Residual Dried Blood and New Born Screening in Minnesota

Note: The Bioethics Program blog is moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Courtney Jarboe, Bioethics Program Student

In Minnesota, residual dried blood (RDB) samples collected for newborn screening had been stored, retained, and used for research without parental consent. It had been presumed that the Minnesota Department of Health (MDH) had the statutory authority to do so. In 2011, the Minnesota Supreme Court ruled (in the case of Bearder v. Minnesota) that the newborn screening program was subject to the Genetic Privacy Act (2006) (pdf), which requires written consent for secondary uses of genetic information. This ruling led to revisions of newborn screening legislation and the destruction of 1.1 million newborn screening RDB samples. Since the legislative dust has settled, MDH has begun aggressive educational campaigns to rebuild trust and awareness between parents and healthcare providers in Minnesota and address information gaps in the public’s understanding of the newborn screening program and the associated research.

In February of this year, I received a letter from the Citizen’s Council for Health Freedom (CCHF), an organization that actively supported the nine families in Bearder v. Minnesota who sued to stop the use of RDB samples for research. (see image) The letter details CCHF’s concerns about the MDH newborn screening program. The letter also suggests that MDH can use the RDB and the associated child’s DNA without parent consent. Included with the letter were a letter addressed to MDH and a copy of the MDH ‘Directive to Destroy’ form.

CCHF disclosed in late March that they distributed the letter to roughly 10,000 parents across the state based on birth certificate records. Within just a week of CCHF’s distribution of the letter, MDH received 59 directives to destroy RDB samples and related results. This was more than the total number of requests in the previous 5 months before these letters were sent out.

I was particularly interested in this letter because of my master’s project on Minnesota’s newborn screening program. Because this wasn’t my first exposure to the newborn screening program in Minnesota, I realized that I might be able to help clarify some of the aspects of this letter that other parents should be aware of. First, CCHF claims that, “Consent requirements mean ownership claims. But now, only if you object will the State release ownership claims to your baby’s DNA.”  However, CCHF is asking parents to complete “the official state opt-out form” and return the “I Did It” postcard. However, this is misleading as the form is actually the ‘Directive to Destroy Newborn Screening Samples and Test Results’ form. CCHF does not inform these parents that they could submit a request to MDH to return the remaining samples back to them. The ‘Directive to Destroy’ may not be the best choice for every family. What if that family should avoid destroying the sample due their medical history?

CCHF also claims “Without consent, the law allows research to be conducted on your child.” After Bearder v. Minnesota, this claim is simply not true. MDH stores and retains residual dried blood samples and test results from infants that participated in the newborn screening program as of August 1, 2014. These samples are used for quality assurance testing and the development of new tests for the screening panel, but the law does not allow research to be conducted on these samples. If they should wish to do research, researchers and MDH must obtain written informed consent from parents in order to use samples (Parental Consent for Research Use of Newborn Screening Blood Spots and Test Results).

Parents who have questions about their state’s newborn screening program practices should consult with their primary care provider or state’s newborn screening program office. If their provider cannot provide the answers, the state’s newborn screening program should have staff available to assist them. For more information about Minnesota’s newborn screening program, visit the state’s website. Information about other state programs, including contact information can be easily found on Baby’s First Test.

Jarboe Minnesota Letter (1) Jarboe Minnesota Letter page 2 (1)

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Advertisements

Guatemala, the GDR and Research Ethics Policy Development

Note: The Bioethics Program blog will be moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Andrei Famenka, Bioethics Program Alum (2013)

When it was first announced, I was particularly intrigued by a recent webinar called, ‘Gonorrhea, Guatemala and Gung-Ho Researchers: The Role of Controversy in Shaping Research Ethics Practice and Policy’. This particular topic was of special interest to me because of my interests in research ethics policymaking and the role of social, cultural, and economic factors in this process.

As good as the webinar was, it highlighted a peculiar fact: although a good deal of attention has been paid to unfair research conducted in developing countries, such as Guatemala Gonorrhea study, such analyses have primarily focused on the impact of these controversial studies on research ethics policy development in the United States. Missing from these analyses is the impact that the scandals have had on research ethics policies in developing and transitional countries where the unfair practices have occurred. This lack of analysis is significant because these controversies often fail to lead to policy changes in developing and transitional countries.

