J Korean Med Sci.  2013 Jun;28(6):803-807. 10.3346/jkms.2013.28.6.803.

Analysis of Human Tissue Management Models for Medical Research: Preparation for Implementation of the 2012 Revision of the Bioethics and Safety Act of Korea

Affiliations
  • 1Department of Pathology, Kangwon National University College of Medicine, Chuncheon, Korea.
  • 2Department of Medical History and Medical Humanities, Seoul National University College of Medicine, Seoul, Korea.
  • 3Department of Pathology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea.
  • 4Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
  • 5Department of Medical Humanities and Social Sciences, University of Ulsan College of Medicine, Seoul, Korea. ymkoo@amc.seoul.kr

Abstract

Efficient management of human tissue samples is a critical issue; the supply of samples is unable to satisfy the current demands for research. Lack of informed consent is also an ethical problem. One of the goals of the 2012 revision of Korea's Bioethics and Safety Act was to implement regulations that govern the management of human tissue samples. To remain competitive, medical institutions must prepare for these future changes. In this report, we review two tissue management models that are currently in use; model 1 is the most common system utilized by hospitals in Korea and model 2 is implemented by some of the larger institutions. We also propose three alternative models that offer advantages over the systems currently in use. Model 3 is a multi-bank model that protects the independence of physicians and pathologists. Model 4 utilizes a comprehensive single bioresource bank; although in this case, the pathologists gain control of the samples, which may make it difficult to implement. Model 5, which employs a bioresource utilization steering committee (BUSC), is viable to implement and still maintains the advantages of Model 4. To comply with the upcoming law, we suggest that physicians and pathologists in an institution should collaborate to choose one of the improved models of tissue management system that best fits for their situation.

Keyword

Bioethics and Safety Act; Bioresource Bank; Human Tissue Management Model; Ethics Committees, Research

MeSH Terms

*Bioethics
Biomedical Research/*legislation & jurisprudence
Humans
Models, Biological
Republic of Korea

Figure

  • Fig. 1 Schematic drawings of models. (A) Model 1: Human tissue sample archive managed by the pathology department. (B) Model 2: Government-certified bioresource bank managed by the hospital. (C) Model 3: Dual government-certified bioresource banks, managed independently by the hospital and the pathology department. (D) Model 4: Single government-certified hospital bioresource bank managed by the pathology department that stores both fresh and FFPE tissue samples. (E) Model 5: Single government-certified comprehensive hospital bioresource bank operated by the bioresource utilization steering committee.


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