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ICH-GCP 2.3 Institutional Review Boards（3）
来源：www.zuowenzhai.com 作者：编辑 日期：2024-05-31
Part 7: Investigators' Responsibilities to the IRB
Part 8: IRBs and Multi-Site Research
Part 9: Summary of Key Points
The investigator must:
Ⅰ、Ensure that the IRB receives all the documents it requires to review the proposed research.
Ⅱ、Admit no participant to a study before the IRB has issued its written approval of the study.
Ⅲ、Make no changes to or deviations from the study protocol without prior written approval from the IRB, except when necessary to eliminate immediate hazards to participants.
Ⅳ、Report promptly to the IRB:
i、Changes to or deviations from the protocol, including changes made to eliminate immediate hazards to study participants.
ii、Changes that increase the risk to participants or significantly affect the conduct of the study.
iii、All adverse drug reactions that are both serious and unexpected.
iv、New information that may adversely affect the safety of participants or the conduct of the study.
研究人员必须：
1、确保IRB收到审查拟议研究所需的 所有文件 。
2、在IRB书面批准 研究之前，不得允许任何参与者参与研究 。
3、未经IRB事先书面批准， 不得更改或偏离研究方案 ，除非有必要消除对参与者的直接危害。
4、及时向IRB 报告 ：
（1）对方案的 更改或偏离 ，包括为消除对研究参与者的直接危害而进行的更改。
（2）增加参与者风险或显著影响研究进行的 变化 。
（3）所有严重和意外的药物 不良反应 。
（4）可能对参与者安全或研究进行产生不利影响的 新信息 。
Reporting requirements may vary, and it is the investigator's responsibility to know the individual reporting requirements of each IRB involved with the research study. For example, an IRB may require that every serious adverse drug reaction be promptly reported, whether it was unexpected or not.
报告要求可能有所不同，研究人员有责任了解参与研究的每个IRB的个人报告要求。例如，IRB可能要求及时报告每一个严重的药物不良反应，无论它是否出乎意料。
Ⅰ、Respond in a timely fashion to all requests from the IRB for additional information about a research study.
Ⅱ、Submit progress reports to the IRB annually, or more frequently, if requested by the IRB, and submit a final report to the IRB when the study is completed or terminated.
1、及时回复IRB关于研究的 附加信息 的所有请求。
2、每年向IRB提交 进度报告 ，或在IRB要求时更频繁地提交进度报告，并在研究完成或终止时向IRB提交 最终报告 。
Multi-site trials funded by NIH are characterized by the involvement of multiple institutions and study sites engaged in a single research study. CTN studies are an example of multi-site trials funded by the National Institute on Drug Abuse (NIDA).
由NIH资助的多站点试验的特点是 涉及多个机构和研究地点参与一项研究 。CTN研究是由国家药物滥用研究所（NIDA）资助的多站点试验的一个例子。
When a research study involves more than one institution, each institution is responsible for safeguarding the rights and well-being of research participants at that institution.
当一项研究涉及多个机构时，每个机构都有责任保障该机构研究参与者的权利和福祉。
With the implementation of the NIH policy on Use of a Single Institutional Review Board for Multi-Site Research (effective May 25, 2017), multi-institutional research in the U.S. involving non-exempt human participants will use a single IRB. Based on 45 CFR 46.114, the use of a single IRB allows for a more streamlined IRB review and increases efficiencies while maintaining the protection of human study participants (NIH Office of Extramural Research, 2016).
随着国家卫生研究院（NIH）关于使用单一机构审查委员会进行多地点研究的政策的实施（2017年5月25日生效），美国涉及非豁免人类参与者的多机构研究将使用单一IRB。根据45 CFR 46.114， 单一IRB的使用允许更精简的IRB审查并提高效率，同时保持对人类研究参与者的保护 （NIH校外研究办公室，2016）。
For more information, including the scope and applicability of the Use of a Single Institutional Review Board for Multi-Site Research, reference the NIH policy .
更多信息，包括使用单一机构审查委员会进行多地点研究的范围和适用性，请参考NIH政策。
Additional resources are available on the NIH Office of Science Policy’s website for single IRB (sIRB).
更多资源可在NIH科学政策办公室的单一IRB（sIRB）网站上获得。
Ⅰ、The purpose of an Institutional Review Board (IRB) is to safeguard the rights, safety, and well-being of all human research participants.
