ETHICS AS A DIMENSION OF TECHNOLOGY ASSESSMENT

As the main studies show, technology assessment emerged in the 1970s because of cost considerations; these consideration have been a major stimulus to establishing assessment agencies and procedures. Several concerns underlie the need for cost control. With the development of new and powerful technologies since the 1960s various concerns have been growing about the uncontrolled introduction of new technologies into health-care practice.

WHY IS ETHICS OFTEN NOT INCLUDED?

The Swedish study argues that we need to reinvent the concept of health-care technology assessment, transforming it into more comprehensive evaluation research (returning to the broader notion of HTA of the early days) (4). That is, we should go beyond the dimensions of safety, effectiveness, and cost-effectiveness. It also suggests that recommendations are not only science-based but also normative and require an examination of the relevant value judgments. Although this proposal should be endorsed, it is important to explain why ethics thus far has not often been included in HTA studies.

Evaluating medical treatment is usually one-dimensional: selected parameters are limited in number and have a quantitative biomedical character. Evaluations tend to work within the domain of the dominant medical paradigm, proceeding with a well-defined benefit model. This model contains one or more well-defined measurable effect parameters or “output” parameters, scrutinized in terms of efficacy. The model also provides an explicit hypothesis describing the assumed relationship between the modifying parameter and what is being modified. It should also make explicit what risks and costs are involved. For example, in evaluating cochlear implants, the input will be the implant, the causal hypothesis the bypassing of a malfunctioning cochlea to a functional auditory nerve and intact central auditory pathways, the output is measured in terms of functional audiologic gain, and risks are quantified in terms of medical complications (28). When these implants were first used in children, the assumption was that, with the aid of implants, deaf children can learn to communicate; what could be more valuable than restoring hearing capacities in erstwhile deaf children? To the surprise of many, the deaf community itself protested against cochlear implants in children, by arguing that the new technology threatens the slowly obtained recognition of the specific culture of the deaf, namely sign language and communication systems developed within the world of the deaf. Now that it is accepted that the deaf are physically inconvenienced but not handicapped or disabled, implant technology may reintroduce the idea that deafness is a physical defect that is reparable. The point is that instead of being able to create their own world and instead of being accepted in a shared culture, the deaf will now be pressured into adapting to the world of hearing. This adaptation will be necessarily partial and incomplete. Learning to communicate with implants is more difficult than learning sign language, and the result of implantation is always imperfect. This result will continuously reinforce the marginality of those who cannot meet the standards of the hearing world without technical aids. This critical patient perspective illustrates that there is a dissimilarity between “effect” or “output” and “benefit.” Identification and measurement of output presuppose some concept of benefit, which is often too restrictive because it is developed from the dominant medical paradigm. That we can improve hearing through cochlear implantation is easily equated with benefiting deaf children. From a medical perspective, restoration of bodily dysfunction is regarded as being beneficial to patients. However, this perspective not only gives priority to bodily functioning, but also to some level of social functioning: it assumes that oral communicative skills are necessary to realize a child's future opportunities. Precisely this normative assumption is contested by the deaf community itself: a deaf child's best interest is not determined by his or her future speech ability alone (17).

Similar controversies have arisen in the context of other technologies, especially life-sustaining technologies. Here, the assumed effect is also often equated with benefit. If human life is at stake, it is considered evident that making a treatment effort and running into failure is better than not attempting to treat and face certain defeat. This “no lose philosophy” drives health professionals into “activism,” often disregarding a wider benefit perspective (21). “Being alive” does not necessarily suggest a “good life.” Rather than asking whether a new technology brings immediate relief to a medical problem, questions should be asked about likely long-term medical consequences, the state of life that has been saved, and the meaning of the overall life of the patient (3). In other words, the value of medical treatments and interventions should always include the nonmedical context in which people live their lives.

Ethical analysis is rarely incorporated in HTA studies for two reasons. First, technology has a particular conceptualization in present-day evaluation research, demarcating it from ethical issues. Second, bioethics is often regarded as a specific technology itself, aimed at resolving or at least “pacifying” the moral consequences of the use of medical technologies.

