A protocol is required for each of the two situations presented below; determine which participant(s) is responsible for providing the protocol, SOP, consent forms, approvals, etc. for a proposed study of the problem. In other words, what is each participant required to provide in the way of paperwork. (In this context, participant may be an individual or it may be a laboratory, organization, or collaborators in a study.) Please to be sure to briefly describe what information should be included.
1. During the last five years, the alligator population has diminished significantly in Lake Apopka It has been postulated that pesticides used in the area accumulate in alligator eggs thereby causing a reduced birth rate. In order to study this problem, the principal investigator will collect the alligator eggs and give them to the departmental GC/MS laboratory that will determine the levels of pesticides in the egg yolks Using this data, the investigator will see if there is a correlation between alligator population and pesticide usage. (10 points)
2. Ace Pharmaceutical Company is developing a new antihypertensive drug that has been found to lower hypertension and has low toxicity in rats At this point, Ace plans to initiate studies on the effect of the drug on monkeys at several universities. If results from these animal studies show promise, clinical studies will be initiated at five sites. (10 points)