For purposes of this case study, you are the manager of the hospital’s Outpatient Oncology Center. The Center provides a range of therapies -- including chemotherapy and radiation therapy -- to adults and children who have been diagnosed with cancer. You have held this position for two months. You are still getting to know the “lay of the land” and who you can trust.
You receive a call from your boss, the hospital’s divisional director for the Oncology Service Line. She asks for a confidential meeting to discuss a new project for the Center.
She comes to your office, closes the door, and proceeds to lay out plans for the new project. She asks you to access the hospital’s information system and create a spreadsheet that would compile certain demographic and clinical data concerning approximately 125 individuals previously treated by Dr. Jones, one of the oncologist physicians who also serves as Medical Director of the hospital’s Oncology Service Line. She states that Dr. Jones needs this information to complete a research project for one of the pharmaceutical companies that is prominent in the hospital’s chemotherapy drug formulary.
You ask if the hospital’s Institutional Review Board (IRB) has completed its review and approval of the project. Your boss states that an exception to the rule applies and that no documents are required and no review or approval by the IRB is necessary. Before leaving, she promises to return on Friday to pick up the requested information which should be downloaded from the hospital’s system onto a CD.
You are torn even though she is your boss and the data request is coming from the Medical Director of the Oncology Service Line. You go to the hospital’s intranet and look at the list of hospital documents that might give you some direction here. You also examine the hospital directory and make a short list of the people who likely could give you some time on their business schedule (and some guidance) this afternoon.
Analysis
In your own words, frame the issues and the various rules that likely apply. Also, identify the various hospital documents and resource persons that would likely be helpful to you in addressing these issues. List the steps that need action before your boss returns on Friday morning.