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2_Exploiting a Research Underclass

2_Exploiting a Research Underclass - PERSPECTIVE Exploiting...

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n engl j med 358;22 www.nejm.org may 29 , 2008 PERSPECTIVE 2317 to the drugs in question, if and when they are approved. Volun- teers are unlikely to have full-time employment or, therefore, to have health insurance. Placing the bur- den of safety testing on the poor appears to contravene article 19 of the Declaration of Helsinki, which states that medical research is eth- ically justified only if there is a reasonable chance that the pop- ulation in which it is conducted will benefit from the results. Second, the U.S. oversight sys- tem is not well equipped to mon- itor a highly competitive, market- based, multinational research industry. The Office for Human Research Protections has no juris- diction over privately sponsored studies, and the Food and Drug Administration inspects only about 1% of clinical trials. 2 IRBs, the most important bodies charged with protecting subjects, were de- signed primarily to review trial de- sign, risk–benefit ratios, and in- formed-consent documents. Recent research scandals — which have been uncovered largely by investi- gative reporters rather than regu- lators — have concerned a very different set of issues: fraud, con- flicts of interest, unfair payment practices, and unsafe or degrading trial conditions. Such problems are magnified still further when stud- ies are conducted at private testing sites and reviewed by for-profit IRBs that are financially depen- dent on research sponsors.
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