Dynamic Consent - A Model for Translational Research
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Abstract
Broad consent has been adopted as a practical solution for biobanks as it has been impossible to apply the requirements of informed consent as articulated in the Declaration of Helsinki. This is because consent to involvement in a biobank must be obtained before the biobank commences when all of the researchers and research users are not known. Re-consent maybe necessary, unless the information can be anonymised for use by researchers or a legal exemption is obtained. Broad consent is strongly contested in the bioethics literature.
We have built a patient IT interface which uses a ‘dynamic consent’ approach. In this model, consent is not a mere communication exercise but a bidirectional, ongoing, interactive process between patients and researchers. Through the interface individuals can make and express preferences about the choices they are given about the use of their data and samples for research. The benefit of this interface is that it enables individuals to exercise their autonomy by giving informed consent for new types of research in real time rather than being asked to give a broad consent at the beginning of the research process when they are recruited into a biobank. The benefits for the research process are that recruitment is easier, less costly and more efficient; the legal and ethical requirements of consent can be met with ease; there is greater transparency and accountability in the research process and research findings can be returned to research participants as part of a personalised medicine approach. Dynamic consent has the potential to enhance patient confidence and enable long term patient-researcher collaborations in research.
This interface moves away from manual, paper–based processes to an e-governance system. We anticipate that the ‘dynamic consent’ interface will become an essential and sustainable component of research infrastructure and will further advance translational research initiatives. In this paper we present the dynamic consent model and show how it can be used as a tool for translational research and personalised medicine.
We have built a patient IT interface which uses a ‘dynamic consent’ approach. In this model, consent is not a mere communication exercise but a bidirectional, ongoing, interactive process between patients and researchers. Through the interface individuals can make and express preferences about the choices they are given about the use of their data and samples for research. The benefit of this interface is that it enables individuals to exercise their autonomy by giving informed consent for new types of research in real time rather than being asked to give a broad consent at the beginning of the research process when they are recruited into a biobank. The benefits for the research process are that recruitment is easier, less costly and more efficient; the legal and ethical requirements of consent can be met with ease; there is greater transparency and accountability in the research process and research findings can be returned to research participants as part of a personalised medicine approach. Dynamic consent has the potential to enhance patient confidence and enable long term patient-researcher collaborations in research.
This interface moves away from manual, paper–based processes to an e-governance system. We anticipate that the ‘dynamic consent’ interface will become an essential and sustainable component of research infrastructure and will further advance translational research initiatives. In this paper we present the dynamic consent model and show how it can be used as a tool for translational research and personalised medicine.
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