ABSTRACT
Article Selection. Two authors were responsible for selecting and summarizing articles, and identifying nontherapeutic procedures within. At the time of the study, one author (ADM) was a fourth-year medical student with an interest in ethical and methodologic issues in randomized, controlled trials and training in the use of component analysis. The other author (CW) is a physician-philosopher with a PhD degree in experimental medicine, whose dissertation work was on ethical and statistical issues in cancer clinical trials. Both authors are intimately familiar with U.S. federal regulations governing a waiver of consent and exception from consent (45 CFR 46.116d and 21 CFR 50.24, respectively), and with similar Canadian guidelines.8
