S&T Ethics 6

4. Experiments with animals and humans

A special critical issue in science and research is experiments that involve animals or humans. This topic can’t be sufficiently covered with the virtue approach described in chapter 3. Arguments in favour and against animal and human experimentation as well as on procedural questions are more sophisticated and need deeper insights into ethical reasoning. Next to the introduction of the debate on animal testing and ethical dimensions of human subjects in research, this chapter will, therefore, also give an overview of utilitarian and deontological ethical thinking as well as bioethical considerations.

4.1 Animal testing

We start with a few numbers: It is estimated that around 100 million vertebrate animals are used worldwide per year for experiments. This doesn’t include invertebrates like insects (e.g. fruit flies). More than 60% of those are rats and mice, 25% are fish, 10% reptiles and amphibians, and the rest are birds and mammals.

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Experiments with and on animals are conducted for the purpose of basic research (more than 50%), medical testing (25%), breeding (16%), regulatory testing (1,7%) and education (1%).

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Animal testing dates back very far in history. The Cartesian worldview that regards animals as some kind of biomechanical machines was totally fine with treating animals as objects, examining them in the cruelest ways (e.g. nailing dogs onto boards and cutting them open to observe the beating of a heart). When the scientific experimenting with animals turned into a more systematic method on a large scale (in the 19th century), also the first movements of resistance formed, the anti-vivisectionists. Today, organised activism against animal research is widespread. Animal rights movements like that organised by PETA are well known. Sometimes, the protest even turns violent against individual scientists and/or their institutions, for example in the form of attempts to set research labs on fire or threatening researchers at their home.

Why is animal testing such a hot topic? Those supporting research on animals defend their approach by referring to the huge benefits for mankind, for example safety and efficiency of new drugs and cosmetics, anatomic and other medical knowledge, understanding of natural (biological) processes, etc., for a relatively low price – “only” animals, avoiding human suffering. The contra arguments are much more diverse and focus on different aspects of animals and their usage for research. Indeed, some activists put a strong focus on emotion and aesthetics, pointing at the suffering and despair of animals, and the misuse of “beautiful”, “cute” and “lovely” animals. This is, understandably, target of criticism, since personal preferences and aesthetic standards can’t be applied in a philosophical debate. Here, I’d like to focus on different ways of arguing against (or in favour of) animal experiments.

4.2 Ethical perspectives

Many people argue against animal testing on the grounds of utilitarianism which is a form of consequentialism, an ethical theory that evaluates the goodness of an action by the consequences: “good” is what maximises the benefit of the largest possible number of affected entities. For ethicists like Peter Singer, we can’t just point at the benefits for mankind without granting animals their place in the equation. Animals as ethically relevant entities have no benefit at all from those experiments. Their suffering diminishes the benefits so massively that it is impossible to regard such experiments as morally acceptable. There are two things we have to check at this point: Is consequentialism an appropriate theory to apply here, and are animals justifiably part of the equation?

4.2.1 The Trolley Problem

A famous thought experiment to question the validity of consequentialist reasoning is the Trolley problem. Imagine the following situation:

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A trolley (a tram car) is out of control and rolling down a slop, threatening to kill 5 workers on the tracks (or 5 otherwise “trapped” people). You stand at a lever that can switch the track to another one on which the trolley would kill only one person. If you do nothing, 5 people die. If you switch the lever, only 1 person dies. Will you pull the lever? 90% of people exposed to this problem answer “yes”. The simple consequentialistic consideration is: 1 person dead is better than 5 people dead. Now we can introduce some special variations: What if the 1 person is a 2-year-old boy and the 5 people on the other track are all above-90-year-old terminally ill cancer patients? What if the 1 person is a member of your family and the 5 are all strangers? What if the choice is to be made between 1 of your family member and 1000 strangers? We can see, these considerations often come to limits where simple numerical calculation of “benefits” (or “consequences” in general) becomes impossible or insufficient. Let’s see another variation of the thought experiment:

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Again, the trolley is approaching the five people on the track, certainly killing them if nothing stops it. You are on a bridge above the track, together with a very fat man. It is clear that if you push down that fat man, he would block the trolley, saving the five people, but dying himself. In essence, the outcome is the same: 1 person dying instead of 5. However, in this case, only around 30% of people respond that they would push down that man. There is a clear difference between the first and the second variation: In the first case, all deaths can be regarded as an accident, an unlucky chain of events. Either the one or the five are just unlucky. In the second case, however, pushing down the fat man (instead of simply pulling a lever) is an act of killing – murder. It seems, for most people, it makes a huge difference to act passively or to actively get involved in the fate of other people. Calculating benefits alone, therefore, obviously can’t determine the goodness or rightness of a decision. Again, we can vary this scenario slightly: What if the fat man is a villain who put those 5 poor people onto the track? Would it be different? Under these circumstances, would it be “allowed” to push him down to save his victims and take his own death into account. Most people answer “yes”.

The Trolley episode tells us that another consideration that is beyond mere consequentialistic calculation of benefits is important: The rights of people and the ethical duties that stand behind actions and decisions to act.

4.2.2 Deontology

In the former example, the basis for the idea to look at the outcome of an action as ethically relevant factor was the “benefits” (in terms of well-being) of human beings or other entities. Philosophers inquired that “well-being” is a too vague concept, very subjective and “corrupt”, or hedonistic. As a kind of “counter movement”, almost at the same time as the rise of consequentialism, another idea found many followers: The basis of human existence is our free will. As rational beings we can reflect upon our “self”, form desires and interests and express those in our decisions and intentions. This has severe consequences: Every rational being (and no being can be more rational than the human) has dignity. Later, the idea of “human rights” was derived from this. Moreover, every rational being has a legitimate interest in autonomy and self-determination. As a conclusion, freedom is the highest good: freedom from suffering and pain, freedom from outer power or force, freedom to decide how to live one’s life. However, one’s own freedom has a limit: the freedom of the others! Here, the “Golden rule” that is found in many cultures and societies and their Philosophies over the globe (also strongly in Confucianism) comes into play: “Don’t do to others what you don’t want to be done to you!“. A famous variation is Immanuel Kant’s “categorical imperative”: “Act as if your maxims should serve at the same time as a universal law. (只依據那些你可以同時願意它成為普遍法則的準則行動.)” Kant’s philosophical reflections have been so fundamental and influential that he can be considered the most important thinker of Europe. He is a central figure in the European Enlightenment movement and the essence of his findings found its way into many social institutions such as Democracy, the law-and-order system, or our modern idea of education. His famous categorical imperative as the core of his ethical system can be applied like this: When you consider doing a certain action you have to ask yourself: If the motivation (“maxim”) for this action would be a law (or allowed by law), would that be a world (or society, or state) I’d like to live in, or a world that would be “reasonable”? For example: Is “lying” a moral or immoral act? Can we imagine a society in which “lying” is allowed by law that works reasonably well? A rational person with a sufficiently clear mind would surely find that a society of liars could never work out well. Therefore, we conclude that lying is unethical. That means, as the ultimate conclusion, from our rationality (esp. the rational insight that we “have to do good” in order to keep social peace) and our free will (esp. the ability to decide what to do) we derive the duty to do “good”. This idea of “duty ethics” – the moral obligation to act morally – is known as “deontology”, with Immanuel Kant as its most prominent advocate. Here, within 10 minutes, I tried to explain a philosophical topic to you that would need a whole year regular lectures and we still wouldn’t be able to understand it to the fullest. Myriads of Philosophers have analysed, debated, deconstructed and reconstructed Kant’s reasoning approach. It was criticised, refined and applied to many questions of daily life. For our purpose here – animal testing and later experiments with humans – I’d like to introduce an alternative reading of his categorical imperative: “Never treat a moral agent merely as means, but always also as ends! (行動時對待人性的方式是,不論是自己或任何一個他人,絕對不能當成只是手段,而永遠要同時當成是目的.)” The term “moral agent” is introduced by myself, here. Kant would refer solely to human beings. However, this way of expressing the golden rule is applied by most animal rights activists – those who are not utilitarian (see above) but who argue that animals are moral agents that need moral protection. In animal experiments, they argue, animals are treated merely as means for ends that they have nothing to do with or that are not for themselves, which makes it unethical to perform such experiments. But are animals really “moral agents”? This question overlaps with the question whether animals are part of the utilitarian equation of “benefits”. Let’s see, therefore, what is the moral status of animals.