1、机构审查委员会（IRB）的目的是保障所有人类研究参与者的 权利 、 安全 和 福祉 。
Ⅱ、Any federally funded research involving human participants must be reviewed and approved by an IRB.
2、任何 涉及人类参与者 的联邦资助研究，必须由IRB审查和批准。
Ⅲ、Any clinical investigation involving a product regulated by the FDA must be reviewed and approved by an IRB.
3、 涉及FDA监管产品 的任何临床研究，必须由IRB审查和批准。
Ⅳ、An IRB has the authority to approve or disapprove all research activities that fall within its jurisdiction. It may disapprove a research project with a request for modification. It also has the authority to suspend a research study that it previously approved.
4、IRB 有权批准或不批准其管辖范围内的所有研究活动 。它可能会以修改请求的形式否决某个研究项目。它也有权暂停先前批准的一项研究。
Ⅴ、All previously approved ongoing research must be reviewed by an IRB at least once a year to determine whether approval should be continued.
5、所有先前批准的正在进行的研究必须由IRB 至少每年审查一次 ，以确定是否应继续批准。
Ⅵ、Every institution, including in the NIDA Clinical Trials Network (CTN), that participates in a clinical study must identify all IRBs that have jurisdiction to review and approve the protocol.
6、 每个参与临床研究的机构 ，包括在NIDA临床试验网络（CTN）中，必须识别所有有管辖权的IRB，以审查和批准议定书。
Ⅶ、To approve a research protocol, the IRB must ensure that:
i、Risks to participants are minimized.
ii、Risks to participants are reasonable in relation to anticipated benefits.
iii、Selection of participants is equitable.
iv、Informed consent is properly obtained and documented.
v、Adequate provision is made for monitoring the data collected to ensure the safety of participants.
vi、Adequate provision is made to protect participants and maintain confidentiality of data.
vii、Additional safeguards are included for vulnerable populations.
6、为了批准研究方案，IRB必须确保：
（1）将参与者面临的 风险降至最低 。
（2）参与者面临的 风险相对于预期收益 而言是合理的。
（3）参与者的选择是 公平 的。
（4）正确获得并记录 知情同意书 。
（5）对收集的 数据 进行监控，以确保参与者的安全。
（6）制定了充分的规定，以保护参与者和维护数据的 机密性 。
（7） 为弱势群体提供额外保障 。
Part 8: IRBs and Multi-Site Research
Part 9: Summary of Key Points
The investigator must:
Ⅰ、Ensure that the IRB receives all the documents it requires to review the proposed research.
Ⅱ、Admit no participant to a study before the IRB has issued its written approval of the study.
Ⅲ、Make no changes to or deviations from the study protocol without prior written approval from the IRB, except when necessary to eliminate immediate hazards to participants.
Ⅳ、Report promptly to the IRB:
i、Changes to or deviations from the protocol, including changes made to eliminate immediate hazards to study participants.
ii、Changes that increase the risk to participants or significantly affect the conduct of the study.
iii、All adverse drug reactions that are both serious and unexpected.
iv、New information that may adversely affect the safety of participants or the conduct of the study.
研究人员必须：
1、确保IRB收到审查拟议研究所需的 所有文件 。
2、在IRB书面批准 研究之前，不得允许任何参与者参与研究 。
3、未经IRB事先书面批准， 不得更改或偏离研究方案 ，除非有必要消除对参与者的直接危害。
4、及时向IRB 报告 ：
（1）对方案的 更改或偏离 ，包括为消除对研究参与者的直接危害而进行的更改。
（2）增加参与者风险或显著影响研究进行的 变化 。
（3）所有严重和意外的药物 不良反应 。
（4）可能对参与者安全或研究进行产生不利影响的 新信息 。
Reporting requirements may vary, and it is the investigator's responsibility to know the individual reporting requirements of each IRB involved with the research study. For example, an IRB may require that every serious adverse drug reaction be promptly reported, whether it was unexpected or not.
报告要求可能有所不同，研究人员有责任了解参与研究的每个IRB的个人报告要求。例如，IRB可能要求及时报告每一个严重的药物不良反应，无论它是否出乎意料。
Ⅰ、Respond in a timely fashion to all requests from the IRB for additional information about a research study.
Ⅱ、Submit progress reports to the IRB annually, or more frequently, if requested by the IRB, and submit a final report to the IRB when the study is completed or terminated.
