Contents

Part 1: Introduction

Part 2: Confidentiality of Clinical Trial Participant Records

Part 3: Exceptions to Confidentiality Requirements

Part 4: Maintaining Confidentiality of Research Participants

Part 1: Introduction

Federal regulations require that research records identifying the participant be kept confidential to the extent permitted by applicable laws and regulations. For example, if the results of a clinical study are published, participants’ identities must remain confidential ( 45 CFR 46 ; ICH GCP 4.8.10(o)).

聯(lián)邦法規(guī)要求在適用法律和法規(guī)允許的范圍內(nèi)，對識別參與者的研究記錄進行保密。例如，如果臨床研究的結(jié)果被公布，參與者的身份必須保密(45 CFR 46;我GCP 4.8.10 (o))。

Federal law also protects the confidentiality of individually identifiable health information for all research participants. Other federal laws and regulations protect the records and identity of vulnerable populations as well as study participants receiving alcohol and drug abuse treatment.

聯(lián)邦法律還保護所有研究參與者個人可識別的健康信息的機密性。其他聯(lián)邦法律和法規(guī)保護弱勢群體的記錄和身份，以及接受酒精和藥物濫用治療的研究參與者。

This module summarizes federal laws and regulations that protect the confidentiality and privacy of study participants.

本模塊總結(jié)了保護研究參與者的機密性和隱私的聯(lián)邦法律和法規(guī)。

In addition to federal laws and regulations, many states have enacted their own laws and regulations to protect the confidentiality and privacy of individuals receiving health care. Researchers must be familiar with the confidentiality and privacy provisions that apply in the state where their studies are conducted.

除聯(lián)邦法律法規(guī)外，許多州還制定了自己的法律法規(guī)，以保護接受醫(yī)療保健的個人的機密性和隱私。研究人員必須熟悉研究所在州適用的保密和隱私規(guī)定。

Part 2: Confidentiality of Clinical Trial Participant Records? ?臨床試驗參與者記錄的保密性

What records must be kept confidential?

45 CFR 46 provides protections for the confidentiality of research participants as follows:

Ⅰ、Subpart A – Basic protections of human research participants

Ⅱ、Subpart B – Additional protections for research participants that are pregnant women, fetuses, neonates

Ⅲ、Subpart C – Additional protections for participants that are prisoners involved biomedical and behavioral research

Ⅳ、Subpart D – Additional protections for research participants that are children

45 CFR 46提供了研究參與者的機密性保護，如下所示：

1、子部分A——人類研究參與者的基本保護

2、子部分B——對孕婦、胎兒、新生兒等研究參與者的額外保護

3、子部分C——對參與生物醫(yī)學和行為研究的囚犯的額外保護

4、子部分D——對兒童研究參與者的額外保護

In addition to 45 CFR 46, the Health Insurance Portability and Accountability Act (HIPAA) mandates privacy protections for individually identifiable health information under 45 CFR 160 and 164. In general, whether research related or not, all records of the identity, diagnosis, prognosis, or treatment of any person in a clinical trial must be maintained. This includes any record in connection with alcohol or drug abuse prevention, education, training, treatment, rehabilitation, or research must be kept confidential. “Identity” includes not only the participant’s name but also any other information that could be readily linked to the participant. Additionally, applicable information may be in any form (e.g., paper, electronic, verbal). The HIPAA Security Rule, also under 45 CFR 160 and 164, establishes standards to protect individuals’ electronic personal health information.

除45 CFR 46外，《健康保險可攜帶性和責任法案》（HIPAA）還要求根據(jù)45 CFR 160和164對個人可識別健康信息進行隱私保護。一般來說，無論是否與研究相關(guān)，臨床試驗中任何人的身份、診斷、預(yù)后或治療的所有記錄都必須保留。這包括與酒精或藥物濫用預(yù)防、教育、培訓、治療、康復(fù)或研究有關(guān)的任何記錄必須保密。“身份”不僅包括參與者的姓名，還包括任何其他可隨時鏈接到參與者的信息。此外，適用信息可以是任何形式（例如，紙質(zhì)、電子、口頭）。《美國聯(lián)邦法規(guī)匯編》第45卷第160條和第164條規(guī)定的HIPAA安全規(guī)則確立了保護個人電子個人健康信息的標準。

For example, clinical research staff may not disclose that a participant is enrolled in an HIV study. This type of disclosure would be in violation of the participant’s confidentiality and can make things difficult for the participant given the stigma associated with the disease in certain communities.

