Contents

Part 1: What is an Institutional Review Board (IRB)?

Part 2: Purpose of an IRB

Part 3: Membership of an IRB

Part 1: What is an Institutional Review Board?

Structure

An Institutional Review Board (IRB) is an independent body established to protect the rights and welfare of human research participants. Under Title 45 Part 46 of the Code of Federal Regulations (45 CFR 46), any research that is federally funded must be reviewed and approved by an IRB.

机构审查委员会（IRB）是为保护人类研究参与者的权利和福利而设立的独立机构。根据《联邦法规》（45 CFR 46）第45篇第46部分，任何由联邦资助的研究 必须由IRB审查和批准。

Any clinical investigation involving a product regulated by the U.S. Food and Drug Administration (FDA) must also be reviewed and approved by an IRB (21 CFR 56). Individual institutions or sponsors may require that all research, no matter how it is funded, be reviewed and approved by an IRB.

涉及美国食品和药物管理局（FDA）监管的产品 的任何临床研究也必须由IRB（21 CFR 56）审查和批准。个别机构或赞助者可能要求 所有研究，无论其资金来源如何，都必须经过IRB的审查和批准。

An IRB has specific authority over the conduct of research under its jurisdiction. No clinical study may begin enrolling participants until it has received IRB approval. The IRB has the authority to:

Ⅰ、Approve, disapprove, or terminate all research activities that fall within its local jurisdiction according torelevant federal regulations and institutional policy.

Ⅱ、Require modifications in protocols, including protocols of previously approved research.

Ⅲ、Require that participants be given any additional information that will assist them in making an informed decision to take part in research. (Requirements for informed consent are covered in the Informed Consent module.)

Ⅳ、Require documentation of informed consent or allow a waiver of documentation. (Documentation of informed consent is covered in the Informed Consent module.)

IRB对其管辖范围内的研究具有特定权限。在获得IRB批准之前，任何临床研究都不得开始招募参与者。IRB有权：

1、根据相关联邦法规和机构政策，批准、不批准或终止其地方管辖范围内的所有研究活动。

2、需要修改方案，包括先前批准的研究方案。

3、要求向参与者提供有助于他们做出知情决定参与研究的任何额外信息。（有关知情同意的要求，请参见知情同意模块）

4、要求提供知情同意的文件或允许放弃文件。（知情同意模块涵盖知情同意的文件）

Every institution that participates in research studies must identify an IRB to review and approve those studies. The IRB must follow the requirements of 45 CFR 46 (described in this module) and of the Office for Human Research Protections. Some research sites are under the jurisdiction of two or more IRBs. In these cases, the IRBs may perform joint review, separate review or agree to abide by the review of one of the involved IRBs.

每个参与研究的机构都必须确定一个IRB来审查和批准这些研究。IRB必须遵守45 CFR 46（本模块中描述）和人类研究保护办公室的要求。一些研究地点受两个或多个IRB管辖。在这些情况下，内部评级机构可进行联合审查、单独审查或同意遵守其中一个相关内部评级机构的审查。

This module provides an overview of the regulations governing IRBs. Many of the topics covered here are also addressed in other modules of this training program. Links to those topics are provided where relevant.

该模块概述了IRB的规定。此处涵盖的许多主题也在此培训计划的其他模块中解决。提供与这些主题相关联的链接。

Part 2: Purpose of an IRB?

The purpose of an IRB is to safeguard the rights, safety, and well–being of all human research participants. The IRB fulfills this purpose by:

IRB的目的是保护所有人类研究参与者的权利、安全和福祉。IRB通过以下方式实现此目的：

Ⅰ、Reviewing the full study plan (see section IRB responsibilities for the documents which comprise a full protocol) for a research study to ensure that the research meets the criteria specified in 45 CFR 46.111. (See summarized Criteria for IRB approval of research.)

1、审查完整的研究计划（见IRB责任部分，包含完整方案的文件），以确保研究符合45 CFR 46.111中规定的标准。（参见IRB批准研究的汇总标准。）

Ⅱ、Confirming that the research plans do not expose participants to unreasonable risks.

2、确认研究计划不会使参与者面临不合理的风险。

Ⅲ、Reviewing and approving proposed payments or other compensation to study participants.

3、审查和批准向研究参与者提出的付款或其他补偿。

Ⅳ、Ensuring that human participant protections remain in force throughout the research by conducting continuing review of approved research. This continuing review is conducted at intervals appropriate to the degree of risk posed by each study, but not less frequently than once a year.

