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An algorithm for evaluating the ethics of a placebo‐controlled trial
Author(s) -
Amdur Robert J.,
Biddle C.J.
Publication year - 2001
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.1026
Subject(s) - placebo , harm , altruism (biology) , concomitant , medicine , research ethics , control (management) , psychology , computer science , alternative medicine , surgery , social psychology , artificial intelligence , psychiatry , pathology
The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo‐controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo‐controlled trial are as follows: ( i ) Is placebo being used in place of standard therapy? ( ii ) Is standard therapy likely to be effective? ( iii ) Is the toxicity of standard therapy such that patients routinely refuse this treatment? ( iv ) Could the use of placebo result in severe suffering or irreversible harm? ( v ) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? ( vi ) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. © 2001 Wiley‐Liss, Inc.