# Part 1: What is an Institutional Review Board (IRB)?
# 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) 是一个独立机构，旨在保护人类研究参与者的权利和福利。
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.
任何涉及美国食品药品监督管理局 (FDA) 监管产品的临床研究也必须经过 IRB (21 CFR 56) 的审查和批准。个别机构或赞助商可能要求所有研究，无论其资助方式如何，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.
IRB 对在其管辖范围内开展研究拥有特定权力。在获得 IRB 批准之前，任何临床研究都不得开始招募参与者。
The IRB has the authority to:
IRB 有权：
- Approve, disapprove, or terminate all research activities that fall within its local jurisdiction according to relevant federal regulations and institutional policy.
根据相关联邦法规和机构政策，批准、不批准或终止所有在其本地管辖范围内的研究活动。 - Require modifications in protocols, including protocols of previously approved research.
要求修改方案，包括之前批准的研究方案。 - 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.)
要求向参与者提供任何额外信息，以帮助他们在知情的情况下做出参与研究的决定。（知情同意书模块涵盖了知情同意书的要求。） - Require documentation of informed consent or allow a waiver of documentation. (Documentation of informed consent is covered in the Informed Consent module.)
要求提供知情同意文件或允许放弃提供文件。（知情同意书文档包含在知情同意书模块中。）
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指定一个 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，IRB 可以进行联合审查、单独审查或同意遵守其中一个 IRB 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.
