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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :Historical Events in Clinical Research: Part III.. 2009-12-17 22:31:54 
Harrison
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1832: Physician William Beaumont signs a contract with Alexis St. Martin, a long-term research subject with a permanent gastric fistula (hole to his stomach), whereby Mr. Martin enlists in the Army for one-year – with no military duties – and receives payment of $150.

1833: Physician William Beaumont publishes research ethical guidelines, including voluntary consent and right to withdraw.

1836:
Army Surgeon General establishes library, later to become the National Library of Medicine, the world’s largest.

1836: French physician Pierre-Charles-Alexandre Louis conducts a quantitative epidemiologic study of the treatment of pneumonia with bloodletting. (Bloodletting may relieve pulmonary edema – excess fluid in the lungs.) He finds that the duration of the disease is shorter in patients who are bled sooner rather than later, with the caveat that mortality is 76% higher.

1845: Max Simon writes that experimentation is necessary to advance science, but under no circumstances could a physician “sacrifice the interests of the individual to those of society” or to “scientific speculation.”

1847: American Medical Association adopts a code of ethics, including the “sacred duty” to avoid disclosures that would discourage or depress the patient.

1848:
Drug Importation Act requires U.S. Customs Service to inspect all medications entering U.S. ports for quality, purity, and fitness for medical purposes.

1849: In “Physician and Patient,” Worthington Hooker discusses the doctor-patient relationship, writing that “the good, which may be done by deception in a few cases, is almost as nothing, compared with the evil which it does in many cases.”

1851: American Pharmaceutical Association founded, later renamed the American Pharmacists Association.

1852: Physician Marion Sims, the “father of gynecology,” reports in the Journal of the American Medical Sciences that on his thirtieth attempt with slave women – probably without their informed consent and perhaps without their consent at all – he successfully repaired a vesicovaginal fistula (without anesthesia).

1862: President Abraham Lincoln appoints Charles M. Wetherill, a chemist, to the Department of Agriculture, the first step towards formation of the Bureau of Chemistry, predecessor of the Food and Drug Administration.

1865: In “An Introduction to the Study of Human Experimentation,"" French physiologist Claude Bernard states "Never perform an experiment that might be harmful to the patient even though highly advantageous to science or the health of others.”

1866: American Society for the Prevention of Cruelty to Animals is founded.

1868: Pharmacy Act requires testing and registration of persons who dispense drugs such as morphine, cocaine, and barbiturates, but not patent medicines that may contain those drugs.

1871: Court rules in Carpenter v. Blake that the physician must fully inform the patient before departing from standard medical practice.

1875: UK Sale of Food and Drugs Act prohibits sale of drugs not of the proper nature, substance and quality.

1876: Britain passes Cruelty to Animals Act and Animals (Scientific Procedures) Act, protecting animals used in research.

1877: American Humane Association is founded to protect animals and, later, children.

1879: S. Potter and Eugene F. Storke conduct double-blind experiment at the Milwaukee Academy of Medicine, comparing a homeopathic remedy to a sugar pill.

1880: German physician Gerhard Armauer Hansen, co-discoverer of the leprosy bacillus, loses his license to practice medicine after deliberately infecting the eye of a patient with leprosy bacilli.
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