ICH-GCP2.2InstitutionalReviewBoards（2）Contents
Part 4: Responsibilities of an IRB
Part 5: Criteria for IRB Approval of Rearch
Part 6: Expedited Review
Part 4: Responsibilities of an IRB
The principal responsibilities of an IRB include the following:
IRB的主要职责包括：
Ⅰ、Provision of an Infrastructure to Support the Ethical Review of Propod and Ongoing Rearch. This infrastructure includes the following IRB process:
i、Perform its functions according to written operating procedures.
ii、Maintain written records of its activities and minutes of its meetings.
iii、Comply with all applicable federal and state regulatory requirement(s).
iv、Should review a propod clinical trial within a reasonable timeframe.
v、Make its decisions at announced meetings at which a quorum is prent.
vi、Retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of a study and make them available upon request from any regulatory authority.
vii、Notify investigators promptly in writing of its decisions, stating the reasons for tho decisions and noting the procedures for appeal.
提供基础设施，⽀持对拟定和正在进⾏的研究进⾏伦理审查。包括以下IRB流程：
1、提供基础设施，⽀持对拟定和正在进⾏的研究进⾏伦理审查。
执⾏其功能。
（1） 根据书⾯操作程序执⾏
会议记录。
书⾯记录和会议记录
（2）保存其活动的书⾯记录
联邦和州监管要求。
（3）遵守所有适⽤的联邦和州监管
审查拟定的临床试验。
（4）应在合理的时间范围内审查
决定。
（5）在法定⼈数出席的已宣布会议上作出决定
记录（如书⾯程序、成员名单、成员职业/从属关系列表、提交的⽂件、会议记录和信函）保留⾄少3年，并在任何（6）完成研究后，将所有相关记录
监管机构要求时提供。
调查⼈员其决定，说明作出这些决定的原因，并说明上诉程序。
（7）⽴即以书⾯形式通知调查
Ⅱ、Reviewing and Understanding the Full Plan of Study. To provide a full review, the IRB should obtain the following documents (examples of information included in a full plan of study):
i、Study protocol(s) and protocol amendment(s).
ii、Written Informed Connt Form(s) and connt form updates that the investigator propos to u.
iii、Documents and other media relating to participant recruitment procedures (e.g., advertiments).
iv、Written information to be provided to participants including questionnaires and explanatory materials.
v、Information about payments and compensation available to participants.
vi、Investigator's Brochure.
vii、Available safety information, including references to relevant literature.
viii、Investigator's current curriculum vitae and/or other documentation that provides evidence of the investigator's qualifications.
ix、Any other documents needed to fulfill the IRB's responsibilities.
回顾和理解整个学习计划。为提供全⾯审查，IRB应获得以下⽂件（完整研究计划中包含的信息⽰例）：
2、回顾和理解整个学习计划。为提供全⾯审查，IRB应获得以下⽂件
⽅案修订。
（1） 研究⽅案
研究⽅案和⽅案修订
书⾯知情同意书和同意书更新。
（2）研究⼈员拟使⽤的书⾯知情同意书
招聘程序有关的⽂件和其他媒体
其他媒体（如⼴告）。
（3）与参与者招聘程序有关的⽂件
说明材料。
问卷和说明材料
（4）向参与者提供的书⾯信息，包括问卷
报酬信息。
（5） 参与者可获得的付款
付款和报酬信息
调查员⼿册。
（6）调查员⼿册
安全信息，包括相关⽂献的参考。
（7）可⽤的安全信息
资格证明的其他⽂件。
（8）研究⼈员的当前简历和/或提供研究⼈员资格证明的其他⽂件
（9）履⾏IRB职责所需的任何其他⽂件。
Ⅲ、Keeping a Written Record of IRB Decisions. The following written records should be kept pertaining to an IRB's review of a propod study:
i、Identification of the study.
ii、List of documents reviewed.
iii、Decision reached: Approval, Disapproval, Rationale for disapproval.
iv、Termination or suspension of prior approval.
v、Date decision was reached.
vi、Correspondence with the investigator.
