An Impoverished Student
This case discusses the potential dilemmas encountered by postdoctoral fellows in a research setting, discussing whether is it ethical for drug trials to offer money to participants in the study and also explores the potential problems with clinical trials and vulnerable populations.
Gary is a graduate student in history at Eastern State University. He has completed his course work, passed his qualifying exams and finished his research, and he is working on his dissertation. He has been working as a teaching assistant for Professor K, the chair of his committee, for the last three years. However, the university did not renew his TA contract for the current academic year, and he has been desperately seeking funds to finish his studies.
Gary spoke with his friend Anthony about his financial problems. Anthony informed him that a number of pharmaceutical companies were looking for volunteers to participate in clinical trials to evaluate new drugs in healthy individuals.
Gary investigated the first clinical trial that he learned about through his conversation with Anthony. He was accepted and received $500 for his participation. The trial was to continue for one week, and he was required to take a pill each day and visit the evaluation center for tests. On the third day of the study, Gary decided to sign up for a second study, at a different center, which was paying $3000 for "volunteers." He hoped that the $3,500 would be sufficient to allow him to complete his thesis.
During the second recruitment interview, the interviewer, in his haste to recruit enough volunteers before the company-imposed deadline for filling the quota, failed to ask whether Gary was involved in any other clinical trials. Gary was completely truthful during the interview, but he did not volunteer any additional information beyond what was asked. Therefore he did not disclose that he was participating in another study, or that he was regularly using herbal remedies for the treatment of chronic allergies.
Two weeks later, Gary began feeling very sick and sought medical attention at the University Hospital Emergency Department. During his hospitalization, physicians suspected that his symptoms were etiologically related to a drug interaction caused by the drug combination he was taking (the two drugs given to him during the two separate research studies, as well as the herbal remedies). Due to his hospitalization, Gary was not able to complete his dissertation or defend it in time for the university's deadline for graduation in June.
- If money is offered for participation in clinical trials, what ethical issues arise (for example, exploiting vulnerable groups such as the poor, students, intravenous drug users, etc.)?
- Is it ethical to receive money for participation in clinical trials, or should participation be an altruistic act?
- How much money should a volunteer receive for participation in a clinical trial? How common is it for needy persons to lie in order to participate in drug trials?
- What if a volunteer uses a controlled substance? Probably, it is quite common for narcotics users to lie to protect themselves. Is the cash incentive so attractive that it invites participation of volunteers who do not really qualify, thus invalidating the study?
- What responsibilities do the investigators have to ensure that study participants are not enrolled in other studies or using nonprescription drugs? How thorough should their admissions interview be, in order to weed out nonqualifying subjects? Will interviewers be able to recognize candidates who are so desperate for money that they are willing to lie in order to qualify?
- Do universities have an obligation to better support their graduate students during the long years of research and writing required to complete a dissertation?
Brian Schrag, ed., Research Ethics: Cases and Commentaries, Volume 5, Bloomington, Indiana: Association for Practical and Professional Ethics, 2001.