Human Health Research Ethics

Silbergeld, Ellen K.; Lerman, S; Hushka, Leslie J.

doi:10.1126/science.1096862

Cited by 3 publications

(4 citation statements)

References 1 publication

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“…For the purposes of this paper, we focus on those toxicological studies related to defining hazard and quantifying risk; exposure assessment, which is the other element of risk-based decision making, involves other disciplines and methodologies. Hazard and risk are common to the practice of risk assessment and to application of the precautionary principle, which has been advanced as a partial alternative to risk assessment based methods related primarily to reducing the burden of information required for undertaking assessments (Silbergeld et al, 2004).…”

Section: Assessing Current Practice In Toxicologymentioning

confidence: 99%

“…This will not be a simple task. Since toxicology is fundamentally a science of prevention (Silbergeld et al, 2004), its aim is to detect likely harms prior to human exposure. For this purpose, experimental studies are the only source of truly preventive information, and thus the focus of eBt should be on experimental toxicology and test methods in the broadest sense.…”

Section: Challenges For Ebtmentioning

confidence: 99%

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Evidence-based toxicology: Strait is the gate, but the road is worth taking

Silbergeld

Scherer

2013

ALTEX

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The concept of evidence-based toxicology (EBT) was proposed in 2006, but progress since that time has been impeded by differing definitions and goals. This paper describes the parallels and discontinuities between the approach and methods of evidence-based medicine and health care and those proposed for toxicology. The critical element of an evidence-based approach for either discipline is the adoption of unbiased, transparent methodologies during the collection, appraisal, and pooling of evidence. This approach, implemented during the conduct of a systematic review, allows evaluation of the breadth and quality of available evidence. At present, systematic reviews are rarely done in toxicology by regulatory agencies, international organizations, or academic scientists. Adopting an EBT approach will necessitate significant changes in practice as well as attention to distinctive characteristics of toxicological studies, notably their emphasis on identifying harms and their reliance on experimental animal studies. An evidence-based approach does not obviate the role of judgment and values in decision making; its goal is to ensure provision of all available information in a transparent and unbiased manner.

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Section: Assessing Current Practice In Toxicologymentioning

confidence: 99%

Section: Challenges For Ebtmentioning

confidence: 99%

Evidence-based toxicology: Strait is the gate, but the road is worth taking

Silbergeld

Scherer

2013

ALTEX

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“…Toxicology, almost always involving nonhuman subjects, is the main source of such information. Bioethical principles of human subjects research have developed in response to several examples of morally reprehensible research involving humans over the past 70 years ( Josefson 2001 ; Katz et al 2006 ) that prohibit the deliberate testing of humans for the purpose of establishing toxicity without expected benefit to the subjects of such testing ( Silbergeld et al 2004 ).…”

Section: Introductionmentioning

confidence: 99%

Evidence from Toxicology: The Most Essential Science for Prevention

Mandrioli

Silbergeld

2016

Environ Health Perspect

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BackgroundThe most essential goal of medicine and public health is to prevent harm (primum non nocere). This goal is only fully achieved with primary prevention, which requires us to identify and prevent harms prior to human exposure through research and testing that does not involve human subjects. For that reason, public health policies place considerable reliance on nonhuman toxicological studies. However, toxicology as a field has often not produced efficient and timely evidence for decision making in public health. In response to this, the U.S. National Research Council called for the adoption of evidence-based methods and systematic reviews in regulatory decision making. The U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the European Food Safety Agency (EFSA) have recently endorsed these methods in their assessments of safety and risk.ObjectivesIn this commentary we summarize challenges and problems in current practices in toxicology as applied to decision making. We compare these practices with the principles and methods utilized in evidence-based medicine and health care, with emphasis on the record of the Cochrane Collaboration.DiscussionWe propose a stepwise strategy to support the development, validation, and application of evidence-based toxicology (EBT). We discuss current progresses in this field produced by the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program and the Navigation Guide works. We propose that adherence to the Cochrane principles is a fundamental prerequisite for the development and implementation of EBT.ConclusionThe adoption of evidence-based principles and methods will enhance the validity, transparency, efficiency, and acceptance of toxicological evidence, with benefits in terms of reducing delays and costs for all stakeholders (researchers, consumers, regulators, and industry).CitationMandrioli D, Silbergeld EK. 2016. Evidence from toxicology: the most essential science for prevention. Environ Health Perspect 124:6–11; http://dx.doi.org/10.1289/ehp.1509880

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“…In the notice, the U.S. EPA requested public comments on many different issues concerning industry-funded human studies submitted to the agency. The agency did not unconditionally endorse applicability of the Common Rule [Department of Health and Human Services (DHHS) 2001] to those studies, even though it has adopted the Common Rule for U.S. EPA–sponsored research (Silbergeld et al 2004). …”

Section: Introductionmentioning

confidence: 99%

Pesticide Testing on Human Subjects: Weighing Benefits and Risks

Resnik¹,

Portier

2005

Environ Health Perspect

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In the debate surrounding testing pesticides on human subjects, two distinct positions have emerged. The first position holds that pesticide experiments on human subjects should be allowed, but only under stringent scientific and ethical standards. The second position asserts that these experiments should never be allowed. In this article, we evaluate what we consider to be the strongest argument for the second position—namely, that the benefits of the experiments are not significant enough to justify the risks posed to healthy subjects. We challenge this argument by examining the benefits and risks of testing pesticides on human subjects. We argue that a study that intentionally exposes humans subjects to pesticides should be permitted if a) the knowledge gained from the study is expected to promote human health; b) the knowledge cannot be reasonably obtained by other means; c) the study is not expected to cause serious or irreversible harm to the subjects; and d) appropriate safeguards are in place to minimize harm to the subjects.

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Human Health Research Ethics

Cited by 3 publications

References 1 publication

Evidence-based toxicology: Strait is the gate, but the road is worth taking

Evidence-based toxicology: Strait is the gate, but the road is worth taking

Evidence from Toxicology: The Most Essential Science for Prevention

Pesticide Testing on Human Subjects: Weighing Benefits and Risks

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