Experimenting on Your Fellow Humans in 2001. Update of the Declaration of Helsinki and Progress from the International Conference on Harmonization

Abstract

We are all the beneficiaries of a culture sufficiently developed that we can expect to prescribe drugs that are effective. We expect that the side effect profile of an approved drug is well enough understood, such that there is agreement that the benefits outweigh the risks of taking the drug. We also universally believe that, in the process of developing drugs, subjects of research should not be abused. On the other hand, we would not think that every country would require completely different types of information in order to make such decisions. Nonetheless, this has been the case for many years. In general, it was easier to introduce a new drug in Europe than in the United States even though there is little reason to suspect that the risk:benefit ratio would be different on one side of the Atlantic versus the other. Furthermore, the information used to bring a drug to market in Europe and the United States had little value when seeking regulatory approval from Japanese authorities. Therefore, a number of international efforts to develop and support international standards have developed. These developing frameworks of global perspective on Pharmaceuticals and human subject protections have both seen recent updates.