Title:
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The ethical and societal implications of consent strategies in large-scale epidemiological studies
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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.
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