The blog of the Presidential Commission for the Study of Bioethical Issues

A discussion on the ethics of neuroscience

In the ethics surrounding neuroscience, an initial question considered by the Presidential Commission for the Study of Bioethical Issues today was the definition of the words “self” and “person.”

The subject of neuroscience is one of three that the Commission is taking up this year. The other two are whole genome sequencing and effective countermeasures to protect children.

The discussion also delved into developments in neuroscience; the use of those tools; the rights of a person; and what happens in situations such as when a person suffers a brain injury or descends into dementia.

“We know when someone suffers a brain injury, or has Alzheimer’s Disease, we’re quick to say they have become a different person,” said James Wagner, the Commission Vice-Chair and the President of Emory University. “It may not be clear what we mean by that, or what we know about that, so in light of that we want to understand words like person and self.”

John Perry, Distinguished Professor of Philosophy at the University of California, Riverside, Emeritus Professor of Philosophy at Stanford, and co-host of “Philosophy Talk,” a radio program that “questions everything… except your intelligence,” said it was important to demystify the definition of self.

“It’s a fairly straightforward concept,” he said. “Self is just a way of talking about ourselves.”

He continued: “What we know about ourselves, or think about ourselves isn’t just limited to the special ways people have to know about themselves. For example, this morning, trying to figure out where I should come to the meeting, I looked at the Commission Website and … part of that was seeing my name. ‘Ah this is where I should be.’ You have a John Perry concept., and I have a John Perry concept that is different than from my self concept.”

Marya Schechtman, Professor of Philosophy at the University of Illinois at Chicago, and author of The Constitution of Selves, talked about the identity of a person revolving around their narrative.

A narrative, she said, is a story of how people view themselves. “Lives are full of happenstance and trivia as well as important events, and they are part of our narrative as well,” she said.

Dr. Bernard Lo, Professor of Medicine and Director of Program in Medical Ethics at University of California, San Francisco, turned the discussion toward “change in self” and what that meant in real-life situations faced by patients, families and doctors.

He told the story of his favorite aunt who developed dementia in old age. She had told him years earlier that if she faltered badly in her later years she did not want to be kept alive. He said when he visited her during her period of dementia, she remembered him and his son and “was smiling.” Then she contracted pneumonia. The question, he said, was whether her contentment should override her earlier conviction not to prolong her life if any complications developed.

“To put this in ethical terms, what do you do when priority directions contradict current best interests?” Lo said.

Anthony Wagner, Professor of Psychology and Neuroscience at Stanford University, described new advances in neuroscience. Some involved the use of functional MRI (fMRI). He said some initial conclusions from studies showed that fMRIs can detect whether someone is remembering an episode “with reasonable high accuracy.”
He also said that in some cases, fMRI tests in patients in “vegetative states” have shown detection of brain responses to questions.
Those developments, Commission members said, meant that it may be time to consider ethical questions around the use of neuroimaging before the technology progresses further.

Experts give top concerns on genetic tests

In the final session today before the Presidential Commission for the Study of Bioethical Issues, Chair Dr. Amy Gutmann asked all the experts who presented information to talk about their greatest concern with genetic tests.

Gutmann, the President of the University of Pennsylvania, told them: “The Commission is very likely to focus its report on issues of privacy broadly construed. Anything that is relevant to privacy would be of great interest to the Commission.”

Among the responses:

Jane Kaye, Director of the Centre for Law, Health and Emerging Technologies at Oxford University: “I would say I see the whole genome sequencing is another twist on things happening already on science. … What we need to do is make (privacy concerns) more nuanced and allow individuals to say how whole genomes are used.”

George Annas, Chair of Health Law, Bioethics & Human Rights at Boston University School of Public Health: “This is fundamentally a reductionist (perspective), but the more we look at genes, the less we will look at the whole person and take the whole person into account.”

Pilar Ossorio, Associate Professor of Law and Bioethics at the University of Wisconsin-Madison: “We have used anonymity as a way to protect research participants from harm , and we are not taking seriously the fact we really are having decreasing amounts of anonymity and decreasing ability to provide that to people.”

