Ethical Aspects of Medical Experiments Research Paper

1. The Nature of Experiment

While a precise definition of an experiment is hard to give, for present purposes we can identify the key elements as (a) a definite state of affairs for investigation (the experimental object); (b) a second definite state of affairs, similar in all relevant respects to the experimental object (the control object); (c) deliberate and controlled modification of the experimental object; (d) observation of the experimental object, the process of modification, the modified object and the control; (e) systematic comparison of the modified object and the control. ‘Object’ or ‘state of affairs’ is deliberately vague: experiments can be performed on physical systems (for instance, atoms), biological systems (organisms, populations or ecosystems), or social individuals or systems (people, social groups, economies). The experimental and control objects are normally constructed through selection or statistical sampling to represent a specified population or natural or social kind.

1.1 The Ethical Orientation of Experimental Methods

The ethical issues in experiments arise out of the various operations performed to constitute, observe, modify and compare the experimental object and the control. These issues fall into three main groups: the interests of the experimental object and control; the character, motivation and behavior of the experimenters; and the impact the experiment has on current and future social interests. In addition, consideration must be given to the ethical issues of scientific research generally: including sound methodology, accurate and open publication, and fair dealing with the public.

1.2 Experimental Objects, Subjects and Participants

Confusingly, in the literature what is called here the ‘experimental object and control’ are usually referred to as the subjects of the experiment. There is a whole history of philosophy leading up to this terminology. Here it has been avoided, in order not to prejudice the question of what kinds of thing are the objects of the experiment. For instance, plants would not normally be thought of as ‘subjects,’ but people would be. The term ‘object’ is preferred here, to designate the ‘thing’ on which the experimenter acts. Most experiments presume or create a docile object which is malleable to the experimenter’s will. The language of ‘subjects’ is illuminating too. The subject in an experiment is both ‘subject to’ the experimenter in the political sense, albeit normally with the subject’s consent (again, there is a political analogy). But in philosophy or linguistics, ‘subject’ normally means the agent (the subject of a sentence, the knowing subject), as distinct from the object, which is acted upon.

These terminological issues are far from academic. Practically, there is a debate in medical research with patients about whether it is better to call the ‘subjects’ participants, in part because human-subject research usually requires the cooperation of its subjects and their action in compliance with the requests of the researcher, and in part because the ‘subject’ designation is felt to be demeaning and oppressive.

Theoretically, what we call the experimental object tells us something about what the relationship is between the researcher and the object. In medical research into new drugs, early phase research will involve experimentation on the bodies of animals and, later, healthy humans, to carry out pharmacological investigations into the chemistry of the drugs in complex biological systems. Here the human or animal body is the research object, not the person of the individual who ‘owns’ that body and who is the ‘subject’ governing that body. The researcher requires the cooperation of the individual subject, however this cooperation is achieved, in order that the body of the subject be docile and available for objective, pharmacological study.

Thus it is clear that the relationship between researcher and object in an experiment is philosophically complex, and essentially ethical. This ethical relationship may take on a range of values from the wholly good to the unequivocally evil, however.

2. The Rights and Interests of the Experimental Object

The recent history of the ethics of research has tended to concentrate on the rights and interests of the experimental object, and control. Humans certainly have interests, although these may be very difficult to identify in some circumstances. Adult humans (historically, adult male, white, middle-class humans) form the paradigmatic instance of the subjects with interests. At the very least, consideration of interest involves avoiding unnecessary harm and exploitation of the experimental object and control. For instance, placebo controlled trials in medicine can only be justified if the treatment of the control group is no worse than it would be if they were not taking part in the experiment.

2.1 Vulnerable Subjects

Children, the mentally ill, and the unconscious are often characterized as ‘vulnerable’ subjects. This relates to their physical vulnerability (exposure to risk of assault or degradation), and to their inability (or diminished ability) to consent or refuse to participate in the experiment. Other kinds of subject (prisoners or students and employees of the researcher) are defined as vulnerable because they can consent, but are vulnerable to exploitation or oppression. More controversially, some kinds of animals are regarded by some as possessing interests, by virtue of their degree of consciousness or their ability to suffer pain. Even more difficult is the relationship between rights and potential interests, as in the case of embryo research,

for example. In these instances, we move away from a consideration of the rights and interests of the experimental object, towards a focus on the duties and moral character of the experimenter.

