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Medical research has long been performed on human volunteers who risk their own well-being for society's greater good. Safeguarding human rights and upholding ethical standards are fundamental to sound medical research. The globalization of science and medicine relocated clinical trials offshore to low-and middle-income countries (LMIC). Because these communities may otherwise have little to no access to this level of care, are researchers providing a public health benefit or are they exploiting economically disadvantaged communities to serve more affluent ones abroad? Some question whether experimentation is ethical altogether.
THE PROGRESSION OF CLINICAL RESEARCH
There is little debate about which study was the first contemporary controlled clinical trial. James Lind, a ship surgeon in 1747, was alarmed by the high mortality rate of sailors suffering scurvy. One dozen patients with similar cases were placed in the same environment, on similar diets, but given different treatments. He found that those who received citrus fruit were the ones who healed with, by far, the most speed and were restored to the best health.
Over 100 years later, physician Austin Flint treated 13 rheumatism sufferers with an herbal remedy rather than a medical treatment, and he recorded their out-comes. He described this clinical study, the first of its kind comparing an active treatment to a dummy, as the "placeboic remedy."
In 1943, the first modern-era, double-blind comparative clinical trial with concurrent controls was organized by the UK Medical Research Council. They sought treatment for the common cold. Both physician and patient were blinded to the treatment, using an alternation procedure to keep the study strictly controlled. Treatment was dispensed in a discrete room with all identifying information stricken from patient records and treatments.
The first randomized control trial tested the efficacy of streptomycin on tuberculosis in 1946. Subjects were randomly assigned to either the control group (typically receiving conventional treatment) or the experimental group (receiving the regimen being tested). Experimental bias was eliminated here further than in prior clinical trials, patients, investigators, and coordinators all blind to subject placements. Medical providers determined the patients' progress by reading x-rays, analyzing sputum, and reviewing vital signs blind to the identity of the experimental group. Today, we almost universally use randomized allocation in trials.
THE EVOLUTION OF PROTECTIONS FOR HUMAN SUBJECTS
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