Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005
We read with interest the commentary on “Deception in the Pursuit of Science,” by Wendler and Miller.1 As members of the Institutional Review Board (IRB) and the Health Care Ethics Committee of the Hospital Privado de Comunidad in Mar del Plata, Argentina, we wish to briefly comment on our experience with a situation we were confronted with 6 years ago as a result of a research protocol submitted to us in March, 1998, by researchers at our institution. The study was a fourth-phase, open, prospective, multicentric study of an antihypertensive medication that consisted of 2 distinct phases. The first phase included a placebo, without informing the patients (simple blinding), whereas the second (with the drug) was characterized as the “titration and maintenance” phase. The proposed information brochure for the patients did not make any mention of the possibility of receiving placebo at any time during the study.
Hechem MI, Gonorazky S. Looking for Ways to Avoid Deception in the Pursuit of Science. Arch Intern Med. 2005;165(10):1199-1200. doi:10.1001/archinte.165.10.1199-b