TY - JOUR

T1 - Consent and confidentiality in the light of recent demands for data sharing

AU - Williams, Garrath David

AU - Pigeot, Iris

N1 - This is the peer reviewed version of the following article:Williams, G. and Pigeot, I. (2017), Consent and confidentiality in the light of recent demands for data sharing. Biom. J., 59: 240–250. doi:10.1002/bimj.201500044 which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1002/bimj.201500044/abstract This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.

PY - 2017/3

Y1 - 2017/3

N2 - 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.

AB - 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.

KW - Data protection

KW - Ethical review

KW - Informed consent

KW - Privacy

KW - Research ethics

KW - Trustworthiness

U2 - 10.1002/bimj.201500044

DO - 10.1002/bimj.201500044

M3 - Journal article

VL - 59

SP - 240

EP - 250

JO - Biometrical Journal

JF - Biometrical Journal

SN - 0323-3847

IS - 2

ER -