The relation of ethics and HTA is first of all determined by the view of whether technology is value-neutral or value-laden (9). According to the first view, technology itself is neither good nor bad; it represents value-neutral means to an external end. It seems that this value-neutrality view is the most dominant one in the area of HTA (3;10). It is common to differentiate between direct and indirect effects of technology, or technology assessment in a narrow and broader sense. The moral dimensions of new technologies used to be considered as “second-order consequences”; they arise at the policy level when the data of evaluation studies must be implemented into health-care practice. This conception of HTA implies that ethics does not belong to the core processes of assessment. Values are not intrinsically connected with technology itself, but they are related to its application. Elsewhere, it is argued that this distinction originates from problematic presuppositions regarding the relations between technology and society, knowledge and its application, information and decision making, and the medical and nonmedical domains (25). A modified neutrality view also underlies the distinction made between assessment and appraisal (20). Assessment is the scientific analysis, gathering and summarizing information and producing knowledge. Appraisal is the political process of decision making, taking into account information as well as values. The evidence produced by assessment must be interpreted within a framework of values and preferences to generate a decision. Whereas Stevens and Milne restrict HTA to assessment, Carlsson (4) argues for a broader concept of HTA, combining the descriptive, scientific approach with the normative, pragmatic role of policy recommendations. However, Carlsson's argument presupposes the usual notion that technologies can be scientifically assessed without implicating values.

The second reason for the difficult relation between ethics and HTA is related to bioethics itself. Bioethics has developed into an autonomous discipline assisting health practices, but it has also become a component of the technologic order (6). It is dominated by an engineering model of moral reasoning using the idea of technologic rationality in addressing a particular set of practical problems through the application of moral principles (in particular the principle of respect for autonomy). In this approach, bioethics is a sophisticated technology to make a particular set of (potential) problems manageable and controllable (25). Usually the focus of ethical analysis is narrow and not too critical. That technology confronts us with moral problems is, according to philosophers such as Habermas, Foucault, and Illich, basically related to the penetration, domination, or even “colonization” of our life and world by science and technology. The answer to such problems cannot be given by an ethics that is itself technologically orientated. In fact, a type of bioethics that is approaching moral problems in an engineering way, technically applying principles to cases and dilemmas, has become itself another manifestation of the same basic problem.

HOW CAN ETHICS CONTRIBUTE?

A repositioning of ethics will be necessary to uncover and analyze the moral dimension of practices of developing, testing and using technologies in the context of health care. The following distinction is helpful to specify the potential contributions of ethics in connection with medical technology assessment.

First, there is the category of moral questions arising within the framework of the particular technology. Examples are debates about the moral status of the embryo in the context of stem cell technology (examining whether the fertilized or “activated” egg is similar or different from the “traditional” embryo), or about the conditions for gamete donation. Questions of this type remain inside the framework of the technology; they proceed from the acceptance of the technology as a datum, trying to define its responsible and appropriate use. This type of question is usually addressed in HTA studies—in those studies that include any ethical analysis at all. The theoretical framework for these ethical studies is provided by the present-day conception of “applied ethics”: this is, the application of general ethical theories, principles and rules to specific problems which may arise in health-care delivery, research, and therapeutic practice (26). The aim of the ethical contributions is to analyze these problems and to offer solutions that are morally justified. The main instrument of this approach is a set of moral principles. Usually three or four basic principles are used: respect for autonomy, beneficence, non-maleficence (which is sometimes included in beneficence), and justice. These principles are considered to be basic, because they are general judgments serving as justification for particular prescriptions and evaluations of human actions. Principles are normative generalizations that guide actions. From principles, ethical guidelines and rules can be derived. The advantage of the (four) principles is that they are defensible from a variety of theoretical moral perspectives. They provide an analytical framework, a universal tool, to clarify and resolve moral issues (8).