例如，臨床研究人員可能不會透露參與HIV研究的參與者。這類披露將違反參與者的保密性，并可能給參與者帶來困難，因為在某些社區(qū)，這種疾病會帶來恥辱。

With certain exceptions, an alcohol or drug abuse treatment program may not disclose to anyone outside the program that a particular person attends the program, or disclose any information that identifies a person as an alcohol or drug abuser, unless:

Ⅰ、the person consents to the disclosure in writing, or

Ⅱ、the disclosure is allowed by a court order and the study or research site is not operating under a Certificate of Confidentiality (see Part 5 of this module for the provisions and exceptions of Certificates of Confidentiality).

除某些例外情況外，酒精或藥物濫用治療計劃不得向該計劃外的任何人透露某一特定的人參加該計劃，或披露任何表明該人為酒精或藥物濫用者的信息，除非:

1、該人書面同意披露，或

2、該披露是由法院命令所允許的，并且該研究或研究站點不是在保密證書下運行的(關(guān)于保密證書的規(guī)定和例外，請參閱本模塊的第5部分)。

A breach of confidentiality is usually defined as any disclosure of protected information about a participant to a third party without either a court order or consent of the participant. The breach of confidentiality may be oral or written and may occur by telephone, fax, or electronic means (e.g., electronic mail or other internet- based method of communication).

違反保密通常被定義為未經(jīng)法院命令或參與者同意而將參與者的受保護信息泄露給第三方。對保密的違反可以是口頭或書面的，也可以是通過電話、傳真或電子手段(例如，電子郵件或其他基于互聯(lián)網(wǎng)的通信方式)發(fā)生的。

Part 3: Exceptions to Confidentiality Requirements? ?保密要求的例外

Federal regulations identify certain exceptions to the confidentiality requirements for alcohol and drug abuse participant records. Consider the following circumstances for disclosure:

聯(lián)邦法規(guī)確定了酒精和藥物濫用參與者記錄保密要求的某些例外情況。考慮下列披露情況：

“Need to Know” (42 CFR 2.12(c)(3))? ?“需要知道”

Information in a participant's medical record can be disclosed to people within a health program, or between a health program and an entity having direct administrative control over that health program, as they may need this information to perform duties related to the participant's diagnosis and treatment. For example, a physician at the research site may provide participant information for the purpose of referral for treatment of alcohol or drug abuse to another health entity within the site or program.

參與者的醫(yī)療記錄中的信息可以向健康計劃內(nèi)的人員披露，也可以透露給健康計劃與對該健康計劃具有直接行政控制的實體之間的信息，因為他們可能需要這些信息來履行與參與者的診斷和治療相關(guān)的職責。例如，研究地點的醫(yī)生可以提供參與者信息，以便轉(zhuǎn)診到該研究地點或方案內(nèi)的另一個健康實體進行酗酒或吸毒治療。

Criminal Activity (42 CFR 2.12(c)(5))? ?犯罪活動

Information in a participant's medical record can be disclosed to law enforcement officers when the participant has committed or threatened to commit a crime on program premises or against program staff.

The information disclosed must be limited to the circumstances of the incident, including the participant's:

Ⅰ、Participant status.

Ⅱ、Name and address.

Ⅲ、Last known whereabouts.

當參與者在項目場所或針對項目工作人員實施犯罪或威脅實施犯罪時，可向執(zhí)法人員披露參與者醫(yī)療記錄中的信息。

披露的信息必須限于事件的情況，包括參與者的:

1、參與者身份。

2、姓名和地址。

3、最后已知的行蹤。

Suspected Child Abuse or Neglect (42 CFR 2.12(c)(6))? ?涉嫌虐待或忽視兒童

Information in a participant's medical record can be disclosed when it is necessary to report suspected child abuse or neglect to state or local authorities. However, original participant records may not be used in civil or criminal proceedings that arise from the report.

當有必要向州或地方當局報告涉嫌虐待或忽視兒童的情況時，可披露參與者醫(yī)療記錄中的信息。但是，參與者的原始記錄不得用于由報告引起的民事或刑事訴訟。

Armed Forces and Veterans Administration (42 CFR 2.2(e))? ?武裝部隊和退伍軍人管理局

The confidentiality regulations do not apply to the exchange of information regarding suspected child abuse and neglect within the Armed Forces or between the Armed Forces health care facilities operated by the U.S. Veterans Administration (VA). The regulations do not apply to the reporting of child abuse or neglect under State law.

In addition, disclosure of confidential information without a participant's consent is permitted in the situations described below (42 CFR 2.51 ).

