PBS高端访谈:院方因未透漏早产儿临床研究的风险而遭起诉

 　　JUDY WOODRUFF: Now the questions surrounding a research trial with newborn babies that allegedly didn't provide adequate disclosure to parents.

　　The trial involved 1,300 infants at 23 hospitals who were born extremely prematurely² between 2004 and 2009. Doctors were trying to better determine the right amount of supplemental oxygen they need to give to preemies. If the oxygen level is too low, babies can die. But if the rate is too high, it can lead to eye disease and blindness.

　　In the trial, half of the babies were assigned to a lower dose, half to a higher amount. But, last month, the federal Office of Human Research Protections concluded that there wasn't appropriate informed consent. In a letter to the centers, it said hospitals failed to "describe adequately the reasonably foreseeable risks of blindness, neurological damage, and death."

　　The nonprofit watchdog group Public Citizen brought that letter to light this week.

　　And we get more now with David Brown. He's a reporter for The Washington Post.

　　David Brown, welcome to the program.

　　Explain in shorthand, what was this study designed to do?

　　DAVID BROWN, The Washington Post: Well, it was designed to answer a question that has been unanswered and that people have been trying to answer since the 1950s, when it was discovered that oxygen at high concentrations given to premature¹ infants can cause very unexpectedly really serious eye damage and lead to blindness.

　　The problem was that when oxygen was limited to many of these premature infants, their brain didn't get enough oxygen to develop. Many of them developed retardation³. Some of them died. So there has been a real problem for literally⁴ half-a-century to determine what the right amount of oxygen is to sort of balance these two bad outcomes, on the one hand, death and brain damage, and on the other hand blindness.

　　JUDY WOODRUFF: And what was the outcome of this study?

　　DAVID BROWN: Well, this study showed that, as previous studies had hinted, that if you limit the oxygen that premature infants are getting—this is all supplementary⁵ oxygen—this is more oxygen than you get from breathing air—but if you keep it at the lower end of what was the standard of care, then you reduce the chances of them becoming blind, but you slightly increase the chance of them dying.

　　JUDY WOODRUFF: And along the way to that outcome, though, there are now questions being raised about whether parents were adequately notified about the risks.

　　What is known about what parents were told?

　　DAVID BROWN: Well, parents were told that the current standard of care is to keep the amount of oxygen as measured by saturation⁶ of hemoglobin in a range between 85 percent and 90 percent, and that this was standard of care, and that all the babies were going to get oxygen that kept their blood at that -- in that range.

　　What wasn't adequately described is that there was going to be an attempt to essentially—well, to definitely create two groups. One-half of the babies would be randomly⁷ assigned to get oxygen at the low end of the normal range, and the others were randomly assigned to get oxygen at the high end.

　　And the idea was to see if one of these two subranges was better than the other. And the fact that at one of them, there might be a higher risk of blindness and at the other end a higher risk of death, that really wasn't laid out in detail.

　　JUDY WOODRUFF: But now there's a dispute. The University of Alabama at Birmingham, which was the lead hospital out of, I guess, 23 medical institutions that were engaged in this study, they are saying that throughout this trial, they—that physicians conformed to what's called the standard of care.

　　But Public Citizen, the criticism is that they didn't provide—they didn't stay within the band of so-called standard of care. How is that going to be resolved?

　　DAVID BROWN: Well, they did stay within the band of standard of care as measured by these two—this range of hemoglobin saturation, namely 85 percent to 95 percent.

　　Babies who are not in a trial like this, the physician with—conferring with the parents usually, decides someplace where in that range the doctor and the parents think might be best. And, actually, it's somewhat hard to keep infants from—at 1 percentage of saturation, they tend to bounce around.

　　But the—even though that is the standard band of care, there is not enough knowledge to know what is the sweet spot in that—in that range of 85 percent to 95 percent. And this trial was trying to find that sweet spot. The people who ran it say everyone was in the standard of care, and there was actually some evidence that the lower end wasn't only protected against blindness, but might actually increase the survival of these kids.

　　So, it just didn't go into the whole back story. How it will be resolved is—remains to be seen.

　　JUDY WOODRUFF: Well, that's what I wanted to ask you.

　　Attempts now being made to reach out to the parents of these 1,300 infants—of course, some of them did die. Some of them ended up with blindness or other vision issues. What's being done right now to reach out to those families?

　　DAVID BROWN: Well, it should be noted⁸ that babies were going to die, babies were going to go blind whether this trial was run or not, because that is just the hazards of extreme prematurity⁹ and oxygen therapy.

　　At the moment, this office, OHRP, is negotiating with the University of Alabama at Birmingham as to what they're going to do. They have basically been told do a better job next time with informed consent. But whether this is going to involve a formal apology to the parents hasn't been decided¹⁰.

　　The people who've run the trial don't think they did anything wrong. They think that they had adequate explanation of the trial and truly informed consent. But the OHRP office says they didn't. And it's now a matter of negotiation¹¹, what they tell the parents.

