Victoria Wilbur – 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 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 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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Studying the Study Guide: Key Uptake of Educación Ética https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/27/studying-the-study-guide-key-uptake-of-educacion-etica/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/05/27/studying-the-study-guide-key-uptake-of-educacion-etica/#respond Tue, 27 May 2014 14:49:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1302 Since first recommending ethics education across disciplines in New Directions: The Ethics of Synthetic Biology and Emerging Technologies, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has been committed to the production, dissemination, and encouraging the use of ethics educational resources. Accordingly, the Bioethics Commission is eager to learn of examples of how its educational tools are being used and how they might be improved. At a recent workshop held at the Pan American Health Organization (PAHO), the Bioethics Commission was excited to learn that Carla Saenz, Ph.D., Bioethics Regional Advisor at PAHO, recently distributed the Spanish translation of the Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, Educación Ética: La Guía de Estudio para “Éticamente Imposible” Investigación sobre ETS en Guatemala de 1946 a 1948 to the Investigación ÉTICA network. Upon receipt of the Study Guide, the Investigación ÉTICA network – which comprises over 1,100 ethics review committees and research ethicists in Latin America and the Caribbean – sent Saenz “very appreciative responses for sharing such a training tool.”

“I was particularly interested in the translation of the Study Guide and its further dissemination because I think it meets a specific regional need,” said Saenz. Addressing the challenges in bioethics training in the Latin American region is a topic recently explored by Saenz and several co-authors in a paper published in the Journal of Empirical Research on Human Research Ethics.[1] Saenz et al., concluded that resources for ethics education should be created for all levels and incorporate critical thinking exercises and case studies. Additionally, they argued that making resources available in Spanish is the key to strengthening the analytical skills of individuals working in research ethics in Latin America. Bioethics materials in Spanish are “really crucial to close the gap on bioethics training between Latin America and the English speaking world,” said Saenz.

The Bioethics Commission designed the Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 to assist those who wish to focus on the ethical significance of these experiments. Each section of the Study Guide includes a review of relevant facts, excerpts from documents contemporaneous to the experiments, and a set of further readings. This material will assist readers who wish to explore the record in further detail or prepare for a more informed discussion of research in light of this example of gross ethical violations.

“The Bioethics Commission is very pleased to learn that the Spanish Study Guide is being distributed and used by such a large Spanish speaking network of researchers and ethicists. All feedback on the tools is extremely valuable, and we’re grateful to Dr. Saenz both for sharing the resource with her colleagues and for sharing the story with us,” said Hillary Wicai Viers, Bioethics Commission Communications Director.

Please share your stories about using the Bioethics Commission’s educational tools via education@bioethics.gov.

All of the Bioethics Commission’s education materials are free and available on www.Bioethics.gov.

 

[1] Saenz, C., et al. (2014). Twelve years of Fogarty-funded bioethics training in Latin America and the Caribbean: Achievements and Challenges. Journal of Empirical Research on Human Research Ethics, 9(2), 80-91.

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Bioethics Commission Executive Director to Receive Pellegrino Medal https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/04/bioethics-commission-executive-director-to-receive-pellegrino-medal/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/04/04/bioethics-commission-executive-director-to-receive-pellegrino-medal/#respond Fri, 04 Apr 2014 14:21:40 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1217 Lisa M. Lee, Ph.D., M.S., Executive Director of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), will receive the Pellegrino Medal for her contributions to health care ethics. The award will be presented April 11 during the 2014 Conference of Samford University’s Healthcare Ethics and Law (HEAL) Institute in Birmingham, Ala.

Established in 2001 by the HEAL Institute, the Pellegrino Medal honors individuals recognized as “leaders for contributions to healthcare ethics in the selfless spirit of Edmund D. Pellegrino.” The medal’s namesake, Edmund Pellegrino, was the first recipient of a lifetime achievement award from the American Society for Bioethics and Humanities and has been called the “father of the American bioethics movement.” Other notable recipients of the medal include Tom L. Beauchamp, James F. Childress, and Bioethics Commission Member Daniel P. Sulmasy.

“This field calls us and I am honored to be in the company of these bioethics pioneers,” Lee commented upon learning of the award.

“Lisa truly honors Ed Pellegrino’s spirit of expert and selfless devotion to bioethics,” said Amy Gutmann, Ph.D., Chair of the Bioethics Commission.

The author of numerous publications in both science and ethics, Lee has taught graduate-level courses in public health ethics, serves on the editorial board of two health journals, and is the lead editor of Principles and Practice of Public Health Surveillance, 3rd edition (Oxford University Press, 2010). Lee’s current interests include bioethics pedagogy and public health ethics. Before coming to the Bioethics Commission, Lee worked at the Centers for Disease Control and Prevention (CDC) where she led several agency and cross-agency committees working to establish and maintain an environment of scientific integrity and excellence.