One of the latest examples of unethical research which didn’t result in any policy modification comes from Eastern Europe. It has recently come to light that just before the fall of the ‘iron curtain’, some major Western pharmaceutical companies conducted hundreds of controversial drug trials in the German Democratic Republic (GDR, the Communist former country of East Germany), in which more than 50,000 East German patients served as guinea pigs—many without their knowledge or consent. More than 600 drugs were tested on unwitting East German patients, including prematurely born infants, alcohol addicts, and people diagnosed with depression. Moreover, despite suspicions that some of the trials resulted in several fatalities, the participating hospitals were reluctant to investigate.

Despite hot debates in the media, the controversy over this unethical research didn’t push policymakers in the countries of Eastern and Central Europe to revise the current policies and programs on the protection of human subjects. And yet, recent research on Baltic countries, Belarus, and Poland clearly demonstrates these policies are lacking.

Although it has become almost a proverb that research ethics was ‘born in scandal’, a closer look at the history of research ethics provides evidence that no matter how big a scandal might be, it can result in policy change only if it resonates with broader social movements or shifts in public views, ideas, and values. In fact, outrageous scandals, hot debates, and profound controversy can serve only as triggers or catalyzers of change under the right socio-political, cultural, and economic conditions. This reflects the views presented by Ezekiel Emanuel and Christine Grady when they argue that over the past 70 years, the system of research oversight in the United States has evolved through four distinct stages. These stages embodied different values and perspectives on research and reflect dominant views in general society. Research oversight changed as these dominant views evolved over time.

Central and Eastern European countries still lack a strong civil society and sufficient levels of political freedom, economic and social opportunities, and transparency guarantees. The enabling conditions for a strong set of research ethics policies is not sufficiently in place. Attempts to force these policies would only create confusion about the underlying ethical values and the goals of the research oversight.

The way to ensuring the protection of human research subjects in transitional countries is most likely to be a long and difficult one, as it involves efforts to reshape some basic elements of society. In this regard, training programs are an important part of the process, but these will only be successful when they are coupled with broader social changes.

[The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

How to Get A Head in Life

Note: The Bioethics Program blog will be moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Bonnie Steinbock, Bioethics Program Faculty

An Italian scientist, Sergio Canavero, claims that he is two years away from performing the world’s first human head transplant, in which the head of one person would be grafted onto the body of a newly deceased person

Canavero’s proposed procedure would involve cooling the patient’s head and the donor’s body so that their cells do not die during the operation. After the head is cut off the patient’s body, the blood vessels would be lined up, and the spinal cord cut with a very sharp knife to minimize nerve damage. The patient would have to be immobilized by being kept in a coma for several weeks. Canavero believes that the patient would be able to speak when he woke up, although a year or more of physical therapy would be necessary for him to be able to move his body.

The biggest technical obstacle is that no one knows how to reconnect spinal nerves and make them work again, although there has been some success with animals. In 1970, a team at Case Western Reserve transplanted the head of one monkey onto the body of another, although they did not attempt a full spinal cord transfer. The monkey was unable to move its body. In 2014, researchers at Harbin Medical University in China were able to preserve breathing and circulatory function in mice. However, as is well known, “everything works in mice.” Most neurosurgeons are skeptical that this would work in humans. Moreover, it seems unlikely that ethics review boards today would approve experiments to see if the procedure worked in non-human primates.

Technical challenges aside, there are a number of ethical questions to be considered. We know that some people have been unable to adjust to transplanted appendages and have even had them removed. The psychological impact of waking up with a new body is unknown: how would you get truly informed consent for that? Nevertheless, if the procedure would save the patient’s life, and the alternative is death, perhaps this is a risk we should let competent adults take.

But would the patient’s life be saved? This is not a medical or scientific question, but a conceptual or metaphysical one. It depends on one’s theory of personal identity. On one view, known as mind essentialism, we human persons are essentially embodied minds, that is, embodied beings with the capacity for consciousness. Since the capacity for consciousness resides in the brain, we are our functioning brains. If your brain could be transplanted onto someone else’s body and continue to function, you would continue to exist.Indeed, philosopher Jeff McMahan created the hypothetical example of a brain transplant as evidence for mind essentialism.

