Regulating scientific research: should scientists be left alone?

1. 2. Kristen K. Intemann* and Inmaculada de Melo-Martn,1

Abstract

In our current political climate, decisions about whether to fund research on new stem cell lines or do chimera experiments seem to arbitrarily depend on the religious and economic interests of the administration. Not unreasonably, many scientists believe that science should be left to its own devices in determining research priorities and conducting research. When nonscientific considerations constrain research, it is claimed that values are inappropriately dictating scientific decisions. This assumes, however, that all ethical and social values are irrelevant to such decisions. Using the case of embryonic stem cell research to illustrate the debate, we argue here that this position is untenable for several reasons. First, the aims of science, particularly in the case of the biomedical sciences, cannot be completely extricated from ethical and social aims. Hence, value judgments will be necessary to assess research priorities and methodologies. Second, maintaining this position is inconsistent with actual scientific practices. Scientists already recognize that there are some ethical values that appropriately constrain research, such as in human subject experimentation. Therefore, the problem cannot be that ethical values are brought to bear on science per se but that those values are highly questionable or are imposed by those who often lack the scientific expertise necessary to understand how ethical concerns may relate to the research. Finally, we argue that to the extent value judgments must be made, consensus about such values should be reached by a diverse group of stakeholders, including scientists, community members, policymakers, and ethicists.Intemann, K. K, de Melo-Martn, I. Regulating scientific research: should scientists be left alone? MANY SCIENTISTS BELIEVE that science should be autonomous or left to its own internal dynamic in deciding how to define scientific problems, what research to pursue, and how to conduct research (1) . According to this view, these decisions should be governed only by scientific considerations, such as which theories are supported by evidence or which research projects appear to be the most scientifically promising (2) . When nonscientists, including ethicists, politicians, or policy-makers, interfere with science either by setting research priorities, regulating research, or constraining funding, they are seen as introducing arbitrary limits on research (3) . In our current political climate, where decisions about whether to fund research on new stem cell lines or do chimera experiments seem to arbitrarily depend on the religious and economic interests of the present political administration, the belief that science should not be hampered by value considerations appears quite reasonable (4) . Nevertheless, using as an illustration current disputes about stem cell research, we will show that this position is untenable for several reasons. First, the aims of science, particularly in the case of the biomedical sciences, cannot be completely extricated from ethical and social aims. Hence, value judgments will be necessary to assess research priorities and methodologies. Second, a position that denies the significance of values in science is inconsistent with actual research practices. Scientists already recognize that there are some ethical values that appropriately constrain research, such as in human subject experimentation. If we are correct, then the claim that restrictions on federal funding for stem cell research are problematic because they import values into what is properly a scientific matter is mistaken and thus the problem has been misidentified. The trouble is not with the use of values per se but with

the use of values that are highly questionable or are imposed by those who often lack the scientific expertise necessary to understand how ethical concerns may relate to the research. We show that this misidentification is problematic for several reasons and offer alternative recommendations as to how value judgments might be made in ways that are more conducive to scientific progress.

VALUES IN SCIENCE It is not uncommon, when rejecting the role of values in science, to use infamous cases that appear to demonstrate that when ethical, political, or other social values are used disaster follows (5 , 6) . The history of science offers several examples that seem to support the claim that scientific research should be free from the interference of values. A well-known case is that of Russian horticulturist T. D. Lysenko, who directed work in Soviet agriculture toward methods and conclusions that supported a communist ideology rather than toward those supported by evidence (7 , 8) . Lysenko discarded scientific theories and frameworks in genetics and evolutionary biology, not because they were empirically unsound, but because he thought they were inconsistent with achieving aims in Soviet agriculture that promoted collective farming and a particular political world view. This case appears to show that when science is influenced by political or other social values, promising and accurate scientific theories and frameworks are not pursued and scientific knowledge is severely limited. Recent regulations by the Bush administration have raised similar worries. Attempts to limit funding for, and edit reports made by, climate change scientists have been decried as inappropriate political interference in science (9 , 10) . Similarly, scientists have condemned the Bush administrations limitations on funding for stem cell research as well as recent legislative attempts to ban certain kinds of experiments and methodologies, such as the bills introduced by Senator Sam Brownback to prohibit human cloning and the creation of human chimeras (11 12 13 14) . Such attempts are viewed as problematic because they amount to letting religious and moral values determine scientific priorities and methodology. The belief that science should be autonomous, or free of interference from ethical, political, or other social values, presupposes that such values are irrelevant to making decisions about 1) what constitutes an important area of scientific study, 2) how research questions should be framed, 3) which research projects should be funded or given priority, and 4) which methodologies are the most appropriate in conducting scientific research (1 , 15) . Thus, these decisions should be grounded only on epistemic or scientific criteria, such as whether a research project seems scientifically promising or whether relevant theories are supported by evidence or appear to have the most potential to provide more accurate, simpler, and unifying accounts of scientific phenomena. Of course, if epistemic or scientific criteria ought to be taken into account, then scientists, not politicians, ethicists, or policymakers, are in the best position to make these determinations. After all, it is scientists who have the expertise to evaluate whether some area of research or a particular methodology is scientifically promising. However, the assumption that ethical or social values are irrelevant when making decisions about which research to pursue, and how to pursue it, is seriously problematic. Indeed such decisions cannot and should not be made solely on the basis of epistemic or scientific criteria. To begin with, the aims of science are closely linked to certain ethical, social, or political goals and, as a result, conducting science requires making value judgments about how best to pursue such goals. Science aims not only to discover truths about the world but to ascertain particularly interesting or important truths that can help improve the quality of life for all: truths that matter to us (16) . The goals of research are not only an issue of scientific expertise; they are embedded in a particular social context. Therefore, those ends must themselves be open to critical evaluation. Even

