Now, as the administration develops plans for this new group of advisers, is a perfect time to reflect on the history of national bioethics commissions and to consider specifically the work of the last commission. As well, clarifying the goals of a new commission could help to set guidelines for establishing the new commission, such as who should serve and what specific issues it will pursue.

If the Obama administration hopes to take this commission beyond the culture wars that embroiled much of the Bush council’s work,[1] substantial efforts will be necessary to bring together now-divided bioethicists for pragmatic discussion.

The origin and evolution of bioethics commissions

There have been many bioethics commissions over the past 35 years,[2] established for various purposes, as science advanced and the political and cultural climate shifted. The four commissions highlighted here illustrate strengths and weaknesses of commissions in general.

Congress established the first bioethics commission in 1974,[3] dubbed the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Against the backdrop of controversies like Watergate and Vietnam, the commission addressed the issues of how to protect citizens participating in scientific research. In the wake of the Tuskegee Syphilis Study, in which researchers denied African Americans with syphilis information about available treatments, and secret government experiments involving LSD, there was a recognized need to ensure that scientists conducted such research ethically. The commission authored the famous “Belmont Report,” which enumerated the rights of human subjects and the duties of researchers. The report laid out a set of principles that still underscore most bioethical work today: the need for justice, autonomy for research subjects, and beneficence on the part of researchers.

The remarkable success of this commission in translating its recommendations into policy likely lay in the fact that Congress both established the commission and specifically charged it with the mission to make policy recommendations. The members’ success in negotiating decisions seems, from their reports, attributable to a willingness to set aside ideology and work together to solve pressing issues. Although the members came from different ideological backgrounds, they managed to forge a “great Bioethics Compromise” which involved a mission to:

Keep a close eye on scientific innovation for its societal implications, apply the brakes now and then as needed through regulations or guidelines or just the glare of public discussion, and let the bioethicists be the ones to analyze how all this is going.[4]

The compromise relied upon an “implicit agreement that in effect allowed deep divisions about certain issues related to the origins of human life to be courteously ignored.”[5] That is, the commission was able to do the important work of tackling hard questions with a goal of protecting people involved in scientific research without getting bogged down in arguments about sensitive issues like abortion. Although this compromise persisted through the 1970s and 1980s, the culture wars that emerged during the Reagan administration shattered it and forced new commissions to deal with divisive approaches to bioethics. This highlights the new commission’s need to set aside ideological quarrels in order to serve the national need for pragmatic approaches to complex bioethical issues.

The congressionally established President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research operated from 1979 to 1983. This commission produced important reports on difficult topics like informed consent and genetic engineering. In perhaps the commission’s most well-known work on informed consent, “Making Healthcare Decisions,” researchers surveyed members of the public and physicians to reach some of their conclusions. This process, along with the commission’s other efforts, allowed the commission to “bring ethical analysis of the implications of medical practice and research out of the classrooms, the hospital wards, and the scholarly journals and into a public forum in Washington.”[6] The lesson for a new commission is that it should consider the utility of gathering data to inform their recommendations.

In the thick of the culture wars, President Clinton established the National Bioethics Advisory Commission in 1997 by executive order 12975. This commission addressed research ethics, emerging genetic technologies, and public and Congressional concerns about new issues like the ethics of stem cell research, cloning human beings, and conducting research on human subjects in developing countries. No doubt, there will be specific issues the Obama administration wants to address, but it is important that the new commission likewise be permitted to address some newly emerging issues as they see fit.

Although none of the recommendations made by this council were enacted verbatim, according to Elisa Eiseman, a researcher at the RAND institute, many federal and state bills were based on the council’s work and “thirteen bills were introduced in Congress that specifically mentioned NBAC.” Eiseman also explains that many professional societies disseminated NBAC’s publications and many foreign governments considered their recommendations. As Daniel Callahan, a co-founder of the Hastings Center, points out, this commission was largely composed of left-leaning members.[7] Although the commission’s reports were well discussed in the bioethics literature, garnered the attention of policymakers, and the commission did well to probe some important topics, the long-term impact of the group’s work is questionable.

The most recent commission, the President’s Council on Bioethics, emerged during the debate about human embryonic stem cell research. President Bush established this council to assist in his administration’s consideration of this new scientific field, as well as the challenges posed by new biotechnologies. Leon Kass, a prolific scholar from the University of Chicago, initially chaired the council. Given that Kass was well known for his conservative views about biotechnologies, this choice set a tone for the work of the council under his direction. During his chairmanship, from 2001-2005, the council published works on stem cell research, human dignity and human cloning, and the distinction between therapy and enhancement, which often reaffirmed or justified the views of the Bush administration.

In 2005, Edmund Pellegrino, a distinguished physician and professor emeritus at Georgetown University, took charge of the council. Under his chairmanship, the council authored reports on human dignity and bioethics (critiqued here on SP), and on end of life issues. Dr. Pellegrino is well known for his “diplomatic” approach to dilemmas in bioethics, and as expected, under his direction, the council assumed a less “activist” stance.[8]

The roles of a council

Before formally establishing its bioethics commission, the Obama administration should consider the roles it wants the commission to play. Considering these roles will allow the new commission to focus its efforts and resources appropriately. The stated purpose of the Bush council, as set forth in a 2001 executive order was:

1. To undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology;
2. To explore specific ethical and policy questions related to these developments;
3. To provide a forum for a national discussion of bioethical issues;
4. To facilitate a greater understanding of bioethical issues; and
5. To explore possibilities for useful international collaboration on bioethical issues.

Each of these roles, however, requires a different set of tools. The new commission could choose to play each of the roles charged to the Bush council, but each would require a different approach. For example, if a new commission aims to participate in scholarly discourse, it should take much different steps than if it aims to educate the public and gather data about public opinion. Consider, for instance, the issue of creating human admixed embryos recently debated in the United Kingdom.

A human admixed embryo is created using the cytoplasm of a rabbit or cow egg and the nucleus from a human skin cell. The nucleus of the human skin cell is transferred to the cytoplasm of the rabbit or cow egg to create a 99.9 percent human and 0.1 percent animal embryo. Researchers hoped to use the technique to provide an ethically neutral source of human embryonic stem cells, in light of a shortage of human embryos and human eggs. But before this research took off, the issue became moot because induced pluripotency stem, or iPS, cell technology provided an ethically neutral source of embryonic-like human stem cells. However, the British approach to this dilemma is an excellent model for future bioethics commissions interested in public education, public consultation and empirical research.

