Intentional Human Dosing Studies for EPA Regulatory Purposes

- Scientific and Ethical Issues

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Intentional Human Dosing Studies for EPA Regulatory Purposes
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Format:
Bog, paperback
Udgivelsesdato:
04-06-2004
Sprog:
Engelsk
Sidetal:
226
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The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: * The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that cana (TM)t be answered with animal studies or nondosing human studies; * The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and * All recognized ethical standards and procedures for protecting the interests of study participants are observed.* In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies a " both at the beginning and upon completion of the experiments a " if they are carried out with the intent of affecting the agency's policy-making.

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Udgivelsesdato:
04-06-2004
ISBN13:
9780309091725
Bredde:
152 mm
Højde:
229 mm
Format:
Paperback
Bibliotekernes beskrivelse The EPA commissioned the National Academies to provide advice on whether and, under what circumstances EPA should accept and consider intentional human dosing studies to gather evidence relating to the risks of a chemical. This report recommends that such studies be conducted and used for regulatory purposes only if the strict conditions are met.

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