Ethics of Human Experimentation and Informed Consent

Introduction: A History of Human Experimentation

Throughout human history, people have routinely used other human beings in one form of experimentation or another. "Although sporadic, vivisection was practiced by the ancient Greeks and Romans to augment their knowledge of science and medicine. In the third century B.C., vivisection was performed on condemned criminals" (Goliszek, xi). In fact, many great leaps forward in medical knowledge have come from research performed upon humans; often, this research has been conducted without the consent of those involved. Obviously, this presents a moral dilemma: is the good supplied by any specific portion of medical knowledge greater than the harm done to the individual test subjects?

In ancient Greece and Rome, this question was rather inconsequential because these were civilizations based upon the notion of slave labor — particularly Rome — and the exploitation of those who were not rightful citizens to the advantage of those who were. As a result, the rights of certain people were habitually trampled for the purpose of enhancing the lives of others. It was not until more modern conceptions of democratic philosophy were formulated that the idea that every human possesses innate rights presented a serious challenge to human experimentation. Essentially, the trade-off needed to be investigated more carefully — not merely from an "us vs. them" perspective.

Normative Moral Theories and Human Research

At the core of this matter are moral standards of conduct. Different organizations, governments, and people — not surprisingly — hold different philosophies by which they designate actions as either moral or immoral. This type of philosophical concern is called normative theory, and it attempts to specify conditions under which an action is morally right or wrong. "John Stuart Mill, for instance, held that an action is right insofar as it tends to produce happiness. Immanuel Kant thought that one acts rightly only if one is willing to see everyone act in accordance with one's own principles. Thomas Hobbes claimed that an act is right if it is permitted by rules that would be agreed to by self-interested parties seeking to band together to escape anarchy" (Feinberg, 514).

Obviously, each of these claims depends upon the premise that it is possible to classify actions as moral or immoral. By no means is this notion commonly accepted within the field of philosophy. Many philosophers, called ethical nonnaturalists, believe that it is impossible to designate moral judgments as either right or wrong. By contrast, ethical objectivists hold that there is a singular, objective interpretation of morality. Meanwhile, normative subjectivists — Kant, Mill, and Hobbes — argue that morality is unique to the person in question and can be based on any number of criteria.

If human experimentation is seen through Mill's lens of morality, then it is justified assuming that it does actually result in the prevention of mass suffering. However, democratic societies were not founded under the assumption that their ultimate goal was to amplify the overall good; conversely, the rights and privileges of the individual have been stressed in the legal doctrines that form the basis for most modern societies (Browlie, 256). Additionally, through Kant's eyes, research upon humans could only be a moral practice if the person being experimented upon agrees with the underlying principles behind the study — that is, human experimentation is proper if and only if the parties involved agree upon its necessity. Hobbes, on the other hand, would maintain that the laws of any given society are the only criteria for labeling any act as moral or immoral, making research fundamentally a legal issue.

Three Moral Criteria for Acceptable Human Research

From this variety of positions it is possible to formulate some broad criteria that might make research studies performed upon humans morally acceptable.

First, research studies should only use human subjects if the potential outcome of the research will improve human lives. This automatically renders immoral many of the types of experimentation performed by the Nazis and the Japanese during the Second World War, since many were performed without any practical goal in mind. Essentially, "pure" research — in which knowledge is pursued for the sake of knowledge alone — can have no place in human experiments. Knowledge should certainly be sought, but only under the condition that it can be readily applied toward the good of the whole.

Second, the human rights of the weak must be preserved. Commonly, those who become test subjects — either voluntarily or by force — occupy a weakened position in society; they may be poor, they may be criminals, or they may be slaves, as was true in the past. Regardless of the other moral problems linked to these conditions, human experiments must select subjects who are aware of their individual rights and prepared to exercise them as they see fit. Democratic laws demand this; no human being can be denied their human rights without due cause. The international laws formulated after World War II solidified this position as one of the moral keystones of modern society. The Geneva Convention stipulated forced human experimentation as one of the seven most serious breaches of human rights; these included:

(a) willful killing;
(b) torture or inhuman treatment, including biological experiments;
(c) willfully causing great suffering or serious injury to body or health;
(d) extensive destruction and appropriation of property, not justified by military necessity and carried out unlawfully and wantonly;
(e) compelling a prisoner of war or a civilian to serve in the forces of a hostile power;
(f) willfully depriving a prisoner of war or a civilian of the rights of fair and regular trial;
(g) unlawful deportation or transfer or unlawful confinement of a civilian; taking civilians as hostages (Browlie, 256).

Third, research upon human subjects is only acceptable if those involved agree upon the overall purpose of the study and upon their own involvement. Currently, this too is an obvious consequence of the modern understanding of human rights. "FDA rules require that every adult volunteer must agree to participate — in writing — before he or she can enroll in a clinical trial" (Getz, 70). This third moral position underpins the notion of informed consent.

Informed Consent and the Belmont Report

The 1979 Belmont Report organized the structure by which human subjects can give their consent in a manner quite analogous to the United States Bill of Rights. As a result of the Belmont Report, research subjects must be told everything about a study, including its possible risks. Additionally, this information must be presented in a manner that is easily understood, and those who ultimately decide to take part in a research study must do so without feeling pressure from those conducting it to choose one way or the other (Getz, 71). Fundamentally, this addresses the Kantian way of resolving moral predicaments.

These standards determine who is capable of becoming a research test subject by giving each individual a fertile setting in which to exercise their own moral decision-making processes. Accordingly, our notions of right and wrong, our capacities as deductive thinkers, and, in short, our rationality are what make us human and grant us rights above other animals. Historically, this has been a powerful motivation for human rights; however, it is also subject to arbitrary consequences.

Conclusion: The Role of Ethics Committees

Centrally, it is the responsibility of management to uphold the bases of human rights by providing accurate, understandable, and full information to any potential test subjects. Additionally, it must be determined whether individuals possess the capacity to make rational decisions. The position of ethics committees is to decide which studies are worthy of proceeding — whether they may provide substantial benefits to society and whether they pose only minor risks to those involved. Such committees must be comprised of both philosophers and medical professionals to ensure nearly objective decisions. It is undeniable that studies like the Tuskegee Syphilis Study could not have proceeded if human rights had been properly taken into account, and this is as it should be.

Works Cited

Browlie, Ian. Basic Documents in International Law. New York: Library of Congress, 1995.

Feinberg, Joel, and Russ Schafer-Landau. Reason and Responsibility. New York: Wadsworth Publishing, 1999.

Getz, Kenneth, and Deborah Borfitz. Informed Consent. Boston: Thomson/Centerwatch, 2003.

Goliszek, Andrew. In the Name of Science. New York: St. Martin's Press, 2003.