Research Risks, Randomization, and Risks to Research: Reflections on the Prudential Use of “Pilot” Trials

Abstract

I should like to begin my comment and response to Professor Engelhardt by following his method, and ask you briefly to consider an episode from the history of the acquisition of scientific knowledge — but from a slightly different perspective and for somewhat other reasons than Dr. Engelhardt’s excursion into the past. That is, we might take a moment to reflect on the compelling concerns of the past, which, over time, have led to this volume with its principal themes and which make them important enough to warrant our extensive time and energy as we speak and write to the multifarious issues germane to the general topic — the use of human beings in research [39] [42]. For these many issues have been and still are being treated not only in Israel and the United States, but throughout the world wherever support for such research is available. I turn, then, to the early 17th century.

The two methods which we have now stated have many features of resemblance, but there are also many distinctions between them. Both are methods of elimination. This term... is well suited to express the operation, analogous to this, which has been understood since the time of Bacon to be the foundation of experimental inquiry, namely, the successive exclusion of the various circumstances which are found to accompany a phenomenon in a given instance, in order to ascertain what are those among them which can be absent consistently with the existence of the phenomenon. The Method of Agreement stands on the ground that whatever can be eliminated is not connected with the phenomenon by any law. The Method of Difference has for its foundation, that whatever cannot be eliminated is connected with the phenomenon by a law. Of these methods, that of Difference is more particularly a method of artificial experiment ([33], p. 256). John Stuart Mill — A System of Logic (1843)