解放军文职招聘考试案例3：食管癌治疗研究

 案例3：食管癌治疗研究
Case 3: Research on Treating Esophagus Cancer

在食道癌手术后进行放射是否有效的问题上已经争论三十年。悬而未决的原因可能只对少数病人进行过研究，也不清楚哪些病人能从手术后放射疗法中获益最大。
从1986到1997年间，中国一家医院开展了一项为期12年的前瞻性研究以确定食道癌手术后进行放射的治疗价值。为数达485名的食道癌病人在做过完全切除手术后加入了这项研究。这485名病人被随机地分成两组。其中有275名只接受手术治疗，剩下的210名病人既接受手术治疗，也接受放射治疗。病人被告知他们有权选择手术之后是否接受放射治疗。在整个过程中并未有任何伦理方面的审查，因为那时在中国进行临床研究并不要求进行伦理审查。这项研究的结果表明只接受手术治疗的病人五年的存活率总共为32%，相比之下，接受手术加放射治疗的病人的存活率达41%。
这一实验的研究负责人将结果写成论文送交给一家美国医学期刊。该期刊发表了这篇论文，但在论文后面发表了编者按语，大意是说，这项研究解决了一个重要的医学课题，但这项研究不符合伦理，因为违背了知情同意原则，即病人未被告知他们参加的是一项研究，因此他们并非自愿成为研究受试者。在同一期的期刊上，又刊出了一篇名为《不符合伦理的研究报告的发表——知情同意的重要性》的文章。该文章的作者指出“与纳粹的行为和塔斯基奇Tuskegee的实验相比，该研究并非很不合伦理”。 该作者又评论道，中国是一个“专制”国家并且在人权方面多受非议，同时又“强制堕胎和绝育”，所以很容易理解中国在临床研究方面滥用受试者这一现象。主编在刊出这一评论文章前，并未与中国科学家进行过商讨。

问题：
1、20世纪80年代，中国并未有任何有关知情同意的文件，也未开展过任何伦理审查。我们是否可以用目前在美国实行的最新伦理标准来评判这一为期12年的研究是否合乎伦理？
2、该研究的质量和研究成果的意义都很好，是否可以不计较在知情同意方面的欠缺？
3、此案例中，病人未被告知他们参加的是一项临床研究，他们因此受到了怎样的伤害？
4、该杂志主编是否应该给此中国作者一个机会以回应那些批评？

 

Case 3: Research on Treating Esophagus Cancer

Despite three decades of debate, no conclusion has been reached concerning the effectiveness of postoperative radiotherapy for respected esophageal carcinoma. This lack of consensus was related to a scarcity of reports and insufficient numbers of patients studied.  Further, it was unknown which patients, if any, would benefit most from such treatment.

From 1986 through 1997, a prospective randomized study was carried out in a well-respected cancer hospital in China to define the value of this therapeutic modality. A total of 485 patients with esophageal cancer who had undergone radical resection were enrolled in the study. Patients were divided into two randomized groups. 275 had surgery only, while the other 220 had surgery plus radiotherapy.  Radiation treatment was started 3 to 4 weeks after the operation.

The subjects were told they were involved in an innovative therapy rather than in a clinical trial. Each patient could decide whether or not to be treated and had the opportunity to refuse operation or radiotherapy. There was no ethical review procedure in this hospital and few institutions in China had such process. The results of the study demonstrated that the overall 5-year survival rate was 32% with the surgery only and 41% with the surgery plus radiotherapy. The five-year survival rate of those with stage III disease was 14% and 35%, respectively.

The principal investigator reviewed the data and submitted the final paper to a well respected USA-based medical journal. The editor and reviewers believed that the information learned from this study addressed an important question and provided useful information regarding management of this disease The editor commented, however, that this article breeched an important ethical standard in that patients were not informed that they were part of a research study and thus could not voluntary consent to be research subjects. Despite this shortcoming, the editor thought that the quality of the study and the importance of its findings outweighed the ethical transgression, and the paper was published..

The journal, however, publish a related article in the same issue, titled “Publication of unethical research studies: the importance of informed consent”. The author of this article stated that “the study was not egregiously unethical, on the order of the Nazi experiments or Tuskegee study.”  The author who commented that China is an authoritarian state and has been accused of many human rights abuses, forced abortions and sterilizations, it was easy to understand the abuse of human subject in clinical trials. The editor published this commentary article without discussion with the scientists from China.

Questions for discussion:

1.What is the difference between innovative therapy and a study to assess a new treatment?
2.There was no informed consent document and ethical review conducted in China in the 1980s. Can we use the latest ethical standard practiced in U.S.A. to determine whether this 12-year study is ethical or not?
3.Should the quality of the study and the importance of its findings outweigh the perceived ethical transgression?
4.What harm was done to the patients by not informing them that they were subjects in a study?
5.Should the editor give the Chinese author an opportunity to respond to the critics?