4、通过持续审查已批准的研究，确保人类参与者保护在整个研究过程中保持有效。这一持续性审查的时间间隔与每项研究的风险程度相适应，但频率不低于每年一次。

Ⅴ、Considering adverse events, interim findings, and any recent literature that may be relevant to the research.

5、考虑不良事件，临时发现和任何可能与研究相关的近期文献。

Ⅵ、Assessing suspected or alleged protocol violations, complaints expressed by research participants, or violations of institutional policies.

6、评估可疑或指称的违反协议、研究参与者提出的投诉或违反机构政策的行为。

Ⅶ、Reviewing proposed changes to previously approved studies.

7、审查先前批准研究的拟议变更。

The IRB may suspend or terminate ongoing research that:

Ⅰ、Is not being conducted in accordance with IRB requirements, or

Ⅱ、Is associated with unexpected or serious harm to participants.

IRB可暂停或终止以下正在进行的研究：

一、未按照IRB要求进行，或

二、对参与者造成意外或严重伤害。

The IRB may also suspend or terminate research when additional information results in a change to the study's likely risks or benefits.

当附加信息导致研究可能的风险或收益发生变化时，IRB也可以暂停或终止研究。

Part 3: Membership of an IRB

An IRB must have a diverse membership that includes both scientists and non-scientists. Scientist members may include researchers, physicians, psychologists, nurses, and other mental health professionals. Non- scientist members of an IRB may have special knowledge of a certain population (pregnant women, children, or prisoners).

IRB必须拥有包括科学家和非科学家在内的多元化成员。科学家成员可能包括研究人员、医生、心理学家、护士和其他心理健康专业人员。IRB的非科学家成员可能对特定人群（孕妇、儿童或囚犯）具有特殊知识。

Collectively, IRB members must have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, and ethical aspects of a proposed study. An IRB must have at least five members. However, it may have as many members as necessary to perform a complete and adequate review of research activities.

总之，IRB成员必须具备审查和评估拟议研究的科学、医学、行为、社会、法律和道德方面的资格和经验。IRB必须至少有五名成员。然而，它可能有尽可能多的成员来对研究活动进行全面和充分的审查。

ICH VS FDA

ICH:Ⅰ、Minimum 5 members；至少5名成员；

        Ⅱ、Minimum 1 member with scientific background；至少1名具有科学背景的成员；

        Ⅲ、1 member not affiliated with any institution；1名不隶属于任何机构的成员；

        Ⅳ、Independent of sponsor to provide opinion；独立于发起人提供意见；

FDA:Ⅰ、Minimum 5 members；至少5名成员；

        Ⅱ、At least 1 scientific & 1 non-scientific；至少1名科学人员和1名非科学人员；

        Ⅲ、1 member not affiliated with any institution；1名不隶属于任何机构的成员；

        Ⅳ、Diverse (race, gender, culture, vulnerable population representative) ，No conflict of interest；多元化（种族、性别、文化、弱势群体代表），无利益冲突；

Diversity of Membership

IRB membership must be diverse in terms of race, gender, and cultural heritage. Members must be sensitive to issues such as community attitudes.

Every effort must be made to ensure that no IRB consists entirely of men or entirely of women. However, no one can be appointed to an IRB solely on the basis of gender.

IRB成员必须在种族、性别和文化遗产方面具有多样性。成员必须对社区态度等问题保持敏感。

必须尽一切努力确保IRB不完全由男性或女性组成。然而，任何人都不能仅仅基于性别被任命为IRB成员。

No IRB may consist entirely of members of one profession.

任何IRB不得完全由一个专业的成员组成。

Each IRB should include at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in non-scientific areas.

每个IRB应至少包括一名主要关注科学领域的成员和一名主要关注非科学领域的成员。

Each IRB should include at least one member who is not affiliated with the institution or study site.

每个IRB应至少包括一名与该机构或研究现场无关的成员。

Knowledge of Vulnerable Populations

If the IRB reviews research that involves vulnerable populations — such as children, prisoners, pregnant women, or disabled or cognitively impaired persons — its membership should include one or more persons who are knowledgeable about and/or experienced in working with these populations. The individuals specializing in vulnerable populations may be fulltime voting members or alternates to fulltime voting members.

