There was no significant disagreement expressed among the participants on the issues raised; rather there was a strong and consistent tendency to listen to, and appreciate, the various concerns from the different points of view present at the table. The following general questions could be derived from the discussion:

-How can we act justly (in the context of biomedical research) in a world that is essentially unjust?
-What needs changing regarding current international ethical guidelines (Helsinki, CIOMS, GCP)?
-How can we carry out capacity building in the context of biomedical research on the basis of true and equal partnership?

The following points summarise the issues and general disposition of the participants toward the issues:

- The idea of a standard of care is vague and very often misleading in the context of biomedical research, in developed and developing countries. It was termed by one participant 'a medical fallacy'.

-The notions of informed consent and community consent are very much dependent on the research situation and need to be appreciated within the context of the communities and the research project. The notion of community consent is often naively applied without a true understanding of the community where the research takes place. Individual consent always seems necessary, especially to guard against the misuse of those most vulnerable within a community.

-Systems of ethical review need to be supported and promoted throughout the world. Ethical review has become the sine qua non for making research possible. A wide variety of ethical review systems are present today having varying levels of ethical review capacity. Research ethics committees should be further developed alongside 'a culture of ethics'.

-As this was a US sponsored meeting with strong US representation, the problem of US capacity building (with regard to international biomedical research) was a central concern. US research regulations should both inform and be informed by international research, without necessarily insisting on strict interpretations. A dialogue needed to exist between US researchers and their international collaborators that would improve the US capacity for developing internationalcompetence in research. In particular, the US IRBs need to be s trengthened regarding their understanding and appreciation of international research.

-While major international guidelines (Helsinki, CIOMS) are currently under review for revision, there is a need to widen the scope of the dialogue as well as develop mechanisms for implementing ethical and scientific norms.

-In sum, there is a need for further education and training regarding the ethics and science of biomedical research.

Conclusions of the Workshop
Gerald Keusch concluded the Workshop at the end of the second day by summarising the discussion as follows:

-The background principles guiding biomedical research are largely the same and widely agreed on;

-The Workshop had identified issues and problems for patients, subjects, and communities, as well as for researchers and institutions;

-The current level of adequacy of existing mechanisms for guaranteeing a high level of ethics in international biomedical research are suboptimal (referring to existing guidelines as well as current informed consent and ethical review mechanisms);

-Significant differences of various kinds in the approach to bioethics exist around the world.

OPAS Brazil