Research Article: Informed Consent in the Genomics Era

Date Published: September 16, 2008

Publisher: Public Library of Science

Author(s): Deborah Mascalzoni, Andrew Hicks, Peter Pramstaller, Matthias Wjst

Abstract: Matthias Wjst and colleagues argue that traditional informed consent may no longer be
appropriate when dealing with long-term studies using biological material.

Partial Text: Since the Nuremberg trials, informed consent (IC) has been recognized as a basic ethical
requirement for research involving human participants [1] (Table 1). Such consent encompasses two distinct elements: (1) researchers
communicate detailed information about study procedures, outcomes, risks, and benefits for
the participating individual or community, and (2) after understanding and careful
consideration, the participants consent to take part under these conditions. However, the
suitability of IC for genomic studies has been recently challenged [2,3]. Because the research protocol for such studies
may evolve over time, the condition in IC of providing detailed information for a
well-defined protocol is not easily satisfied.