Biom J. 2016 Feb 3. doi: 10.1002/bimj.201500044. [Epub ahead of print]

Consent and confidentiality in the light of recent demands for data sharing.

Williams G1, Pigeot I2,3.

Author information

• 1Department of Politics, Philosophy and Religion, Lancaster University, Lancaster, LA1 4YL, UK.
• 2Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstr. 30, 28359, Bremen, Germany.
• 3Institute of Statistics, Faculty of Mathematics and Computer Science, University of Bremen, Bibliothekstr. 1, 28359, Bremen, Germany.

Abstract

Many attempts have been made to formalize ethical requirements for research. Among the most prominent mechanisms are informed consent requirements and data protection regimes. These mechanisms, however, sometimes appear as obstacles to research. In this opinion paper, we critically discuss conventional approaches to research ethics that emphasize consent and data protection. Several recent debates have highlighted other important ethical issues and underlined the need for greater openness in order to uphold the integrity of health-related research. Some of these measures, such as the sharing of individual-level data, pose problems for standard understandings of consent and privacy. Here, we argue that these interpretations tend to be overdemanding: They do not really protect research subjects and they hinder the research process. Accordingly, we suggest another way of framing these requirements. Individual consent must be situated alongside the wider distribution of knowledge created when the actions, commitments, and procedures of researchers and their institutions are opened to scrutiny. And instead of simply emphasizing privacy or data protection, we should understand confidentiality as a principle that facilitates the sharing of information while upholding important safeguards. Consent and confidentiality belong to a broader set of safeguards and procedures to uphold the integrity of the research process.