Thursday, March 12, 2009
National Ethics Committees:
Mission, Functions, Philosophies, and Modus Operandi
Cynthia Cohen, Ph.D., J.D.,
Kennedy Institute of Ethics,
Mark Kuczewski, Ph.D.,
Neiswanger Institute for Bioethics and Health Policy
Loyola University, Chicago
CHAIRMAN PELLEGRINO: Thank you. Thank you all for assembling. Cynthia, you can join us up here now. This is the Cohen chair. Thank you all for returning approximately on time.
The next session is on the Mission, Functions, Philosophies and Mopus Operandi of National Ethics Committees. And, as I pointed out this morning, we do not provide lengthy bibliographies. Titles will be sufficient for these introductions.
So the first person on the program this afternoon is Dr. Cynthia Cohen, Faculty Affiliate at the Kennedy Institute for Ethics, Georgetown University and an old, dear friend. I hope I can add that little bit without extending the program too much. Cynthia, we're delighted to have you.
DR. COHEN: Well, I'm very happy to be here and thank you very much for inviting me. In the early 1970s, there were outrageous abuses of human subjects that were brought to light. A congressional committee discussed them. They became a matter of public knowledge. And the sense of outrage was such that Congressdecided that it had to establish a national commission to address issues pertaining to the use of human subjects in medical research. This was the first national commission.
There have been five such commissions subsequently, and I have been asked to speak with you about the goals and roles of these commissions, their membership, their methods of deliberation, their guiding philosophies, and how well they functioned — in 30 minutes. So I will necessarily be selective.
And my basic question is whether there is a valuable social role for a federal commission devoted to questions in bioethics.
Let's return to that first national commission. It was established in 1974. By the way, there should be handouts for members of the Council — and I believe for the public — that provide list of what the various commissions have been so that I didn't have to be a PowerPoint of them all. But I hope that you'll learn enough, if you don't have access to one, from what I say so that you'll be able to follow along.
The first one was called the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It was placed under the auspices of the Department of Health, Education, and Welfare. It was an advisory body and had a limited term, although there had been some discussion of making it a permanent body. It's basic mandate, would you believe, was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research — a very tall charge.
It had more specific charges, which included evaluating the effectiveness of various institutional methods of overseeing human subjects research because there were methods in place already and to consider additional protection specifically for children, pregnant women, fetuses, prisoners, the institutionalized mentally infirmed who were asked to become subjects of research.
You've probably heard of the Belmont Report if you're interested in this area. It is the report that the Commission is best known for. It provided the basis for far-reaching federal regulations for the protection of human subjects. And in the course of doing so it created a new social institution, the IRB, which provided a research review process that was guided by clearly articulated principles and procedures.
The Commission provided reports on the issues that it was charged with addressing — I won't go through the whole list — and then finally a comprehensive study on ethical issues raised by advances in research.
This Commission had greater power to control the development of policy than subsequent commissions because its charter required the Secretary of HEW to respond to its recommendations within 180 days. If the Secretary decided they should not be followed, he or she was required to publish reasons for this in the Federal Register. So it was clearly easier to accept the Commission's recommendations than not. Efforts to transform this Commission into a permanent body at the end of its term were unsuccessful.
And in 1978 the Secretary of HEW developed a body known as the Ethics Advisory Board on the recommendation of that first national commission, and its role was to develop policy regarding research into IVF — in vitro fertilization — fetuses, et cetera, and to review research proposals involving them so that it was a two-pronged charge. It had the practical charge to review actual research proposals and the more policy-oriented charge of developing some sorts of guidelines and policies regarding them.
It published a report on IVF in 1979. But the first child born of IVF appeared on the scene at that time and there was tremendous controversy about the use of embryos, the use of IVF, and the EAB was terminated in 1980 presumably due to political considerations.
This meant that no federally-funded IVF research could take place because the board that was supposed to review this research was non-existent. Soon after though, in 1980, Congressonce again created a national bioethics commission, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. I'm going to refer to it as the President's Commission.
Although it was called the President's Commission, it was established
by Congress. Its mission statement was breathtaking. It had a general
clause as did the first commission about principles. It was to address
informed consent, the definition of death, decisions to forego life-sustaining
treatment, and genetic testing and counseling as well as differences
in the availability of health services. It was free to take up other
related matters. And, of course, at the instruction of others, it
would take up their required or suggested issues.
Its report defining death set out the whole brain definition of death and the foundations of the Uniform Determination of Death Act. Prof. Schneider was wondering if any of the French or UK groups had had any practical impact. This is one practical impact that a US commission had. This Act was subsequently adopted by all US jurisdictions.
Another report, Deciding to Forego Life-Sustaining Treatment, had
a major effect on the way in which end-of-life care was and is provided
in this country, not only in a legal sense, but also in a medical
sense in terms of public awareness. It produced ten reports in a
little more than three years. Several of these provided careful
analysis of some widely-held but contrasting views on ethical issues,
but some of them could not resolve them. Its work had a significant
impact due to public interest in the topics and also by efforts
by commissioners to establish contact with Congress, the media,
and the public.
In 1988, a Biomedical Ethics Advisory Committee was created by a Congressional Biomedical Ethics Board. That Board consisted of six senators and six representatives. However, it deadlocked about its membership concerning pro-choice/anti-abortion issues and the Committee simply could not actually be appointed, much less function. It had two meetings before it died in September 1989. So I won't be talking much about that Commission because it didn't do anything, and I won't be talking about the Ethics Advisory Board because it never really was able to do much.
However, after a six-year hiatus, in 1995, President Clinton established
the National Bioethics Advisory Commission by Executive Order. So
this was not Congress, it was the president. It was to advise the
president, National Science and Technology Council, and other appropriate
government entities regarding bioethical issues arising from research
on human biology and behavior and the applications, including the
clinical applications, of that research.
Its major task was to advise federal lawmakers about legislation, regulation, and policy regarding sensitive bioethical issues. It began work in relative obscurity. But four months later scientists announced the birth of Dolly, the first cloned mammal, and President Clinton asked NBAC to prepare a report on reproductive cloning within 90 days. It did so somehow. The staff got beefed up and members worked tremendously hard. A lot of outside consultants were brought in.
It recommended a moratorium on reproductive cloning. However, this
recommendation was not enacted into law due to differences among
members of Congressabout the issue of reproductive cloning and
research cloning. But its report was widely publicized.
NBAC moved from one briar patch to another. It was asked to do a report on stem cell research after the development of human embryonic stem cells in 1998. The President made it clear well before that report was issued that he would not support the adoption of one of its forthcoming recommendations to use federal funds for the derivation of human embryonic stem cell lines from human embryos.
Again, there was widespread discussion of this report, even though the President made it clear he didn't favor parts of it. I think one of the reasons it received widespread notice was that it had a very interesting discussion of the religious views of the moral significance of early embryos.
NBAC produced a total of six reports that addressed ethical and policy issues pertinent to persons with mental disorders, human biological materials, clinical trials in developing countries, and research involving human participants. Some of its recommendations were accepted. For instance, several of the detailed recommendations in its stem cell report were built into the guidelines of an NIH task force that was set up to oversee stem cell research that was to be funded by the NIH. That task force had its first meeting canceled and never met, so those guidelines were not put into effect due to a change in administration.
It's arguable that NBAC had an impact on various federal agencies such as the FDA and the CDC in that they responded to its reports. So this indirectly, or perhaps directly, indicates that it had an impact on policy development. Its work ended five years after it began in October 2001.
