3. Human subjects are commonly participants in research on basic biology, clinical medicine, psychology, and all other social sciences.
4. 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.
7. -believed that the dissection of human cadavers in order to study human anatomy was insufficient to gain knowledge about the malfunction of the body.
32. 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.
33. 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.
34. 4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
35. 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.
36. 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.
47. 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.
48. 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.
49. *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,[20] 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.
50. 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.
51. 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.
52. 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.”
53. 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
54. 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.
55. ♥ 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.).
56. 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.
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