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After the Holmesburg stories reached the public, the government made regulations to restrict the scope of experiments that could be performed on prisoners in order to prevent further abuse. Under the regulations passed in 1978, prisoners can participate in federally financed research only if the study "presents no more than minimal risk and no more than inconvenience to the subjects." This report advised that experiments with greater risks be permitted if they had the potential to benefit prisoners.
The 2006 report's recommendations were drawn up because the Health and Human Services Department decided that the current regulations were too restrictive and outdated. They suggest that instead of restricting the possible tests that can be performed on prisoners to specific categories, all experiments should be considered for review as long as they are in the later phase of FDA approval. To prevent abuse, the report contains several precautionary measures such as suggesting that all studies be subject to independent review, and that at least half the subjects in the trials be nonprisoner volunteers.
The New York Times immediately ran an article on the report under the title "Panel Suggests Using Inmates in Drug Trials." The article said that the report suggested a "loosening" of the current regulations on prisoner drug testing. Ernest D. Prentice, a University of Nebraska genetics professor and the chairman of the Health and Human Services department committee that requested the IOM study, said that the article was misleading. "We are not loosening the regulations," he said.
El-Hinnawy also said that she did not believe that prisoners would have fewer protections. "The set of recommendations was intended to bring the regulations for prisoner subjects more in line with the regulations for ordinary subjects," she said. "In the past, we saw that local Institutional Review Boards had difficulty with prisoners because the regulations are much different from regulations for ordinary human subjects. These regulations were written in the late 70's to 80's, and a lot of things have changed since then." The report seeks to extend the new regulations to not only federally funded clinical trials, but to all trials. Under the current system, only research funded by the HHS, the Social Security Administration, and the Central Intelligence Agency are required to adhere to the regulations, and the rules do not apply to privately funded experiments.