如果IRB审查涉及弱势群体（如儿童、囚犯、孕妇、残疾人或认知障碍者）的研究，其成员应包括一名或多名了解和/或有经验与这些群体合作的人。专门处理弱势群体问题的个人可以是全职有表决权的成员或全职有表决权成员的候补成员。

Conflicts of Interest

No IRB member may participate in the review of any project in which he or she has a conflicting interest, except to provide information requested by the IRB.

除提供IRB要求的信息外，任何IRB成员不得参与其利益冲突项目的审查。

An investigator may be a member of an IRB. However, the investigator (or any other IRB member) cannot participate in the review or approval of any research in which he or she has a current or potential conflict of interest. The investigator should be absent from the meeting room while the IRB discusses and votes on the research in which he or she has an interest.

调查员可能是IRB的成员。但是，调查员（或任何其他IRB成员）不得参与审查或批准其当前或潜在利益冲突的任何研究。当IRB就其感兴趣的研究进行讨论和投票时，调查员应缺席会议室。

Non-Voting Members

The IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that of the IRB members. These consultants are not voting members of the IRB. However, when research involves vulnerable populations, individuals specializing in these areas must be voting members of an IRB and maintained on the IRB roster accordingly.

IRB可邀请在特殊领域有能力的个人协助审查需要IRB成员以外或额外专业知识的问题。这些顾问不是IRB的表决权成员。然而，当研究涉及弱势群体时，专门从事这些领域的个人必须是IRB的投票成员，并相应地保留在IRB名册上。

Interactive: Assemble Your IRB   交互式：组装您的IRB

Read the following Scenario

A multisite clinical study package (including the protocol, informed consent forms, recruitment materials, and other related documentation) is being submitted for IRB approval. This US-based study is to assess the efficacy of BioMedXYZ's drug for Attention Deficit Hyperactivity Disorder in children ages 7 to 15.

多站点临床研究包（包括方案、知情同意书、招募材料和其他相关文件）正在提交给IRB审批。这项基于美国的研究是评估Biomedxyz的药物在7至15岁儿童中注意力缺陷多动障碍的药物的疗效。

Users are instructed as follows:  用户须知如下：

From a list of eight, choose the most appropriate candidates as members of the IRB and ensure that the composition of the IRB meets the minimum criteria outlined for clinical research in the U.S. Each candidate has a bio or biography to review. After reviewing the candidates' bios to determine if they are right for this clinical study, users are to drag the most appropriate candidates to the member area in the interactive, with a total of five voting members and one non-voting expert for consultation, and analyze the feedback based on the members chosen.

从八名候选人中选择最合适的候选人作为IRB成员，并确保IRB的组成符合美国临床研究的最低标准。每位候选人都有一份个人简历或传记审查。在审查候选人的BIOS以确定他们是否适合本临床研究后，用户将把最合适的候选人拖到交互中的成员区域，总共有五名有投票权的成员和一名无投票权的专家进行咨询，并根据所选成员分析反馈。

The feedback box includes ‘must have’ criteria in three areas: (1) diversity, (2) a non-scientific member, and(3) a non-affiliated member. The ‘must have’ feedback box will include all green checks after assembling the best group of experts for the IRB.

反馈框包括三个方面的“必须具备”标准：（1）多样性，（2）非科学成员，（3）非附属成员。“必须具备”反馈框将包括在为IRB组建最佳专家组后的所有绿色检查。

Be careful to avoid any conflict of interest with the chosen candidates. The feedback box includes a notification when a member is selected that has a conflict of interest for this clinical trial.

小心避免与所选候选人发生任何利益冲突。反馈框包括一个通知，当选择的成员对此临床试验存在利益冲突时。

Listed below are the candidates for the IRB, including names, credentials, current title, and a brief bio on the candidate’s background and expertise.  下面列出了IRB的候选人，包括姓名、资历、当前职称以及候选人背景和专业知识的简要简历。

Candidate 1: Juan Telmo, PhD - Statistical Scientist

Juan has an MS degree in Data Analytics, with a concentration in Statistics, and PhD degree in Statistical Science. He has been a statistical scientist working for the past 5 years at BioMedXYZ firm that develops medical devices. He has expertise in statistical theory, methods, analyses, device development, and clinical research.