保留IRB决定的书⾯记录。关于IRB对拟定研究的审查，应保留以下书⾯记录：
3、保留IRB决定的书⾯记录。
研究鉴定。
（1）研究鉴定
审查⽂件清单。
（2）审查⽂件
决定：批准、不批准、不批准的理由。
（3） 达成的决定
事先批准。
（4） 终⽌或暂停事先批准
⽇期。
（5） 达成决定的⽇期
（6） 与调查⼈员的通信。
Ⅳ、Considering the Investigator's Qualifications
The IRB should consider the qualifications of the investigator for the propod study, as documented by a current curriculum vitae or other relevant documentation.
4、考虑研究⼈员的资质
IRB应考虑调查者对所提出研究的资格，如现⾏履历或其他相关⽂件所记载。
Ⅴ、Conducting Continuing Review of Ongoing Studies
The IRB conducts continuing review of each ongoing study at intervals appropriate to the degree of risk to human participants. By regulation, this interval must be at least once per year.
5、对正在进⾏的研究进⾏持续审查
IRB根据⼈类参与者的风险程度，以适当的间隔对每项正在进⾏的研究进⾏持续审查。根据规定，该
间隔必须⾄少每年⼀次。
Ⅵ、Requesting More Information When Necessary
The IRB may request more information to assist in their review. One of the reasons for such a request would be when the IRB judges that the additional information would add meaningfully to the protection of the rights, safety, or well-being of participants.
6、必要时要求提供更多信息
IRB可要求提供更多信息，以协助其审查。提出这⼀要求的原因之⼀是，IRB认为补充信息将有助于保护参与者的权利、安全或福祉。
Ⅶ、Reviewing Incentives for Participation
Payment to participants for their participation in a rearch study must never be coercive in either amount or method of distribution. (This issue is also discusd in the Informed Connt module.)
The IRB should review both the amount and method of payment to participants to assure that neither exerts undue influence on study participants. Payments to participants should be prorated (divided in
a proportional manner) and not entirely contingent on a participant's completion of the study (no large, consolidated payment at the end).
The IRB should confirm that information regarding payment to participants, including the methods, amounts, and schedule of payments to study participants, is justified by the protocol and t forth in the written Informed Connt Form and any other written information provided to participants. The way payment will be prorated should be specified.
Some IRBs have written requirements concerning what is adequate compensation for study participants. Investigators should be familiar with the requirements before submitting a protocol to the IRB for approval.
7、审查参与激励措施
审查参与激励措施
对参与研究的参与者的付款，⽆论是在⾦额上还是在分配⽅式上，都不能是强制性的。（这⼀问题也将在知情同意模块中讨论。）
IRB应审查向参与者⽀付的⾦额和⽅法，以确保两者都不会对研究参与者产⽣不当影响。对参与者的
付款应按⽐例分配（按⽐例分配），且不完全取决于参与者完成研究（最终⽆⼤额合并付款）。
IRB应确认，关于向参与者付款的信息，包括向研究参与者付款的⽅法、⾦额和时间表，符合协议规定，并在书⾯知情同意书和向参与者提供的任何其他书⾯信息中规定。应指定按⽐例⽀付的⽅式。
⼀些IRB对研究参与者的适当报酬有书⾯要求。在向IRB提交⽅案IRB批准之前，调查⼈员应该熟悉这些要求。
Part 5: Criteria for IRB Approval of Rearch
Interactive: Criteria for IRB Approval of Rearch - Principles 交互式：IRB批准研究的标准-原则
The Belmont Report, the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Rearch established three key principles that underlie the current system of human rearch protections: respect for persons, beneficence (do no harm/maximize possible benefits and minimize possible harms), and justice. The principles are the basis for the criteria for Institutional Review Board (IRB) approval of rearch (Reference: The Belmont Report).
尊重⼈、慈
慈《贝尔蒙特报告》是国家保护⽣物医学和⾏为研究⼈体受试者委员会的报告，其中确⽴了当前⼈类研究保护体系的三项关键原则: 尊重⼈
《贝尔蒙特报告》
公正。这些原则是机构审查委员会(IRB)批准研究的标准的基础(参考⽂献: 《贝尔蒙特报告》)
善(⽆害/尽可能获益，尽可能减少伤害)和公正
Urs are instructed as follows: Select from the three principles as they relate to the given criteria and descriptions: Respect; Beneficence ; Justice. Then, after lecting the related principle, feedback is provided on your respon.
