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A transparent oversight policy for human anatomical specimen management: the University of California, Davis
Brandi Schmitt1, Charlotte Wacker, Lisa Ikemoto
1Ms. Schmitt is system-wide director of anatomical services Division of Health Sciences and Services, Office of the President, University of California, Oakland, California. Ms. Wacker is director, Body Donation Program, University of California, Davis, School of Medicine, Sacramento, California. Ms. Ikemoto is professor of law, University of California, Davis, School of Law, Davis, California. Dr. Meyers is executive associate dean, University of California, Davis, School of Medicine; professor of medicine and pathology, University of California, Davis; and executive director of medical education and academic planning, University of California, Merced, Sacramento and Merced, California. Dr. Pomeroy is chief executive officer, University of California, Davis, Health System; vice chancellor for human health sciences, University of California, Davis; and dean, University of California, Davis, School of Medicine, Sacramento, California.
Abstract:
The authors describe the development and implementation of a University of California (UC) system of oversight, education, tracking, and accountability for human anatomical specimen use in education and research activities. This program was created and initially implemented at UC Davis in 2005. Several incidents arising out of the handling of human anatomical specimens at UC campuses revealed significant challenges in the system for maintaining control of human anatomical specimens used in education and research. These events combined to undermine the public perception for research and educational endeavors involving anatomical materials at public institutions. Risks associated with the acquisition, maintenance, and disposal of these specimens were not fully understood by the faculty, staff, and students who used them. Laws governing sources of specimens are grouped with those that govern organ procurement and tissue banking, and sometimes are found in cemetery and funeral regulations. These variables complicate interpretations and may hinder compliance. To regain confidence in the system, the need to set appropriate and realistic guidelines that mitigate risk and facilitate an institution's research and educational mission was identified. This article chronicles a multiyear process in which diverse stakeholders developed (1) a regulatory policy for oversight, (2) a policy education program, (3) procedures for tracking and accountability, and (4) a reporting and enforcement mechanism for appropriate and ethical use of human anatomical specimens in university education and research.
