• home | as gaeilge | site map | contact us | links

• About Us
  • Ministers
  • Role and Mission
  • Divisions
  • Agencies
  • Board Vacancies
  • Contact Us
• Policy
  • Current Issues
  • Health Research
  • Legislation
  • Other Health Issues
  • Public Consultations
  • Healthy Ireland
  • Publications
  • Special Delivery Unit
  • Statistics
  • Working Groups
• Consumer
  • Customer Service
  • Freedom of Information
  • Health Information
  • Nat'l Lottery Grants
  • Recognition of Quals
• Communications
  • Official Languages Act 2003
  • Press and Communications Office
  • Press Releases
  • Speeches

European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004

GUIDANCE TO PERSONS MAKING APPLICATION FOR RECOGNITION AS AN ETHICS COMMITTEE TO APPROVE CLINICAL TRIALS OF MEDICINAL PRODUCTS FOR HUMAN USE UNDER REGULATION 7 OF THE ABOVE REGULATIONS

The following information should be submitted in an application for the recognition of an Ethics Committee for the purposes of the above Regulations. Please read the accompanying Notes before completing the application;

1. Name of appointing authority (and address for correspondence).
2. Name of Ethics Committee (and the address for correspondence, if different from above).
3. Description or class of clinical trials in respect of which it is proposed that the Committee will act.
4. Standing orders and operating procedures proposed for the operation of the Ethics Committee.

5. The standing orders and operating procedures (and any subsequent amendments) are required to be approved by the Supervisory Body. They should include details of the procedures in place for the arrangement and frequency of meetings, the reaching and recording of decisions, the notification of decisions to investigators and for the archiving of documents.

6. Membership of the Ethics Committee

7. The following information should be provided:

   1. a list of not more than 21 members - this list should identify whether the member is an expert member or a lay member and should also include in each case details of their qualifications and relevant experience (including any previous experience as a member of an ethics committee);
   2. the duration for which each member is appointed;
   3. the name of the chairperson, vice-chairperson and alternate vice-chairperson and the period for which each has been appointed;
   4. the name of Secretary of Committee.

   In establishing the membership of an ethics committee, consideration should also be given to the requirements of Regulation 13(8) of the Regulations where the inclusion of persons, with experience in the treatment of certain diseases and patient populations suffering from that disease, would be required on the committee or alternatively the advice of such persons should be available to the committee.

8. Staff premises and facilities

9. A statement should be provided setting out the arrangements for the appointment of such administrative and other staff as are considered necessary to enable the Committee to adequately perform its functions.

   A statement should also be provided setting out the arrangements for the provision of accommodation and other facilities (including maintenance of such facilities).

10. Signature of Applications

11. All applications should be signed by an appropriately authorised person for and on behalf of the appointing authority.

NOTES

1. Applications for recognition should be made by or on behalf of an appointing authority which may be a health board, a hospital, a university or other similar body involved in higher education or in the award of post-graduate medical or dental qualifications or in the provision of continuing medical or dental education.
2. Applications should be made in writing and addressed to the Department of Health and Children (Recognition of Ethics Committees), Second Floor, Hawkins House, Dublin 2 and, if possible, should also be submitted in an electronic form to paula_smeaton@health.irlgov.ie.
3. Applications should be accompanied by such information, documentation and particulars as are necessary to enable the Department of Health and Children to determine the application.
4. Recognition will be granted if the Supervisory Body is satisfied that the proposed arrangements for the membership and operation of the committee would enable the committee to adequately perform its functions as an ethics committee under the Regulations and that it complies with the provisions of Schedule 2 to the Regulations.
5. In making application for recognition of an ethics committee, it must be realised that the committee concerned will be required to accept responsibility for the grant of approvals for clinical trials to be conducted at its own site or at another site (in the case of trials at single sites) or at a number of sites (in the case of trials at multiple sites). The acceptance of this responsibility is important in the context of obtaining a single ethics committee opinion for a multi-centre that is a requirement of the Directive (and of the Regulations).
6. It will be a condition of the grant of recognition that the ethics committees will also be subject to accreditation for compliance with Good Clinical Practice on a regular basis. The first of these will be undertaken about 12 months after recognition.
7. On recognition of an ethics committee, a notice will be placed in Iris Oifigiúil by the Department of Health and Children. This notice will also be available on the Department's website.

Medicines Unit
Department of Health and Children
Tel. 01 635 4000
May 2004