In November 2001, President Bush established the President's Council on Bioethics by Executive Order. Its charge was very broad. It was to advise the president — no other public officials or agencies were mentioned — and was to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology. It was also to explore specific ethical and policy questions related to these developments. So it was not only to discuss general matters but to look at specific issues and to provide a forum for national discussion of bioethical issues. There is no sense, though, that it was to perform these tasks as a prelude to legislation.
The President's Council has had the longest life of any of the six serving from 2002 to 2009. It has considered specific developments in biomedical research as charged, cloning, and stem cell research, for example, and it has prided itself on addressing these from a broad prospective. It has also addressed more general issues that we face as human beings in search of the human good.
The Council has produced a slew of reports. The one on Alternative
Sources of Pluripotent Stem Cells appears to have been the
only one — and you correct me on this — the only one to have
had a specific response from Congress. There was legislation passed
that took up several of its recommendations.
Other reports such as those on enhancement, Being Human, [and]
human dignity have been directed to the educated public. In them,
the Council has sought to persuade readers of the importance of
a set of ideas and questions. Clearly, the primary role of the Council
has been educational.
As this discussion of the charges of these commissions suggests, these commissions have played several different but interrelated roles. Initially, their function was to recommend ways in which government agencies could address certain unethical practices related to the pursuit of biomedical research. So they've had an activist-reformist charge from the beginning.
In carrying it out, they've sometimes played a quasi-legislative role as when the President's Commission stepped into a major legislative breach due to disarray about the definition of death and produced one that was written into law.
National bioethics commissions have also been called upon to promote a national discussion of ethical questions that have been raised by specific developments in biomedical sciences. This is the case, for instance, when the National Bioethics Commission addressed research on human biological materials. In this role, they've sort of served as a crucible to define more sharply what's at stake ethically for policymakers and the public. And as this example suggests, their educational function has often led them to perform their activist-reformist function as well.
They've not always been successful as you may have concluded from my opening discussion of them in this function. For instance, the National Commission's report on providing special protections for those institutionalized as mentally infirmed was never adopted due to conflicts among relevant interest groups. The National Commission, by the way, was the first.
National Bioethics Commission — I don't know if I should say numbers,
but I hope you're hanging in there and following me with which commission
I'm talking about — that was the one under President Clinton — and
the President's Council of Bioethics under President Bush had little
success in enticing the president or the Congress to introduce policies
they had recommended with regard to cloning.
This leads me to another purpose for which these councils have been formed, a political one. Some say that one commission or another has been created to advance the political agendas of liberals or conservatives. NBAC had a goodly dose of known political philosophical liberals and the President's Council of known political philosophical conservatives giving weight to the belief that political affiliation was a consideration in the structuring in of their membership.
Others maintain that some of these commissions have been political
in a somewhat different sense. They have allowed the president and
the Congress to toss hot potato issues in their direction so that
they could be rid of them and not have to get into deep political
grounds. So the National Commission was the dumping ground for an
issue that was too difficult for the ordinary political process
to handle, fetal research.
Meslin and Shapiro suggest that assigning NBAC to review human stem cell research had the dual political effect of focusing national attention on the subject and yet defusing the urgency associated with it.
It should be pointed out that national bioethics commissions can play political roles on their own initiative and terms. They can bring pressure to bear on the Congressand government agencies to pursue certain policies as did the President's Commission with regard to the definition of death. I see some of you smiling back there, but it really was the case back in the olden days, I guess. As such, their educational function rolls over into a watchdog function.
As Dr. Pellegrino has observed, there are ethically sound ways of being political and ethically unsound ones. Such commissions have an implicit charge to use their watchdog function in ways that are ethically sounds, no attempt at political blackmailing, for instance.
What about the composition of the councils? Given their roles as discussed so far, who should be appointed to these commissions? The educational and activist roles that they have would require a diverse membership. Commissioners need to provide ethical and social perspectives and professional expertise on a given topic.
The National Commission, for instance, drew five of its eleven members from the research community and the other six from such areas as — this is a long one — medicine; law; ethics; theology; the biological, physical, behavioral and social sciences; philosophy; humanities; health administration; government; and public affairs. So that was going to be for six.
The President's Commission was larger. It had eighteen members. They had a similar background requirement except that the NBAC members included, in addition, members of the general public. I won't go into detail about it. The President's Council does not have a similarly broad requirement for its members, does not include public members. No federal bioethics commission has formally designated by bioethicist as a member, although certainly there have been people who call themselves bioethicists who have been appointed probably under the rubric of being an ethicist or in the field of ethics.
Some contend as the commission movement developed membership tended to be composed primarily of bioethicists and became somewhat clubby. Members tended to know one another from working together on other sorts of bioethics groups or other groups that weren't necessarily focused on bioethics. They seemed to adhere to the same language and conceptual framework that led to certain conclusions. And some maintain that when a commission has no dissenters to its recommendations, its members have been drawn from the same school of bioethical thought rather than a more representative and varied background in ethics.
In a related vein, the liberal-conservative dichotomy has become an issue with the appointment of members known to be politically liberal or else conservative. One argument for doing this is, if you tried to appoint members with an eye to balance in terms of political convictions, this could result in polarization and an inability to get anything done. Perhaps the answer is to select members who are known to be open to understanding different and even opposing points of view, even though they themselves tend in one direction.
The staff plays an important role in the work of these commissions. The President's Commission, for instance, had a staff of about twenty. They prepared, revised and disseminated its reports. The staff, though, should not be allowed to control the discussion. You might be interested in the issue of the Kennedy Institute of Ethics Journal that's just coming out. There's an article by Dan Sulmasy in it that talks about the role of the staff with regard to the work of the New York Stem Cell Task Force, which he found to be most unhelpful, and I will leave it at that.
Methods, Mode of Deliberation. We live in a pluralistic and fractured society in which citizens manifest many conflicting theoretical persuasions and notions of the good. It seems that we lack common ground that could serve us in good stead in addressing fundamental value conflicts. And yet the basic charge of three out of the four main commissions, forgetting or setting aside temporarily the two that really never were able to function, the basic charge that those three commissions had was to sort through the ethical issues at hand and to address them. And when I say three commissions, they had specific assignments: address these issues, do something about them.
Well, how did these commissions proceed? We know that, although
the National Commission didn't adopt a basic ethical or political
theory, three basic principles emerged from the Belmont Report
to govern research ethics, which curiously surfaced
in the UK analysis that John Harris did — respect for persons,
beneficence, and justice. According to some commissioners, these
principles did not emerge full-borne from the heads of the commissioners
during discussions. They were developed as a sort of afterthought
to meet their charge to develop some principles. This was their
So what did they do during the working hours? Jonsen and Toulmin who served on this Commission in different capacities observed that commissioners could agree on some rather vexing issues in research ethics, for instance, and yet disagree strongly about the rationale behind their respective positions. They reached agreement, Jonsen and Toulmin maintained, by starting from paradigm cases of what they took to be ethical research and reasoning analogically from them to more marginal or problematic cases so that they basically used a case-based method. But they invoked their preferred ethical theories on a broader plane or their religious beliefs to explain and justify their votes. And when they did that at times disagreement resurfaced.
After the commission — the commission sort of sifted out, what are the three principles? Apparently, they did this in the home study of one of the commissioners because they were just having a terrible time meeting the charge. They drew these principles together and then dumped them on Tom Beauchamp — Tom Beauchamp was on the staff of the President's Commission — and said to Tom, "You figure out what they mean." Well, Tom, of course, went on to make bioethics history along with Jim Childress by developing these and a fourth principle into the mid-level principles of bioethics.