保密規(guī)定不適用于武裝部隊內(nèi)部或美國退伍軍人管理局(VA)運營的武裝部隊保健設(shè)施之間有關(guān)涉嫌虐待和忽視兒童的信息交換。這些規(guī)定不適用于州法律規(guī)定的兒童虐待或忽視的報告。

此外，在下述情況下(42 CFR 2.51)，允許未經(jīng)參與者同意披露機密信息。

Medical Emergencies (42 CFR 2.51(a))? ?醫(yī)療緊急情況

Confidential information about a participant may be given to medical personnel in a medical emergency for the purpose of treating a condition that poses an immediate threat to the health of any person and requires immediate medical intervention.

在醫(yī)療緊急情況下，為了治療對任何人的健康構(gòu)成直接威脅并需要立即進行醫(yī)療干預(yù)的情況，可向醫(yī)務(wù)人員提供有關(guān)參與者的機密信息。

Research Activities (42 CFR 2.52)? ?研究活動

Confidential information about a participant may be disclosed for research purposes, provided that the recipient of the information:

Ⅰ、Is qualified to conduct the research.

Ⅱ、Has a research protocol that ensures the information will be kept secure and will not be re-disclosed except to the source from which it was obtained.

Ⅲ、Will not identify any individual participant in any report of the research.

參與者的保密信息可能會因研究目的而被披露，前提是信息的接收者:

1、有資格進行研究。

2、有一項研究協(xié)議，以確保信息的安全，不會再次披露，除非從哪里獲得信息。

3、不會在任何研究報告中確認任何參與者的身份。

In addition, a group of at least three independent persons must review the protocol to ensure that:

Ⅰ、The rights and welfare of participants will be adequately protected.

Ⅱ、The risks of disclosing information about participants are outweighed by the potential benefits of the research.

此外，至少由三名獨立人士組成的小組必須審查議定書，以確保:

1、參與者的權(quán)利和福利將得到充分的保護。

2、該研究的潛在益處超過了披露參與者信息的風險。

Audit and Evaluation Activities (42 CFR 2.53)? ?審核及評價活動

Confidential information about a participant may be disclosed for management audits, financial audits, or program evaluation activities provided that the information:

Ⅰ、Is not re-disclosed except to the source from which it was obtained.

Ⅱ、Is used only to carry out an audit or evaluation purpose or to investigate or prosecute criminal or other activity as authorized by a court order.

在管理審核、財務(wù)審核或項目評估活動中，可能會披露有關(guān)參與者的機密信息，條件是:

1、除來源外，不得再次披露。

2、僅用于執(zhí)行審計或評估目的，或調(diào)查或起訴法庭命令授權(quán)的犯罪或其他活動。

Danger to Self (42 CFR 2.51; 45 CFR 164.512(j)(4))? ?對自我的危險

If a participant speaks of an intention to kill himself or herself, the participant must be evaluated by a qualified mental health professional. If the participant is found to be at risk for suicide, confidential information may be disclosed to ensure his or her safety. Specifically, it may be necessary to admit the participant to a hospital or to notify an emergency response team.

如果參與者提到有自殺意圖，必須由合格的心理健康專業(yè)人員對其進行評估。如果參與者被發(fā)現(xiàn)有自殺的危險，機密信息可能會被披露，以確保他或她的安全。具體來說，可能需要讓參與者住院或通知緊急反應(yīng)小組。

A member of the research team who suspects a participant is in danger of harming himself or herself should notify a supervisor, qualified counselor, or physician.

研究小組的成員如果懷疑參與者有傷害自己的危險，應(yīng)通知主管、合格的顧問或醫(yī)生。

Danger to Others (42 CFR 2.51; 45 CFR 164.512(j)(4))? ?對他人的危險

If a participant speaks of an intention to harm another person, he or she must be evaluated by a qualified mental health professional. If the threat is considered credible, a report must be made both to the police (42 CFR 2.12(c)(5)) and to the identified target. A member of the research team who suspects a participant is in danger of harming another person should notify a supervisor, qualified counselor, or physician.

如果參與者表示有意傷害他人，他或她必須由合格的心理健康專家進行評估。如果認為威脅可信，則必須向警方（42 CFR 2.12（c）（5））和確定的目標報告。研究團隊成員如果懷疑參與者有傷害他人的危險，應(yīng)通知主管、合格顧問或醫(yī)生。

Communicable Diseases? ?傳染病

Confidential information about a participant may be disclosed when the participant has a disease that poses a risk to public health. All states require that cases of selected communicable diseases be reported to local health authorities. Since 1999, certain infectious diseases have also been designated as notifiable to the National Notifiable Diseases Surveillance System (NNDSS) of the U.S. Centers for Disease Control and Prevention. However, state reporting to the NNDSS is voluntary. All states generally report the internationally quarantinable diseases (e.g., cholera, plague, yellow fever) in compliance with the World Health Organization's International Health Regulations.

