美國約翰霍普金斯大學公共衛(wèi)生學院

1、PAGE PAGE 9美國約翰霍普金斯大學公共衛(wèi)生學院與人類相關研究的倫理學培訓指南(9/2009)本指南是用于培訓將要參加與人類有關研課題的工作者。本指南主要是幫助約翰霍普金斯大學的項目負責人對其他相關研究人員進行培訓，使他們的研究行為符合倫理學要求，并以符合倫理要求的方式去：1) 取得研究對象的知情同意， 2) 通過對研究對象進行個人或小組的面談、檢查、身體測量，或以其他直接接觸的渠道收集數(shù)據(jù) (以下簡稱“調查員”)。本指南所采用的特定的內容和語言水平，是為了幫助項目負責人向調查員傳達基本的研究準則和相應的行為標準。目 錄1. 在和研究對象接觸中的道德準則a. 調查員的任務b. 尊重待人的

2、重要性c. 自愿參與d. 知情同意e. 弱勢人群f. 個人隱私g. 個人信息的保護 h. 回應研究參與者 (研究對象) 的問題 2. 數(shù)據(jù)的完整性a. 尊重研究的科學性b. 研究數(shù)據(jù)的收集、記錄和存儲c. 研究過程的偏離1. 在和研究對象接觸中的道德準則a. 調查員的任務代替研究團隊收集數(shù)據(jù)的研究人員是整個項目的代表。有時調查員是項目參與者唯一直接接觸到的人。他們的行為決定了與其接觸的研究對象對整個研究印象的好壞。調查員有責任確保研究對象是在知情同意基礎上提供研究所需信息的。他們還必須確保信息的收集記錄準確無誤。否則，研究目標將無法完成。為了保證項目進行順利，調查員必須認真遵守研究計劃、項目實

3、施手冊和其它與參與者有關的研究程序進行操作。b. 尊重待人的重要性作為研究團隊的一部分，每個研究人員都必須尊重： 該研究項目的目標， 該項目的負責人， 該研究的參與者， 參與該研究的社區(qū)，以及 有助于實現(xiàn)項目目標而收集的數(shù)據(jù)。 科研項目最終將造福社會，但是研究課題組必須先要完整地完成該科研項目。每個研究團隊成員在與社區(qū)參與者的接觸中必須始終保持對對方的尊重。這包括尊重社區(qū)參與者的文化習慣、性別、年齡、社會地位、宗教信仰和其它獨立的特征，以及他們提問的權利?？蒲许椖繀⑴c者不承擔必須幫助研究課題組的義務，所以如果研究課題組成員不尊重他們的選擇權利，或不為他們提供最誠懇的態(tài)度和真實的信息，科研項目參

4、與者將不會合作。調查員以專業(yè)和尊重的方式收集數(shù)據(jù)會使每個參與者體會到研究項目的重要性。例如： 無論參與者是否同意參與這項研究，始終禮貌待人。 調查員需用清晰的聲音提問。 在調查表上整潔地記錄信息。 如果參加者提出了一個問題，請給與正確的回答。如果你不知道答案，但是可以從你的上級獲得信息，如實告訴參與者你將在獲得答案時告訴他們。 向完成了研究程序的參與者表示感謝。c. 自愿參與沒有任何人必須要參加一個研究項目。如果某項研究包括了知情同意過程，被邀請的潛在研究對象有權利拒絕聽取有關研究的內容，并有權拒絕參加該研究。即使已經(jīng)加入了研究項目，參與者仍然可以拒絕回答調查中的某些具體問題，拒絕提供某項標本

5、或者參加某項測試，或者決定退出該研究項目。 征集參與者的研究小組成員必須負責確保參與者理解研究項目的目的和過程，完全自愿參加該研究，而不是因為害怕或其他原因被迫參加。d. 知情同意向可能被邀請參加研究項目的研究對象提供真實而準確的信息是進行有關人類研究的一個重要環(huán)節(jié)。知情同意是一個隨著研究人員開始向參加者解釋研究項目而進展的過程。知情同意的目的不僅是讓參與者簽署同意書和同意參加。事實上，知情同意的過程延續(xù)到整個研究過程；例如，調查員和參與者的每次接觸都會有一個繼續(xù)知情同意過程。如果參與者沒有充分理解被要求做什么, 他們便沒有真正的“自愿”加入該研究。調查小組需要提前決定信息傳達的“充分” 程度