when we might recognize the worthiness of a particular goal (i.e., feeding the hungry, improving health, or fostering biodiversity,) such recognition ought not prevent us from reflecting on which aims should be prioritized or how we should pursue them. After all, we often have a variety of equally valuable goals and limited time and resources to fulfill them. We must then evaluate our ends in order to make decisions about which ones to try to reach at a particular moment. Such evaluation will then necessarily involve appeals to ethical, political, and other social values. In addition, most ends are themselves a means to some other goal and thus they need to be evaluated in order to ascertain whether they will achieve it. For example, although improving human health is an end of the biomedical sciences, such an end is also valued as a means to the goal of furthering human well-being. Certainly health is a very important element of our well-being, but it is not the only one. Ignoring the fact that certain aims in science might also be means to other social aims will fail to provide us with a basis for rational action. This is so because our judgments of the worth of an end are inextricably bound to our beliefs about the costs of achieving it. For instance, whether we think that reducing pollution is a worthy end depends on what we can do to reach it and on the implications of doing so. These reflections are also inextricably tied to ethical, political, and other social values. Furthermore, if the goals of research, particularly in the biomedical sciences, involve improving human health, and if resources are limited, then ethical and social values will be among the appropriate criteria for determining which research to fund and pursue. Although a goal of stem cell research is to obtain information about the complex events that occur during human development, a better understanding of the genetic and molecular aspects of cell division and differentiation, and more insight into tissue regeneration (17) , the ultimate aim of such research is to improve human health and save lives. Given that other possible research projects might also have this ultimate goal, then decisions must be made about which one of such projects is most likely to achieve the desired aim. It is obvious that scientific considerations are essential in making such a determination, but it seems equally clear that values other than scientific ones are necessary. For example, research indicates that embryonic stem cells are a promising source of cells for transplantation (18) . To use hESCs in cell-based therapies and thus avoid tissue rejection, it is necessary to create enough cell lines to cover the variety of transplant antigens (19 , 20) . However, most current stem cell research uses stem cell lines derived from embryos left over from in vitrofertilization. Because these embryos come mainly from Caucasian couples, these cells are unlikely to reflect the genetic diversity in the U.S. population (21) . As a result, this research may generate knowledge that is less valuable or applicable to individuals from minority groups. Contrast this with a research project that included embryos from a more diverse population. Which research project should be given priority? If an aim of the research is to produce scientific knowledge that will improve health for a diverse population, rather than the health of a particular group, then deriving cell lines from embryos of all ethnic groups present in the relevant population will be particularly important. If this is not a concern, then transplant antigens will be less of a worry. Either way, however, we must make value judgments about how best to pursue stem cell research given the particular aims of the research. Moreover, by explicitly making these value judgments, we will better understand the applicable context of research results. Thus, we are more likely to produce scientific knowledge that better advances the scientific and social aims we adopt. A position that denies the relevance of values in science is not only questionable in virtue of the fact that scientific aims involve ethical and social values; such a position is inconsistent with actual research practices. Indeed when pressed, virtually all scientists would agree that there are some limits on scientific research based on ethical values, not only scientific ones, that are quite appropriate. For example, although we could learn a significant deal by experimenting on human subjects without their consent, few researchers would think that restrictions on human subject testing are an inappropriate ethical interference with scientific research. Restrictions intended to prevent the kinds of experiments conducted by Nazis (22) or those done at Tuskegee on syphilis

