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What to Expect from Our New Bioethics Commission

three stacks of petri dishes SOURCE: flickr/dee_gee A welcome focus on pragmatism over philosophizing adds new challenges the commission’s task to move ideas move from recommendation to implementation.

The new members of the Presidential Commission for the Study of Bioethical Issues have the opportunity to shape national policy in the life sciences. Little is known about the formal agenda of PCBSI since it has yet to meet nor has a full time staff been named, so any assessment of priorities or approaches would be premature. But there are signs of the possible work ahead. As the Executive Order establishing the commission and announcements from the Office of Science and Technology Policy make clear, the president expects that this commission will be focused on progressive policy initiatives, on problems that matter, and on potential solutions. This emphasis, if undertaken in a serious way by the PCSBI, would be a marked departure from the most recent commission, President Bush’s President’s Council on Bioethics, which explicitly eschewed the pragmatic for a theoretical emphasis in its work.

But this welcome focus on pragmatic approaches to policy adds new challenges to the commission’s task. In order to be useful, its deliberations must not only be rigorously supported by good science and good ethics, but must also include strategies to translate its recommendations into implementation. Moreover, the imperative to make practical recommendations is directly connected to the need to do work that is accessible to various audiences, including Congress, executive departments, health industry professionals, academics, and the public at large. To hit the ground running, nearly a year and a half into the Obama administration, the PCSBI will also have to rethink the process of commission transition itself as it builds a professional staff that can shape the research of the commissioners into public-facing products that meet the needs of the White House.

As the process of implementing the Obama administration policy on federal funding for human embryonic stem cell research demonstrates, truly progressive bioethics policy requires careful implementation. Ideas alone will not solve the problems the commission addresses. Rather, the commission and its staff will need to develop and communicate those ideas effectively so they can support appropriate policies, guidelines or research, rules, or even legislation.

In addition to these new ways of doing business, the commission has the opportunity to examine pressing ethical questions outside the purely biomedical realm, including environmental and public health in the face of climate change. As well, the commission agenda could encompass fundamental questions about how governmental and nongovernmental organizations allocate scare resources to protect the health of citizens in need of humanitarian aid.

The potential agenda: beyond bioethics as usual

On April 7, 2010 President Obama appointed 10 members to the commission, completing the process he started in November 2009 when he named Amy Gutmann and James Wagner as the chair and vice chair of the new body. The PCSBI thus becomes the sixth such body established by Congress or the White House to advise the government on substantive ethical and policy issues in the life sciences.[1]

We might expect this commission to divide its time between issues for which substantive prior research and policy deliberation has been done but which still lack the final push towards implementation, and issues that have not received the attention of a national deliberative bioethics body. For instance, previous commissions have called for a fully harmonized federal system for the protection of human subjects, something that still does not exist. But it would also make sense for the PCSBI to take an in-depth look at the ethical and policy challenges of fully implementing the Patient Protection and Affordable Care Act. Similarly, more work needs to be done to clarify the remaining discrepancies in federal regulations relating to biobanks and electronic databases.[2]

Although it is conceivable that PCSBI could fill up its agenda only with immediate, implementable policy issues, limiting its attention to this type of agenda would not take full advantage of the commission’s expertise or to the convening power it has as a presidential commission to undertake other important challenges. Elsewhere I wondered whether it would be appropriate for a progressive national bioethics commission to move beyond some of the “usual suspects” that have occupied commission agendas for the past 40 years[3]—medical research, genetics, death and dying, reproductive medicine—and to weigh on other issues, including those that extend to other areas of domestic and foreign policy. The PCSBI is well-positioned to do so.

We can expect attention to engineering and technology issues, hardly a difficult prediction since the Executive Order makes explicit reference to these, and Vice Chair James Wagner has scholarly expertise in this area. Prior commissions focused on reproductive technologies and on the many machines used to keep patients alive. But developments in nanotechnology and robotics—areas ripe for investigation given the impact that these technologies will have on predictive health, genetic testing, and diagnostics—will be brand new to a U.S. bioethics commission. Moreover, the opportunity to focus on engineering and technology will be a debut on the national bioethics stage worth watching for another reason, as President Obama seeks to double the National Science Foundation budget just as President Clinton sought to double the National Institutes of Health budget. Perhaps the PCSBI should provide input on NIH or NSF budget priorities given that the investment in research, as contrasted with other components of the domestic budget, are among the most value-laden and politically charged policy discussions inside the beltway.

