Human ExperimentationThe Moral IssueHistory of Medical ResearchThe history of medical research on human subjects is as old as the history of medicine itselfHuman Cadavers

Ancient Physicians believed that the dissection of human cadavers in order to study human anatomy was insufficient to gain knowledge about the malfunctions of the body.Aristotle (384-322BC), the great Greek philosopher, known as the inventor of formal logic and ranking as one of the great biologist of all time taught that one had to study the living body in order to understand biological functions and malfunctions.More Facts about Aristotle:

He was acquainted with more than 500 different species of animalsAristotle had dissected and investigated in detail some fifty kinds ranging over the whole animal kingdom

Vivisection Latin vivus living , alive + sectio cuttingA vivisection was an ancient experimentation performed on living animals by means of operationsIn those days the human subjects of vivisections were condemned criminals.

Inspired by the biological views of Aristotle, ancient doctors experimented with vivisection in order to advance medical Science. It was designed to promote some knowledge of physiological and pathological process. In those days the human subjects of vivisections were condemned criminals. This ancient medical practice was practiced later on by doctors in European countries and in the United states (5

Human Experimentations- Nazi Experiments- Several of the medical experiments on prison inmates reportedly conducted in German Concentration camps include the following6Sulfanilamide

To test the effectiveness of sulfanilamide, cuts were deliberately made on the bodies of prisoners, then the wound were infected with bacteria.The infection aggravated by forcing wood shavings and ground glass into the wounds. Then sulfanilamide and other drugs were tested for their effectiveness in combatting the infectionMalariaHealthy inmates were injected with extracts from the mucous glands of mosquitoes to produce malariaVarious drugs were then used to determine their relative effectivesNumerous healthy prisoners were deliberately infected with the spotted-fever virus for the sole purpose of keeping the virus alive.Over 90 percent of those infected subsequently died

PoisonVarious kinds of poisons were clandestinely administered to a number of inmates to test their efficacyThe inmates died or were killed at once so that autopsies could be performedSome experimental subjects were shot with poisoned bullets

Sealed ChambersTo help the German Air Force. Investigations were made into the limits of human endurance and existence at very high altitudesPrisoners were placed in sealed chambers, then subjected to very high and very low atmospheric pressuresMany victims died as a result of these experiments and others suffered grave injury, torture, and ill-treatment

Post-World War II Nuremberg trials15 German medical professionals who allegedly conducted such human experimentations were convicted of war crimes and crimes against humanity in the now famous post-World War II Nuremberg trials handled by the International Military Tribunal 1945-1946

Nuremberg Code (1946)The Nuremberg code is a ten-point principle s that should be followed in conducting human experimentationsFrom the trials emerged the historic Nuremberg Code12Number one

The voluntary consent of the human subject is absolutely essential.This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.Number twoThe experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

Number Three

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.Number Four

The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.Number Five

No experiment should be conducted, where there is anapriorireason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.Number Six

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.Number Seven

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.Number Eight

The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.Number Nine

During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.Number TenDuring the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Informed Voluntary ConsentThe German physicians tried at Nuremberg were charged with conducting human experimentation without the consent of the inmates.AS a significant aftermath of such horrible experiments, the idea of informed consent, was born.

Informed Consent is understood as knowing of an individual or his/her legally authorized representative, so situated as to be able to exercise free power of choice, without undue inducement or any element of force, fraud, deceit, or other form of constraint or coercion

Information ElementExplain the procedures and their purposes and make clear which are experimentalUnderscore the risks and discomforts that can be reasonably expectedDescribe the possible benefits that the research will yieldPoint out appropriate alternatives that might be helpful to the subjectOffer to answer any questions about the proceduresMake it clear to the subject that he/she is free without penalty to withdraw consent and abandon the research project at any timeJustifications of Human ExperimentationsDespite the moral horrors that were divulged at Nuremberg, health professionals still feel the need for medical experimentation involving human subjects.

Investigations involving nonhuman organisms are essential, but ultimate tests of the correctness and effectiveness of medical treatments must involve human beings as research subjects

Animal studies are inadequate precisely because human physiology and psychology are different and unique

Contemporary MedicineContemporary medicine could not have developed into what it is today if not for human experimentationsContemporary Medicine conducts studies and research in which data are collated to test hypotheses and general theories related to their disease and treatment

The development of polio and smallpox vaccination, for example, as well as the treatment of herpes, hepatitis, AIDS, TB, and many other medical advances in the call of public health are mainly attributed to the experimentation with human beings

Experimentations on human subjects is necessary if we want to develop new drugs, new therapies, or new preventives for serious disease It is necessary for the sake of the common good of the human race to develop certain vaccines and drugs that stop the spread of contagious diseases

Therefore If human experimentation is a necessary prerequisite for the development of drugs and vaccines, then it seems to be a moral duty to experiment on humansThe moral issue

The basic moral issue, however, is that the purpose of human experimentation is not to help this patient (who now is the experiment subject) but to advance medical knowledge so that future patients (suffering from the same ailment as the experimental subject) may be healed This leads to the distinction between therapeutic and nontherapeutic experiments because in effect this experimental patient is now being treated as a means for the benefit of future patientsMedical Therapy vs Medical ResearchMedical therapy focuses more on a particular patient, whose well-being is their primary concern

Medical Research is interested in the effectiveness of therapies in ending disease processes and restore functioning

Drug Testing and the Use of PlacebosDrug Testing refers to the medical procedure whereby a new drug is tried and experimented to determine its effectivity, usefulness, and other effectsThe procedure is twofold:Preclinical Testing it is done on animalsClinical Testing conducted with human beings as experimental subjectsPreclinical TestingDetermines:Therapeutic indexIndicate the exact dosage of a therapeutic drugDetermine the drugs effects on body tissues and on particular organsCheck for side effects and hazardsClinical TestingConducted in three phasesFirst Phase: To determine whether it produces toxic effectSecond Phase: It is tested on a limited number of patients that can benefit from itThird Phase: If the drug produces desirable results then it is administered to a large number of patients by a large number of clinical investigatorsPlaceboClinical Placebo is a medically harmless ineffective substance (sugar or dummy pill) that is usually used in testing a new drug when it is given to a control group

Single-Blind TestSingle-blinddescribesexperimentswhere information that could introduce bias or otherwise skew the result is withheld from the participants, but the experimenter will be in full possession of the facts.In a single-blind experiment, the individual subjects do not know whether they are so-called "test" subjects or members of an "experimental control" group. Double-Blind TestDouble-blinddescribes an especially stringent way of conducting anexperimentwhich attempts to eliminate subjective, unrecognized biases carried by an experiment's subjects experiments are regarded to achieve a higher standard of scientific rigor than blind or non-blind experiments.In these double-blind experiments, neither the participants nor the researchers know which participants belong to thecontrol group, nor the test group. Only after all data have been recorded (and, in some cases, analyzed) do the researchers learn which participants were which. Performing an experiment in double-blind fashion can greatly lessen the power of preconceived notions or physical cues (e.g., theplaceboeffect,observer bias,experimenter's bias) to distort the results (by making researchers or participants behave differently from in everyday life).Justifications of the Use of PlacebosPaternalistic Defense:Justifies the use of placebos in clinical drug testing through its therapeutic effects on the experimental patients themselves. It is being carried out for their own good and for others who are similarly situated

Utilitarian Defense:- Considers placebic experiments as acceptable insofar as it promises to benefit the whole of society in many instances and not only the experimental subjects