PART V: CRAFTING AN ESSAY 9. Using your responses to the questions above, develop an essay describing the context of the case, explain the reasoning for the majority decision, explain the reasoning of concurring [and dissenting] Supreme Court decisions, and explain similarities and differences among related Supreme Court decisions and opinions.

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