We might also hope that the PCSBI sees the opportunity to reunite under one umbrella the long-separated studies of bioethics and environmental ethics. The 40th anniversary of Earth Day roughly coincides with publication of one of the first synergizing arguments about the relationship between bioethics and the environment in Van Rensselaer Potter’s book, Bioethics: Bridge to the Future,[4] where he defined bioethics as “the global integration of biology and values for human survival.” While this phrase seemed to capture perfectly the relationship between health, climate, the social responsibility, we have seen that bioethics and the commissions established to study it tended to equate the “bio” with biomedical science and not the biosphere, the full planet and its contents, envisioned by Potter.

While some ethical issues in environmental health research have been addressed at a national level,[5] none of the previous U.S. bioethics commissions have taken on these issues in any depth. The one exception may be a study from the Advisory Committee on Human Radiation Experiments that referred to the impact of non-ionizing radiation released into the environment.[6] The absence of this topic from the national bioethics agenda may be a result of siloing on both sides—with bioethics focusing much of its attention on ethical problems in clinical care and research, and environmental ethics focusing on questions about sustainability, endangered species, extinction, pollution, resource overuse/over-management, and stewardship. The PCSBI might be in a position to “de-silo” these fields and tackle issues that lie at their intersection: the impact of environmental toxins on human health, planning for pandemics, food safety, and water policy are just a few of these. Moreover, climate change will have a significant impact on human health, but understanding its consequences will require wide-ranging research, according to a recent report from the National Institutes of Environmental Health Sciences. On the issue of climate, the PCSBI could also issue an assessment of how science may be used (or misused) in the service of certain ideologies.

In turning to unaddressed bioethical concerns, the commission should be encouraged to focus on areas that are urgent and in need of attention but that invoke other areas of policy besides health and research. The broader view of environment suggested above serves to remind us of the close relationship between the environment and economic policy, a point made recently by Thomas Friedman in Hot, Flat and Crowded.[7] A broader view of environment can galvanize attention to the interconnectedness between domestic and international security policy. We need look no further than the tragedy of September 11, 2001, when Mr. Justice Michael Kirby of the High Court of Australia, worried that “[E]normous amounts of capital are being spent on the armaments of war… [taking] important funds away from public health.”

An expanded scope for bioethical work can also caution us about how we distinguish between foreign aid, trade, and humanitarian intervention. Whether it was the Indonesian tsunami, or the earthquakes in Haiti, Pakistan, or China, a gratifying amount of international benevolence poured out to respond, help, and heal. It showed how small the world was and how little political borders mattered. But little in the way of a national (let alone an international) ethics conversation occurred about how much aid should be sent and how we ought to respond in other circumstances. Should PCSBI give consideration to the criteria that the U.S. government ought to use when deciding who to support and at what level? We’ve seen one instance of this issue played out regularly as successive presidents have variously supported or condoned the odious “Mexico City Policy” first implemented by Ronald Reagan. Also known as the “Global Gag Rule,” the policy prevented nongovernmental organizations that receive federal funding from providing or promoting abortion services. But there is more to the issue of international aid and philanthropy. It has become an area of fertile investigation, for which ethical issues are deep and significant both at the level of how philanthropic support should be provided[8] and because of the close connection between aid and international humanitarian intervention.[9] Policymakers might even ask if it is ethical to withhold humanitarian aid from countries whose human rights records we disagree with; the PCSBI should be prepared to respond.

Potter’s call for an integration of biology and values in the service of human survival can also be undertaken in the service of global health ethics and human rights issues. President Clinton’s National Bioethics Advisory Commission, referred to as NBAC, may have been the first to put international health research ethics on the domestic U.S. agenda, but its focus on clinical trials barely scratched the surface of a set of issues that include the ethics of developing and exporting science and technology, the increasing complexity of international collaborations between public/private and philanthropic organizations, and the relevance of human rights compliance as a condition of international cooperation.

Priority setting: thinking about impact, right from the start

The list of topics above is long and impossible to achieve even under the most optimistic scenario. Besides, as the NBAC learned, even when you plan to take a slow and steady approach to developing the commission’s working style, along comes a cloned sheep from Scotland or the unexpected announcement of the isolation and culture of human embryonic stem cells to throw a wrench into existing priorities. The PCSBI should expect the unexpected.

