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News From IUPS
Department of Anatomy, University of Berne, CH-3000 Berne 9, Switzerland
Abstract
Physiologists are bound to test their scientific theories in experiments on living matter and, ultimately, on living organisms—animals or humans. This confronts the physiologist with ethical dilemmas: can we engage in physiological eperiments in the face of possibly harming the interests of living beings, or should we refrain from such studies, thus preventing the good that can be derived from scientific progress?
It is our business as physiologists to study life and the multitude of processes that make it happen, from the functioning of membrane channels, through the electrical activity and hemodynamics of the heart, to the integrative events in the brain. Our obligation is to study all of this with the approach of science, starting with a theory, leading to a hypothesis, which is tested by experiments whose results are analyzed, followed by a critique of the theory—and the game goes on. Most of this approach is common to all of science. But there is one significant difference: since our object is the understanding of life processes, the experimental tests of theories and hypotheses must be performed on living matter, from cells to whole organisms, even on humans.
This raises ethical issues—and presents us with ethical dilemmas—because such experiments must, in part, be performed on living animals or on humans. Good experiments are, by necessity, based on controlled interventions, on perturbing the normal functioning of the organism. This is also the case with the new physiological research strategy of functional genomics. Do we have the right to do such experiments, to interfere with the life of another creature, perhaps to cause suffering or even some risks? If so, how can this be justified and what are the conditions that must be fulfilled? The basic ethical dilemma we are facing is this: can we engage in the physiological experiments that our scientific interests impose in the face of possibly harming the interests of living beings, animals or humans, or should we refrain from such studies?
Clearly, these are very difficult questions, and they cannot be dealt with in any depth in this short note. I would therefore just like to make a few reflections that I consider central to the issue, discuss existing guidelines for this work, and direct you to further reading on this matter. A good start is a small booklet published a few years ago and based on a symposium organized by IUPS and UNESCO in Paris, entitled The Ethics of Life (10). Here fundamental questions relating to physiological research and its ethical justifications—and limitations—are discussed. It contains a chapter on the "Respect for life and the foundations of bioethics" and one on "Respect for life and the law of the living" that show the vast complexity of the ethical issues we need to consider. The book also features chapters on legal aspects of the question as well as some historic background on physiological experimentation on humans and animals, to some of which I shall refer later.
Respect for life: a guiding principle
One of the key ethical concepts pertinent to this discussion is "respect for life," a principle first proposed and discussed extensively by Albert Schweitzer early in the 20th century (12). Schweitzer starts with a fundamental statement that immediately defines our challenge and our responsibility: "I am life that wants to live in the midst of life that wants to live." The central issue here is the will to live, the striving for life, which is common to all living beings, animals and humans, and which we humans must respect in all life forms. For Schweitzer, ethics is "that I experience the need to respect all will to live equally as I do my own." I personally cherish this principle because it calls on our direct personal responsibility toward other living beings, be they humans or animals. Because of this, I consider it much stronger than other statements that assign certain higher properties, such as (a poorly defined) dignity, to all living creatures.
The principle of respect for life is at the very basis of important ethical movements, such as the human rights movement, that have developed since the Second World War in the interest of preventing future atrocities like those that occurred during the Nazi reign (13). The so-called Nuremberg Codex, formulated in 1947 by the court ruling about the scandalous human experiments by Nazi physicians, marked the beginning of a movement to regulate biomedical research involving human subjects. This led to two significant declarations of an ethical nature. On the one hand, the United Nations broadened the scope of the Codex in the Universal Declaration of Human Rights of 1948, stipulating that "everyone has the right to life, liberty, and the security of person," which applies to all humans. On the other hand, the World Medical Association (WMA) refined the 10 theses of the Nuremberg Codex, and this resulted in the Declaration of Helsinki adopted by the 18th WMA General Assembly in 1964. This declaration set the universally accepted rules for research involving humans. It has undergone several revisions and was issued anew in October 2000 by the 52nd WMA General Assembly held in Edinburgh, Scotland (15).
The principle of respect for life also applies to animals, whose rights must be adequately protected. It is perhaps unfortunate that large international bodies such as the United Nations or WMA have not followed their declarations on human rights with similar statements on the relation of humans and animals and on animal rights. In the absence of such statements, animal rights activists and antivivisection movements have taken the stand that the protection of animal rights does not permit any experiments on animals. It cannot be as easy as that, however. First, we humans use animals for many purposes, such as for labor and for meat production. To use animals for biomedical research is then only a special variant of this relation of humans to animals. Second, if we are allowing
"...respect for life is the guiding ethical principle for physiological research...."research to be done on humans under certain conditions, it appears justified to permit it also for animals. However, it is ethically imperative that we set proper conditions for this work, ethical rules for animal experimentation that adhere to similar ethical standards to those for humans, as discussed below.