Melissa Mourges, Assistant District Attorney and Chief of the Forensic Sciences/Cold Cases Unit in the New York County District Attorney’s office: “Knowledge is power and I would hate to give up the knowledge you can gain from this project. I think we figured out how to do it with the forensics database and we are ruthlessly, smart people and we need to figure out a way to get it done.”

Daniel Masys, Affiliate Professor of Biomedical and Health Informatics at the University of Washington School of Medicine: “The genome will tell the book of humanity, and as it is, we only understand one third of the words. … My major concern is that privacy not materially inhibit the ability to decode that book and understand what that means.”

Retta Beery, mother of twins who benefited from improved diagnosis through whole genome sequencing: “I agree that information is a good thing, and it is a good thing that can be used in diagnosing rare diseases, and it is something that should be shared in a broader format.”

A positive use of genetic data: Justice

After a morning that dealt in large part with privacy concerns in the use of genetic data, the Presidential Commission for the Study of Bioethical Issues heard another side of the issue: The data can lead to justice.

Melissa Mourges shows the DNA profile of a suspect.

Melissa Mourges, Assistant District Attorney and Chief of the Forensic Sciences/Cold Cases Unit in the New York County District Attorney’s office, described how DNA data has been invaluable.

With DNA profiles, Mourges said, “we can get cold hits matching a suspect to a crime. … For instance, we can learn a rape from California and a rape in Oklahoma are done by the same guy.”

She also said that authorities have kept tight restrictions on how the data has been used. Her comments followed other participants who raised questions about whether authorities could protect the privacy of an individual’s genomic sequencing.

Mourges said the Combined DNA Index System (CODIS), which are forensic databases maintained by all 50 states and the FBI, keeps DNA profiles of all known offenders. She said the system doesn’t allow for identification of a suspect until there’s a match in a case.

“We are never moving back with this technology,” she said, referring to law enforcement’s use of DNA data. “We have evidence who proves who done it, and not beyond a reasonable doubt, but beyond all doubt.”

Ethical questions around genetic testing

Just 10 years ago, a complete personalized genome test cost $3 billion. Some groups say that this cost could drop to as low as $1000 this year.

With the tests becoming more affordable, and more and more people getting whole genome sequencing tests, a host of related ethical issues are getting more attention, experts told the Presidential Commission for the Study of Bioethical Issues today in San Francisco.

Among them: Who will interpret this genetic data? Is it ethical to allow health care providers to interpret the data without a health systems infrastructure to help them interpret it? What will be the privacy protections to people who have the testing? Are privacy issues around genetic testing any different from other personal health information?

The Commission heard differing views on the thicket of ethical issues surrounding the emerging field.

First, though, it heard from an expert who tried to put the field in perspective.

“Our ability to acquire person-specific DNA data far exceeds our understanding of this information,” said Dr. Daniel Masys, Affiliate Professor of Biomedical and Health Informatics at the University of Washington School of Medicine. “… Genomics is the poster child for complexity in health care.”

Said Masys: “The Marcus Welby model that doctor knows everything and can do it right is hopelessly inadequate” for deciphering the intricacies of whole genome sequencing.

“This is on a scale of science that we’ve never seen before,” he said, adding later that in order to detect extremely rare diseases, scientists may need to look at a “group of 10,000 people, or even a million people” to detect genetic mutations in a handful of people.

Commission Chair Dr. Amy Gutmann, President of the University of Pennsylvania, said she was concerned about the public’s lack of understanding around genetic testing.

“There are snake oil salesmen out there for everything, and if you go on the Web you will likely find all kinds of offers” or claims about the benefits of genetic testing, Gutmann said. “As a president of a university, I believe in not only getting more knowledge, but getting it out there to the public. But to what extent, given that science takes time to develop, is there any concern about the amount of misinformation out there?”

Dr. Richard Gibbs, Director of the Human Genome Sequencing Center at the Baylor College of Medicine, agreed with Gutmann that misinformation was an issue.

“The slow pace of discovery that can transform lives is dramatically affecting … the distribution of this data. That is a vastly higher risk than someone who may foolishly sign onto a snake oil saleman. I come from another (perspective).”

Gutmann persisted, “People get harmed and sometimes killed by malpractice. You can’t just brush it away.”

“Absolutely,” Gibbs said. “There’s tension here. But the danger of not knowing is also a risk.”

