365英国上市官网 IRB Review Procedures

Before Submitting Your Review

以确定您的项目是否构成需要审查的人体研究, refer to the information provided on the Do I need IRB Review? page.

任何涉及人类参与研究的活动 MUST 获得365英国上市官网审核委员会的批准或豁免 before the research may be undertaken.

In order to gain approval or exemption for their research, all investigators must also complete the CITI Training prior to their submission.

Timeframe for Review After Submission

平衡记分卡审核委员会以分级制度审核建议.

First, 研究者必须确定他们的研究是否有资格获得豁免, Expedited, or Full review. 有关确定项目位置的帮助，请参阅 Frequently Asked Questions page. 身份的最终确定必须由内部审查委员会确认.
Once your project's review level has been determined, please fill out the appropriate form:
1. 申请IRB审查涉及人类受试者的豁免研究
2. 申请IRB审查涉及人类受试者的非豁免研究
如果这是你第一次提交给365英国上市官网 IRB, 请提交所有研究人员的花旗认证.
然后将完成的审核表格提交到 IRB Administrator.
您可以按照如下方式收到每个级别的审查决定
1. Exemption: Within five business days
2. Expedited/Minimal Risk: Within two weeks
3. 全部/大于最低风险:四周内
Once you have received numbered, signed approval from the 365英国上市官网 IRB, you may begin data collection.
All non-exempt projects must complete annual renewal prior to one year after the date of initial approval or latest numbered, signed renewal. To file for renewal, please use the 申请IRB审查涉及人类受试者的非豁免研究表格, with the "Renewal" box checked.
如果研究者对方案做了实质性的修改(包括, but not limited to, informed consent, instruments and measures used, sample size and / or ，则必须使用申请IRB审查涉及人类受试者的非豁免研究表格，并选中“修改”框，在实现这些更改之前.
项目完成后，调查人员必须提交一份 Project Closure Form.

请注意，周转时间取决于提交的文件 complete and accurate proposal as well as the Principal Investigator's responsiveness to the review requirements and requests. 写得不好的提案是申请人拖延和沮丧的最大原因. 不完整的提案将不经审查退回给研究者.

Exempt IRB Review Procedure

人类研究保护办公室(OHRP)提供了 decision charts to determine if a research project involving human subjects must be reviewed by an institutional research board. These charts are quite useful in determining whether to submit a Request for Exemption with the IRB.

A Request for IRB Review of Exempt Research Involving Human Subjects must be filed with the IRB if you are conducting research with human participants. IRB的豁免批准是保护研究参与者的保障措施, the investigators, and the institution.

Exemptions are not allowed for research with vulnerable populations. Vulnerable populations include: pregnant women, fetuses, prisoners, minors/children (<19 years), and persons with cognitive disabilities.

以下豁免条件已在 Federal Common Rule (45 CFR 46):

在公认的或普遍接受的环境下进行的研究 教育环境，包括正常的教育实践, 如(1)对常规和特殊365英国上市官网策略的研究, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods (Chart 3).
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside of the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation (Chart 4).
涉及使用教育测试(认知)的研究, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior that is not exempt under category (b) of this section; if: (i) the human participants are 被选举或任命的公职人员或公职候选人; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (Chart 4).
研究:涉及收集或研究…的研究 现有资料、文件、记录、病理标本或诊断标本, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, 直接或间接地通过与主题相连的标识符(Chart 5). (注:根据人权保护办公室[OHRP], "to qualify for this exemption, the data, documents, records, 或者在项目开始前必须有标本. The principle behind this policy is that the rights of the individuals should be respected; subjects must consent to participation in research.")
Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (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 (Chart 6).
口味和食品质量评价及消费者接受度研究, (一)食用不含添加剂的健康食品, or (ii) if a food is consumed that contains a food ingredient at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection of the U.S. Department of Agriculture (Chart 7).

Non-Exempt IRB Review Procedure

The 365英国上市官网 IRB uses criteria 46.111 of the Federal Code to evaluate research and criteria 46.416 to evaluate Informed Consent forms.

