Local boards, set up at research sites under federal regulations adopted in the 1970s, review and approve experiments. These Institutional Review Boards, numbering about 6,000 in the USA, serve as the foundation for patient protection. The boards generally consist of physicians, scientists and community members. Many researchers have financial ties with private companies that pay for clinical trials. 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.