Human experimentation or Human Subject Research (HSR) refers to the use of human beings as research subjects. HSR is of significant scientific value especially in biomedical research. Usually the experiments bears high risk of death or diseases, thus there are several ethical issues concerned and requirements for regulations.
Human groups used as research subjects change over time and over space. Human experimentation can be voluntary-based, carried out on people who have signed informed consents, or non-voluntary based, generally targeting to inferior groups such as slaves, prisoners, minority groups etc. Scientists may also perform experiments on family members, relatives or even themselves (self-experimentation) in order not to bring harms to other groups of people.
E.g. Johann Jorg tried different quantities of 17 drugs on himself to study the characteristics of them
The act of human experimentation dates back to early as 1700s, basically in the form of medicinal trials, when early stages of vaccine research was carried out.
Famous examples are Edward Jenner¡¯s smallpox vaccines carried out on his own son and neighborhood children and Louis Pasteur¡¯s rabies vaccine trial on Joseph Meister.
However, human experimentations can also be in large scale, without informed consent from the human subjects. Victims are usually those publicly considered as ¡°less valuable¡± in historical context.
For example, from 1932 to the 1970s, experiments pertaining to the study of a variety of STDs such as syphilis are carried out on male black people in America. During wartime, human experiments are usually related to war crimes. In WWII, Unit 731 of the Japanese Army conducted a wide range of biomedical experiments in conquered cities such as Nan king, Guangzhou and Singapore.
Figure 1.1 Body disposal at Unit 731
Figure 1.2 Human subjects were autopsied while still alive (vivisection)
Figure 1.3 Children victims subjected to experimentation
Rationales behind human experimentation and criticism
Patients¡¯/susceptible groups¡¯ perspective:
Human beings are the ultimate recipient of benefits from biomedical research. Thus, whatever tested on human successfully seems to be the most powerful proof to effectiveness and safety. Although there are substitutes such as animal tests and computer-constructed models, Humans are more complex in terms of biological structures and may have diverse responses to drugs, vaccine trials, organ transplantation operations or exposure to different experimental conditions (temperature, radiation, chemicals etc.) Thus, animal tests and other alternatives cannot grant 100% safety to the general public. This leads to the preference of human experimentation.
The basic rationale for human experimentation is discussed in terms of utilitarianism.
Utilitarianism is the belief that the moral value of a process is determined by its consequential benefits to the whole population. In the case of human experimentation, it argues that the resultant benefits to greater number of people outweigh the sacrifices from the minority groups or individuals which are of low utility, i.e. those who are discriminated. Utilitarianism advocates maximum benefit to the most number of people. In other words, those bearing the risk may sacrifice their own health or even lives in return for the welfare of the whole human nation. This justifies inhumane actions and coercions used in the implementation of human subject research.
Scientists¡¯ concerns are mainly on the research results which may not only benefit the general public, but also bring fame and profits to themselves. This eagerness to succeed also serves as a reason for self-experimentation and unconsented human experimentations.
Sometimes clinical trials and drug tests are taken without sufficient information to the volunteers, and thus they are not aware of the risks and implication of the experiments. Patients suffering from terminal diseases are often more willing to take the risk in the hope of a successful trial and getting cured. Also, people driven by poverty in less developed countries may also volunteer for economic purposes.
Since utilitarianism advocates that the various human groups in the world differ in terms of their utility, which suggests that the human subjects under research are inferior. This will encourage discrimination, since it justifies the sacrifice of a small group of people to benefit the whole population.
Torture is difficult to avoid since the potential danger of the experiments are unpredictable. Human beings may still suffer physically or mentally, even if similar experiments with animals showed that the process is harmless.
Violation of human rights, crossing of moral borderlines and torture to the victims is justified by scientific goals or political purposes in certain cases. However, scientists¡¯ preference may not represent that of the whole population. Comparison of satisfaction between different people is extremely difficult, as they may have different priorities. For example, people in developed countries may focus more on euthanasia studies probably due to the high stress level, compared to developing countries such as Africa, where the study of euthanasia is not very applicable.
