Guidelines for IRB Review of International Collaborative Medical Research: A Proposal

Abstract

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts.