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.Scientific and Ethical Issues Committee on the Use of Third Party Toxicity Research with Human Research ... (Moreno, 1999), embodied in the ten abasic principlesa for human research, now known as the Nuremberg Code. ... In 1953, Department of Defense Secretary Charles Wilson issued a directive outlining a policy for human research related to atomic, biological, and chemical warfare ( Wilson, 1953).
|Title||:||Intentional Human Dosing Studies for EPA Regulatory Purposes:|
|Author||:||Committee on the Use of Third Party Toxicity Research with Human Research Participants, Science, Technology, and Law Program, Policy and Global Affairs, National Research Council|
|Publisher||:||National Academies Press - 2004-06-04|