(23) are in fact seen as important and apt limitations on how we can achieve scientific knowledge. Thus, when scientists claim that ethical and political values should not play a role in determining appropriate methodologies, they are failing to acknowledge what is already an accepted part of scientific practice. Similarly, the values that underlie integrity in research such as honesty, transparency, and fairness in attribution are thought to legitimately constrain research practices. Although many of these virtues are likely to be truth-conducive, their legitimacy also springs from the fact that science is a social enterprise. As such, ethical norms are essential to its functioning. Hence, if occasionally dishonesty or concealment were thought to be likely to produce scientific results, arguably we would not reject the values of honesty and openness as legitimate constraints on research. Thus, even if there are cases where problematic moral, political, or social values have inappropriately influenced science, this does not mean that the solution is to abandon values altogether. This would effectively be to throw the baby out with the bathwater. Previous SectionNext Section IDENTIFYING THE PROBLEM Admittedly, there are cases where moral and political values inappropriately constrain research or hamper objectivity. However, as we have seen, decisions about which research projects to pursue and how best to conduct them cannot and should not be made solely by scientific or epistemic criteria. Ethical and social values are relevant and important to such decisions. Thus, it is overly simplistic and misleading to think that the problem with regulations on science is that they are cases where values in general, rather than particular values, are illegitimately constraining research priorities or methodologies. The misidentification of the problem raised by restrictions on federal funding for stem cell research is in part due to a common belief that ethical and social values are subjective. That is, such values are thought to be a matter of personal preference, and thus cannot be rationally supported, anymore than someones preference for tea rather than coffee can be rationally supported (24) . Not surprisingly, much of the scientific community insists on eliminating them from our discussions on research. However, this view of ethics is highly problematic and not reflected in our ethical practices. Indeed, ethical value judgments can be supported by good reasons. For example, we can give reasons why it is wrong to experiment on someone without their consent by appealing to moral principles that are widely accepted. Similarly, if one could show that embryos used in stem cell research have the same morally relevant features as adult humans have, then this would be a very good reason to consider restrictions on experiments on embryos. Of course, it is unclear that embryos used in stem cell research do have any of the properties of the sort we take to be relevant in restricting experiments on adult human beings. However, whether or not this is the case is something that can be supported with good reasons and empirical evidence. Unfortunately, in much of the debate on stem cell research, good reasons and attention to empirical evidence have been lacking. For example, the Bush Administration has not offered widely accepted reasons or evidence to show that embryos have properties that would make them deserving of the same moral consideration as an adult human being. Indeed, if one thought that the deliberate destruction of an embryo is tantamount to killing an adult human being, for instance, then it would be inconsistent to allow private funding for stem cell research. We certainly would not permit experimentation on human beings without their consent, much less their killing, even if private money were used to do so. Thus, given the fact that we live in a democratic pluralistic society, the particular value judgments that the Administration has made are problematic because they are

unsupported by reasons that reasonable persons can accept (25 , 26) . The problem then is not that value judgments are brought to bear on deciding how to regulate science. Rather, the trouble is that restrictions seem to be based on disputed values. The mischaracterization of the problem of limiting scientific research as one that results from using ethical or political values is also in part due to the fact that those who try to make value judgments relevant to regulating research often lack the scientific expertise necessary to understand how ethical concerns may relate to the research under debate. In the stem cell case, it is not clear that politicians or policymakers truly understand the properties that embryos have or fail to have at the stage they are used in stem cell research or how this might be similar or dissimilar to other widely accepted practices such as in vitro fertilization. Nonscientists often do not know how cloning techniques work or what exactly occurs in chimera experiments, so they are ill equipped to determine the extent and nature of ethical issues that might arise. It seems then that in, at least some of the cases where particular values and their imposition has badly shaped science, it has been because such imposition has demanded that we turn away from, if not outright ignore, some of what science could tell us. When someone argues that science should be understood as value-free, the evidence offered is often in terms of cases in which demonstrably bad science followed, in terms of ignoring the best available evidence. Hence, it will not always be appropriate to appeal to ethical and social values in scientific reasoning. Such values may not be legitimate, for example, when they are irrelevant to the aims or content of the research or when they require that we ignore existing scientific evidence. However, it seems clear that the problem that values can sometimes hamper scientific research will not be solved by trying to eliminate values from decisions about what research to pursue or how to do so. Rather, the solution will need to address how we can ensure that value judgments used to regulate science will be adequately supported and informed by empirical evidence, including evidence about the nature of the science in question. Moreover, if the misidentification of this problem led us to reject or ignore the role of values in science, this would have several negative consequences. First, if ethical and social values are intricately tied to the aims of biomedical sciences, then trying to eliminate values altogether would actually hinder us in promoting the aims of science. As we have said, value judgments can help scientists and policymakers determine which research projects will be most likely to generate the kind of knowledge that will be most useful in achieving biomedical policy aims. Thus, making such value judgments will help generate the most useful scientific knowledge. In addition, because values play a necessary role in determining which research projects to pursue and how best to pursue them, trying to eliminate such values will be futile. If the ethical and social dimensions of research are ignored, then the value judgments inevitably made will be obscured or swept under the rug, rather than explicitly acknowledged and open to critical scrutiny. This would make it less likely that we will use appropriately supported values that would be accepted by reasonable people living in a pluralistic society. If values do play a significant role, then we must reflect carefully on which values ought to be sanctioned. Of course, making these determinations will not always be easy. There will not always be a consensus about which values should be endorsed and there will be some cases where there is legitimate disagreement. This raises an important question. Given that there is disagreement about ethical and social values, then who exactly should be responsible for making value judgments that will help regulate research priorities and methodologies? While providing a comprehensive account of how such decisions should be made is beyond the scope of this paper, the next section reflects on some factors that need to be taken into account when assessing this issue.