Thus respect for life is the guiding ethical principle for physiological research involving human subjects as well as for animal experiments in physiology. It helps us to define the limits of what we can and should do, and it allows us to take responsibility for our acts. It may therefore lead us in resolving the dilemmas we are facing when engaging in experiments to test physiological theories. However, this principle is too general for immediate application, so we depend, in our everyday work, on guidance on the basis of a consensus on how respect for life translates into specific judgments and practices. Here we must clearly differentiate between experiments on humans and those on animals.
Physiological research involving human subjects
The Helsinki Declaration of the WMA (15) sets the internationally accepted basic standards for all research on human subjects. It is oriented toward biomedical research but is applicable to all research in human physiology and also, for example, to investigations in sports physiology whose goals may be to improve the physical performance of athletes. The Declaration says that "the duty of the physician is to promote and safeguard the health of the people," and this must also be a directive for physiologists. It notes that "medical progress is based on research which must ultimately rest in part on experimentation involving human subjects, but that this research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature...and, where appropriate, animal experimentation." An important postulate is to assess the risks and burdens on the subject and to abstain from engaging in research projects involving humans unless these risks are adequately manageable. "Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject."
One of the central claims, derived from the original Nuremberg Codex, is that of informed consent of the subject; in the 2000 version of the Declaration, this is even strengthened inasmuch as the investigator must make sure that the subject has really understood what will and can happen. This is particularly important with healthy volunteers, because they will often be engaged in physiological research.
The Helsinki Declaration is a statement of principles not really suited to give guidance to those who need it when setting up and performing studies. In some countries, ethical guidelines for research involving human subjects or even corresponding legislation have been formulated. An important part of this are the regulations on good clinical practice, which primarily concern clinical trials of drugs but are also applicable to other types of studies. At the international level, actual guidelines (Ethical Guidelines for Biomedical Research involving Human Subjects) were worked out and published, for the first time in 1982, by the Council for International Organizations of Medical Sciences (CIOMS) of the World Health Organization in Geneva, and most medical academies adhere to this guide. A thorough revision of these guidelines has been undertaken over the past several years, and a draft revision has recently been published, with extensive commentary, on the World Wide Web at www.cioms.ch (2).
These guidelines start out by setting down the prerequisites of biomedical research: 1) the research must be justified, 2) there must be a detailed protocol, and 3) all proposals must be submitted for review and approval to an independent ethical and scientific review committee. The first two points appear self-evident, and the third I find most important because it allows us to share our concerns with peers and with people outside of the science enterprise, who may sometimes have a different, more detached view of the situation. The question of how to obtain and ascertain informed consent is dealt with in great detail, and, finally, some consideration is given to the question of equitable distribution of burdens and benefits resulting from such research.
On the whole, these ethical guidelines of CIOMS have already served a useful purpose. They have helped to align guidelines and legislation in different nations by setting a common ground of minimal standards for research involving human subjects and thus for research in human physiology.
Physiological research involving animals
The Declaration of Helsinki, as well as the CIOMS Guidelines on Research Involving Human Subjects, stipulate that some studies on humans can only be performed if preliminary animal experiments have shown their safety and efficacy. Physiology is not limited to serving medical research. As a basic biological science, it has the obligation to advance the understanding of life processes independent of any possible medical application. Such studies must involve animals lest they are not performed at all, another dilemma facing the physiologist.
The principle of respect for life and the ethical postulate that like should be treated equally require that we set rules for experiments involving animals that follow similar standards to those for human experiments. There is, however, a fundamental difference. Humans can give their consent to be "used" in research, so we can ask for their permission to be included in a research protocol as volunteers. Animals cannot consent. We humans are instrumentalizing animals for our purposes, and this raises ethical problems. The implementation of the principle of respect for life must therefore take a different form. Jeremy Bentham said in 1789 with respect to animals: "The question is not Can they reason? nor Can they talk? but Can they suffer?" There is now agreement that animals can suffer. It is therefore an ethical requirement that animals should not suffer at our hands if we use them for research purposes.