This does not mean that priorities shouldn’t be set or that criteria for taking on projects can’t be described. But the PCSBI will be progressive indeed if it emphasizes impact as an important criteria for selecting topics. It is important to remember that “impacts” can be assessed in different ways using different measures and time horizons. Legislation and regulation that follow from recommendations are rarely the best measures for a bioethics commission’s effectiveness.[10] A commission’s processes and products may do more. Meetings can create a forum for public education, establish a best practice standard, influence current institutional practice, and, perhaps most importantly, model respectful and informed democratic deliberation. Reports and published products can provide an interpretation of extant law or regulation, present a careful analysis of matters of public concern, assist students and scholars in examining and developing their own views, and influence policy development abroad.

Therefore, the commissioners need to consider right from the start not only how they will disseminate their work as it is produced, but also what their expectations are for follow-through after their work is completed. Given that all U.S. bioethics commissions so far have had an expiry date, they have emphasized report writing rather than report implementation. This is in contrast with standing committees, such as the French National Bioethics Commission, which has been in continuous operation since 1985 and is able to take both a near and long-term approach to its work—even seeing some of its recommendations implemented in law. Other commissions, most notably the Nuffield Council on Bioethics, have successfully positioned themselves to provide reliable advice to Parliament and the British people on a variety of topics, again with positive results.

On method

Critics of progressive approaches to policy try to draw a bright line between careful philosophic analysis and the messiness of policy deliberation as if these were mutually exclusive. Indeed, much has been made of the contrasting styles and methods of the two most recent bioethics commissions. The former chair of the President’s Council on Bioethics, Leon Kass, described the PCB’s method as follows: “If our scope is to be broad our manner of inquiry must be searching and open…. Because reasonable and morally serious people can differ about fundamental matters it is fortunate that we have been liberated from an overriding concern to reach consensus.”[11] These remarks would appear to characterize a particular disdain for efforts to craft pragmatic solutions to moral issues using consensus—as if there was an un-navigable gulf between serious moral reasoning and finding solutions. But it is more than this. There is a buried epistemological distinction that may characterize the gulf. In their 2004 stem cell report, the PCB wrote “We still have a long way to go before stem cell based therapies can be developed and made available…For now, neither side to the debate seems close to fully persuading the other of the truth it thinks it sees”(emphasis added).[12] The suggestion that disputes of this kind are about ultimate truths, rather than, say, about reasoned disagreements about possible approaches to a problem suggests a closed rather than open approach to public deliberation. The PCSBI should strive to be both philosophically rigorous and pragmatically focused.

Products, reports, and public communication in the digital age

The impact of the commission’s work will depend in part on the effectiveness of its communications and published products. This can happen in two ways. First, commission reports must be intellectually credible—supported by evidence and sound argument—and accessible to the public. Recommendations supported by argumentation that would pass academic muster are necessary but not sufficient. The writers must craft documents accessible to different types of readers. If a report addresses a topic about which the American public is in deep disagreement, alternative views and their foundations should be carefully explained, regardless of the ultimate recommendations. It is expected that the PCBSI will actively anticipate differing responses to novel issues and, in analyzing them, contribute to a more constructive public conversation. Likewise, information concerning the way other countries have responded to bioethical issues can be illuminating and may inspire creative thinking outside the bounds of the prevailing domestic discussion.

Second, the commission must carry out its work in public, to the extent possible. The Federal Advisory Committee Act, or FACA, which governs the PCSBI and all other federal advisory committees, was constructed more than three decades ago with the aim of ensuring that the public would be able to see government policy advice being developed in the sunshine rather than in secret. But FACA was written long before the Internet, blogs, social networking sites, and other new media communication. Just as President Obama is the first chief executive of the country to carry a Blackberry, the PCSBI will be operating squarely within the Internet age and has a special responsibility and opportunity to mix live and virtual methods of communicating with the public. This can be leveraged for advantage and transparency.

Some meetings of the full body should be held outside the Beltway. Members of the commission could also host more informal regional discussions. Of course the web presents excellent opportunities for dissemination of reports, transcripts, and other committee documents. The administration’s commitment to open government also provides the opportunity to stream public commission deliberations on urgent matters of science and technology policy live online.

Commissioner and staff expertise

We can expect careful scrutiny of the academic and professional records of the new Obama appointees. Indeed it has become something of a contact sport amongst the chattering bioethics classes—mea culpa—to focus on membership as a window into the political or philosophical bent of the overall commission.[13] For example, many observers of President Clinton’s National Bioethics Advisory Commission and the Bush administration President’s Council on Bioethics believed that commissioners were card-carrying members of the Democratic or Republican parties, respectively, or that their positions on various topics had to satisfy a pre-existing set of criteria on certain topics. There is little evidence of this for either commission.

