亲爱的志愿者朋友：

真诚地欢迎您参与我院的临床研究。在您决定参加一项临床研究之前，请您仔细阅读以下内容以充分保障自己的权益。

感谢您为医学发展所作的无私奉献。

Dear Participants:

We sincerely welcome you to participate in clinical research. Before you decide to participate in a clinical research, please read the following in order to fully protect your interests.

Thank you for your selfless dedication on the medical development.

什么是临床研究或试验？

临床研究或试验是为了了解或解决一个疾病或健康问题而进行的一次有计划的有健康人或患者参加的研究。

一次研究或试验可能是为了达到以下目的：

Ÿ　了解人们对疾病或一般健康知识的需求。

Ÿ　对药物或设备的安全性和有效性进行测试。

Ÿ　确定治疗和预防疾病的最佳方式。

Ÿ　找出最有成效的健康护理方式。

What is a research study?

A research study is an organized way of learning more about a problem or answering a question.

A research study may be done to:

• Understand health needs, concerns, or feelings people have about an illness or their general health.

• Test if a product, such as a drug or piece of equipment, is safe and effective.

• Determine the best way to treat or prevent an illness.

• Find out what health care practices work best.

我参与研究会受益吗？

试验用药在开始用于人的临床试验之前会进行一系列的药理学、毒性以及动物试验。临床试验又分为Ⅰ~Ⅳ期。没有人可以预测一项研究的确切结果。一般来说，期别越高，您可能的受益越多。例如，参与Ⅰ期临床试验不能确定会给您的健康或健康状况带来直接的好处，但是参与研究所提供的信息可能为人类攻克某种疾病提供有力帮助；而Ⅱ-Ⅳ期期临床试验极有可能对您所患疾病有较好的治疗作用。

所以您能否临床研究中受益与否或受益大小可能和研究药物临床试验前的研究结果以及试验所处的期别有关。

我们这里只是泛泛而谈研究受益的可能性，每一个临床研究的可能受益的情况会在项目中仔细阐述，因此我们建议您如果对某项研究有兴趣，最好有针对性的阅读或咨询具体研究项目。

Are there benefits to being in a research study?

Study drugs have been done a series of pharmacology, toxicity and animal testing before clinical trials. Clinical trials are divided into Ⅰ~Ⅳ period. No one can predict the exact results of a study. In general, the higher of the trial, you may benefit more. For example, in phase Ⅰ clinical trial will not sure bring immediate benefits to your health or health condition, but the information provided in the study may provide effective help to overcome a disease; and Ⅱ-Ⅳ of clinical trial is likely to have better therapeutic effect for your disease.

So whether you can benefit from it or not is related to the result of the research before the clinical trial and the phase of the clinical trial.

We are here only generalities of the possibility of benefit, each clinical study will be carefully explained in the project, so we recommend that if you are interested in a study, you should do targeted specific reading or consulting the research projects’ informer.

我参与研究会有风险吗？

药物临床试验的目的就是要获得一种研究性药物用于人体的安全性和疗效结果。因而任何一项临床试验都有不能预期的潜在风险。但是在用于人体之前肯定会有一些实验室或动物实验的数据提示可能的风险，药监部门会召集专家论证、严格审批，研究者也会根据可能的风险制定出应对措施；在临床试验过程中会严密观察您的反应和身体状况，一旦出现不适会及时处理。所以您参加一项临床研究不排除有一定风险的可能性，但也会有一系列措施使这些风险最小化。在研究记录中涉及到的您的个人信息和隐私会像常规病历一样机密保存。

Are there risks to being in a research study?

The purpose of clinical trials research is to obtain safety and efficacy informations of a drug for human. Thus any one clinical trial have potential risks that could not be expected. But certainly there will be some hint from the laboratory data or animal experimental. SFDA will convene experts to strict examine and approve; the researchers will develop procedures how to deal with the possible risks; you will be closely observed in clinical trials.Once your physical condition is out of sorts there will be a timely treatment. So you participate in a clinical study does not rule out the possibility of a certain risk, but also a series of measures to minimize these risks. Like your medical record, the information in your research record will be kept confidential.

什么是知情同意？

知情同意是在了解有关临床研究的细节和背景之后决定是否参加试验作为受试者的过程。您同意作为志愿者之前必需清楚地了解真实的研究过程以及可能对您产生的影响。

知情同意开始时研究人员会向您解释研究的具体过程、您可能经历的程序如需要做什么检验、怎样用药等、可能的受益和风险，以及作为一名研究志愿者的权利。

如果您的问题已经得到答复，并且您已经完全了解有关研究试验的真实情况并决定参加试验，就需要签署一份“知情同意书”。请仔细阅读知情同意书，如果您有任何问题，请向研究人员询问。在决定前，与家庭成员、朋友或您的医生商量也是很有帮助的。

What is informed consent?

