Dossier n. 183/2009 [Abstract] Local Ethics Committees in Emilia-Romagna

Introduction

This document has been prepared to inform the discussion of the most urgent critical issues in the functioning of Local Ethics Committees (EC) in Emilia-Romagna Region (RER).

For a Region, such as RER, that has explicitly stated (see its Regional Law no. 29/2004 on the reorganization of the Regional Health Service) that research is part of its core mission, issues of governance, promotion, as well as surveillance on transparency and integrity of research play a central role. At the same time, while preserving ECs’ autonomy, it is a Region’s responsibility to make sure that ECs’ activities are in keeping with their reference Local Health Trusts and have the necessary infrastructure to work in an effective and efficient way.
This report uses information collected through a survey conducted in late 2008 within the Ethics Committees in Emilia-Romagna aimed at identifying the most relevant conceptual and operational issues (in Appendix 2 there is a brief description of the methodology by which the research was conducted) and at the identification of the most urgent improvements to be undertaken, in light of the recent comprehensive policy document on research (Regional decree n. 1066/2009 “Research as institutional activity of the Emilia-Romagna Regional Health Service”).

The information and considerations reported in this document can be used for discussion at the local level between individual Ethics Committees and Local Health Trusts and to allow a comparison between local contexts with different characteristics and variable degrees of involvement in research activities.

In Emilia-Romagna there are now 9 Local Ethics Committees (for a population of 4.3 million inhabitants). Most ECs have a provincial catchment area with the exception of Bologna where 2 different Committees serve, respectively, the large metropolitan Health Units and the S. Orsola Teaching Hospital, and the Romagna Area where 1 EC serves 4 Local Health Trusts and the “Istituto Romagnolo per lo studio dei Tumori” (IRST).

Organization of the document

The document is organised in three sections.

In the first, the general themes of the role and functions of Ethics Committees are briefly summarized. A summary of the main policy decisions taken by the Emilia-Romagna Region in the last few years is also presented.

The Second Section is organised in three Chapters that report the main findings of a regional survey carried out within ECs in late 2008:

• critical issues in the relationship between the ECs and reference Local Health Trusts;
• organizational and economic problems in the activities of ECs;
• role of ECs in improving the quality of research and its support at a local level.

This Third Section also addresses some specific issues related to studies on medical devices, the variability of criteria and judgments among ECs, the recent organizational issues posed by new legislation, the general theme of surveillance and prevention of conflicts of interest and the issues related to informed consent.

To facilitate reading these Chapters a structured reporting format has been adopted in Sections II and III: after a brief description of ECs’ activities and key conceptual and operational issues, proposals for improvement are presented. Specific summary tables are part of each section. In Appendix 1 the main reference legislation relating to each Chapter is listed.

The first issue addressed in Section II concerns the relationship(s) between ECs and Local Health Trusts. The results of the survey showed a different level of implementation of these relationships between CEs and reference local health organisations, which, in turn, is affected by different levels of development of the local infrastructure implemented to support research activities.

Specific actions to be undertaken are: a) to make sure that ECs have decisional autonomy on how to use the revenues deriving from the evaluation of protocols and to decide on the modalities of use of any savings of such resources; b) to define precisely what Local Health Trusts expect from their referent ECs, avoiding to assign them inappropriate roles; c) to define what Local ECs’ roles should, and should not, do with respect to methodological support to the investigators (especially those willing to embark in non profit research), to fund raising activities, to economic evaluation of projects funded in various ways, to support the participation in national and European calls, and finally in the the management of research outputs (patents, etc.).

Regarding issues related to organizational and economic aspects, the main findings that emerged from the survey and that would call for explicit guidelines are: a) criteria that should guide the management of funds coming from the trials and their use; b) details of the contract between the healthcare trust and the sponsors.

In the third part of Section II the issues surrounding the implementation of legislation to support non profit research and the methodological support for research are discussed. The document strongly states that local ECs should not provide methodological support directly to investigators whose proposal would then be submitted to the same Committee.

The document also highlights that there is legitimate reason for concerns given the growing number of the studies labelled “non profit”. It is considered useful in this context to investigate retrospectively at regional level to detail whether and how the studies presented as non profit are actually such, along with an action for clarification and more explicit definition of how one could really stimulate such research.

The Third Section of the document contains some brief remarks on five general issues relating to CEs’ activity:

• organizational problems introduced by Ministerial Decree 21/12/2007;
• studies with medical devices;
• the variability in the evaluative judgments between the EC and training components;
• research integrity and prevention of conflicts of interest;
• informed consent.

What is the optimal number of ECs remains an open issue and it is of particular relevance for multicentre studies. It would seem appropriate to develop shared policies among the Italian Drug Agency (AIFA) and the Regions in order to combine the thoroughness and quality of the evaluation with the efficiency needed to avoid unnecessary delays in the assessment process. It is also urgent to develop guidances around some critical scientific and ethical issues such as “non inferiority” trials, trials using placebo as well as studies where the use of randomised designs are particularly complex.