候选人1：Juan Telmo博士-统计科学家

Juan拥有数据分析硕士学位，专注于统计学，以及统计科学博士学位。在过去的5年里，他一直是一名统计科学家，在开发医疗设备的BioMedXYZ公司工作。他拥有统计理论、方法、分析、设备开发和临床研究方面的专业知识。

Candidate 2: Tomer Teivel, RN - Social Worker

Tomer had a rough start in life, his mother was an alcoholic when he was a child. He found his passion helping people dealing with addiction. He earned his MS degree in social work and obtained his social worker license (LCSW). He has worked for the past 12 years in schools, hospitals, and other agencies and also in community drug treatment programs. Previously, Tome had participated in numerous research studies involving participant drug use. He has expertise in mental health treatment, research, families, and community.

候选人2：Tomer Teivel，注册护士-社会工作者

托默的生活起步很艰难，他小时候母亲是个酒鬼。他发现自己的热情帮助人们戒毒。他获得了社会工作硕士学位，并获得了社会工作者执照（LCSW）。在过去的12年里，他在学校、医院和其他机构以及社区药物治疗项目中工作。此前，Tome曾参与过许多涉及参与者吸毒的研究。他拥有心理健康治疗、研究、家庭和社区方面的专业知识。

Candidate 3: Lilith O’Conner, BS - Teacher

For the past 3 years, Lilith has worked as a Teacher at the local Elementary School. She serves as the Youth Committee Secretary for the local Community Center and is a teacher representative for the local Board of Education. Lilith has expertise in children, education, and community. She earned her BS degree in Psychology and Early Childhood Education.

候选人3:Lilith O'Conner，理学士-教师

在过去的三年里，莉莉丝一直在当地小学担任教师。她是当地社区中心的青年委员会秘书，也是当地教育委员会的教师代表。Lilith在儿童、教育和社区方面拥有专业知识。她获得心理学和幼儿教育学士学位。

Candidate 4: Carla Fox, JD, MHA - Ethicist

Carla earned her JD and MHA degrees in Health Care Law. She serves as Chairperson on the local chapter for the Board of Bioethics in Hospital Administration. She also works as a lawyer for healthcare organizations. Carla has expertise in health policy, bioethics law, and community engagement.

候选人4：卡拉·福克斯，法学博士，MHA-伦理学家

卡拉获得了医疗保健法的法学博士和医学硕士学位。她担任医院管理生物伦理委员会地方分会主席。她还担任医疗机构的律师。卡拉在卫生政策、生物伦理法和社区参与方面拥有专业知识。

Candidate 5: Brian Bradford, MD - Pediatrician

Brian attended medical school, completed residency in a children's hospital, and obtained his medical licensure. He is a partner pediatrician in general practice for 20 years. He has expertise in pediatrics and clinical care.

候选人5：Brian Bradford，医学博士-儿科医生

布莱恩上了医学院，在一家儿童医院完成了住院治疗，并获得了医疗执照。他是20年的全科合作儿科医生。他拥有儿科和临床护理方面的专业知识。

Candidate 6: Dorian Picard, MD - Therapist

Dr. Picard earned a PhD in behavioral therapy and has been working in both the hospital and private sector for the last 15 years, specializing in children and adolescent behaviors with a special interest in ADHD. Due to his schedule he has limited availability.

候选人6：Dorian Picard，医学博士-治疗师

皮卡德博士获得了行为疗法博士学位，在过去15年中一直在医院和私营部门工作，专门研究儿童和青少年的行为，对多动症有着特殊的兴趣。由于日程安排，他的可用性有限。

Candidate 7: Dung Nguyen, MPH - Policy Analyst

Ms. Nguyen obtained a Master’s degree of Public Health and Policy and now works as a management policy analyst at a firm that advises hospital and legislative administrators on health care policies. She has expertise in public health policies, epidemiology research, and biostatistics.

候选人7：Dung Nguyen，公共卫生硕士-政策分析师

阮女士获得了公共卫生和政策硕士学位，目前在一家为医院和立法行政人员提供医疗政策建议的公司担任管理政策分析师。她拥有公共卫生政策、流行病学研究和生物统计学方面的专业知识。

Candidate 8: Manfred Howard - Minister

Manfred was formerly incarcerated in the state criminal justice system. He is now a minister at the local church. He’s worked for 6 years as an advocate for adults leaving the prison system and transitioning-to- work programs. He has expertise in prisoners and community.

