Terms of Reference

1. Name of Committee:
Group of Specialists on Biomedical Research (CDBI-CO-GT2)

2. Type of Committee:
Ad hoc Advisory Group

3. Source of terms of reference:
Committee of Ministers on a proposal by the Steering Committee on Bioethics (CDBI)

4. Terms of reference:

Having regard to:

  • Resolution Res(2005)47 on committees and subordinate bodies, their terms of reference and working methods;
  • the Declaration of Warsaw and the Action Plan adopted at the Third Summit of Heads of State and Government of the Council of Europe (Warsaw, May 2005) and in particular its chapter II.6 - "Promoting ethics in biomedicine";
  • the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) and its Additional Protocol concerning Biomedical Research (CETS No. 195).

Under the authority of the Steering Committee on Bioethics (CDBI), and in relation with the implementation of Project 2008/DG3/1377 "Bioethics", of the Programme of Activities, the Group is instructed:

  • i. to examine the ethical and legal questions related to biomedical research, to make proposals (and, where appropriate, alternative proposals) to the CDBI on any question related thereto;
  • ii. to supplement, where appropriate, existing instruments;
  • iii. to follow developments of the issues addressed in the Additional Protocol concerning Biomedical Research and to submit to CDBI appropriate proposals with a view to promoting respect of the principles laid down in this text;
  • iv. to facilitate the implementation of the existing legal instruments in the field of biomedical research, for example by the elaboration of texts intended for health professionals, researchers and ethics committee members;
  • v. to contribute to ensuring coherence of the texts at international level in this field.

5. Composition of the Committee:

5.A Members:

The Group shall be composed of 4 members designated by the CDBI or its Bureau, taking into account the expertises required to address scientific, medical, ethical and legal questions related to biomedical research.

The Council of Europe budget will bear the travel and subsistence expenses for the 4 members of the Group.

5.B Other Participants:

  • i. The European Commission may send representatives to meetings of the Group, without the right to vote or defrayal of expenses.
  • ii. The following intergovernmental organisations may be invited, upon decision of the Group or its Chair, to send representatives to participate in meetings of the Group, without the right to vote or defrayal of expenses:
    • United Nations Educational, Scientific and Cultural Organisation (UNESCO);
    • Organisation for Economic Co-operation and Development (OECD);
    • World Health Organisation (WHO).

6. Working methods and structures:

To fulfil its terms of reference, the Group or its Chair may request, within the limits of budgetary appropriations, the Secretary General to have recourse, where appropriate, to the service of one or more consultants. The consultants may, at the request of the Group or its Chair, take part in the works of the Group.

7. Duration:
These terms of reference will expire on 31 December 2011.

Documents in progress. Reserved for intergovernmental delegations.