4.2.3 “Centrisms” in Bioethics

There are several positions in bioethics on who or what “counts in” in ethical considerations. These are so called “centrisms”, based on what the respective worldview puts into the “center” of its morality. The most confined viewpoint is “I only take care of myself!”. This is known as egocentrism and certainly not helpful for an ethical discussion. The next level would be a kind of “sociocentrism”: Members of a “society” (for example a family, a clan, a village, a nation) care about the members of this particular society and give them ethical relevance. A variety of that, ethnocentrism, would define the group that carries moral status by ethnicity. It is obvious that these criteria are very selective and discriminative, a form of fascism or racism. Therefore, reasonable philosophical approaches start at the “mankind” level.

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Some might say, only the human sphere is important for us humans. We can reflect on ethical aspects only for mankind because other spheres (like animals, mountains, planets) can’t participate in the discourse, can’t express what they want, and wouldn’t understand what we conclude. Therefore, we have no choice but conducting ethical debates from the human point of view. We do Ethics only for human. The rest is beyond our capability and responsibility. This is called “anthropocentrism”. It doesn’t mean that animals, plants, the planet, the cosmos don’t matter to us! But if it does, we must understand it as a human interest! We have to treat dogs nicely for the sake of our own good, not for the sake of the dog! Kant, for example, pointed out that mistreatment of animals has negative impact on the personal character disposition. Violence against animals just forms a bad character. The suffering of the dog is not a point at all. The next level of “ethical relevance” is a pathocentric viewpoint: Every sentient being, at least every being that obviously feels pain and tries to escape from it, has a moral interest for its own sake. For some of you that might sound somehow “incomplete”. Why only those organisms that feel pain? What about the border cases where we just don’t recognise the expression of pain? Taking the feeling of pain as a criterion bears the danger of “speciesism”: Putting some species above others (same as “anthropocentrism” is a form of speciesism, putting mankind above other animals). If you think this is not valid, you might be a “biocentrist” and give all living organisms (including animals and plants, and maybe life forms of other planets) the status of being an “ethical entity” having an ethical value “for its own sake”. Some people argue that this is still incomplete: Also geological formations, mountains, landscapes, the whole planet with its ecosystem has an ethical value as such. This is an ecocentristic viewpoint. It is also possible to extend the ethical realm to the whole universe: everything counts in! Cosmocentrism or Holism is based on the idea that everything in the universe is connected and everything has its place. The harmony of “the whole” is, therefore, the fundamental value of all existence. Chinese and Indian Philosophy, especially Daoism (Laozi’s teachings) and Buddhism (Gautama’s teachings, fundamentally extended by Nagarjuna (龍樹)), are based on this holistic worldview. [There is, indeed, a difference – especially for Buddhists – between cosmocentrism (still a “putting something (everything) into the center of importance“) and holism (no center of attention, everything has equal status). This, however, shall not be discussed here.] All these considerations come into play when we reflect on environmental impact of science and technology. Do we only care about the well-being of mankind? Do we want to protect the environment because we understand that we, as the human race, need an environment that functions well? Or do we want to protect it because we believe that “Nature” has a value independent from mankind? Is it acceptable to take the pollution of a river into account as the prize for a few more jobs in a nearby factory? May we shoot polluted materials (like, for example, radioactive waste) to the moon, to Mars or into the sun to get rid of them, risking to pollute extraterrestrial places? We will come back to questions like this in later classes. Now, we want to see how it affects our arguments concerning animal experiments.

The pressing question for both utilitarian and deontological arguments is whether animals have an intrinsic value or an extrinsic one. According to biocentrists (and those with “larger” centers, or holists), animals have an intrinsic value for the sake of themselves. Pathocentrists would grant this at least to those animals that can feel pain, roughly defined as “higher organisms” with a central nervous system such as vertebrates. Anthropocentrists argue that animals can only be attributed with extrinsic value by us – we value them (for something). This can be an instrumental value (they are good for something, for example human purposes or the balance of the global eco-system), aesthetic value (they are beautiful, and there is beauty in global biodiversity), personal preference (we like animals), emotional value (we feel sad when we see them suffering). Only a deontological bio- or pathocentrist, for example, could grant “animal rights”. A utilitarian biocentrist would argue that animals’ benefits (or well-being) plays a role in our calculation of consequences. An anthropocentric utilitarian has to take the instrumental or other mankind-related values of animals into account when making statements about risks and benefits. Anthropocentric deontologists might find no argument for the protection of animals, except – like Kant – that a mistreatment affects the person’s character and personality negatively. Let’s try to make these considerations clearer by looking closer at the means-ends-relations in animal experimentation.