Previous SectionNext Section MAKING VALUE JUDGMENTS ABOUT SCIENCE: WHO SHOULD DECIDE? If we are correct, values are necessary to making decisions about what biomedical research to conduct and how to go about doing so. Also, given that values are relevant in such an endeavor we must strive to appeal to values that are well supported. However, assuming that, at least some times, value judgments can be well supported raises the question of which values should be endorsed and who, exactly, should be making such decisions. Some may argue that, given that scientists are intimately involved with the research process and have the necessary scientific expertise, they should be the ones deciding research priorities and methodologies. However, it seems clear that although scientists need to be involved in the decisionmaking process, they should not be making such judgments on their own. First, scientists are not trained in ethics. Determining which values should help regulate science requires the ability to identify the competing values at stake and reason about how those might be best balanced. Such skills are not taught as a part of scientific training. This makes it important that individuals with training in ethics are a part of the decision-making process. Second, individual scientists will often have self-interested reasons for giving more weight to the importance of their own research projects, and so it is important that there be some more neutral third party to play a role in such choices. This might be particularly crucial in cases where working scientists also have financial interests. Therefore, scientists should not be left alone to make value judgments relevant to funding and regulating their own research. At the same time, it seems clear that it should not be only politicians who are charged with making value judgments about the direction of scientific research and appropriate methodologies. First, politicians lack the scientific expertise to determine when and how ethical issues might be relevant to scientific methodologies. For example, the Human Chimera Reproduction Act sponsored by Senator Brownback seems to mistakenly assume that experiments where rats are injected with human brain cells will produce some sort of human thinking rats, when there is very little scientific evidence for such a belief. Of course, there might be other reasons to attempt to restrict humananimal chimera experiments. However, whatever those reasons may be they cannot be grounded on false or inadequate scientific evidence. Moreover, politicians often have self-interested or politically motivated agendas that might cause them to endorse certain value judgments because they are politically popular, rather than on the basis of whether such judgments are supported by good reasons. Thus, we propose that there needs to be a diverse group of scientists, community members, policymakers, and ethicists, who work together to come to a consensus on identifying the relevant ethical issues related to some proposed area of study and how to address them. Having a diverse group of people that represent expertise in both the relevant science and the relevant ethical issues at stake will help promote a more open and rigorous discussion about how research is best prioritized and pursued given certain ethical and social aims of the research area. Of course, not only the decisions, but also the membership of the groups, will need some isolation from fiduciary and political pressures. For example, the Presidents Council on Bioethics is comprised of a, at least partially, diverse group of people, but membership of the council is determined solely by the president and may reflect certain political interests (27) . As we indicated earlier, we cannot provide a full account of how, or by what mechanisms, this might be achieved in practice. It is clear, however, that a discussion about which values should be endorsed and who should make those decisions is a conversation that is appropriate and necessary.

It is a discussion that will not take place if scientists continue to assume that values have no business in science. Previous SectionNext Section CONCLUSION The belief that ethical and other social values have no legitimate role in deciding what research to pursue or which methodologies to use is widely held in the scientific community. Nonetheless, as we have discussed, such a belief is problematic. This is because, particularly in the biomedical sciences, the aims of research are closely tied to ethical and social aims. Both the evaluation of such aims and the assessment about what means to use to attain them requires one to make value judgments. And although often there is disagreement about matters of values, such disagreements are not evidence that values are simply subjective preferences, that they are groundless, or that agreement is not possible. Similarly, current scientific practices reflect the idea that there are some legitimate ethical constraints on research. Even scientists who object to the interference of values in research, implicitly rely on value judgments in constraining their own methodology, such as in human experimentation. Although there have been instances when ethical, political, or religious values have inappropriately constrained research, such events show neither that the problem was with values per se nor that values are irrelevant to scientific research. Indeed, by framing the problem in this way and trying to shield science from values altogether we are preventing a more fruitful discussion about which value judgments are the best supported and provide good reasons for guiding research. Furthermore, since scientists have part of the expertise necessary to inform debates over regulations, funding, and so on, then they need to be part of this process. Obviously, they can hardly do so if they believe that values are irrelevant. They will then be excluding themselves from the conversation about which values to endorse, and that would not benefit anyone.
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