指导⽤户如下：从与给定标准和描述相关的三个原则中进⾏选择：尊重 ；慈善；司法。然后，在选择相关原则后，将对您的回答提供反馈。Criteria 1: Risks to Participants are Minimized
The IRB should ensure that procedures ud in the propod rearch are consistent with sound rearch design, that they do not expo participants to risk unnecessarily, and, when appropriate, involve diagnostic or treatment procedures that po no further risk.
标准1：将参与者⾯临的风险降⾄最低
IRB应确保拟议研究中使⽤的程序与合理的研究设计⼀致，不会使参与者⾯临不必要的风险，并在适当的情况下，包括不构成进⼀步风险的诊断或治疗程序。
Criteria 2: Risks to Participants are Reasonable in Relation to Anticipated Benefits
The IRB should consider only risks and benefits that may result from the rearch, as distinct from risks and benefits of therapies participants would receive even if they were not participating in the rearch. The IRB should not consider the possible long-range effects of applying the knowledge gained in the rearch.
标准2：参与者的风险相对于预期收益⽽⾔是合理的
IRB应该只考虑研究结果可能带来的风险和益处，这与参与者参与治疗的风险和益处不同，即使他们没有参与研究。IRB不应该考虑应⽤在研究中
获得的知识的可能的长期影响。
Criteria 3: Selection of Participants is Equitable
No single gender or racial, ethnic, or socioeconomic group should disproportionately carry the burde
n or reap the benefits of the rearch. The IRB should ensure that the gender and racial, ethnic, and socioeconomic status of the participants of a rearch study match as cloly as possible to that of the persons expected to benefit from the rearch.
The IRB should also be mindful of the special challenges of rearch involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
标准3：参与者的选择是公平的
没有单⼀的性别或种族，种族或社会经济集团应该不成⽐例地承担负担或获得研究的好处。IRB应确保研究研究研究的性别和种族，种族和社会经济地位，尽可能接近预期从研究中受益的⼈员。
IRB也应该注意到涉及弱势群体的研究的特殊挑战，例如⼉童，囚犯，孕妇，精神残疾⼈，或经济或教育弱势群体。
Criteria 4: Informed Connt is Properly Obtained and Documented
The IRB must review the informed connt form and ensure that Informed Connt is sought from each prospective participant or from the participant's legally authorized reprentative. The IRB must
also ensure that the process of obtaining Informed Connt is properly documented. (This topic is discusd in detail in the Informed Connt module.)
Adequate provision is made for monitoring the data collected to ensure the safety of participants.
The IRB must review the plans for data collection, storage and analysis and for ensuring participant safety. This includes the plan for capturing and reporting information about adver events. (Adver events are covered in the Participant Safety and Adver Events module.)
Complex or high-risk studies may be required to have a data and safety monitoring plan. Some sponsors may require all studies to have a data safety monitoring plan. For example, in the Clinical Trials Network, all studies must have a data and safety monitoring plan and be monitored by a Data and Safety Monitoring Board.
标准4：正确获得并记录知情同意
IRB必须审查知情同意书，并确保征求每个潜在参与者或参与者的合法授权代表的知情同意。IRB还必须确保获得知情同意的过程得到适当记录。（本主题将在知情同意模块中详细讨论）
为监测所收集的数据作出了充分的规定，以确保参与者的安全。
IRB必须审查数据收集、存储和分析以及确保参与者安全的计划。这包括获取和报告不良事件信息的计划。（不良事件包含在参与者安全和不良事件模块中）
复杂或⾼风险研究可能需要有数据和安全监测计划。⼀些赞助者可能要求所有研究都有数据安全监控计划。例如，在临床试验⽹络中，所有研究必须有数据和安全性监测计划，并由数据和安全性监测委员会进⾏监测。
Criteria 5: Adequate Provision is Made to Protect Participants' Privacy and Maintain the Confidentiality of Data
Protection of participants' privacy. The IRB must consider whether the rearch involves an invasion of privacy. Factors to be considered include:
Ⅰ、The private or nsitive nature of the information sought.
Ⅱ、The likelihood that participants will regard the study as an invasion of privacy.