To address ethical questions surrounding this sort of research, the Human Fertilization and Embryology Authority, the body charged with investigation and regulation of reproductive technologies in the United Kingdom, conducted a three-month, large-scale public consultation, which resulted in a published report that included data gathered during the consultation, for use in policy formulation. The consultation process involved offering members of the public balanced, accessible information about the technology, including a small educational booklet. As well, the HFEA brought leaders in science, academia, theology, and interest groups to speak at public forums and to answer questions. After all of these efforts, the HFEA decided to grant licenses to researchers interested in creating human admixed embryos, so long as the researchers could demonstrate that the embryos were “necessary and desirable.” The HFEA granted two licenses to King’s College London and Newcastle University to study admixed embryos. However, the attractiveness of the research as an alternative source of stem cells decreased in light of iPS cells.

In contrast, the Bush bioethics council published tomes that discuss issues firmly rooted in the academic weeds as a starting point for public education (e.g., as mentioned above, the difference between therapy and enhancement and the role of human dignity in bioethics). Certainly, these efforts are commendable, and might have enlivened some academic debates, but they do not engage the public en masse.

After the administration clarifies the role of the next commission, its membership needs to be tailored to fulfill its mission. The last was a who’s-who of right-leaning bioethicists, along with some scientists. The next commission might choose to recruit a more diverse membership of both distinguished right- and left-leaning bioethicists, as well as scientists, theologians, practicing physicians, and a few members of the public. Doing so will enable the new commission to make decisions based on the best available evidence, scholarship, and public sentiment. Diversity of membership also tends to yield a diversity of views and approaches to addressing dilemmas, essential to confronting increasingly complicated issues.

Finally, if the new commission chooses public engagement as one of its goals, it should harness new technologies to garner public interest and to enliven public debate, including social media tools such as Twitter, Facebook, MySpace, email outreach, blogs, podcasts, YouTube, and other outlets used daily by members of the public.

If the new commission hopes to craft policy for the president and for various governmental agencies, it will need to take notice of the proverb “easier said than done.” As James Fossett and Michelle Meyer point out in a recent Bioethics Forum article:

Bioethical policy in this country is typically made in a decentralized, market-driven fashion in which state legislatures and courts, professional societies, insurance companies, and individual patients and providers are major players.

If the commission gathers data, considers public sentiment and through careful analysis offers balanced, thoughtful reports and policy recommendations, it could become a major player in policymaking by informing decision makers, stakeholders, and constituents. And this may be the best role for a president’s commission hoping to play a role in crafting policy.

Another possible role for the new commission in a globalized world, Fossett and Meyer explain, is “attending to international law and policy, and there is a clear role for a federal commission to play in this regard.” The new commission might choose to partner with similar bodies to accomplish this goal, or it might choose to assist the current work by the United Nations’ Bioethics Programme.

Finally, the commission should consider its role in academic conversations. If the council wants to be a subject of discussion because of its actions, it might be best to proceed by informing the public, working with foreign nations, and offering “practical policy options.” However, if the commission chooses to directly participate in academic bioethical discourse by publishing in journals or writing about philosophical nuances, which are important, it should structure itself appropriately.

A “data-driven” council

To go beyond the culture wars, the new bioethics commission needs to engage in “data-driven” or “question-driven” inquiry, rather than “ideology-driven” inquiry. Consider how the process of thinking about stem cell research ethics operates in each approach.

Proceeding from ideology-driven inquiry entails starting from an answer: “Research on human embryonic stem cell should be forbidden because embryos are equivalent to human lives” and working backwards to a question: “Is research on human embryonic stem cells ethical?” Proceeding with data-driven inquiry means starting with the question: “Is embryonic stem cell research ethical?” and then taking the time to educate the public, gather information about public sentiment on the topic, carefully analyze the costs and benefits of proceeding with or prohibiting the research, and offering a pragmatic recommendation that takes all of these considerations into account.

Recognizing the need for fast decision making in rapidly advancing scientific fields, at the minimum, data-driven inquiry entails considering the best available evidence before making decisions. Considering the delays in research that the Bush administration’s moratorium on human embryonic stem cell research and ideology-driven inquiry caused, a bit of time lost in the more pragmatic data-gathering process is a small cost.

Fossett and Meyer also argue the council might consider empirical analysis one of its main goals, like analyzing the effectiveness and outcomes of various local, state, national, and international bioethical policies. Offering analysis of the outcomes of these policies could aid policymakers in the United States in making better-informed decisions, in crafting policy that avoids mistakes of the past, and in offering the most pragmatic recommendations.

Rules of the road

From potential disease treatments derived from human embryonic stem cells to pre-implantation genetic diagnosis, the 21^st century already presents us with unparalleled biotechnological power. But with these technologies comes the risk of misuse, and we need regulation based on the best available science, data, and public opinion. As renowned futurologist James Martin explains,

You should think then of the 21^st century as taking us though a driving test and then establishing a Highway Code so that we can be reasonably safe with the forces of technology and globalism we are unleashing.[9]

Will we establish an appropriate Highway Code that permits scientific progress while ensuring that we do not harm ourselves? Of course, our future depends on it. And establishing a new bioethics commission is an excellent step in that direction.

Michael Peroski is a student at Allegheny College and a former intern with the Progressive Bioethics initiative at CAP, where he co-authored the report “A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically.”

Endnotes

[1] For a detailed discussion of the culture wars as they affect bioethics, see: Fox, R., C., Swazey, J., P., Observing Bioethics (New York: Oxford University Press, 2008).

[2] The source of this historical chronology is: http://bioethics.gov/reports/past_commissions/index.html. The President’s Council of Bioethics repackaged this information, with permission, from: Poland, S.C. (1998). “Bioethics Commissions: Town Meetings with a ‘Blue, Blue Ribbon.’” Kennedy Institute of Ethics Journal, [Scope Note 34], March; 8(1):91-109.

[3] Although the first formally established bioethics commission came into existence in 1974, several panels, which debated how to address unethical, secret government experiments in the 1950s and 1960s, are its precursors. For a more complete discussion of these precursors see: Moreno, J.D., Undue Risk (New York: Routledge, 2001).

[4] Moreno, J.D., “The End of the Great Bioethics Compromise,” The Hastings Center Report, Jan-Feb (2005); 35 (1): 14-15.

[5] Moreno, 2005.

[6] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (1983). Summing Up: The Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research.

[7] Callahan, D., “Bioethics and Culture Wars,” Cambridge Quarterly of Healthcare Ethics, (2005) 14, 424-431.

[8] The source of the assertion that the council became less “activist” under Dr. Pellegrino’s direction is: Fox, R., C., Swazey, J.P., Observing Bioethics (New York: Oxford University Press, 2008).

[9] Martin, J., The Meaning of the 21^st Century: A Vital Blueprint for Ensuring our Future (London: Eden Project Books, 2006).

