Contents
Part 4: Responsibilities of an IRB
Part 5: Criteria for IRB Approval of Research
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 Proposed and Ongoing Research. This infrastructure includes the following IRB processes:
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 proposed clinical trial within a reasonable timeframe.
v、Make its decisions at announced meetings at which a quorum is present.
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 those decisions and noting the procedures for appeal.
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。包括以下IRB流程：
（1） 根据书面操作程序执行其功能。
（2）保存其活动的书面记录和会议记录。
（3）遵守所有适用的联邦和州监管要求。
（4）应在合理的时间范围内审查拟定的临床试验。
（5）在法定人数出席的已宣布会议上作出决定。
（6）完成研究后，将所有相关记录（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，并在任何监管机构要求时提供。
（7）立即以书面形式通知调查人员其决定，说明作出这些决定的原因，并说明上诉程序。
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 Consent Form(s) and consent form updates that the investigator proposes to use.
iii、Documents and other media relating to participant recruitment procedures (e.g., advertisements).
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.
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（完整研究计划中包含的信息示例）：
（1） 研究方案和方案修订。
（2）研究人员拟使用的书面知情同意书和同意书更新。
（3）与参与者招聘程序有关的文件和其他媒体（如广告）。
（4）向参与者提供的书面信息，包括问卷和说明材料。
（5） 参与者可获得的付款和报酬信息。
（6）调查员手册。
（7）可用的安全信息，包括相关文献的参考。
（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 proposed 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.
3、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：
（1）研究鉴定。
（2）审查文件清单。
（3） 达成的决定：批准、不批准、不批准的理由。
（4） 终止或暂停事先批准。
（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 proposed 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 research study must never be coercive in either amount or method of distribution. (This issue is also discussed in the Informed Consent 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 set forth in the written Informed Consent 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 these requirements before submitting a protocol to the IRB for approval.
7、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 Research
Interactive: Criteria for IRB Approval of Research - 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 Research established three key principles that underlie the current system of human research protections: respect for persons, beneficence (do no harm/maximize possible benefits and minimize possible harms), and justice. These principles are the basis for the criteria for Institutional Review Board (IRB) approval of research (Reference: The Belmont Report).
《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、慈善(无害/尽可能获益，尽可能减少伤害)和公正。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》)
Users are instructed as follows: Select from the three principles as they relate to the given criteria and descriptions: Respect; Beneficence ; Justice. Then, after selecting the related principle, feedback is provided on your response.
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 used in the proposed research are consistent with sound research design, that they do not expose participants to risk unnecessarily, and, when appropriate, involve diagnostic or treatment procedures that pose 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 research, as distinct from risks and benefits of therapies participants would receive even if they were not participating in the research. The IRB should not consider the possible long-range effects of applying the knowledge gained in the research.
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 burden or reap the benefits of the research. The IRB should ensure that the gender and racial, ethnic, and socioeconomic status of the participants of a research study match as closely as possible to that of the persons expected to benefit from the research.
The IRB should also be mindful of the special challenges of research 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 Consent is Properly Obtained and Documented
The IRB must review the informed consent form and ensure that Informed Consent is sought from each prospective participant or from the participant's legally authorized representative. The IRB must also ensure that the process of obtaining Informed Consent is properly documented. (This topic is discussed in detail in the Informed Consent 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 adverse events. (Adverse events are covered in the Participant Safety and Adverse 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 research involves an invasion of privacy. Factors to be considered include:
Ⅰ、The private or sensitive nature of the information sought.
Ⅱ、The likelihood that participants will regard the study as an invasion of privacy.
Ⅲ、The importance of the research.
Ⅳ、The availability of alternative ways to conduct the study.
Confidentiality of data. IRBs must evaluate whether adequate provisions exist to safeguard the confidentiality of information that is collected. (See Confidentiality module.)
Feedback: Which of the three principles relates to this criterion: Respect, Beneficence, or Justice? This criterion relates to the principle of respect for persons in the Belmont Report.
标准5：制定了充分的规定，以保护参与者的隐私和维护数据的机密性
保护参与者的隐私。IRB必须考虑研究是否涉及侵犯隐私。要考虑的因素包括：
1、所寻求信息的隐私或敏感性质。
2、参与者将研究视为侵犯隐私的可能性。
3、研究的重要性。
4、开展研究的替代方法的可用性。
数据的保密性。IRB必须评估是否有足够的条款来保护所收集信息的机密性。（参见保密模块）
Criteria 6: Additional Safeguards are Included for Vulnerable Populations
Some individuals' willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or by actual or perceived coercion by persons in positions of authority. Examples of such vulnerable populations include:
Ⅰ、Children.
Ⅱ、Prisoners.
Ⅲ、Pregnant women.
Ⅳ、Mentally disabled persons.
Ⅴ、Economically or educationally disadvantaged persons.
Ⅵ、Patients with incurable diseases.
Ⅶ、Patients in emergency situations.
Ⅷ、Medical, nursing, dental, and pharmacy students.
