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保护人类受试者委员会

CPHS Reporting Responsibilities

POLICY

Reportable incidents and certain IRB determinations will be promptly reported to appropriate authorities and agencies.

Key Terms

意外的问题涉及参与者或其他人的风险is a problem that is unanticipated or unexpected, related to the research and places subjects or others at a greater risk of harm than was previously known or recognized.

PROCEDURE

可报告事件：机构官员或指定人员将报告以下IRB确定：

  1. IRB determination of unanticipated problems involving risks to subjects or others;
  2. IRB determination of serious or continuing noncompliance; and
  3. IRB批准的任何暂停或终止。

Report Recipients:IRB Director or designee will report incidents to the following entities as applicable:

  1. Institutional Official (IO):
    1. IO for UTHealth for all research under IRB jurisdiction.
    2. IO纪念赫尔曼医院系统，用于纪念赫尔曼工作人员或纪念赫尔曼设施进行的所有研究。beplay苹果手机能用吗
  • IO for Harris Health System for all research being conducted in Harris Health facilities.
  1. OHRP for all nonexempt human subjects research that is:
    1. conducted or supported by HHS;
    2. conducted or supported by any non-HHS federal department or agency that has adopted the Common Rule and is covered by a Federalwide Assurance (FWA) determined to be appropriate for such research; or
  • covered by an FWA, regardless of funding source.
  1. Sponsor, if applicable including federal agencies like Department of Defense, Department of Education etc.
  2. FDA适用于适用的临床研究。

报告中包含的信息：

  1. 进行研究的机构的名称；beplay苹果手机能用吗
  2. Title of the research project and/or grant proposal in which the problem occurred;
  3. Name of the Principal Investigator on the protocol;
  4. Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
  5. A detailed description of the problem; and
  6. Actions the institution is taking or plans to take to address the problem.

报告程序

IRB董事或指定人员将准备事件报告。IRB董事或指定人员可以征求IRB执行主席或主席的指导，该指导审查了准备该报告的协议。

IRB董事将向IO和 /或OHRP提交报告。Uthealth IO可以将这封信的副本转发给：

  1. Office of Legal Affairs and Institutional Compliance;
  2. Chair of the Principal Investigator’s department;
  3. 主要调查员，教职员工或学生学校的院长；
  4. Office of Sponsored Projects Administration for research that receives funding by grant or contract;
  5. 任何其他被认为适当的权威。

报告事件的时间范围- IRB董事或指定人员应在IRB决定后30天内报告所有事件。IRB董事或指定人员可以发送初始报告，并指出在完成调查或已执行纠正措施计划时，将在特定日期之前提交后续报告或最终报告。

例外 -当继续审查研究协议beplay苹果手机能用吗not occur prior to the end of the approval period specified by CPHS, CPHS approval expires automatically. Such expiration of CPHS approval will not be reported to OHRP and IO as a suspension of IRB approval.

APPLICABLE REGULATIONS

  1. 45 CFR 46保护人类受试者
  2. 21 CFR 56 Institutional Review Board
  3. OHRP向OHRP报告事件的指南
  4. 强制性IRB报告：FDA联系人

参考其他政策

  1. Unanticipated Problems Involving Risks to Subjects or Others.
  2. Non compliance
  3. 暂停和终止

附件

  1. Flow chart – What incidents should be reported to OHRP?

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

Document Number:

101-E01

文档名称：

Reporting

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Jan 2009

Revision History:

2011年8月1日，2016年6月1日，2019年1月21日，2021年6月1日

CPHS求助热线713-500-7943
Iris Holpline 713-500-7960
Uthealth的合规性热线（1-888-472-9868）

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保护人类受试者委员会
6410 Fannin, Suite 1100
德克萨斯州休斯顿77030

Phone 713-500-7943
Fax 713-500-7951
Emailcphs@uth.tmc.edu

IRIS Support713-500-7960

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