Elizabeth Schaub – 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 See you at APHA in Boston https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/30/see-you-at-apha-in-boston/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/30/see-you-at-apha-in-boston/#respond Wed, 30 Oct 2013 14:32:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=994 The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) will be participating in the 141st Annual Meeting and Exposition of the American Public Health Association in Boston, Mass. We look forward to seeing you at the following sessions:

Panel Session – Enumerating Ethical Considerations of Medical Countermeasure Research with Children (3442.0) at 4:30 p.m., Monday, November 4

Moderated by Bioethics Commission Associate Director Kayte Spector-Bagdady, J.D., M. Bioethics

                          Ethical Considerations for Medical Countermeasure Research with Children
                          Bioethics Commission Executive Director Lisa M. Lee, Ph.D., M.S.

                          Conducting Ethical Pre-event Medical Countermeasure Trials with Children
                          Bioethics Commission Associate Director Michelle Groman, J.D.

                          Conducting Ethical Post-event Medical Countermeasure Trials with Children
                          Commission Member Christine Grady, M.S.N, Ph.D.

Panel Session – Ethics of Privacy and Health Data (4105.0) at 11:10 a.m., Tuesday, November 5

                          Enabling Privacy and Progress: Protecting Individual Participants in Big Data
                          Bioethics Commission Associate Director Kayte Spector-Bagdady, J.D., M. Bioethics

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See you at ASBH in Atlanta https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/23/see-you-at-ashb-in-atlanta/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/23/see-you-at-ashb-in-atlanta/#respond Wed, 23 Oct 2013 21:10:42 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=982 The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) will be participating in the American Society for Bioethics and Humanities (ASBH) 15th Annual Meeting in Atlanta, Ga. We look forward to seeing you at the following sessions:

Plenary Session, Friday, 9:15 a.m.
A Conversation with Amy Gutmann, Chair, Ph.D., Presidential Commission for the Study of Bioethical Issues

Panel Session (324), Saturday, 11:45 a.m.
Post- “Privacy and Progress”: Emerging Legal and Ethical issues in Whole Genome Sequencing with Senior Policy and Research Analyst Elizabeth R. Pike, J.D., LL.M; Associate Director Kayte Spector-Bagdady, J.D., M.Bioethics; and Research Analyst Nicolle K. Strand, J.D., M.Bioethics. Associate Director Michelle Groman will moderate.

Paper Session (345), History/Research Ethics, Saturday, 3:15 p.m.
“Something of an Adventure”: Postwar NIH Research Ethos and the Guatemala STD Experiments with Associate Director Kayte Spector-Bagdady, J.D., M.Bioethics

Panel Session (414), Sunday, 9:45 a.m.
Moral innovation in a Changing World: Ethically Researching Medical Countermeasures with Children with Associate Director Michelle Groman, .J.D.; Professor of Philosophy David DeGrazia, Ph.D., George Washington University; Lead Medical Officer Robert M. Nelson, M.D., Ph.D., Food and Drug Administration. Executive Director Lisa M. Lee will moderate.

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Bioethics Commission Executive Director Featured on Genetic Alliance Webinar https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/18/bioethics-commission-executive-director-featured-on-genetic-alliance-webinar/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/10/18/bioethics-commission-executive-director-featured-on-genetic-alliance-webinar/#respond Fri, 18 Oct 2013 19:18:05 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=974 The Genetic Alliance recently posted a webinar featuring Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) Executive Director Lisa M. Lee. The webinar examined some of the ongoing and timely issues raised by to the Bioethics Commission report Privacy and Progress in Whole Genome Sequencing. Lee was joined by Kelly Edwards, Acting Associate Dean, Associate Professor, Bioethics and Humanities, University of Washington.

Lee said the purpose of this webinar was to “briefly review the findings, analysis and recommendations made in Privacy and Progress, as well as use recent news events to illustrate how the recommendations made by the Bioethics Commission are necessary and pressing matters.”

Three months after Privacy and Progress was released, Science published the study Identifying Personal Genomes by Surname Inference by Melissa Gymrek, et al. This study proved that whole genome sequencing privacy breach concerns are no longer hypothetical; researchers had successfully uncovered the full identities of 50 individuals. Lee also referenced a story about an artist who creates 3-D renderings of faces from DNA she sequences from items like chewed gum or cigarette butts found in public places. From the sequencing the artist is able to learn information about the unwitting donor like eye color, hair color, and other facial features.