Lee earned a Ph.D. in epidemiology from Johns Hopkins University and an M.S. in bioethics from the Alden March Bioethics Institute at Albany Medical College.

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Anticipating and Communicating Through Education https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/25/education-blog-anticipating-and-communicating-through-education/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/25/education-blog-anticipating-and-communicating-through-education/#respond Tue, 25 Feb 2014 17:34:29 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1175 Since its inception, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has repeatedly recommended that ethics education be widely available at the undergraduate, graduate, and professional levels. In Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Bioethics Commission made the broad recommendation that public and private entities create educational materials for all stakeholders describing the ethical, practical, and legal questions raised by incidental and secondary findings.

The Bioethics Commission highlighted entities in each context it believed to be well-placed to provide additional education materials. In the clinical context, private organizations such as the American Association of Medical Colleges and the Accreditation Council for Graduate Medical Education could provide materials to guide clinicians on managing incidental and secondary findings. In the research context, the Public Responsibility in Medicine and Research’s (PRIM&R) institutional review board (IRB) education and certification programs could provide training to IRB members on these ethically challenging topics. In the direct-to-consumer (DTC) context, governmental agencies, like the U.S. Federal Trade Commission and the Food and Drug Administration, should continue to provide guidance on their websites about the types of findings DTC services could reveal.

The Bioethics Commission is also well-placed to provide ethics education guidance. Beyond the recommendations set forth in its reports, the Bioethics Commission continues to reinforce its commitment to ethics education itself. Through online modules, context-specific study guides, and source data, the Bioethics Commission strives to supplement existing curricula in traditional and non-traditional settings, including the classroom, workplace, or IRB training sessions. The staff continues to develop additional educational content.

Additionally, the Hastings Center and the Bioethics Commission are co-sponsoring an issue of the Hastings Center Report to address current themes in bioethics education, including the state of bioethical education, methods for bioethics instruction, and more. For more information on the submission requirements please visit this website.

For more information on all of the Bioethics Commission’s educational efforts, please watch the video Promoting and Providing Materials for Bioethics Education. The Bioethics Commission also held a webinar on September 19, 2013 to introduce and review the pedagogical materials.  The webinar, Advancing Bioethics Education, can be viewed here.

All Bioethics Commission pedagogical materials are available at no cost at www.bioethics.gov.

The Bioethics Commission encourages feedback on the materials at education@bioethics.gov.

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Educación Ética: La Guía de Estudio para “Éticamente Imposible” Investigación sobre ETS en Guatemala de 1946 a 1948. https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/21/educacion-etica-la-guia-de-estudio-para-eticamente-imposible-investigacion-sobre-ets-en-guatemala-de-1946-a-1948/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/21/educacion-etica-la-guia-de-estudio-para-eticamente-imposible-investigacion-sobre-ets-en-guatemala-de-1946-a-1948/#respond Fri, 21 Feb 2014 21:14:55 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1166 La Comisión Presidencial para el Estudio de Cuestiones Bioéticas se complace a publicar la traducción en español de la Guía de Estudio para “Éticamente Imposible” Investigación sobre ETS en Guatemala de 1946 a 1948.

En lo que actualmente se reconoce como un infame episodio en la historia de la ética de investigación, el Servicio de Salud Pública de EE.UU. (PHS, por sus siglas en inglés) llevó a cabo experimentos sobre enfermedades de transmisión sexual (ETS) en Guatemala de 1946 a 1948. Los experimentos sobre ETS en Guatemala se llevaron a cabo bajo supervisión continua del PHS y con la aprobación y participación de funcionarios del gobierno de Guatemala. Involucraron, exponiendo intencionalmente e infectando, a varias poblaciones guatemaltecas vulnerables, incluidos encarcelados, soldados y pacientes psiquiátricos, como sujetos de investigación a enfermedades, sin su consentimiento.

Después de que una publicación académica reveló la existencia de registros de estos experimentos en el 2010, la Comisión Presidencial para el Estudio de Cuestiones Bioéticas (la Comisión) realizó una investigación detallada de los eventos que rodearon e incluyeron los experimentos. Su informe, “Éticamente Imposible”: Investigación sobre ETS en Guatemala de 1946 a 1948, ofrece una descripción detallada y una evaluación ética de estos estudios.

La Comisión diseñó esta Guía de Estudio para “Éticamente Imposible” Investigación sobre ETS en Guatemala de 1946 a 1948para ayudar a los que deseen concentrarse en la importancia ética de estos experimentos. Cada sección de la Guía incluye una recitación de datos relevantes, extractos de documentos contemporáneos a los experimentos y un conjunto de lecturas adicionales. Este material será de ayuda para los lectores que deseen explorar el expediente con mayor detalle o prepararse para una discusión más detallada de la investigación a la luz de esta grave violación a la ética.

