and Law Program Science, Technology – författare
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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 can''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–both at the beginning and upon completion of the experiments–if they are carried out with the intent of affecting the agency''s policy-making.
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The National Academies Science, Technology, and Law Program convened three workshops focusing on specific aspects of OMB''s "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies." The workshops were intended to assist the agencies in developing their agency-specific implementation guidelines. This workshop report details the approaches agencies are considering using to implement the guidelines.
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The National Academies Science, Technology, and Law Program convened three workshops focusing on specific aspects of OMB''s "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies." The workshops were intended to assist the agencies in developing their agency-specific implementation guidelines. This workshop report details the approaches agencies are considering using to implement the guidelines.
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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 can''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–both at the beginning and upon completion of the experiments–if they are carried out with the intent of affecting the agency''s policy-making.
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