Researchers say changes needed in recruitment policies for NIH trials.
Researchers say changes needed in recruitment policies for NIH trials.
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研究人员表示，美国国立卫生研究院试验的招募政策需要改变。
DOI：
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发表时间：
2003
期刊：
影响因子：
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通讯作者：
B. Vastag
中科院分区：
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作者：
B. Vastag
涉及农药和人类的毒性研究一直被美国环保署接受，直到1998年该机构实施暂停，理由是20世纪80年代开始出现的科学和伦理问题。这一行动，沿着1996年《食品质量保护法》的通过（该法案通过另一个可变的不确定因素降低了儿童体内允许的农药含量），促使农药制造商对环保署提起诉讼，迫使该机构取消暂停令。该诉讼的口头辩论定于3月开始。在法律的程序展开的同时，NAS委员会的工作仍在继续。位于加尔维斯顿的得克萨斯大学医学分支医学人文研究所的研究伦理学家哈罗德·范德普博士质疑NAS是否能为足以解除EPA暂停的人体毒性测试找到伦理理由。“人类研究的一个标准必须是利益和危害的平衡，”范德普说。“此外，有义务做好事，也有义务不做坏事。不造成伤害的责任是一个更严格的要求，我不确定这种毒性测试是否可以辩护。NAS委员会预计将在12月公布其建议。美国环保署在没有强制期限的情况下工作，然后将考虑该小组的建议，并决定是否将人类毒性研究纳入化学品审批程序。
Toxicity studies involving pesticides and humans were accepted by the EPA until 1998 when the agency imposed the moratorium, citing scientific and ethical concerns that began emerging in the 1980s. The action, along with passage of the Food Quality Protection Act of 1996 (which reduced allowable pesticide levels in children by yet another variable uncertainty factor) prompted pesticide manufacturers to file a lawsuit against the EPA to force the agency to lift the moratorium. Oral arguments in that suit are scheduled to begin in March. While the legal process unfolds, the NAS committee’s work continues. Harold Vanderpool, PhD, a research ethicist with the Institute for the Medical Humanities, University of Texas Medical Branch in Galveston questions whether the NAS can find ethical justification for human toxicity testing that would be sufficient to lift the EPA moratorium. “One criterion for human research has to be a balance of benefits and harms,” said Vanderpool. “Also, there is a duty to do good and a duty not to do harm. The duty not to do harm is a more stringent requirement, and I’m not sure this toxicity testing can be defended.” The NAS committee is expected to release its recommendations in December. The EPA, working under no mandated deadline, will then consider the group’s advice and make a decision whether to include human toxicity studies into the chemical approval process.