Objective
The aims of this project are: to explore the way in which Independent Ethics Committees (lECs) assess clinical trials protocols for ethical suitability; to assess which variations are necessarily a consequence of local cultural differences, and which are not; to highlight the way in which European pharmaceutical harmonisation can incorporate ethical diversity and develop best practice for lECs.
As a result of the Directive on Good Clinical Practice (GCP), since the 1st of May 2003 Independent Ethics Committees have had a statutory role under European Legislation in the ethical assessment of clinical drugs-trials. This is part of a general move towards the harmonisation of pharmaceutical regulations, both worldwide and within Europe (e.g. the setting up of the EMEA).
But there is a largely unexplored tension between this drive towards harmonisation, now seen in ethical review, and the important role cultural and ethical diversity plays within Europe. For example, even within a single member state (the UK), there has bee n considerable tension between the requirement that clinical trials be assessed by ethics committees and the range and diversity of opinion such committees have, even regarding the same clinical trial.
This problem will be magnified at the European level. This project will use qualitative methods to compare the decision-making processes of ethics committees in four different countries (UK, Sweden, Portugal and Hungary). The team will recruit a researcher from each of these countries, showing a high degree of mobility.
In its analysis the team will use dimensions of comparison such as: differing interpretations of what is meant by informed consent; the relationship between need for technical ability to understand material and the democratic principle of lay members; and the influence of different cultural/social factors (e.g. religious traditions;
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
FP6-2002-MOBILITY-8
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
FALMER, BRIGHTON
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.