1、及时回复IRB关于研究的 附加信息 的所有请求。
2、每年向IRB提交 进度报告 ，或在IRB要求时更频繁地提交进度报告，并在研究完成或终止时向IRB提交 最终报告 。
Multi-site trials funded by NIH are characterized by the involvement of multiple institutions and study sites engaged in a single research study. CTN studies are an example of multi-site trials funded by the National Institute on Drug Abuse (NIDA).
由NIH资助的多站点试验的特点是 涉及多个机构和研究地点参与一项研究 。CTN研究是由国家药物滥用研究所（NIDA）资助的多站点试验的一个例子。
When a research study involves more than one institution, each institution is responsible for safeguarding the rights and well-being of research participants at that institution.
当一项研究涉及多个机构时，每个机构都有责任保障该机构研究参与者的权利和福祉。
With the implementation of the NIH policy on Use of a Single Institutional Review Board for Multi-Site Research (effective May 25, 2017), multi-institutional research in the U.S. involving non-exempt human participants will use a single IRB. Based on 45 CFR 46.114, the use of a single IRB allows for a more streamlined IRB review and increases efficiencies while maintaining the protection of human study participants (NIH Office of Extramural Research, 2016).
随着国家卫生研究院（NIH）关于使用单一机构审查委员会进行多地点研究的政策的实施（2017年5月25日生效），美国涉及非豁免人类参与者的多机构研究将使用单一IRB。根据45 CFR 46.114， 单一IRB的使用允许更精简的IRB审查并提高效率，同时保持对人类研究参与者的保护 （NIH校外研究办公室，2016）。
For more information, including the scope and applicability of the Use of a Single Institutional Review Board for Multi-Site Research, reference the NIH policy .
更多信息，包括使用单一机构审查委员会进行多地点研究的范围和适用性，请参考NIH政策。
Additional resources are available on the NIH Office of Science Policy’s website for single IRB (sIRB).
更多资源可在NIH科学政策办公室的单一IRB（sIRB）网站上获得。
Ⅰ、The purpose of an Institutional Review Board (IRB) is to safeguard the rights, safety, and well-being of all human research participants.
1、机构审查委员会（IRB）的目的是保障所有人类研究参与者的 权利 、 安全 和 福祉 。
Ⅱ、Any federally funded research involving human participants must be reviewed and approved by an IRB.
2、任何 涉及人类参与者 的联邦资助研究，必须由IRB审查和批准。
Ⅲ、Any clinical investigation involving a product regulated by the FDA must be reviewed and approved by an IRB.
3、 涉及FDA监管产品 的任何临床研究，必须由IRB审查和批准。
Ⅳ、An IRB has the authority to approve or disapprove all research activities that fall within its jurisdiction. It may disapprove a research project with a request for modification. It also has the authority to suspend a research study that it previously approved.
4、IRB 有权批准或不批准其管辖范围内的所有研究活动 。它可能会以修改请求的形式否决某个研究项目。它也有权暂停先前批准的一项研究。
Ⅴ、All previously approved ongoing research must be reviewed by an IRB at least once a year to determine whether approval should be continued.
5、所有先前批准的正在进行的研究必须由IRB 至少每年审查一次 ，以确定是否应继续批准。
Ⅵ、Every institution, including in the NIDA Clinical Trials Network (CTN), that participates in a clinical study must identify all IRBs that have jurisdiction to review and approve the protocol.
6、 每个参与临床研究的机构 ，包括在NIDA临床试验网络（CTN）中，必须识别所有有管辖权的IRB，以审查和批准议定书。
Ⅶ、To approve a research protocol, the IRB must ensure that:
i、Risks to participants are minimized.
ii、Risks to participants are reasonable in relation to anticipated benefits.
iii、Selection of participants is equitable.
iv、Informed consent is properly obtained and documented.
v、Adequate provision is made for monitoring the data collected to ensure the safety of participants.
vi、Adequate provision is made to protect participants and maintain confidentiality of data.
vii、Additional safeguards are included for vulnerable populations.
6、为了批准研究方案，IRB必须确保：
（1）将参与者面临的 风险降至最低 。
（2）参与者面临的 风险相对于预期收益 而言是合理的。
（3）参与者的选择是 公平 的。
（4）正确获得并记录 知情同意书 。
（5）对收集的 数据 进行监控，以确保参与者的安全。
（6）制定了充分的规定，以保护参与者和维护数据的 机密性 。
（7） 为弱势群体提供额外保障 。
（编辑：平尤松）
