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  • Final Activity Report Summary - ED-REG-HAR (Ethical diversity and regulatory harmonisation: an empirical exploration of research ethics committees following the Directive on Good Clinical Practice)
FP6

ED-REG-HAR Résumé de rapport

Project ID: 509551
Financé au titre de: FP6-MOBILITY
Pays: United Kingdom

Final Activity Report Summary - ED-REG-HAR (Ethical diversity and regulatory harmonisation: an empirical exploration of research ethics committees following the Directive on Good Clinical Practice)

The project has completed all its main objectives including:
-to explore the way in which IECs 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 IECs.

The members of the research team carried out the following work:

- Hungary: observations of 14 meetings (between 1 and 4 hours long) at 3 committees over 12 months. Interviews with 50 people: including 18 committee members, 7 commentators, 3 policy makers, 2 industry representatives, 5 researchers and 3 patient group representatives.

- Sweden: observation of 23 meetings (3-4 hours long) at 6 different regional EPNs. 62 interviews with 24 EPN members (from 3 committees), 14 administrators, 4 policy makers, 5 commentators, 4 industry representatives, 6 researchers, and 2 representatives of patient groups.

- Portugal: Observation of 50 meetings at central ethics committee in Lisbon (each between 3 and 7 hours) and 7 meetings at local ethics committees (each between 2 and 3 hours). A total of 74 interviews with: 56 members of the central and local ethics committees; 6 policy makers; 7 representatives of pharmaceutical companies; 2 politicians; 4 researchers; 4 representatives of patients groups.

United Kingdom: 32 observations of committee meetings (each 3-4 and 1/2 hours long); 58 interviews with REC members (37 interviews), industry representatives (6 interviews), policy-makers (8 interviews) and other interested parties (7 interviews).

This project created a highly interdisciplinary team, which explored an area of research which has been largely neglected by social scientists and policy-makers, using a multi-national, empirically based comparative study of ethics decision-making. This project has allowed the Team leader to develop his research interest in an under-explored area, and to consolidate the research experience he has gained in his PhD and postdoctoral fellowship. Team members gained experience of small-team work which is unusual in the social sciences, and consolidated PhD and previous postdoctoral work, as well as developing new research skills.

Reported by

UNIVERSITY OF SUSSEX
FALMER, BRIGHTON
United Kingdom
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