Tag: regulation

Bioethics Blogs

Human genome editing: We should all have a say

Controversial gene editing should not proceed without citizen input and societal consensus. (Shutterstock)

Shoukhrat Mitalipov, a reproductive biologist at Oregon Health and Science University, is nothing if not a pioneer. In 2007, his team published proof-of-principle research in primates showing it was possible to derive stem cells from cloned primate embryos. In 2013, his team was the first to create human embryonic stem cells by cloning. Now, in 2017, his team is reported to have safely and effectively modified human embryos using the gene editing technique CRISPR.

Mitalipov’s team is not the first to genetically modify human embryos. This was first accomplished in 2015 by a group of Chinese scientists led by Junjiu Huang. Mitalipov’s team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique.

This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children.

Ethically controversial

Those who support human embryo research will argue that Mitalipov’s research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease.

This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications – genetic changes that can be passed down through subsequent generations.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

End-of-Life Healthcare Sessions at ASBH 2017

The 2017 ASBH
conference
 in October 2017 includes over 400 workshops, panels, and
papers in bioethics and the health humanities.  Here are ones that pertain
to end-of-life issues.


THURSDAY, OCTOBER 19


THU 1:30 pm:  End-of-Life Care and Decision-Making in the ICU – Limited
English Proficiency as a Predictor of Disparities (Amelia Barwise)


Importance: Navigating choices in predominantly English-speaking care settings
can present practical and ethical challenges for patients with limited English
proficiency (LEP). Decision-making in the ICU is especially difficult and may
be associated with disparities in health care utilization and outcomes in critical
care. 


Objective: To determine if code status, advance directives, decisions to limit
life support, and end-of-life decision-making were different for ICU patients
with LEP compared to English-proficient patients. 


Methods: Retrospective cohort study of adult ICU patients from
5/31/2011-6/1/2014. 779 (2.8%) of our cohort of 27,523 had LEP. 


Results: When adjusted for severity of illness, age, sex, education, and
insurance status, patients with LEP were less likely to change their code
status from full code to do not resuscitate (DNR) during ICU admission (OR,
0.62; 95% CI, 0.46-0.82; p


Conclusion: Patients with LEP had significant differences and disparities in
end-of-life decision-making. Interventions to facilitate informed
decision-making for those with LEP is a crucial component of care for this
group.


THU 1:30 pm:  “But She’ll Die if You Don’t!”: Understanding and
Communicating Risks at the End of Life (Janet Malek)


Clinicians sometimes decline to offer interventions even if their refusal will
result in an earlier death for their patients. For example, a nephrologist may
decide against initiating hemodialysis despite a patient’s rising creatinine
levels if death is expected within weeks even with dialysis.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Grounding ethics from below: CRISPR-cas9 and genetic modification

By Anjan Chatterjee

The University of Pennsylvania

Anjan Chatterjee is the Frank A. and Gwladys H. Elliott Professor and Chair of Neurology at Pennsylvania Hospital. He is a member of the Center for Cognitive Neuroscience, and the Center for Neuroscience and Society at the University of Pennsylvania. He received his BA in Philosophy from Haverford College, MD from the University of Pennsylvania and completed his neurology residency at the University of Chicago. His clinical practice focuses on patients with cognitive disorders. His research addresses questions about spatial cognition and language, attention, neuroethics, and neuroaesthetics. He wrote The Aesthetic Brain: How we evolved to desire beauty and enjoy art and co-edited: Neuroethics in Practice: Mind, medicine, and society, and The Roots of Cognitive Neuroscience: behavioral neurology and neuropsychology. He is or has been on the editorial boards of: American Journal of Bioethics: Neuroscience, Behavioural Neurology, Cognitive and Behavioral Neurology, Neuropsychology, Journal of Cognitive Neuroscience, Journal of Alzheimer’s Disease, Journal of the International Neuropsychological Society, European Neurology, Empirical Studies of the Arts, The Open Ethics Journal and Policy Studies in Ethics, Law and Technology. He was awarded the Norman Geschwind Prize in Behavioral and Cognitive Neurology by the American Academy of Neurology and the Rudolph Arnheim Prize for contribution to Psychology and the Arts by the American Psychological Association. He is a founding member of the Board of Governors of the Neuroethics Society, the past President of the International Association of Empirical Aesthetics, and the past President of the Behavioral and Cognitive Neurology Society. He serves on the Boards of Haverford College, the Associated Services for the Blind and Visually Impaired and The College of Physicians of Philadelphia. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Don’t Feed the Trolls: Bold Climate Action in a New, Golden Age of Denialism

by Marcus Hedahl and Travis N. Rieder

ABSTRACT. In trying to motivate climate action, many of those concerned about altering the status quo focus on trying to convince climate deniers of the error of their ways. In the wake of the  2016 Election, one might believe that now, more than ever, it is tremendously important to convince those who deny the reality of climate science of the well-established facts. We argue, however, that the time has come to revisit this line of reasoning.  With a significant majority of voters supporting taxing or regulating greenhouse gases, those who want to spur climate action ought to focus instead on getting a critical mass of climate believers to be appropriately alarmed. Doing so, we contend, may prove more useful in creating the political will necessary to spur bold climate action than would engaging directly with climate deniers.

