includes experiments (formally known as interventional studies) and observational studies.
Human subjects are commonly participants in research on basic biology, clinical medicine, psychology, and all other social sciences.
Humans have been participants in research since the earliest studies. As research has become formalized the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects.
-believed that the dissection of human cadavers in order to study human anatomy was insufficient to gain knowledge about the malfunction of the body.
-The great Greek philosopher, known as the inventor of formal logic,
-one had to study the living body in order to understand biological functions and malfunctions.
BIOLOGY he made an extensive, observant, and exhaustive research into distinctive structure.
More than 500 species of animal.
*inspired by biological views of Aristotle, ancient doctors experimented with
( Latin vivus “living”, “alive” + sectio, -onis “cutting”)
Ancient experimentation performed on living animals by means of operation design to promote some knowledge of physiological and pathological process.
-those days vivisection were condemned criminals. It is fallowed European countries and united states( alleged by German physicians by Nazi Regime)
B. HISTORY Nazi Germany and the Third Reich are the common English names for Germany between 1933 and 1945, while it was led by Adolf Hitler
*Medical experiments on prison inmates reportedly conducted in German concentration test effectiveness of SULFANILAMIDE- -Cuts deliberately made on the bodies of prisoners. Then the wounds were infected with bacteria. The infection aggravated by forcing wood shavings and ground grass into the wounds. Tested for effectiveness combating infection.
Another case; healthy inmates were injected with extracts from mucus glands of mosquito to produce malaria. Various drugs were then used to determine their relative effectiveness. Numerous 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.
*Further more various kinds of poison were clandestinely administered to a number of inmates
Either died or were killed once the autopsies could be performed. Some experimental subjects were shot with poison bullets.
*To help German Air Force, investigations were made into the limits of human endurance and existence of very high altitudes. Prisoners were placed in sealed chambers, then subjected to very high and very low atmospheric pressures. Many victims died as the result of these experiments and others suffered grave injury, torture and ill treatment.
*Fifteen German medical professionals who allegedly conducted such a human experimentations were convicted as “war crimes and crimes against Humanity” in now famous post-World War II Nuremberg trials handled by the International Military Tribunal in 1945-1946. From the trial there emerged the historic NUREMBERG CODE 1946.
Developed by Allies after WW2
Standards against which to judge Nazis
Silent regarding informed consent if incompetent
Declaration of Helsinki (1964)
Beyond Nuremberg code
Differentiates clinical versus nonclinical research
Primary emphasis on medical/clinical
1.The voluntary consent of the human subject is absolutely essential.
2.The 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.
3.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.
4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6.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.
7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8.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. 9.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 seems to him to be impossible. 10.During 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 judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
II. ADVANTAGES AND DISADVANTAGES Advantages
Gain insight into methods of instruction
Intuitive practice shaped by research.
Researcher can have control over variables.
Can be combined with other research methods for rigor.
Use to determine what is best for the population.
Subject human error
Personal bias of researcher may intrude.
Can produce artificial results.
Groups may not be comparable.
Human response can be difficult to measure.
*JUSTIFICATION* JUSTIFICATION OF HUMAN EXPERIMENTATION -despite of moral horrors that were divulge at Nuremberg heath professionals still feel the need for medical experiments. Investigating involving nonhuman organisms are essential but “Ultimate test of the correctness of the medical treatment must involve human being as research subject. Animal studies are inadequate. -Medicine could not have developed into what it is today if not for human experimentation; it become scientific -In doing so research and experimentation on human being has been increased. e.g; vaccination -Experimentation on human subjects is necessary if we want new drugs, new therapies’ or new preventives for serious disease for beset mankind. “If Human experimentations is a necessary prerequisite for the development of drugs and vaccine, then it seems to be a moral duty to experiment on human” PURPOSE; not t help the patient, but to advance medical knowledge so future patients maybe healed. This lead to the distinction of therapeutic and non therapeutic experiments.
The Justifiability of Experiments Using Human Subjects To the extent that human experimentation exposes subjects to risks -- as it generally does -- it requires justification Utilitarian Justification Two ways in which research is beneficial Human research enhances the discovery of new therapeutic and diagnostic techniques, e.g., polio vaccine transplants coronary bypass surgery Controlled experiments are necessary for sound medical practice to weed out treatments that have no therapeutic benefits (e.g., bloodletting) even harmful treatments Where these outweigh the risks of harmful consequences to subjects the research will be justified: human experimentation is not only morally permissible but morally required or obligatory Justice-based Justification We are the beneficiaries of advances due to past medical research. Therefore, we have a moral duty to reciprocate by serving as subjects ourselves Rejoinder: Medical progress is an optional goal, not an imperative. Therefore, no obligation to participate in research can be derived from this goal.
