Ethical considerations arising from vaccine trials
While many existing documents provide guidance on ethical issues in biomedical research and some specifically address vaccine research, few were drafted with a focus on the particular ethical issues posed by vaccine trials among children in developing countries. Current ethical guidance to assist ethics committees, sponsors and investigators involved in such trials in developing countries is sparse. As part of an effort to address this situation, the World Health Organization (WHO) held a meeting in Accra, Ghana on 26-28 November 2002 to consider various ethical issues that might arise during the performance of vaccine trials in paediatric populations in developing countries. The objectives of the meeting were:
- to identify ethical issues that have arisen or are likely to arise in the conduct of such trials;
- to explore possible solutions to address such ethical concerns;
- to produce a document that outlines some of the relevant considerations that might assist those involved in such trials, e.g. governments, communities, ethical committees, sponsors, funding agencies and investigators.
This document is the result of that meeting. It highlights some of the critical ethical issues that should be considered in vaccine development and evaluation, largely from the perspective of those conducting trials among paediatric populations in developing countries. (See list of participants, Annex 1.) Each section of the document comprises subsections entitled "Considerations", summarizing the points that participants at the meeting considered most relevant to the topic at hand, and "Discussion" noting some of the broader issues that pertain to these points.