2.2 Limits of the Rights and Interests Approach

While the greater part of the academic and practical literature stresses the rights and interests of individuals as the foundation of research ethics, there are important tensions. First, the rights interests focus tends to be difficult to assess directly. Most argue, moreover, that it is indeed paternalistic to try to assess what other adults ought to want or is in their interest. Hence, great stress is placed on informed consent. There is a large research literature on the best ways of obtaining informed consent, including a literature on the readability of consent forms. This leads to a number of philosophical and legal problems. Is signing a consent form the same as consenting ‘authentically’? Does consent indicate a true, reflective judgment of understanding and a wish to participate? Can people consent to something that is not in their interest? Is consent a sufficient protection? Consent could be governed by a ‘freedom of contract’ doctrine, which allows that where two informed consenting adults make an agreement, no one else has a right to interfere, unless some third party is harmed by the arrangement. But this would disallow consideration of exploitative relationships, in which one of the parties is not harmed, but on the other hand is not fairly benefited. More generally, consent focuses on individuals, where the role of the group might be more significant.

The difficulties around consent do not invalidate its importance, but they do remind us that other factors are significant too. In the case of subjects unable to consent, we are forced to consider their interests objectively, so far as we can, but also the ethical status of the experimenter. In other words, the duties and character of the researcher are quite as significant as the rights and interests of the subjects.

2.3 Respect and Dignity

In the European literature on research ethics, considerable attention is paid to the ‘dignity’ of the human subject. This is often understood to be a peculiar property of human beings, from embryo to cadaver, although arguably there is such a thing as feline dignity or the dignity of other species too. It would be unusual to refer to the dignity of a landscape, but many would argue that while speaking of the rights of a landscape is absurd, assigning it ‘dignity’ or something similar, such as ‘grandeur’ or ‘intrinsic value’ would be quite sensible. Dignity arguments are hard to apply, and it has been said that ‘dignity’ is something assigned only to ‘objects’ which are not autonomous. Thus it is best understood as a concept which orientates the researcher’s attitude: ethical researchers take up a certain attitude of respect towards their subjects.

Most of the ethics of experiments is common morality—avoiding unnecessary harm, seeking permission, treating people (or animals) with respect and fairness. What gives experiments their special moral character is the experimental relationship, which transforms natural subjects (people, animals, societies, environments) into objects of deliberate manipulation. A basic principle of ethics, formulated by Kant, is that one should treat other people as ends in themselves, rather than merely as means to reach one’s own ends. Here the important words are ‘merely’ and ‘people.’ Kant’s principle has been criticized because it apparently excludes societies, animals and environments from moral consideration. His position can be rescued in two ways: extending the concept of ‘person’ to include any creature which has interests, and arguing that mistreatment of nonhuman objects involves indirect mistreatment of the humans whose interests are affected indirectly. More imaginative explorations of the ethical relationship between researcher and the object have been proposed, notably by Heidegger, who proposes that the ‘technological’ attitude itself is what requires moral assessment. Heidegger strongly criticizes the attitude to nature which is involved in turning people and things into mere ‘resources’. Marxian concepts of alienation and exploitation, and feminist discussions of the construction of the docile (female) body run along similar lines. While these concerns are alien to most medical ethics and most analytic philosophy, these themes do arise in many bioethics contexts—for instance, in discussions of cloning, genetic engineering, environmental ethics, and ‘healthy volunteer’ research in pharmacology.

3. The Social Impact of Experiments

An issue now widely discussed is who should have a say in the moral evaluation and social control of experiments. Most scientific experiments on physical systems have from the nineteenth century until the end of the twentieth century been regarded as morally neutral, progressive and acquiring moral significance only when ‘applied’. Medical experiments have had a much more complex public ideology. Some sorts of intervention—for instance, in economics—have not been regarded as experiments at all until recently (because some aspect of controlled and observed manipulation has been lacking).

Most experiments have a social impact, internally (the way humans must behave in order for the experiment to succeed) and externally (the socioeconomic impact of the research). Experiments in economics or medicine, for instance, can have important consequences for the participants, which may persist long after the completion of the study. Appropriate mechanisms for rewarding and compensating subjects are needed. Participants may be required to adhere to the experimental protocol longer than they would otherwise choose, in order to preserve the integrity of the experiment. On the other hand, it should also be noted that nonexperimental interventions can be even more consequential than controlled and observed experimental ones, as the move toward ‘evidence-based medicine’ attests.

In many large scale social experiments, participation needs to be protected by democratic assent to the study, which can stand in tension with the need for the subjects to be ‘disciplined’ to behave in compliance with the protocol. This leads to a need for the social control of experiments.

3.1 The Social Control of Experiments

In most democratic societies it is now believed that public scrutiny of research is a good thing, through participation in the governance and ethical oversight of research. One important form of participation in this process is the ‘ethics committee,’ which has been adopted widely as the chief form of ethical review. Other forms of public participation, including helping to set research agendas and standards of performance, have begun to be tried, particularly in areas of widespread public concern (genetic engineering or nuclear power, for instance). A second form of ethical or social assessment is now extensively practiced, the ‘technology’ or ‘impact’ assessment. This involves social and economic analysis of interventions, usually on the basis of more experimentation, and often involving sociological research.

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