Ⅸ、Subordinate hospital personnel.
Ⅹ、Members of the armed forces.
When some or all of a study's participants are likely to be drawn from a vulnerable population, the IRB must ensure that appropriate additional safeguards are included in the study to protect the rights and welfare of these participants. Such additional safeguards may include:
Ⅰ、Heightened monitoring of the informed consent process. In some cases, the IRB may wish to approve the enrollment of each participant in the study.
Ⅱ、Changes to the composition of the IRB. For example, when research involving prisoners is being reviewed, at least one voting member (or Alternate) of the IRB must be a prisoner or a prisoners' representative with appropriate background and experience to serve in that capacity. If a particular research project is under the jurisdiction of more than one IRB, each IRB of record needs to satisfy this requirement.
标准6：包括针对弱势群体的额外保障措施
一些个人自愿参加临床试验的意愿可能会受到与参与相关利益的期望（无论是否合理）的过度影响，或者受到处于权威地位的人实际或感知到的胁迫的影响。这类弱势群体的例子包括：
1、儿童。
2、囚犯。
3、孕妇。
4、精神残疾人。
5、经济或教育上处于不利地位的人。
6、不治之症患者。
7、紧急情况下的患者。
8、医学、护理、牙科和药学专业学生。
9、所属医院人员。
10、武装部队成员。
当一项研究的部分或全部参与者可能来自弱势群体时，IRB必须确保研究中包括适当的额外保障措施，以保护这些参与者的权利和福利。此类额外保障措施可包括：
1、加强对知情同意过程的监控。在某些情况下，IRB可能希望批准每个参与者参与研究。
2、内部评级机构组成的变化。例如，在审查涉及囚犯的研究时，IRB的至少一名投票成员（或候补成员）必须是具有适当背景和经验的囚犯或囚犯代表，以该身份任职。如果一个特定的研究项目受多个IRB管辖，则每个记录的IRB都需要满足这一要求。
反馈1-慈善；反馈2-慈善；反馈3-正义；反馈4-尊重；反馈5-尊重；反馈6-慈善和尊重。
Part 6: Expedited Review
An IRB may use an expedited review procedure for research that:
Ⅰ、Involves no more than minimal risk and
Ⅱ、Falls into a category that appears on an approved list of categories of research eligible for expedited review.
IRB可对以下研究使用快速审查程序：
1、涉及最小的风险和危险
2、属于符合加急审查条件的研究类别核准清单上的一类。
An IRB may also use expedited review to approve minor changes in previously approved research that are made during the period (1 year or less) for which the approval is authorized. The IRB must have written procedures that specify how an expedited review will be conducted.
IRB也可以使用快速审查来批准在授权批准期间（1年或更短）对先前批准的研究进行的微小更改。IRB必须制定书面程序，规定如何进行快速审查。
An expedited review (which may involve less waiting time for IRB approval) may be carried out by the IRB chairperson or by one or more experienced IRB members designated by the chairperson. The reviewers may exercise all of the authorities of the IRB except that of disapproving the research. A proposal submitted for expedited review may be disapproved only by the full IRB.
可由IRB主席或由主席指定的一名或多名经验丰富的IRB成员进行快速审查（可能涉及较少的等待IRB批准的时间）。评审员可以行使IRB的所有权限，但不批准研究的权限除外。提交以供快速审查的提案只能被完整的IRB否决。
Research Eligible for Expedited Review 符合加急审查条件的研究
The Department of Health and Human Services has determined that certain types of research involve no more than minimal risk and are therefore eligible for expedited review.
卫生和公共服务部（HHS）已确定，某些类型的研究只涉及最低风险，因此有资格进行快速审查。
The following are examples of research that may be eligible for expedited review:
Ⅰ、Collection of hair or baby teeth.
Ⅱ、Collection of external secretions, including sweat and saliva.
Ⅲ、Recording of data from adults using noninvasive procedures that are routinely employed in clinical practice (not including exposure to electromagnetic radiation outside the visible range, for example, x- rays or microwaves.)
Ⅳ、Collection of blood samples by venipuncture.
Ⅴ、Voice recordings made for research purposes, such as investigations of speech defects.
Ⅵ、Moderate exercise by healthy volunteers.
Ⅶ、Study of existing data, documents, records, pathological specimens, or diagnostic specimens.
以下是有资格进行快速审查的研究示例：
1、收集头发或乳牙。
2、收集外分泌液，包括汗液和唾液。
3、使用临床实践中常规使用的无创程序记录成人数据（不包括暴露于可见范围外的电磁辐射，例如x射线或微波）
4、静脉穿刺采集血样。
5、为研究目的而录制的语音记录，如语音缺陷调查。
6、健康志愿者适度运动。
7、现有数据、文件、记录、病理标本或诊断标本的研究。
Further information about the types of research that may be eligible for expedited review may be found on the Office of Human Research Protections website.
关于有资格进行快速审查的研究类型的更多信息，请访问人类研究保护办公室网站。