4.2.4 Means and ends in animal testing

We apply means to achieve certain ends in almost all our actions. Sometimes we take other people as means (for example a busdriver) to realise ends (for example being transported from A to B). The ethical guideline never to take anyone solely as means but always also as ends expresses (in this example), that the busdriver we exploit in his role as busdriver has to be treated at the same time as a human being with all the rights we grant to everyone. In this case it is easy for us. What about animals? The following considerations might play a role.

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In this sketch, the size of the arrow (the means) and the circle (the ends that are to be achieved with the help of those means) illustrate the significance, importance or value of the respective means and ends. When the ends are very “big” (important, with huge benefit, etc.) and the means are “small” (cheap, easily available, uncritical, not conflict-laden, etc.) the case is unproblematic. When the ends are small (meaningless, unimportant) but the means (costs, risks, harm) are big, we better refrain from this option. However, sometimes it is debatable whether the ends are really “big” or not. In other words: Are the ends justified? In regard of animal testing, the “ends” are either scientific knowledge (as we have seen: more than 50% of animals experiments are for basic research) and its dissipation (education), or efficient and safe drugs (through medical research), or efficient and safe cosmetics. Many people see a strong necessity to perform drug testing, but cosmetic products are considered a “luxury good” that animals shouldn’t suffer for. A variation of the question of the legitimacy of ends is whether they justify the means. Are these achievements really so important that torturing and killing animals is an acceptable strategy? We can also ask about the size of the means: Is the sacrifice of animals for science and research really such a big issue, or are these “only” animals? Does it make a difference if we use chimpanzees, mice or fruit flies, or should we generally treat all animals the same? Wouldn’t it otherwise be speciesism? Here we are at the bioethical considerations of the former section again.

Specific problems in the means-ends-relations in animal testing have been pointed out by several scholars and the public. First, the means-ends-relation is here highly asymmetric. The ones who benefit from the ends (humans) are not the ones who are affected by the means. Or with other words: The ones exploited as means (animals) have no benefits at all from the ends. This is expressed in campaign poster like this:

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Second, by referring to several empirical studies, it has been argued that the means are not effective in achieving the ends. Animal models are not adequate to relate to the conditions in human physiology, so that medical testing on animals gives no important insights. Also, it is often sufficient to perform “in vitro” experiments (on tissue samples) rather than “in vivo” experiments (on living organisms).

A third aspect has been raised recently by some scientists: When “suffering” and “pain” are the core problems, what if with the methods of genetic engineering a genetically modified synthetic animal is produced that can’t feel pain? It is possible (not just theoretically) to “knock out” certain genes and grow “mice” that literally have no central nervous system. Then, pathocentrists’ arguments have no more power. Still, many people think this is disgusting and humiliating. The scientists’ argument is clearly utilitarian (reduced suffering increases the benefit-cost-relation), but a deontologist might argue against a severe case of animal rights violation by producing “Frankenstein”-animals. This is an even stronger case of “reducing animals to mere means” and granting them no ends at all.

4.3 Regulations on animal experiments

All these considerations, more or less, found their way into current regulations and guidelines on animal testing. The EU and also USA implemented rules and laws on how to conduct animal experiments. The underlying principle is known as the “3R-guideline” that claims that the following methods should be applied in animal experiment planning and conduct:

  • Replacement: When it is possible to answer a research question without using an animal, replace the animal with a methodology that does not use animals, such as cell studies or computer modeling. When it is possible to answer a scientific question using a morally “lower” species of animal, replace the “higher” species with a lower one.
  • Reduction: When it is possible to answer a research question using a smaller number of animals, reduce the number of animals used.
  • Refinement: Wherever possible, refine research methods, techniques, concepts, and tools to reduce the need for animals in research and to reduce harms to animals.

The three Rs can be justified on the grounds that they minimize harm to animals and promote animal welfare within the context of animal experimentation. Of course, these three Rs make sense only if one believes that the research protocols are likely to yield results with scientific, medical, or social value. Thus, a fourth R should also apply to animal research:

  • Relevance: Research protocols that use animals should address questions that have some scientific, medical, or social relevance; all risks to animals need to be balanced against benefits to humans and animals.

Finally, a fifth R is also important (and plays a key role in U.S. animal research regulations):

  • Redundancy avoidance: Avoid redundancy in animal research whenever possible—make sure to do a thorough literature search to ensure that the experiment has not already been done. If it has already been done, provide a good justification for repeating the work.