About two million patients take warfarin, or coumadin, each year to prevent blood clotting during medical procedures. But thousands of these patients experience bleeding complications due to inappropriate dosing of the blood thinner, and many die. From August 4^th through September 3^rd this year, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services invited public commentary on whether Medicare should fund genetic tests to determine a patient’s warfarin response. Genetics, weight, sex, and age factors determine roughly 45-60 percent of the variance in response to warfarin, so these tests could prevent many adverse events. This possible change in policy might save thousands of lives and highlights the need for a more comprehensive approach to the field of personalized medicine.

Determining the appropriate amount of warfarin to administer to a patient is very difficult for physicians because there is a wide variance in response to the medication. The Food and Drug Administration approved a genetic test last year that allows physicians to better gauge how much warfarin to administer by checking two genes. Although the cost of these tests has dropped, the current price is approximately $500, which prohibits many seniors from benefiting from the best available care.

Some research indicates that using this genetic test might result in savings for the healthcare system. For example, Genelex reports, “cost effectiveness will be achieved if 33-47 percent of the anticipated number of bleeding events are avoided.” Doctor Raymond Woosley of the Critical Path Institute told U.S. News and World Report that “this test can save $1.1 billion in health-care costs and 18,000 lives a year.” There are methods for checking how a patient responds to warfarin, but as Wired explained, “In a perfect world, physicians would use both [the genetic tests and handheld devices like the Roche CoaguChek system that allow physicians to constantly monitor a patient’s blood] to aid in their decisions.”

If DHHS approves Medicare to fund this test, it could provide a push for the developing industry of pharmacogenomics. Moreover, this potential application of personalized medicine offers an alternative to conventional trail-and-error techniques by allowing physicians to tailor care to an individual’s unique clinical, genetic, and environmental information. This might well be the next medical frontier, but the field itself is in need of help due to genetic data that may not be ready for clinical application. In a recent Science Progress article discussing genomics, bioinformatics, and proteomics, Arthur Caplan explained:

This rapidly growing sector is riding an ill-grounded wave of hype that makes weak, next-to-useless correlations between gene markers and disease states without really having much idea what to tell its customers to do about the risk information that testing companies find.

To unleash the full potential of pharmacogenomics, the FDA and DHHS will need to make sure that the useful products get to the patients who need it and that the snake oil salesmen do not discredit the whole industry.

Given recent research advances in regenerative medicine, ethical questions surrounding federally approved stem cell lines, and the likelihood that the next president may change existing rules for research, it’s time for some new thinking on stem cell policy.

In order to streamline research and improve research collaboration, the federal government needs to establish either a national stem cell registry and or a national stem cell bank for all human embryonic stem cell lines. A stem cell registry would be simply a database of all stem cell lines that are available to researchers through an organization such as the National Institutes of Health. The registry would contain all information about the cells, including the date and place of their procurement, the informed consent protocols used to obtain the embryos from which the cells originated, the biological makeup of the culture media used to nourish the cells, and the results of tests performed on the cells. A bank, on the other hand, would provide a central physical location where the cells could be stored so that a research organization could then distribute them to approved scientists who request them.

The National Stem Cell Bank contract expires in September 2009, and needs to be reconsidered, modified, extended, or terminated depending on the utility of the bank and the next administration’s stem cell policy.

Banks and registries are useful because they help to coordinate research and facilitate research collaboration. Indeed, major innovations in the United States are usually driven by research collaboration. A recent study from the Information Technology and Innovation Foundation found that over the past 35 years, America’s most economically significant innovations (as noted by the annual R&D 100 awarded by R&D Magazine) have more and more often come from federally funded research programs (from 14 percent of the top innovations in 1971 to 69 percent in 2006). Nevertheless, total federal levels of R&D spending have been decreasing in real terms since 2003 and the funding efforts for collaborative research have been limited. The report urges the federal government to improve the funding of research collaboration and for the federal government to rein in its decentralization of research funding, which it has recently been carrying to an “unproductive extreme.”

Currently, the NIH maintains a registry of the 21 approved stem cell lines. The NIH also contracts out the maintenance of the National Stem Cell Research Bank to the WiCell Research Institute at the University of Wisconsin-Madison, which was established through a $16 million, four-year contract in 2005. Currently, the bank contains 18 of the 21 lines (another line is held by the University of California, San Francisco and two others by the Swedish/British biotech company Cellartis). The National Stem Cell Bank contract expires in September 2009, and needs to be reconsidered, modified, extended, or terminated depending on the utility of the bank and the next administration’s stem cell policy. Ultimately, it remains the responsibility of Congress and the president to determine whether to continue or expand the national stem cell bank.

Difficulties may arise if federal funding of embryonic stem cell research suddenly opens up and unleashes a deluge of new hES cell lines for banking. Since the current business model has been unable to bank stem cells at economies of scale (at WiCell it cost $16 million to hold 18 lines for 4 years), the NIH and WiCell may not be able to get up to speed on cell banking in a cost-effective manner. We therefore suggest that the NIH explore multiple options and encourage competition among the many institutions across the country that store biological materials, including WiCell. The NIH can then arrange a new contract with the institution, or combination of institutions, that can maintain the most cost-effective bank.

The benefits of a stem cell registry are overwhelming, and even private entities that may be reluctant to bank their cells will still have clear incentives to register them.

Given the difficulty of getting a large and cost-effective stem cell bank up and running, the NIH should focus its initial efforts on expanding their existing stem cell registry and making sure that it is comprehensive. The NIH’s existing hESC registry sets a precedent for a national stem cell registry, but it is woefully incomprehensive. Not only must this registry be expanded to contain all cell lines for which federal funding is approved, the registry should also go beyond compiling the usual and rather basic information that it has maintained thus far. This expanded stem cell registry should be more sophisticated and offer information about the compatibility of lines with one another and with the laws governing embryo procurement in various states, locales, or institutions. This registry would optimize collaboration among research groups, as it would make voluntary registration very easy.

On June 20, 2007, President Bush attempted to expand the NIH’s stem cell registry by changing the name from the “Human Embryonic Stem Cell Registry” to the “Human Pluripotent Stem Cell Registry.” Nearly a year has passed and the NIH has still not settled on a definition of “pluripotent” that would set criteria for whether a given stem cell line would be allowed in the registry. Due to the failure of national-scale efforts like these, we recommend funding for projects intended to stimulate competition among private contractors in order to create a model for a sophisticated national stem cell registry which would then be developed specifically for the NIH.

The benefits of a stem cell registry are overwhelming, and even private entities that may be reluctant to bank their cells will still have clear incentives to register them. For example, listing stem cell lines enables more researchers (and hence potential customers) to know that the lines exist.