The second commission, the President's Commission, in contrast did not explicitly develop a set of principles. It used a variety of argument forms depending on what was at issue to reach its conclusions. Some of these implicitly used principles of bioethics. But basically the group was trying to figure out reasons that most of its members would agree to for its conclusions because there was a heavy push toward consensus from the chairman who felt that anything they came out with would be useless unless it had the firm backing of the vast majority of council members. So some critics say it actually wound up putting out rather watered-down reports, taking very complex issues and oversimplifying them. But I think others would argue against that view.
The National Bioethics Advisory Commission aimed to reach both policymakers and the general public. So, for instance, in its stem cell report, it began its discussion by saying it would attempt to resolve ethical and policy disagreements by referring to shared views, the public consensus, and common ground. But it maintained it would not accept shared views blindly. It would only do so when these could be supported by sound deliberative reasoning. So the quality of reasoning used to reach consensus mattered.
Now, John Rawls' name was not, to the best of my knowledge, specifically
mentioned in NBAC's report. The work of others who drew from his
thinking was. I'm going to run out of time if I go into this in
too much depth. But basically let me just say that people built
from his ideas.
He basically had a notion that procedure was very important in the way that you reached conclusions in a liberal, broadly-speaking liberal, democratic polity; that there were some basic essentials that people had to work with in such a polity. These were Constitutional essentials and the principles of justice, which could be used procedurally as well. And he put a great deal of emphasis on the duty of civility, that people ought to sit down, listen to what other people are saying with whom they disagree, try to meet them halfway, figure out if there's some way of getting their views together in light of what he called public reason. And he eventually took a position where he was open to bringing in comprehensive views of all sorts and seeing what they had to contribute to public reason.
While Gutmann and Thompson built from his ideas — these were two political theorists, I guess. I'm not sure actually. I don't know what their affiliation is. But basically their point was the same, that when bioethics commissioners or others are participating in public debate about public policy they should use principles and standards that they consider reasonable for everyone to accept and yet be willing to discuss the terms that other propose. They should seek significant points of convergence between their own understandings and those of citizens who have more comprehensive stands that they take on the basis of philosophical or religious views, views that they might reject individually, that the council members might reject individually. So mutual respect for persons and their positions was important.
NBAC adopted this approach to deliver to decision-making in its stem cell report, and it claimed to find an area of common ground and shared values between liberals and conservatives regarding the moral significance of early embryos. Again, I'm not going to go into detail here. But basically what they concluded was that, if both sides were consistent, they would have to agree that it is permissible to carry out stem cell research using embryos remaining after the completion of IVF treatment in order to attempt to develop cures for serious diseases. It believed it had found an area of reasonable mutual agreement or consensus that was shared by those participating in this discussion.
In contrast, Leon Kass, who, when he chaired it, spoke on behalf of the President's Council fairly often, was very leery basing conclusions on some sort of consensus. He had the ear of the president apparently who, in his Executive Order establishing the Council, charged the commission with proceeding by offering a variety of views on a particular issue rather than to attempt to reach a single consensus position.
This was something that the Council attempted to follow to present various views, for instance, on the moral significance of early embryos. But the Council found that it really could not come to any agreement about that issue. Despite the fact that it was supposed to be biased in one direction, there really was tremendous variation of the views of members of the Council. And the majority of the Council in their cloning report embraced consensus. They had gotten so backlogged and unable to reach a conclusion that when they were recommending a four-year moratorium on research cloning they said they were doing this to allow for further democratic deliberation and for seeking a consensus about whether this research should proceed.
So it sounds like after being frustrated by being unable to reach any sort of common conclusion, they were willing to think of resorting to some of the deliberative procedures that could reach a reasoned conclusion based on consensus.
Basically, no one deliberation method has been used by all four councils. I won't even review them for you because I'm running out of time. I hope that you've picked up the general approach that they have taken.
One of the points I want to make in talking about future possibilities and future modes of functioning is that panels need to do more to communicate with public officials and the government persuasively. And I'll get to ways that that could be done as I go along. But perhaps I can bring this out by asking, why do we need a governmental commission to address these issues when there are private groups that can do so? We've seen in the UK that the Nuffield Council has done so.
The main difficulty in keeping this work, and there's a article of mine that's been distributed in which in my more naïve period of education in bioethics I advocated for the use of private groups. I no longer have that position having worked with the private group for four years. I can tell you about that if you want later on. But basically private groups are not responsible to any elected body, and the American public is the basic issue. They may be considered one more interest group pushing its own agenda as they emerge from behind closed doors.
National bioethics commissions have a sort of moral power that private ones may not, and this comes with their distinctive mandate to articulate an ethical perspective on issues raised by biomedical technologies on behalf of those to whom they're legally and morally responsible. They're legally responsible to the president; in certain instances, to certain agencies. Morally, they're also responsible to the public.
Their clout as national bodies puts them in a better position than private groups to obtain necessary relevant information and expertise, and their conclusions are considered to have great weight. This is not necessarily the case for private organizations.
The view that I have come to about the future of national commissions is that their activist roles should be primary. A bioethics commission that serves as a national seminar to provide publicly funded education about the impact of our developing scientific powers on the human condition has its place, but its place is secondary to the need to address pressing ethical and public policy issues that effect real living people in their everyday lives that are raised by some of the new developments in the biomedical sciences.
The President's Council under Dr. Pellegrino, it seems to me, has been moving more in that direction in several of its recent efforts and I applaud that effort. There's still much work for commissions to do to address newly-developing issues. I could give you a list that I have to suggest, but I understand others are doing that later on.
But I think they need to avoid falling into the trap of becoming another interest group pursuing their own objectives. The major step that they can take to avoid this narrow fate is to engage in greater consultation with the public. They could do so by developing more fulsome public consultations as is done in the UK, done in France — I served on the Canadian Stem Cell Oversight Committee. They engage in public consultations whenever any changes are made to any major provisions of such commissions — make greater use of the Internet, organize meetings that engage members of the public who have jobs or play roles that are relevant to the topic at issue, various ways of doing this that I think national commissions could do more to develop.
In the conclusion to its final report summing up, the President's Commission observed that in a pluralist society a commission on bioethics can play an important role in engendering and encouraging the process by which a vibrant and ever-developing society reexamines, revives and reaffirms its system of value and beliefs.
Such commissions are in existence to serve as vehicles for digging out, reconsidering, and revising current ways of thinking about how we should proceed with our uses of biomedical technology on behalf of all of us. This is a role I hope will be honored and protected in future administrations as it has been in the present and in the past. Thanks.
CHAIRMAN PELLEGRINO: Thank you, Dr. Cohen, for a very, very complete review of a complicated subject, and we appreciate your giving us that background for our further cogitations.
Our next speaker will be Dr. Mark Kuczewski, who is the Director of the Neiswanger Institute for Bioethics and Health Policy at Loyola University in Chicago.
DR. KUCZEWSKI: Thank you, Dr. Pellegrino and members of the Council. It's a pleasure and an honor to have this opportunity.
In my remarks today, I would like to speak to the question of the mission of a federal bioethics body. I wish to suggest that a federal bioethics body, whether commission or council, is at its most useful when it contributes to the development of a stable societal consensus on biomedical ethical issues.
I believe this assertion requires little direct argumentation for it. After all, who would not like consensus? But, I think that it must be supported by saying a bit about what I mean by "consensus" and the role consensus plays in our society.
In other words, the main obstacles that I believe my position faces are two. First, some may challenge an emphasis on consensus by arguing that fundamental value disputes prevent anything such as a genuine consensus from emerging. To seek consensus is to ask some persons to give up or compromise their important values. According to this objection, reaching consensus requires that some act disingenuously.
