Cristina Nigro – 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 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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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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New Education Materials from the Bioethics Commission on Research Design Now Available https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/12/new-education-materials-from-the-bioethics-commission-on-research-design-now-available/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/05/12/new-education-materials-from-the-bioethics-commission-on-research-design-now-available/#respond Tue, 12 May 2015 16:40:40 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1623 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on research design. The materials on research design increase the breadth of topics covered by the Bioethics Commission’s educational resources. Previous topics include privacy, community engagement, compensation for research-related injury, informed consent, and vulnerable populations. The new series includes both a background module, and a module to accompany the Bioethics Commission’s Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1).

The Research Design Background module provides a brief introduction to research design; relates research design to guiding ethical principles; describes practical and ethical considerations in research design generally; identifies design components and ethical considerations in randomized controlled trails for biomedical research with human participants specifically; and explains the relevant regulatory requirements and guidelines that promote ethical research design.

The Research Design in Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society module emphasizes the importance of integrating ethics early and explicitly throughout the research endeavor, including in the determination of research design; explains how foundational domains of ethical conduct support ethical research design; and provides examples of approaches to ethics integration in neuroscience research design.

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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Bioethics Commission recommends the responsible inclusion of participants with impaired consent capacity in neuroscience research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/22/bioethics-commission-recommends-the-responsible-inclusion-of-participants-with-impaired-consent-capacity-in-neuroscience-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2015/04/22/bioethics-commission-recommends-the-responsible-inclusion-of-participants-with-impaired-consent-capacity-in-neuroscience-research/#respond Wed, 22 Apr 2015 15:02:17 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1613 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.

To make discoveries about the brain and related neurological disorders that will benefit society, neuroscientists need to conduct research. Well-established ethical guidelines generally require that participants give their fully informed consent before enrolling in research. This might not be possible, however, if an individual cannot give consent because of an impaired capacity to do so. In such cases, U.S. regulations allow a legally authorized representative (LAR) to give permission for participation.

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 sixth recommendation, the Bioethics Commission called for the responsible inclusion of participants with impaired consent capacity. Specifically the Commission recommended that:

Researchers should responsibly include individuals with impaired consent capacity who stand to benefit from neuroscience research. Participation, with ethical safeguards in place, can ensure progress aimed at understanding and ameliorating neurological disorders and psychiatric conditions.

The Bioethics Commission acknowledged the need for additional safeguards to ensure that participants with impaired consent capacity are adequately protected. Numerous national panels over the last four decades have attempted to establish uniform guidelines and safeguards to ensure ethical research with adults who have impaired consent capacity. Despite these efforts no federal regulations specifically address research with this population.

Protections might include robust initial and ongoing assessment of consent capacity; methods to improve informed consent processes to accommodate participants’ needs, for example, including audiovisual means and paced verbal instructions; methods to respect participant assent and dissent when consent capacity is partial or in question; and clear parameters and procedures for obtaining the permission of an LAR when a participant lacks consent capacity. In addition, use of research advance directives (a set of written instructions articulated by an individual to appoint a proxy and direct their involvement in future research) and stakeholder engagement can provide protection.

Neuroscience research is a principal means of promoting progress and benefiting populations affected by neurological disorders and psychiatric conditions, including those associated with impaired consent capacity. Substantial progress in understanding many of these disorders has been possible because of the advances in research, yet more needs to be done. The Bioethics Commission’s recommendations are intended to promote vital neuroscience research while protecting those with impaired consent capacity.

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

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New Education Materials from the Bioethics Commission on Privacy Now Available https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/12/02/new-education-materials-from-the-bioethics-commission-on-privacy-now-available/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/12/02/new-education-materials-from-the-bioethics-commission-on-privacy-now-available/#respond Tue, 02 Dec 2014 16:51:32 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1500 The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has posted to Bioethics.gov a new series of educational modules on privacy. The materials on privacy increase the breadth of topics covered by the Bioethics Commission’s educational resources; previous topics include community engagement, compensation for research-related injury, informed consent, and vulnerable populations. The new series includes a background module and one module to accompany the Bioethics Commission report Privacy and Progress in Whole Genome Sequencing.

