Human experimentation

Human experimentation refers to the use of human beings as experimental subjects. A subject is defined as an individual who is observed or experimented with by an investigator; an investigator is a qualified individual who conductsresearch. Humans have long been used as subjects for a variety of experiments. However, the most publicized are those that are medical in nature, for medical science has an impact on human health and life in crucial ways. Althoughmost medical experimentation is carried out using laboratory animals, the results cannot always be extrapolated to humans with certainty. Some human diseases are known that occur spontaneously in certain animal species or that caneven be induced; however, most human diseases do not have animal models. Furthermore, the functioning of an animal is not identical to that of humans. Therefore, the final tests need to be done on human subjects; for certain tests(e.g., drug tests), human testing is required by federal regulations.

Experiments on people have contributed in great measure to medical progress;human life span has increased significantly, infant mortality has decreased by more than 75%, and many human diseases that were once fatal or widespread have become curable or have disappeared.

Two kinds of experimentation have contributed to this progress: self-experimentation by an investigator (in rare cases) and experiments using patient volunteers. Of the variety of tests conducted in humans, the testing of clinically useful drugs is most common. A number of drugs that are preventive, curative, or palliative (i.e., pain reducing) in nature have been developed this way. The procedure for testing drug compounds involves multiple steps; the favorable outcome of the preceding step determines the next step in the study. Drug testing is divided into at least three phases. Phase I determines the safety of the compound under study when administered to human beings. The test iscarried out in normal, healthy individuals under controlled conditions of diet, exercise, rest, etc. Once the drug is determined to be tolerated well by the human body, it is tried out on a limited number of patients suffering fromthe disease that the drug is meant to cure; this forms the second phase (Phase II). In Phase III, the drug is given to a large number of patients suffering from the disease in question to further assess the safety and effectiveness of the drug and determine optimal dosage schedules. This phase is popularlyknown as the clinical trial. The results from clinical trials are evaluatedstatistically and medically, and then reported to various health authoritiesaround the world; they are also usually published in a scientific review.

In 1981, the U.S. Food and Drug Administration (FDA) began requiring writteninformed consent to all human studies of products the FDA regulates. Before the FDA will approve a new drug or device for marketing, the manufacturer mustprovide evidence of the product's safety and effectiveness. This evidence must first come from tests with rabbits, rats and other laboratory animals, andafterwards from clinical trials using human volunteers. Persons taking partin clinical trials may be hospital patients, patients of private medical practitioners involved in clinical research, or simply healthy individuals who have been recruited for the study through a newspaper ad, poster, or other source.

In 1976, the FDA issued regulations requiring that an Institutional Review Board (IRB) review all studies involving institutionalized subjects. Regulations amended in 1981 required that all studies needing an FDA research permit bereviewed and approved by an IRB before any tests involving humans begins, whether or not subjects are institutionalized. The FDA's IRB and informed-consent regulations are intended to ensure that all research subjects are informedand willing participants of the test, and that their health and safety are not unnecessarily endangered by the research.

Each IRB is made up of at least five members with varying backgrounds who aregenerally knowledgeable through training or experience in the area of research under consideration. Racial, ethnic and other interests must be represented; at least one member must come from a nonscientific discipline, such as lawor the clergy; and at least one member must be unaffiliated with the research institution. The diverse membership of the board helps the IRB maintain objectivity.

The IRB reviews the research plan for the proposed project, and decides whether or not to approve or disapprove it; the board frequently requires that changes be made to the plan before granting its approval. It also reviews the informed consent form to be given to research subjects, and conducts continuingreviews while research is under way. The IRB review ensures that any risks to subjects are minimized; that the procedures used are consistent with good research design and do not expose the subjects to unnecessary risk; that informed consent is obtained from each subject; that selection of subjects is fairand equitable; that risks to subjects are reasonable in relation to expectedbenefit to those subjects and the importance of the knowledge that may be gained; and that provisions exist to protect the privacy of subjects and to maintain data confidentiality. The IRB is also responsible for making sure thatappropriate additional safeguards are in place to protect the rights and welfare of vulnerable populations, such as women, children, prisoners, those withmental disabilities, and persons who are economically or educationally disadvantaged.

