Ashley Turner
www.CNBC.com
Originally posted May 21, 2019
Here is an excerpt:
Former FDA Commissioner Scott Gottlieb said Tuesday that He’s research was a “horrible experiment and it established a horrible precedent.” Gottlieb said He’s experiment risked causing people to “rightfully” turn away from the science.
Gottlieb said he has yet to see any compelling arguments in favor of human germline editing.
Paul Dabrowski, CEO of Synthego, a genome engineering company, agreed the scientific community is not yet ready for germline editing. He wondered whether allowing parents to choose to genetically alter their future children can be ethical if they’re not the one who is having their DNA changed.
“How do you make sure you can align the person who is consenting and the person who is taking the risk?” Dabrowski asked.
Stanford’s Hurlbut said there are risks to editing DNA, as those traits can then be passed down to future generations. Editing certain genes can also cause changes in other genes, according to Hurlbut.
“We want to be very careful, nature is a profound balance and if we intervene in a way that is not profound we can upset things,” Hurlbut said.
The info is here.
Showing posts with label Genomic Data. Show all posts
Showing posts with label Genomic Data. Show all posts
Friday, June 28, 2019
Sunday, March 19, 2017
Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations
James G. Hodge Jr. and Lawrence O. Gostin
JAMA. Published online February 22, 2017
On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.
Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.
The article is here.
JAMA. Published online February 22, 2017
On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.
Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.
The article is here.
Saturday, July 16, 2016
Federal panel approves first test of CRISPR editing in humans
By Laurie McGinley
The Washington Post
Originally posted on June 21, 2016
A National Institutes of Health advisory panel on Tuesday approved the first human use of the gene-editing technology CRISPR, for a study designed to target three types of cancer and funded by tech billionaire Sean Parker’s new cancer institute.
The experiment, proposed by researchers at the University of Pennsylvania, would use CRISPR-Cas9 technology to modify patients’ own T cells to make them more effective in attacking melanoma, multiple myeloma and sarcoma.
The federal Recombinant DNA Advisory Committee approved the Penn proposal unanimously, with one member abstaining. The experiment still must be approved by the Food and Drug Administration, which regulates clinical trials.
The article is here.
The Washington Post
Originally posted on June 21, 2016
A National Institutes of Health advisory panel on Tuesday approved the first human use of the gene-editing technology CRISPR, for a study designed to target three types of cancer and funded by tech billionaire Sean Parker’s new cancer institute.
The experiment, proposed by researchers at the University of Pennsylvania, would use CRISPR-Cas9 technology to modify patients’ own T cells to make them more effective in attacking melanoma, multiple myeloma and sarcoma.
The federal Recombinant DNA Advisory Committee approved the Penn proposal unanimously, with one member abstaining. The experiment still must be approved by the Food and Drug Administration, which regulates clinical trials.
The article is here.
Monday, June 20, 2016
Scientists debate effort to build a human genome
By Andrew Joseph
STAT
Originally posted on June 4, 2016
Here is an excerpt:
Church said the core science of assembling a human genome from basic molecular ingredients dates back to at least 2009. And he noted that scientists have been grappling with related ethical questions for more than a decade, since the early days of synthetic biology opened the door to the idea of someone being able to build a pathogen from basic genetic components.
He said that although the project has no intention of spawning actual humans, the project’s leaders would not ignore the “ethical, social, legal” issues that inherently materialize given where the project could lead.
The article is here.
STAT
Originally posted on June 4, 2016
Here is an excerpt:
Church said the core science of assembling a human genome from basic molecular ingredients dates back to at least 2009. And he noted that scientists have been grappling with related ethical questions for more than a decade, since the early days of synthetic biology opened the door to the idea of someone being able to build a pathogen from basic genetic components.
He said that although the project has no intention of spawning actual humans, the project’s leaders would not ignore the “ethical, social, legal” issues that inherently materialize given where the project could lead.
The article is here.
Sunday, June 19, 2016
The Ethics of Large-Scale Genomic Research
Benjamin E. Berkman, Zachary E. Shapiro, Lisa Eckstein, Elizabeth R. Pike
Chapter in Ethical Reasoning in Big Data
Part of the series Computational Social Sciences pp 53-69
Abstract
The potential for big data to advance our understanding of human disease has been particularly heralded in the field of genomics. Recent technological advances have accelerated the massive data generation capabilities of genomic research, which has allowed researchers to undertake larger scale genomic research, with significantly more participants, further spurring the generation of massive amounts of data. The advance of technology has also triggered a significant reduction in cost, allowing large-scale genomic research to be increasingly feasible, even for smaller research sites. The rise of genetic research has triggered the creation of many large-scale genomic repositories (LSGRs) some of which contain the genomic information of millions of research participants. While LSGRs have genuine potential, they also have raised a number of ethical concerns. Most prominently, commentators have raised questions about the privacy implications of LSGRs, given that all genomic data is theoretically re-identifiable. Privacy can be further threatened by the possibility of aggregation of data sets, which can give rise to unexpected, and potentially sensitive, information. Beyond privacy concerns, LSGRs also raise questions about participant autonomy, public trust in research, and justice. In this chapter, we explore these ethical challenges, with the goal of elucidating which ones require closer scrutiny and perhaps policy action. Our analysis suggests that caution is warranted before any major policies are implemented. Much attention has been directed at privacy concerns raised by LSGRs, but perhaps for the wrong reasons, and perhaps at the expense of other relevant concerns. We do not think that there is yet sufficient evidence to motivate enactment of major policy changes in order to safeguard welfare interests, although there might be some stronger reasons to worry about subjects’ non-welfare interests. We also believe that LSGRs raise genuine concerns about autonomy and justice. Big data research, and LSGRs in particular, have the potential to radically advance our understanding of human disease. While these new research resources raise important ethical concerns, any policies implemented concerning LSGRs should be carefully tailored to ensure that research is not unduly burdened.
