Neal, a twelve-year-old, buys a pair of skis from Outdoor Outfitters (OO), telling the salesperson that he has never been skiing but “really wants to do it.” The salesperson urges Neal to take a lesson in the sport before attempting a run, but Neal ignores the advice. On the first run, Neal loses control, hits a tree, and is injured. Neal files a suit against OO, alleging that it was negligent to have sold the skis to him, when he was clearly too young and inexperienced. Issue: How might OO defend itself?  Define, explain and decide

Asubject in a clinical research trial experiences a serious, unanticipated adverse drug experience. how should the investigator proceed, with respect to the irb, after the discovery of the adverse event occurrence? a. do not report the adverse drug experience to the irb since it is a common adverse experience. b. report the adverse drug experience to the irb only if there are several other occurrences. c. report the adverse drug experience as part of the continuing review report. d. report the adverse drug experience in a timely manner, in keeping with the irb's policies and procedures, using the forms or the mechanism provided by the irb