When it comes to stem cell banks, however, many for-profit companies may perceive challenges and be more resistant to banking their cells. For example, some for-profit owners of stem cell lines might not want to share their lines with every research group for reasons such as quality control, the amount of time it takes to deposit cells into a bank, and the expectation of payment. However, banking saves costs for companies by providing federally funded stem cell vetting comparisons of lines from multiple institutions. Banking also improves efficiency for researchers by centralizing research-quality stem cells, allowing for the easy scientific comparison of lines, and improving research collaboration. Ultimately, in spite of the initial difficulties that the NIH and other institutions might have in developing a cost-effective business model for stem cell banking, there would nevertheless be long-term payoffs.

Creating both a federally funded stem cell bank and registry would not be redundant, as the registry would catalog the bank’s lines, and the official registry of the bank would be the national registry. If the president and the Congress decide to continue funding and expand the national stem cell bank, it must be linked to the national registry. Carried out in a smart, efficient, and innovative manner, banks and registries will streamline research and foster collaboration by providing researchers with a uniform display of all available cell lines.

Michael Rugnetta is a Fellows Assistant at the Center for American Progress. Michael Peroski is an undergraduate majoring in biochemistry and philosophy at Allegheny College and a former bioethics intern with CAP.

The new field considers timely questions about morality, empathy, and the way in which people perceive the world. One study reports that people were willing to say that a robot “believes that triangles have three sides,” but were unwilling to say “it feels happy when it gets what it wants.” This sheds light on how individuals approach what philosophers call “phenomenal consciousness,” the capacity of something to have a subjective experience of feeling.

Joshua Knobe, author of the Scientific American article and an assistant professor of philosophy at University of North Carolina Chapel Hill, interprets the results by suggesting that, “perhaps the issue here is that people only attribute phenomenal consciousness to creatures that have the right sort of bodies.” This type of argument emerges in debates over embryonic stem cell research when proponents of the research argue that philosophical objections to the work do not coincide with the cultural practice of the objectors. Proponents argue, for instance, that whereas a baby is embodied, an embryo is not, or the embryo lacks “continuity of form.” In other words, when someone sees a baby picture and says, “That is me as a baby,” they would likely lack the same response if shown a picture of an embryo from which they developed.

Delving into this issue, experimental philosophers need to distinguish between a view based on the particular body of an entity and a view that reflects trained empathy, one comment on the site points out. Trained empathy differs from basic empathy in that the former is the product of an individual’s cultural identity. For example, the comment offers, killing and eating certain animals, like dogs and cats, is frowned upon and criminalized in the United States; in other cultures, this is not the case. Further experimentation could expand our understanding of moral decision-making process and the reasons that certain policies are acceptable or objectionable to certain individuals.

It is not entirely clear whether experimental philosophy lies under the umbrella of cognitive science or sits as a distinct but connected field. A researcher’s training, experimental methodology, and the questions used in opinion surveys may all determine whether a project is experimental philosophy or cognitive science. Studies in experimental philosophy start from philosophical questions and often shed light on cognitive phenomena, where studies in cognitive science start from cognitive phenomena and often shed light on philosophical questions. Undoubtedly, there are shades of grey between the fields that make placing a study in one camp or the other complicated.

But this consideration misses the point. Philosophers are now wielding the tools of social science to shed light on challenging philosophical questions. This adds a quantitative dimension to discussions in moral philosophy and thereby gives policymakers more data with which to work.

Expansion of communication and outreach efforts, particularly with respect to real and perceived benefits and risks associated with nanotechnology;

Developing and implementing standards critical for nanomaterial identification, characterization, and risk assessment; and

Coordinating strategically-guided nanotechnology environmental, health, and safety research across agencies, sectors, and countries and including a balanced assessment of risks and benefits in the context of specific, real-world applications.

H.R. 5940, the National Nanotechnology Initiative Amendments Act of 2008, is a step in the right direction to address these issues. The act authorizes the designation of an associate director of the Office of Science and Technology Policy as “the Coordinator for Societal Dimensions of Nanotechnology,” responsible for coordinating, planning, and prioritizing budgets of activities all required by section 2 (b) (10) of the 21st Century National Nanotechnology Research and Development Act of 2003. These activities include: developing an understanding of control and manipulation of particles at the nano scale, providing research grants, establishing a network of advanced technology user facilities and centers, and establishing interdisciplinary nanotechnology research centers.

Where this 2003 act offers a huge set of requirements for ensuring that ethical, societal, and health issues in nanotechnology are addressed, H.R. 5940 articulates a mechanism, the position of the Coordinator for Societal Dimensions of Nanotechnology, by which to fulfill these requirements. The other provisions of H.R. 5940 also provide programs to educate the public about nanotechnology and provide means for assessing the success of the NNI . H.R. 5940 was passed to the Senate and is currently in the hands of the Committee on Commerce, Science, and Transportation. The Senate also received the Nanotechnology in the Schools Act, which would require the director of the National Science Foundation to establish a nanotechnology in the schools program that would fund secondary education in nanotechnology, and passed it to the Committee on Health, Labor, Education, and Pensions.

Some clinicians abroad use adult or umbilical cord stem cells. For example, thousands of people seek implants of umbilical cord stem cells at Xiaoshan Hospital in China. One group, EmCell, offers treatments for everything from aging to cancer using adult stem cells. Others offer more peculiar treatments, like the Bio-Cellular Research Organization, a Delaware-based company operating abroad, which touts its ability to treat patients with an injection of stem cells from fetal and newborn rabbits. Interestingly, many other U.S.-based companies offer stem cell treatments abroad.

As Kieran Breen, director of research and development at the Parkinson’s Disease Society in the United Kingdom explains, “there is no evidence whatsoever that these [therapies] work, and indeed they may be particularly harmful for people, with the potential for irreversible side effects.” To some who oppose human embryonic stem cell research in the U.S., a single adverse event resulting from a clinical application represents an opportunity to make a case against federal funding. But regulating these therapies abroad poses challenges. Ubaka Ogbogu, a research associate at the Health Law Institute at the University of Alberta elaborates, “it’s really difficult to deal with this from a policy standpoint, but that doesn’t mean we’re not going to try.”

Aside from highlighting the lack of therapies in the United States, this situation underscores a need to promote scientific progress in the U.S. through federal funding of embryonic stem cell research. As the FDA recently delayed approval of a private sector proposal for Phase I clinical trials of an embryonic stem cell therapy, the need to evaluate U.S. policies on clinical application of embryonic stem cells seems especially pertinent.

The International Society for Stem Cell Research unveiled its suggestion for clinical translation at its recent annual meeting. (Science Progress editor-in-chief Jonathan Moreno spoke at this event on legal and ethical considerations in human embryonic stem cell research). Another approach, suggested by Congresswoman Diana DeGette (D-CO), involves making the NIH the agency to formally ensure that the research proceeds ethically. As of now, labs voluntarily follow the National Academies of Science guidelines and the ISSCR protocol. Animal use committees, IRBs, and in the case of clinical trials, the FDA, all regulate current research. As embryonic stem cell research and clinical applications grow in the U.S., policy solutions will be necessary to handle cross-institutional collaboration, intellectual property issues, and the complexity of working with Embryonic Stem Cell Research Oversight committees.