The abstract to the book chapter is here.
You may want to contact the author for a copy for personal use.
Chapter in Ethical Reasoning in Big Data
Part of the series Computational Social Sciences pp 53-69
Abstract
The potential for big data to advance our understanding of human disease has been particularly heralded in the field of genomics. Recent technological advances have accelerated the massive data generation capabilities of genomic research, which has allowed researchers to undertake larger scale genomic research, with significantly more participants, further spurring the generation of massive amounts of data. The advance of technology has also triggered a significant reduction in cost, allowing large-scale genomic research to be increasingly feasible, even for smaller research sites. The rise of genetic research has triggered the creation of many large-scale genomic repositories (LSGRs) some of which contain the genomic information of millions of research participants. While LSGRs have genuine potential, they also have raised a number of ethical concerns. Most prominently, commentators have raised questions about the privacy implications of LSGRs, given that all genomic data is theoretically re-identifiable. Privacy can be further threatened by the possibility of aggregation of data sets, which can give rise to unexpected, and potentially sensitive, information. Beyond privacy concerns, LSGRs also raise questions about participant autonomy, public trust in research, and justice. In this chapter, we explore these ethical challenges, with the goal of elucidating which ones require closer scrutiny and perhaps policy action. Our analysis suggests that caution is warranted before any major policies are implemented. Much attention has been directed at privacy concerns raised by LSGRs, but perhaps for the wrong reasons, and perhaps at the expense of other relevant concerns. We do not think that there is yet sufficient evidence to motivate enactment of major policy changes in order to safeguard welfare interests, although there might be some stronger reasons to worry about subjects’ non-welfare interests. We also believe that LSGRs raise genuine concerns about autonomy and justice. Big data research, and LSGRs in particular, have the potential to radically advance our understanding of human disease. While these new research resources raise important ethical concerns, any policies implemented concerning LSGRs should be carefully tailored to ensure that research is not unduly burdened.
The abstract to the book chapter is here.
You may want to contact the author for a copy for personal use.
Friday, June 3, 2016
Secret Harvard meeting on synthetic human genomes incites ethics debate
By Joel Achenbach
The Washington Post
Originally published May 13, 2016
About 150 scientists assembled at Harvard on Tuesday for an off-the-record, no-media-allowed discussion of how to create, from scratch, an intact genome, including the genetic code of a human being. The idea is to go beyond "reading" genetic material to actively "writing" it, George Church, a Harvard Medical School researcher who helped organized the event, told The Post in an interview Friday morning.
Scientists can synthesize DNA chemically, and these techniques could ultimately lead to complete genomes that could be implanted in cells for research purposes. No one should panic just yet about mad scientists running amok: The researchers are not talking about making synthetic human beings. But the gathering drew a rebuke from two academics who heard about the event and didn't think it should have been held behind closed doors.
The article is here.
The Washington Post
Originally published May 13, 2016
About 150 scientists assembled at Harvard on Tuesday for an off-the-record, no-media-allowed discussion of how to create, from scratch, an intact genome, including the genetic code of a human being. The idea is to go beyond "reading" genetic material to actively "writing" it, George Church, a Harvard Medical School researcher who helped organized the event, told The Post in an interview Friday morning.
Scientists can synthesize DNA chemically, and these techniques could ultimately lead to complete genomes that could be implanted in cells for research purposes. No one should panic just yet about mad scientists running amok: The researchers are not talking about making synthetic human beings. But the gathering drew a rebuke from two academics who heard about the event and didn't think it should have been held behind closed doors.
The article is here.
Monday, September 9, 2013
Is Individuality the Savior of Eugenics?
By Nathaniel Comfort
Scientific American Blog
Originally published August 23, 2013
Is eugenics a historical evil poised for a comeback? Or is it a noble but oft-abused concept, finally being done correctly?
Once defined as “the science of human improvement through better breeding,” eugenics has roared back into the headlines in recent weeks in both Mr. Hyde and Dr. Jekyll personae. The close observer may well wonder which will prevail. The snarling Mr. Hyde is the state control over reproduction. Although this idea may evoke visions of Nazi genocide, the U.S. itself has a long, unsavory eugenic history, peaking between 1910 and the mid-thirties but tailing out through the 20th century. And now into the 21st: the recent investigation by the Center for Investigative Reporting, which showed that between 2006 and 2010 nearly 150 pregnant prisoners had been sterilized against their will in California, was a stunning reminder that traces of the old eugenics remain in our own time.
The entire blog post is here.
Scientific American Blog
Originally published August 23, 2013
Is eugenics a historical evil poised for a comeback? Or is it a noble but oft-abused concept, finally being done correctly?
Once defined as “the science of human improvement through better breeding,” eugenics has roared back into the headlines in recent weeks in both Mr. Hyde and Dr. Jekyll personae. The close observer may well wonder which will prevail. The snarling Mr. Hyde is the state control over reproduction. Although this idea may evoke visions of Nazi genocide, the U.S. itself has a long, unsavory eugenic history, peaking between 1910 and the mid-thirties but tailing out through the 20th century. And now into the 21st: the recent investigation by the Center for Investigative Reporting, which showed that between 2006 and 2010 nearly 150 pregnant prisoners had been sterilized against their will in California, was a stunning reminder that traces of the old eugenics remain in our own time.
The entire blog post is here.
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