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10. Medical Research Ethics 10. Medical Research Ethics Medical research ethics is of course part of both medical ethics and general research ethics. From medical ethics it takes over ‘the Four Principles’ just presented (Chapter 9.6), and from general research ethics it inherits the norm ‘Be Honest in Research!’, which we touched upon when discussing what a scientific fact is (Chapter 3.1). Apart from these moral norms, research also contains intra-scientific methodological norms, i.e., each scientific disciplines default rules for how to do good and efficient research. Since moral norms overrule all other kinds of norms, it may seem as if the relationship between the moral and the methodological norms is one-sided; moral norms can put constraints on methodological norms – period. But this is spurious. One then forgets that ethics (classical deontology apart) often needs to take consequences into account, too. And to constrain the methodological rules for moral reasons may have bad consequences. In this way, moral and methodological norms may interact. This interaction will be highlighted below, and in the last subchapter (Chapter 10.5) we will present a mixture of moral and methodological norms that are called ‘the CUDOS norms’. Since medical research is typically done on human beings and animals, medical research has a moral aspect that is absent from research in physics and chemistry. But it should not be forgotten that much medical research (e.g., on tissues, genes, and cell-lines) is also done in physico-chemical laboratories. A simplified but common division of medical research is: 1) preclinical research, 2) clinical research, and 3) public health research. 1) Preclinical research overlaps with natural scientific research. One might define it as natural scientific research that aims at finding knowledge that is helpful in inventing new medical therapeutic strategies. It is often concerned with chemical, physiological, microbiological, anatomical, histological, molecular-biological, and genetic analyses. Both experimental and observational studies are used; the experiments can be made on animals. 346 2) Clinical research involves healthy and/or more or less seriously ill human beings, and it tries directly to test newly invented drugs and medical diagnostic and therapeutic devices, involving all clinical specialties. Sometimes, this kind of research is divided up into four phases, I-IV, preceded by phase 0, which is preclinical research. In phase III, one performs the kind of randomized control trials that we presented in Chapter 6.3; phase 4 is mainly post-launch safety and generalization surveillance. In phase I there can be experiments on animals; it is a kind of safety studies made in order not to put the human participants of phases II and III into too risky situations. 3) Public health research is dominated by epidemiology, but it also contains specialties such as environmental medicine, social medicine and health care sciences. It often aims at finding preventive measures; and to this effect the researchers study very large groups or whole populations. Often, in this undertaking phenotype and genotype information from different registers and bio-banks are used. When, here, researchers move from their statistical findings to making claims about causal relations, they may use Bradford Hill’s criteria, which we presented and commented upon in Chapter 6.2. To repeat: this tripartition is a simplification. It does not, for instance, consider mutual interdisciplinary collaborations typical of some fields. Nor is it complete; research in disciplines such as medical sociology, medical anthropology, and medical ethics, have got no place in the list. As a main memory device in relation to the list, the following chart can be used: Preclinical research Involving animals Clinical research Research ethics Involving human beings Public health research 347 Today, there exist a number of research ethical guidelines that regulate how to deal with research in different medical fields. We will describe below their historical background, as well as comment more on the overarching research ethical aspects that medicine has in common with other scientific areas. First of all, however, we would like to make it clear why it can be regarded as unethical to abstain from carrying out medical research. 10.1 Is it unethical not to carry out medical research? The aim of health care is to prevent illness; when this is not possible, to cure; and when this is not possible, to alleviate suffering; and when even this is not possible, to comfort the patient. In all these undertakings, one should avoid harming people. These rankings are in accordance with the principles of beneficence and non-maleficence. Now, in order to prevent, cure, alleviate, comfort, and even to avoid harming, we need knowledge; therefore, we must to produce knowledge. We need of course knowledge in relation to illnesses, diseases, and disabilities that we cannot at the moment do anything at all about, but often we also need new knowledge in order to be able to improve on already existing therapies. Therefore, it is unethical to abstain from medical research. Let us concretize. When cytostatics were introduced in cancer treatment, they were given to all cancer patients, even to terminally ill patients. The latter were treated with cytostatics for palliative reasons, and sometimes simply in order not to take away the patient’s hope of being cured. In the latter case, the doctor did not know whether the treatment would have any effect other than the side effects, which for most cytostatics include nausea, vomiting, diarrhea, hair loss and more life-threatening conditions as leucopenia with risk of lethal infections. Sometimes the main effect of the treatment on the terminally ill patients was that their last days on earth were made excruciating. In this way the treatment harmed the patients, but if it kept their hope of being cured alive, then at the same time it comforted the patients a little. How to weigh these factors against each others? Answer: research. How to improve the situation radically? Answer: research. As there are numerous different cancer diseases, as well as plenty of different mechanisms by means of which treatment functions, we need to find out whether certain combinations of cytostatics and other drugs prolong 348 survival in relation to quality of life, and which treatments might be useful for palliative purposes for different kinds of cancer. The argument in favor of research in the two paragraphs above seems straightforward, but it is much too simplified. It forgets the fact that research has its costs. If in order to make some sick people healthy, we have – in research – to make some healthy people suffer, it is no longer obvious that the research in question should be performed. We have to start to weigh the pros and cons. And if many research projects are involved, we have to start thinking about making rules that prohibit that research costs too much from a human suffering point of view. The main principle that has emerged during the development of medical research is the principle of informed consent: • Participants in medical research investigations of all kinds must have given their explicit consent – after having been informed about what the investigations amount to. The relationship between this principle and the principle of respect for autonomy is obvious. However, if patients in a trial are informed in detail and in advance about what kind of treatment they are receiving, e.g., placebo or a promising new treatment, this information may render the result of the trial hard to assess (see Chapter 6.3). But problems are there to be solved. The introduction of the randomized double-blind test solves this problem. Instead of being given detailed information about what treatment they will be provided, the participants are informed generally about the design of the study, and are then asked to participate. That is, when they consent they know that neither they nor the doctors will until afterwards know whether they belong to the experimental group or the control group (which is given placebo or the old treatment). This respects the autonomy of the participants, even though among some of them it may create uneasiness that they do not know whether they receive a treatment or not. Sometimes, one wants to investigate a new treatment in relation to a life- threatening disease where previously no treatment has been available. If the new treatment proves to provoke numerous bad side effects and is ineffective, the placebo group might well have received the less harmful treatment. But if the new treatment proves to be effective and life saving, 349 most of the patients in the placebo group have missed an effective treatment; several of them might even have died before the result of the trial had become clear and they could have received the new treatment. It is only in retrospect, and then in a metaphorical sense, that one can say that the placebo patients were ‘sacrificed’ for the happiness of future patients. Autonomy, as we have said, takes degrees. Therefore, if possible, already acceptable designs should be improved on. One proposal that works when the control group receives an old treatment, is the so-called ‘Zelen’s pre-randomization procedure’; after Marvin Zelen (b. 1927). In this design, the participants are randomized to the control group and the experimental group, respectively, before the informed consent is asked for; and the consent is then asked for only in the experimental group. In this way, no participant needs to live with the uneasiness of not knowing whether he receives a treatment or not. Furthermore, it seems to respect the autonomy of the members of the experimental group even more than in the ask-first-randomize-then procedure, since now the patients in the experimental group is given the information that they belong to this group.
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