When Ellen M. Roche, 24, volunteered for the asthma experiment, she didn't expect to benefit from it--except for the $365 she'd be paid. Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds To find out, scientists led by Dr. Alkis Togias of Johns Hopkins University had Roche and other healthy volunteers inhale a drug called hexamethonium. Almost immediately Roche began to cough and feel short of breath. Within weeks her lungs failed and her kidneys shut down. On June 2 Roche died--a death made more tragic by the possibility that it was preventable. Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.
The worst part is that Hopkins, one of the nation's premier medical institutions, is not alone. Two years ago the inspector general of the Department of Health and Human Services warned that the system safeguarding human subjects is in danger of a meltdown. The boards that review proposed studies are overburdened, understaffed and shot through with conflicts of interest. Oversight is so porous that no one knows how many people volunteer to be human guinea pigs (21 million a year is an educated guess), how many are hurt or how many die. "Thousands of deaths are never reported, and adverse events in the tens of thousands are not reported," says Adil Shamoo, a member of the National Human Research Protections Advisory Committee and professor at the University of Maryland. Greg Koski, head of OHRP, has called the clinical-trials system "dysfunctional."
The OHRP findings on Hopkins are nothing short of devastating. After a three-day inspection last week, OHRP concluded that the Hopkins scientists failed to get information on the link between hexamethonium and lung toxicity, even though data were available via "routine" Internet searches and in textbooks. The drug is not approved for use in humans; the hexa-methonium Togias used was labeled [F]OR LABORATORY USE ONLY. The review board, OHRP charges, never asked for data on the safety of inhaled hexamethonium in people. The consent form that Roche signed states nowhere that hexamethonium is not approved by the FDA (the form describes it as a "medication") and didn't warn about possible lung toxicity.
Hopkins itself concluded that the review board did not do all it could to protect the volunteers, and suspended all 10 of Togias's studies. Still, the university--whose $301 million in federal grants for 2,000 human studies made it the largest recipient of government research money last year--is seething. "Hopkins has had over 100 years of doing clinical trials," says Dr. Edward Miller, CEO of Johns Hopkins Medicine. "We have had one death in all of those years. We would have done anything in the world to prevent that death, but [suspending the studies] seems out of proportion." Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous." OHRP is letting trials continue "where it is in the best interests" of subjects. The rest of the studies can resume once Hopkins submits a plan to restructure its system for protecting research subjects. How quickly that happens, says a government spokesman, depends on Hopkins.
1.In the opening paragraph, the author introduces his topic by
[A]explaining a phenomenon
[B]justifying an assumption
[C]stating an incident
[D]making a comparison
2.The statement “The OHRP findings on Hopkins are nothing short of devastating.”(Line 1, Paragraph 3) implies that
[A]The OHRP findings on Hopkins are much too impressive.
[B]The OHRP findings on Hopkins are much too shocking.
[C]The OHRP findings on Hopkins are much too convincing.
[D]The OHRP findings on Hopkins are much too striking.
3.The main reasons for Roche’s death are as following, except that _______.
[A]the protecting system hasn’t been set up
[B]the review board has neglected their duty
[C]the research team was not responsible enough for its volunteers
[D]the possibility of lung toxicity was overlooked
4.The OHRP has found that
[A]Hopkins has loose control over the experiment.
[B]the volunteers knew nothing about the experiment.
[C]there is something wrong with every aspect of the experiment.
[D]there exist many hidden troubles in human subjects safeguarding system.
5.What can we infer from the last paragraph
[A]Hopkins had no fault in this accident.
[B]Hopkins seemed not to quite agree with The OHRP
[C]Togias's studies shouldn’t be suspended.
[D]Hopkins wanted to begin their experiments as soon as possible.