Because mind reading and near-flawless detection of deception would avoid many of the limitations of conventional lie detectors, national security agencies and the courts stand to significantly benefit from this technology. Investment in this research by the Pentagon and by private companies highlights interest in its development.

In the most common form of fMRI research, scientists focus their observations on oxygen in the brain, because the magnetic properties of hemoglobin change when it carries oxygen. The fMRI scanner transmits information on the rate of oxygen-carrying blood flow in the brain to a computer, where software translates data into a representation of the brain. This is not a picture of the brain, but rather a map of blood flow in the brain. With this information, researchers can correlate increases in blood flow during controlled activities with various brain functions. Experiments built on this technology can determine with accuracy whether or not a subject under observation is making truthful statements.

Most ethical and policy concerns do not require immediate attention, given the present state of this technology.

Some cognitive researchers predict a startling increase in the accuracy of this technology, making the detection of deception nearly flawless. If that ever happens, concerns arise about forensic applications. For example, some worry that a machine of such accuracy will challenge the “province of juries.” National security interests would almost certainly harness such technology for both interrogations and interviews. And will this extend to regular penetration of civilian thought? Fortunately, most ethical and policy concerns do not require immediate attention, given the present state of this technology, especially considering that national security and court use hinges on the ability to accurately scan individual subjects. To remove “background noise” from a scan, researchers establish a baseline and subtract this recording from experimentally obtained data. This works well for groups but poorly for individual analysis; distinguishing signal from background noise on an individual level proves difficult.[1]

Generating a representation of this neural activity presents additional problems. For example, current techniques measure changes in neural activity on the order of seconds, where most neural processes occur on the order of milliseconds. Additionally, when software translates data into images, smoothing and magnification to ensure a view of high-order brain functions reduces resolution.[2]

There are other limits to fMRI. Few studies investigate variance between scans of individuals of differing age, sex, race, fitness level, cultural background, or account for the prevalence of mental disorder and other characteristics that might have a significant effect on the data gathered in experiments. Researchers also face the challenge of testing fMRI for detecting deception in settings more realistic than the lab. Lying in court generally entails both rehearsal and reasoning. In this setting, suspects feel emotional pressure and stress as they try to deliver a convincing story. Lab studies don’t replicate that kind of pressure.

fMRI lie detection likely falls under the existing policy for polygraph use. State law and federal law differ with regard to lie detection through polygraph, and will probably differ with regard to fMRI lie detection. Federal law seems more permissive of polygraph in courts, whereas 27 states and DC entirely prohibit its use.[3] Until recently, a 1923 court precedent, called the Frye Standard, arising out of Frye v. United States, set the general acceptance of a technology or scientific development as the standard for admission in court.

Although national security interest in fMRI extends to interrogation, screening job candidates and employees seems the most practical application.

Today, Rule 702 of the Federal Rules of Evidence supplements this criterion, explaining, “if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact at issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise.”[4] This rule allows judges to determine whether the science has been tested, subjected to peer review, the known or suspected rate of error, and whether or not the scientific community generally accepts the technology.[5] Under the Frye Standard, courts prohibited polygraph use, however, after Rule 702, exclusions of polygraph tests no longer presented a foregone conclusion. If fMRI scans for lie detection reach 99 percent or better accuracy, standard use in courts seems possible. So what happens then?

It is clear that regulation of fMRIs for lie detection parallels, in some ways, regulation of polygraphs. For example, implementation in courts requires evaluation under Rule 702, including the general acceptance of efficacy, something which has yet to occur. Despite these similarities, fMRI brings up many new issues associated with both its potential accuracy and invasion of privacy. Jurors without knowledge of error rates and competing evidence will likely give undue credibility to an fMRI reading. The difference between perceived accuracy and actual accuracy jeopardizes the likelihood of an “impartial jury,” as guaranteed under the Sixth Amendment. As neuroscience scholar and neuroethicist Judy Illes explains, “The sheer complexity of neuroscience research poses challenges for integration of knowledge and meaningful interpretation of data.”[6] The most challenging problem at this time, she argues, is that, “with dynamic images in hand, we may forget the limits of how the images were produced, including variability in research designs, statistical treatment of the data, and resolution.”[7]

There are other constitutional issues. The courts will have to determine whether fMRI lie detection constitutes an unreasonable search or seizure under the Fourth Amendment, and high-accuracy lie detection likely carries implications on the Fifth Amendment clause on self-incrimination.

Specific issues arise with the use of fMRI in the context of national security. For example, would this technology be applied in interrogations as an acceptable alternative to currently controversial techniques? At least one former intelligence officer has stated that it has been used in the “war on terror.”[8] However, applying fMRI in this context still seems to invite debate on questions of international law. Although national security interest in fMRI extends to interrogation, screening job candidates and employees seems the most practical application. National security agencies are among the largest users of polygraphs at present, despite their flaws, so a promising technology like fMRI surely opens new doors.

The Employee Polygraph Protection Act prohibits the administration of polygraph to civil employees, except in the case of ongoing investigations. However, this act does not apply to government employees, specifically exempting those working in national security with access to sensitive information. So just as national security agencies legally use polygraphs, legal application of fMRI seems possible.

Even if researchers overcome the technical problems in brain-scanning lie detection, other practical issues make implementation of fMRI challenging. For instance, the size of an fMRI machine and the necessary subject cooperation present serious problems—a person must lie prone inside a giant magnet and hold perfectly still for the device to function properly. Portable fMRI machines or long-range fMRI scanners might quell these issues, but such developments require significant scientific leaps. Gathering any significant valid data from a scan also requires an immobile subject. Even moving one’s tongue during a scan compromises the validity of results. At this point in time, the cost and inconvenience of using this technology makes its reliable use unrealistic, even if its accuracy is incredibly high, except in the most pressing of matters.

But the technology has to make significant strides before any of these issues become pressing. Improvements in fMRI brain scans stand to benefit medical treatments as well—imaging brain tumors, for example—and have applications outside of national security and the legal system. The reservations and cautions expressed here are not reasons to inhibit the development of this technology, but are rather encouragement to continue.

Michael Peroski is an undergraduate majoring in biochemistry and philosophy at Allegheny College.

Notes

[1] Pearson, Helen. “Lure of Lie Detectors Spook Ethicists.” Nature 441 (2006): 918-919.

[2] Yousuf, Sameer. “The Legal and Ethical Implications of fMRI Lie Detectors.” Unpublished thesis (2007).

[3] Ford, Elizabeth B. “Lie Detection: Historical, Neuropsychiatric, and Legal Dimensions.” International Journal of Law and Psychiatry 29 (2006): 159-177.

