Word: irbe
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This group, known as an Institutional Review Board (IRB), follows the template of thousands of similarly directed efforts in other institutions, employing both scientists and laypeople to enforce certain standards of procedure for human subject research...
...institution receiving federal funding for research is required to use an IRB, although many private pharmaceutical companies also employ similarly run third-party groups...
...that his first subject (Roche was the third) had developed a cough. It went away, and Togias assumed it had to do with a viral infection making the rounds at Bayview at the time. To be safe, he added a buffer solution to the hexamethonium--but without informing the IRB, which he should have done. That omission may be a reflection of the prevailing sentiment at many hospitals: that the IRB and its review process are a bureaucratic pain in the neck, not a clinical necessity...
Johns Hopkins' response to the crisis, as in Oklahoma and at the University of Pennsylvania, was to rereview all its clinical trials and completely restructure its institutional review system; Johns Hopkins also brought in an outside IRB to evaluate all new applications until the process is complete. The University of Oklahoma, for its part, is spending hundreds of thousands of dollars to create a model system for human-subject protection--including requiring its researchers to become certified in subject safety. And last July, Penn instituted a new policy on financial conflicts of interest: any potential conflict, whether it involves funding...
...involved in an experiment has the duty to put the subjects' interests first. Says Duke's Sugarman: "The moral responsibility for the protection of patients lies with the investigator, the sponsors, the people who carry out the research: nurses, assistants, technicians, research pharmacists. You can't just say, 'The IRB said...