[1655] Who Owns the Specimen?

R Coriat, J Melamed. NYU, NY

Background: Specimens are submitted to pathology for diagnosis. Additional activities (education, research) are performed with these specimens with the understanding that they are not to compromise the diagnostic process. Explicit consent for this is almost never exiged. In an era where patient autonomy and self determination have given rise to many legal battles, an unequivocal understanding of specimen ownership is essential. The study examines whether a consensus on specimen ownership exists amongst pathologists. Derivative behaviors as to various approaches to specimen ownership are tallied.
Design: The following questions were asked of 30 pathologists promised anonymity of identity and institution: Who owns the specimen? Have you ever made a slide for a personal collection? Have you used pathology material for teaching? Research? Would you ever consider discussing directly with a patient what becomes of their specimen? Have you ever heard of a case where a negative legal outcome had resulted as a result of non diagnosis related activity? If you did, would it change your current approach? Do you feel this study is exposing legal gray zones? Would you have agreed to answer these questions in a format that would include identifying information about yourself?
Results: 40% said the specimen is owned by the patient, 33%-jointly by the patient and the department, 20% -solely the department, and 6% did not know. 100% have made a slide for a personal collection, and used material for teaching and research. 97% stated they would never speak directly with a patient. 80% never heard of a negative outcome ensuing. 60% stated that hearing of a negative outcome would alter their behavior. 40% said it would not. 93% felt the study is exposing legal grey zones. 6% did not. 50% would have agreed to participate had their answers been recorded with identifying parameters. 50% would not.
Conclusions: No consensus exists as to who owns the specimen. Nevertheless, everyone treats specimens beyond diagnosis as if they are owned by the department. Pathologists do not speak with patients about their preferences. Although this practice is tradition, there was concern patients would not agree, causing a compromise of research and education. A possible conflict of interest is therefore avoided by avoiding communication. A negative outcome would encourage many to change their approach, but not all. Many felt a lost lawsuit would not convince them they are wrong. Despite standing ground on the ethical front, most recognized legal grey zones in these practices. Nearly half were so concerned with the ambiguity surrounding these issues they would not have participated had anonymity not been promised.
Category: Quality Assurance

Monday, March 9, 2009 1:00 PM

Poster Session II # 241, Monday Afternoon