Under the heading of respect for life, we can identify three points in which animals and humans are alike (10):
On this basis, one can argue that animals and humans should be treated equally. We are not allowed to make them suffer because we do not allow torture of humans, and animals should not be killed. These are radical positions that are only acceptable if one also refuses to make any use of any benefits resulting from the utilization of animals. In view of this discussion, it cannot be disputed that research involving animals has made possible major and important advances in the medical sciences and has thus benefited the welfare of humans and animals. As scientists, we have the obligation to pursue this avenue. It would raise other ethical conflicts if we were to deny the future generations of humankind the benefits that we enjoy.
Accepting the need to utilize animals for research purposes, we are now faced with the ethical dilemma that in safeguarding human life we are violating the principle of refraining whenever possible from inflicting suffering on other living beings. We must strive to minimize this dilemma as far as possible. Again, we need guidance on what this means. Legislation on animal protection and experimentation varies greatly among different countries, depending on different cultural values. In my own country, Switzerland, the rules are very strict, both in law and in practice. Some twenty years ago, Ethical Principles and Guidelines for Scientific Experiments on Animals [Ethische Grundsätze und Richtlinien für wissenschaftliche Tierversuche (1995)] were issued jointly by the Swiss Academy of Medical Sciences (SAMS) and the Swiss Academy of Sciences; they can be found on the website of the SAMS (www.samw.ch). They discuss in some detail the basic ethical principles involved and how they can be used to legitimize as well as limit experiments on animals. The conduct of animal experiments and the responsibility of all concerned are elaborated in some detail. The reduction in the number of experiments, the duty to be heedful of the well being of the animals, and the need to ensure the least possible suffering are central to these arguments.
A few years later, CIOMS issued International Guiding Principles for Biomedical Research Involving Animals (3), which can be found on the CIOMS website (www.cioms.ch). These principles were based on a broad collaboration of the international biomedical community and should therefore be applicable worldwide to ensure similar standards everywhere. They emphasize the need for animal research for the advancement of the biomedical sciences and thus also of physiology, but they strongly state that "the biomedical scientists should not lose sight of their moral obligation to have a humane regard for their animal subjects." These principles are patterned on and linked to the guidelines for research involving human subjects, with obvious differences. They discuss questions of animal care and the possibilities and potentials of alternatives to animal experiments.
The physiologist's dilemmas
As physiologists, we are faced with a series of dilemmas that each of us needs to resolve. The advancement of the understanding of life processes with which we are mandated depends crucially on testing theories of how things work by experiments in nature, and this means on living matter. Some have resolved the dilemma by limiting their experiments to small subunits such as ion channels, units that cannot "suffer." But, in fact, the study of channel function depends on obtaining material from cells and organisms, particularly if one resorts to genomic manipulation of channel properties. Ultimately, the results of such studies make sense only when they are related to organismic function, and here experiments on humans or animals can hardly be avoided.
To ensure similar ethical standards for physiological research worldwide, the Council of IUPS, at its recent meeting in New Zealand, adopted a resolution that declares the two above-mentioned sets of guidelines from CIOMS as binding for all members of IUPS (see box on p. 45
).
| Resolution of Council of IUPS Concerning Ethical Principles for Physiological Research on Humans and Animals In order to serve the wellbeing of humans and animals by advancing knowledge on life processes, physiological research must depend on experiments using humans or animals. Even though many fundamental questions can be approached in model systems such as cell or tissue preparations the significance of such studies must ultimately be tested in relation to the whole organism. Such studies much, however, respect fundamental ethical principles that safeguard the integrity and safety of the subjects. A. Ethical Guidelines for Physiological Research In order to ensure similar ethical standards for physiological research on humans and on animals in all countries, IUPS declares the following international guidelines as binding for all research conducted by physiologists associated with IUPS and for all research presented and communicated at meetings under the auspices of IUPS:1)
B. Committee on Ethics The Committee on Ethics of IUPS is mandated to:
Christchurch, New Zealand, August 24, 2001
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We must face it: the ethical dilemmas of the physiologist cannot be resolved. We must live with them. It is important, however, that we remain conscious of the ethical problems raised by physiological research involving humans or animals. But we must make every effort to reduce the number of animal or human experiments as well as their potential burden on the subjects to the minimum. We must accept that such research must be well justified and performed with concern and empathy. The best justification is, of course, that the study is done with high competence and that it provides a significant step forward in our understanding of life.
Further reading
This article has been cited by other articles:
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  P. A. Hansen PHYSIOLOGY'S RECONDITE CURRICULUM Advan Physiol Educ, September 1, 2002; 26(3): 139 - 145. [Abstract] [Full Text] [PDF]
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