Federal regulations governing pharmacologic research require scientific
proof of efficacy. Although these regulations are often interpreted to mean
that a placebo-controlled trial is necessary, it is difficult to justify
use of placebo controls when effective standard therapy exists.
Justification is especially problematic in psychopharmacologic research
because of the added concern that subjects with compromised decision-
making capacity cannot give valid consent. To promote discussion and
consensus, this article presents guidelines for the ethically justifiable
use of placebo controls in research with psychopharmacologic agents. The
guidelines, developed by a university's institutional review board, are
designed to help investigators design studies and to protect vulnerable
subjects.
Abstract Teaser