保护人类受试者委员会

加急评论

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POLICY

Research is reviewed by CPHS at convened meetings unless it is minimal risk and qualifies for expedited review. An expedited review procedure consists of a review of research involving human subjects by the IRB chair or by one or more experienced reviewers designated by the chair from among the IRB membership who have received training relative to the expedited review categories.

CPHS可以使用快速的审查程序来审查以下审查列表类别中出现的以下研究。beplay苹果手机能用吗如果研究属于下面的列表中的类别，则认为该研究是最小的风险。如果审阅者确定研究涉及的风险最小，则必须记录确定的基本原理。

为了通过加急流程进行审查，研究建议必须符合以下标准：beplay苹果手机能用吗

1. 该研究建beplay苹果手机能用吗议对人类受试者的风险最小，
2. 识别受试者和 /或他们的回应并不能合理地使他们处于刑事或民事责任的风险，或者损害其财务状况，就业能力，可就业能力，声誉或污名化，除非实施合理和适当的保护，以便实施相关风险侵犯隐私和违反机密性的侵犯不比最低限度大
3. 该研究没beplay苹果手机能用吗有分类，并且
4. 研究活动beplay苹果手机能用吗在下面的评论类别中列出。

Categories of Expedited Review

类别1：仅在满足条件（a）或（b）时才对药物和医疗设备进行临床研究。

1. beplay苹果手机能用吗不需要研究新药的药物研究。（注意：对销售beplay苹果手机能用吗药物的研究显着增加风险或降低与产品使用相关风险的可接受性不符合快速审查的条件。）
2. beplay苹果手机能用吗对医疗设备的研究；
   1. 不需要调查设备豁免申请；或者
   2. The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

类别2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

1. From healthy, non-pregnant adults who weigh at least 50 kg. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
2. From other adults and children, considering the age, weight and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

类别3：前瞻性收集无创手段用于研究目的的生物标本。beplay苹果手机能用吗示例包括：

1. Hair and nail clippings in a non-disfiguring manner;
2. 去角质时或常规患者护理表明需要提取时倾斜的牙齿；
3. 如果常规患者护理表明需要提取，则牙齿牙齿；
4. Excreta and external secretions (including sweat);
5. 未浸泡的唾液以未刺激的方式收集，或者通过咀嚼面膜或蜡刺激，或者通过在舌头上涂稀柠檬酸溶液。
6. Placenta removed at delivery;
7. 在分娩前或分娩过程中膜破裂时获得的羊水；
8. 如果收集程序比牙齿的常规预防缩放更具侵入性，并且根据公认的预防技术来完成该过程；
9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
10. Sputum collected after saline mist nebulization;

类别4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).

1. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy.
2. 称重或测试感觉敏锐度。
3. 磁共振成像。
4. 心电图，脑电图，热力学，自然发生的放射性，电子模拟，超声检查，诊断红外成像，多普勒血流和超声心动图。
5. 鉴于个人的年龄，体重和健康，适当的情况下，适度的运动，肌肉力量测试，身体成分评估以及柔韧性测试。

类别5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

类别6:数据收集从语音、视频、数字,or image recordings made for research purposes.

类别7：研beplay苹果手机能用吗究个人或团体特征或行为（包括但不限于对感知，认知，动机，身份，语言，沟通，文化信念或实践以及社会行为的研究）或采用调查，访谈，口述历史，重点的研究小组，计划评估或质量保证方法。

Category 8:继续对先前召集的IRB批准的研究进行审查：beplay苹果手机能用吗

1. 该研究永久关闭了新科beplay苹果手机能用吗目的入学率，以及以下一项：
   1. 只有剩下的beplay苹果手机能用吗研究活动才能从受试者作为临床护理的一部分的程序中访问随访的临床数据
   2. All remaining research specific activities are eligible for review by expedited procedure;
   3. Only research activity that remains is data analysis, including analysis of identifiable private information or identifiable biospecimens.
2. where no subjects have been enrolled at this site and no additional risks have been identified.

