Exam for continuing education: Research Practitioner 5.6.

Five years after the death of Jesse 1.5 CE hours

Gelsinger: Has anything changed? 1.5 CME hours

1. Where did Jesse Gelsinger participate in a gene therapy trial?

A. St. Elizabeth's Medical Center (Tufts University School of Medicine)

B. The University of Pennsylvania

C. Washington University

D. None of the above

2. What were potential risks in tire therapy received by Jesse Gelsinger?

A. Flu-like symptoms

B. Hepatitis

C. Death from needle biopsy of the liver

D. All of the above

3. Gelsinger's family filed a lawsuit in the Philadelphia Common Pleas Court that alleged that the university deliberately downplayed the risks posed by the experiment, that Gelsinger should have been rejected from the program because his condition failed to meet the trial protocol, and that subject safety was compromised by the investigators' conflicts of interest. In less than 2 months, a $15 million settlement was reached.

A. True B. False

4. A March 1996, a GAO report detailed findings of an inquiry into human subjects protection. What problem areas were identified?

A. The increasing complexity and rapid advance of scientific research creates challenges for IRBs, as members cannot be experts in every research protocol.

B. Pressure to recruit subjects can drive researchers, and their IRBs, to overlook deficiencies in …