Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial.
The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research--social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.
Emanuel
Ezekiel J
EJ
Department of Clinical Bioethics, The Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. eemanuel@nih.gov
Miller
Franklin G
FG
D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000191:economics / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D018579:Patient Selection / Q000941:ethics*; D018570:Risk Assessment / Q000941:ethics
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412