Second, I wish to characterize consensus not as mere agreement among the members of a federal bioethics body but as a template that may contribute to a stable societal consensus. By showing ways to respect seemingly contrary values, the federal bioethics council may offer a blueprint to assist us in living out our values. Because societal consensus is not the telos of this Council, I would like to briefly characterize how I understand societal consensus in order to show that it is also achievable.
Of course, in contrast to my position, many argue that an emphasis on consensus is misplaced and a bioethics commission does a better service by giving detailed outlines of all major positions on particular controversies. There is little doubt that such a commission may also perform a public service. So please understand that I do not assert that option to be wrong simpliciter. In fact, this mission which I understand to be that of the current Council certainly has a variety of virtues.
The Council, in its quest to accurately portray all relevant viewpoints has included members with views that have historically been artificially dismissed too easily because they are not common among academics. As a communitarian in the Aristotelian tradition, I have also been particularly encouraged by the restoration to prominence of considerations concerning what kind of life our choices regarding technology have fostered and how these choices affect our humanity. Such considerations are commonly passed over when seeking consensus.
So in no way do I wish to downplay the contributions of conceptions of bioethics commissions that differ from my own. Nevertheless, it is my considered belief that when a commission takes the step of putting forward a particular position, one that might advance consensus in our society, it probably contributes something of greater value than if it chooses to refrain from so doing.
We are a pluralistic and diverse society which has been noted many times today, and such an assertion may very well understate the case. There are moments when it can seem that each individual is his or her own idiosyncratic amalgam of beliefs, values, and judgments. In such a moment, consensus can seem a pipedream. But, as is the case in Western industrialized societies, we also have a realm of shared practices in which we live and interact together. For instance, health care is financed and delivered in ways that involve strong public sector support for a traditional private profession. And, there is a complex and constant ongoing negotiation about the expectations and standards that the public and profession have of each other.
While much of the rhetoric surrounding health care sounds individualistic, e.g., the doctor-patient relationship, privacy, confidentiality, et cetera, the medical enterprise seems to be generally located within the "commons." There is no ideological leap in saying that in common, we subsidize medicine, medical education, and health insurance in many ways and for large swaths of our citizenry in order to promote the health of our nation. Thus, we all have a vested interest, not only in considering what kind of subsidies and which services promote the general well-being of our people, but also in arriving at solutions that make our health-care institutions the kind of trustworthy institutions in which we may live out the dramas of birth, illness, and death. Biomedical ethics can be viewed as a scholarly and practical discipline in which we try to find morally acceptable ways to continue to live together in this shared realm of medicine and health care.
It is the commonality of these very dramas that call for shared agreements and also make the possibility of consensus realistic. While we may hold a variety of world views, only the most dogmatic relativist would argue that living through the experiences of birth, illness, and death within the same institutions would not lead to some shared insight and the possibility of dialogue.
In living out life and death in the clinic, we move beyond being mere moral strangers. We develop some shared experience and a desire to make this realm humane for our intimates as well as those with whom we are less acquainted. We can aspire to, at minimum, become moral colleagues.
But what is a commission aiming at when it aims at consensus? The kind of consensus that has characterized some of the work of the various bioethics commissions is a combination of values and specific insights regarding practices. This has often been described as a balancing of principles and/or considerations. Consensus becomes possible because agreement is always possible if we can find ways of proceeding that respect the range of key values at stake.
Conversely, skepticism about consensus usually stems from believing that some parties hold values incompatible with those of others. We may not see ways of adjudicating between or among values and thereby lose faith in the possibility of genuine dialogue.
While this certainly may be true at some times and in some instances, it is also evident that many people simultaneously hold these seemingly incompatible values within their own world view and wish to respect each. This has been most commonly advanced by bioethicists in terms of the prima facie duties of the four principles of biomedical ethics that we just heard about: autonomy, beneficence, non-malfeasance, and justice. But many bioethicists and ordinary citizens also simultaneously value such seeming oppositions as choice and respecting life, freedom to choose a good death and not killing, choosing to participate in research but minimizing risk.
Approaches to particular problems that enable both sides of the opposition to be respected will be preferred by the public to having to choose between these values. Consensus might require that we cannot always have all of everything we want. But a stable consensus requires that we not be asked to give up the most important elements of each opposition.
To some extent, we can characterize the work of a bioethics commission as acting as a deliberative microcosm for a society. Its members seek to build a consensus among themselves that is potentially reproducible within the larger society.
Such a requirement has a variety of kinds of implications for the meaning and contours of consensus. In particular, we must characterize consensus so that we do not mistake the differences of opinion that can easily be found among people within a large nation with the lack of a shared way to live together, a consensus.
The work of a bioethics commission does not seek to end all debate in society. It aims to create a relatively stable consensus that is semi-performative in nature, that provides a core for shared living even as challenges and controversies arise around it, and that can seemingly disappear from public view at times. However, if well constructed in honoring a range of the core values of society, it emerges from these ongoing challenges and temporary eclipses and may undergo further development. Please indulge me for a moment in describing these characteristics a bit more.
First, consensus is sometimes said to be performative or semi-performative. By "performative," some mean that consensus exists at the moment that the points of consensus are recognized. However, that would seem too strong. After all, consensus is achieved because the elements of that consensus are implicit within the values and beliefs many in society hold.
Consensus is probably better characterized as semi-performative in that making the elements thematic and publicly pronouncing them reiterates and reinforces the consensus. This is a major reason why bioethics commissions should lay such a groundwork. While a consensus among commissioners is not a societal consensus, a carefully constructed consensus may help our society to discover and affirm such a consensus within itself.
Second, consensus does not bring an end to strong feelings among various groups, or end debate, discussion, or controversy. But it brings ways of proceeding that remain relatively stable in the face of challenges and controversies. For instance, the consensus on forgoing life-sustaining treatment faced a challenge during the Schiavo case but came through intact.
It has been challenged via referenda on assisted suicide but such challenges have achieved modest success. Clearly, consensus does not mean we all agree on how to treat patients in PVS or whether assisted suicide is morally illicit. Nevertheless, it has given us wide areas of agreement that allow us to die with dignity and respect within our shared institutions.
A bioethics commission faces a particular challenge in that the commissioners deliberate about the consensus, but the public must live it. Thus the commissioners will always be aiming to create constructs that they believe will resonate with people once they have an opportunity to live through situations in which the consensus holds sway.
This is an imprecise science as thought and being always have a tenuous relationship. Nevertheless, this lived application is the test of consensus. Each time a family makes decisions for a loved one who is near death, the consensus on forgoing life-sustaining treatment is tested and reinforced. The sense of its prescriptions is made evident.
Consensus can be hidden from sight when divorced from its experiential component. For instance, unusual cases such as that of Theresa Marie Schiavo may present a moral quandary for which the tenets of the consensus do not apply in obvious ways. Thus, bioethicists watched in amazement as the public divided for an extended period before coming back together in a consensus-affirming manner.
Cases in which the tenets of a consensus are not easily applied to the specific situation can be mistaken for situations in which the tenets of that consensus are facing serious challenge. We may confuse the inability of the public to apply its values and intuitions to a particular instance with the lack of shared values and intuitions.
Of course, consensus does not usually go straight from commission to the clinic. The deliberations of such groups have sometimes laid foundations for the reasoning of courts of law, professional societies, and legislative and regulatory bodies. Thus the reasoning toward a consensus must accord with the standards of such bodies, and it must reflect the values of the citizenry who seldom think about such matters until they are directly involved in relevant situations. For them, consensus will mean what-I-would-think-if-I-thought-about-it within the appropriate set of experiences and contexts, a point I think I'm borrowing from Jonathan Moreno.