[4] “Federal Rules of Evidence.” Cornell Law School. 18 Feb. 2008. http://www.law.cornell.edu/rules/fre/rules.htm

[5] Ford (2006); Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 US 579 (1993)

[6] Illes, Judy and Racine, Eric. “Imaging or Imagining? A Neuroethics Challenge Informed by Genetics.” The American Journal of Bioethics 5 (2005): 5-17.

[7] Illes and Racine (2005).

[8] “High Tech Interrogations Might Promote Abuse,”  Penn State Live,  March 17,  2008, available at  http://live.psu.edu/story/29457; JH Marks, “Interrogational Neuroimaging in Counterterrorism: A No-Brainer or a Human Rights Hazard?” The American Journal of Law and Medicine 33 (2007): 483-500.

Virtual worlds similar to those popularized by games like World of Warcraft, Sims Online, and Second Life have potential applications in health care, education, business and military training. This of course raises the issue of the commercial use of virtual worlds, litigation in virtual worlds, and the necessity for regulation.

Blitz Games produces a medical-triage simulator to train physicians, paramedics, and fire fighters in prioritizing care in disaster situations. Cisco systems uses a virtual world to improve internal collaboration. Despite the entertainment value the benefits to the workforce, disputes in these environments can lead to litigation in the real world—because virtual goods and services sell for real money. In South Korea, courts have heard over 300 cases of fraud and over 60 cases of hacking in virtual game worlds.

Sean Kane, a virtual-worlds expert at Drakeford & Kane explains that the value of virtual goods traded worldwide hit $1 billion in 2006 and interests governments eager to tax the sales of the commodities. The United States, Britain, and Australia are all considering taxes on real-world profits from virtual trade.

Where a third of drug candidates do not pass into clinical trials for evaluation, microdosing provides a potential solution for cost-minded pharmaceutical companies to test drug promise before investing. Using technology similar to radio carbon dating, researchers observe the absorption and persistence of the active ingredients of a drug, inserting a few radioactive carbon atoms into drug molecules and then administering the tagged drugs to participants in doses small enough to ensure safety. Tests on blood, urine, and fecal samples every few hours for two or three days reveals the presence of radioactive carbon. If the radiocarbon is absorbed and persistent, then the drug is worthy of further consideration.

The Economist reports that, “crossing mobile phones with social-networking sites would help people find friends, and potential friends, nearby.” Using Bluetooth and short-range radio technology built into mobile devices, one company Aka-Aki, allows subscribers to check for nearby friends or other registered members with similar interests. If someone similar is nearby, the program displays whatever information the person allows. But there are of course questions of privacy, as the unique Bluetooth identifier associated with a device could be used to tag people with derogatory messages.

New nanotechnology uses a method similar to screen-printing in which researchers build nanoscale devices using stencils. First, researchers make a patterned template coated in gold ink. Then they transfer the gold from the stencil to a screen by pressing the template onto it. Dr Kraus, of IBM’s Research Laboratories in Switzerland, believes that future researchers could use this technology to print biosensative particles onto solid surfaces to make biosensors. While there is concern about the unforeseen behavior of particles with such small surface areas, the larger issue is the current lack of a regulatory framework for nanotechnology despite calls for legislation.

With the use of unmanned aircrafts in warfare comes the possibility of civil applications of this useful technology. This feature reports that “civil regulators are worried about unmanned aircraft sharing the sky with the usual manned variety, since UAVs have previously been limited to war zones or remote areas.” Wireless data connections allow control of unmanned aircrafts. However, even with the Pentagon’s current expenditure on satellite bandwidth the necessity of piping full-motion video back from UAVs requires a new method of communication. Further, allowing UAVs to fly alongside commercial airliners presents a new set of challenges, including the development of “sense and avoid” programs and new air traffic control systems based on electric signals rather than voice communication. The Centre for Strategic and Budgetary Assessments suggests cutting back the next generation of manned jets and using more UAVs. But despite the technology’s promise, there must be coherent regulations to address even benign issues like whether a human directing a military UAV should receive a medal for combat performance.

Several large retail chains utilize various technologies to monitor customer habits, increase profit margins, and enhance product delivery. Some of these systems, like Smartlane, monitor the number of customers entering and exiting the stores and the number of patrons in the shopping lanes and use the data to improve efficiency at checkout. Some retailers use BehaviorIQ to reengineer store layout; the system gathers data on where customers go, how long they stop, and how they react to products. Pioneering Research for an In-Store Metric, one of the largest of such enterprises, just ran a trial in over 160 stores in the United States. As it is somewhat invasive, this technology raises privacy concerns. Recordant, however, is an even more invasive marketing technology. It involves tethering a recording device to the neck of a store clerk and recording dialogue between the clerk and customer to evaluate employee performance and customer behavior. Despite in-store signs explaining the technology to customers, and the fact that a dispassionate computer, not a human, analyzes the conversations, the devices, its use concerns employees and customers alike.

Although without using a chimeric model, researchers at Stanford University Medical School regenerated a mouse immune system by transplanting mouse blood-forming stem cells into mouse bone marrow. This research pioneered the use of toxins to remove the mouse immune system, where previously scientists had used high-risk chemotherapy or radiation. Although cause for celebration, principal investigator Irving Weissman explained that the downside is that the mouse is a poor mimic of the human immune system. A chimeric mouse model with an entirely human immune system would offer a solution. The potential of such a model was high enough to warrant a $17 million grant from the Gates foundation for research at Yale University and the Howard Hughes Medical Institute and a $1.9 million grant for research at Peking University in China.

Some policymakers are alarmed by a lack of national oversight of chimeric research. A recent Science Progress article pointed out that Senator Sam Brownback (R-KS) proposed a ban (S.1373) on the creation of human-nonhuman chimeras in 2005. This November, he and Senator Mary Landrieu (D-LA) introduced the Human-Animal Hybrid Prohibition Act 2007 (S-2358), which criminalizes the use of some chimeric organisms. Policymakers recognizing the important role chimeric models can play in laboratory research should work to ensure that properly regulated use of these important models can continue.

Researchers recently cured sickle-cell anemia in a mouse model using iPS cells, highlighting the promise of iPS cells for future research and affirming the importance of preventing the current excitement about iPS cells from hastily ending embryonic stem cell research.

George Q. Daley, a stem cell researcher at Children’s Hospital Boston explains, “I think it is a really exciting proof-of-principle that clinical applications of iPS cells are technically feasible, [however], there will be lots of unanticipated setbacks before we end up in the clinic.” The study suggests significant promise for application in humans with time and further research.

