Study Criticisms Unjustified

Manley, Ian S. Chart Ann; Youngren, Susan Hunter

doi:10.1289/ehp.112-a151

Cited by 2 publications

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“…Some scientists and activist groups challenged the ethical and scientific validity of the studies, contending among other things that people should not be put at risk for the purpose of reducing the stringency of regulatory standards [3,6,8,11,12]. Other scientists and industry groups argued that the human dosing studies were needed to ensure the scientific quality and accuracy of EPA's safety evaluations and that they had been and could be conducted ethically [4,5,10,26,27]. In response to the controversy, EPA commissioned the National Academy of Sciences to advise whether and under what circumstances the Agency should consider and accept intentional human dosing studies.…”

Section: Review Findingsmentioning

confidence: 99%

“…The critique further pointed out that the lack of power in the study would invalidate any inferences for or against a NOAEL. In response, Chart and colleagues [4] disputed the biological significance of the modest cholinesterase decline since a) no clinical effects were seen and b) the decline was said to provide evidence of exposure, but was too small to indicate hazard. With regard to the power issue, Chart et al acknowledged the relatively small study size, but pointed to an overall database of hundreds of animal and human studies with dichlorvos, arguing that the available health data on any given substance should be evaluated as a whole in risk assessments.…”

Section: Review Findingsmentioning

confidence: 99%

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The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

et al. 2010

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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.

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Section: Review Findingsmentioning

confidence: 99%

Section: Review Findingsmentioning

confidence: 99%

The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

et al. 2010

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Toxicity Data Obtained From Human Studies

Wilks

Kupferschmidt²

2009

General, Applied and Systems Toxicology

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The purpose of this chapter is to look at the ethical, scientific and practical issues concerning human data which may be helpful in chemical risk assessment. Such data can come from a variety of sources; case reports, case series and toxicosurveillance data often contain a high level of detail and may allow an estimate of the likelihood of adverse effects occurring. However, they are dependent on relatively few data collection systems, for example those of poison control centres. Exposure studies, in particular those involving biomonitoring, provide insight into individual exposure to chemicals in the workplace or environment. However, it is generally difficult to link the often very low levels of chemicals or their metabolites to health outcomes. Conversely, health surveillance may pick up an increased burden of disease but the degree of underlying chemical exposure is often unknown. Human volunteer studies with nonpharmaceutical chemicals have the advantage of well‐characterized exposure combined with information on the pharmacokinetic behaviour and/or effects of the compound. Nevertheless, outside the area of consumer products their usefulness is limited by ethical concerns and scientific challenges such as study design and small study populations. It is hoped that the present controversy surrounding some aspects of volunteer studies can be resolved through rational, scientific debate involving all stakeholders.

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Study Criticisms Unjustified

Cited by 2 publications

References 0 publications

The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

Toxicity Data Obtained From Human Studies

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