Todos los materiales de educación de la Comisión son libre y disponible en Bioethics.gov.

Ethics Education: A Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is pleased to publish a Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 in Spanish.

In what is now recognized as an infamous episode in the history of research ethics, the U.S. Public Health Service (PHS) conducted sexually transmitted disease (STD) experiments in Guatemala from 1946 through 1948. The Guatemala STD experiments were carried out with ongoing oversight by PHS and with the approval and engagement of Guatemalan government officials. They involved intentionally exposing and infecting several vulnerable Guatemalan research subject populations—prisoners, soldiers, and psychiatric patients—to disease, without their consent.

After a scholarly publication disclosed the existence of records of these experiments in 2010, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) conducted a detailed investigation of the events surrounding and including the experiments. Its report, “Ethically Impossible” STD Research in Guatemala from 1946 to 1948, provides a detailed description and ethical evaluation of these studies.

The Bioethics Commission designed this Study Guide to “Ethically Impossible” STD Research in Guatemala from 1946 to 1948 to assist those who wish to focus on the ethical significance of these experiments. Each section of the Guide includes a recitation of relevant facts, excerpts from documents contemporaneous to the experiments, and a set of further readings. This material will assist readers who wish to explore the record in further detail or prepare for a more informed discussion of research in light of this gross violation of ethics.

All of the Bioethics Commission’s education materials are free and available on Bioethics.gov.

 

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Ethics in Context: Anticipating and Communicating Incidental and Secondary Findings in the Direct-to-Consumer Context https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/04/ethics-in-context-anticipating-and-communicating-incidental-and-secondary-findings-in-the-direct-to-consumer-context/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2014/02/04/ethics-in-context-anticipating-and-communicating-incidental-and-secondary-findings-in-the-direct-to-consumer-context/#respond Tue, 04 Feb 2014 16:20:20 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=1115 In Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) explored the ethical issues surrounding incidental and secondary findings arising in a variety of settings, including the direct-to-consumer (DTC) context. A growing number of DTC companies offer consumers a variety of services outside of the traditional clinical or research environment, including genetic testing, whole body scans, computed tomography (CT) colonography, non-medical fetal ultrasounds, and cholesterol tests. Some of these tests, like whole body wellness scans, aim to find any and all anomalies and therefore, by design, do not give rise to incidental or secondary findings. Other DTC tests—such as computed tomography (CT) colonography—can potentially give rise to incidental and secondary findings.

The Bioethics Commission’s recommendations in the DTC context are particularly timely because the DTC market is relatively new and growing, the technologies used are still evolving, and the topic is rather underexplored in the literature.  Because DTC service providers straddle both the business and medical realms, the Bioethics Commission interpreted the ethical principles—respect for persons, beneficence, justice and fairness, and intellectual freedom and responsibility—in light of “private industry’s role in providing health information, as well as the economic nature of the relationships between providers of DTC testing and consumers.”

The Bioethics Commission recommended that DTC companies:

  • Communicate and provide consumers with enough information about their services to allow consumers to make informed decisions regarding their purchase of DTC testing. DTC companies must inform consumers of the testing procedures, communicate which findings will be returned, and disclose any results that will not be returned according to the user agreement.
  • Help in the creation of industry-wide best practices pertaining to the management of incidental and secondary findings. These practice guidelines should include when and how findings should be disclosed to the consumer, as well as standards for referrals to clinicians who could aid in the management of the findings. The Bioethics Commission believed that through a collaborative effort among DTC companies and professional organizations, industry-wide best practices could become standard expectations for consumers thereby giving other companies the incentive to adopt such practices.

The Bioethics Commission further recommended that:

  • Federal agencies continue to evaluate regulatory oversight of DTC health services to ensure safety and reliability and that state governments adopt regulations that ensure a consistent floor of protections for consumers who purchase DTC testing. Policy makers should examine existing regulations governing DTC testing services to identify potential gaps and barriers that affect the safety and reliability of DTC testing. Policy makers should also consider adopting regulations governing the disclosure of incidental and secondary findings.

In Anticipate and Communicate, the Bioethics Commission concludes that consumers, the government, DTC professionals, and society “all share responsibility for ensuring that incidental and secondary findings are responded to in an ethically appropriate manner” in the DTC context.

