Ethics Research Committees in Reviewing Nanotechnology Clinical Trials Protocols

Abstract

As we know, social developments depend mostly on scientific and technological progress. In the context of nanotechnology, nano-products and nanomaterials offer new possibilities because of their characteristics that can really contribute to making clinical trials faster and more accurate. At this time, in the United States, a search for the term ‘nanoparticles’ retrieves 153 studies, while a search for the prefix “nano” retrieves 56 clinical trials. Some of these studies are ongoing and others are just showing first results (Davis ME, Zuckerman JE, Choi CH et al., Nature 464:1067–1070, 2010) like the FDA approval of a nano-based drug in 2005. In Italy, for example, a phase II study has been taking place since Dec. 1, 2010. It is a single blinded randomized and controlled versus placebo employing a nano antibody for the study of the efficacy, and dose response for a rare disease (Osservatorio Nazionale sulla Sperimentazione Clinica dei medicinali National Report N. 8, 2009). There are incertitudes and complexities involving applications of nanotechnologies, in particular in clinical trials, but the Ethics Research Committees for human experimentation play a key, decisive role because they are the public guarantor of the respect of the rights and the welfare of subjects, while they contribute to more knowledge about human health in clinical trials. In particular, the Ethics Research Committees (ERCs) must verify that the chosen methodologies are the most suitable to the aims of the protocol, the risk to be assessed in terms of probability, magnitude and duration, to verify the identification, in the protocol, of all those elements that may influence that risk. All this is bearing in mind that nanotechnologies show different risks and toxicity and that information on them may not be very clear.