An opposing view of personal identity holds that we are not essentially minds, but human animals or organisms. Its primary supporter, David DeGrazia, holds this to be a matter of educated common sense, and its denial by mind essentialism to be a serious defect in the theory. But what about the plausible intuition that “you go where your mind goes”? Its plausibility stems from the conflation of two distinct senses of identity: numerical and narrative. Narrative identity is psychological. It involves our sense of who we are: our beliefs, memories, values, and intentions. By contrast, numerical identity refers to what makes me the same individual, over time. On the human organism view of identity, I would continue to exist as the same individual even if my narrative identity were lost, as it would be if I permanently lost consciousness, as in permanent vegetative state (PVS).

We care deeply about narrative identity, DeGrazia says. Indeed, it is “what matters in survival.” That is why most people would not want to be sustained in (reliably diagnosed) PVS. Nevertheless, the organism account allows us to say that we can become PVS. On the embodied mind view of identity, this is literally impossible. My organism could become permanently unconscious, but since I am not my organism, I would no longer be there.

Both are plausible metaphysical views: which one is correct? In my view, neither, because both rest on the questionable assumption that we are essentially something. Why insist that we must be either embodied minds or organisms? Why can’t we be both? As a person, Terri Schiavo, ceased to exist when her cerebral cortex permanently ceased functioning in 1992. As a human organism, she died in 2005. And if she has an immortal soul, she continues to exist today.

From a practical perspective, the view of identity one takes doesn’t really matter as regards head transplants, since it is narrative identity that matters in survival. But would narrative identity be preserved? This is not simply a matter of reconnecting the spinal nerves, enabling the reconstructed person to be awake and sentient. If the patient woke up and had none or few of the memories, beliefs, values, or concerns he had before the head transplant, his narrative identity would be lost. Unless there was a possibility of recovering many of the mental contents of his mind, it is hard to see what benefit there would be in even a successful head transplant.

[The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Can Social Media Save Us from the “Spiral of Silence?”

by Karen Solomon, Bioethics Program Student

Studies suggest that, before the advent of the Internet, we are unlikely to share minority or unpopular viewpoints with our co-workers, friends and relatives. This inclination creates, in essence, a “Spiral of Silence.”

But does the Internet provide a remedy to the “Spiral of Silence,” by encouraging online discussion of viewpoints that may be unpopular? Contrary to the hopes of social media advocates, new research finds that social media may not provide a voice to those who feel uncomfortable expressing minority viewpoints in face-to-face relationships.

Scientists at the Pew Research Center surveyed 1801 adults regarding a political issue over which public opinion was divided: Edward Snowden’s leak of the US government’s extensive surveillance program. The survey examined three areas: subjects’ opinions about the leaks, subjects’ willingness to express their opinions about the leaks in both online and face-to-face contexts, and subjects’ perceptions of others’ opinions in online and face-to-face settings.

They found that those who were not comfortable discussing their opinion about the Snowden leaks in face-to-face discussions were also unwilling to use social media as an outlet to post their viewpoints. Among the 14% who would not discuss the leaks in face-to-face discussions, only 0.3% of these were willing to post their opinions on social media.

In fact, researchers found that the “Spiral of Silence” also applied to social media. Those on Facebook were twice as willing to share their views with their Facebook network when they believed their network was in agreement.

Several factors may explain our continued unwillingness to share controversial opinions, including concerns that online posts may be viewed by future employers or by those in authority. It could also be that social media users, exposed to a wide range of opinions via their social networks, are less willing to speak up because they are “especially tuned into” others’ opinions.

But what would it mean if use of social media does not provide a voice for discussing viewpoints we believe are unpopular? What if social media does not encourage more diverse outlooks on topics we care about? What if instead of encouraging discussions, it turns out that use of social media does the opposite and actually stifles expressing opinions our face-to-face interactions, even when we feel others would agree?