Thus, we have a picture of bioethics commissions as aiming to lay down ways to proceed in the health care enterprise that reflect the best within citizens, their cherished values and judgments. And, as noted, we can easily overlook such achievements in a society that constantly gives voice to differences of opinion.
Nevertheless, we have clearly seen such consensus develop regarding end-of-life decision-making and the ethics of research involving human subjects. It remains, perhaps for our discussion, whether such an implicit consensus has developed in regard to universal health insurance coverage and whose advancement could be assisted by a deliberative body.
Of course, I face the question of whether consensus is irrational. As I stated at the outset, I believe that societal consensus on bioethical issues and having a bioethics commission lay the groundwork for these consensus is intrinsically desirable. I've tried to illustrate that this kind of contribution and outcome is possible for I believe it is doubt about the achievability of such outcomes that could lead some to avoid taking this step.
Of course, as Dr. Cohen has pointed out in one of her background articles, we might also reject consensus as a goal or as a fact because it fails to accord with our view of rationality. However, this would be to privilege a view of rationality that is highly theoretical, academic, and based in the view of rationality conditioned by the biases of the Enlightenment.
The view I have been trying to advance follows the Aristotelian tradition in respecting the wisdom embodied in people of appropriate experience. Facts and values are closely related in a dialogical relationship rather than separated by an unbridgeable gulf. This view was advanced by Al Jonsen and Stephen Toulmin in the 1990s under the banner of casuistry. By examination of paradigmatic cases and increasingly distant approximations, Jonsen believed that bioethics commissions could devise a moral taxonomy to guide our society through its bioethical controversies. The case was paramount, reasoning about the case is secondary.
While this primacy of the particular may seem peculiar and irrational, one only need think about the prohibition of killing in the consensus on forgoing life-sustaining treatment. Our resistance to directly taking the life of patients can be supported by any of a large number of considerations. We do not have a single theoretical system that underpins the prohibition. Similarly, the question of assisted death sits on the periphery of the consensus because the case of the patient in uncontrollable pain and suffering still haunts us as we think about our individual futures. Nevertheless, directly taking the life of patients still clearly sits outside the consensus. There is little that is irrational about this situation. Why a theoretical underpinning rather than a number of "good reasons" would be needed to make this tenet rational is simply not clear.
As I have indicated, part of what makes this consensus a consensus is that it demonstrates its "livability" in practice. In some sense, it is "received" by the public. This is not too different from how moral teaching works in some organized religious institutions such as the Roman Catholic Church. While recent years have seen an emphasis on the formal teaching documents set forth by the hierarchy known as the magisterium, genuine teaching must reflect the "sense of the faithful," i.e., be received by the faithful. If teaching is set forth that is too discontinuous with the tradition and not adaptable to the circumstances of the varied lives of the faithful, the teaching set forth will fall into disuse rather than become a part of the living tradition.
Jonsen and Toulmin acknowledge this narrative element of the casuistry of public bioethics but their rhetoric can, at times, sound as if it is a narrow or naïve realism. Nevertheless, bioethics integrates moral perceptions and intuitions with reflection on values in an ongoing feedback loop. So understood, the role of a bioethics council is to be a key contributor to the social construction of a shared narrative through its reflections and recommendations.
However, as with the magisterial role in my example, such reflections can fail to be received and to bear fruit. In other words, there is always the possibility of error. Error is not a mere failure of apprehending facts or reasoning logically, but missing the mark of devising recommendations that appropriately incorporate the values and needs of those affected by the deliberations.
This line of reasoning entails that among the important virtues for any bioethics commission will be courage and humility. Commissioners must have the courage to put forward their creative attempts to honor and balance the values and considered judgments of the citizenry. This courage will be reinforced by the humility of knowing that the deliberations of bioethics experts are just one part of the process and a part that might ultimately be shown to have been mistaken.
One of the implications of this approach to the deliberations of an ethics commission is that it works best in situations in which the public has some access to experiential content relevant to the issue. That is, if stable societal consensus is best produced by a process of deliberation and recommendations followed by the public encountering the framework in its clinical experience and reiterating, refining, or rejecting it, issues that make it difficult for the public to ground its reception or rejection in experience will create difficulty in anchoring the stability of a consensus.
Thus, it is easily understandable why the most stable consenses have been produced in regard to forgoing life-sustaining treatment and human subjects research. These are areas in which thousands if not millions of citizens have relevant experiences each year. Thus, these consenses are activated, reiterated, and reaffirmed each day. And, it explains why a case like that of Terri Schiavo can seem to threaten a consensus but never actually place it in jeopardy.
The specifics of a case can be so far removed from the ordinary ways in which people encounter it that it may not even be obvious to them that the principles and values that these citizens have relied on are at issue. But, this particular case continued until a clearly cherished value was threatened and the public reacted.
This would tend to make issues such as access to and affordability of health insurance and methods of procurement of organs for transplantation good candidates for the consideration of a bioethics commission and development of a societal consensus. Possibly, health disparities, the treatment/enhancement distinction, and matters of provider conscience, might seem to hold some potential in this regard.
An issue such as the funding of embryonic stem cell research would seem the least likely among these issues to be a candidate for a stable societal consensus. With this issue, it's not clear what would constitute relevant moral experiences and it would seem that the debate is mediated by other issues such as that of in vitro fertilization or abortion.
The more the questions are seen through the lens of in vitro fertilization and the discarding of "leftover" embryos, the more the public is likely to coalesce in support of research. The more the question is viewed through the lens of abortion, the less likely it is to command widespread support.
The former case seems to be winning in the court of public opinion. However, there are considerations that suggest it is difficult to found a consensus on such an analogy including that the analogy will not prove stable if the discarded embryos are not sufficient for the purposes involved.
In closing, I would just like to say a couple of words about the future of commissions and commissioners. There is no sure formula for selecting commissioners. But my reasoning to this point suggests that a variety of perspectives is better than fewer perspectives. In particular, it is important to have perspectives of people whose implicit concept of rationality is more practical than theoretical. Thus academics should probably be more than balanced by non-academics.
Similarly, it is important to have a variety of views along the spectrum represented. While this may seem obvious, it is easy for academics to devalue viewpoints from other parts of the spectrum as irrational and dismiss them from consideration. As I mentioned, it has been a virtue of the current Council to have broadened the spectrum of views beyond the typical viewpoints common among academics.
The goal of contributing to a societal consensus is probably best facilitated by having people of strong, but not necessarily inflexible, views. That is, societal consensus is best achieved by finding ways to honor the core value or values or most cogent kernel of truth in each of the viewpoints along the spectrum. Commissioners will not serve the nation well if they do not hold to such core values. But consensus is ruled out a priori if commissioners are wedded to the idea that anything but agreeing with an uncompromising systematic development of one particular position can be the only reasonable and acceptable outcome.
In making these modest suggestions, I have taken seriously the Aristotelian dictum that the end of practical wisdom is not solely "to know," but also "to do." And I have tried to indicate that, in fact, we must take seriously that we do not always truly know in advance of doing. There is a complex relationship between these elements.
Of course, perhaps such an insight has been assimilated by the biomedical community and bioethics is more mainstream than we have recognized. For instance, in this decade, the Institute of Medicine of the National Academy of Sciences has published important and influential reports on insuring the uninsured, health disparities, and increasing the number of organs available for transplantation. Each report has significant ethical components and some, albeit few, bioethicists were among the authors. So perhaps it is possible that bioethics is being mainstreamed with less work left to specialized commissions.
Thus, I think part of our challenge might be to ask what distinctive contribution a commission that is per se a bioethics commission might make if we believe that practical wisdom is actually practical.
