Cell and Tissue Banking

, 9:151

Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

Review Paper

DOI: 10.1007/s10561-008-9101-4

Cite this article as:
Ravid, R. Cell Tissue Banking (2008) 9: 151. doi:10.1007/s10561-008-9101-4

Abstract

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP’s which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, “financial gain” and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

Keywords

Brain/Tissue/Bio banking Code of Conduct Donors Ethics Financial gain Funding Genetic testing Informed consent Safety Sharing 

Abbreviations

AD

Alzhemiers disease

BTB

Banks—Brain/tissue/Bio banks

EBBN

European Brain Bank Network

SOP

Standard Operating Procedure

MTA

Material Transfer Agreement

QMS

Quality Management System

TubaFrost

European Human Frozen Tumour Tissue Bank

Copyright information

© Springer Science+Business Media B.V. 2008

Authors and Affiliations

  1. 1.Netherlands Institute for NeurosciencesRoyal Dutch Academy of ScienceAmsterdamThe Netherlands