當參與者患有對公眾健康構(gòu)成威脅的疾病時，可能會披露有關(guān)參與者的機密信息。所有州都要求向地方衛(wèi)生當局報告選定的傳染病病例。自1999年以來，某些傳染病也被指定為美國疾病控制和預(yù)防中心的國家法定傳染病監(jiān)測系統(tǒng)(NNDSS)的法定傳染病。然而，各州向國家減災(zāi)戰(zhàn)略報告是自愿的。所有國家一般都按照世界衛(wèi)生組織的《國際衛(wèi)生條例》報告國際檢疫疾病(如霍亂、鼠疫、黃熱病)。

State, local, or institutional policies may also require that communicable diseases be reported to other agencies. Researchers should contact their state health departments to obtain current and complete information about communicable disease reporting requirements in individual states.

國家、地方或機構(gòu)的政策也可能要求向其他機構(gòu)報告?zhèn)魅静　?/b>研究人員應(yīng)聯(lián)系其所在州的衛(wèi)生部門，以獲得有關(guān)各州傳染病報告要求的最新和完整的信息。

Court Order? ?法庭命令

Disclosure of confidential information about a participant may be authorized by a court order if the disclosure is:

Ⅰ、Necessary to protect against a threat to life or a threat of serious bodily injury (e.g., child abuse, neglect, and threats against third parties) (42 CFR 2.63(a)(1)).

Ⅱ、Necessary to the investigation or prosecution of a serious crime (e.g., homicide, rape, kidnapping, armed robbery, and assault with a deadly weapon) (42 CFR 2.63(a)(2)).

Ⅲ、Relevant to a legal or administrative proceeding in which the participant offers evidence that pertains to the confidential disclosure (42 CFR 2.63(a)(3)).

在以下情況下，法院可授權(quán)披露參與者的保密信息:

1、為防止生命威脅或嚴重身體傷害威脅(例如，虐待兒童、忽視和對第三方的威脅)所必需的(42 CFR 2.63(a)(1))。

2、調(diào)查或起訴嚴重犯罪(例如，殺人、強奸、綁架、持械搶劫和使用致命武器襲擊)(42 CFR 2.63(a)(2))所必需的。

3、與參與者提供與機密披露有關(guān)的證據(jù)的法律或行政程序相關(guān)(42 CFR 2.63(a)(3))。

A court order alone does not compel disclosure of confidential information. A subpoena or other legal?mandate must be issued to compel disclosure.

僅憑法院命令并不強制披露機密信息。必須發(fā)出傳票或其他法律命令來強制披露。

Requirements of State Law? ?國家法律要求

States may determine additional exceptions to the requirements for confidentiality of alcohol and drug abuse participant records. In some states, health care providers must report suspected domestic violence to authorities. Members of the research team should be familiar with their state's laws and regulations. Copies of relevant state laws should be on file at each study site.

各國可確定酒精和藥物濫用參與者記錄保密要求的其他例外情況。在一些州，醫(yī)療保健提供者必須向當局報告疑似家庭暴力。研究團隊成員應(yīng)熟悉所在州的法律法規(guī)。相關(guān)州法律的副本應(yīng)在每個研究現(xiàn)場存檔。

When the research is protected by a Certificate of Confidentiality (CoC), research participants must be informed of the conditions that the certificate does not prevent disclosure. The CoC conditions for disclosure are not all inclusive of the circumstances mentioned above. (See Part 5 of this module for more information on Certificates of Confidentiality.

當研究受保密證書（CoC）保護時，必須告知研究參與者該證書不阻止披露的條件。CoC披露條件并不包括上述所有情況。（有關(guān)保密證書的更多信息，請參閱本模塊第5部分）

Part 4: Maintaining Confidentiality of Research Participants? ?保持研究參與者的機密性

Maintaining the Security of Written Records? ?維護書面記錄的安全

When not in use, written records covered by the confidentiality regulations must be kept in a secure room, a locked file cabinet, a safe, or other secure place. Each program must adopt written procedures to control access to and use of these records.

保密條例規(guī)定的書面記錄在不使用時，必須保存在安全的房間、上鎖的文件柜、保險箱或其他安全的地方。每個程序必須采用書面程序來控制這些記錄的存取和使用。

What happens to participant records when a program is discontinued?? ?當程序停止時，參與者記錄會發(fā)生什么?