Lee argued that both examples illustrate the need to implement the recommendations made by the Bioethics Commission, including the need for strong baseline protection while promoting the data access and sharing required for progress. Currently different states have various levels of protections in place. For example, in New York, where the aforementioned artist resides, it is legal to sequence whatever DNA might be found. Sequencing is legal as long as a person is not sequencing to find information such as a predisposition to a genetic disease or disability in the individual or the individual’s offspring. In Florida, this same act is illegal as state law says that the term “DNA analysis” means the medical and biological examination and analysis of a person to identify the presence and composition of genes in that person’s body. The term includes DNA typing and genetic testing. These examples also demonstrate the need for better data security and researcher accountability.

The Genetic Alliance, started the monthly webinar series, What about Privacy and Progress in Whole Genome Sequencing?, in February. The series is based on The Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing. A webinar is held on the first Tuesday of every month, and the series will run through January.


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The Bioethics Commission Posts recent Webinar, Advancing Bioethics Education https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/09/24/the-bioethics-commission-posts-recent-webinar-advancing-bioethics-education/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/09/24/the-bioethics-commission-posts-recent-webinar-advancing-bioethics-education/#respond Tue, 24 Sep 2013 18:35:22 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=951 The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently posted a recording of its recent webinar, Advancing Bioethics Education; the webinar served as an introduction to the Bioethics Commission’s new pedagogical materials. Executive Director Lisa M. Lee, Associate Directors Kayte Spector-Bagdady and Michelle Groman, and Research Analyst Misti Ault Anderson provided an overview of the available materials and discussed potential ways to implement them in an educational setting.

Providing easily accessible and free materials based on the Bioethics Commission’s own analysis is an effort to help meet the recommendations the advisors have made repeatedly that, given the multidisciplinary nature of science and research, bioethics education should be available to a wide variety of disciplines at the undergraduate, graduate, and professional levels. The materials can also be used in continuing education and professional training courses, in graduate or professional school seminars, and in workplace discussion, IRB training, and other ses­sions.

The pedagogical materi­als comprise two ap­proaches: a report-specific approach and topic-oriented approach. The topic-based modules are designed to offer max­imum flexibility for integration into existing courses or for use as stand-alone curricula. The materials are not intended to provide a comprehensive bioethics curriculum; rather, they complement a teaching strategy with contemporary examples of real-life ethical challenges addressed by a presi­dential commission.

If you have any questions or comments about the educational materials, or the webinar, please email education@bioethics.gov. Also, be sure to follow the Bioethics Commission on Twitter, @bioethicsgov, for more updates.

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Member Spotlight: Nita Farahany https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/09/member-spotlight-nita-farahany/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/09/member-spotlight-nita-farahany/#respond Fri, 09 Aug 2013 13:48:23 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=788 Nita Pink ShirtNita Farahany, J.D., Ph.D. wrote in her high school “last will and testament” that she aspired to be both a lawyer and a doctor one day. Farahany achieved that goal, and then some. In April 2010 President Obama appointed her to the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission). She is also the Director of Science and Society at the Institute for Genome Sciences & Policy, Professor of Law and Philosophy, and Professor of Genome Sciences and Policy at Duke University. Her research focuses on the legal, philosophical, and social issues arising from developments in the biosciences, particularly behavioral genetics and neuroscience.

Farahany is the daughter of Iranian immigrants to the United States who dreamed of their daughter becoming a lawyer or a doctor. She enrolled in Dartmouth College with the goal of attending medical school, and she studied pre-med for most of her college career. After a medical school visit during her junior year, however, Farahany reconsidered that goal.

“During that visit I saw my first cadaver and nearly fainted! It was the final nudge that I needed to convince me that practicing medicine was not my chosen path,” she said.

On a new path, Farahany completed her B.A. in genetics, cell and developmental biology and afterwards accepted a job with a strategy consulting company in Cambridge, Mass. While there, she began working toward a master’s degree at Harvard. As she studied behavioral genetics in that program she was intrigued by how science and law came together with the use of genetics in criminal law. It inspired her to pursue a dual degree program in law and philosophy at Duke University, where, on her first day, she told her criminal law professor that she wanted to study the role of behavioral genetics and neuroscience on criminal responsibility. That focus continued from day one through her dissertation.  Her dissertation was entitled The Impact of Behavioral Genetics on Criminal Law.

