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This section is comprised of questions and answers for "The Case of the Promising New Drug" and "The Case of the Entrepreneurial Anthropologist". It also contains questions for deeper reflection.
1: What is a conflict of interest? »Answer
2: Why does a conflict of interest matter? Why should the university be concerned? »Answer
3: What types of conflicts of interest can you identify in this case? »Answer
4: Should Westfield University Hospital undertake the clinical drug trial? If so, should Dr. Roberts participate? »Answer
5: Does it matter if Dr. Roberts' financial interest in Arthrid consists of consulting fees, or common stock (equity), or both? »Answer
6: Should Dr. Roberts recommend to her patients that they enroll in the clinical trial if it is carried out at Westfield University Hospital? What about elsewhere? »Answer
7: Is Dr. Roberts being faithful to her obligation to provide an educational experience for Dr. Chung? »Answer
8: Is Dr. Roberts acting properly in the way she chooses to allocate her time? Is this in violation of Westfield University Medical School policy? »Answer
9: How should Dr. Roberts respond to Dr. Bonita's request for the reagent? »Answer
10: What are the implications of the Arthrid-Westfield non-disclosure agreement for academic freedom? »Answer
Think about the following questions for Dr. Roberts, her department, and the medical school. Which scenarios do you think pose insurmountable conflicts that could jeopardize scientific objectivity or even potentially harm patients?
1: The medical school, the department, and Dr. Roberts retain their share in the patent and embark on a joint venture with Arthrid to manufacture the drug. If the drug is useful and gains FDA approval, the profits will be used to fund the laboratory, and would include salary support for Dr. Roberts.
In this scenario, what problem, if any, would there be if Dr. Roberts organized and participated in the clinical trial?
2: If Dr. Roberts believes that any connection with a commercial enterprise such as Arthrid threatens the objectivity of her science, she could recuse herself from serving as the principal investigator in the clinical trial. Without her participation, neither her laboratory nor the medical school can claim any of the profits from the development of the drug. What options do Dr. Roberts and the medical school have in promoting objectivity in this promising research?
3: What difference would it make if there were an internal review committee (scientists and others from the same laboratory and school) or an external review committee (scientists and others from outside the medical school) that would monitor the clinical trial?
4: The IRB is under some pressure to approve the proposal submitted by Dr. Roberts so that the clinical trials can begin. What role, if any, should the IRB play in determining whether Dr. Roberts has a conflict? Is there a problem if some IRB members have equity interests in Arthrid? If yes, what is the appropriate course of action?
1: What types of conflicts can you identify in this case? »Answer
2: Is there a problem with Dr. Cardoza reviewing his colleague's manuscript, given that he is probably the most qualified reviewer? »Answer
3: Does Dr. Cardoza have a conflict of commitment regarding the time spent at the office of Mayan Adventures? »Answer
4: Is there an upper limit to the amount of compensation that Dr. Cardoza can receive from Mayan Adventures before he must disclose this to university officials? Does he also have to disclose this extra income to the National Science Foundation? »Answer
5: Accepting the request to assist his chair, Dr. Goodwin, on her Aztec project will hinder Dr. Cardoza's career trajectory. Not accepting may also have deleterious effects if Dr. Goodwin is not pleased with him for refusing her request. How would you advise Dr. Cardoza to proceed? »Answer
Continue to the next section: → Annotated Case: The Promosing New Drug