Also, regulation and control are difficult to carry out because of limitations to the system itself. Although informed consents serve as a legal means to ensure autonomy, it is difficult to ensure that information given to the volunteers is completely understood, due to cultural and linguistic differences. Also, it is not possible to confirm that the consent is on voluntary basis if the patients are incapable of signing the consents.
The Nuremberg Code 1947
In response to the Nazi human experimentation in Nuremberg Trial, The Nuremberg Code was established, explicitly outlining the boundaries of acceptable medical experimentation:
- Autonomy is ensured ¨C voluntary informed consent
Voluntary informed consent: a legal process in which the agent is informed of all the possible risks and benefits so as to prevent a wrong decision not reflective his or her values. The decision can be made by the patient or by next-of-skin of patients who are unable to make the decisions. Patients can also grant decision-making to another party.
- Prior experiments have been conducted on animals to minimize risks
- Scientists carrying out the experiment must be qualified
- Medical torture must be avoided and no death or disabling injury is expected
- Anticipated benefits outweighs the risks - high benefit to risk ratio
Declaration of Helsinki in 1964
Belmont Report in 1979
Alleged North Korean human experimentation
In 2004, a BBC programme reported on human experimentation, in which poison testing were carried out on North Korean prisoners without consent. A few similar reports follows, but the North Korean government denied the act of human subject research, claiming that humane treatment is ensured in their prisons...
STDs research in developing countries
In the world today, STDs vaccine trials and research on the effects of STDs are mainly concentrated in developing countries, especially African countries, where appropriate healthcare is lacking or inaccessible to the poor. For example, in 2007, the number of adults and children suffering from STDs is 22.5 million. While there is a flow of researchers and advanced healthcare services from developed countries to Africa, two different focus leads to a number of ethical issues...
Utility of Nazi data in modern biomedical research
Although obtained by inhumane methods and medical torture, admittedly the data obtained by Nazi human experimentation are of scientific value in modern biomedical research. For example, modern approaches on human being¡¯s responses to extreme temperatures and the use of phosgene gas are mainly based on Nazi data obtained in WWII. Is it justifiable to use unethically obtained data for the purpose of saving lives?
STDs (Sexually transmitted diseases): Diseases that are transmitted mainly through sexual contact, such as kissing, sexual intercourse and oral sex.
In the world today, STDs vaccine trials and research on the effects of STDs are mainly concentrated in developing countries, especially African countries, where appropriate healthcare is lacking or inaccessible to the poor. For example, in 2007, the number of adults and children suffering from STDs is 22.5 million. While there is a flow of researchers and advanced healthcare services from developed countries to Africa, two different focus leads to a number of ethical issues. The two focuses are generally focus on scientific research and the focus on social responsibility.
Biomedical experiments are carried out on human beings basically by conducting clinical trials. Africans who are used for research need to sign the informed consent to ensure autonomy. However, people taking the trials may not be able to understand thoroughly the consequences, since translation to another may contribute to misunderstandings.
In the case of HIV, the risks of taking its vaccine trials are very high, including both risk of HIV infection and significant adverse reactions to the vaccines.
Though so, from the supporting side, clinical trials promises to the poor Africans better living conditions and healthcare. It also provides more opportunities for Africans to get vaccinated or treated compared to the previous situation, in which vaccines and drugs are hardly accessible.
Another issue concerned is whether the research carried out serves its goal of saving people in Africa from STDs. The supporting side argues that the outcome of the research will benefit not only people in Africa, but also humanity as a whole. Although the human subjects are facing high risks, the outcome of the experiments outweighs the harms.
However, the opposing side may argue that the focus of research is based on the developed countries¡¯ priorities, not the need of African countries suffering from STDs. Safe vaccines which are proved by human experimentation are mainly used by the rich who possess the purchasing power.
In a word, a long time period is needed to observe whether the benefits will finally reach to majority of Africans.
¡°Ethical Issues in HIV Research Trials in South Africa¡± South African Journal of science 96, June 2000