Biomedical Experimentation Lesson 2 PDF

BIOMEDICAL EXPERIMENTATION  Rule of the Scientist to our society?  In biomedical research why do scientist use animals as there subject for experimentation?  What can you say about human experiment? There are several reasons why the use of animals is critical for biomedical research...

BIOMEDICAL EXPERIMENTATION  Rule of the Scientist to our society?  In biomedical research why do scientist use animals as there subject for experimentation?  What can you say about human experiment? There are several reasons why the use of animals is critical for biomedical research:  nimals are biologically very similar to humans. In A fact, mice share more than 98% DNA with us!  Animals are susceptible to many of the same health problems as humans – cancer, diabetes, heart disease, etc. Biomedical Experimentation with Animals Table 1. Brief history of US legislation/regulation of animal use in research 1960 Federal legislation requiring individual animal researchers to be licensed was proposed, owing to the initiatives of Animal Welfare Institute 1963 The Guide for the Care and Use of Laboratory Animals (shortened to the Guide) was published by the US National Institutes of Health (NIH). The Guide was revised several times from 1965 to 1996. 1966 The Laboratory Animal Welfare Act was enacted, owing to the public clamor over an article in Life magazine. The legislation underwent a series of amendments from 1970 to 1985, and is presently termed as the Animal Welfare Act (AWA) 1985 NIH was required, through the Health Research Extension Act of 1985, to establish guidelines concerning the use of animals in both biomedical and behavioral research. 1986 The NIH Office of Protection from Research Risks published the Public Health Service (PHS) policy on the Humane Care and Use of Laboratory Animals, whereby PHS laboratories (as well any other institution that would request for funding from PHS) must abide by the PHS policy and the Guide. 2010 The US National Academy of Sciences published the 8th edition of the Guide. Such publication signaled the wide acceptance of the Guide by the US and international animal research institutions. Ethical Guidelines  As proposed by William Russell and Rex Burch in 1959, animal research institutions should conform to the three principles (3 R’s) concerning the human use of animals for biomedical experimentation. These principles are:  (1) Replacement  (2) Reduction  (3) Refinement (1) Replacement  refer to methods which avoid or replace the use of animals (i.e. replacing animals by computer models) (2) Reduction  the number of animals used in experiments is reduced to the absolute minimum to achieve meaningful and representative results (3) Refinement  experimental conditions as well as animal housing during experiments is to always be optimized where possible and the most animal – friendly experimental set – up chosen. Biomedical Experimentation with Humans The 10 Nuremberg Principles (Nuremberg Code) 1. 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, overreaching, 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. 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 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. 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.  In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research presented the Belmont Report, which contains three basic ethical considerations in using humans as subjects for research. Generally accepted by IRBs(Institutional Review Board/s), the three principles are (1) Respect for Persons – requires that the research subjects to be capable of making their own decisions. (2) Beneficence – requires that the risk to human subjects be minimized and that the benefits of conducting the research be maximized. (3) Justice – requires that the burden on human subjects be equally distributed and not merely concentrated on an individual or a single group of individuals.