审查委员会的级别

The following are exempt from IRB review. 适用于下述第(1)至(4)项, exempt status is 自动 and investigators do not need to seek IRB approval. 然而, 第(5)及(6)项, the determination of exempt status is not relegated to the investigator. It must be determined by a department representative or by the Executive Committee. In these latter cases, the investigator must submit an 申请豁免资格 to their department representative. In cases for which the appropriate department representative is unclear, the investigator should contact the IRB chair for guidance.

这项研究有资格 自动 以下情况可获豁免:

1. it does not involve human subjects.
2. 这是一个由教师监督的课程, 专为提高学生的教育经验而设计的以班级为基础的项目(见 注1 下图) and all of the following criteria are met:
   1. 项目发现不会与研究对象分享，除非他们也是项目发起班级的成员.
   2. 项目的研究结果将不会在项目起源的课堂之外的任何公共论坛上展示.
   3. 项目中的程序和材料使研究对象在日常生活中通常遇到的身体或心理伤害的风险最小.
   4. 该项目不涉及收集受试者行为的敏感方面, 比如物质使用, 违法行为, or sexual behavior that can be linked through identifiers to any specific subjects.
   5. 该项目不旨在满足部门顶点课程的论文要求.
   6. Prior to the collection of data, the class instructor has submitted to the IRB a 培训声明 证明他/她已完成本局对部门代表的培训要求(见 注1 下图).
   7.  在收集数据之前，班主任还向IRB提交了一份表格 道德保证表格 指示他/她将指导学生在伦理研究的原则，并确保他们的项目符合这些原则(见 注2 下图).
3. 人类受试者是当选或任命的公职人员或公职候选人(联邦法规法典), 标题45, 部分46.101, b-3节).
4. it examines “(i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs” (Code of Federal Regulations, 标题45, 部分46.101, b-5节). 此外，它必须遵守以下OPRR指南，以豁免此类研究:
   1. The program under study must deliver a public benefit or service.
   2. There must be no statutory requirement that the project be reviewed by an IRB.
   3. 研究不得涉及重大的身体侵犯或侵犯受试者的隐私.

这项研究有资格 IRB批准 以下情况可获豁免:

1. its principal investigator is a member of the 澳门足彩app教职员, 政府, or staff; no students, 教师, 政府, or staff are employed as research subjects; no facilities are utilized for the research protocol; and it has been approved by an external IRB acceptable to the Executive Committee of the IRB. 在数据收集之前，研究者必须向执行委员会提交适当的外部批准文件.
2. the research is conducted in established or commonly accepted educational settings, 这具体涉及正常的教育实践，这些实践不太可能对学生学习所需教育内容的机会或对提供指导的教育者的评估产生不利影响. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, 课程, 或者课堂管理方法. (《澳门足彩app》第46条.10, d-1节) 
3. the research only includes interactions involving educational tests (cognitive, 诊断, 资质, 成就), 调查程序, 面试程序, 或观察公共行为(包括视觉或听觉记录)，如果至少符合以下标准之一: 
   1. 所获得的信息由研究者以一种无法轻易确定人类受试者身份的方式记录下来, directly or through identifiers linked to the subjects;
   2. 在研究之外披露人类受试者的任何反应都不会合理地使受试者面临刑事或民事责任的风险，也不会损害受试者的财务状况, 就业能力, 教育的进步, 或声誉. (《澳门足彩app》第46条.10, d-2部分)

注1 ——Faculty-supervised, 不符合上述所有标准的班级项目必须提交给部门代表进行审查，使用豁免地位申请或 Application for IRB 加快审查. 如果合适，必须向IRB主席提交全面审查申请.

注2 -导师培训声明及道德保证表格的有效期为三年，由提交日期起计. Both can be renewed for additional three year terms through resubmission.

应用程序部署

正常情况下, within seven days of receiving an 申请豁免资格，部门代表必须通过电子邮件将其处置通知首席研究员. The following three dispositions are possible:

1. 豁免处理-项目符合豁免状态的标准，可以按照描述进行.
2. 已批准待修订-项目不符合豁免地位的标准，但经修订后可获批准. The representative must specify the changes required. If the investigator makes the required changes and submits an amended 申请豁免资格, the amended project can proceed as described.|
3. 拒绝-项目不符合豁免地位的标准，但不能轻易修改. 该代表必须说明拒绝的原因，并建议进行快速审查或全面审查. 然后，研究者可以通过提交适当的申请来寻求对项目的加速或全面审查.

不符合豁免标准的研究，如果符合以下所有标准，可能有资格获得部门代表的快速审查和批准.  调查员必须提交一份 Application for IRB 加快审查 to his/her department representative.  In cases for which the appropriate department representative is unclear, the investigator should contact the IRB chair for guidance.