Less than a month after the 2016 presidential election, incoming White House Chief of Staff Reince Priebus stated that climate change denialism would be the “default position” of the Trump administration (Meyjes 2016). In March 2017, Scott Pruit, President Trump’s choice to lead the Environmental Protection Agency, expressed his belief—contrary to the estabilished scientific consensus—that carbon dioxide was not one of the primary contributors of climate change (Davenport 2107). Given this existence of climate denialism at the highest reaches of U.S. government, one might believe that, now more than ever, it is tremendously important to convince those who deny the reality of climate science of the well-established facts.[1] Surely, with truth on our side, we must trumpet the evidence, making deniers our primary target and acceptance of the truth of climate change our primary goal.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to … Continue reading

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Elon Musk Urges U.S. Governors to Regulate AI Before “It’s Too Late”

July 17, 2017

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He may want to send us all to space and make the world drive electric cars, but Elon Musk isn’t gung ho about all technologies. In particular, he’s famously uneasy about the development of machine learning, and has in the past gone so far as stating that he believes building a general intelligence AI as tantamount to “summoning the demon.” Now, he’s reaffirmed that message to U.S. governors, urging them to regulate AI—and quickly.

Speaking at the National Governors Association meeting in Rhode Island on Saturday, Musk called AI “the biggest risk that we face as a civilization,” according to the Wall Street Journal. That’s a sentiment shared by a small but influential crowd of techno-thinkers. Whether it’s an accurate assessment of the situation is very much up for debate, however, as Oren Etzioni, the CEO of the Allen Institute for Artificial Intelligence and Professor of Computer Science at the University of Washington, has argued on these very pages.

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Image via Flickr Attribution Some rights reserved by Heisenberg Media

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Diagnostic dilemmas: When potentially transient preexisting diagnoses confer chronic harm

By Elaine Walker
Elaine Walker is the Charles Howard Candler Professor of Psychology and Neuroscience at Emory University.   She leads a research laboratory that is funded by the National Institute of Mental Health (NIMH) to study risk factors for psychosis and other serious mental illnesses.  Her research is focused on the behavioral and neuromaturational changes that precede psychotic disorders.   She has published over 300 scientific articles and 6 books. 
The diagnostic process can be complicated by many factors. Most of these factors reflect limitations in our scientific understanding of the nature and course of disorders. But in the current US healthcare climate, legislative proposals concerning insurance coverage for preexisting conditions add another layer of complexity to the diagnostic process. It is a layer of complexity that is riddled with ethical dilemmas which are especially salient in the field of mental health care. The following discussion addresses the interplay between medical practice and health-care system policy in the diagnostic process. The diagnosis of psychiatric disorders is emphasized because they present unique challenges [1]. 

Of course, some of the complications associated with diagnosis are a function of ambiguous and/or changing diagnostic criteria. For example, the criteria for designating the level of symptom severity that crosses the boundary into clinical disorder change over time as a function of scientific advances. This has occurred for numerous illnesses, including metabolic, cardiovascular, and psychiatric disorders [2]. Further, especially in psychiatry, diagnostic categories undergo revision over time, even to the extent that some behavioral “syndromes” previously considered an illness have been eliminated from diagnostic taxonomies.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

The following is a re-post of Steven Mile’s original February 2017 post.


by Steven H. Miles, MD

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.[i] The new Rules defines the obligations of an enormous number of personnel at the National Institutes of Health as well as virtually any other government agency engaged in research with human subjects. The Rules define the requisite knowledge, training, and work of staff who oversee and conduct clinical research in the United States.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In Memoriam: John A. Robertson

by David Magnus, Ph.D.

Sadly, the field of bioethics lost one of its best this week. John Robertson, a law professor at the University of Texas and a major figure in law and bioethics, passed away on July 5th. John was an important scholar whose work spanned major contributions to scholarship on end of life, organ transplantation, and genetics, but he is best known for his work on reproductive technology. John’s articulation and defense of the importance of procreative liberty, though both his articles and his important book, Children of Choice, stands as an exemplar for scholarship in bioethics. I have used his work in my classes for over 20 years, because no one has better articulated the perspective he brought to bear on issues in reproductive technology.

In addition to his scholarly contributions, what I will miss most about John is that he was a tireless and enthusiastic mentor and advocate for younger scholars. Without his support, I doubt that my career would have turned out the way it has. First, if you are reading this blog, you are aware of the success of the American Journal of Bioethics. The journal owes a great deal of its success (and perhaps its continued existence) to John. When the journal was first launched, most leaders in the field expressed a great deal of skepticism about the need or value of another journal. John not only supported us and encouraged us, he made a major contribution to ensure our success. As the Chair of the ethics committee of the American Society for Reproductive Medicine, John was instrumental in promoting a position to accept uses of new technologies for sex selection (at least in the context of family balancing).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Participants’ Testimonials: GBI Summer School a Smashing Success, (June 19-30), 2017

The GBI Summer School proved to be even better than anticipated or described. As a newcomer to the discipline, I had expected the course to provide a broad overview of topics and speakers. Indeed, while broad, the degree of expertise and timely subject material provided an excellent and comprehensive survey of the discipline in global and local settings. Moreover, the students provided another dimension of diversity, both in nationalities and areas of expertise. The speakers made their presentation materials readily available, answered questions, and were willing to address topics of interest offline. I would strongly recommend the course to both novices and subject matter experts alike. The course especially demonstrated the need, relevance, and desirability for global bioethics to be better incorporated into public policy formulation.

Geoffrey Pack, Prevention and Protection Officer, Office of Homeland and Security, City of San Diego, M.A.L.D., Fletcher School of Law and Diplomacy, Tufts University in Cooperation with Harvard University

The GBI Summer School, in the heart of NYC’s Pace University Campus, is a fantastic opportunity! International scholars and professionals from all over the world attended the program, contributing their experiences and engaging with bioethics experts. The City of New York – with the nearby Pace University Campus, Brooklyn Bridge, City Hall, and 9/11 Memorial – provided the perfect setting to discuss the global ethical challenges in technology and medicine. Discussions ranged from law and politics to culture and psychology, encompassing the ethical dilemmas that define the 21st century. I have immensely enjoyed not just the internationally known faculty but also hearing from the learners who come from all over the world representing diverse fields.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.