Experimentation with human subjects

Human Experimentation

Experimentation with human subjects raises a number of important moral implications. Modern protections for human subjects have their history in the Nuremberg Code, written for the Nuremberg Military Tribunal as a standard for judging the human experiments performed by the Nazis in WWII. The Declaration of Helsinki in 1964 further defined codes for human research, and the United States first implemented regulations for protecting human subjects as late as 1984 under the auspices of the Department of Health, Education and Welfare (DHEW). That same year the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research began work on the Belmont Report. The report, published in 1978, set out the key ethical principles of respect for persons, beneficence, and justice that now underlie legislation involving research that on human subjects (United States Department of Health & Human Services). Today, the Department of Health and Human Services (HHS) regulations at 45 CFR 46 govern human research (Office for Protection from Research Risks).

The lengthy history of such attempts to define codes of conduct for human research reflects the philosophic difficulties underlying such attempts. Human research brings into consideration a large number of moral issues, including the rights of the individual, the needs of larger society, economic benefits of research, and potential for grievous harm.

One of the most important moral issues raised by human research is the potential for individual harm due to such research. For example, consider a medical experiment designed to determine the effect of high dietary cholesterol on mortality. In a situation where researchers are allowed to manipulate cholesterol levels, some subjects would receive high levels of dietary cholesterol, while others received little dietary cholesterol. Given the known correlation between high cholesterol and cardiovascular disease, researchers would be directly placing the subjects given diets high in cholesterol at increased risk for heart disease and stroke. As such, this experiment would harm the physical health of some participants. Here, the moral issue of individual rights comes into play.

If we accept that all individuals have the basic rights of safety and self-determination, then the cholesterol experiment described above is clearly unethical. In damaging the physical health of some participants, the study clearly violates the basic rights of participants.

However, the violations of basic individual human rights must also be balanced against the potential good for all of society. Imagine a situation where a medical experiment would decisively show that a given treatment could cure a common form of cancer, but where subjects not given the treatment would have a high chance of death. Here, the individual rights of individual patients are clearly violated. However, the potential good for greater society is high, in that all of society would benefit from such knowledge. It is important to consider where (or if) this greater good for society balances or supersedes the rights of the individual. Would it be ethical to go ahead with the experiment if only one subject was to die, and potentially millions would benefit? What if ten subjects were to die, or twenty, or a hundred, or one thousand? At what point, if ever, would the experiment be ethically viable?

There are several opposing points-of-view that can help answer this dilemma. First, one point-of-view argues that harm to an individual is a fundamental moral law that should not be broken, under any circumstances. As such, this view argues that no matter the potential good to society of such an experiment, it is morally indefensible to harm even one human life.