親愛的志愿者朋友：

真誠地歡迎您參與我院的臨床研究。在您決定參加一項臨床研究之前，請您仔細(xì)閱讀以下內(nèi)容以充分保障自己的權(quán)益。

感謝您為醫(yī)學(xué)發(fā)展所作的無私奉獻。

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.

什么是臨床研究或試驗？

臨床研究或試驗是為了了解或解決一個疾病或健康問題而進行的一次有計劃的有健康人或患者參加的研究。

一次研究或試驗可能是為了達到以下目的：

?　了解人們對疾病或一般健康知識的需求。

?　對藥物或設(shè)備的安全性和有效性進行測試。

?　確定治療和預(yù)防疾病的最佳方式。

?　找出最有成效的健康護理方式。

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.

我參與研究會受益嗎？

試驗用藥在開始用于人的臨床試驗之前會進行一系列的藥理學(xué)、毒性以及動物試驗。臨床試驗又分為Ⅰ~Ⅳ期。沒有人可以預(yù)測一項研究的確切結(jié)果。一般來說，期別越高，您可能的受益越多。例如，參與Ⅰ期臨床試驗不能確定會給您的健康或健康狀況帶來直接的好處，但是參與研究所提供的信息可能為人類攻克某種疾病提供有力幫助；而Ⅱ-Ⅳ期期臨床試驗極有可能對您所患疾病有較好的治療作用。

所以您能否臨床研究中受益與否或受益大小可能和研究藥物臨床試驗前的研究結(jié)果以及試驗所處的期別有關(guān)。

我們這里只是泛泛而談研究受益的可能性，每一個臨床研究的可能受益的情況會在項目中仔細(xì)闡述，因此我們建議您如果對某項研究有興趣，最好有針對性的閱讀或咨詢具體研究項目。

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.

我參與研究會有風(fēng)險嗎？

藥物臨床試驗的目的就是要獲得一種研究性藥物用于人體的安全性和療效結(jié)果。因而任何一項臨床試驗都有不能預(yù)期的潛在風(fēng)險。但是在用于人體之前肯定會有一些實驗室或動物實驗的數(shù)據(jù)提示可能的風(fēng)險，藥監(jiān)部門會召集專家論證、嚴(yán)格審批，研究者也會根據(jù)可能的風(fēng)險制定出應(yīng)對措施；在臨床試驗過程中會嚴(yán)密觀察您的反應(yīng)和身體狀況，一旦出現(xiàn)不適會及時處理。所以您參加一項臨床研究不排除有一定風(fēng)險的可能性，但也會有一系列措施使這些風(fēng)險最小化。在研究記錄中涉及到的您的個人信息和隱私會像常規(guī)病歷一樣機密保存。

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關(guān)臨床研究的細(xì)節(jié)和背景之后決定是否參加試驗作為受試者的過程。您同意作為志愿者之前必需清楚地了解真實的研究過程以及可能對您產(chǎn)生的影響。

知情同意開始時研究人員會向您解釋研究的具體過程、您可能經(jīng)歷的程序如需要做什么檢驗、怎樣用藥等、可能的受益和風(fēng)險，以及作為一名研究志愿者的權(quán)利。

如果您的問題已經(jīng)得到答復(fù)，并且您已經(jīng)完全了解有關(guān)研究試驗的真實情況并決定參加試驗，就需要簽署一份“知情同意書”。請仔細(xì)閱讀知情同意書，如果您有任何問題，請向研究人員詢問。在決定前，與家庭成員、朋友或您的醫(yī)生商量也是很有幫助的。

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.

在同意作為志愿者之前，我應(yīng)該咨詢哪些問題？

如果您被邀請作為志愿者時，您需要了解以下問題，然后決定是否參與研究。

?　誰負(fù)責(zé)這次研究，這項研究想要解決什么問題？

?　什么部門審查并批準(zhǔn)了這項研究？

?　如果我參與研究，我的健康會受到什么影響（好的或壞的）？

?　我可能被分配到安慰劑組嗎？

?　在研究期間，我會接受哪些檢查？程序是怎樣的？

?　這項研究會持續(xù)多久？

?　如果我決定參與，對我的日常生活將產(chǎn)生什么影響？

?　由誰負(fù)責(zé)對我進行治療？我可以繼續(xù)到門診看病嗎？

?　我需要為這次研究支付一些費用嗎？

?　我參加這次研究需要告訴誰？他們會收到什么信息？

?　我的試驗標(biāo)本（如血、尿、便）會被用來做什么？

?　研究結(jié)束后，我會發(fā)生什么變化？

?　研究結(jié)果會告訴我嗎？

?　我如果改變主意，該如何停止參與研究？

?　如果我決定不參與這次研究，我還有其它的選擇嗎？

?　要了解有關(guān)本次研究的問題和信息需和誰聯(lián)系？

?  試驗期間可以懷孕嗎？

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會怎么樣？

?　如果您決定參與一項研究試驗，您就是一位志愿者。這是您自主做出的決定。

?　如果有人讓您參與研究試驗，您有權(quán)選擇不參與。

?　您的決定不會影響您在佑安醫(yī)院的就醫(yī)權(quán)益。

?　您有必要權(quán)衡研究潛在風(fēng)險和潛在利益。

?　您可以在研究試驗過程的任何階段改變主意，即使這樣也不會影響您在佑安醫(yī)院診治疾病的任何權(quán)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.

您準(zhǔn)備參與或者已經(jīng)參與我院的臨床研究了嗎？您對作為一個受試者的權(quán)益有疑問嗎？或者您想為北京佑安醫(yī)院的臨床研究提供一些建議嗎？或者您想獲取更多有關(guān)臨床研究和人體研究保護方面的信息嗎？

如果您愿意，請隨時與我們聯(lián)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:

倫理辦公室 EC office　       盛艾娟  Aijuan Sheng

電話 Tel:　010-83997028     Email: [email protected]

國家藥物臨床試驗機構(gòu)辦 National Institution of Drug Clinical Trial Office   賈  敏  Min Jia

電話 Tel:　010-83997322     Email: [email protected]

科研處 Scientific Research Division      孟  莎  Sha Meng

電話 Tel:  010-83997022     Email: [email protected]