6、和傳達方法。負責知情同意的工作人員的任務是用參加者可以理解的語言，讓他們了解這項研究的目的、過程、潛在的風險和研究的好處。所用的語言和溝通方式應該保證參加者能夠理解。這種討論應該給參與者足夠的時間來提出問題，并思考和決定是否要參加研究。有時，研究人員需要不時地向參與者確認他們是否已經(jīng)理解研究內容和研究涉及的其它方面。負責獲取知情同意的工作人員有時需要向參與者提問，以確定他們了解了些什么，理解的是否正確。另外，因為參與者可能看起來身體不舒服或有點困惑，但沒有明確說出來，所以研究人員也應該留意觀察參與者的肢體語言。如果觀察到這些反應，研究人員應該告知他/她的上級人員來獲得更多的指導。 e. 弱勢人

7、群在征集某些人群參加項目時，需要特別注意和關心，因為他們的一些情況，使他們自己很難理解聽到的內容，以及提供知情同意。例如，兒童需要額外的“保護”，同時他們的父母必須為他們作出某些決定。患有老年癡呆癥的成人可能不明白你要求他們做什么。項目負責人準備的研究計劃和實施手冊應該告訴你如何接近這些人群和是否征集他們參加該項目。研究組成員必須非常小心地按照規(guī)則征集弱勢人群參加研究，因為大多數(shù)時候弱勢人群不能自行做出決定。如果該研究將征集不能自行做決定的參與者，必須有授權看護者或其他適當?shù)拇砣四艽硭麄儧Q定。f. 個人隱私研究人員必須理解和尊重個人擁有的隱私權。即使文化中沒有提倡或承認“隱私”的概念，盡可

8、能地保護隱私仍然是很重要的。例如，如果沒有被邀請就不能進入別人的家中，可能就是當?shù)氐囊粋€習俗。研究組必須尊重這一習俗?；蛘?，一個調查員在訪問一個家庭時，可能會吸引好奇的旁觀者。他們的出現(xiàn)可能會分散調查員和調查對象的注意力而對重要的數(shù)據(jù)收集過程產(chǎn)生不良影響。研究組必須預見到這個問題，并使它最小化。調查員要求保證個人隱私的舉動，保證了對參與者的尊重，因為他們的家是家人生活的地方, 而不是公共場所。研究組成員也必須尊重參與者的個人隱私，避免造成任何不必要的尷尬或不適。涉及敏感信息采訪，應該在他人不能聽到問題或答復的地方進行。體檢不應該在他人可以看到的場所進行。此外，有些話題是私人的敏感話題，如性生活

9、、個人健康，或參與者不希望當眾談論的想法。g. 個人信息的保護如果研究參與者透露了參與者的個人信息，原本是高度保密的個人隱私就可能成為公開信息。也就是說，個人隱私可能受到侵犯。如果研究項目以外的人得到這些信息，參與者可能會遭遇尷尬、失業(yè)、法律問題，甚至來自社會各方面的傷害。研究人員應負責保護參與者避免受到這種傷害。 必須保證研究參與者所提供的個人信息的安全。任何無適當授權的人都不得看到或獲取這些信息。如果這些信息是記錄在紙上的，那么在鎖進文件柜之前這些文件應該受到保護。只有經(jīng)研究負責人授權的工作人員才能翻閱和處理這些信息。如果是電子信息，必須采取一切必要的防范措施以防止未經(jīng)授權的人訪問它。 有

10、時，可使用隨機調查數(shù)字標識數(shù)據(jù)，以保證無人知道數(shù)據(jù)是哪位參與者提供的。任何把數(shù)字與相關參與人的姓名聯(lián)系起來的文件都必須被鎖好以保持安全可靠。研究人員必須嚴格按照研究計劃和實施手冊的要求和內容保證研究數(shù)據(jù)的安全可靠。 h. 回應參與者的問題一個調查員會遇到許多人向他/她詢問關于研究的問題，這些人包括潛在的參與者、現(xiàn)有的參與者，以及好奇的旁觀者。有些人不理解什么是“研究”，或不了解研究項目人員的任何情形。他們可能有各種各樣的問題，其中一些可能和研究過程沒有任何關系。 研究負責人需要事先培訓調查員，讓他們恰當回答人們可能提出的各種問題。因為，在日常的工作現(xiàn)場，是調查員代表了研究團隊的所有人出現(xiàn)在參與

