Dr. Frankenstein is a spinal surgeon. While performing surgery on Penelope Darling, he accidently nicks Penelope's spinal cord. As a result, Penelope suffers a loss of mobility in her left leg. Penelope sues Dr.
Frankenstein for negligence.
1. What would Penelope have to show in order to win against Dr. Frankenstein?
2. What could Dr. Frankenstein raise as a defense?
3. How would the standard of care be determined in this case?
4. In your opinion, who would win the case, Penelope or Dr. Frankenstein?

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