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)).

联邦法规要求在适用法律和法规允许的范围内，对识别参与者的研究记录进行保密。例如，如果临床研究的结果被公布，参与者的身份必须保密(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.

联邦法律还保护所有研究参与者个人可识别的健康信息的机密性。其他联邦法律和法规保护弱势群体的记录和身份，以及接受酒精和药物滥用治疗的研究参与者。

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

本模块总结了保护研究参与者的机密性和隐私的联邦法律和法规。

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.

除联邦法律法规外，许多州还制定了自己的法律法规，以保护接受医疗保健的个人的机密性和隐私。研究人员必须熟悉研究所在州适用的保密和隐私规定。

Part 2: Confidentiality of Clinical Trial Participant Records   临床试验参与者记录的保密性

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提供了研究参与者的机密性保护，如下所示：

1、子部分A——人类研究参与者的基本保护

2、子部分B——对孕妇、胎儿、新生儿等研究参与者的额外保护

3、子部分C——对参与生物医学和行为研究的囚犯的额外保护

4、子部分D——对儿童研究参与者的额外保护

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，《健康保险可携带性和责任法案》（HIPAA）还要求根据45 CFR 160和164对个人可识别健康信息进行隐私保护。一般来说，无论是否与研究相关，临床试验中任何人的身份、诊断、预后或治疗的所有记录都必须保留。这包括与酒精或药物滥用预防、教育、培训、治疗、康复或研究有关的任何记录必须保密。“身份”不仅包括参与者的姓名，还包括任何其他可随时链接到参与者的信息。此外，适用信息可以是任何形式（例如，纸质、电子、口头）。《美国联邦法规汇编》第45卷第160条和第164条规定的HIPAA安全规则确立了保护个人电子个人健康信息的标准。

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，临床研究人员可能不会透露参与HIV研究的参与者。这类披露将违反参与者的保密性，并可能给参与者带来困难，因为在某些社区，这种疾病会带来耻辱。

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).

除某些例外情况外，酒精或药物滥用治疗计划不得向该计划外的任何人透露某一特定的人参加该计划，或披露任何表明该人为酒精或药物滥用者的信息，除非:

1、该人书面同意披露，或

2、该披露是由法院命令所允许的，并且该研究或研究站点不是在保密证书下运行的(关于保密证书的规定和例外，请参阅本模块的第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).

违反保密通常被定义为未经法院命令或参与者同意而将参与者的受保护信息泄露给第三方。对保密的违反可以是口头或书面的，也可以是通过电话、传真或电子手段(例如，电子邮件或其他基于互联网的通信方式)发生的。

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:

联邦法规确定了酒精和药物滥用参与者记录保密要求的某些例外情况。考虑下列披露情况：

“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.

参与者的医疗记录中的信息可以向健康计划内的人员披露，也可以透露给健康计划与对该健康计划具有直接行政控制的实体之间的信息，因为他们可能需要这些信息来履行与参与者的诊断和治疗相关的职责。例如，研究地点的医生可以提供参与者信息，以便转诊到该研究地点或方案内的另一个健康实体进行酗酒或吸毒治疗。

Criminal Activity (42 CFR 2.12(c)(5))   犯罪活动

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.

当参与者在项目场所或针对项目工作人员实施犯罪或威胁实施犯罪时，可向执法人员披露参与者医疗记录中的信息。

披露的信息必须限于事件的情况，包括参与者的:

1、参与者身份。

2、姓名和地址。

3、最后已知的行踪。

Suspected Child Abuse or Neglect (42 CFR 2.12(c)(6))   涉嫌虐待或忽视儿童

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.

当有必要向州或地方当局报告涉嫌虐待或忽视儿童的情况时，可披露参与者医疗记录中的信息。但是，参与者的原始记录不得用于由报告引起的民事或刑事诉讼。

Armed Forces and Veterans Administration (42 CFR 2.2(e))   武装部队和退伍军人管理局

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 ).

保密规定不适用于武装部队内部或美国退伍军人管理局(VA)运营的武装部队保健设施之间有关涉嫌虐待和忽视儿童的信息交换。这些规定不适用于州法律规定的儿童虐待或忽视的报告。

此外，在下述情况下(42 CFR 2.51)，允许未经参与者同意披露机密信息。

Medical Emergencies (42 CFR 2.51(a))   医疗紧急情况

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.

在医疗紧急情况下，为了治疗对任何人的健康构成直接威胁并需要立即进行医疗干预的情况，可向医务人员提供有关参与者的机密信息。

Research Activities (42 CFR 2.52)   研究活动

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.

参与者的保密信息可能会因研究目的而被披露，前提是信息的接收者:

1、有资格进行研究。

2、有一项研究协议，以确保信息的安全，不会再次披露，除非从哪里获得信息。

3、不会在任何研究报告中确认任何参与者的身份。

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，至少由三名独立人士组成的小组必须审查议定书，以确保:

1、参与者的权利和福利将得到充分的保护。

2、该研究的潜在益处超过了披露参与者信息的风险。

Audit and Evaluation Activities (42 CFR 2.53)   审核及评价活动

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.