CHAIRMAN PELLEGRINO: Thank you very much, Mark. We appreciate your presentation. Thank you very much for taking us through a careful consideration of one of the major issues that I see.
I'm going to ask Carl Schneider to be the Council member to open the discussion, and then we'll throw the discussion open to all the other members.
DR. SCHNEIDER: I want to add my thanks to Dr. Pellegrino for unusually intelligent and helpful presentations, and I with some embarrassment cannot prevent myself from saying that Dr. Cohen's presentation shows why we are so proud of the graduates of the University of Michigan Law School.
DR. COHEN: I might add that graduates of the University of Michigan Law School are very proud of Dr. Schneider.
DR. SCHNEIDER: Oh, dear. What I want to do is to build mostly on what Dr. Cohen was saying. I've already expressed some discomfort about the question of what kinds of consequences these commissions actually have and talked about the post hoc ergo proctor hoc error of believing that just because something happens after something else that the prior event caused the subsequent event.
But what I want to do now is to talk about these commissions insofar as they are attempting to affect public policy because public policy is what lawyers worry about and I'm a lawyer. I want, however, to make it clear that I'm not going to talk about the work of this Council partly because that seems otiose and partly because I think this Council has been quite different from a lot of its predecessors. And I've already explained the reasons I think that our Council is different from many of its predecessors before, so I won't bore you with a repetition of it.
I have often thought that the law of bioethics is the law of failure,
that the law of bioethics has repeatedly failed to achieve the goals
which it is set out to achieve. And my question is whether a commission
of accomplished amateurs, assisted by a staff that is expert, but,
(necessarily), experts who are generalists, can make a
useful contribution to writing public policy. And I want to build
on what Dr. Cohen was saying by taking as my example the IRB system
that has been a major focus of both the presidential commission
reports and numerous other private and public kinds of reports.
There really has come to be something that I call "big ethics." There are now so many councils and commissions and people who make their living by selling ethical expertise and advice or by enforcing what are taken to be ethical rules that I think thinking of it in industrial terms is quite appropriate.
If one looks at the history of the commissions that deal with human subject research, I think what one sees is a consistent failure to ask the right questions and to bring the right kind of information to bear. The commissions — and I have to generalize unspeakably, but I must. The commissions have never thought critically about the definition of human subject research. As a result, human subject research encompasses biomedical research and social science research and treats them virtually identically even though they are radically different. And no prolonged considered discussion of this comes in any report that I have been able to find, and I have read these reports. Livelier, more graceful writing would be gratefully received by the consumers of these reports.
The commissions have never seriously asked how dangerous human subject research actually is. They have never asked whether it is dangerous enough to merit any kind of regulation at all. They have simply recited the names of scandals and left it at that. A scandal is not an argument for regulation. A scandal raises the question whether regulation is needed and invites an inquiry into that subject. The recitation of scandals, in fact, serves to prevent discussion of whether or not regulation is actually needed.
The commissions have never asked what kinds of costs the regulations that they propose of human subject research might incur, even though that is surely one of the two or three most elementary questions to ask. The administrative costs of these systems have grown and grown and grown, but the commissions do not look into those costs partly because the costs are concealed by the fact that they don't appear on budget lines. The real costs are in the time of the IRB members and in the time of the researchers who are extremely expensive people. But they do not work on a budget and those costs have been ignored.
What has never been considered in any way that I have ever been able to find is the cost of stopping research. The IRB system deters, delays, and denies research. If you believe that human subject research saves lives, prevents and cures illnesses, and ameliorates social distress, then you have to believe that setting up a major block in the way of human subject research will have consequences in lives. It may be that is a consequence that is well worth paying. But to ignore it, to have commission after commission after commission ignore it seems to me to be a very poor testimonial to the commissions.
The IRB system has done enormous damage to the infrastructure of research. Without any genuine consideration, students were lumped in along with everybody else when it came to regulating human subject research. As a result, it is very difficult to get many kinds of training for graduate students. It is very difficult for young people who are not tenured to take on human subject research projects in many kinds of areas. And even old people like me say that it is not worth the trouble of dealing with IRBs when you have so many other things that you could usefully do with your life. And I have given up human subject research myself exactly for these sorts of reasons.
The IRB system is a system of censorship. It tells people, "You may ask these questions and may not ask those questions." It specifies the exact language in which you have to talk to people. Remember that social science research is the other half of human subject research. So we're talking about my ability as a citizen to talk with my congressman if I'm doing it for research purposes.
There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both. The commissions have never seriously asked, "What are the regulatory choices available to us if we do conclude that human subject research is dangerous and needs to be regulated?"
This is particularly bizarre because the kind of regulatory choice made is one of the weirdest regulatory choices available, which is prior licensing of each single research event. Doctors do not have to have each one of their decisions licensed in advance. You license the doctor, not the decision. Journalists don't have to be licensed at all, even though they ask exactly the same questions the social science researchers do.
The commissions have repeatedly bemoaned the fact that IRBs swim in paperwork, that they impose huge amounts of paperwork on other people. The commissions have repeatedly bemoaned the fact that IRB members spend endless amounts of time fiddling in trivial ways with informed consent forms, but they have never — they, the commissions — have never asked whether that might possibly be because of the incentive structure that is inherent in the IRB system.
When they were thinking about their regulatory choices, they never asked whether good decisions were likely to be made by the people who wind up on IRBs. That is a problem partly because IRBs are now responsible for making such a very wide range of decisions that it is impossible for any group of five people or so to be truly knowledgeable about it. In addition, the work has become so unpleasant that senior people will no longer serve on them. If you're a medical school dean, who are you going to ask to serve on your IRB? Your best researcher?
Furthermore, in thinking about the regulatory choices available to them, these national commissions have never asked whether you make a good decision and whether you can be fair to the people about whom you're making a decision if you have an agency for making these decisions, a governmental agency for making these decisions, that does not obey a single one of the precepts of the rule of due process — not a single one. The commissions have believed that what they were doing, if they were doing anything, was to supply researchers with ethical principles to use.
The Belmont Report is repeatedly described by people at OHRP, for example, as, I kid you not, "the best governmental report ever issued," "the most influential government report ever issued." If we look at the Belmont Report as a source of guidance to the regulators and the regulatees, it is — I'm struggling to control myself. It breaches a system of ethics that are impoverished, that are incoherent, that are simple-minded, and that are befuddling.
Read the Belmont Report with an eye to figuring out what it means if you are a regulator and you will be a jumble of vague ideas which cannot be given regulatory meaning. And if you see how these ideas are taken by governmental agencies and used — a colleague of mine and I recently took the NIH test that will determine whether or not we were ethical enough to be allowed to do research. To answer the test in the way designed to get you 100 percent, we had to lie. We had repeatedly to say things we didn't believe because of the kindergarten ethics that researchers are now taught.
So the question is, are we not under notice to inquire whether there isn't something wrong with a system of commissions that gives rise to and continues to approve of a system with so many questions? And I think that the reasons to be worried are two. First, you cannot make good public policy if you don't know anything. And the empirical basis for thinking about these questions intelligently is absent. The commissions repeatedly say, "We don't know anything about how dangerous research is. We don't know how it's actually regulated. We don't know anything. But we know that we have to protect human subjects, so let's do it as thoroughly as we can."
You can't study human subject research regulation because to do that you have to get the permission of the IRB. And if you actually get their permission to study them, you have to realize that if you offend them, they believe themselves entitled to say, "A failure to show respect for us is a failure to show respect for ethics, and you are therefore unqualified for doing any more human subject research."
