The government investigators did praise the FDA, as well as the NIH, for efforts to follow up on safety and enforcement questions as well as offering education and training services. In the last three years, the NIH and its Office for Protection from Research Risks have significantly increased their on-site investigations, as has the FDA, according to the report.
Finally, the report points out the need to streamline the so-called Common Rule that governs treatment of human subjects over 17 federal agencies. While the Rule provides consistency, says the OIG, it makes it difficult to change things quickly.
Well-placed sources tell WebMD that within six months the Clinton administration will propose major changes in the IRB structure aimed at improving patient protection.