SHOPPING FOR IRBs.  Looking for an IRB with the “best deal” is not an option for faculty, nor should it be. A recent article in Science (296:1953, 2002) discusses efforts by the FDA to prevent sponsors from seeking approval from multiple [commercial] IRBs until approval for a particular protocol is obtained. The article also describes research sponsors who attempt to intimidate local IRBs (in multicenter trials) with comments like  “[your IRB is] the only one expressing such concern” when the local IRB questions a protocol. Expect to see new guidance from the FDA in the next few months on this subject.
 

PLACEBO-CONTROLLED CLINICAL TRIALS.  The use of placebos in clinical trials is a hotly debated area of research ethics. The FDA often requires the use of a placebo control in clinical trials used to support a New Drug Application, whereas the revised version of the Declaration of Helsinki, issued in October, 2000, prohibits the use of placebos. Now the use of placebo surgery is the focus of an ethics discussion. The study by Moseley et al (NEngJMed 347:81, 2002) demonstrating no benefit of arthroscopic knee surgery compared with placebo surgery demonstrates the potential value of the use of a surgical placebo to inform clinical practice. But the ethics of placebos is unsettled. Horng and Miller argue reasonably in the same issue of the New England Journal (July 11, 2002, 137) that the use of surgical placebos can be ethical and should be employed before new procedures are adopted for general clinical use.