近日，南宁市桃源南社区一栋居民楼下出现一张医院征集受试者参与新药品临床研究的广告，一时间在社区引起众多居民的热议，“是去做试验品？”“不会是乱来的吧？”“这种行为合法吗？”居民对此议论纷纷。10月16日至17日，记者前去了解情况，广西食品药品监督管理局有关部门也对此作出了回应。

recently,Nanning city south taoyuan community residents in a building in a hospital downstairs for subjects participate in new drug clinical research advertising,Time in the community caused numerous residents' hot debate,"Is to do a test article?""Won't be fooling around it?""This kind of behavior legal?"Residents to comment in succession.October 16 to 17,Reporters to understand the situation,Guangxi food and drug supervision and administration relevant departments also have responded to this.

居民反映： Residents reflect:

小区出现非同寻常小广告 Village appear unusual small advertising

　　10月16日，记者来到桃源南社区看到，广告已经被居民撕下来，但还是有很多人议论纷纷。

On October 16,,The reporter comes to taoyuan south community to see,Advertising has been residents to tear down,But there are still many people comment in succession.

　　记者看到，该招募广告上大致写着：广西一家公立医院正在进行一项治疗细菌性结膜炎的药品的临床研究，该药品2003年已在美国批准上市，此次临床研究正在招募受试者以期在中国能上市。广告上还写出受试者条件及联系人姓名和电话等，但结尾没有落款和盖章。居民梁阿姨说，这则广告贴有一两天了，她第一次看到时并没太在意，以为是保健药品在贴小广告宣传，但16日开始有不少居民在谈论此事，有居民担心是他人假借大医院之名进行违法的药品研究，梁阿姨担心居民上当受骗，所以就把广告撕了下来。

The reporter sees,This recruit advertisement generally write:Guangxi a public hospital is going to carry out a treatment of bacterial conjunctivitis drug clinical research,The drug has been approved in the United States in 2003 listed,The clinical research is to recruit subjects in China can be listed.Advertising also write subjects conditions and contact name and telephone, etc,But the end no badging and affix one's seal.Residents beam aunt said,The AD the labeled a day or two,When she first saw and didn't care about,Thought is the health care drugs in the post is a small advertising,But 16 began to have a lot of people are talking about it,Residents have worry is that others in the guise of big hospital the name of illegal drug research,Beam aunt worry people rise to the bait,So the advertising tore down.

医院解释： Hospital explain:

不是谁都可以成为受试者 Not everyone can become a subjects

　　16日，记者与该临床研究项目的罗医生取得联系。罗医生表示，该医院确实在进行这种眼科药品的临床研究，且有国家相关部门的批件，临床研究严格按照国家相关规定执行。由于近期到医院就诊的这类病人较少，因此他们才到居民小区张贴招募广告。

16,Reporters and the clinical research project ROM. The doctor get in touch.ROM. The doctor said,The hospital did in the ophthalmic drug clinical research,And the relevant state department approval,Clinical research in strict accordance with the relevant state provisions.Due to the recent to this kind of hospital patients less,So they just to residential area post recruitment advertisement.

　　在该医院六楼眼科，记者看到有几个居民看到广告后也来咨询。罗医生说，只有符合眼部发红、眼部瘙痒或者眼部有黄色或绿色分泌物等症状，且不存在使用过其他眼部药物等条件的才可以进入初选，医生还会根据应征者治疗和病史等因素来决定其能否参与到该项临床研究当中。如果受试者满足条件，他们会跟受试者讲明利害关系并签订“知情同意书”，实验结束后会根据受试者参与的次数和程度对受试者进行务工补助等。罗医生说：“不是每个人都可以成为受试者，这是一个双选的过程，符合条件的受试者明晰各方面情况后可自愿选择是否参加。”

In the hospital the sixth floor eye,The reporter sees a few residents after see advertisements also to consultation.ROM. The doctor said,Only accord with red eye/Eye itching or eye have yellow or green secretion wait for a symptom,And does not exist used other eye conditions of drugs can enter the primary,The doctor will also according to factors such as candidates treatment and history to determine whether it can participate in the clinical studies.If participants meet the requirements,They will speak with subjects interests and sign"Informed consent",After the experiment according to subjects to participate in the number of times and the degree of subjects such as work subsidies.ROM. The doctor said:"Not everyone can become a subjects,This is a double choose process,Eligible subjects on all aspects of the clear after voluntary choice whether or not to participate."

部门说法： Department statement:

按规定进行研究属合法行为 According to the provisions of the legal behavior research

　　医院贴广告招募受试者参与临床研究是否符合相关规定？记者向广西食品药品监督管理局有关部门寻求答案。

Hospital advertised recruiting subjects participating in clinical research in compliance with the relevant provisions?Reporter to guangxi food and drug supervision and administration relevant departments to seek the answer.

　　该局药品注册处的一名工作人员答复称，药品在推广上市前必须做临床研究实验。该医院有临床实验的资质，具有临床实验资质的医院在取得国家食品药品监督管理局的相关批件后，按照国家相关规定进行临床研究是合法的。进行临床研究时，必须与受试者签订“知情同意书”，知情同意书上写明实验的过程和背景材料。受试者以自愿为原则，如果已参加临床研究实验的受试者想中途退出，也可随时退出。如果医院中途发现受试者不符合他们的条件，也可以中途将受试者剔除。

The drug registry of a staff reply said,Drug in the promotion before listing must do clinical research experiment.This hospital has the qualifications of clinical trials,Has the qualification of clinical trials in hospital has the state food and drug administration after the approval related,In accordance with the relevant state provisions for clinical research is legal.To conduct clinical study,Must be signed and subjects"Informed consent",Informed consent mention expressly on the experiment process and background material.Subjects to volunteer for the principle,If already participating in clinical research experiment of subjects want to fall by the wayside,Also you may withdraw at anytime.If the hospital found that subjects did not meet their condition,Can also midway will eliminate the subjects.

　　该工作人员提醒，进行实验的医疗机构应该跟受试者讲明实验的收益和风险，任何临床实验都具有一定的风险，应征的居民应慎重对待。(当代生活报 记者 农芝)

The staff reminded the,Experiment of medical institutions should follow participants to stipulate the returns and risk,Any clinical experiment has certain risk,The inhabitants of to should be taken seriously.(Contemporary ShengHuoBao reporter agriculture cheese)