批准通常为一年.

The primary investigator of the project will be notified of the Board's decision in writing. The investigator may be asked to file an amended application reflecting any recommended changes with the 365英国上市官网 IRB by a stated deadline. 批准的协议将获得批准号和签名.

New Research

Expedited Review
如果调查人员在IRB请求中指出涉及人类受试者的非豁免研究审查表 that the proposed project involves no risk to participants, 如果365英国上市官网 IRB主席同意这个评估, 李会长将把调查计划副本分发给3名理事会成员. 如果三名成员向主席提供批准项目的书面通知, no meeting will be held, and the chair shall give formal written 365英国上市官网 IRB approval of the project for up to one year.

Board members may offer approval with the provision that minor procedural changes be made in the protocol. 如果建议在主席看来是合理的, 椅子把它们传递给调查员, 研究者同意执行这些建议, 没有必要召集董事会来讨论这些问题. The investigator will be asked to file an amended application reflecting any recommended changes with the 365英国上市官网 IRB by a stated deadline.

If at least one member of the board does not want to approve the project without a meeting, or if the chair believes that the suggestions offered by one or more board members should be discussed, 然后，主席应安排一次会议，对项目进行全面审查.

Full Review
If the investigator indicates on the IRB 涉及人类受试者的非豁免研究审查表 that the proposed project involves putting the participants at risk or if the 365英国上市官网 IRB chair disagrees with the investigator's assessment that the project involves no risk to participants, 主席将向每位董事会成员分发调查计划的副本. 主席将安排一次会议来讨论这个项目. 在全体董事会审查会议上，至少有四名董事会成员必须投票. 投票的大多数人必须同意以下三种结果之一:

- - 365英国上市官网 IRB approval of project
  - 365英国上市官网 IRB rejection of project
  - 365英国上市官网 IRB approval of project with modifications

Modification of Prior-Approved Research

If modifications are made to research procedures at any time during the 365英国上市官网 IRB approval period (typically one year from approval date), a formal Modification is required using the IRB 涉及人类受试者的非豁免研究审查表 with "Modification" box checked. Expedited review by the 365英国上市官网 IRB chair or designated member is allowed if modifications do not change the initial risk assessment of a no-risk proposal. 如果最初的提案被归类为“有风险”,“修改可能会在全面审查之前提出, at the discretion of the 365英国上市官网 IRB chair. Approval of modifications does not change the original 365英国上市官网 IRB approval expiration date indicated in the original 365英国上市官网 IRB approval letter.

Annual Review Procedures

联邦指导方针要求365英国上市官网 IRB评估风险, potential benefits, informed consent, and safeguards for human subjects both at the initial review and when researchers file for Annual Review and Renewal. 最初批准的有效期最长为一年. When conducting continuing review, 平衡记分卡审核委员会需要确定是否有任何新信息出现, either from the research itself or from other sources that could alter the 365英国上市官网 IRB's previous determinations, 尤其是对受试者的风险. In addition, any unanticipated problems involving risk to participants or others that occurred since the previous 365英国上市官网 IRB review will also be relevant to the 365英国上市官网 IRB's decision about continued approval.

Expedited Review of Continuing Research can occur in two possible ways:

由平衡记分卡审核委员会主席或指定人员进行快速审核

如果最初的研究是最小的风险，并且没有发现额外的风险

这项研究将永久停止新参与者的登记, 参与者已完成所有研究干预, 而且这项研究只对参与者进行长期随访, OR

持续的研究活动仅限于数据分析.

Expedited review by three Board members

如果继续进行的研究只有很小的风险.

持续研究的完整365英国上市官网 IRB审查
如果最初的手术风险大于最小, new risk issues emerged over the year, 或者继续进行的研究包括额外的风险问题, 评审将由法定人数的平衡计分卡审核委员会在召开的平衡计分卡审核委员会会议上进行. 研究人员可能会被邀请参加这个会议来解决问题.