Informed consent is the process of learning important facts about the research study before you decide whether or not to volunteer. If you agree to volunteer, it should be based on a clear understanding of what will take place in the study and how it might affect you.

Informed consent begins when the research staff explains the study to you. These facts include details about the study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.

Once your questions have been answered and you fully understand the facts about the research study, you will be asked to sign an “informed consent form.” You should take your time when you read the informed consent form. If you have any questions, ask the research staff to explain. It may be helpful to talk with family members, friends, or your health care providers before you make a decision.

在同意作为志愿者之前，我应该咨询哪些问题？

如果您被邀请作为志愿者时，您需要了解以下问题，然后决定是否参与研究。

Ÿ　谁负责这次研究，这项研究想要解决什么问题？

Ÿ　什么部门审查并批准了这项研究？

Ÿ　如果我参与研究，我的健康会受到什么影响（好的或坏的）？

Ÿ　我可能被分配到安慰剂组吗？

Ÿ　在研究期间，我会接受哪些检查？程序是怎样的？

Ÿ　这项研究会持续多久？

Ÿ　如果我决定参与，对我的日常生活将产生什么影响？

Ÿ　由谁负责对我进行治疗？我可以继续到门诊看病吗？

Ÿ　我需要为这次研究支付一些费用吗？

Ÿ　我参加这次研究需要告诉谁？他们会收到什么信息？

Ÿ　我的试验标本（如血、尿、便）会被用来做什么？

Ÿ　研究结束后，我会发生什么变化？

Ÿ　研究结果会告诉我吗？

Ÿ　我如果改变主意，该如何停止参与研究？

Ÿ　如果我决定不参与这次研究，我还有其它的选择吗？

Ÿ　要了解有关本次研究的问题和信息需和谁联系？

Ÿ  试验期间可以怀孕吗？

What questions should I ask before volunteering?

If you are asked to participate in a research project, you might want to ask the following questions to help you decide whether or not you want to take part in the study.

• Who is doing this study and what questions might it answer?

• Who reviewed or approved this study?

• What could happen to my health, good or bad, if I take part in this study?

• Is it possible that I will receive a placebo (inactive substance)?

• What tests or procedures will I have during the study?

• How long will this study last?

• If I decide to participate, how will it affect my daily life?

• Could my condition get worse during the study? What happens if it does?

• Will I be charged anything or paid anything to be in this study?

• Who will be in charge of my care? Can I continue seeing other doctor?

• Who will be told I am taking part in this study? What information will they receive?

• What happens to any specimens that I give?

• What happens after the study ends?

• Will I be told the results of the study?

• How do I end my participation in the study if I change my mind?

• What other options do I have if I decide not to take part in this study?

• Whom do I contact for questions and information about the study?

• Can I or my spouse be pregnant during the study?

如果我不想加入研究会怎么样？

Ÿ　如果您决定参与一项研究试验，您就是一位志愿者。这是您自主做出的决定。

Ÿ　如果有人让您参与研究试验，您有权选择不参与。

Ÿ　您的决定不会影响您在佑安医院的就医权益。

Ÿ　您有必要权衡研究潜在风险和潜在利益。

Ÿ　您可以在研究试验过程的任何阶段改变主意，即使这样也不会影响您在佑安医院诊治疾病的任何权益。

What if I do not want to take part in a research study?

• If you decide to take part in a study, you do so as a VOLUNTEER. This means YOU decide.

• If anyone asks you to take part in a research study, you have the right to say “no.”

• Your decision will not affect your YouAn health care or benefits.

• You need to weigh both the potential risks and potential benefits of the study.

• You can change your mind and leave a research study at any time without losing any of your VA health care benefits.

您准备参与或者已经参与我院的临床研究了吗？您对作为一个受试者的权益有疑问吗？或者您想为北京佑安医院的临床研究提供一些建议吗？或者您想获取更多有关临床研究和人体研究保护方面的信息吗？

如果您愿意，请随时与我们联系：

Are you a subject in a research study? Do you have questions about your rights as a study subject? Do you want to give suggestions or information to YouAn hospital HRPP about research on you, your family, or your friends?
If you have any questions or concerns about your role and rights as a research participant, would like to obtain information about human subject research protections or offer input, please contact, anonymously if you wish:

伦理办公室 EC office　       盛艾娟  Aijuan Sheng

电话 Tel:　010-83997028     Email: youanlunli@126.com

国家药物临床试验机构办 National Institution of Drug Clinical Trial Office   贾  敏  Min Jia

电话 Tel:　010-83997322     Email: youangcp@126.com

科研处 Scientific Research Division      孟  莎  Sha Meng

电话 Tel:  010-83997022     Email: mengsha2001@sina.com