| Title: Participants Withdrawn Scenario
Characters: Dr. Dan Morisky, a Researcher Dr. Fernando Bravo, his Colleague INTERIOR, DAY. RESEARCH INSTITUTE CAFETERIA Morisky is reading the newspaper when Bravo approaches his table carrying his breakfast on a tray. Bravo speaks with exaggerated formality, the two men are friends. BRAVO May I join you, Dr. Morisky? MORISKY I would be honored, Dr. Bravo. BRAVO It's really cold out. MORISKY I know. A homeless man died of exposure. ( Shows the paper .) BRAVO Of exposure? Jeez, what is the world coming to? MORISKY You can't force them to go to the shelters if they don't want to. BRAVO Dan, this man was one of our subjects. MORISKY No! BRAVO “Pedro Esplanar, 53 years old, no known address.” MORISKY Esplanar. I thought that name sounded familiar. BRAVO Guess what, they are erasing him from the database. MORISKY Why? BRAVO Because, if he's dead, he can't give informed consent. MORISKY He gave consent when we enrolled him; he hasn't withdrawn his consent. BRAVO You can't be serious. The man is dead. MORISKY We've been collecting data for a year now. During that time several of our subjects have died. Some have moved away. Some are incarcerated. Still others we can't trace. They're still in the database. When you're researching tuberculosis you don't have the luxury of a, middle-class study population. BRAVO They're poor and their lives are chaotic, but they're still human beings. We should respect their privacy. MORISKY Fernando, how many people do you think we're talking about here? BRAVO Couple dozen? MORISKY Try 150. About 20% of all participants. Erase their data and you weaken the baseline. BRAVO Pedro Esplanar doesn't care about the baseline. We collect all this data from him, we take blood and tissue samples, we say “thank you very much” and then we send him out to sleep in a cardboard box? If he were here, he'd tell you to shove your baseline. ( He spills coffee on himself .) Dang it! Pass me a tissue, will you? MORISKY I can see you feel strongly about this, but the baseline matters. We can't adequately assess patient compliance if we modify the participant population half way through the study. BRAVO He's not a participant , Dan. He's a corpse: a man who can't comply. MORISKY If we're going to help people like him, we can't afford to be too delicate about informed consent. A tubercular man who shuns treatment and sleeps outdoors in sub-freezing weather takes himself off the planet. It's terrible. But, we should and will use the data he gave us when he was enrolled. (a beat) BRAVO I disagree. Patients who withdraw, as you put it, are fundamentally different from those we can still interview. They should be transferred to a separate database. We should make every effort to find out in what ways they differ from those who complete the intervention. MORISKY We can't get to them. We can't collect data from them. How are they different? BRAVO It's a question of research integrity.