In 2004 Farahany graduated with a J.D. and an M.A. in Philosophy from Duke Law School. In 2006 she fulfilled her high school pledge and became both a lawyer and a doctor by earning a Ph.D. in Philosophy, also from Duke. In 2007, she was awarded her ALM in Biology from Harvard.

The path to becoming both a lawyer and a doctor was not the one Farahany imagined, nor did she foresee that she would serve on a presidential commission. “It’s been extraordinary honor to serve on the Bioethics Commission. Particularly at this relatively early stage in my career, the opportunity to serve alongside such a talented and distinguished group of commissioners and staff has given me the chance to expand my horizons,” Farahany said.



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Member Spotlight: Raju Kucherlapati https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/02/member-spotlight-raju-kucherlapati/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/08/02/member-spotlight-raju-kucherlapati/#respond Fri, 02 Aug 2013 16:59:09 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=783 raju-kucherlapati_portrait“Growing up, I thought of the United States as a shining beacon of hope. I came here as a nobody, but this country has given me so much,” Raju Kucherlapati, Ph.D., said. President Obama appointed Kucherlapati to the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) in April 2010 because of Kucherlapti’s extensive knowledge and background in genetics. Kucherlapati is the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics and is also a professor in the Department of Medicine at Brigham and Women’s Hospital. He has chaired many NIH committees and is a member of the Cancer Genome Atlas project. Currently, his research focuses on gene mapping, gene modification, and cloning disease genes.

Kucherlapati grew up in Andhra Pradesh, India. He started his scientific career in India by earning a B.S. in Biology from P.R. College in Kakinada, and an M.S. in Biology from Andhra University in Waltair. In 1967 Kucherlapati came to the United States to begin a doctoral program at the University of Illinois at Urbana. It was during this time that he became interested in human gene mapping. After Kucherlapati obtained his doctoral degree he was offered the opportunity do his post-doctoral work at Yale University in the lab of the late Dr. Frank Ruddle. Ruddle was an innovator in genetics and his work was at the foreground of mapping human genes. At Yale, Kucherlapati started research that would be the foundation for his future work on gene targeting. He conducted some of this work in collaboration with the Nobel Prize winner Oliver Smithies.

During the course of his career Kucherlapati has done research with gene targeting, gene cloning, and on mapping and sequencing human chromosome 12. He holds 12 patents and has served as editor in chief of the journal Genomics. Kucherlapati currently heads his own lab at Harvard where the work is focused on using genetics to understand cancer. Kucherlapati believes that diseases that are fatal today might not be so for patients in the future.

Kucherlapati might believe he came to the United States as “a nobody,” but he has earned his role as a top geneticist who has helped the Bioethics Commission navigate several ethically challenging questions of our time. He said that when he was originally offered the appointment to the Bioethics Commission he questioned whether he was right for the job. However, projects like Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission tackled pressing privacy and data access issues raised by the emergence of low cost whole genome sequencing, helped him realize how important it is to have experts from a diverse set of fields wrestle with these contemporary ethical dilemmas to offer the Administration the best analysis. “I’ve learned so much from everyone and they all have such different backgrounds. It’s been very interesting and a true pleasure,” he said.


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Member Spotlight: James Wagner https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/19/member-spotlight-james-wagner/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/07/19/member-spotlight-james-wagner/#respond Fri, 19 Jul 2013 15:06:00 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=761 james-wagner_portraitPresident Obama appointed the nineteenth President of Emory University, James W. Wagner, Ph.D., to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) in November 2009. Wagner serves as Vice Chair on the Bioethics Commission.

Wagner holds a bachelor’s degree in electrical engineering, a master’s degree in clinical engineering and a Ph.D. in materials science and engineering. Wagner said he became an engineer because it is a creative discipline. “From shingles on a roof to the creation of the iPhone, they all were created by someone. They aren’t natural, but a vision of their creator,” he said. Wagner initially wondered how his engineering background would help a bioethics commission, but he now believes it serves a valuable role.

Prior to Emory, Wagner developed quality-assurance methods at the FDA and performed failure analyses on medical devices. Wagner says he had to rely on basic ethical principles as he encountered quality assurance challenges like whether a less expensive and thus more available cardiac pacemaker could be produced if it did not have to go through time consuming and costly steps such as qualifying the electronic components and batteries for medical use.

