Framework of guidance

Download a PDF of Chapter 5 – Framework of guidance (11 pages)

When planning research in developing countries, researchers and sponsors may be subject to a wide range of national and international guidance, guidelines, declarations and regulations, including:

  • World Medical Association (WMA): Declaration of Helsinki, last revised 2000; Note of Clarification on Paragraph 29, Dec 2002; Workgroup Report on the revision of Paragraph 30, May 2004.
  • The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO): International Ethical Guidelines for Biomedical Research Involving Human Subjects, last revised 2002.
  • Council of Europe (CoE): Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, prepared by the Steering Committee on Bioethics (CDBI) of the Council of Europe adopted by the Committee of Ministers, June 2004.
  • European Council and European Parliament (EU): Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April 2001, brought into force by May 2004.
  • The European Group on Ethics in Science and New Technologies (EGE): Opinion Nr 17 on the ethical aspects of clinical research in developing countries, published in Jan 2003.

However, there have been criticisms that these guidelines are often inconsistent and inappropriate for the developing country setting. Interpreting and applying international guidance in a specific context is often extremely difficult.

We conclude

Developing countries should produce their own national guidance to promote ethically sound research.

Further comparison of the guidelines on the issues of consent, standards of care, ethical review, and after the research is over, is given in The ethics of research related to healthcare in developing countries: a follow-up Discussion Paper (Appendix 1).

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