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EthicsCaseStudyForm edit

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?
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Topic revision: r4 - 13 Nov 2011 - 19:21:24 - MarkYarborough
 
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