Year: 2006
Type: article
Abstract: The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo is still missing. The central issue in the ongoing controversy is the justification of placebo-use if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying placebo-use according to each guideline are in the focus of our attention. First, we will first present a formalized general principle that defines the ethical acceptability of placebo use in all regulations. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow to expose the participants of clinical trials to be exposed to a risk of serious harm, while others do not. The normative difference of each guideline could influence strongly the decision of researchers or IRBs concerning the ethical acceptability of placebo use.
Source: Ethik in der Medizin
Authors: Hans-Jörg Ehni, Urban Wiesing
Institution: University of Tübingen
Language: German
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,290
OpenAlex ID: W1499400228