这项研究有资格 expedited review if –

1. 它没有故意包括高危人群的成员，如18岁以下的儿童(除非是A节中免税教育研究的描述), 第4部分), cognitively or emotionally compromised adults, 孕妇, 胎儿, 或者把囚犯当作实验对象.
2. it does not involve the collection of sensitive data on substance use, 违法行为, or sexual behavior that can be linked through identifiers to specific subjects; and which, 如果被别人知道, could reasonably place subjects at risk for criminal or civil liability, or damage their financial standing, 就业能力, 或声誉.
3. 它采用的程序和材料使受试者在日常生活中通常遇到的身体或心理伤害的风险降到最低.
4. 它不涉及研究者故意误导受试者关于研究目的或程序的委托欺骗.
5. 任何通过遗漏而使用的欺骗, 研究者未能披露研究目的或程序的所有相关细节, is scientifically justified and debriefing procedures are detailed and appropriate. 研究人员必须在申请中解释为什么完全披露会使研究结果无效，以及为什么替代的非欺骗性程序不合适. 研究人员还必须详细说明如何以及何时向受试者汇报隐瞒信息的性质以及遗漏的原因.
6. it does not involve audiotaping, videotaping or photographing of participants.

 应用程序部署

正常情况下, within seven days of receiving an Application for IRB 加快审查，部门代表必须通过电子邮件将其处置通知首席研究员.  The following three dispositions are possible:

1. 已批准-研究方案符合快速审查的所有标准，并符合人类受试者研究的伦理标准.  Applications approved by a department representative are deemed approved by the IRB.  The investigator may proceed with data collection.  It is expected that most applications will fall into this category.  Please note that IRB approval is limited to a term of one year.  Any project extending beyond that term must submit to the IRB an 续期申请 indicating there has been no material changes in the research protocol.
2. 已批准待修订-研究方案不符合快速审查的标准和/或不符合人类受试者研究的伦理标准.  然而, with revisions, the protocol can be approved.  The representative must specify the changes required for approval.  如果研究者做了必要的修改并提交了修订后的IRB审查申请, he/she can proceed with the amended protocol upon approval from the representative.  If the investigator rejects the required changes, 他/她可要求该代表将申请转交执行委员会进行全面审查，并附上批准申请的书面理由.  研究者还必须完成IRB审查申请的第4节，以便进行全面审查.
3. 被认为需要全面审查-研究方案不符合快速审查的标准，部门代表认为有必要进行全面的IRB审查.  The investigator must complete and submit an 申请审查委员会全面审查.

IRB申请必须通过以下三种途径提交执行委员会进行全面审查:

1. The principal investigator is unaffiliated with 澳门足彩app.
2. 一个澳门皇冠app附属的首席研究员认为他/她的研究不符合豁免地位或加速审查的标准.
3. 一个澳门皇冠app附属的首席研究员提交他/她的申请进行快速审查, 但部门代表认为它不符合相关标准，必须提交全面审查. 在这种情况下, 研究者有责任完成申请的第4部分，并在提交申请材料之前附上申请材料中规定的研究方案的详细描述. 部门代表, 由他/她自行决定, may also forward his/her recommendation with justifications to approve, approve pending revision or deny the investigator’s application.

In all the above cases, the investigator must submit an 申请审查委员会全面审查 以及所有支持文件，至少在预定的全面审查会议前一周提交给IRB主席. 除了 to two scheduled meetings per semester, IRB主席有权在需要时安排额外的全面审查会议. 作出决定, a quorum of four Committee members, 包括 the community representative(s), 必须出席整个评审会议并充分了解申请. 除了, 委员会在审查其成员缺乏足够专门知识的拟议研究时，保留征求具有专门知识的个人意见的权利. If the committee cannot achieve a consensus  decision, the majority opinion determined by ballot prevails. If no majority emerges, the more ethically conservative opinion prevails.

应用程序部署

正常情况下, within three days of the full review meeting, 指定的委员会成员必须通过电子邮件将申请的处理通知首席研究员, 包括, 当可适用, the committee’s reasons for requiring revision of, 或拒绝, 应用程序. The following three  dispositions are possible:

1. 批准-该研究方案符合人类受试者研究的所有伦理标准.  The investigator may proceed with data collection. Please note  that IRB approval is limited to a term of one year. 任何超过该期限的项目必须向IRB提交延期申请, indicating there  have been no material changes  in the research  protocol.
2. 批准待修订-该研究方案未能满足人类研究的所有伦理标准.  然而, with revisions,  the protocol can be approved. The committee must specify the changes  required for approval. 如果研究者做了必要的修改并提交了修订后的IRB审查申请, 经执行委员会批准后，他/她可继续执行经修订的议定书. If the investigator rejects  the required changes, he/she can appeal the IRB decision (see link for Appealing Adverse IRB Dispositions).
3. 拒绝——该研究方案不符合人类受试者研究的所有伦理标准，不能轻易修改以达到这些标准. 委员会必须详细说明拒绝的理由，并强调拟议的研究不能继续进行. If the investigator believes  the IRB decision is in error, he/she can appeal the IRB decision (see link for Appealing Adverse IRB Dispositions).