The “Privacy Background” module describes a brief history of privacy; provides definitions of privacy and related concepts; relates privacy to the Bioethics Commission’s guiding ethical principles; identifies how U.S. case law, U.S. statutory protection, and the European approach have contributed to legal notions of privacy; explains privacy concerns and protections for health information; and addresses challenges to the de-identification of health-related data.

The “Privacy in Privacy and Progress in Whole Genome Sequencing” module describes the technique of whole genome sequencing and presents the privacy concerns related to whole genome sequencing. It identifies the ethical principles involved in reconciling individuals’ privacy and scientific progress in whole genome sequencing and explains the legal and policy considerations associated with protecting the privacy of individuals who contribute whole genome sequencing data and information to support scientific research.

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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Bioethics Commission Addresses Approaches to Ethics Integration in Neuroscience Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/28/bioethics-commission-addresses-approaches-to-ethics-integration-in-neuroscience-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/28/bioethics-commission-addresses-approaches-to-ethics-integration-in-neuroscience-research/#respond Wed, 28 May 2014 14:19:51 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1307 On May 14 the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society (Gray Matters, Vol. 1). This report on neuroscience and related ethical issues emphasizes the importance of integrating ethics into neuroscience research across the life of a research endeavor. Ethics integration is a process by which scientists and ethicists engage with each other, and often other stakeholders, to understand the social and ethical dimensions of their work, including the relationship between science and the societal context in which it operates.

Gray Matters, Vol. 1 contains four recommendations for integrating ethics into neuroscience research. In its second recommendation, the Bioethics Commission called for evaluating existing and innovative approaches to ethics integration. Specifically the Commission recommended that:

Government agencies and other research funders should initiate and support research that evaluates existing as well as innovative approaches to ethics integration. Institutions and individuals engaged in neuroscience research should take into account the best available evidence for what works when implementing, modifying, or improving systems for ethics integration.

The Bioethics Commission emphasized that institutions and individuals engaged in neuroscience research should learn from collective experience to improve existing systems and inform others about what works and what does not. In addition, they should evaluate innovative approaches to prevent reliance on approaches that are familiar, but potentially outdated, inefficient, or counterproductive. Funders, institutions, and researchers should look to best practices while evaluating existing and new approaches to integration in order to inform innovation, foster improvement, and measure success. Researchers should share widely their findings and conclusions to support more robust and informed ethics integration.

In Gray Matters, Vol. 1, the Bioethics Commission highlighted several implementation strategies for ethics integration into scientific research. One such strategy is ethics integration through research ethics consultation. An example consultation service is the Benchside Ethics Consultation Service (BECS) at Stanford University, which makes ethics advice available through all stages of research to bench scientists, clinical researchers, biotechnology and pharmaceutical companies, institutional review boards, journal editors, and research participants. Evaluating the impact of research ethics consultation services, assessing the quality of their recommendations, and providing best practices for creating and maintaining these services are crucial to their success and the success of future integration efforts. Dr. Mildred Cho described to the Bioethics Commission that evaluation is a priority for the BECS:

“[An] important aspect of this [integration] for us has been trying to think about what it means to have a successful program in research ethics consultation and what is a successful consultation service, which obviously requires definition of what the goals are….You have to really think about what the goals are. Is it engagement in and of itself or are there other products that you would like to see that come out of that?”

She explained that researchers are examining factors such as “whether uptake of the service has increased [and] whether the stage of utilization…has increased.” Other measures of success might include “products such as publications, modifications to research projects, [and] policy changes” as well as “researcher satisfaction and attitudes.”

