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EthicsCaseStudyForm edit

Title Uncertainties and Conflicting Interests in Lung Transplantation
Long Title Uncertainties and Conflicting Interests in Lung Transplantation
Contributor/Contact John Banja, PhD (jbanja@emory.edu)
Contributor Details John Banja, PhD
Director, Section on Ethics in Research
Atlanta Clinical and Translational Science Institute
Emory University
Atlanta, GA 30322
CTSA Emory
Case Study Provided Some years ago, I worked as a bronchoscopy technician on a lung transplant service. This service maintained a very aggressive post transplant surveillance regimen that was formally connected with the hospital's translational research efforts.
After lung transplantation, patients were seen 9 or 10 times over the course of the first year. They routinely had bronchoscopy, which included a saline flush whereby tissue from the lobe could be collected and then analyzed for signs of infection or rejection. Additionally, patients underwent transbronchial biopsies with the tissue sent to pathology for evaluation of developing allograft rejection. The tissue was also sent to the research labs for collaborative translational studies. Patients also went through a series of breathing tests, thoracic CT scans, and blood draws during their regular checkups.
This aggressive follow-up was not without controversy. Many, probably most, in the field believed it was necessary to detect rejection or infection early so as to intervene rapidly and as effectively as possible. Others felt that these patients should be left alone after transplant unless symptoms actually arose. I recall one transplant group in particular claiming that their center's overall post transplant survival times are just as good as those at centers that use the more aggressive regimen.
I believed that it was an honest question as to whether the aggressive management at my facility was, in fact, providing better patient care. The central problem was that lung graft survival times are less than desired overall and have not changed much over the past decade. More research is needed to better understand and be able to predict and treat episodes of lung allograft rejection before total graft failure occurs and the patient dies. So, it is certainly fair to say that while aggressive management for both clinical and research purposes might have problematically put the patient at an increased risk without immediate personal benefit, transplant knowledge gained through the diligent and extensive collection of clinical and biological data is the only way to better understand the pathology of lung allograft rejection and why some treatments do or don't work. Of course, the most likely beneficiaries of this knowledge will be future patients, not the ones we are currently treating.
The second ethical problem with this research was the collection of lung alveolar tissue by transbronchial biopsy for both clinical and research purposes. This is a procedure that poses serious risks with even the possibility of death. However, the procedure is currently the gold standard for diagnosis of lung allograft rejection. The problem is that while we wanted to take biopsies for both clinical as well as research purposes, sometimes the decision had to be made to skip one or the other because of an occasionally limited ability to obtain tissue.
Multiple biopsies are the gold standard because rejection can be occurring in a portion of the lung not sampled, thus leading to false negatives. But when the tissue samples at a particular visit only go to research and the patient eventually goes into rejection, I have wondered whether we would have caught some of the false negatives sooner had the samples only gone to the clinical lab.
Perhaps there is no ethical solution to these issues because lung transplantation is hardly a perfect science. But there certainly seems to be ample room for ethical reflection on the somewhat conflicting stakes between research and patient care, and the clinical uncertainties that are part and parcel of lung transplantation.
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

Research Misconduct Topics No research misconduct topics
Conflicts of Interest, Law and Policy Topics
The significance of conflicts of interest
Human Subjects Human subjects research

URL http://www.actsi.org/areas/erks/ethics/index.html
RCR Keyword Conflict of Interest
Other RCR Keywords Allograft Rejection; Bronchoscopy; Clinical; Clinicians; Investigators; Pathology; Research; Technician; Transbronchial Biopsies
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.


Topic revision: r3 - 01 Nov 2011 - 13:10:27 - DebieSchilling
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