Protection of Human Subjects in Research Questioned
While patient advocates and scientific organizations are lobbying to boost government investment in biomedical research and the director of the National Cancer Institute has called for a fivefold increase in the number of clinical trials, the system charged with protecting human subjects involved in medical research is in jeopardy, according to the Department of Health and Human Services (HHS) inspector general's office.
"Research and medicine have changed dramatically in the past decade. However, our system for ensuring human subject protections has not kept up with these changes," said George Grob of the HHS inspector general's office at a June 11 House Subcommittee on Human Resources hearing. Other witnesses at the hearing, however, immediately took exception to HHS's analysis.
HHS believes that the Institutional Review Board (IRB) system for protecting human subjects has become outdated by scientific advances and the changing nature of research. Many IRBs lack the scientific expertise necessary to adequately assess proposals, and advances such as genetic testing and gene therapy involve complex ethical issues that members of IRBs may not be aware of or able to handle. To deal with this issue, Grob recommended enhancing education for research investigators and IRB board members.
In addition, Grob said, the Office of Protection from Research Risks (OPRR) at NIH generally does not evaluate IRB effectiveness. OPRR's oversight is limited almost entirely to an up-front assurance by an institution that it will adhere to federal requirements. The Food and Drug Administration (FDA) focuses mostly on IRB compliance with procedural requirements, not effectiveness.
Federal IRB regulations, now two decades old, require that all federally funded research or experiments involving a drug or medical device in need of FDA approval be reviewed in advance by an IRB. Until the 1980s, most research involving human subjects was federally funded and conducted at one site by one investigator. Now there are multicenter clinical trials involving thousands of subjects across the country and even the world. …