The FDA periodically inspects IRB records to certify that all approvals, human subject safeguards, membership, and conduct of business are in order. Sometimes these inspections yield evidence of problems, such as in 1993 when FDA imposed penalties on a large California university's IRB for infractions thatincluded failure to report deaths.

Despite the compelling need for tests on human subjects and the resulting benefits for mankind, human experimentation has drawn considerable criticism. Particularly controversial has been the use of human subjects for research thatdoes not specifically entail the benefit of the subject. This is termed nontherapeutic experimentation. Its most grotesque form occurred during the WorldWar II in the well-documented "experiments" conducted by the Nazis on prisoners in concentration camps. At least 26 different types of experiments were conducted for the explicit purpose of gaining medical and scientific information, with the larger goal of benefiting the German people and race. The Nazis'"experimentation" was in fact torture--it was characterized by coercion andlack of consent; the use of men, women, and children in blatant disregard oftheir health and humanity; a sadistic avoidance of anesthesia; dehumanizing conditions; and the murder of the subjects as part of the experimental design.

There have also been documented instances of inappropriate nontherapeutic experiments on human beings in many other countries, including the U.S. In 1963,physicians at a New York hospital injected some elderly ill and feeble patients under the skin with cancer cells to study their immune response. The patients were not told what the injections were, only that their "resistance" wasbeing measured. Fortunately, the experiment was aborted soon after it began,and none of the patients developed cancer. That same year, government officials learned that some U.S. physicians had been treating pregnant women with the drug thalidomide, even though thalidomide had never been approved for usein the United States. This uncontrolled testing of the drug resulted in someinfants in this country being born with birth defects due to exposure to thedrug. And in early 1994, the federal government released documents describinghundreds of radiation experiments that were performed on civilians and military personnel in the 1940s and 1950s without, in some cases, the knowledge orconsent of the participants. The experiments included giving food laced withtracer doses of radioactive substances to subjects, and injecting infants with radioactive iodine.

Although this kind of blatant disregard for the rights and welfare of patients is far less likely to occur today, these and other nontherapeutic experiments have attracted public outcry and have led many people to question the ethics and morality of the whole endeavor and to raise a fundamental question: ismedical and scientific progress, though beneficial to mankind, to be valuedmore highly than human rights and the individual, or vice versa? What emergedfrom the concentration camp experience was a landmark document, the Nuremberg Code, which contains propositions for the ethical conduct of experiments onhuman beings. Over the years, several regulatory bodies all over the world (Declaration of Helsinki I and II, National Health and Medical Research Council, American Psychological Association, Transplantation and Anatomy Act, etc.)have refined existing regulations and expanded the scope for the enforcementof ethical conduct in various aspects of human experimentation. At the rootof these guidelines lie the values of human freedom and the inviolability ofthe human person, regardless of the therapeutic or nontherapeutic nature of human experimentation. All codes share the principle of consent as their firstcommandment. This means that every effort should be made by the investigatorto inform the potential subject about all aspects of the experiment, and anindividual can be used as an experimental subject only upon receipt of his orher informed consent. Besides the issue of consent, there are numerous otheraspects of human experimentation that merit ethical consideration and have been dealt with in the above mentioned codes. In contrast, the issue of limitson scientific enquiry--what kind of scientific questions one is permitted toask and pursue in order to gain knowledge, and how far can one go in this pursuit--is not clearly addressed. The application of these principles is a continuously evolving process, and it is propelled by present day experimentation in, for example, gene therapy, human genome project, human fetal research,and human cloning.

Discussions of the ethics of human experimentation have focussed on the uniqueness of human experimentation, the relationship of the individual to society, health as a public good, informed consent and nondisclosure, special privileges of the sick, and on the definition of death, the design of experiments,the distinctions between research and practice, therapeutic versus nontherapeutic research, risk, and intentional deception.

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