The dilemma of bioengineering research on human subjects

The increased scrutiny of human subject research is underscored by the recent suspension of authority of several prestigious medical centers by the federal Office of Human Research Protection (OHRP). Fueled in part by the well-publicized death of a young patient enrolled in a gene therapy trial in 1999, the OHRP\´s "reign of terror" has had far-reaching implications for all scientists, patients, and administrators engaged in human subject research. In summary, there are fundamental differences in the way that standards are generated for clinical medicine, bioengineering research, and human subject research. The standards for both clinical medicine and research have generally been set by the practitioners and scientists through peer review. This is not the case with human subject research, and any practitioner or scientist that merely follows his or her internal ethical standards does so at the institution\´s peril. The standards for human subject research are rightfully set by agencies of the international community and federal government and strict adherence is mandated by law. Whether or not the rigid ethical standards can ever reasonably be relaxed depends on the commitment of the scientific community to the consistent performance of human subject research with vigilant respect for persons, beneficence, and justice.