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Member Spotlight: Barbara Atkinson https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/15/member-spotlight-barbara-atkinson/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/15/member-spotlight-barbara-atkinson/#respond Thu, 15 Aug 2013 16:21:17 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=802 barbara-atkinson_portraitPresident Obama appointed Barbara Atkinson, M.D., to the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) in April 2010. Atkinson is Executive Vice Chancellor Emeritus at the University of Kansas Medical Center and Professor Emeritus of Pathology and Laboratory Medicine at the University of Kansas School of Medicine. She was elected to membership in the Institute of Medicine of the National Academy of Sciences in 1997.

As a cytopathologist, a physician who studies diseases at the cellular level, Atkinson brings both medical and institutional perspectives to the issues before the Bioethics Commission. However, Atkinson did not always know she wanted to work in bioethics. She was first introduced to this emerging field when she began teaching general ethics to her medical students. In its infancy, bioethics was not formally taught in the classroom, but learned and picked up through practice, Atkinson said. It was through her experience in patient care and research that Atkinson became more and more interested in bioethics. Upon accepting the position Executive Vice Chancellor of the University of Kansas Medical Center, Atkinson became responsible for addressing many ethical issues arising from the research and clinical activities of the school. As her work progressed, Atkinson’s professional interests began to shift to bioethical issues such as health disparities and potential conflicts of interest, and later to end of life care and research issues related to the human genome.

Atkinson is also a proponent of mentorship in her field through programs like the Executive Leadership in Academic Medicine (ELAM) for women. When Atkinson graduated from medical school, only 10% of medical students were women, and even fewer of them were leaders in academic medicine. “As I moved through my career, I made it a point to mentor other women,” Atkinson said.

Atkinson particularly values the opportunity to contribute to national discussions on new, significant issues like pediatric medical countermeasure research, implications of research on the human genome, and neuroscience. “The ethics piece is an integral piece of the whole discussion and to be able to have an impact on those studies is incredibly meaningful,” she said. The Bioethics Commission’s first report, New Directions in Synthetic Biology, remains Atkinson’s favorite report to date because she found the process of putting forth recommendations on cutting edge technology fascinating, and she appreciates that it was widely read by diverse audiences.

Like so many of her peers, Atkinson said that the best part of working with the Bioethics Commission is the company of fellow members and distinguished speakers who come to publicly present at Bioethics Commission meetings. “At meetings, each person is able to offer different perspectives and different views. To be a part of a discussion with them on those issues is what I really enjoy.”

When she is not deliberating challenging bioethical issues, Atkinson enjoys birding. She and her husband have identified 565 species in the United States and Canada.

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Considering Opt In vs. Opt Out Consent Procedures in WGS Research https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/06/considering-opt-in-vs-opt-out-consent-procedures-in-wgs-research/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/12/06/considering-opt-in-vs-opt-out-consent-procedures-in-wgs-research/#respond Thu, 06 Dec 2012 19:55:29 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=475 When it comes to whole genome sequencing research, consent procedures can be complex, especially for the patient. Some patients could be unaware that their whole genome sequence data might be used in future research without additional consent. To highlight the issue, consider this hypothetical example:

After a painful gallbladder attack, 27-year-old Cindy allowed surgeons to remove her gallbladder. Before the surgery, Cindy read and signed the necessary lengthy consent forms. During surgery, doctors took a blood sample and placed it in the hospital’s stored collection of biological samples. Her de-identified DNA is now available to researchers who have access to that collection.

To determine the type of research consent Cindy signed, we need to look at how researchers structured the consent: Was Cindy required to opt in – to affirmatively choose to allow her data to be used for future research purposes? Or was she required to opt out – a default in which her data is used for future research unless she specifically declines to participate?

If researchers used opt in, Cindy would have been required to consent explicitly to future research. In opt in consent the default is to prohibit the researcher’s use of the samples without an individual’s active consent. If instead researchers obtained opt out consent, the default would be that researchers could use Cindy’s samples in future research. In this type of consent, at the time researchers collected the samples, Cindy must have specifically refused to participate in future research, or her samples could be used in this manner.

In some contexts, it might be more advantageous to use a consent process that makes it easier for individuals to participate. For example, organ donation policies in Europe, which uses an opt out consent model, have donation rates over 99 percent, as opposed to a 44 percent donation rate in the United States, which uses an opt in model. Although the Commission recognizes the substantial public benefit of widespread participation in whole genome sequencing research, the Commission firmly believes that the most important issue in respecting persons is not the type of consent obtained, but rather that the consent is properly informed and consistent with voluntary choice.

In Privacy and Progress in Whole Genome Sequencing, the Commission recommends the evaluation and adoption of “robust and workable consent processes that allow research participants, patients, and others to understand who has access to their whole genome sequences.” The Commission believes that as long as an individual is fully informed in the consent process, and as long as the process does not overly influence an individual’s ability to make genuine and voluntary choices, there is no ethical imperative to use opt in or opt out consent.

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