However, one should remember that the power and privilege of appointment means the president can be expected to select individuals whose record of achievement he respects and whom he expects will fulfill their responsibilities with seriousness and commitment. The formal selection and vetting decisions are made through the White House Office of Personnel Management, and undertaken through a confidential process that is largely unknown to staff or other commission members. Still, I have no doubt that a veritable forensic investigation is now underway of the writings, presentations, funding arrangements and prior public positions taken by PCSBI members in order to divine certain positions that each might take as a commissioner. I would urge caution on this front: while the portfolio of a particular commissioner may provide a map of possible routes they might take, and while individual expertise is a prerequisite for an expert commission, a committee is greater than the sum of its parts.

But there are some intriguing stories to follow with PCSBI’s membership. An ongoing issue is whether and to what extent membership should be “representative” of the public’s views and those of various groups, or whether members should be selected based on their professional expertise, or some combination of public representation and expertise. Some may wonder (I don’t) about whether the appointment of Lonnie Ali is a wise selection, not because she is famous, but because she has focused her public efforts on advocacy for a particular cause: Parkinson’s Disease. Other commissions, including NBAC, had public members who represented certain constituencies and I think this helped and did not hurt. Better to have public members, even with developed views on certain issues, than none at all.

More intriguing is the inclusion of three government officials on the commission itself, which may be the first time this has occurred. Dr. Alexander G. Garza is Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security; Dr. Christine Grady is Acting Chief of the Department of Bioethics at the National Institutes of Health Clinical Center; and Dr. Nelson Michael is Director of the Division of Retrovirology at the Walter Reed Army Institute of Research and the Director, U.S. Military HIV Research program. The benefits of having this expertise substantially outweigh any perceived conflict of interest—which one would be hard to describe anyway. Far more relevant is the effort to keep the size of the commission smaller than past groups. The maximum number on PSCBI is 13 (12 have been appointed), 5 fewer than the two previous commissions. This is more in keeping with what we now know are optimal sizes for deliberative groups.

While no single model is perfect, perhaps greater transparency will promote greater trust by the public that the deliberations of these bodies reflect the necessary diversity of views and expertise.

History tells us that there will be a period of growing pains in identifying needed resources as members and staff become acquainted with their roles and with their peculiar place in the executive branch bureaucracy. Such an initial period of adjustment is to some extent unavoidable. More important than the growth issues however, is the decision to match the needs of the commission with the necessary skills of a professional staff. A commission whose members are very active, involved, and committed to writing sections of text will have very different staff needs than a commission that relies on its staff to provide comprehensive drafts materials and suggested language for recommendations.

Excellent professional staff with appropriate skills can be especially difficult to identify in a complex field like bioethics, although with the growth of high-quality graduate programs and bioethics research centers, the focus of bioethics by many professional societies, and greater emphasis on ethics in teaching and research, the pool of experts is larger than ever. But academic expertise in bioethics is not the same as policy expertise in bioethics. This is primarily because there is a significant difference between writing about and researching bioethics topics for a graduate term paper, or even for a bill that may be introduced in Congress, and carrying out these functions under very strict time deadlines, under the gaze of national and international media, and the sometimes withering political pressure exerted by the Executive Branch and the respective organizations (public and private) about whom reports were being written.

Conclusion: thinking about transition

The U.S. approach of using time-limited, temporary commissions appointed by the president or Congress inevitably means that some projects will be “works-in-progress,” with unfinished business falling to commissions that follow. In the absence of a “transition,” U.S. bioethics commissions have relied on the good will of staff and members of outgoing committees to brief the incomers. Not only is a formalized transition process highly desirable, but so too is a better process of assessing the impact of commission work and follow-through. If the United States continues to embrace the time-limited model, commissions, beginning with the PSCBI, should consider among their first tasks an assessment of the status of the recommendations of its predecessors and its plans for transitioning to the next commission—whenever such a body is created.

Eric M. Meslin, Ph.D. is the Director of the Indiana University Center for Bioethics. He served as the Executive Director of the National Bioethics Advisory Commission from 1998-2001.


Although admittedly it is somewhat arbitrary as to how one decides which ones should count as national bioethics commissions, the CSBI is certainly the next in a line that includes: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1979), the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-83); the Advisory Committee on Human Radiation Experiments (1994-95); the National Bioethics Advisory Commission (1996-2000); and the President’s Council on Bioethics (2001-2009).

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