In a second panel, George Annas, Chair of Health Law, Bioethics & Human Rights at the Boston University School of Public Health, argued that the results of genetic testing were “uniquely private” and that any use of that information for research should be closely controlled.
“The most important part of genetic information is individual to you,” Annas said. “It’s the way you look at your life. You can look at your genome as your future diary. No one should open that diary without your consent.”

Mark Rothstein, the Herbert F. Boehl Chair in Health Law and Medicine at University of Louisville School of Medicine, said that privacy concerns were just one of numerous issues around genetic testing.

Among those concerns, he said, were whether people should have to opt in to a study using genetic information or whether they had to specifically say they wanted to opt out of it.

“If you test it, sequence it, the results will be used,” Rothstein said. “The only questions are how broadly and for what purposes, what consequences? Will genomic information replace Social Security numbers? Will we become a society of the worried well?”

He continued: “And will genomic information increase health inequality? At the very least, genomic information will likely be used in ways we can’t predict now.”

Genetic testing that saved a life

The Presidential Commission for the Study of Bioethical Issues dove into the ethics of complete genome sequencing today in San Francisco, and it wasn’t long before they understood the benefits of the technology.

Retta Beery

They heard a story about how the test saved a life.

Retta Beery, the mother of twins Alexis and Noah Beery, recollected a tale of assorted severe health issues affecting both of them, including a misdiagnosis of cerebral palsy when they were 2 years old; seeing dozens of medical specialists; and then learning on her own through a newspaper article about how the two had a rare disorder.

But after years of better health, in 2009, when Alexis Beery turned 13, she developed a new life-threatening complication. She had trouble breathing. In the space of two months, the girl was rushed to a hospital emergency room seven times, and she was given daily injections of adrenaline just to keep her air passageway open.

The Beerys decided they needed more information and turned to genetic testing at the Baylor College of Medicine Human Genome Sequencing Center in Houston. Beery’s husband, Joe, is the chief information officer at Life Technologies, a biotechnology systems and services company that helped fund the study at Baylor. Baylor also used the company’s sequencing technology, which helped determine that the twins carried mutations in a gene, causing their health problems.

The discovery led to new treatment, and the siblings are now in good health. Alexis is playing soccer and is on her school’s track team. Her mother showed a video today of the girl competing in the long jump.

“We had black and white evidence on what was going on with Noah and Alexis,” Retta Beery said. “We got the whole picture for the first time. We had a new path to follow.”

During the question and answer period, Commission member Lonnie Ali asked Beery whether she had worried about the consequences of going public with the story of her family.

“This must have weighed on you as a mother, but how concerned are you with these issues of privacy for these children as they try to seek insurance coverage,” Ali said.

Beery said that she and her husband talked about it but saw the benefits of helping other was more important than potential risks.

“We believe this saved Alexis’ life, and … her life far outweighed the privacy issues,” she said.

She said so far they have had no trouble getting health insurance for the family. She also said the testing gave them another gift: It revealed that their eldest son, Zach, did not have the genetic condition that caused the conditions affecting the twins. “We no longer have to worry that Zach will be affected in the future,” she said.

Commission to take up ethics around protecting children in bioterror attack

The chair of the Presidential Commission for the Study of Bioethical Issues announced today the panel has agreed to a US administration request to study ethical questions around safe and effective countermeasures for children following a bioterror attack.

Chair Dr. Amy Gutmann, speaking at a Commission session in San Francisco where the panel is discussing issues related to genetics and neuroethics, said that the panel will start to look at the issue later in the year, starting in a May meeting.

On Jan. 6, Health and Human Services Secretary Kathleen Sebelius asked the Commission for ethical advice on conducting clinical trials to develop medical countermeasures for the protection of children in the event of an attack.

“The safety of our children is paramount, and it is vital that we thoroughly address any and all ethical considerations relative to having adequate and available safety and immunogenicity data on our medical countermeasures to protect them before, during and after an event,” Sebelius wrote in a letter addressed to Gutmann as Commission chair.

Gutmann said in response today: “This issue gained significant public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine. We have been asked by Secretary Sebelius to look in-depth at the ethical issues surrounding” countermeasures to protect children.