11、者和整個社區(qū)面前。重要的是，調查員要尊重他人并盡其所能地回答問題。調查員必須有耐心，并準備回答任何參加者提出的問題。如果調查員知道答案，應當場回答。如果調查員自己不十分清楚答案的問題，則不應自行作答，因為給出錯誤的信息，比暫時無法回答會產(chǎn)生更大的負面作用。如果你是調查員，當研究參與者提出了一個你不知道答案的問題，你應該告訴他你不確定，但你會把問題轉達給上級，并將答案傳達回給參與者。這一過程非常重要，因為一方面表明你尊重參與者，另一方面也確保你傳遞給參與者的答案會是準確的。當你覺得參與者沒有問題了，你可以問“您還有其它問題嗎？”，以確保所有得疑問都已經(jīng)解決了。如果沒有其它問題，那么你可以繼續(xù)下一

12、步。2 數(shù)據(jù)的完整性a. 尊重研究的科學性數(shù)據(jù)是“研究的成果”。確保收集、記錄，和存儲數(shù)據(jù)的準確性是至關重要的?？茖W家們將利用這些數(shù)據(jù)來回答在研究計劃中提出的問題。如果數(shù)據(jù)是錯誤的，那么科學家們得到的答案將是錯誤的。由于這些結論和由此產(chǎn)生的行動是錯誤的，人們的生活可能因為錯誤的研究結果而受影響。所以，任何時候任何數(shù)據(jù)，正確收集、 記錄并妥善貯存數(shù)據(jù)都是非常重要的。如果你犯了一個錯誤，必須要馬上告訴你的上級, 以便讓項目負責人或其他研究團隊負責人知道。他們也許能解決這個問題，或判定有些數(shù)據(jù)可能無法使用。b. 研究數(shù)據(jù)的收集、記錄和存儲研究計劃應該詳細闡明該項目的目標，以及研究組將如何達到這些目標

13、。數(shù)據(jù)的收集和記錄的詳細方法也應該包括在內，通常研究實施手冊更加詳細地列出這些步驟。調查員必須清楚理解究竟如何收集和記錄數(shù)據(jù)。研究組負責人應當給調查員進行這方面的培訓。如果調查員有任何問題，應當及時提出。事實上，如果調查員對具體怎樣操作不清楚卻不提問題，他們將無法確保數(shù)據(jù)是正確的。一旦培訓結束后，調查員開始數(shù)據(jù)收集工作。正確的數(shù)據(jù)收集需要按實施手冊要求一步步完成并將數(shù)據(jù)完整無誤地記錄在調查表上。恰當?shù)挠涗洶▽⒋鸢赣们逦?、明確的方式寫下來。調查員必須記錄真實而準確的信息。調查員不得記錄未在調查表上列出的的額外信息。例如，如果調查表上沒有“姓名”或“地址”這兩欄，這些數(shù)據(jù)就不應該記錄。調查表上不

14、應該有虛構的信息.恰當?shù)臄?shù)據(jù)存儲指在數(shù)據(jù)傳輸?shù)阶罱K存儲處的過程當中，采取各種安全防范措施。調查員不能把調查表放在可能會丟失、被盜或被研究組外的人看到的地方。調查表應由專門負責保管的人按事先定好的規(guī)范進行保存，以保護數(shù)據(jù)的保密性。如果數(shù)據(jù)是通過電子方法收集的，也應遵循同樣的原則去維護其真實性、保密性和安全性。c. 研究過程中的偏差有時，一個調查員因為非個人原因而無法遵循原定的研究步驟，或者犯了錯誤。很重要的一點是必須將這些問題告知項目負責人，因為研究項目負責人可能有責任把這些問題報告給倫理審查委員會（IRB）。報告這些問題不要有羞恥感，這類問題會經(jīng)常發(fā)生。調查員不上報這些問題是不對的，因為這可能

15、意味著數(shù)據(jù)無效，或者某一個參與者在研究中有問題。同時這也意味著項目負責人無法將問題報告給倫理審查委員會。 稱職的調查員應該將這些問題報告給上級，讓其決定采取何種行動。JHSPH HUMAN SUBJECTS RESEARCH ETHICS FIELD TRAINING GUIDE This guide is intended to be used as a tool for training individuals who will be “engaged” in some aspect of a human subject research interaction or interventi

16、on. It is directed, in particular, to Johns Hopkins principal investigators who are responsible for training of study team members who will (1) obtain informed consent from research participants, or (2) collect data from human participants through individual or focus group interviews, testing, physi

17、cal measurements, or other procedures involving direct contact, hereafter called a “data collector”. The content and language level of this guide is specifically worded to help the investigator convey basic research principles and behavior that accords with those principles to data collectors. We en

