Abstract 4571: An international overview of the “state of the science” of regulatory standards for human tissue biobanking

Abstract

Abstract Human biospecimens are critical in the development of molecular-based diagnostics and therapeutics that form the basis of personalized medicine. Globally, there are significant efforts, particularly in the Unites States and Europe, to develop regulations and policies that will harmonize biobank activities. Currently there are no specific regulations governing biobanks in the United States. However, within the US, regulations and laws do exist that address human subject protection, occupational safety and handling of human biologics. In developing standards for biobanks operating in the US, it is important to consider the work being done around the globe, so that practices can be harmonized both nationally and internationally. In Europe recommendations Rec (2006)(4) and directive EU92004)/23/EC sets standards of quality and safety for donation, processing, testing, storage, distribution of human tissue and cells. Both documents reaffirm the need for obtaining donor consent and insuring protection of data and confidentiality. European countries have national laws that provide the framework for biomedical research for patient privacy and protection. However these national laws are not necessarily specific to biobanking. In South America the LatinBank project is a study of the legal and social implications of biobanking in Latin America. The aim of this project is to “elaborate proposals for optimizing the legal structures, organization and forms of participation”. Some Asian countries publish recommendations, principles and guidelines that address genetic research and the use of human tissue. As a result of efforts in these Asian countries to develop these guidelines, it is more likely that specific laws and regulations will be implemented. In an attempt to standardize biobanking collection procedures several organizations, such as the International Society for Biological and Environmental Repositories, the International Agency for Research In Cancer, and the National Cancer Institute, and others, publish guidelines that define the criteria to assess the quality of work performed by biobanks. Further, the International Organization of Standardization publishes standards as a basis for biobanking quality management. Similar efforts have been made in France with the publication of NF S96-900. This document outlines quality management and technical requirements pertaining to biobanking. Finally, internationally derived opinion papers published by counseling bodies offer a comparative analysis of policies and regulations that can be used by government bodies regarding biobanking. The purpose of this project is to describe the “state of the science” with regard to the establishment of evidence-based standards for human tissue biobanking, to evaluate the relative position of the United States of standards development, and to identify the areas for further investigation. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 4571. doi:1538-7445.AM2012-4571