“Engineers understand that risk management is different from risk elimination and so [engineers] engage in the same kinds of decision processes that challenge the Bioethics Commission,” Wagner said. He pointed to one example of this that can be seen in New Directions: The Ethics of Synthetic Biology and Emerging Technologies, the Bioethics Commission’s first project. President Obama asked his bioethics advisors to “develop recommendations about any actions the Federal government should take to ensure that America reaps the benefits of this developing field of science while identifying appropriate ethical boundaries and minimizing identified risks.”

Wagner approached this charge with an engineering mindset, one that aims to reduce risk, but not stymie development. In particular he feels the principle of responsible stewardship is one of the most important principles that the Bioethics Commission identified and applied as it considered the developing field of synthetic biology.

As defined in the Bioethics Commission’s report, responsible stewardship is “a shared obligation among members of the domestic and global communities to act in ways that demonstrate concern for those who are not in the position to represent themselves (e.g., children and future generations). A responsible process will continue to assess safety and security as technologies develop and diffuse into public and private sectors.” Wagner said that the Bioethics Commission Members realize that with all new technologies there will be risks that cannot be eliminated, and it is the role of the Bioethics Commission to offer the Administration advice on how to manage those risks for the public.

“I’ve learned a great deal,” Wagner said of his time with the Bioethics Commission. “This is a group committed to helping society navigate its way through these emerging technologies, while protecting everyone; this has truly been a satisfying experience.”

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Member Spotlight: Christine Grady https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/06/28/member-spotlight-christine-grady/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/06/28/member-spotlight-christine-grady/#respond Fri, 28 Jun 2013 18:17:24 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=727 christine-grady_portraitNurses take great pride that one of President Obama’s bioethics advisors is an R.N.  The President appointed Christine Grady, R.N., Ph.D., to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) in April, 2010. Grady is the Chief of the Department of Bioethics at the National Institutes of Health Clinical Center. She also serves as Head of the Department’s Section on Human Subjects Research.

In high school Grady decided to become a nurse, a career in which she grappled with bioethical questions. Grady served as a nurse in a neuro unit, a research unit, for hospice, and for Project Hope, an organization that that delivers health care,  medicine, medical supplies, volunteers, and health care education to communities  in need. In each role she came across situations and people confronting ethical issues including the type of care patients received, the boundaries and limitations of providers, patients’ access to resources, and the distribution of scarce resources.  Grady loved being a nurse and loved taking care of her patients.  But after years of helping the sick, Grady decided a Ph.D. in philosophy would help her begin to find the answers to some of these tough issues she watched patients and health care providers struggle with daily. 

Grady says that in her work on the Bioethics Commission, and in other professional capacities, she often thinks about the patients she has met along the way.  She thinks of the mother in Brazil who lost her battle with leukemia. Grady remembers how fearful the mother was of leaving her children. Years later, Grady still wonders if this mother could have survived if she had had access to quality affordable health care.  

When working in a Boston research unit she knew there were people down the street who could have benefitted from prenatal care, but they could not afford it. It bothered her that some were not receiving care, while in the acute care setting others might have three nurses assigned to their case. 

Grady has made the focus of her life’s work how to improve care for those currently in need and for future generations, while making sure that changes to care are  evidence- based and motivated by promoting patients’ best interests. Grady says she strives to speak for those who do not have the opportunity to speak for themselves.

When asked about her time spent on the Bioethics Commission Grady said, “It’s been a privilege, even being asked to be a part of this was an honor. Working with the other Commission Members has been a wonderful opportunity. Also, the staff is amazing in the depth and breadth of their backgrounds. Together we are putting out products that benefit society.”

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Member Spotlight: John D. Arras https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/06/11/member-spotlight-john-d-arras/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/06/11/member-spotlight-john-d-arras/#respond Tue, 11 Jun 2013 17:41:10 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=698 President Obama appointed philosopher John D. Arras, Ph.D., to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) in May 2010. Dr. Arras is the Porterfield Professor of Biomedical Ethics and Professor of Philosophy at the University of Virginia, where he directs the Program in Bioethics and is affiliated with the Center for Biomedical Ethics and Humanities in the School of Medicine. He has also served as a longtime fellow and former board member of the Hastings Center, consults regularly at the National Institutes of Health, and is a founding member of the ethics advisory committee of the Centers for Disease Control and Prevention.