The principles approach in analyzing moral issues is usually very helpful in identifying and mapping out the relevant moral considerations regarding medical technologies and services; it is also instructive because it points out where further studies are required. For example, in transplantation of organs from living human donors, three fundamental issues are identified: the risks and harms affecting the donor, and questions about voluntary consent, and buying organs harvested from the living (5). The principles of beneficence and non-maleficence generate moral concerns about justifying harm to the donor. Is it justified to remove somebody's kidney when the removal harms the healthy person without producing any medical benefit to him or herself? Or is the donor more harmed by the loss of a family member or friend than by the loss of a healthy kidney? The principle of respect for autonomy generates concerns about consent. If an adult person is asked to give informed consent to surgery to remove a kidney for a family member, can the consent be truly voluntary in such circumstances? In the case of a child whose kidney is the best match for a sibling, can the parents give consent? A decision to “donate” is clearly not in the best interests of the child. Finally, the principle of justice generates concerns about the donation and transplantation systems. What kind of criteria are used to allocate donated organs within a particular area? At the same time, it seems that commercial arrangements are increasingly used, although the sale of organs for transplantation is prohibited in many countries.

The moral issues identified by using the principles approach show that two methodologic approaches need to be combined: empirical and theoretical studies (23). To know, for example, whether the autonomy of potential donors is compromised in practice, ethicists need to engage in empirical research. To evaluate the probability and extent of harms and benefits, ethicists need to use or produce quantitative data. Insights into the factual dimensions of a technology are required before these can be assessed from normative points of view. The moral principles identify not only which facts are relevant for further consideration from a moral point view, but they also provide a normative framework for further assessment. Theoretical research here requires analysis of the philosophical and ethical literature, articulating, for example, the implications of deontologic and teleologic ethical theories with regard to the problems at hand. Usually, this is intensive and innovative work, because the existing literature has rarely foreseen or addressed the moral issues arising in present-day medicine.

Ethics can also contribute to technology assessment by going beyond the framework of the technology itself. It then concentrates on a second category of moral questions. Within this category, analysis focuses on the question of whether the technology, as such, is justified in the light of moral values. Here, ethical analysis does not, a priori, take the technology for granted. It starts from a critical perspective, assuming that technologies are not value-neutral but incorporate particular values themselves. Technologies are expressions of values, such as the values of searching for knowledge, having offspring, or relieving suffering. However, these values are often implicitly given and not articulated. Ethical research is now taking them as the starting point for a debate on (other) motivating values in society. This type of research focuses on values underlying or embedded in the development of technology itself. For example, studies in this category will not take for granted that the progress of transplantation technologies is beneficial. They will question the specific framing of notions such as personal integrity, altruism, death, and body, which is associated with these emerging technologies (7). They critically examine the implied notion of “body ownership," where the moral principle of respect for autonomy is indeed helpful to facilitate organ donation but at the same time reiterates the traditional dualistic image of the human person: an autonomous subject with a material body as its property (24). These studies will also explore the recent expansion of these technologies with cell and gene transplantation. They call attention to the claims of perfectibility and immortality, often implicit in the bewildering progress of stem cell technologies, and relate such claims to a philosophical, and sometimes utopian, body of knowledge. The methodology of such studies is historical as well as synthetic. They attempt to provide a diachronic and synchronic perspective: values embodied in current technologies are explained in connection to similar values in history, but they are also clarified in connection to developments in other scientific disciplines, thus looking beyond the framework of present times and existing disciplines. The presupposition of this type of ethics research is that ethics, first of all, is the philosophical and theologic effort to understand ourselves and our existence in terms of what is desirable or undesirable, supportable or reprehensible, good or bad.

The second type of research in this category of ethics contributions to HTA focuses on the values of the stakeholders involved or affected when the technology is introduced in the health-care system. Recent studies of the introduction of pediatric cochlear implants have set examples, although retrospectively. They have used a narrative ethical analysis of the “moral landscape,” interviewing parents of deaf children and examining their experiences before diagnosis and some time after diagnosis when crucial decisions must be made regarding language and education (28). Some studies have tested the method of interactive evaluation to identify and analyze the multiple, often contradictory, perspectives of the different persons involved (17). Compared with the traditional biomedical model, these types of studies provide a much richer perspective of relevant values that need to be taken into consideration in the political decision-making process.