Review
The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas
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* Corresponding author: Leslie London leslie.london@uct.ac.za
1 Centre for Occupational and Environmental Health Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
2 MRC Epidemiology Resource Centre, University of Southampton, Southampton, UK
3 Department of Occupational and Environmental Health, Università degli Studi di Milano, Milan, Italy
4 Department of Medical Sciences, Uppsala University, Akademiska sjukhuset, Uppsala, Sweden
5 Swiss Centre for Applied Human Toxicology, University of Basel, Klingelbergstrasse 61, Basel, Switzerland
6 Department of Occupational and Environmental Health, Università degli Studi di Milano, Italy
7 International Centre for Pesticides and Health Risk Prevention, "Luigi Sacco" Hospital, Milan, Italy
8 International Centre for Rural Health, San Paolo Hospital, Via di Rudini 8, 20124 Milan, Italy
Environmental Health 2010, 9:50 doi:10.1186/1476-069X-9-50
Published: 18 August 2010Abstract
The controversy about the use of data from human volunteer studies involving experimental exposure to pesticides as part of regulatory risk assessment has been widely discussed, but the complex and interrelated scientific and ethical issues remain largely unresolved. This discussion paper, generated by authors who comprised a workgroup of the ICOH Scientific Committee on Rural Health, reviews the use of human experimental studies in regulatory risk assessment for pesticides with a view to advancing the debate as to when, if ever, such studies might be ethically justifiable. The discussion is based on three elements: (a) a review of discussion papers on the topic of human testing of pesticides and the positions adopted by regulatory agencies in developed countries; (b) an analysis of published and unpublished studies involving human testing with pesticides, both in the peer-reviewed literature and in the JMPR database; and (c) application of an ethical analysis to the problem. The paper identifies areas of agreement which include general principles that may provide a starting point on which to base criteria for judgements as to the ethical acceptability of such studies. However, the paper also highlights ongoing unresolved differences of opinion inherent in ethical analysis of contentious issues, which we propose should form a starting point for further debate and the development of guidelines to achieve better resolution of this matter.