类别9：这项研究不beplay苹果手机能用吗是根据调查新药应用或研究设备的豁免进行的，其中类别2至第8类不适用，但是CPHS在召集会议上已确定并记录了该研究的研究涉及不超过最小风险，也没有其他风险已经确定了，可以通过加急过程进行未来的审查。

类别10：Research not federally funded or supported that involves no greater than minimal risk but involves activities that do not fall under category 1-8 above.

Key Terms

Minimal risk-Minimal risk这意味着，研究中预期的伤害或不适的可能性和幅度比日常生活中通常遇到的危害或不适感并不高，或者在常规的身体或心理检查或测试中表现出来。beplay苹果手机能用吗

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PROCEDURE

提交加急审查：虹膜系统将IRB跟踪号分配给提交。IRB员工审查提交的内容，以确保提供的信息已完成。如果提交如果不完成，则IRB工作人员将提交的内容退还给首席调查员以获取更多信息。

IRB员工评估研究建议，并确定其是否有资格beplay苹果手机能用吗进行快速审查。当难以确定一项协议是否有资格使用加急程序进行审查时，IRB工作人员将咨询IRB董事。如有疑问，该提案将分配进行全面董事会审查。

Documents to be submitted for expedited review are the same as those for review by a convened IRB as outlined in CPHS policy and procedure, Initial Review.

加快审核过程：IRB员工筛选提交内容，并确定研究建议是否有资格进行快速审查。beplay苹果手机能用吗如果IRB工作人员确定该提案没有资格进行快速审查，则该提案将由召集的IRB转介审查。如果IRB的工作人员确定该提案有资格进行加急审查，IRB工作人员将通过IRIS将该提案分配给审稿人。

Members who have at least one-year experience as an IRB member are considered automatically designated by the IRB chair as members who may be assigned as expedited reviewers.

审阅者可以通过IRIS访问所有相关文档。审阅者应遵循相同的过程，即批准的标准，如政策和程序初始审查中概述的初步审查过程。此外，审阅者将评估该提案是否符合加急审查的适用性标准，并确定研究建议的加急类别。beplay苹果手机能用吗如果根据政策和程序，CPHS成员和顾问的利益冲突，审稿人有利益冲突，审阅者将披露冲突，IRB工作人员将将该提案重新分配给另一位审阅者。

审查的可能结果: In reviewing the research, the reviewer may approve, approve pending or defer. The reviewer may not disapprove the research proposal. If the reviewer has concerns about the research proposal, the reviewer may request a second reviewer, scientific review, a consultant or refer the research proposal to the full board for further review.

当审阅者建议批准或批准待处理时，审阅者还确定了政策和程序初始审查中概述的批准期。IRB工作人员将根据初步审查的政策和程序传达决策和规定。

文档：IRB staff will ensure that the following information is documented when a submission is approved by the expedited process:

1. 具体允许的类别；
2. 评论的描述；
3. 审稿人采取的行动描述；
4. 对于需要协议特定决定的人：
   1. The determination
   2. Protocol specific findings that justify the determination

通知CPHS：When a proposal is approved by expedited review, all the members of the IRB panel will be notified of the actions taken via expedited review at the next convened meeting. The IRB staff will include a list of the expedited approvals that were reviewed and approved on the next meeting agenda.n

适用的法规：

1. 45 CFR 46保护人类受试者
2. 21 CFR 56机构审查委员会
3. OHRP加急评论类别
4. FDA-可以通过加急程序进行审查的研究类beplay苹果手机能用吗别

Reference to Other Policies:

1. Initial Review
2. Conflict of Interest – CPHS Members and Consultants

附件：

1. 初始申请表
2. Continuing Review Form

If you find errors in this document, contactcphs@uth.tmc.edu

文件编号：	101-C05
文档名称：	加急评论
审核者：	Executive Director, Research Compliance
有效的：	2008年8月1日
Revision History:	1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 Jan 2018, 1 Jun 2021

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