Ethicist Sees Decline in Human Research Protections
In general, Woodward says that national oversight is lacking. "We need to get a comprehensive view of what's going on. We need a comprehensive view of all the adverse events. We don't have that at all," she says. She points out in her article that the federal Office for Protection from Research Risks (OPRR) suspended research activities at eight institutions in the last year, at least in part for failing to provide proper patient consent.
Meanwhile, NBAC itself is in the midst of reviewing safeguards for those involved in medical research. In an earlier report quoted by Woodward, the agency said "the U.S. government cannot know how many Americans currently are subjects in experiments ? cannot ensure that research subjects know and understand the risks they are undertaking, and cannot ascertain whether they have been harmed."
In an accompanying JAMA editorial, Gary Ellis, PhD, of OPRR, says Woodward's conclusion that patient protections are eroding is "too strong." However, he says that scientific research can only be done in keeping with the highest ethical standards, and that institutions that don't educate themselves about research ethics are "courting trouble."
Not only is the IRB mechanism flawed, says Lawrence Gosten, JD, co-director of the Georgetown/Johns Hopkins Program on Law and Public Policy, but many kinds of research in the private sector don't go through any formal review mechanism. "The system of legal safeguards is way behind the current push for more research, and we need to upgrade the safeguards," Gosten tells WebMD.
While the Department of Health and Human Services could issue rules regulating federal research, Gosten says that Congress would have to pass a law to impose standards on the private sector.