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Withholding proven treatment in clinical research

In this editorial Huston and Peterson suggest that the concern about withholding treatment in research has been inappropriately focused on placebos. They note the difference between the Declaration of Helinksi’s criterion of ‘no proven treatment’ and the regulatory criterion of ‘no irreversible harm’ as standards for the appropriate use of placebo groups in clinical trials, and the debates that have arisen as a result.

The authors propose that instead a broader understanding of the ethics of withholding treatment is required. They question whether concerns about withholding treatment can be addressed solely by identifying an acceptable level of risk and providing careful monitoring of participants. Examples are given of instances in which placebo groups receive adjunctive treatment as part of research, and where placebo groups have outperformed patients who decline to participate in the research and received standard care. They conclude that to protect the best interest of research participants the ethics of withholding treatment needs to be considered in the broader context of clinical trials.