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平衡计分卡审核委员会审核程序

平衡计分卡审核委员会审核程序

提交评论前

To determine whether your 项目 constitutes human research that requires review, 参考提供的信息 我需要IRB审查吗? 页面.

ANY activity involving humans as participants in research 必须 gain approval or exemption from the 365英国上市官网 IRB 在进行研究之前.

为了获得批准或豁免他们的研究，所有研究者还必须完成 花旗集团的培训 在提交之前.

时间表 提交文件后检讨

The 365英国上市官网 IRB Committee reviews proposals in a tiered system.

  1. 第一个, investigators must determine if their research qualifies for Exemption, 加快, 或全面审查. For help in determining where your 项目 falls, refer to question 6 on the 常见问题 页面. Final determination of status must be confirmed by the IRB.
  2. 一旦您的项目的审查级别被确定，请填写适当的表格:
    1. 申请IRB审查豁免研究 Involving Human Subjects
    2. Request for IRB Review of Non-Exempt Research Involving Human Subjects
  3. If this is your first submission to the 365英国上市官网 IRB, please submit CITI certification for all study personnel.
  4. Then submit your completed review forms to the IRB管理员.
  5. You can expect to receive a review decision for each level of review as follows
    1. 豁免:五个工作日内
    2. 加急/最小风险:两周内
    3. Full/Greater than Minimal Risk: Within four weeks
  6. 一旦您收到365英国上市官网审核委员会编号、签名的批准，您就可以开始数据收集.
  7. 所有非豁免项目必须在首次批准或最迟批准之日起一年内完成年度续期 编号, 签名更新. 申请续期，请使用 Request for IRB Review of Non-Exempt Research Involving Human Subjects form，并勾选“续订”.
  8. If 调查人员 make any substantive changes to the protocol (including, 但不限于, 知情同意, 仪器 和 使用的测量方法，样本量 和/或 population), they must submit a Modification request using the Request for IRB Review of Non-Exempt Research Involving Human Subjects form, with the "Modification" box checked, prior to implementing those changes.
  9. Upon completion of a 项目, investigators must submit a 项目收尾表格.

Please note that turn-around time is dependent on the submission of a 完整准确的提案 以及首席研究员对审查要求和请求的响应. Poorly written proposals are the largest source of delays 和 frustration for applicants. Incomplete proposals will be returned to the investigator without review.

豁免IRB审查程序

The Office for Human Research Protections (OHRP) has provided 决定图表 决定一个涉及人类受试者的研究项目是否必须由机构研究委员会审查. 这些图表在决定是否向税务审核委员会提交豁免申请时非常有用.

A 申请IRB审查豁免研究 涉及人类受试者必须在IRB备案，如果你正在进行与人类参与者的研究. An exemption approval from IRB is a safeguard that protects research participants, 调查人员, 以及这个机构.

豁免是 不允许 针对弱势群体的研究. 弱势群体 包括: 孕妇, 胎儿, 囚犯, minors/children (<19 years), 还有有认知障碍的人.

The following exempt conditions have been developed 和 described within the 联邦普通法(45 CFR 46):

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular 和 special educational instructional strategies, 或(ii)研究教学技术的有效性或教学技术之间的比较, 课程, 或课堂管理方法(图3).
  • 涉及使用的研究 教育测试(认知测试), 诊断, 资质, 成就), 调查程序, 面试程序, 或者对公众行为的观察, 除非:(i)以可识别人类受试者的方式记录所获得的信息, directly or through identifiers linked to the subjects; 和 (ii) any disclosure of the human subjects' responses outside of the research could reasonably place the subject 处于危险之中 of criminal or civil liability or be damaging to the subjects' financial st和ing, 就业能力, 或声誉(图4).
  • 涉及使用的研究 教育测试(认知测试), 诊断, 资质, 成就), 调查程序, 面试程序, or observations of public behavior that is not exempt under category (b) of this section; if: (i) the human participants are elected or appointed public officials or c和idates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research 和 thereafter (图4).
  • Research involving the collection or study of existing data, 文档, 记录, pathological specimens, or 诊断 specimens, 如果这些来源是公开的，或者研究者以无法识别受试者的方式记录信息, directly or indirectly through identifiers linked to subjects (图5). (NOTE: According to the Office of Human Rights Protection [OHRP], 才有资格获得这项豁免, 的数据, 文档, 记录, or specimens must be in existence before the 项目 begins. The principle behind this policy is that the rights of the individuals should be respected; subjects must consent to participation in research.")
  • 由部门或机构负责人进行或经其批准的研究和示范项目, 它们是用来研究的, 评估, 或以其他方式检查:(i) 公共利益或服务项目; (ii) procedures for obtaining benefits 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 (图6).
  • Taste 和 food quality evaluation 和 consumer acceptance studies, (i) if wholesome foods without additives are consumed, 或(ii)如果一种食品所含的食品成分达到或低于美国食品和药物管理局认定的安全水平，或低于美国环境保护局或美国食品安全检验局批准的安全水平.S. 农业部(图7).

