In the case of teenager Jesse Gelsinger, the principal researcher had a financial stake in a company that funded the gene therapy research and stood to profit from it. Federal regulators are undermanned. The Office for Human Research Protections, a principal oversight agency in the health department, has only six people on its compliance staff yet has about 150 open investigations. One inquiry can take a year or more to complete. Officials promise more staff.
Some regulators see no crisis.
We do not have massive problems in clinical trials. But prodded by the health department's inspector general, regulators are doing more inspections of review boards and research centers. In their boldest move, they shut down briefly all 2,000 medical experiments at Duke University in North Carolina in May 1999 because of safety issues. Even so, the government's chief regulator, Greg Koski, says he hopes that voluntary standards for Institutional Review Boards will help cure the problem. The standards are to be issued this spring.