The issue arose following a simulation of an anthrax attack in San Francisco to test whether emergency responders were prepared for the aftermath of such a crisis. One of the conclusions from the simulation was that the anthrax vaccine had never been tested in children, raising questions about whether health authorities should administer it to them following an attack.

The HHS National Biodefense Science Board, a federal advisory panel on issues related to bioterrorism and biodefense, recommended in October that bioethicists should examine issues surrounding effective countermeasures to protect children. Sebelius then turned to the Commission.

One of the sensitivities around testing the vaccine in children is that children cannot give informed consent on their own. Sebelius asked the Commission to look at the issue broadly, examining “how best to obtain clinical data on medical countermeasures in children.”

There was no discussion around the issue at today’s meeting.

Live from San Francisco

Welcome to the blog for the Presidential Commission for the Study of Bioethical Issue’s public meeting in San Francisco, which opens Thursday and ends on Friday, Feb. 2-3.

The meeting will focus on two issues: whole genome sequencing and neuroethics.

For a year, the Commission has been following issues surrounding the emergence of the whole genome sequencing as a part of clinical care and genetic research. Media reports say that the cost of whole genome sequencing will be reduced to around $1000 this year, which could lead to a significant increase in the use of the tests.

But many ethical issues remain around the testing, including data protection, privacy, consent, and counseling, and the potential use and abuse of data for nonmedical reasons. The Commission is expected to issue a report on the issue sometime in the fall of this year.

On neuroethics, the Commission will likely focus on advances in neuroimaging and the implications for moral philosophy and for moral and legal responsibility.

The meeting is scheduled to open at 9 a.m. PST on Thursday, and close at noon PST on Friday.

Please follow the proceedings of the Commission’s meeting through this blog and through a live-stream Webcast on the Commission website at www.bioethics.gov. The Webcast will be archived on the website, and a transcript of the proceedings will be posted following the meeting.

Compensation Expert Addresses Commission

In the course of its review of current human subjects research protections, the Presidential Commission for the Study of Bioethical Issues asked an international panel of experts to advise them on how the current system might be improved.  One of the recommendations of the international panel was that the U.S. government “should implement a system to compensate research subjects for research-related injuries.”  Many countries require provision for compensation, but the U.S. currently does not.  One key concern is that the current tort system does not compensate for non-negligent injury.  

Kenneth R. Feinberg

 To further explore that issue, the Commission turned to Kenneth R. Feinberg, Esq., who spoke to the Commission yesterday evening.  “We are honored and pleased to have you here today and admiring of the work you have done above and beyond the call of duty,” Commission Chair Amy Gutmann said. 

Mr. Feinberg was appointed the Special Master of the September 11 Victim Compensation Fund in 2001 and served until 2004.  As such, he was charged by the U.S. Government with determining how much compensation the families of the victims of 9/11 would receive.  About 97% of those eligible for the fund participated in it.    

In 2007, Virginia Tech asked Feinberg to serve as the fund administrator for the Hokie Spirit Memorial Fund following the shootings on the Virginia Tech campus. Feinberg was responsible for awarding compensation, paid for out of the $7 million donated to Virginia Tech in the wake of the shootings, to members of the Virginia Tech community affected by the tragedy and their families.  

He currently serves as the administrator of the Gulf Coast Claims Facility, which is a $20 billion fund established by BP to compensate those affected by the oil spill in the Gulf of Mexico in 2010.  

As he briefed the Commission, Mr. Feinberg emphasized that the Commission should consider: 

1)  Should there be compensation at all? 

2)  If you want to compensate, what form will the compensation take? For example, will it include money, medical treatment or loss of future wages? 

3)  If it means cash payments, who is paying for it? Is the Government?  Is private insurance? 

4)  How much compensation? 

5)  Who should receive payments? Should it be limited to research subjects or their dependents? 

6)  What are the criteria that trigger the payment?  Does there need to be negligence, recklessness, or intentional misconduct? 

7)  What are the procedures for establishing fact-finding and determination? 

The Commission will wrap up its discussion of compensation systems today and will hear from Daniel Wikler, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health in the Department of Global Health and Population at Harvard University, and Karen E. Moe, Director and Assistant Vice Provost for Research in the University of Washington Human Subjects Division.  The meeting concludes at noon today and the Commission’s final report on human subjects protections will be delivered to the President and released to the public in mid-December.

