International research ethics

ETHICA

International research ethics

CTC-ETHICS: Ethical issues in clinical trial collaborations with developing countries

This project is funded by the European Commission from 2000 - 2003. Click here for more information

EURO-ELSAV

The Euro-ELSAV pages contain a lot of information about this topic.

Training workshops in research ethics

We have developed and organized three workshops for UNAIDS to train members of research ethics committees. Click here for more information. We are now in the process of making the training material available in electronic form.

Background document on ethical issues in clinical trial collaborations

This document was written as a background document for UNAIDS to assist in its process on developing guidelines for HIV vaccine research. It is available in in pdf-format here. A similar background document for CIOMS on justice in international research is in preparation and will be available in August, 2000.

In addition, our interests in research ethics include the following topics:

Issues of informed consent in preventive AIDS vaccine trials
Availability to developing countries of drugs and vaccines after successful clinical testing
Community representation in clinical trials

Informed consent issues

Recent papers on informed consent to AIDS vaccine trials: Summaries and comments on some recent work on informed consent issues
Informed consent and preventive AIDS vaccine research: An empirical study on how much prospective participants in Brazil understand of central elements of the informed consent form to trials

Availability of pharmaceutical products

The Praziquantel Report from Harvard's Takemi Program: This report investigates the availability of praziquantel for the treatment of schistosomiasis after it was shown to be effective. It argues that there are important lessons to be learned concerning the availability of new products to poor countries. In particular, the recent TRIPS (Trade related aspects of intellectual property) agreement "could delay the delivery of benefits of new products for tropical diseases to poor people in poor countries". And "While WHO's assistance in drug development was critical in demonstrating praziquantel's safety and efficacy, WHO's strategy did not effectively address issues related to access, availability, pricing, procurement, or distribution". These conclusions are important in light of WHO's involvement in the planning of preventive AIDS vaccine trials in developing countries.
Ethical issues in preventive AIDS vaccine research: A paper outlining some of the ethical issues.

Community involvement in clinical trials

Report on a Workshop on Community Advisory Boards

Report of a Community Advisory Board established by Immuno AG