在管理审核、财务审核或项目评估活动中，可能会披露有关参与者的机密信息，条件是:

1、除来源外，不得再次披露。

2、仅用于执行审计或评估目的，或调查或起诉法庭命令授权的犯罪或其他活动。

Danger to Self (42 CFR 2.51; 45 CFR 164.512(j)(4))   对自我的危险

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.

如果参与者提到有自杀意图，必须由合格的心理健康专业人员对其进行评估。如果参与者被发现有自杀的危险，机密信息可能会被披露，以确保他或她的安全。具体来说，可能需要让参与者住院或通知紧急反应小组。

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.

研究小组的成员如果怀疑参与者有伤害自己的危险，应通知主管、合格的顾问或医生。

Danger to Others (42 CFR 2.51; 45 CFR 164.512(j)(4))   对他人的危险

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.

如果参与者表示有意伤害他人，他或她必须由合格的心理健康专家进行评估。如果认为威胁可信，则必须向警方（42 CFR 2.12（c）（5））和确定的目标报告。研究团队成员如果怀疑参与者有伤害他人的危险，应通知主管、合格顾问或医生。

Communicable Diseases   传染病

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.

当参与者患有对公众健康构成威胁的疾病时，可能会披露有关参与者的机密信息。所有州都要求向地方卫生当局报告选定的传染病病例。自1999年以来，某些传染病也被指定为美国疾病控制和预防中心的国家法定传染病监测系统(NNDSS)的法定传染病。然而，各州向国家减灾战略报告是自愿的。所有国家一般都按照世界卫生组织的《国际卫生条例》报告国际检疫疾病(如霍乱、鼠疫、黄热病)。

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.

国家、地方或机构的政策也可能要求向其他机构报告传染病。研究人员应联系其所在州的卫生部门，以获得有关各州传染病报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)).

在以下情况下，法院可授权披露参与者的保密信息:

1、为防止生命威胁或严重身体伤害威胁(例如，虐待儿童、忽视和对第三方的威胁)所必需的(42 CFR 2.63(a)(1))。

2、调查或起诉严重犯罪(例如，杀人、强奸、绑架、持械抢劫和使用致命武器袭击)(42 CFR 2.63(a)(2))所必需的。

3、与参与者提供与机密披露有关的证据的法律或行政程序相关(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.

仅凭法院命令并不强制披露机密信息。必须发出传票或其他法律命令来强制披露。

Requirements of State Law   国家法律要求

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.

各国可确定酒精和药物滥用参与者记录保密要求的其他例外情况。在一些州，医疗保健提供者必须向当局报告疑似家庭暴力。研究团队成员应熟悉所在州的法律法规。相关州法律的副本应在每个研究现场存档。

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.

当研究受保密证书（CoC）保护时，必须告知研究参与者该证书不阻止披露的条件。CoC披露条件并不包括上述所有情况。（有关保密证书的更多信息，请参阅本模块第5部分）

Part 4: Maintaining Confidentiality of Research Participants   保持研究参与者的机密性

Maintaining the Security of Written Records   维护书面记录的安全

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.

保密条例规定的书面记录在不使用时，必须保存在安全的房间、上锁的文件柜、保险箱或其他安全的地方。每个程序必须采用书面程序来控制这些记录的存取和使用。

What happens to participant records when a program is discontinued?   当程序停止时，参与者记录会发生什么?

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.

如果一个研究地点停止运作或被另一个项目收购，就临床记录而言，必须遵守一定的医疗记录责任。每个站点首席研究员必须了解由主办方和具有监督权力的监管实体建立的医疗和研究相关记录的程序和保存期限要求。例如，在临床试验网络中，当一个项目终止时，发起者要求项目主管立即通知NIDA，讨论在临床研究期间所创建的用于获得研究数据的任何重要源文件的保留问题。此外，这些文件必须保存在研究地点，或由主办方保存，保存期限由主办方确定。

Medical Record Responsibilities   医疗记录职责

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.

程序必须从其记录中清除参与者识别信息或销毁记录，除非:

1、记录的主体书面同意将记录转让给获取程序或任何其他指定程序。

2、法律规定记录必须保存一段时间。

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.

保存的记录必须密封在信封或其他容器内，并且:

1、密封在信封或其他容器内。

2、按照42 CFR 2.19(b)(1)，标记如下:

“根据 [根据法令、法规、法院命令或其他要求保存记录的法律权威] 要求保存的 [项目名称] 记录，直至不迟于 [插入适当日期] 为止。”

3、由负责人持有，该负责人必须在实际可行的情况下，在指定的保存期结束时尽快销毁记录。

Recommended Routine Practices for Maintaining the Confidentiality of Research Participants   研究参与者保密的推荐常规做法

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.

研究人员通常将研究参与者自愿披露或提供的信息（即在知情同意的情况下）用于研究目的。由于研究者和研究参与者之间的关系是基于信任的，因此最重要的是确保这些信息的保密性。

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.

为确保研究参与者的机密性，建议进行以下常规操作:

1、用代码代替识别与会者的信息(例如，用数字代替名字来识别与会者)。

2、移除包含标识符（如姓名和地址）的面板。

3、妥善处理所有含有标识的纸质文件。

4、限制对识别参与者的所有数据的访问。

5、教育研究人员保密的重要性。

6、将纸质记录保存在锁着的柜子里。

7、为电脑记录分配安全代码。