候选人8：曼弗雷德·霍华德-部长

曼弗雷德以前被关押在州刑事司法系统。他现在是当地教会的牧师。他作为成年人离开监狱系统并过渡到工作项目的倡导者工作了6年。他在囚犯和社区方面有专长。

Let’s consider the feedback for the Non-Voting Member.  让我们考虑对无投票权成员的反馈。

One candidate has a conflict of interest – he works for BioMedXYZ. He would not be an appropriate choice for the IRB. That candidate is Juan Telmo, PhD. Additionally, while Manfred Howard may be an expert in his field, he is not a good choice in this case because his area of expertise is adults and prisoners.

一位候选人存在利益冲突——他为BioMedXYZ工作。他不是IRB的合适人选。那个候选人是胡安·特尔莫博士。此外，尽管曼弗雷德·霍华德可能是该领域的专家，但在本案中，他不是一个好的选择，因为他的专业领域是成年人和囚犯。

Several candidates would serve the IRB best as a voting member instead of a non-voting member for consultation. For example, Tomer Teivel, RN, works in environments that cater to the age group targeted for the study. He would serve the IRB better as a voting member as well as Lilith O’Conner, BS, because she has experience in early childhood education and expertise working with the target study population. Carla Brown, PhD, has legal experience and serves on a board of bioethics and Dr. Brian Bradford has a pediatric medical practice. Dung Nguyen, MPH, has expertise in epidemiology research and biostats. These candidates will be a good fit for the IRB as voting members.

若干候选人最好作为有投票权的成员而不是作为无投票权的成员进行协商。例如，Tomer Teivel，RN在适合研究目标年龄组的环境中工作。作为一名投票成员，他将更好地为IRB服务，Lilith O'Conner，BS，因为她在幼儿教育方面具有丰富的经验，并具有与目标研究人群合作的专业知识。Carla Brown博士拥有法律经验，在生物伦理学委员会任职，Brian Bradford博士从事儿科医疗实践。Dung Nguyen，公共卫生硕士，拥有流行病学研究和生物统计方面的专业知识。这些候选人非常适合IRB作为投票成员。

That leaves one candidate who is a good choice to be added to the IRB as an advisor and a non-voting member, Dorian Picard, MD. His expertise is in children and adolescents with ADHD. However, his busy schedule only allows for limited availability. So, he has agreed to be available for expert advice only.

这就留下了一位很好的候选人作为顾问和无投票权成员加入IRB，Dorian Picard，医学博士。他的专长是研究多动症儿童和青少年。然而，他的繁忙日程只允许有限的可用性。因此，他同意只接受专家建议。

Now, consider the feedback for the ideal candidates to serve as voting members of the IRB for this clinical trial.  现在，考虑对理想候选人的反馈，作为IRB的投票成员进行临床试验。

Several candidates have experience working directly with the age group targeted for the study - Tomer Teivel has additional experience in drug treatment and research, Lilith O’Conner has experience in early childhood education, and Dr. Brian Bradford has a pediatric medical practice. Another candidate has legal experience and serves on a board of bioethics, Carla Brown. Having regulations and ethics covered, the final ideal voting member has expertise on epidemiology research and biostatistics, Dung Nguyen. Each of these candidates would serve the IRB well as voting members.

一些候选人有直接与研究目标年龄组工作的经验——Tomer Teivel在药物治疗和研究方面有额外的经验，Lilith O’conner有早期儿童教育经验，Brian Bradford博士有儿科医疗实践经验。另一位候选人卡拉•布朗(Carla Brown)拥有法律经验，并在生物伦理委员会任职。最终理想的投票成员阮勇(Dung Nguyen)拥有流行病学研究和生物统计学方面的专业知识，他的工作涉及法规和道德规范。每一位候选人都将很好地作为伦理委员会的投票成员。

Conversely, there a few candidates that are not ideal to serve on the IRB as voting members.   相反，也有少数候选人不适合作为投票成员在IRB中任职。

Dr. Telmo has a conflict of interest. He works for BioMedXYZ, the pharmaceutical company supplying the drug for the study. While Manfred Howard may be an expert in his field, he is not a good choice in this case because his area of expertise is adults and prisoners. Dr. Picard would be a great addition to the IRB; however, his schedule does not allow him to commit to being a voting member of the team.

Telmo博士有利益冲突。他为Biomedxyz工作，制药公司为该研究提供了药物。虽然曼弗雷德霍华德可能是他领域的专家，但在这种情况下，他不是一个不错的选择，因为他的专业领域是成年人和囚犯。Picard博士将是IRB的一个很好的补充;但是，他的时间表不允许他承诺成为团队的投票成员。