18、courage users who translate the document into local languages to submit those translations (with certifications of the translators qualifications) to our office () so we can make them available to other investigators. TABLE OF CONTENTS1. Ethical Interaction with Human Participants

19、a. Role of the Data Collector b. Importance of Respect c. Voluntary Participation d. Informed Consent e. Vulnerable Populations f. Personal Privacy g. Protection of Personal Information h. Response to Participant Questions 2. Data Integrity a. Respect for the Science of the Study b. Collecting, Reco

20、rding, and Storing Study Data c. Deviations from Study Procedures 1. Ethical Interaction with Human Participants a. Role of the Data Collector The person who collects information on behalf of a research team is an “ambassador” for the study. The data collector is sometimes the only person on the stu

21、dy team with whom a research participant will come into contact. People who come into contact with that person will have a good impression of the study or a bad impression of the study, depending on how the data collector presents him- or herself. The data collector has the responsibility for making

22、 sure that the information collected for the study comes from individuals who understand what they are agreeing to do. In addition, the data collector must ensure that the information collected and recorded is accurate and protected from loss. Otherwise, the study objectives will not be achieved. To

23、 be successful, the data collector must carefully follow the research plan, study operations manual and other procedures involving contact with human participants. b. Respect Each person who is part of the research team must show respect for: the goals of the research project, the leaders of the pro

24、ject, the individual study participant, the participant community and the data collected that will help achieve project objectives. The scientific project has the potential to benefit the community that will be studied, but only if the research team is able to complete all the parts of the study. Ea

25、ch individual research team member must conduct all interactions with members of the participant community with respect. This includes respecting the participant communitys culture, gender, age, social status, religion and other characteristics that make people different from each other, as well as

26、their right to ask questions. The individual does not have to help the research team by participating in the study, and they will not do so if the research team is not respectful of the participants right to say “yes” or “no”, or to receive honest and true information from all team members The data

27、collector conveys to each participant the importance of the study purpose by collecting data in a professional and respectful manner. For example: Always be polite to the participant whether or not she or he agrees to participate in the study. If the data collector is asking questions, ask them in a

28、 clear voice. Record the information neatly on the data collection sheets. If the participant asks a question, provide an answer that is correct. If you do not know the answer, and it is possible for you to obtain the information from your supervisor, tell the participant that you will obtain an ans

29、wer to their question and that you will let them know what you find out. Thank the participants once they have completed the study procedures. c. Voluntary Participation No individual person is required to participate in a research project. If the study includes an informed consent process, then eac

30、h person approached by a study team member has the right to refuse to hear about the study, and the right to refuse to join the study. Even if a person joins the study, he or she may refuse to answer specific questions in a survey or questionnaire, refuse to give a specimen or refuse to take a test,

31、 and may decide to withdraw from a study at any time. The research team member who obtains informed consent from participants is responsible for ensuring that the individual understands what the study is about and truly agrees to join the study and is not joining because they are afraid not to, or f

32、eel forced to join. d. Informed Consent Providing correct, factual information to persons being approached to join a study is an essential part of human subjects research. Informed consent is an ongoing process that begins with the research team member explaining the study to the participant. Inform

33、ed consent does not end with the participant signing the consent form and agreeing to be in the study. The process of informed consent continues throughout the study; for example, it can occur each time a data collector and participant interact. There is no true “consent” to join a study if a person

34、 does not adequately understand what is being asked of them. The investigative team determines ahead of time what is “adequate” and how that information should be conveyed. The job of the person conducting informed consent is to present information about the study to the potential participant in lan

35、guage that s/he can understand, and in a way that reveals the study purpose, procedures, potential risks and benefits of the study. The language and style of communication should enable a participant to understand. That discussion should give the participant enough time to ask questions and to think

36、 about the decision whether or not to join the study. Sometimes it is important to check in with the participant from time to time to make sure that the participant continues to understand what the study is about, or what it involves. The study team member who is obtaining consent may have to ask th

37、e participant questions to see what the participant has learned, and whether the participant has the correct understanding. The research team member should also be aware of the participants body language, as the participant may look physically uncomfortable or confused, but not say so. If these resp

38、onses are observed, the study team member should notify his/her supervisor for further guidance. e. Vulnerable Populations Some people need extra attention and care when approached to participate in a research project because they have conditions that make it difficult for them to understand what is