Executed well, ethics integration is an iterative and reflective process that enhances both scientific and ethical rigor. It assists neuroscientists in recognizing fundamental ethical and social dimensions of the complex phenomena they seek to understand. The Bioethics Commission’s recommendations are intended to strengthen ethics integration infrastructure for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative and neuroscience more broadly, ensuring that this important science will advance the public good.

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Bioethics Commission staff discuss the multidisciplinary implementation of Commission education modules at APPE https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/04/bioethics-commission-staff-discuss-the-multidisciplinary-implementation-of-commission-education-modules-at-appe/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/03/04/bioethics-commission-staff-discuss-the-multidisciplinary-implementation-of-commission-education-modules-at-appe/#respond Tue, 04 Mar 2014 18:18:10 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1186 Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) staff members Misti Ault Anderson, M.S., M.A., Karen Meagher, Ph.D., and Nicolle Strand, J.D., M. Bioethics, have just returned from Jacksonville, Florida after a successful presentation at the Twenty-third Annual International Conference of the Association for Practical and Professional Ethics (APPE). As part of the panel “Multidisciplinary Implementation of Bioethics Commission Education Modules,” Anderson, Meagher, and Strand demonstrated how two of the Bioethics Commission educational modules on informed consent might be taught in three different educational settings: a philosophy course, a science course, and a law school lunch-and-learn.

The presenters drew from the Informed Consent Background and from the Informed Consent in Privacy and Progress in Whole Genome Sequencing modules, applying the content to each subject matter and educational setting. Informed consent is particularly interesting in genomics given that as the cost of whole genome sequencing rapidly declines, its increased use in research and health care raises significant privacy issues regarding the availability and dissemination of personal genomic information.

Meagher illustrated how the topic-based educational modules can be used to update a syllabus for a course covering philosophical aspects of bioethics. The modules can be mined for recommended reading, used to modify a lecture, or combined to facilitate class discussion.

Anderson continued with examples of how these modules can be used to provide foundational bioethical concepts for biology or genetics students and future researchers. Students can benefit from an explanation of the ethical necessity of informed consent, history of and applicable federal regulations, and challenges in the informed consent process.

Strand rounded out the presentation with a demonstration of how the modules can be used to educate future lawyers who might work either for the government with federal research protection regulations or as legal counsel for universities or private companies conducting human genetic or genomic research. An educator might use the modules to help future lawyers understand the importance of informed consent, specifically in genetic and genomic research and clinical genomics; develop consent materials; analyze the compliance of consent processes with federal regulations; and identify common challenges in implementing informed consent processes.

Bioethics education can be incorporated into courses in many disciplines, at all levels, in traditional and nontraditional settings. The Bioethics Commission’s topic-based modules are designed to be flexible to support multiple approaches to implementation, for example, embedding content and exercises into existing lectures or creating a sequence of in-depth discussions on the topic in a seminar. “Session participants were very engaged and asked about using our materials to train IRBs [institutional review boards], and about how to use our modules to encourage science educators to integrate ethics into their curricula,” Anderson said.

The Bioethics Commission’s pedagogical materials demonstrate ethical analyses and applications of foundational ethical principles to contemporary biomedical and scientific challenges. The educational modules integrate material across applicable Bioethics Commission reports, including Privacy and Progress in Whole Genome Sequencing, “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, and Moral Science: Protecting Participants in Human Subjects Research.

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Bioethics Commission Requests Comment on the Ethical Considerations of Neuroscience Research and the Application of Neuroscience Research Findings https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/05/bioethics-commission-requests-comment-on-the-ethical-considerations-of-neuroscience-research-and-the-application-of-neuroscience-research-findings/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/05/bioethics-commission-requests-comment-on-the-ethical-considerations-of-neuroscience-research-and-the-application-of-neuroscience-research-findings/#respond Wed, 05 Feb 2014 14:36:34 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1123 On January 31, 2014 the Federal Register published a request for public comment on behalf of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission seeks to collect information from a wide range of stakeholders on ethical issues related to neuroscience. The comments collected will help inform the Bioethics Commission’s response to President Obama’s request to “identify proactively a set of core ethical standards—both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”

The Bioethics Commission is a Federal Advisory Committee of the nation’s leaders in medicine, science, ethics, religion, law, and engineering. The Bioethics Commission amasses much of the information for its reports by holding quarterly public meetings, receiving input from subject matter experts, reaching out to stakeholders, and gathering written public comment. By submitting written comment, the public has the opportunity to provide input that could inform the Bioethics Commission’s reports and the recommendations it makes to the Administration.

