The revised Declaration of Helsinki--is justice served?

The World Medical Association revised the Declaration of Helsinki in October 2000. The Declaration is intended to provide a universal set of principles, which direct the ethical conduct of clinical medical research involving human subjects throughout the world. Previous research ethics codes emphasized the principles of informed consent and beneficence toward research subjects. The revised Helsinki Declaration places a premium not only upon these values but also the principle of distributive justice. The new Declaration demands that scientists see to it that the risks and benefits of scientific inquiry are distributed fairly to those that participate in research and to the communities from where participants are drawn. The authors of the Declaration have sought to establish justice by minimizing the use of placebo controls, insisting that populations from where research subjects are drawn stand to benefit from the research, and by requiring that therapeutic agents be made available to all trial participants long after a trial is completed. This paper argues that the aim of seeking a morejust distribution of the risks and benefits of research may actually be undermined by the tools that the Declaration employs to enforce justice.