Ethical and social issues in the use of biomarkers in epidemiological research.

The use of biomarkers in epidemiological research may raise ethical and social issues. These issues stem from the belief that research participants have 'rights' to appropriate information before, during and after studies so that they can make informed decisions. Ethical issues can arise during protocol development, obtaining participation, and in the interpretation and notification of text and study results. Additionally, there are ethical considerations concerning the use of biological specimens collected and stored for one purpose and subsequently used for other research purposes. A major ethical issue is the maintenance of participants' privacy and the confidentiality of their test and study results. Ethics committees need to be well-informed about the scope, limitations and expectations of biomarker research in order to be able to respond to social and scientific developments in the use of biomarkers.