Researchers used a mouse model developed by Tim Townes, in which they replaced the genes responsible for producing mouse hemoglobin with genes coding for the hemoglobin structure normally found in humans with the sickle cell phenotype. The experiment involved reprogramming mouse skin cells with retroviruses to produce the iPS cells, correcting the sickle-cell mutation in these cells using homologous recombination, differentiating these cells into blood-producing stem cells, and then transplanting the blood-producing stem cells into the mouse from which they were derived. After transplanting these cells into the mouse, it soon began producing healthy blood cells.

The use of iPS cells alleviated concerns associated with embryonic stem cell research, such as administering immunosuppressant drugs to prevent rejection of unmatched transplanted cells. Investigator Rudolph Jaenisch noted: “This demonstrates that iPS cells have the same potential for therapy as embryonic stem cells, without the ethical and practical issues raised in creating embryonic stem cells.” The study claims that the outcome opens the opportunity to repair genetic defects through homologous recombination and to repeatedly differentiate iPS cells into desired cell types for therapeutic applications. Jaenisch’s lab chose sickle cell anemia given its simple cause, and is now developing techniques to treat other diseases using the same method. Though if these new techniques succeed in humans, experts anticipate FDA approval of personalized treatments to take a long time.

Notwithstanding this breakthrough, many obstacles stand in the way of human application. Among them: bypassing the use of genes known to cause tumors as inducers of cellular reprogramming, avoiding the use of retroviral vectors which pose the risk of unintentional changes to an organism’s genes, and improving methods for human iPS differentiation. Jaenisch acknowledged that, “the big issue is how to replace these viruses.”

Despite this success, scientists need a greater understanding of how the iPS cells work before considering a step away from embryonic stem cell research. With the Bush administration’s advocacy for non-embryonic stem cell research and their celebration of the development of human iPS cells, they will naturally present this development as further encouragement to stop embryonic stem cell research. Representative Diana DeGette (D-CO), who championed the Stem Cell Research Enhancement Act (H.R.3, S.5) explains that pitting iPS research against the embryonic research is the wrong approach: “None of this feels like it should be one versus the other…That’s the politicization of science.”

The United Nations University Institute for Advanced Studies recently published a report on human cloning offering the international community two choices: either prepare for the legal and ethical issues associated with living, cloned humans, or prohibit human reproductive cloning. The report suggests an opinio juris for a prohibition on human reproductive cloning; there is multinational opposition to human reproductive cloning, and more than fifty nations forbide the practice.

Therapeutic cloning techniques generate human embryos through somatic cell nuclear transfer to harvest embryonic stem cells. Reproductive cloning techniques seek to create humans with nuclear DNA identical to a currently or previously existing human.

Brendan Tobin, a human rights lawyer and co-author of the report explains:

Failure to outlaw reproductive cloning means it is just a matter of time until cloned individuals share the planet…If failure to compromise continues, the world community must accept responsibility and ensure that any cloned individual receives full human rights protection.

The report cautions that without an international prohibition, researchers could practice reproductive cloning in nations without a regulatory framework.

Reflecting on the history of UN efforts to ban cloning, the report highlights the best of possible solutions as outlawing human reproductive cloning and permitting therapeutic cloning. The report comes after a lengthy UN debate beginning shortly after the 1997 adoption of the Universal Declaration on the Human Genome and Human Rights, In 2004, the Bush administration pushed for a global treaty banning both reproductive and therapeutic cloning, which failed by one vote to pass the General Assembly. The administration settled in 2005 on the UN Declaration on Human Cloning (A/RES/59/280), a non-binding statement against both reproductive and therapeutic cloning. The success of the declaration largely hinged on it being non-binding, allowing nations to use therapeutic cloning for research without consequence.

In the United States, congressional action paralleled U.S. advocacy for a global ban. The House of Representatives twice voted in favor of criminalization of research on human cloning in 2001 and 2003 (H.R. 2505, H.R. 534), but these bills failed both times in the Senate (S. 245, S. 658). In 2002, the President’s Council on Bioethics voted 10-7 in favor of a moratorium of therapeutic cloning and unanimously for a prohibition of human reproductive cloning.

As is the case for stem cell research policies, a current patchwork of state policies exist regulating cloning, where not overarching federal framework guides. Most states prohibit reproductive cloning and the majority allowing therapeutic cloning foreruns the U.S. stem cell research efforts.

In order to address some of these issues, the Center on Nanotechnology and Society will hold a conference tomorrow in Washington, D.C. (Full disclosure: Science Progress Editor-and-Chief Jonathan Moreno is a speaker.)

In a recent study, Dietram Scheufele found that experts reflect greater concern than the public about nanotechnology (Via Framing Science). Another study concluded that in discussion of similar science policy issues, absent a conflicting viewpoint, safety reassurance from scientists and governmental officials satisfies the public opinion. Glenn McGee, director of the Alden March Bioethics Institute, points out that any field with the potential to effect both scientific research and industry necessitates responsible public dialogue—and the time is now, as the public is demonstrating interest in nanotech possibilities.

A 2006 UNESCO report concluded that although research outcomes will impact developing nations, weak or nonexistent policies pose a hazard to the world community. John Daly, a UNESCO board member, explains that because nanoparticles behave differently than materials in bulk, scientists need to explore their potential hazards. In addition to the ethical concerns associated with nanotechnology, there are unaddressed practical and safety concerns including: nomenclature, definitions, and standards; hazard characterization; exposure and effects assessment; environmental fate, transport, and persistence; and measurement, sampling, and monitoring of nanomaterials.

The potential for nanotech requires that international dialogue involve both developed and developing nations (some 44 nanotechnology labs operate outside of the US). A recent call for regulations in India reflects this concern, where potential problems for ongoing research must balance unanswered ethical questions with $225 million in government-funded support for the new technologies.

In the United States, the National Nanotechnology Initiative, a multi-agency organization leads the government in its development of policy and distribution of financial resources. With $1.44 billion in funding allocated for nanotechnology in 2008 and just $59 million allocated for the study of ethical, legal, and social concerns, the U.S. stands to face problems stemming from substandard regulatory preparation. NNI published a report on the regulation of nanotechnology; however, actualization of any recommendations will prove problematic and involves navigating the logistics, staffing, and other constraints of its 25 member agencies. Of concern is the lack of any individual regulatory agency for any area of nanotechnology.

Image credit: Michael Ströck

State policies differ in their ethical and legal reasoning; some have voted to completely ban all forms of human embryonic stem cell research, while others permit and encourage it. Problems between states arise regarding which stem cell lines are acceptable for use in research, how to make use of research data from other states, and how to coordinate collaboration on research. At this point, states are left to navigate between their own regulations, the regulations of other states, and the progress of their own science. Science Progress recently covered the state of research in Missouri and New Jersey.