As a child Arras already seemed to have the mindset of a philosopher. At an early age he developed a love for fly fishing; a sport that he says allows an individual the opportunity to be one with their thoughts. He spent many childhood family vacations fishing by himself, pondering life’s questions.

Arras went to college at the University of San Francisco knowing that his father wanted him to join the family engineering business. However, in his freshman year he found himself bored with business classes and intrigued by classes that left him wrestling with difficult ethical issues.

He later studied in Paris. While there he had the opportunity to study with French philosopher Paul Ricœur. Ricoeur is known for combining phenomenological description with hermeneutics; in 2000 he was awarded the Kyoto Prize in Arts and Philosophy.  Arras said this time with Ricoeur is what led him to realize his future. “Debating the nature of freedom and time with this world-famous philosopher, holding my own but realizing that he was certainly holding way back, gave me the confidence to go forward with graduate studies in philosophy.”

The Bioethics Commission’s recent report, Safeguarding Children: Pediatric Medical Countermeasures Research, responded to a question that, as Arras put it, keeps a person up at night. Health and Human Services Secretary Kathleen Sebelius asked the Bioethics Commission to conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures with children, and to make recommendations regarding the conduct of trials of anthrax vaccine absorbed (AVA) post-exposure prophylaxis in children. This report, Arras felt, offered him the opportunity to stretch his philosophical muscles. He said the Bioethics Commission’s recommendations on these issues had to find the right balance to ensure protection for children enrolled in research studies, while also developing the knowledge needed to save children’s lives during a possible emergency. Arras is proud of the conclusions that the Bioethics Commission reached because he feels they found that balance.

Arras said he never dreamed that his career would take him to a Presidential Commission, but instead saw himself “as a modest laborer in the fields of academe and bioethics.” While, he never envisioned himself serving on the Bioethics Commission he said the experience “has been truly enriching and educational. I not only like but admire my colleagues; this experience is a privilege and pleasure.”

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Hunter College High School Students Visit the Bioethics Commission https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/05/22/hunter-college-high-school-students-visit-the-bioethics-commission/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2013/05/22/hunter-college-high-school-students-visit-the-bioethics-commission/#respond Wed, 22 May 2013 16:22:13 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=682

Executive Director Lisa M. Lee talks with Hunter College H.S. students

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently welcomed 35 students and faculty from Manhattan’s Hunter College High School. The Hunter College High School students participated in the 61st Annual Washington Seminar on Government in Action, a seminar that allows students to engage in domestic and international issues facing the U.S. government.

The Bioethics Commission staff offered the students three sessions designed to provide insight into different aspects of bioethics:  science, law, and philosophy.

Executive Director, Lisa M. Lee, Ph.D., M.S., Research Analyst Misti Ault Anderson, M.S., M.A., and Research Associate Olivia Nevitt, M.P.H., led the first session on science.  Bioethics Commission intern Ruquyyah Abdul-Karim also joined the discussion.  During this session students heard background about the Bioethics Commission, its members, staff, and the process of deliberative democracy it uses to develop its recommendations for the President and the Administration.  Advances in biomedicine and related areas of science and technology can create a range of ethical dilemmas. The students learned that the Bioethics Commission, a federal advisory committee, seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted by the U.S. in a socially and ethically responsible manner.

Associate Directors, Michelle Groman, J.D., and Kayte Spector-Bagdady, J.D., M. Bioethics, led the law discussion. The students came well prepared with many questions, including several that focused on emerging technologies. The discussion highlighted that the law alone cannot ensure that emerging technologies such as synthetic biology and whole genome sequencing be conducted ethically.  Ethical conduct is also dependent on other things including responsible codes of conduct within industry and professional organizations, sound research design and good education. 

Senior Policy and Research Analyst Karen Meagher, Ph.D., and Research Associate Michelle Spektor, B.S., led the final discussion on philosophy. One topic brought up by the students was the issue of unequal distribution of the benefits from technological advances.   Another pointed out that various countries have differing approaches to such challenges based on their different cultural world views.

The Bioethics Commission staff was pleased to meet the students of Hunter College High School, and was impressed with the quality of the questions asked. In several of its reports the Bioethics Commission has stressed the importance of expanding ethics discourse and education.  That certainly includes fostering curiosity in today’s high school students and encouraging them to study bioethics.

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