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Ethical diversity and regulatory harmonisation: an empirical exploration of research ethics committees following the directive on good clinical practice

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.