Title | Scientific Research and Clinical Care |
Long Title | Scientific Research and Clinical Care |
Contributor/Contact | Michele A. Carter, PhD (mcarter@utmb.edu) |
Contributor Details |
Michele A. Carter, PhD Director, Ethics Support Key Resource, Institute for Translational Sciences |
CTSA | UTMB Galveston |
Case Study Provided |
Ten patients/subjects were enrolled in a Phase I Clinical Trial of a new drug for Hepatitis B. These participants were recruited from around the United States. Participation in the study required all subjects to travel to the NIH in Bethesda and stay for the two-month duration of the trial. The NIH liver group has a world class reputation, and the ability to be followed by these physicians was one of the “selling points” to get patients to participate in this trial. The other incentive was that the enrollees would get the opportunity to take this new drug for an otherwise incurable disease, even though its safety and efficacy have not been established. One month into the study one of the patients described adverse side effects (ASEs) and asked to withdraw from the trial. The NIH group investigated his symptoms and concluded that they were not related to the study drug. They advised the patient that he was free to withdraw at any time but that once he did so the NIH group would no longer follow him since they were investigators supervising the study and not physicians providing his clinical care. After two months on the experimental drug a number of the patients began getting sick. Eventually, nine of the ten individuals developed multi-organ system failure. Seven of these patients died. |
Data Acquisition, Management, Sharing and Ownership Topics | No Data acquisition_management_sharing and ownership Topics |
Mentor and Trainee Responsibilities Topics | No mentor and trainee responsibilities topics |
Publication Practices and Responsible Authorship Topics | No publication practices and responsible authorship topics |
Peer Review Topics | No peer review topics |
Collaborative Science Topics | No collaborative science topics |
Research Misconduct Topics | No research misconduct topics |
Conflicts of Interest, Law and Policy Topics | No conflicts of interest_law_and policy topics |
Human Subjects | Human subjects research |
Citation | |
URL | |
RCR Keyword | |
Other RCR Keywords | Human Subjects; Phase I Clinical Trial; Drug Study; NIH; Patients; Adverse Side Effects; Investigators; Physicians; Scientist; Clinician; Clinical Research |
Case Difficulty | Advanced |
Type of Case | |
Source for Topic Areas | Du Bois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70. |
References | |
Other |
Issues: • How is clinical investigation different than clinical practice? • What conflicts arise when one individual occupies both the role of the scientist and the role of the clinician? Questions: • Do the professional obligations of an Investigator differ from those of a Physician? • What are the foundations or origins of these obligations? • Can these obligations be in conflict and if so, how can they be reconciled? • Were patients offered an unfair incentive to participate in the trial? Did this inducement constitute a form of coercion? • Was it ethically appropriate for the scientists to state that withdrawal from the study constituted termination of the relationship with the NIH? |