The second thing that you would need in order to make good public policy is some understanding of regulatory choices and regulations. These commissions have repeatedly failed to discuss regulatory choices in a way that leads me to wonder whether they actually realize that when you make laws, you make choices about institutions and methods that are extremely consequential. I think what you tend to get from almost any commission of this sort is a reflection of somebody's conventional wisdom. I think that, if there is a problem in mainstream bioethics today, it is that it is all conventional wisdom and very little dissent.
Do we need another agency that reflects the conventional wisdom in bioethics today?
CHAIRMAN PELLEGRINO: Thank you, Carl. Further comments from the Council members or response from any of our visitors? Gil, did I see you make a motion?
PROF. MEILAENDER: You didn't see me make a motion, though I was about to do that. So you anticipated —
CHAIRMAN PELLEGRINO: Well, I'm getting pretty good at predicting.
PROF. MEILAENDER: You can probably even predict what the question is about. This is for Prof. Kuczewski. Am I pronouncing your name correctly? I just want to think about your commitment to consensus or to what I would think if I thought about it, which is a formulation sort of like the formulation of that great theorist of consensus, Rousseau, that the general will is, even though I opposed it, is what I do actually believe if you force me to be free.
You're looking for something that sort of both sides can respect each other, or you said "a shared way of living together." You had various formulations. I thought we had a way of accomplishing that. We call it votes. You take a vote. Some people are in a majority. Other people are in a minority. And you, if you're in the minority, you live for another day when maybe you're persuade more people. That's a way of respecting other people, and it's a shared way of living together. It's precisely not a search for consensus. And I am just wondering sort of what you have against voting on these matters.
DR. KUCZEWSKI: Nothing. I like the democratic process for many purposes, and clearly the democratic process lays some framework for how these matters get decided and whether there are commissions and so forth. So clearly that kind of thing is true.
But there is a level of practicality at which voting isn't a way to get at something, a way to live. For instance, I mentioned the Schiavo case several times. The public reacted most strongly when elected officials decided to put their hand in that because that seems to be one of the tenants of the consensus, foregoing life-sustaining treatment, whether it's implicit or explicit. But these things need to be decided as best they can by families and patients and doctors and when they can't, they can go to the court of law and they can argue their cases, but that the public should stay as far as possible out of these kinds of decisions.
And so there's a level of this at which it doesn't work well for us to be necessarily voting on things. But, again, the votes we cast will frame some of the values that are in play in these issues and sometimes a referenda in a state will decide an issue, such as assisted suicide on the West Coast.
So there is a place for it, but I doubt on the everyday level for most of these issues we can get down to that level by voting, such as the kinds of concerns Prof. Schneider had about the IRB system. I don't know that those would be effectively tackled through voting.
PROF. MEILAENDER: Just quickly, I thought we were talking about national bioethics bodies and how they might best work.
DR. KUCZEWSKI: Right. But what national bioethics bodies are doing is laying the groundwork for these lower levels of decision.
CHAIRMAN PELLEGRINO: Thank you. I have Dr. Rowley, Dr. Gómez-Lobo, and Diana —
PROF. SCHAUB: Okay. I want to pile on. In other words, you presented an ideal council as perhaps a microcosm of public manipulation, and I think what Gil was maybe saying is, isn't that in a way to displace the political process and to sort of shift the locus of decision-making? You spoke of perhaps the hope of that councils can arrive at policies that wouldn't even been seen by the public and I guess it would be a mark of their success.
I guess I would rather see a council which provides materials which are really preparatory to public deliberation, so that the ideal is really to inform and debate. And councils can do that by clarifying positions of the parties because the real political process only works through parties and partisanship so that a council can clarify the parties. And beyond that, a council could try to see further than the parties themselves see or bring forward considerations that the parties perhaps have not thought of, but that when it comes down to it, these things will be decided and ought to be decided by majority rule, which is something different than consensus.
CHAIRMAN PELLEGRINO: Did you want to respond briefly?
DR. KUCZEWSKI: Well, I'll wait for more questions first. If we're going to take more questions first, I'll wait.
CHAIRMAN PELLEGRINO: Okay. Janet?
DR. ROWLEY: Well, as people have spoken, I have more comments and questions. With regard to the vote, I think it's very informative reading. Dr. Cohen 's analysis of the council is to point out that the majority on this Council regarding stem cell research changed and that there were two, at different times, but very close in chronological time to one another. There were two different majorities depending on the first vote and the second vote. So a vote partly depends on the question and how it's framed. So I think that that's not necessarily such a sacrosanct goal.
I also think that, in fact, a part of what has been presented, both earlier today as well as today, is that the councils are contributing to public policy, not setting it, but we are, in fact, part of a larger discussion. And certainly one doesn't look to parties to present this because within both parties there are both — to take one example, pro-life and pro-choice, so that a party isn't again the effective way to do this. And I think we have to recognize that.
And, finally, as a person whose research has been directly affected by IRB decisions, I have to say that much of what Carl said is right on. And I think I don't come at it from anything but the user's point of view or the affected point of view. But when one is prevented from using tissue that could lead to — well, I'm self-serving here — but what I consider important research of somebody who is dead, but whose tissues could lead to important medical information and the inability to have access — I have the tissue but I can't use it — that leads to enormous frustration.
CHAIRMAN PELLEGRINO: Thank you, Janet. Just so you all know where we're going and what the chronological problem — first, I want to ask Cynthia to respond and then Alphonse Gómez-Lobo, Rebecca Dresser, Paul McHugh, Bill Hurlbut, and Peter Lawler, and we do have some need for lunch. As a clinician, I want to be sure that you're fed and ready for the afternoon. So, therefore, let's go quickly. I'll stop talking.
PROF. LAWLER: Is there any way our two guests could stay — the list is so long — they could stay around and we could start off this afternoon with them?
CHAIRMAN PELLEGRINO: Surely.
DR. COHEN: I'm going to have to excuse myself.
CHAIRMAN PELLEGRINO: Let's go along first. I'll make the decision when it comes. Okay, Peter?
PROF. LAWLER: I'll make the decision — okay. I can go along with that.
CHAIRMAN PELLEGRINO: That was a little bit devious.
DR. COHEN: I'm staying a little longer than I had anticipated right now. I have a family member in the hospital, so I'm going to have to excuse myself.
But I must say I had Prof. Schneider for two elective courses, one of which was a seminar that went on for hours — I've never seen him so mad. Human subject research is not a field that I've looked into and obviously you have much more extensively than I have. I've looked at it from the other end, not from the point of view of sort of vague generalities that you may have found in Presidential Commission recommendations, but as a member of panels at the NIH. And I have finally said, "I will not be on your panels anymore," but for different reasons from yours.
I feel that patients are being abused who are in some of these research protocols, and they're confidential so I can't really go into detail, except to say in one patients were being exposed to a procedure that is risky as controlled — in fact, that was true in both of them — as controls, and the study had sufficient evidence in my mind to show that the whole thing should be stopped. They had the answers that they needed. I couldn't get them to stop it. I wrote to the Director of the Institute. He refused to stop it. I resigned from the committee, got a colleague on who's a lawyer and more forceful, perhaps, than I am. He got it stopped within a month. So I'm concerned about abuse of people who are patients and controls at the same time.
I resigned from another committee for the same reason. I could not get them to do studies that did not involved patients who had serious conditions who were being used as controls and having certain procedures done on them that were highly risky. And I had an alternative way for them to do the study. They totally rejected it.
So I've given up from that point of view, not because I think the regs are insufficient or totally unusable, but because whatever regs there are, they're not protecting patients in my mind. I think you have a good point on the need to separate social scientific research from biomedical research. They are rather different kinds of research. I think your point is well-taken there.