　　JUDY WOODRUFF: This is the Office of Human Research Protections we mentioned that falls under the Department of Health and Human Services.

　　So, just quickly, David Brown, who or what is to determine now whether there was liability in all this?

　　DAVID BROWN: Well, of course, that's a big question that the Office of Human Research Protections doesn't want to the address. In fact, I asked them about that today.

　　If there is an apology, and that can be interpreted by a lawyer as some statement of culpability¹² and liability, there probably will be lawsuits¹³. But it's clear that blindness and death were going to happen regardless of the study. And it may be difficult to pinpoint¹⁴ which babies actually had a bad outcome because of the study.

　　JUDY WOODRUFF: David Brown, reporter for The Washington Post, thank you very much.

　　DAVID BROWN: You're welcome.

1 premature   

adj.比预期时间早的；不成熟的，仓促的

参考例句：

• It is yet premature to predict the possible outcome of the dialogue.预言这次对话可能有什么结果为时尚早。
• The premature baby is doing well.那个早产的婴儿很健康。

2 prematurely   

adv.过早地，贸然地

参考例句：

• She was born prematurely with poorly developed lungs. 她早产，肺部未发育健全。 来自《简明英汉词典》
• His hair was prematurely white, but his busy eyebrows were still jet-black. 他的头发已经白了，不过两道浓眉还是乌黑乌黑的。 来自辞典例句

3 retardation   

n.智力迟钝，精神发育迟缓

参考例句：

• Asbestos reinforcement confers excellent flame retardation properties on a composite. 石棉增强材料使复合材料具有优异的防火性能。
• The theory confirms the increase in the retardation effect with decrease in particle size. 理论证实，随着颗粒尺寸的减小，这一减速效应将增大。

4 literally   

adv.照字面意义，逐字地；确实

参考例句：

• He translated the passage literally.他逐字逐句地翻译这段文字。
• Sometimes she would not sit down till she was literally faint.有时候，她不走到真正要昏厥了，决不肯坐下来。

5 supplementary   

adj.补充的，附加的

参考例句：

• There is a supplementary water supply in case the rain supply fails.万一主水源断了，我们另外有供水的地方。
• A supplementary volume has been published containing the index.附有索引的增补卷已经出版。

6 saturation   

n.饱和(状态)；浸透

参考例句：

• The company's sales are now close to saturation in many western countries.这家公司的产品销售量在许多西方国家已接近饱和。
• Road traffic has reached saturation point.公路交通已达到饱和点。

7 randomly   

adv.随便地，未加计划地

参考例句：

• Within the hot gas chamber, molecules are moving randomly in all directions. 在灼热的气体燃烧室内，分子在各个方向上作无规运动。 来自辞典例句
• Transformed cells are loosely attached, rounded and randomly oriented. 转化细胞则不大贴壁、圆缩并呈杂乱分布。 来自辞典例句

8 noted   

adj.著名的，知名的

参考例句：

• The local hotel is noted for its good table.当地的那家酒店以餐食精美而著称。
• Jim is noted for arriving late for work.吉姆上班迟到出了名。

9 prematurity   

n.早熟，过早，早开花

参考例句：

• Associated anomalies and prematurity significantly influence the mortality rate. 并发畸形与早产儿显著地影响死亡率。 来自辞典例句
• Prematurity may also result in visual impairment or blindness. 早产也可导致视力障碍或失明。 来自互联网

10 decided   

adj.决定了的，坚决的；明显的，明确的

参考例句：

• This gave them a decided advantage over their opponents.这使他们比对手具有明显的优势。
• There is a decided difference between British and Chinese way of greeting.英国人和中国人打招呼的方式有很明显的区别。

11 negotiation   

n.谈判，协商

参考例句：

• They closed the deal in sugar after a week of negotiation.经过一星期的谈判，他们的食糖生意成交了。
• The negotiation dragged on until July.谈判一直拖到7月份。

12 culpability   

n.苛责，有罪

参考例句：

• As if the estrangement between them had come of any culpability of hers. 姐弟俩疏远的责任竟仿佛落到了她的身上！ 来自英汉文学 - 双城记
• The offence, as now defined in English law, covers a wide spectrum of culpability. 英国法律规定，违法包括很多种过失行为。 来自互联网

13 lawsuits   

n.诉讼( lawsuit的名词复数 )

参考例句：

• Lawsuits involving property rights and farming and grazing rights increased markedly. 涉及财产权，耕作与放牧权的诉讼案件显著地增加。 来自辞典例句
• I've lost and won more lawsuits than any man in England. 全英国的人算我官司打得最多，赢的也多，输的也多。 来自辞典例句

14 pinpoint   

vt.准确地确定；用针标出…的精确位置

参考例句：

• It is difficult to pinpoint when water problems of the modern age began.很难准确地指出，现代用水的问题是什么时候出现的。
• I could pinpoint his precise location on a map.我能在地图上指明他的准确位置。