Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective

Abstract

The purpose of this paper is to formulate a professional and scientific view on the social, ethical, and legal issues that impact on data storage and DNA banking practices for biomedical research in Europe. Many aspects have been considered, such as the requirements for data storage and DNA banking in the public and private sectors in Europe and the issues relating to DNA banking, that is to say the consent requirements for the banking and further uses of DNA samples, their control and ownership, and the return of benefit derived from DNA exploitation to the community. The methods comprise primarily the review of the existing professional guidelines, legal frameworks and other documents related to the data storage and DNA banking practices in public and private sectors in Europe. Then, the issues related to DNA banking were examined during an international workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in Paris, France, 07 -08, April, 2000. A total of 50 experts from 12 European countries attended this workshop. It came out that DNA banking for medical and research purposes is indispensable. It facilitates the constitution of large collections, sharing of samples, multiple testing on the same samples, and repeating testing over the years. However, banking organization is complex, requires multiple actors, and concerns are expressed in various countries. International standardization of ethical requirements and policies with regard to DNA banking has been recommended. Such standardization would facilitate a greater protection of individuals as well as future international cooperation in biomedical research.

Public concerns regarding the storage and secondary uses of residual newborn bloodspots: an analysis of print media, legal cases, and public engagement activities

“…Ownership In many NBS jurisdictions, RBS are considered property of the NBS governing body (or local government) (e.g., European countries (Godard et al 2003); most American states (Fleck et al 2008; Minnesota Genetic Information Work Group 2009); Australia (Muchamore et al 2006)). In some of the reviewed public engagement activities, participants expressed concern that the current ownership policy gives preference to the rights of the general public over those of the individual donor (Fleck et al 2008).…”

The Ethics of Research Biobanking: A Critical Review of the Literature

“…In France, a series of scandals concerning therapeutic biobanks received more public attention than research biobanking (Patel, 1993), even if national pride made American use of a French research biobank into a contested issue in academic circles (Rabinow, 1999). But despite the heterogeneity of the problems debated, informed consent once more became a key element of the "solutions" considered when contemplating the "biobank problem" and the consent requirement was entrenched in law already in 1994 (Godard et al, 2003). The plethora of new laws and circulars, nationally and internationally, has caused considerable confusion and has given rise to a call for harmonization of the consent requirement (Bauer et al, 2004;Clayton, 2005 ;Kapp, 2006;Morente and Alonso, 2005).…”

Italian Rett database and biobank

“…The database design assures patients' anonymity, privacy, and confidentiality, according to international criteria [Godard et al, 2003]. Moreover, the informed consent has been written explicitly, covering all aspects of stored samples and personal data management [Godard et al, 2003].…”