Trends in ethical and legal frameworks for the use of human biobanks

Abstract

Numerous studies of genetic epidemiology and post-genomics in respiratory diseases rely on the use of biobanks, defined as organised biological sample collections with associated personal and clinical data. The use of biobanks is increasing and raises several ethical issues. What are the ethical trends and legal frameworks in the post-genomic era? Are there new issues in relation to the developments of techniques and new study designs? How does this affect the clinician's attitudes and relationship with the patients?The main ethical issues encountered are: informed consent; confidentiality; secondary use of samples and data over time; return of results; and data sharing. Different levels and modalities of dealing with such issues are identified and vary from legally binding measures to ''soft'' regulations, such as ethical recommendations by various committees or professional organisations.A further level of complexity appears with the increasing international dimension of such activities in a context in which national positions vary on those topics. There is a tension between a necessary level of diversity in ethical positions and an indispensable common pedestal of principles and procedures to manage these issues in order to foster research.Current legal and ethical trends favour the facilitation of secondary use of samples, more biobank openness, balanced with a growing attention to dialogue and public/stakeholder consultation, an increased role for research ethics committees and more sophisticated data protection and governance structures.

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil

“…It is employed in the main studies with this design and represents new ethical and legal challenges. 5,6,12 In the ELSA-Brasil, the storage of genetic and cellular material, enabling access to DNA codes and to expression patterns of RNA and proteins, will allow testing associations between cellular and molecular alterations that precede the emergence of a series of diseases. New science fi elds that have just started to develop, called genomics and proteomics, will enable, in a future that is not so distant, a better prediction of chronic diseases that constitute public health problems in many countries, including Brazil.…”

Ethics and biobanks

“…It has been suggested that special governance frameworks should be created to promote public trust (Caulfield et al, 2003;Cambon-Thomsen et al, 2007) and the UK Biobank established accordingly a separate ethics and governance council with this end in mind. Public trust is also believed to require different participatory approaches so that donors of tissue material should have control over how their specimens and data are used and for what purposes.…”

An empirical examination of the management of return of individual research results and incidental findings in genomic biobanks

“…22 The literature reveals widespread concern over the lack of guidance on these issues. [23][24][25] Yet to date, few studies have empirically examined how these ethical issues are being addressed, particularly with regard to genetic research with biological materials stored in biobanks. Focused examination of the publically available policies of biobanks is essential.…”