Social media is still relatively new, despite its far-reaching impact on how many of us communicate. If we accept that our willingness to share opinions and reactions to events and information is important to how we learn, understand, and think about what is important for us in managing work, school, and our relationships, then this study provides plenty of food for thought. Online learning is ever more important for higher education, which is increasingly provided online and integral to the training and education of professionals, including tomorrow’s bioethicists.

Discussions that nurture diversity of opinion foster sound ethical decision-making. Research into group decision-making cites diversity of opinion as an essential quality of “wise groups.” Diversity of opinion allows for the consideration of all relevant information, surmounting the “herd mentality” that can rob groups of their independence when tackling ethical dilemmas. Recognizing and addressing obstacles to deliberative decision-making is integral to the consistent application of ethical principles across domains, including social media and ethics blogs, discussion boards in online bioethics courses, and hospital ethics committee meetings.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

The Early Bird Get the Ethics?

by Karen Solomon, Bioethics Program Student

Does early to bed and early to rise, make a man healthy, wealthy and more ethical? Earlier research suggested a “morning morality effect”: that people are more ethical early in the morning, becoming less so as they “wear out as a day wears on.”

Not so fast, researchers now say. New research casts doubt on conceptions that night owls are less ethical than their early rising lark counterparts. Instead, a better predictor for ethical behavior takes into account the “fit” between one’s chronotype — night owl or morning lark — and the time of day when ethical behavior is implicated.

Consider the night owls who have more energy as the day wears on, with peak energy levels in the evening. Researchers postulated if internal body clocks supply the energy for ethical behavior, then the body clocks of night owls, people who have more energy as the day wears on, should overcome the morning morality effect, and demonstrate more ethical behavior in the evening.

To test this hypothesis, researchers asked participants to complete a matrix task or a die role and report the outcome, for the opportunity to earn a nominal monetary reward or tickets toward a raffle. What researchers evaluated, however, was the participant’s honesty in reporting the actual task outcome. Researchers found morning larks more likely to report task outcome honestly in the morning, during the larks’ peak energy hours. Conversely, night owls were more likely to behave ethically in the evening, confirming researchers’ belief that the fit between chronotype and time of day are better predictors of ethical behavior than chronotype alone. (Gunia, Barnes, & Sah, 2014)

Future research is needed to uncover the underlying mechanisms involved in the “chronotype morality effect” and the impact of interventions that boost the match or aggravate the mismatch between chronotype and time of day. However, these results clearly have broad implications, particularly for shiftwork in the workplace.

For example, understanding how body clocks inform ethical decision-making by health care professionals, particularly those involved with hospital emergency rooms and critical care units, may become a valuable tool in responding to the intense and often unpredictable nature of ethical dilemmas that characterize medical ethics. Such decision-making encompasses a range of highly personal and emotional health care decisions, including end-of-life care, organ donation, starting and stopping life-sustaining treatment, and informed consent. Such medical ethics decision-making also reflects the untimely nature of accidents, illness, and other tragedies.

In the future, health care administrators and professionals who understand the importance of aligning those involved with ethical decision-making with processes that take into account optimal times for ethical decision-making may provide the best opportunity for ethical decisions that stand the test of time. For example, scheduling ethics consultations and professional staffing consistent with optimal times for sound ethical decision-making may confirm the conventional wisdom that timing is, in fact, everything.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Taking the Icy Plunge (Or Not)

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

There’s an epidemic that is sweeping this country. It’s not Ebola, despite all of the hype and misinformation about that disease that has dominated the news in the past two weeks. Rather, I’m talking about the ice bucket challenge.

Anyone who has watched television in the last couple of weeks has seen this: newscasters, celebrities and athletes like Matt Lauer, Martha Stewart and Nick Swisher being doused with a bucket of ice water in the name of charity. The goal of the ice bucket challenge is to raise money and awareness about amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease).

ALS is a neurodegenerative disease that affects nearly 30,000 Americans. It primarily affects people in their mid-40s to mid-60s, and is characterized by an increasing loss of motor function. Initial symptoms include muscle weakness or slurred speech. As the disease progresses these symptoms become increasingly pronounced. Patients with ALS gradually lose the ability to walk, speak, eat and (eventually) breathe. They slowly become prisoners in their own bodies, fully aware but trapped in an increasingly uncooperative shell.

