So they used Jesse Gelsinger as a human subject in a clinical trial. 1 See answer lakingoland9246 is waiting for your help. Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days Search OHRP Database for Registered IORGs and IRBs, Approved FWAs and for Documents Received by OHRP in the Last 60 days. Federal regulators shut down Johns Hopkins University’s human medical-research program last week following the June death of a healthy woman in an asthma study. by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous." Most importantly, the risks are much more on the side of not doing it than doing it. In seeking an explanation for the OHRP action, Linscott posits, "I have to say my guess is that this was a mistake. [The OHRP statement] shows an almost complete lack of understanding of what quality management is, or quality in general," Pronovost adds. After Pronovost was profiled in the New Yorker by Gawande in 2007, OHRP shut down data collection for the checklist study, claiming that it amounted to research being done without patients' informed consent. C. "Shut Downs" by OHRP D. Death of Jesse Gelsinger. "The regulations do not apply when institutions are only implementing practices to improve the quality of care, even when this includes collecting information to track/monitor/confirm the results of that implementation," says Patricia C. El-Hinnawy, public affairs coordinator for OHRP. "It's not just the checklist. McGee was fired., Do Not Sell My Personal Information  Privacy Policy  Terms of Use  Contact Us  Reprints  Group Sales, For DSR inquiries or complaints, please reach out to Wes Vaux, Data Privacy Officer,, Design, CMS, Hosting & Web Development :: ePublishing, Healthcare Benchmarks and Quality Improvement 2008-03-01, Hospices start their trip down the road of quality improvement, Hospices start down road of quality improvement, When disaster strikes: Treating patients when your department shuts down. My reading is exactly what you said: If you at all try to collect data, it will fall under the regulations, and that's just wrong. The Agency for Healthcare Research and Quality, he notes, supported the study. Start studying CITI-Exam 1. C. "Shut Downs" by OHRP. The issue that remains unclear (and hopefully will be further explained) is this: Do all QI projects that involve the tracking of results potentially put them in the crosshairs of OHRP? "I still don't think they've answered why this is different than any other population-based research, which does not require informed consent.". Get the latest %COMPANY_NAME% OHRP detailed stock quotes, stock data, Real-Time ECN, charts, stats and more. The local IRBs that approve clinical projects became more cautious. And in an 11-page letter to the University of B.C. Here are the basic issues, as outlined by OHRP, in a statement issued Jan. 15: "The purpose of the study was to find out whether that intervention [i.e., the checklist] decreased the rate of certain infections, which had not previously been proven. Peter Pronovost, MD, PhD, medical director of the Center for Innovation in Quality Patient Care, an assistant professor in the department of anesthesiology/critical care medicine at Johns Hopkins School of Medicine, and lead author of the NEJM paper, says, "I was shocked to see [OHRP's] statement. It occurs where AR