But I'm going to leave the rest up to Rebecca because she's the authority on this.
CHAIRMAN PELLEGRINO: Peter, to get you off the hook, I was playing games. Obviously, Cynthia and Mark Kuczewski are invited to stay when we invite them for the whole session as much as they want. I just wanted to be sure they were fed while they were here. That's my Latin background. Lunch takes precedent over everything. Dr. Gómez-Lobo?
DR. GÓMEZ-LOBO: I think I can formulate my question in the afternoon to Dr. Eric Meslin, so I will pass.
CHAIRMAN PELLEGRINO: Dr. Cohen is leaving on her own volition, Peter.
Dr. Gómez-Lobo, you are next. And you want to go for the afternoon, right? I want to be sure that's what you want.
DR. GÓMEZ-LOBO: Yes. I'm passing now, and I'd like to formulate the question in the afternoon.
CHAIRMAN PELLEGRINO: All right. Rebecca Dresser next.
PROF. DRESSER: Well, I can pass, too. My question could be deferred. It's a general question that will be addressed in the afternoon, too, so I can wait.
CHAIRMAN PELLEGRINO: Okay. I just want to indicate my chairman prerogative allows me to extend us until 1:00 o'clock for lunch, so I don't want to inhibit you. I just gave the names in order. Do you still want to postpone it? There may be not time in the afternoon if we keep postponing it.
PROF. DRESSER: That's true. All right.
Well, I wanted to make another comment about the problem of policy advice. In the US we tend to have these different commissions at different times because they tend to be linked to different administrations unlike in France and even Nuffield, which goes on.
It seems to me, if you look back, there are different councils and commissions for different times and different appropriate roles. So in certain cases policy advice is more appropriate than in other cases. It depends on what you're asked to do. It also depends on the topic. So topics such as the definition of death, end-of-life issues, those are matters of state law. The federal government can say little about those areas, and so a federal bioethics group can certainly put information and thought out there, but there is no direct connection.
Similarly, with a presidentially-appointed group, there's no direct
connection to Congress and Congress makes the laws. Even if you're
talking about regulations, any documents by groups, such as even
the National Commission, then went to HEW and then were put into
proposals by officials there and then were put out for a notice
and comment, and then became final regulations. So the connection
is far from direct in any of these cases.
End-of-life, those issues, have been played out a lot in the courts. So the influence we can have on courts is, again, indirect.
So I guess that has influenced me in my view that a frequent and probably appropriately deferential role for these groups is to put out some documents that try to state a thoughtful discussion, deliberation, and including highlighting differences and then let them be taken up by the appropriate people. I don't think we are qualified or asked to form specific policy, and I don't think we should.
CHAIRMAN PELLEGRINO: Thank you, Rebecca. Mark, I have three Council members who wish to comment. I would like to give them the opportunity and then give you the opportunity for closing comment on any one that you wish. So I have in this order Paul McHugh, Dr. Hurlbut, and Peter Lawler.
DR. McHUGH: I can't quite put this in relationship to a question, but it goes along with what my fellow Council members have been asking in relationship to both of these interesting and important contributions to our discernment, both of previous councils and of the present Council. I see myself warned by Prof. Schneider that I shouldn't speak about the present Council. But it's the only one I really understand at all, Carl, so I'm stuck. I have to speak a little bit about my experience here.
And the major point that I want to make is that this Council was different, not only in its constitution, but in the way it went about its business. And I felt that the way it went about its business was most useful to someone like myself.
Leon, at the beginning, told us all that what we were going to do was, in fact, a process of dealing with problematic matters by really studying them at the beginning from the best experts in science we could find. That was a most remarkable and distinct approach because it got us all up to speed. We heard from the best people in the world about what was going on, for example, in the realm of cell biology, embryology, and the like, and we could question them about the science and develop from then on a sort of sense of the meaning that we saw in them.
It was an approach, not simply to inform the world about what questions that they had about things like the end of life, but to consider a technique, a new technique, and consider it from the point of view of what, if any, harm, what it might threaten to ourselves. And so we then found ourselves ready to have a conversation that was very far-reaching. And the comment from Dr. Cohen 's interesting program that somehow or another at the end we decided to seek consensus outside in the so-called democratic process, I didn't see it that way at all.
I saw it rather that we had come to a point in the contemporary knowledge of science where there were interesting issues to still be debated that probably needed further discussion, not only discussion in the public media, but also in the laboratories to discern really what was at stake with these matters. And the democratic process was working itself out in a most appropriate way.
I want to be clear, therefore, that I think that we did a remarkable job in not seeking internal consensus but by spurring public discussion in a most informed way and the fact that our Council was, during at least that episode, constantly in the newspapers and constantly wondering about what we were saying and why were saying it, did a good service to our country at the time, I believe.
I suppose I'm discouraged by the fact that I'm not sure that conversation has carried itself terribly much further, even at the same time that another approach to bioethics has produced the Belmont Report, which I agree with you is kindergarten ethics. So it can be discouraging.
CHAIRMAN PELLEGRINO: Dr. Hurlbut?
DR. HURLBUT: I'll just defer until the afternoon.
CHAIRMAN PELLEGRINO: Thank you very much. Peter Lawler?
PROF. LAWLER: I'm not going to go through all the details coming out against consensus through kindergarten ethics. If you look at this embryo thing, for example — let's say Clinton's Commission — if both sides really thought about it in a Rawlsian way, they would come to this consensus, that if you really think about what you're saying you'd be all in favor of killing IVF left over embryos for research. But no one's ever bought that.
So the actual embryo policy, three stages, Bush compromises with his restriction on research. Our Council compromises — I wasn't here then, but I read about it. Our Council compromises with the moratorium. And Obama breaks the spirit of compromise, but for consensus. He just says the majority is on my side and that's what I'm going to do. There's no consensus in there.
CHAIRMAN PELLEGRINO: Any further comment? Alphonso, do you still want yours for the afternoon? Thank you.
DR. KUCZEWSKI: I'll be very brief. But thank you for this last opportunity.
Part of what I think that the difference between people who like to put forward recommendations to try to model a consensus and those who think of it as preparatory and just outlining positions is whether you think there's somewhere else that that deliberation then happens once you do it.
And as a philosopher, I like the model of a New England town hall meeting where everybody decides everything and then we could all deliberate and these reports would help us do that. But most people would find that extremely cumbersome, and it doesn't happen. And so for the most part, as Prof. Whittall said this morning, the public education part is actually quite hard when you're talking about common people because, where do you ever go? And then once you educate them, they say, "Well, what do I do about it?" Well, the answer is, "Not much. You don't have much direct say."
And so I have tried to argue that, in fact, rather than be preparatory, it's better if the deliberative work gets done here and aims it at a recommendation that one believes can garner support once people have to live with it.
And the only real danger though to the current model, I think, it the false impression that nobody could ever agree on anything and because we're just outlining things. Well, don't sometime conclusions hit you in the face when you outline a couple of positions?
And an ethicist I think there are occasions when they just call us to put those forward. The fact of so many people with no health insurance in this country, I think it's very clear when you look at the facts of this, this is an injustice. This calls for something to be done. Ethicists, I think, should have a hard time not saying that in that, in fact, the public seems to be running ahead of us with the consensus in that we've never really contributed to articulating that I think is not a good thing.
And I think they miss the creativity we could have employed in putting forward some thoughts and deliberations on that. So I feel that there is a contribution to be made that we should sometimes not shy away from. Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Mark. We will return at 2:00, and we have a heavy afternoon so please be on time.