Commission Calls for Transparency in U.S. Government-Funded Research

As the Presidential Commission for the Study of Bioethical Issues continued its assessment of current protections for human subjects in research at its public meeting in Boston this afternoon, Commission member, Christine Grady, proposed that the Commission recommend improving transparency in U.S. Government-funded research.  Grady said that federal agencies could develop systems – or improve existing systems – to establish a publicly available listing of federally supported human subjects research. The call for such systems is in line with increasing appeals for government transparency and public access to information about research.

The recommendation stems in part from the Commission’s own Landscape Project.  As it worked to define the volume and scope of scientific studies supported by the government, the Commission found information to be incomplete, with no single listing available.  The Commission therefore requested basic data directly from eighteen federal departments and agencies to define the “landscape” of federally supported human subjects research. 

Commission Member, Lonnie Ali, expressed surprise at the lack of publicly available information because this research “involves individuals and people” – surprise echoed by other Commission members as well.

Amy Gutmann, Commission Chair, explained that such a database is not a “magic bullet” in assuring that human subjects are adequately protected from harm or unethical treatment.  But, she continued, although not sufficient, such a database is absolutely necessary to ensure ethical research. Without transparency into what research the federal government is supporting, there cannot be accountability in the conduct of that research. 

Commission Member, Dan Sulmasy, echoed that thought, saying that although a listing of U.S. Government-supported research projects cannot, in and of itself, reveal problematic research, it can provide insight into where to look to further to examine the ethics of research taking place.

The Commission’s final report, with recommendations, will be presented to the President and posted for public view in mid-December.

Commission Work Will Dovetail Nicely with HHS’ ANPRM

The Presidential Commission for the Study of Bioethical Issues today discussed how its current work assessing the contemporary rules and regulations that protect human subjects in research will nicely dovetail with the Department of Health and Human Service’s Advanced Notice of Proposed Rulemaking (ANPRM), which was released last summer. The ANPRM is entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

In August, at its last public meeting in Washington, the Commission heard from Zeke Emanuel, Former Chief of the Clinical Center Department of Bioethics at the National Institutes of Health, regarding the importance of this reconsideration of the regulations governing human subjects research. Indeed, it’s the first time the topic has been revisited in 20 years.

Today the Commission commended the drafters of the ANPRM for their thoughtful treatment regarding the revision of what has come to be known as the “Common Rule,” i.e. the rules for human subjects research protection ostensibly common across the government. The opportunity for the Commission to comment on the ANPRM is particularly valuable in light of their current charge from the President to “determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal government.” Indeed, the ANPRM itself commits to taking into account “the deliberations of the Presidential Commission for the Study of Bioethical Issues.”

Commission Member John Arras introduced the idea that the Commission has the opportunity to recommend the proper “pruning” and allow for the proper “budding” of professional standards of ethical requirements for researchers. In other words, prune where excessive regulations should be cut back, and encourage budding where further creative methods to achieve ethical standards could be developed.

“There’s an opportunity for us to be very specific about some places we think there should be pruning,” Chair Amy Gutmann said. However, she cautioned that one can prune well and “something more vigorous can prosper, or you can prune and kill.”  Gutmann added that obviously the Commission does not “want to kill important rules, we want them to actually be stronger as a result.”

Commission Member Barbara Atkinson emphasized that when revisiting regulations, it is of primary importance not to lose sight of what the rules were intended to achieve, namely creating a regulatory structure to enact the ethical principles behind human subjects protection. In particular, the Commission considered the ANPRM discussion on the importance of “harmonization” and improving the consistency of guidance on the protections of human subjects across federal departments and agencies.

Indeed, the Commission’s subcommittee, the International Research Panel, in its publication, “Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues,” recommended to the Commission in August that “continued efforts to harmonize and guide interpretation of rules should be made a priority over creating new rules.” The International Research Panel acknowledged that new rules may be needed to harmonize existing U.S. rules, but any additions must be clear, sound, and streamlined. The Commission agreed that harmonization across the federal government would add clarity to the U.S. oversight process, particularly for international clinical trials.

“We should put forward a standard that maintains the highest level of protection,” Atkinson concluded.