答案:CBACB
篇章剖析
本文采用提出问题——分析问题的模式，着重分析了约翰-霍普金斯大学参与医学实验的自愿者死亡事件发生的原因以及产生的后果。第一段指出一名自愿者在人体实验中不幸死亡；第二段指出人体实验保护系统存在的漏洞和缺陷；第三段指出人类研究保护办公室在霍普金斯大学令人震惊的发现；第四段指出霍普金斯大学的态度和反应。
词汇注释
crackdown on sb/sth 制裁；取缔
therapy[5WerEpI]n.治疗
irritant[5IrItEnt]n.刺激物
shed light on sth. v.使某事清楚明白地显示出来
inhale[In5heIl]vt.吸入vi.吸气
hexamethonium[9heksEme`WEJnIEm]n.[药]六甲铵(降血压药)
premier[5premIE(r); (@) pri:5mIEr]adj.第一的, 首要的
inspector general n.检查长, 监察长
meltdown n. 彻底垮台
overburden[EJvE5b\:d(E)n]vt.装载过多, 负担过多, 使过劳
understaffed[QndE5stB:ft; (@) -5stAft]adj.人员不足的, 人手不足的
shot through with sth 很有（某气质）；充满着
conflict of interest 违背公众利益的行为,利益冲突
guinea pigs n.豚鼠
adverse[5Adv\:s]adj.不利的, 敌对的, 相反的
clinical trial n.临床试验
dysfunction[dIs5fQnkF(E)n]n.[医] 机能不良, 功能紊乱, 官能障碍
nothing short of 简直不比…差，简直可以说…
devastating[5devEsteItIN]adj.令人十分震惊的;具有强大冲击力的
toxicity[tCk`sIsEtI]n.毒性
FDA abbr.Food and Drug Administration(美国)食品及药物管理局
medication[medI5keIF(E)n]n.药物治疗, 药物处理, 药物
suspend[sE5spend]vt.吊, 悬挂v.延缓
recipient[rI5sIpIEnt]n.容纳者, 容器
seething[`si:TIN]adj.沸腾的, 火热的
CEO abbr.Chief Executive Officer 执行总裁
out of proportion 不合情理的
shutdown[5FQtdaJn]n.关门, 停工, (广播电台)停播(时间)
paralyze[5pArElaIz]制止，破坏阻碍进展或发挥功能；使无效或无力：
precipitous[prI5sIpItEs]adj. 急躁的, 鲁莽的, 轻率的
in the interests of 为了…的利益；为了…的缘故：
submit to v.使服从, 使受到, 服从, 忍受；呈递，提交
restructure[ri:5strQktFE(r)]vt.更改结构, 重建构造, 调整, 改组
难句突破
Unlike clinical trials, in which most patients hope that an experimental therapy will help them, this study was designed just to answer a basic question: how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds
主体句式：… this study was designed to answer a basic question…
结构分析：“Unlike clinical trials”做句子的伴随状语，介词“unlike”的意思是“不象…一样”，后面跟“in which”引导状语从句来修饰“clinical trials”；状语从句中“hope”后面跟的是“that”引导的宾语从句；“how does the way a normal lung reacts to irritants shed light on how an asthmatic lung responds”是“a basic question”的同位语；其中“a normal lung reacts to irritants”做后置定语来修饰“the way”;词组“shed light on”意思是“使某事清楚明白地显示出来”。
句子译文：在临床实验中，大多数病人都希望实验性的疗法能够缓解他们的病情。但是这项研究跟临床实验有所不同，它旨在回答一个基本的问题：如何利用正常的肺对刺激物的反应方式来弄清楚哮喘病人的肺的反应。
题目分析
1.答案为C，属事实细节题。文章开头作者以科学实验的一个牺牲者为例引出论题。