The root cause of the disease is still unknown, and there is no known cure. Treatments can slow the onset of symptoms, but most patients succumb to the disease rather quickly. The majority of people living with ALS die within 3-5 years of their initial diagnosis, although there are notable exceptions like famed physicist Stephen Hawking, who has lived with the disease for over 50 years

The federal government spends about $60 million on ALS research. Private organizations like the ALS Association also spend money, both to develop new treatments and to provide care for those affected by the disease. As a non-profit organization, however, the ALS Association depends on contributions from people like you and me, and that’s where the ice bucket challenge comes in.

The challenge is simple. A person either donates $100 to the ALS Association or agrees to post a video of them getting doused with ice water on a social media site like Facebook (usually with a hash tag like #IceBucketChallenge or #StrikeOutALS). That person then challenges three of their friends to do the same: donate or get doused.

The campaign has been remarkably successful. In the past month, the ALS Association has raised over $1.5 million. Donations are up nearly a hundredfold since the campaign began. That’s a good thing, so what I’m about to say is likely to be surprising and even a little upsetting to some.

I think the ice bucket challenge is a crock, and I want no part of it. To all my friends who have called me out on Facebook to participate, my answer is ‘no’.

This isn’t to say that I don’t believe that ALS is a terrible disease. It is. I have seen the effects first hand, when the brother of a close friend contracted the disease. I have also donated to the ALS Association in memory of a former student’s father, who died from complications related to ALS last year

I am opposed to the ice bucket challenge for a number of reasons. First, I don’t believe that it does anything to raise awareness of ALS in the long term. Most of the videos that I have seen posted on Facebook, Vine and other social media sites say little to nothing about the disease and its impact on the families affected by ALS. They also don’t discuss why monetary donations are desperately needed, where to donate to, or how the money will be used.

Second, I have a real problem with a fundraising campaign in which public humiliation or exhibitionism seems to be the primary goal, with donations to a charitable cause an afterthought. Consider the rules of the ice bucket challenge: you either film yourself getting doused with ice water or you donate $100 to a charity. Charitable donations are the consolation prize in this extortive game.

In fact, what most people don’t realize is that the ice bucket challenge predates the ALS Association campaign. It was actually started as a game among pro athletes like golfer Greg Norman, with those who refused asked to donate to a charity of the challenger’s choice. The original challenge was never about raising money or awareness of a charitable cause, and now we have thousands or millions of Americans who feel like they’ve contributed to ALS research without actually doing anything.

If you want to help those living with ALS, dunking a bucket of cold water over your head is not the way to do it. Rather, you should visit the websites of organizations like the ALS Association and learn more about the disease. You should donate money to the cause and encourage your friends and family to do the same (without subjecting them to hypothermia). You should write your Congressional representatives and encourage them to increase funding for ALS research. Finally, you should consider donating your time to help those with the disease and their families.

Save the ice for your drinks.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on August 14, 2014, and is available on the WAMC website. The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

My Slate Article on the Importance of Replicating Science

By Michelle N. Meyer, Assistant Professor and Director of Bioethics Policy

I have a long article in Slate (with Union psychology professor Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:

  • The facts that replication, despite being a cornerstone of the scientific method, is rarely practiced (and even less frequently published) not only in psychology but across science, and that when such studies are conducted, they frequently fail to replicate the original findings (let this be a warning to those of you who, like me, cite empirical literature in your scholarship);
  • Why replications are so rarely conducted and published, relative to their importance (tl;dr: it’s the incentives, stupid);
  • Why it’s critical that this aspect of the academic research culture change (because academic science doesn’t only affect academic scientists; the rest of us have a stake in science, too, including those who fund it, those who help researchers produce it (i.e., human subjects), those who consume and build on it (other scholars and policy-makers), and all of us who are subject to myriad laws and policies informed by it); and
  • Some better and worse ways of facilitating that cultural change (among other things, we disagree with Daniel Kahneman’s most recent proposal for conducting replications).

[The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]