If a research site discontinues operation or is acquired by another program, there are certain medical record responsibilities that must be followed regarding the clinical records. Each site Principal Investigator must be aware of the procedures and retention period requirements for medical and study related records established by the sponsor and regulatory entities with oversight authority. For example, in the Clinical Trials Network, when a program is discontinued, the sponsor requires the program director to notify NIDA immediately to discuss the retention of any essential source documents created during the clinical study from which study data were obtained. Additionally, these documents must be kept at the study site, at the site, or by the sponsor, for a period defined by the sponsor.

如果一個研究地點停止運作或被另一個項目收購，就臨床記錄而言，必須遵守一定的醫(yī)療記錄責任。每個站點首席研究員必須了解由主辦方和具有監(jiān)督權(quán)力的監(jiān)管實體建立的醫(yī)療和研究相關(guān)記錄的程序和保存期限要求。例如，在臨床試驗網(wǎng)絡(luò)中，當一個項目終止時，發(fā)起者要求項目主管立即通知NIDA，討論在臨床研究期間所創(chuàng)建的用于獲得研究數(shù)據(jù)的任何重要源文件的保留問題。此外，這些文件必須保存在研究地點，或由主辦方保存，保存期限由主辦方確定。

Medical Record Responsibilities? ?醫(yī)療記錄職責

The program must purge participant-identifying information from its records or destroy the records unless:

Ⅰ、The subject of the records gives written consent to transfer of the records to the acquiring program or to any other designated program.

Ⅱ、The law requires that the records be kept for a specified period.

程序必須從其記錄中清除參與者識別信息或銷毀記錄，除非:

1、記錄的主體書面同意將記錄轉(zhuǎn)讓給獲取程序或任何其他指定程序。

2、法律規(guī)定記錄必須保存一段時間。

Retained records must be sealed in envelopes or other containers and:

Ⅰ、Sealed in envelopes or other containers.

Ⅱ、In accordance with 42 CFR 2.19(b)(1), labeled as follows:

“Records of [insert name of program] required to be maintained under [insert citation to statute, regulation, court order, or other legal authority requiring that records be kept] until a date not later than [insert appropriate date].”

Ⅲ、Held by a responsible person who must destroy the records as soon as is practicable at the end of the specified retention period.

保存的記錄必須密封在信封或其他容器內(nèi)，并且:

1、密封在信封或其他容器內(nèi)。

2、按照42 CFR 2.19(b)(1)，標記如下:

“根據(jù) [根據(jù)法令、法規(guī)、法院命令或其他要求保存記錄的法律權(quán)威] 要求保存的 [項目名稱] 記錄，直至不遲于 [插入適當日期] 為止。”

3、由負責人持有，該負責人必須在實際可行的情況下，在指定的保存期結(jié)束時盡快銷毀記錄。

Recommended Routine Practices for Maintaining the Confidentiality of Research Participants? ?研究參與者保密的推薦常規(guī)做法

Researchers ordinarily use information that study participants have disclosed or provided voluntarily (i.e., with their informed consent) for research purposes. Because the relationship between researcher and study participant is based on trust, it is most important to ensure that the confidentiality of this information is maintained.

研究人員通常將研究參與者自愿披露或提供的信息（即在知情同意的情況下）用于研究目的。由于研究者和研究參與者之間的關(guān)系是基于信任的，因此最重要的是確保這些信息的保密性。

The following routine practices are recommended to ensure the confidentiality of research participants:

Ⅰ、Substitute codes for information that identifies the participant (e.g., use numbers instead of names to identify participants).

Ⅱ、Remove face sheets that contain identifiers, such as names and addresses.

Ⅲ、Properly dispose of all paper documents that contain identifiers.

Ⅳ、Limit access to all data that identifies participants.

Ⅴ、Educate research staff on the importance of maintaining confidentiality.

Ⅵ、Store paper records in locked cabinets.

Ⅶ、Assign security codes to computerized records.

為確保研究參與者的機密性，建議進行以下常規(guī)操作:

1、用代碼代替識別與會者的信息(例如，用數(shù)字代替名字來識別與會者)。

2、移除包含標識符（如姓名和地址）的面板。

3、妥善處理所有含有標識的紙質(zhì)文件。

4、限制對識別參與者的所有數(shù)據(jù)的訪問。

5、教育研究人員保密的重要性。

6、將紙質(zhì)記錄保存在鎖著的柜子里。

7、為電腦記錄分配安全代碼。