Evaluating the consent preferences of UK research volunteers for genetic and clinical studies.

Susan E Kelly,Barbara Prainsack,Juliette M Harris,Timothy D Spector,Lynn F Cherkas

doi:10.1371/journal.pone.0118027

Susan E Kelly, Barbara Prainsack + Show 3 more

Open Access

https://doi.org/10.1371/journal.pone.0118027

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Journal: PloS one	Publication Date: Mar 11, 2015
Citations: 63	License type: CC BY 4.0

Affiliation: King's College London, University of Exeter

Abstract

ObjectivesTo establish the views of research volunteers on the consent process; to explore their views on the consent process in different research scenarios; to inform debate on emerging models of consent for participation in research.Design, Setting and Participants2,308 adult volunteers from the TwinsUK Registry (www.twinsuk.ac.uk) completed an online survey about their views on the consent process for use of their DNA and medical information in research. Their views on the re-consenting process in different scenarios were assessed.ResultsThe majority of volunteers preferred to be informed of the identity of the main researcher of a study in which they are participating, which is contrary to current practice. Over 80% were willing to complete the consent process online instead of face to face. On the whole, respondents did not view their DNA differently from their medical information with regard to the consent process. Research participants were more willing to give broad consent to cover future research if their DNA was to be used by the original researcher than by another researcher, even if the disease under investigation varied, in contrast to the traditional ‘gold standard’ whereby specific consent is required for all new research projects.DiscussionIn some scenarios, research participants reported that they would be comfortable with not signing a new consent form for future research uses of their data and DNA, and are comfortable with secure, online consent processes rather than traditional face-to-face consent processes. Our findings indicate that the perceived relationship between research participants and researchers plays an important role in shaping preferences regarding the consent process and suggest that this relationship is not captured by traditional consent processes. We argue that the development of new formats of consent should be informed by empirical research on volunteers’ perceptions and preferences regarding the consent process.

Highlights

Biomedical research is often underpinned by large international and collaborative datasets
Our findings indicate that the perceived relationship between research participants
We argue that the development of new formats of consent should be informed by empirical research on volunteers’ perceptions and preferences regarding the consent process

Summary

Introduction

Biomedical research is often underpinned by large international and collaborative datasets It increasingly entails the integration of different types of data, including DNA, other molecular data, and clinical information. Examples of this modality of research include Genomics England, the initiative recently announced by the UK government to create a database of 100,000 anonymised whole genome sequences matched with clinical data, and the UK Biobank resource of 500,000 volunteers with genetic and clinical data. It is impossible to predict all future scenarios of data use and the risks that these may pose [14, 15, 16, 17]

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