Privacy Issues

A biobank is a repository of human biological material DNA or RNA that would allow genetic analysis. It originally referred to large population banks of human tissue and related data. The storage of tissue samples and data linked to them needs to be clearly distinguished. These data comprise information about the donor of the material, such as demographic characteristics, the type of disease associated with the sample, the outcome of the disease, etc.

Privacy Issue

Guidelines developed by the Ethics Committee of the Swedish Medical Research Council stress the importance of protecting individual data. It advises that codes linking data held in a biobank to an individual should be kept within a public institution such as a university or medical authority.Its very important that adequate attention is paid to security, unauthorized individuals can access electronically stored information and use it for illicit purposes. As a result people are increasingly worried about their privacy and want stricter control over who has access to information about them and under what conditions.

Issues of privacy have become entangled with bioinformatics as, increasingly, we rely on technology rather than on human beings to resolve privacy issues. Fears of discrimination by employers and insurers are definitely of increasing importance for participants in genetic research. Many may fear that their genetic information could be shared with third parties (insurers, employers), who sometimes require that the individual provide a general release of his medical records or information relating to his participation in research projects.

It is essential that operational rules be established by Research ethics board (REBs) so that the conditions of access to biobanks are clearly determined and are acceptable to the research participants.

Informed consent

The necessity of informed consent within the context of research is an absolute imperative. The two main principles to be taken care of for the benefit of participants are:

• obtaining his informed consent
• determining the risk/benefit balance by the REB

It is essential for REBs to put in place means for the logistics involved in the uses of donor=s specimens stored in biobanks for the purposes of medical research.

Confidentiality Issue

The handling of identifiers, physical and other kinds of security and transfer of information. The breach is a serious issue in pharmagenomics. This informational risk is due to the personal, familial, and social nature of genetic information as well as its potential to discriminate and stigmatize. Points to consider by researchers and Institutional Review Boards (IRBs) have recently been suggested in determining various levels of confidentiality, within the framework of pharmacogenomics research where researchers decide the level of protection best suited for their research protocols.

Consent and anonymization in research involving biobanks

Differing terms and norms present serious barriers to an international framework

Bernice S Elger1 (Author photo) and Arthur L Caplan2 (Author photo)

EMBO Rep. 2006 July; 7(7): 661–666.

Christiane Auray-Blais1 and Johane Patenaude2

1Service of Genetics, Department of Pediatrics, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001, 12th Avenue North, Sherbrooke, Qc, J1H 5N4, Canada, BMC Med Ethics. 2006; 7: 4.

Nitika Gupta BMI512 F 2007