Vaccine mandates Premature Babies, Targets of Unethical Experimentation Beware of medical research institutions whose physicians violate medical ethics with impunity, exposing vulnerable patients to serious risks of harm without disclosing the nature of the experiment or the risks. The IRB-approved consent forms falsely assured parents that the study posed no risk: But lacking a comparator group of babies who received standard-of-care which is, individually titrated oxygen, the experiment could not inform physicians whether either of the experimental groups compared favorably or worse than standard-of-care in terms of deaths and rate of retinopathy.
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The trials were testing new methods for preventing the spread of HIV infection Unethical research pregnant women to their babies before or after giving birth in developing countries in Africa, Asia and the Caribbean. In each of these trials, most of which were funded by the U. Unfortunately, nearly 20 years later, similarly unethical trials continue to be conducted.
One recent such trial in India, reported in The Lancet in June, evaluated an experimental vaccine for preventing a very common, potentially life-threatening viral infection called rotavirus.
Two rotavirus vaccines have been available for the past decade: Large clinical trials of both vaccines demonstrated that they were highly effective in preventing rotavirus-induced gastroenteritis -- including the most severe cases -- and the need for hospitalization.
Despite the availability of these vaccines, more than 2, children in the India trial received placebo injections of salt water rather than one of the available effective vaccines.
Prior to the introduction of effective rotavirus vaccines, nearly every child in the world developed a rotavirus infection by ages 3 to 5, and 2 million children were hospitalized annually.
Inthe World Health Organization WHO issued a report estimating that inapproximatelychildren died from rotavirus infection globally, accounting for about 5 percent of all child deaths.
Not surprisingly, 90 percent of these deaths occurred in countries in Africa and Asia. The experimental vaccine was given by injection in three doses at 6 to 7 weeks, 10 weeks or older, and 14 weeks or older.
Two thirds of the infants received the vaccine, and one third received saltwater placebo injections. The trial results showed that, as with the two available oral rotavirus vaccines, the new vaccine was effective in preventing severe rotavirus-induced gastroenteritis and hospitalizations.
Given the availability of two highly effective rotavirus vaccines at the time the India study was initiated, the failure to provide infants with one of these two vaccines instead of a placebo violated international ethical standards for conducting human research.
A rotavirus vaccine study in which infants received a placebo would never have been permitted in the U. The continued conduct of such trials reflects a persistent, troubling disregard for international ethical principles for human subjects research, particularly research involving disadvantaged subjects in the developing world.
Allowing such research creates a double standard that allows research using unacceptable designs to proceed in developing countries. Sidney Wolfe and Peter Lurie argued for the need to implement a single international standard of ethical research.
As Wolfe and Lurie predicted, the number of clinical studies taking place in developing countries has increased dramatically. Unfortunately, the troubling rotavirus vaccine trial in India indicates that we still have a long way to go to achieve implementation of a single international ethical standard for human subjects research.The efforts of AHRP to hold the medical research community and government administrators accountable for unethical exploitation of vulnerable children in medical experiments conducted in violation of federal regulations.
May 02, · Disclosures of unethical research such as those made by Beecher prompted the federal government four decades ago to issue regulations intended to protect human subjects involved in research . Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research.
For example, some unethical authorship practices probably reflect traditions and practices that . Premature Babies, Targets of Unethical Experimentation Beware of medical research institutions whose physicians violate medical ethics with impunity, exposing vulnerable patients to serious risks of harm without disclosing the nature of the experiment or the risks.
UNETHICAL CONDUCTHe lamented that it was the third time Murang'a MCAs are said to have engaged in fighting and unethical conduct, following other two fights at a Kiambu hotel and inside the clerk's office.
Despite the unethical experiment, Zimbardo is still a working psychologist today. He was even honored by the American Psychological Association with a Gold Medal Award for Life Achievement in the.