n engl j med 358;22www.nejm.org may 29, 2008PERSPECTIVE2317to 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.2IRBs, 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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