人体解剖标本管理的透明监督政策：加州大学戴维斯分校的经验。

A transparent oversight policy for human anatomical specimen management: the University of California, Davis experience.

机构信息

Ms. 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.

出版信息

Acad Med. 2014 Mar;89(3):410-4. doi: 10.1097/ACM.0000000000000135.

DOI:10.1097/ACM.0000000000000135

PMID:24448034

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.

摘要

作者描述了加利福尼亚大学（UC）系统的开发和实施情况，该系统用于监督、教育、跟踪和问责人类解剖标本在教育和研究活动中的使用。该计划于 2005 年在加州大学戴维斯分校创建并初步实施。在加州大学校园处理人类解剖标本时出现的几起事件表明，在控制用于教育和研究的人类解剖标本方面，该系统存在重大挑战。这些事件共同破坏了公众对涉及公共机构解剖材料的研究和教育工作的看法。使用这些标本的教师、员工和学生并没有充分了解与标本获取、维护和处置相关的风险。规范标本来源的法律与规范器官采购和组织库的法律归为一类，有时也包含在公墓和殡仪馆法规中。这些变量使解释变得复杂，并可能阻碍合规性。为了重新获得对该系统的信心，需要制定适当和现实的指导方针，以减轻风险，并促进机构的研究和教育使命。本文记录了一个多年的过程，其中不同的利益相关者制定了（1）监管监督政策，（2）政策教育计划，（3）跟踪和问责程序，以及（4）在大学教育和研究中适当和道德使用人类解剖标本的报告和执行机制。