Ethics Committee: Subject 13 Part 2

Read the two commentaries on the Subject 13 case.

Part 1: Pre-Class Reading Questions

Submit your individual answers to this discussion below BEFORE 8:30am on Friday.

1. There are various actors and institutional forces involved in the Subject 13 case: Dr. Olson, the Institutional Review Board (IRB), the University, AstraZeneca (the pharmaceutical company funding the research), and the way that universities get funds for research.

(a) Which actor or force do you think the authors of the first commentary (Part 2 of the PDF) think is most responsible or at least was in the best position to prevent the ethical problems that arose in the study? Support your answer with a sentence or two.

(b) Which actor or force do you think the authors of the second commentary (Part 3 of the PDF) is primarily responsible for what happened in the CAFE study?

In-Class Discussion Questions

Key Concepts: (short answers)

  1. What is the basic moral conflict between when doing research on vulnerable populations?
  2. What justifies doing research on the severely mentally retarded or on those with severe psychiatric illness?
  3. What makes research on children permissible?

Discussion Questions for Subject 13: Part 2

  1. There are various actors and institutional forces involved in the Subject 13 case: Dr. Olson, the Institutional Review Board (IRB), the University, AstraZeneca (the pharmaceutical company funding the research), and the way that universities get funds for research. Put these in order of responsibility. Justify you answer for whichever is most responsible.
  2. Identify at least 3 possible conflicts of interest/duties/obligations in the case. For each one conflict, explain
    1. which of the competing interests should have priority and
    2. how the other interest undermines the one that should have priority.

Example: (1) There is a conflict of interest between the duty to do X and the financial need to generate income. The duty to do X should be given priority because Y. (2) The financial need to generate income interferes with/undermines the duty to do X because …. .

3. Suppose that before the clinical trial, Markinson’s, mother had been contacted and interviewed to see if she would give consent to enroll her son in the trial. She denies consent but her son insists on being part of the trial. Should Markinson be allowed to participate in the trial? Why or why not?

4. (Not graded) Suppose the details of the case were a little different. Markinson has been estranged from his mother and family since he left for California after high school. His psychotic incidents are non-violent. He thinks he’s been pursued by a group of alien bounty hunters. When he enrolls in the trial he specifically requests that no one tell his family where he is. He doesn’t want them to know he’s suffering from psychiatric problems.

  1. Does Dr. Olson have an obligation to contact Markinson’s family or is he required to uphold patient confidentiality? (No need to explain your answer)
  2. Under these conditions is it permissible to forgo consent from the family? (Yes or no is fine).