Treatment of Animals in Clinical Trials - Animals Essay Example
Treatment of Animals in Clinical Trials
The Clinical trials are carefully controlled research studies that are done with patients - Treatment of Animals in Clinical Trials introduction. to test whether a new treatment is safe and how well it works in patients, or they may test new ways to diagnose or prevent a disease. In clinical trials
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There are 4 phases of clinical trials, which are numbered I, II, III, and IV.
Phase I clinical trials: The purpose of a phase I study is to find the best way to give a new treatment safely to patients. the team closely watches patients for any harmful side effects. For this the drug has already been tested in lab and animal studies, but the side effects in patients are not fully identified. very low doses of the drug are given to patients and increase the doses until side effects appear or the desired effect is seen.
Phase II clinical trials: These studies are designed to test and determine how the drug works. Patients are given the best dose as determined from phase I studies. They are closely watched for an effect. The side effects are also determined.
Phase III clinical trials: Phase III studies involve large numbers of patients — most often those who have just been diagnosed with a specific type of disease. Phase III clinical trials may enroll large numbers of patients.
Phase IV clinical trials: Once a drug has been approved and is available for all patients, it is still studied in other clinical trials. This way more can be learned about short-term and long-term side effects and safety as the drug is used in larger numbers of patients with many types of diseases.
There are two types of boards that exist as the primary protectors of patient safety in human clinical research. They have not always existed – they evolved out of a growing awareness of the dangers inherent in clinical research and the rights of the human subjects participating in the research.
There is no proper legal protection law that is put in place to ensure that in place that minimal suffering of animals in clinical research trials.
Most proposed research is required to undergo prospective review by an IRB to “review the ethics, the scientific soundness, the relevance of the intervention and for inclusion in the law, and the patient consent process. The purpose of prospective review of research is important to assure the rights and welfare involved in the proposed research.
The membership of an IRB is defined in 45 CFR 46.107 and requires that “each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.” In addition, it further states that “the IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.” It is also charged with ensuring that no IRB consists “entirely of men or entirely of women.” The regulations require that it have at least one member whose primary concerns are in scientific areas, one member whose primary concerns are in non-scientific areas, and one member who is not otherwise affiliated with the institution.
The criteria under which research can be approved are established in 45 CFR 46.111. These criteria include that:
Risks to subjects are minimized:
(i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk,
(ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Selection of subjects is equitable.
Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
Informed consent will be appropriately documented.
a) To ensure recognition of the seriousness of the workload pressures faced by many and to take actions to moderate these pressures
b) To protect conflicts that may compromise their mission of protecting human subjects. This would require increased representation of non-scientific and non-institutional members.
c) Federal requirements should be recast such that they grant it greater flexibility, but also hold them more accountable for results.
d) To strengthen the continuing protections for human subjects participating in research
e) To enact federal requirements to help ensure that investigators and IRB members are adequately educated about and sensitized to human subject protections. This would require that research institutions have programs for educating its investigators and board members on these protections.
f) The final recommendation is to completely re engineer the federal oversight process requiring revamping the FDA on-site inspection process and requiring the registration of all trials. The registration of clinical trials is a timely topic that is discussed in more detail in the Publication of Results and Decision Making section later in this paper (section 8.5)
Berg, Kare, and Tranoy, Knut Erik, eds. Research Ethics. Progress in Clinical and Biological Research, Vol. 128. New York: Alan R. Liss, 1983.
Bernard, Claude. An Introduction to the Study of Experimental Medicine, translated by N.C. Greene. New York: The Macmillan Company, 1927.
Cohen, Carl. “Moral Issues in Medical Experimentation on Humans.” Philosophic Exchange 2 (No. 5, Summer 1979): 37-51.
Davidson, Richard A. “Source of Funding and Outcome of Clinical Trials.” Journal of General Internal Medicine 1 (No. 3, May-June 1986): 155-158.
Faden, Ruth R. and Beauchamp, Tom L. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.