International human subject research: taking stock in the wake of the Guatemala affair.

The recent unearthing of a US-funded study wherein unknowing Guatemalans were exposed to syphilis, gonorrhea, or chancroid sent shock waves throughout the scientific community. Prompted by this revelation, the Presidential Commission for the Study of Bioethical Issues has been convened to determine if current "standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government." This communication revisits the statutory and regulatory framework undergirding federally sponsored human subject research and explores its continued relevance in a rapidly globalizing enterprise. The emerging patterns are daunting and disconcerting. Over half of all clinical trials registered with ClinicalTrials.gov (http://clinicaltrials.gov/) (>100,000) are presently conducted in 145 (often poorly resourced) nations under the jurisdiction of over 2000 international IRBs. Review of the operational characteristics of the Office of Human Research Protection, the relevant oversight authority, reveals it to be underfunded and understaffed and thus unable to discharge its rapidly globalizing responsibilities. A review of federally sponsored human subject research by the Presidential Commission-now underway-could not be timelier.