Review of Clinical Trial Ethical Standards for Inclusion of Children. Paediatric Regulators Network Meeting Geneva, 15-17 February 2010 - Discussion Paper
(2010; 14 pages)

Abstract

This discussion paper analyzed three reviews of ethical guidelines and 14 individual guidelines.

Three reviews of inclusion of children in ethical guidelines were examined: The Survey of Current Guidance for Child Health Clinical Trials, Best Practices for Research Involving Children and Adolescents, and the International Compilation of Human Research Protections, 2010 edition. The Survey of Current Guidance reviewed approximately 22 guidelines. The Best Practices document reviewed and compared 8 international ethical guidelines and 2 Canadian guidelines. The International Compilation of Human Research Protections, 2010 edition, compiled by the Office for Human Research Protections, US Department of Health and Human Services lists the approximately 1100 laws, regulations and guidelines that govern human subjects research in 96 countries, as well as standards from a number of international and regional organizations. Standards were collected in the following categories:

  1. general,
  2. drugs,
  3. privacy/data protection,
  4. human biological materials,
  5. genetic research and
  6. embryo, stem cells and cloning.

Relevant key organizations, legislation, regulations and guidelines are given for each category. This discussion paper analyzes regulations and guidelines for the general and drug categories. The compilation excludes ethics codes of academic, medical or other professional organizations.

The main source for identifying international and country-specific ethical guidelines was the International Compilation of Human Research Protections, 2010 edition, compiled by the Office for Human Research Protections, US Department of Health and Human Services. A total of 14 specific guidelines were reviewed in detail: 2 international (WHO, CIOMS); 1 regional (EMEA), 1 consensus document (ICH), 12 from African countries, and 1 from India. Guidelines from Africa and India were selected as these are examples of guidelines from low and middle income countries. Each guideline was reviewed for all statements that mentioned children.

 
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