非豁免IRB审查程序

365英国上市官网 IRB使用标准 46.联邦法典第111条 评估研究和标准.416评估知情同意书.

Approval is typically granted for one year.

委员会的决定将以书面形式通知该项目的主要研究者. 研究者可能会被要求在规定的截止日期前向365英国上市官网伦理委员会提交一份反映任何建议变更的修订申请. Approved protocols will receive an approval number 和 signature.

一项新的研究

加快审查
If the investigator indicates on the Request for IRB Review of Non-Exempt Research Involving Human Subjects form 所提议的项目所涉及的 没有风险 参与者, 和 if the chair of the 365英国上市官网 IRB agrees with that assessment, the chair will distribute copies of the plan of investigation to three board members. If the three members provide the chair a written notice of approval of the 项目, 不召开会议, 主席应向平衡计分卡审核委员会正式书面批准该项目，有效期最长为一年.

执董会成员可提出批准，但规定可对议定书的程序作轻微修改. If the suggestions appear to the chair to be reasonable, 和 the chair conveys them to the investigator, 和 the investigator agrees to implement the suggestions, it will not be necessary to convene the board to discuss them. 研究者将被要求在规定的截止日期前向365英国上市官网 IRB提交一份反映任何建议变更的修订申请.

如果董事会中至少有一名成员不希望在没有会议的情况下批准项目, 或者主席认为应该讨论一位或多位董事会成员提出的建议, then the chair shall schedule a meeting for a full review the 项目.

完整的检查
如果研究者在IRB对涉及人类受试者的非豁免研究的审查表格中指出拟议的项目涉及到参与者 处于危险之中 或者平衡计分卡审核委员会主席不同意研究者的评估，即该项目对参与者没有风险, the chair will distribute copies of the plan of investigation to each board member. The chair will schedule a meeting to discuss the 项目. At the full board review meeting, at least four members of the board must vote. A majority of those voting must agree to one of the three following outcomes:

      • 365英国上市官网 IRB批准 项目
      • 365英国上市官网 IRB拒绝 项目
      • 365英国上市官网 IRB批准 项目 与修改

修改先前批准的研究

如果在365英国上市官网审核委员会批准期间(通常自批准之日起一年)任何时候对研究程序进行了修改, 需要使用IRB对涉及人类受试者的非豁免研究的审查表格进行正式修改，并勾选“修改”框. 如果修改不会改变无风险提案的初始风险评估，则允许平衡计分卡审核委员会主席或指定成员进行快速审核. If the initial proposal was classified as "处于危险之中," modifications may be brought before full board review, 由平衡计分卡审核委员会主席酌情决定. 修改的批准不会改变原365英国上市官网 IRB批准信中显示的原365英国上市官网 IRB批准截止日期.

年度检讨程序

Federal guidelines m和ate that the 365英国上市官网 IRB assesses risks, 潜在的好处, 知情同意, 以及在初始审查和研究人员申请年度审查和更新时对人类受试者的保障. Initial approvals are good for up to one year. 在进行持续评审时, the 365英国上市官网 IRB needs to determine whether any new information has emerged, 要么来自研究本身，要么来自可能改变365英国上市官网 IRB先前决定的其他来源, particularly with respect to risk to subjects. 除了, 自上次365英国上市官网审核以来发生的涉及参与者或其他人风险的任何未预料到的问题也将与365英国上市官网审核委员会关于继续批准的决定相关.

持续研究的快速审查 可以以两种可能的方式发生:

  1. 加快 review by 365英国上市官网 IRB chair or designee
    • If the initial study was minimal risk AND no additional risks are identified AND
    • The research is permanently closed to the enrollment of new participants, participants have completed all research interventions, 和 the research is active only for long-term follow-up of participants, OR
    • Continuing research activities are limited to data analysis.
  1. 由三名董事会成员进行快速审查
    • If the continuing research has only minimal-risk.

Full 365英国上市官网 IRB Review of Continuing Research
If the initial procedures were more-than-minimal risk, 今年出现了新的风险问题, or the continuing research includes additional risk issues, the review will be made by a quorum of the 365英国上市官网 IRB at a convened 365英国上市官网 IRB meeting. The researcher may be invited to attend this meeting to address questions.