The Massachusetts Public Health Council recently addressed the issue of interstate collaboration by changing the language of a regulation that might have criminalized the use of stem cell lines from other states derived for research purposes. Other states face similar obstacles. California prohibits paying women for their eggs (apart from basic expense reimbursement) and research on lines generated from paid-for eggs. Connecticut has more relaxed laws on the same issues, meaning that some lines used in Connecticut are prohibited from use in California research.

A recent Nature report explains that although a network of collaborating states would be a boon to research, such a network would distract from the need for a federal framework. (The Center for American Progress has also argued for national funding.) Given the federal prohibition on embryonic stem cell research funding, scientists wishing to investigate hES (outside of the approved lines and within the parameters of the Dickey Wicker Amendment) must use equipment and labs funded apart from the federal government. This requires that institutions receiving federal funding expend extra resources to maintain separate equipment for hES research. The Nature report concludes that while many researchers look to a new administration to change the system, this may not be the panacea they assume.

Warren Wollschlager, chief of the office of research and development in the Connecticut Department of Health, affirms, “By the time that the NIH comes to the table the states will be established funding sources.” Indeed, many state funding initiatives are well on track. But as Executive Director of the Alliance for Aging Research Daniel Perry says, “creating mini-NIH’s at the state level is, at best, a temporary solution,”

With the NIH budget for embryonic stem cell research for the fiscal year 2007 set at $37 million—far below that of many private donors in the states—it is apparent that any federal progress for this research will come at a later date.

The New Jersey state appellate court decided in favor of stem cell research this past Friday. The decision allows the Stem Cell Bond Referendum to go on the November ballot with its present wording so that voters can consider the NJ Research Bond Act of 2007 (S1091/A3186). The referendum seeks necessary voter approval for the enforcement of the act already passed by the legislature. Through the sale of state-held bonds, the act will provide $450 million in funding for stem cell research over the course of ten years. The Commission on Science and Technology will grant funds to research institutions pending independent research review panel approval and review by the NJ Economic Development Authority on the commercial viability of the research.

In the case over the referendum, McKenzie et al. v. Corzine, fifteen individuals and the NJ Right to Life Committee challenged the referendum on grounds that the funds would pay for human cloning, would require state property tax hikes in order to repay the incurred debt, and that bias and a lack of clarity prevented voters from making an informed judgment of the issues. The NJ Court of Appeals ruled against these claims, upholding the decision of Superior Court Judge Neil Shuster, and said that the referendum described the Act faithfully and that it should appear as written on the November 6 ballot.

NJ Governor John Corzine lauded the referendum in a press release saying, “New Jersey continues to forge ahead as a pioneer in stem cell research and discovery.”

If voters pass the referendum, the additional state funding may spur the progress of embryonic stem cell research, but as Faye Armitage points out in a Science Progress editorial, it still remains uncertain as to how much of this funding will go towards embryonic stem cell research and how much will go towards less-promising adult stem cell research. So far, $9 of NJ state funding has gone to adult stem cell research for every $1 that has gone to embryonic stem cell research.

The J. Craig Venter Institute pegs the current cost of personal genome sequencing at around $300,000 per genome, but the X Prize Foundation is offering a $10 million Genomics award for the first group to sequence 100 genomes in 10 days at a cost of $10,000 per sequence. The prize was originally set at $500,000, but in 2005 Venter pushed for the 20-fold increase.

With Venter barreling forward and the X Prize offering a significant incentive for competing groups, we are very close to the advent of widespread personalized genome sequencing, and the ethical framework must catch up to the science.

In the hands of insurance companies and employers, this information raises serious ethical concerns, but various protections are in motion. The question is whether legal protections will come fast enough.

The Genetic Information Nondiscrimination Act of 2007 (H.R.493) passed the House 420-3 on April 25, but it is currently held up in the Senate with no date set for debate. According to CQ (subscription), the President has indicated that he would sign the bill, but Sen. Tom Coburn (R-OK) placed a hold on it so that he and Sen. Edward Kennedy (D-MA) could work out Coburn’s concerns. Rep. Louise Slaughter (D-NY), who sponsored the House bill, speculated that the hold had to do with objections analogous to those raised when the bill went through the House Energy and Commerce Committee, which concerned language providing anti-discrimination protection for fetuses and embryos that would not influence debate over abortion laws.

Forty-one states have taken some form of legislative action, and the NIH-DOE Committee has suggestions for future protections.

Secretary of Health and Human Services Michael Leavitt and Harvard geneticist George Church have both expressed support for legislation prohibiting discrimination based on genetic makeup. Francis Collins, the director of the National Human Genome Research Institute, also called for the development of federal legislation to protect genetic privacy.

In 2000, President Clinton issued an executive order prohibiting discrimination in federal employment based upon genetic makeup.

Cybrid embryos are created through somatic cell nuclear transfer, or SCNT, in which the human DNA from a skin cell is transferred into an enucleated rabbit or cow egg. These embryos are 99.9 percent human and 0.1 percent nonhuman. Ian Wilmut, a biologist instrumental in the cloning of Dolly the sheep, explains in a recent Technology Review interview that most people approve of such research if they understand its purpose. The misfortune of providing sufficient explanation, he laments, is the loss of needed research time.

A loss of research time, however, is better than a complete prohibition of research without deep consideration of public opinion. That almost happened in Britain, where the debate initially resulted in the December 2006 release of a white paper from the British government proposing a ban on such research, caused by public outcry motivated by a knee-jerk reaction from an “overzealous media portending half-human creatures.” Ten months later, however, the ban was finally lifted—after an extensive public debate, many sessions of discussion held by the Human Fertilization and Embryology Authority, and the release of documents intended to reassure the public.

A similar debate can be expected as this research occurs in the United States and is further highlighted by the U.S. media. As U.S. scientists currently working on SCNT develop an interest in using nonhuman eggs rather than human eggs—researchers at Harvard and the University of California, San Francisco are developing SCNT technologies, but are not using nonhuman eggs—they can take a page from the media playbook of their counterparts in Britain.

British officials judiciously informed their citizenry, sought opinions after the research was explained, and subsequently approved this research. The Bush administration presently condemns SCNT research and the federal funding of it without sufficient consideration of public opinion, as was done in Britain.

So the first question is: How can the U.S. scientific community help inform the administration and the mainstream media that blocking this field of research is not in the best interests of the American public? And the second question: What can our current administration learn from the approach of the British government?

Technology Review notes that the Bush administration has suggested so-called reprogramming technologies, in which the “cellular clock” of adult cells is turned back to generate stem cells, as the bridge to moving away from embryonic stem cell research. Wilmut expressed his endorsement of reprogramming technologies, but the potentiality of cybrids, however, is worth serious consideration by the U.S. public and government.

U.S. scientists need to get busy framing the issue in the media before the debate is distorted by those few opposed to embryonic stem cell research in search of new ways to misinform the American public. Beth Kohl covered this very issue at the Huffington Post a few weeks ago.