V. DRUG TESTING Drug Testing and the Use of Placebos DRUG TESTING refers to the medical procedure whereby a new drug is tried and experimented to determine its effectiveness, usefulness, and other effects. PRECLINICAL DRUG TESTING conducted to determine its therapeutic index, whether it is TOXIC or NON-TOXIC, effective or ineffective, to indicate the exact dosage. CLINICAL DRUG TESTING conducted with human beings as experimental subjects.
*PLACEBO USE* Placebo in history The word placebo, Latin for "I shall please", dates back to a Latin translation of the Bible by Jerome It was first used in a medicinal context in the 18th century. In 1785 it was defined as a "commonplace method or medicine" and in 1811 it was defined as "any medicine adapted more to please than to benefit the patient", sometimes with a derogatory implication but not with the implication of no effect. Placebos were widespread in medicine until the 20th century, and they were sometimes endorsed as necessary deceptions. In 1903 Richard Cabot said that he was brought up to use placebos, but he ultimately concluded by saying that "I have not yet found any case in which a lie does not do more harm than good“ In 1961 Henry K. Beecher found that patients of surgeons he categorized as enthusiasts relieved their patients' chest pain and heart problems more than skeptic surgeons.In 1961 Walter Kennedy introduced the word nocebo.
Placebo administration, combined with the verbal suggestion of analgesia (psychosocial context) might reduce pain through opioid and/or non-opioid mechanisms by expectation and/or conditioning mechanisms. The respiratory centres might also be inhibited by opioid mechanisms. Placebos are widely used in medical research and medicine, and the placebo effect is a pervasive phenomenon in fact, it is part of the response to any active medical intervention. The placebo effect points to the importance of perception and the brain's role in physical health. However, when used as treatment in clinical medicine (as opposed to laboratory research), the deception involved in the use of placebos creates tension between the Hippocratic Oath and the honesty of the doctor-patient relationship.
Clinical drug testing, on the other hand is conducted with human beings as experimental subjects. It is usually carried out In three phases; 1. to determine whether it produces toxic effects, a new drug is tested on normal human volunteers 2. if the results of the first phase are acceptable. 3.if drug produces few side effects. Thus, placebos are used in clinical drug testing to test it’s effectively and to rule out any possible biases of patients and investigators.
CRITICISMS on the use of placebo Placebic experiment is deceptive in nature and deception, no matter what it’s purpose, cannot be approved morally. The type of moral injustice done to patients given placebos does not lie in placebo itself but in the manipulation and deception that accompany it’s prescription. “Little by little and bit by bit this will grow and by gradual accessions will slowly increase until it becomes such a mass of wicked lies that it will be utterly impossible to find any means of resisting such a plague grown to huge proportions through small additions.”
VI. BLIND EXPERIMENT A blind or blinded experiment is a Scientific experiment where some of the persons involved are prevented from knowing certain information that might lead to conscious or unconscious bias on their part, invalidating the results. - Blind experiments are an important tool of the scientific method, in many fields of research — from medicine, forensics, psychology and the social sciences, to basic sciences such as physics and biology and to market research. In some disciplines, such as drug testing, blind experiments are considered essential
2 TYPES OF BLIND EXPERIMENT ♥ Single Blind Test describes experiments where 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. - Single-blind experimental design is used where the experimenters either must know the full facts and so the experimenters cannot themselves be blind, or where the experimenters will not introduce further bias and so the experimenters need not be blind.
♥ Double Blind Test - describes an especially stringent way of conducting an experiment, usually on human subjects, in an attempt to eliminate subjective bias on the part of both experimental subjects and the experimenters. In most cases, double-blind experiments are held to achieve a higher standard of scientific rigor. - Performing an experiment in double-blind fashion is a way to lessen the influence of the prejudices and unintentional physical cues on the results (the placebo effect, observer bias, and experimenter's bias) - Double-blinding is relatively easy to achieve in drug studies, by formulating the investigational drug and the control (either a placebo or an established drug) to have identical appearance (color, taste, etc.).
Single-blind and Double-blind test Design Clinical drug testing in the use of placebos has two variations: Single-blind test design and Double-blind test design.The former is one in which the evaluations of the results of a treatment are kept from the patients who have received it. This is done to prevent any alteration of the results which may be done to suit whatever ulterior motives they may have in relation to the researchers or to the patients themselves.The latter,in contrast,is one in which the investigators and the patients involved in the drug testing are kept ignorant about the process-that is,they are not supposed to know who are receiving the drug and who are not.They literally kept "blind" with regard to the test design,hence the name.