To address the President’s most recent charge, the Bioethics Commission is now particularly interested in receiving public commentary regarding:

• the diversity and scope of ethical considerations related to neuroscience as a field;
• core ethical standards that guide neuroscience research, including consistency (or lack thereof) across disciplines, and potential tension among the guiding standards;
• advances in neuroscience research that raise novel ethical issues or heighten existing ethical tensions;
• whether emphasis on particular aspects of the Common Rule (or other research ethics regulations) is needed given the particular implications of some neuroscience research or whether any part of the Common Rule needs clarification in order to adequately protect participants in neuroscience research specifically;
• potential implications of discoveries that might flow from studies of the brain and questions that might arise from neuroscience research findings and their applications, including questions about the potential implications for privacy, personal agency, and moral responsibility for one’s actions; stigmatization and discrimination; and the appropriate use of neuroscience in the justice system;
• strategies for integrating ethical considerations into neuroscience research, technological development, and scientific research from a project’s inception; and
• ethical considerations concerning communication about neuroscience research and neuroscience research applications by scientists, journalists, and others.

Individuals, groups, and organizations interested in commenting on the ethical considerations of neuroscience research and the application of neuroscience research findings can submit comments by e-mail to info@bioethics.gov or by mail to the following address:

Public Commentary
Presidential Commission for the Study of Bioethical Issues
1425 New York Ave., NW
Suite C–100
Washington, DC 20005

Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted.

To ensure consideration, comments must be received by April 1, 2014. Comments received after this date will be considered only as time permits.

The Bioethics Commission looks forward to receiving your comments.

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Promoting “Privacy and Progress” at APHA https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/04/promoting-privacy-and-progress-at-apha/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/11/04/promoting-privacy-and-progress-at-apha/#respond Mon, 04 Nov 2013 16:09:19 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1022 After returning from the American Society for Bioethics and Humanities (ASBH) annual meeting in Atlanta last week, Kayte Spector-Bagdady, Associate Director at the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), is gearing up for another presentation at the American Public Health Association (APHA) meeting in Boston this week. As part of the panel “Ethics of Privacy and Health Data,” Spector-Bagdady will present on Tuesday, November 5th on a panel starting at 10:30 a.m. Her talk, “Enabling Privacy and Progress: Protecting Individual Participants in Big Data,” will focus on the ethical considerations of storing and sharing large amounts of genomic data in biobanks.

Released in October 2012, the Bioethics Commission report Privacy and Progress in Whole Genome Sequencing addresses the pressing privacy and data access issues raised by the advancement of low-cost whole genome sequencing. Scientists rely on human genome sequencing data to explore potential treatments for genetic diseases; however, individuals are less likely to consent to their genetic data being used for research without assurance that their interests in privacy are respected and secured.

“The goal of all of the Bioethics Commission’s reports is to encourage further deliberation and application of the ethical paradigms discussed. Talking about how Privacy and Progress can be applied specifically to the ‘big data’ context helps encourage this conversation,” Spector-Bagdady said.  In its report, the Bioethics Commission specifically urged federal and state governments to develop a process for ensuring a consistent floor of protections covering whole genome sequence data regardless of how they were obtained. It recommended these policies protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual.

The Bioethics Commission also recently released pedagogical materials to promote bioethics scholarship in educational and professional settings. Two of these modules use issues in whole genome sequencing to demonstrate the importance of informed consent and community engagement when human subject data is involved.

Find out more at APHA tomorrow!

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