Current Issues

The Department of Jobs, enterprise and innovation’s Consultation paper on a new national Strategy for Science, Technology & Innovation

Potential implications for Research Funding arising from the European Commission’s proposal in regard to the European Fund for Strategic Investment (EFSI)

The production of Academy position papers on:

  • Clinical Trial Research: Value to Ireland
  • The establishment of the optimum data and information environment for Healthcare in Ireland
  • The establishment of the optimum ethical environment for Healthcare Research in Ireland

Specific  terms of reference have been agreed for each of the groups as follows:

Title – The establishment of the optimum ethical environment for Healthcare Research in Ireland

Initial Terms of Reference

Introduction

Recent European and national legislative, regulatory and organisational changes and proposals for Ethics Research decision making and approval processes will have significant implications for the responsibilities, roles and functions of Ethics Committees in Hospitals and associated Healthcare organisations. In this context, the Irish Academy of Medical Sciences has decided to produce an Academy position paper to review the organisational and governance changes and provide a response to ensure that Ireland’s Ethical Research environment develops and maintains the following characteristics and objectives:

  • Research involving persons is carried out safely, and with considered consent and respect to autonomy and privacy of the subjects
  • Policies and procedures that maximise the potential of achieving optimal, patient-centered outcomes
  • Promotion and maintenance of the rights of patients
  • Promotion and maintenance of a positive ethics culture
  • Promotion and maintenance of a positive and innovative research environment
  • Shared decision making between patients (or their surrogates) and their clinicians
  • Enhance the ethical environment for health care professionals in health care institutions

The Academy is establishing a working group to produce the position paper to be chaired by Professor Noel G. McElvaney and will include representation from the principal participants in the Health Ethics legislation, regulation and governance process, healthcare organisations, healthcare professionals, patients and the pharmaceutical, medical devices and other industries involved in healthcare research.  A consultative forum will also be established to provide input, review and validation from the wider healthcare community.

Actions and Activities

The initial actions and activities of the group in the production of the Academy’s position paper will include

  • Define and agree the specific characteristics and requirements for an optimal ethical research environment.
  • Review, assess and determine the implications of proposed legislative, regulatory and organisations changes.
  • Identify the appropriate actions that need to be undertaken to address the implications arising from the proposed changes in the context of achieving an optimal ethical research environment.
  • Prepare draft of position paper for consideration by the Council of the Academy.

Title – The establishment of the optimum data and information environment for Healthcare in Ireland

Initial Terms of Reference

Introduction

Completeness, accuracy of all appropriate data and information and access to such data and information in a meaningful manner relative to its utilisation is a fundamental resource essential to the delivery of optimum healthcare.

To provide this resource requires the establishment of an environment which addresses:

  • The complexity of clinical and associated social data and information, its definition, agreement, representation and interpretation.
  • The purpose(s) for which it is to be utilised and its acquisition and management methodologies.
  • The relationships between the provider of data and information (patient/client),  the person recording and utilising it (Healthcare professional) and the organisation/system that facilitates and manages its use.
  • The  organisational and workflow processes, in terms of the clinical practices, diagnostic, operative,  therapeutic management and administrative  activities which it supports and  the context within which it is utilised.

The Academy is establishing a working group to produce a position paper to identify how such a data and information environment can be achieved in Ireland. The working group, chaired by Professor Elaine Kay, will include representation from the principal participants in the healthcare management and delivery process, patients and the healthcare industry.  A consultative forum will also be established to provide input, review and validation from the wider healthcare community.

Actions and Activities

The initial actions and activities of the group in the production of the Academy’s position paper will include

  • Definition of the characteristics of the data and information environment which should pertain to ensure this resource is available and accessible within the healthcare system in Ireland.
  • Definition of the range, availability and access methodologies for data and information pertinent to the level of utilisation required by all participants in the healthcare delivery process.
  • A review of the current data and information situation in Ireland to identify the issues which are impeding the creation of an optimal environment. These will include:

o   Data and information definitions and standards

o   Data and information security, data protection and access practices and methodologies

o   Information governance

o   Current and  proposed legislation and regulations

o   Work practices, organisational and management processes

o   Impact of new technologies

  • Identify the appropriate actions that need to be undertaken to address the issues identified.
  • Prepare draft of position paper for consideration by the Council of the Academy

Title – “Clinical Trial Research: Value to Ireland”

Initial Terms of Reference

Introduction

The Irish Academy of Medical Sciences (IAMS) seeks to define the current landscape of clinical trials in Ireland and to map a strategy for future growth and development.  In the context of national reviews of strategic Irish R & D funding, the Academy believes it is an opportune time to clearly define our clinical trials strategy and the benefits to Ireland including the financial, educational and healthcare benefits   of a vibrant Irish clinical trials research sector.

The Academy will invite leading authorities from industry, academia and government agencies to participate in a working Group chaired on behalf of the Academy by Professor Seamas Donnelly, Trinity College Dublin.

Actions & Activities

The position paper will specifically address the following topics:-

  • To define current clinical trials activity currently in Ireland from an economic perspective
  • To illustrate positive patient experiences from participating within clinical trials
  • To map the future strategy and landscape for clinical trials in Ireland
  • To identify potential national roadblocks to maximising the potential of  a vibrant clinical trials infrastructure in Ireland
  • To define solutions to these roadblocks
  • To predict from an economic perspective, and more broadly from the health of a nations perspective, the potential benefits of an integrated future Irish clinical trials sector.
  • Prepare position paper for consideration by the Council of the Academy