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Title: The ethical and societal implications of consent strategies in large-scale epidemiological studies
Author: Schofield, Behnaz
Awarding Body: University of Bristol
Current Institution: University of Bristol
Date of Award: 2013
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This thesis explores both philosophically and empirically, the debate on consent strategies in large-scale epidemiological research studies. The translation and application of regulations which are in place to protect the safety of participants in research studies may be seen as over burdensome in the case of minimal risk epidemiological studies. Whilst there has been agreement in the literature relating to the ethical principles and societal values on which the need for informed consent has been placed, disagreement exists in the application of the regulations referring to informed consent. An empirical bioethics approach is utilised, in which qualitative and quantitative data gathered during the study informs the philosophical debate. The qualitative data is gathered from personal interviews with 22 stakeholders exploring the normative basis for consent decisions. Additionally Chairs of Research Ethics Committees in England and European epidemiologists were invited to complete an online survey. The results of the empirical study support the need for informed consent. Trust was stated as the most important value when considering access to medical data. The qualitative analysis of the stakeholder interviews in combination with the findings of the study of the ethical literature resulted in the production of the TIES Epidemiology Consent Framework the elements of which support a novel Universal Consent Model which was introduced during the interviews and was seen as a sensible and pragmatic approach by all the interviewees. There was no consensus on the use of broad vs. narrow consent strategies. This lack of consensus also existed in the discussion on the opt-out vs. opt-in approaches to informed consent. It was not possible to agree on a definition for the threshold of acceptance relating to minimal risk, harm and proportionality. In the absence of an agreement in these fundamental aspects of consent, future research proposals may continue through an unclear path in gaining approval.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available