ICH-GCP2.1InstitutionalReviewBoards（1）Contents
Part 1: What is an Institutional Review Board (IRB)?
Part 2: Purpo 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 rearch participants. Under Title 45 Part 46 of the Code of Federal Regulations (45 CFR 46), any rearch 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
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。
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 rearch, 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 rearch 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 rearch activities that fall within its local jurisdiction according torelevant federal regulations and institutional policy.
Ⅱ、Require modifications in protocols, including protocols of previously approved rearch.
Ⅲ、Require that participants be given any additional information that will assist them in making an informed decision to take part in rearch. (Requirements for informed connt are covered in the Inf
ormed Connt module.)
Ⅳ、Require documentation of informed connt or allow a waiver of documentation. (Documentation of informed connt is covered in the Informed Connt 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
批准、不批准或终⽌其地⽅管辖范围内的所有研究活动。
修改⽅案，包括先前批准的研究⽅案。
2、需要修改
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）
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
允许放弃⽂件。（知情同意模块涵盖知情同意的⽂件）
知情同意的⽂件或允许放弃⽂件
4、要求提供知情同意的⽂件
Every institution that participates in rearch studies must identify an IRB to review and approve tho studies. The IRB must follow the requirements of 45 CFR 46 (described in this module) and of the Office for Human Rearch Protections. Some rearch sites are under the jurisdiction of two or more IRBs. In the cas, the IRBs may perform joint review, parate 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 addresd in other modules of this training program. Links to tho 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: Purpo of an IRB?
The purpo of an IRB is to safeguard the rights, safety, and well–being of all human rearch participants. The IRB fulfills this purpo 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 (e ction IRB responsibilities for the documents which compri a full protocol) for a rearch study to ensure that the rearch meets the criteria specified in 45 CFR 46.111. (See summarized Criteria for IRB approval of rearch.)
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1、审查完整的研究计划
总标准。）
Ⅱ、Confirming that the rearch plans do not expo 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
确认研究计划不会使参与者⾯临不合理的风险。
Ⅲ、Reviewing and approving propod payments or other compensation to study participants.
审查和批准向研究参与者提出的付款或其他补偿。
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 rearch by conducting continuing review of approved rearch. This continuing review is conducted at intervals appropriate to the degree of risk pod by each study,
but not less frequently than once a year.
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，4、通过持续审查已批准的研究
但频率不低于每年⼀次。
Ⅴ、Considering adver events, interim findings, and any recent literature that may be relevant to the rearch.
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。
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、Asssing suspected or alleged protocol violations, complaints expresd by rearch 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
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 propod changes to previously approved studies.
7、审查先前批准研究的拟议变更
审查先前批准研究的拟议变更。
The IRB may suspend or terminate ongoing rearch that:
Ⅰ、Is not being conducted in accordance with IRB requirements, or
Ⅱ、Is associated with unexpected or rious harm to participants.
IRB可暂停或终⽌以下正在进⾏的研究：
未按照IRB要求进⾏，或
⼀、未按照IRB要求进⾏
对参与者造成意外或严重伤害。
⼆、对参与者造成意外或严重伤害
The IRB may also suspend or terminate rearch when additional information results in a change to the study's likely risks or benefits.
风险或收益发⽣变化时，IRB也可以暂停或终⽌研究。
当附加信息导致研究可能的风险或收益发⽣变化
Part 3: Membership of an IRB
An IRB must have a diver membership that includes both scientists and non-scientists. Scientist members may include rearchers, physicians, psychologists, nurs, and other mental health professionals. Non- scientist members of an IRB may have special knowledge of a certain population (pregnant women, children, or prisoners).
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 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
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。
的⾮科学家成员
Collectively, IRB members must have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, and ethical aspects of a propod 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 rearch activities.
法律和道德
IRB必须⾄少有五名成员。然⽽，
道德⽅⾯的资格和经验。IRB必须⾄少有五名成员。
社会、法律
总之，IRB成员必须具备审查和评估拟议研究的科学
⾏为、社会
科学、医学
医学、⾏为
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、Diver (race, gender, culture, vulnerable population reprentative) ，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 diver in terms of race, gender, and cultural heritage. Members must be nsitive 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.
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。
IRB成员必须在种族、性别和⽂化遗产⽅⾯具有多样性
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.
专业的成员组成。
任何IRB不得完全由⼀个专业的成员
Each IRB should include at least one member who primary concerns are in scientific areas and one member who primary concerns are in non-scientific areas.
⾮科学领域的成员。
每个IRB应⾄少包括⼀名主要关注科学领域的成员
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.
与该机构或研究现场⽆关的成员。
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 rearch 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 the 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 rearch in which he or she has a current or potential conflict of interest. The investigator should be abnt from the meeting room while the IRB discuss and votes on the rearch 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 experti beyond or in addition to that of the IRB members. The consultants are not voting members of the IRB. However, when rearch involves vulnerable populations, individuals specializing in the 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: Asmble Your IRB 交互式：组装您的IRB
R ea d the fo llo w ing Sc ena rio
A multisite clinical study package (including the protocol, informed connt forms, recruitment materials, and other related documentation) is being submitted for IR
B approval. This US-bad study is to asss 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。
rs a
U r s a r e instr uc ted a s fo llo w s: ⽤户须知如下：
From a list of eight, choo the most appropriate candidates as members of the IRB and ensure that the composition of the IRB meets the minimum criteria outlined for clinical rearch 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, urs 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 bad on the members chon.
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 asmbling 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 chon candidates. The feedback box includes a notification when a member is lected 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。
