"The powers delegated by the proposed Constitution to the federal government are few and defined. Those which are to remain in the State governments are numerous and indefinite."—James Madison, Federalist 45, 1788 In at least two paragraphs, discuss how federalism allows states to govern their own unique needs of their population and whether this quote still applies to the U. S. government today. (11 points)

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