Researchers who want to conduct an animal experiment have to provide a protocol that explains why the experiment is necessary. In other words, they have to apply for using animals and give good reasons for it. Such an application needs to address the following points:

  • Scientific necessity: It has to be shown that the experiment delivers new insights (not repeating former experiments) and that the obtained knowledge is valuable.
  • The appropriateness of the animal model: It has to be demonstrated in which way the information gathered from animals can be transferred to the human model (in medical research). Recent studies have shown that toxicity studies on mice are limited in providing any insights of relevance for applications on humans. Researchers are obliged to prove by thorough literature study that their chosen animal model serves the respective purpose.
  • Number of animals used: The researcher has to find the right balance between the principle of reduction (use as few animals as possible) and the statistical significance of the findings (as many as necessary). Good statistical design and ethical practice are intertwined, here.
  • Promote animal welfare and reduce animal harm: Researchers have to make sure that the animals are treated with a minimum of suffering, pain, and torture, including appropriate use of analgesia, anesthesia and euthanasia. Also, lab animals deserve proper living conditions and care.
  • Alternatives to the animal model: the principle of replacement implies that researchers should check whenever it is possible to substitute animal experiments by other methods of knowledge acquisition, for example cell and tissue cultures or computer simulations.

Many legislations also try to respond to the public demand of stopping animal testing for cosmetics. This corresponds to the consideration on “how big” the ends are: Animal use in science and medical testing is acceptable whereas in cosmetic testing it is critical. Many countries including most EU countries (except France, home of the biggest animal testing cosmetic company, L’Oreal), India, Australia, South Korea, Japan and Taiwan, banned animal testing for cosmetics.

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4.4 Experiments with human subjects

Utilitarian and deontological argumentation also plays a role in the discourse on human experiments. Before discussing conflicts and their solutions, let me introduce three historical cases to you.

4.4.1 Famous cases of human research misconduct

  • The Tuskegee study took place from 1932 to 1972 in a public health clinic in Tuskegee, Alabama. The purpose of the study was to follow the natural etiology of later-stage syphilis in African-American men. Six hundred subjects were enrolled in the study, which was funded by the U.S. Department of Health, Education, and Welfare (DHEW), the precursor to the Department of Health and Human Services (DHHS). The subjects were divided between an “experimental” group of 399 subjects with untreated syphilis and a “control” group of subjects without syphilis. The initial plan was to conduct the study for one year, but it lasted nearly 40 years. The subjects who participated in the study were not told that they had syphilis or that they were participating in an experiment. Subjects with syphilis only knew that they had “bad blood” and could receive medical treatment for their condition, which consisted of nothing more than medical examinations. Subjects also received free hot lunches and free burials. An effective treatment for syphilis, penicillin, became available in the 1940s, but the subjects were not given this medication or told about it. In fact, study investigators took steps to prevent subjects from receiving treatment for syphilis outside of study. The study also had scientific flaws: Key personnel changed from year to year, there were no written protocols, and records were kept poorly. Even though Beecher brought the study to the attention of the public, it was not stopped until Peter Buxton, who worked for the U.S. Public Health Service (PHS), reported the story to the Associated Press. The story soon became front-page news, and a congressional investigation followed. In 1973, the U.S. government agreed to an out-of-court settlement with families of the research subjects, who had filed a class-action lawsuit (Jones 1981; Pence 1995). In 1997, the Clinton administration issued an official apology on behalf of the U.S. government.
  • The Nazi experiments conducted during World War II have been regarded by many as the worst experiments ever performed on human subjects. None of the subjects gave informed consent, and thousands were maimed or killed. Many of the experiments were not scientifically well designed or conducted by personnel with appropriate scientific or medical qualifications. Moreover, these experiments were planned, organized, and conducted by government officials. Subjects included Jews, homosexuals, convicted criminals, Russian officers, and Polish dissidents. Some of the experiments included the following:
    – Hypothermia studies where naked subjects were placed in freezing cold water,
    – Decompression studies where subjects were exposed to air pressures equivalent to the pressures found at an altitude of 70,000 feet,
    – Wound-healing studies, where subjects were shot, stabbed, injected with glass or shrapnel, or otherwise harmed to study how their wounds healed,
    – Vaccination and infection studies, where subjects were intentionally infected with diseases, such as typhus, staphylococcus, malaria, and tetanus, in order to test the effectiveness of vaccines and treatments,
    – Josef Mengele’s (1911–1979) experiments designed to change eye color, which resulted in blindness,
    – Mengele’s human endurance experiments, where subjects were exposed to high levels of electricity and radiation,
    – Mengele’s twin studies: exchanging blood between identical twins, forcing fraternal twins to have sex to produce children, creating conjoined twins by sewing twins together at the back, placing children in virtual isolation from birth to test the role of nature and nurture in human development.
    The use of human subjects in research came into sharp focus during the Nuremberg war crimes trials. After the tribunals concluded in 1947, the research community adopted the world’s first international code for research on human subjects, the Nuremberg Code. It emphasized the importance of informed consent of research subjects, minimization of harms and risks to subjects, scientific validity of the research design, and the social value of the research.
  • Stanley Milgram did psychological studies in the 1960s relating to obedience of authority. These experiments involved three participants: an authority figure (such as a scientist), a learner, and a teacher. The teacher was led to believe that the purpose of the experiment was to test the effects of punishment on learning. The teacher provided the learner with information that the learner was supposed to recall. If the learner failed to learn the information, the authority figure instructed the teacher to give the learner an electric shock. The severity of the shock could be increased to “dangerous” levels. Learners would cry out in pain when they received a shock. Most teachers continued to give shocks even when they reached “dangerous” levels and when the learners asked to stop the experiment. In reality, the learners never received an electric shock; they were actors faking agony and discomfort. Milgram was attempting to learn about whether the teachers would obey the authority figures. At the end of each session, Milgram debriefed the teachers and told them the real purpose of the experiment. Many of the teachers reported that they suffered psychological harm as a result of these experiments because they realized that they were willing to do something that they considered immoral. Some showed symptoms of severe post-traumatic stress disorder with suicidal tendencies.

