commission.

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.

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New Educational Module on Informed Consent in Safeguarding Children https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/07/29/new-educational-module-on-informed-consent-in-safeguarding-children/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/07/29/new-educational-module-on-informed-consent-in-safeguarding-children/#respond Tue, 29 Jul 2014 15:37:27 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1362 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the context of pediatric medical countermeasure research. The module integrates material from the Bioethics Commission’s March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research.

The aim of this module is to help teachers and students understand the components of the consent process in the specific context of pediatric medical countermeasure (MCM) research, which investigates interventions to be used for children in the event of a bioterrorism attack. Pediatric MCM research raises complex ethical and regulatory issues. Children cannot ethically or legally give informed consent to participate in research, because their autonomy forms over time and is not fully developed until adulthood. In addition, pediatric MCM research that would take place before a bioterrorism attack occurs (pre-event) is ethically distinct from pediatric MCM research that would take place after an attack (post-event), due to differing risks and potential direct benefits for participants.

The moral and legal equivalent of informed consent in pediatric research involves two components: informed parental permission, and meaningful and developmentally appropriate child assent. In Safeguarding Children the Bioethics Commission’s recommendations emphasize the importance of informed parental permission and meaningful child assent in all pediatric MCM research.

Through discussion questions, scenarios, and exercises this module encourages students to consider the ethical complexities of informed consent in more depth, and offers a timely example and application of the process. The module highlights important differences between pre-event and post-event pediatric MCM research. For example, parents considering enrolling their child in pre-event research need to be well-informed about the lack of any potential direct benefit to their child; and in post-event research, the process of obtaining parental permission might be complicated if parents and children are in different locations.

This module is the latest addition to the Bioethics Commission’s series of modules on informed consent, which includes background material and modules discussing informed consent in the diverse contexts of historical U.S. Public Health Service STD research in Guatemala, whole genome sequencing, and incidental and secondary findings. By introducing students to the ethical nuances of informed consent in pediatric MCM research, this latest module adds a new dimension to the considerable resources the Bioethics Commission has developed on this important topic.

In addition, this module is the first the Bioethics Commission has developed based on its report Safeguarding Children. Future modules from this report, to be released soon, will cover topics including vulnerable populations and compensation for research-related injury.

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

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