39、 being told to them and to provide informed consent. For example, children need extra “protection” and it is important that their parents make certain decisions for them. Adults who have dementia may not understand what you are asking them to do. The research plan and the operations manual, develope

40、d by the investigators, should tell you how to approach these individuals, and if they are to be included in the study. Research team members must be very careful to follow the rules when enrolling vulnerable populations because most of the time they cannot make decisions for themselves. If the stud

41、y will include people who cannot make decisions for themselves, an authorized caregiver or other proper representative must be available to decide for them.f. Personal Privacy Individuals have a right to privacy that the research team must understand and respect. Even if the culture does not promote

42、 or generally give recognition to the concept of “privacy”, it is important that the right to privacy be protected to every possible extent. For example, it may be the custom that no one enters another persons home without being invited. The study team must honor this custom. Or, the visit of a data

43、 collector to a home may attract curious onlookers, whose presence may be undesirable and will distract the data collector and participant from focusing on the important process of data collection. The study team must anticipate this problem and minimize it. When a data collector requests privacy, t

44、hat action assures the respondent that the data collector respects that the home is where the family lives; it is not a public space. Research team members must also respect the participants personal privacy by not causing them any unnecessary personal embarrassment or discomfort. Interviews involvi

45、ng sensitive information should take place where other people cannot hear the questions or responses. Physical examinations should not occur where other people can watch. Also, there are certain things that are considered to be “private”, such as sexual activity, personal health, or thoughts that on

46、e might not want to talk about in public.g. Protection of Personal Information When a study participant discloses personal information about him or herself to a data collector, that participant is at risk of having highly confidential information become “public”. That is, s/he risks losing confident

47、iality. The risk is that if someone outside the study learns about the private information, bad things could happen to the participant, like embarrassment, loss of employment, legal problems, or social damage. The research team is responsible for protecting the participant from this kind of injury.

48、After a study participant has provided information, that personal information must be kept safe. No one without the proper authority should see or have access to the information. If the information is written on paper, then that paper should be protected until it is locked up in a cabinet. It must o

49、nly be seen and processed by study staff who are authorized by the study investigators to handle the information. If the information is electronic, then all necessary precautions should be taken to make sure that no unauthorized person can access it. Sometimes a random study number is used to identi

50、fy the data so that no one will know which participant the data came from. Any document that links a number with the name of the person it is assigned to must be locked up and kept safe and secure. The research plan and operations manual must be followed to make sure that the study data are protecte

51、d exactly as prescribed in the manuals. h. Response to Participants Questions A data collector will meet many people, including prospective participants, existing study participants and curious onlookers not involved in the study, who will have questions about the study. Some people will not underst

52、and what “research” is, or will not know anything about the researchers who are leading this project. They may have all sorts of questions, some of which may not have anything to do with the study procedures at all. Investigators will train data collectors to address the many concerns that are likel

53、y to be expressed by people. This is because, in the “field” on a day to day basis, it is the data collector who represents the study when talking with possible participants and the community at large. It is important that the data collector show proper respect to all individuals and do ones best to

54、 address concerns. A data collector must be patient and answer any question that a participant asks, so long as s/he knows the answer! A data collector should never answer questions for which the answers are not clearly known, because giving wrong information can be worse than giving no information,

55、 at least temporarily. If you are a data collector and a participant asks a question and you are not sure of the answer, heres what should happen: you should tell the person that you do not have a confident answer to the question; that you will ask the study supervisor the question; and that you wil

56、l pass that answer on to the participant. This is very important because it shows respect to the participant and it makes sure that the information you pass on to the participant is accurate. When you think the participant has no more questions, you may ask, “Do you have any other questions?” to mak

57、e sure that all questions have been addressed. If there are no more questions, then you may proceed.2. Data Integrity a. Respect for the Science of the Study Data are the “product” of research. It is very important that the information collected, recorded, and stored by the data collectors is correc

58、t. Scientists will use these data to answer the research questions identified in the research plan. If the data are wrong, then the answers that the scientists produce will also be wrong. People whose lives may be affected by the results of the study may be put at risk, because the answers and actio

59、ns that follow will be wrong. So it is very important that all data at all times are collected properly, recorded properly, and stored properly. If you make a mistake doing any of these things, it is important that you tell your supervisor right away so that the investigators or research team leader

60、s know about it. They may be able to fix the problem, or the will know that some data may not be usable. b. Collecting, Recording, and Storing Study Data The research plan spells out the project objectives and how the research team will reach those objectives. The details of data collection and reco