4.4.2 Important aspects

In medical research, there is a fine line between research and therapy. The distinction between research and therapy can pose a challenge for investigators who are conducting clinical trials, because there may be a conflict between their ethical duties to their patients (who are also human subjects) and their obligations as researchers. Physicians have an ethical obligation to act in the best interests of their patients by providing them with the best available medical care (treatment, diagnosis, etc.). In some research contexts, this duty may be compromised. It must also be asked whether (medical) research on a human is only “ethically allowed” when it has a benefit for that studied person (as in the previous section: when the person who is the “means” also benefits from the particular “ends”).

Utilitarian and deontological viewpoints might collide when weighing the individual risks of a research subject versus the scientific, social or public benefits. Consequentialistic reasoning might favour the positive effects for the many over the integrity or rights of one. Deontologists, however, give priority to the protection of an individual’s autonomy and privacy. Based on the latter, it is globally regarded as absolutely crucial to perform research with a human subject only after the clear communication of an “informed consent”. Participants have to give their free and conscious consent after being informed about the actual content and objectives of the study. Many psychological experiments, however, lose their meaningfulness and explanatory strength when the subjects know the details of the background. In most cases, that is acceptable since the majority of studies are harmless. In cases like the Milgram experiment, where humans are exposed to deception that is critical for their psychic integrity, scientists are obliged to conduct the study in a way that protects the participants from severe physical and psychological harm. Moreover, privacy and confidentiality must be protected by all means! Many clinical trials, medical studies and psychological investigations collect patient data that gives detailed insight into an individual’s health state. It should be guaranteed that third parties (e.g. health insurances, employers) have no access to that data.

The principle of informed consent causes a special situation for vulnerable groups such as pregnant women, fetuses, neonates, children, prisoners and mentally disabled people. Unborn life needs the highest possible protection. [Here, I skip the discussion on embryonic stem cell research and related topics, since this is a matter of medical ethics, not so much of research ethics.] If the study is conducted on the pregnant mother, it must be excluded that the intervention affects the embryo or fetus. Research on fetuses themselves are critical because the consent is given by the mother, not the fetus. Also neonates and children are not able to give informed consent. However, some consider medical studies on children very important, because drugs for children should be tested on children in order to exclude certain risks. The proper organisation of studies with children and a clear communication with parents and the children themselves is an important duty of the involved researcher. Prisoners are a vulnerable group because in many cases the participation in clinical trials is the only way for them to have access to healthcare at all. This might put a bias on their consent by “forcing” them into trials. Also mentally disabled people might have a clearly diminished decision-making capacity. In some cases, legal regulations are insufficient to protect these groups from misconduct. Then, it is upon the ethical conduct and moral responsibility of the researcher or scientist to be aware of the sensitive aspects of human research and to make the right decisions.

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