Advances in Biobanking Practice Through Public and Private Collaborations


by

Elena Salvaterra, Julie Corfield

DOI: 10.2174/97816810851041170101
eISBN: 978-1-68108-510-4, 2017
ISBN: 978-1-68108-511-1





Advances in Biobanking Practice Through Public and Private Collaborations presents an analysis of methods and current models of partne...[view complete introduction]

Rights and Obligations of Different Stakeholders Involved in Access and Use of Samples and Data in Biomedical Research

- Pp. 81-96 (16)

Michiel Verlinden, Herman Nys and Isabelle Huys

Abstract

Millions of human biological samples and associated data are collected each year for a variety of purposes. These purposes may include basic research, clinical trials and epidemiological studies. The legal framework that determines access to biobanks remains presently unclear. The absence of a defined set of applicable rules on international, European and national level creates legal uncertainty for biobanks and applicants. This chapter reports on four studies concerning the legal structure applicable to “Access to Biobanks”. The first study consisted of a comparative analysis of access arrangements of organizations, biobank networks and biorepositories. The second study included interviews to gather qualitative data on the different perspectives held by stakeholders and experts in relation to the rights and obligations of custodians and applicants with respect to access to HBM and data stored in biobanks. The third study focused on the analysis of the legal framework applicable to access to biobanks. The final study (four) analysed the intellectual property rights (IPRs) in biobanking and the return and sharing of research results. These studies allowed us to formulate recommendations on the improvement of the legal framework applicable to public and private biobanks.

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