Response to Striefel and Glaros

Abstract

In this response to the comments of Drs. Striefel and Glaros, we take issue with Dr. Striefel's assertion that the Declaration of Helsinki should not be regarded as a “core” ethical document, and demonstrate that his claim that the Declaration has no significance in or recognition by agencies of the United States Federal Government is in error. A reading of FDA and DHHS documents shows that the Declaration is not, as Dr. Striefel suggested, only an “aspirational” document, but also is clearly regarded as mandatory. Dr. Glaros' observations regarding the slippery concept of “efficacy” is very much on point, and we certainly agree with his call for “more data.” It is the means by which that can be accomplished that is problematic. We have suggested that the logic of placebo controls developed to render drug efficacy studies more rigorous and scientifically grounded does not translate well to many psychological and behavioral studies of efficacy. It is important for our discipline to rethink the standards by which new behavioral and psychological (including psychophysiological) interventions can be demonstrated to be efficacious. One possible approach that avoids ethical pitfalls and design impossibilities is the “active control,” which requires good demonstration of assay sensitivity. We hope that this discussion may stimulate further discussion about other approaches that do not depend upon the flawed “placebo orthodoxy.”