2.答案为B，属推理判断题。文中“nothing short of”和“devastating”是本句的语言难点：“nothing short of”意思是“完全是; 简直可以说”；“devastating”意思是“令人十分震惊的;具有强大冲击力的”。即使没有这些语言知识，根据上下文也能作出判断，分析如下：“The OHRP findings on Hopkins are nothing short of devastating.”是所在段落的中心句，后面给出的事例是为了进一步说明这一论点。我们从所给事例可看出这起事故出自多方的责任，也存在一些违归操作，其中出现的失误真是令人震惊。
3.答案为A，属事实细节题。原文对应信息是“Last week the federal Office for Human Research Protections (OHRP) ruled that Hopkins's system for protecting human subjects is so flawed that virtually all its U.S.-supported research had to stop.”从这个句子我们可以看出虽然存在保护系统，但是这一系统漏洞百出，缺陷太多。因此选项A不正确。选项B、C、D在文中第三段可找到所对应信息。
4.答案为C，属推理判断题。人类研究保护办公室在霍普金斯大学发现了实验过程中存在的很多问题。
5.答案为B，属推理判断题。从句子“but [suspending the studies] seems out of proportion”和“Hopkins calls the shutdown of its experiments "unwarranted, unnecessary, paralyzing and precipitous."”我们可看出霍普金斯大学就此事的观点和态度。
参考译文
当24岁的Ellen M. Roche决定做一项哮喘病研究试验的志愿者的时候，她并没有期望从中获取什么好处——除了应支付她的365美元。在临床实验中，大多数病人都希望实验性的疗法能够缓解他们的病情。但是这项研究跟临床实验有所不同，它旨在回答一个基本的问题：如何利用正常的肺对刺激物的反应方式来弄清楚哮喘病人的肺的反应。为了寻找答案，约翰-霍普金斯大学的Alkis Togias博士让Roche和其他一些健康志愿者吸入一种叫做六甲铵的药物。Roche刚一吸入就开始咳嗽，并且感觉呼吸急促。几周之后，她的肺功能减弱，而且肾脏衰竭。六月二号Roche死亡——这起死亡事件完全有可能避免的，这更加重了它的悲剧色彩。上周，联邦人类研究保护办公室(OHRP)作出裁决：霍普金斯大学对实验人体的保护体系缺陷太多，所有美国支持的研究项目都必须停止。
最糟糕的是，这种情况并不单单只发生在作为全国首屈一指的医疗机构之一的霍普金斯大学。早在两年前，健康与人类服务部监察长就曾警告说，保护实验人体系统有陷于崩溃的危险。负责审阅那些建议性研究的委员会负荷过重，人手不足，充满利益冲突。监管方面漏洞百出，无人确切知晓到底有多少人自愿象实验用的豚鼠一样成为实验对象（根据经验作出的猜测大概是每年2，100万），有多少人受伤，或有多少人死亡。“数千起死亡案例从来没有被公之于众，好几万例不利事件也从未被报道过。”国家人体研究保护咨询委员会成员，同时又是马里兰大学教授的Adil Shamoo如是说。人类研究保护办公室主任把临床试验体系称为“功能失常”。
人类研究保护办公室在霍普金斯大学的发现简直可以说是令人震惊万分。上周，经过为期三天的检查之后，人类研究保护办公室得出如下结论：霍普金斯大学的科学家没能获得六甲铵与肺毒性之间存在着联系这方面的资料，虽然这些资料可以通过“常规”因特网搜索和教科书来获得。这种药物还未经准许用于人体，而且Togias使用的六甲铵药品上还标注有“只用于实验室”的字样。人类研究保护办公室还指控复核委员会从未索要有关人体可吸入的六甲铵的安全用量方面的数据。Roche签署的同意表格里并没有注明六甲铵药品未经美国食品及药物管理局批准使用（表格里只说明它是一种“药物”），更没有告知有可能会出现的肺毒性。
霍普金斯大学自己做出的结论是复核委员会没有尽全力保护好自愿者，并且中止了Togias多达十项的所有研究项目。这所大学——联邦政府授予的高达3.01亿美元用于人体研究的拨款使它成为去年接受政府研究资金最多的学校——现在仍然为此事感到义愤不平。“霍普金斯大学做临床试验的历史长达100多年，” 约翰-霍普金斯医学院执行总裁爱德华·米勒博士说，“这么多年来我们只出现了这么一起死亡事故。如果能避免这起死亡事故，让我们做什么事情我们都愿意。但是，中止研究这样的作法似乎有些不近情理。” 霍普金斯大学把中止实验这种做法称为“无根据的、不必要的、阻碍进展的、轻率的”行为。人类研究保护办公室准许继续进行那些对实验对象“最为有利的实验”。至于其它研究，只要霍普金斯大学提出重组保护研究对象体系的方案，就可以继续进行。政府发言人说，这究竟还需多久，全在于霍普金斯大学他们自己了。