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Handbook of Operating Procedures

Review of Research

Policy Number: 200

Subject:

beplay苹果手机能用吗研究评论

Scope:

Researchers

Date Reviewed:
May 2021
Responsible Office:
Office of the Executive Vice President & Chief Academic Officer
Responsible Executive:
Executive Vice President & Chief Academic Officer

I. POLICY AND GENERAL STATEMENT

To ensure adherence to regulatory, ethical and safety standards, The University of Texas Health Science Center at Houston (“university”) has procedures for reviewing planned research, demonstration and development projects and training grants. Proper reviews of research allow the university to maintain a safe environment, to maintain the confidence of the public, and to preserve federal and other sources of research funding.

部门主席,院长和每个运营部门层次结构中的其他个人具有行政责任和道德义务,以确保个人调查员遵守该政策和相关政策和程序。beplay苹果手机能用吗未能遵守审查要求或未经适用审查委员会要求进行研究的研究人员将要采取纪律处分,直到和包括就业终止。

ii。程序

Research is subject to committee review as described below. Intellectual property matters are defined and addressed inHOOP 201, Intellectual Property

A. Committee for the Protection of Human Subjects

All research involving human participants must be reviewed and approved by the Committee for Protection of Human Subjects (“CPHS”) when:

  • 该研究是beplay苹果手机能用吗由任何大学员工,学生或居民在任何设施/位置进行的(包括但不限于纪念赫尔曼医疗保健系统,哈里斯县精神病医院和哈里斯卫生系统);或者
  • the research involves subjects/patients from any university facility (including Harris County Psychiatric Hospital).

If an activity meets the definition of research involving human subjects (see//www.tjghsg.com/cphs/policies/requires-review.htm), the researcher must submit an application for CPHS review and receive approval prior to initiation of the project. Changes in approved research, during the period for which CPHS approval has already been given, may not be initiated without CPHS review and approval, except when necessary to eliminate apparent immediate hazards to the subject. The researcher must submit and receive approval from the CPHS before initiating any changes to a research study. Continuing review is required as long as the research remains active, including recruitment, enrollment, participant follow-up, and analysis of identifiable data. The researcher is responsible for the accurate documentation, investigation, follow-up and timely reporting of any problems encountered during the course of the research as outlined in CPHS policy. Researchers must submit proposals to CPHS via the iRIS system. To access CPHS policies and procedures see//www.tjghsg.com/cphs/policies/。有关其他信息,请联系CPHS办公室//www.tjghsg.com/cphs/contact-cphs.htm

B.动物福利委员会

必须beplay苹果手机能用吗审查和批准使用脊椎动物动物的研究项目Animal Welfare Committee (“AWC”)before the project is initiated. The researcher must submit anAnimal Protocol form提供了一个完整的描述的动物manipulations and a justification for the use of animals. Researchers who use animals must be familiar with the National Research Council’s Guide for the Care and Use of Lab Animals (current edition), the university’s Public Health Service Animal Welfare Assurance, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Federal Animal Welfare Act. Animal Protocols can be submitted online throughiRIS

All personnel working with research animals must attend the requiredtraining courses,注册或拒绝occupational health program, and complete the Research Conflict of Interest (RCOI)certification form有财务披露。在人员要求完成并批准beplay苹果手机能用吗任何适用的安全协议(生物学,化学,辐射)之前,不会批准动物研究方案。

If portions of the funded research involving animals will be performed at another institution, the AWC must review and approve the Institutional Animal Care and Use protocol from the collaborating institution. This process requires the submission of an Umbrella protocol to the AWC. This form may also be required for the production of certain custom antibodies. The submission form is available iniRIS

在执行AWC之前,必须对批准的协议或人员进行任何更改或对人员进行审查和批准。提议的修正案每周进行审查,可以通过提交Change Request Form

Deviations from the approved protocol, adverse events and unexpected problems must be reported to the AWC and may require reporting to the Office of Laboratory Animal Welfare. Federal funds associated with protocol deviations must be returned to the NIH. Significant deviations may result in the suspension of previously approved animal welfare protocols or activities.

Additional information is available on theAWC网站, 通过电子邮件 (awc@uth.tmc.edu)或通过电话(713-500-3625)。

C. Radiation Safety Committee

Before an investigator may acquire any quantity of radioactive material or any radiation-producing device for use in a research project, he or she must obtain approval from the Radiation Safety Committee. Application forms for the use of radioactive materials (benchtop, within animals, and/or human use) may be accessed via环境健康与安全(“ EHS”)网站

表格必须提交给EHS进行初步审查。然后,EHS工作人员将把申请转发给辐射安全委员会以供考虑和批准。参考辐射安全手册或者激光安全手册适用

有关其他信息和帮助,请联系EHS在OCB 1.330或电话713-500-8100。

D.机构生物安全委员会

与指定为生物安全2级(BSL-2)或生物安全3级(BSL-3)设施和实践的传染剂合作,如Centers for Disease Control and Prevention/National Institutes of Health Biosafety in Microbiological and Biomedical Laboratories出版物,必须注册或审查和批准机构生物安全委员会(“ IBC”),根据NIH指南的工作分类,在开始任何程序之前。如国立卫生研究院所述,适用于重组或合成核酸分子的同样要求NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules。The researcher must submit forms for research procedures; information on the agent(s) to be used; and a protocol with references for the laboratory procedures to be followed when using the agent(s), including details of the containment, safe work practices, decontamination procedures, and methods for handling wastes.

Additionally, work with select agents or toxins requires additional controls and registration with either the Centers for Disease Control and Prevention or the United States Department of Agriculture prior to initiation of work. EHS can assist with the proper designation of agent categories and appropriate application forms, including select agent registration.

EHS协助研究人员确定哪beplay苹果手机能用吗些药物,重组或合成核酸分子被认为是非豁免的。

寻求帮助,联系EHS在OCB 1.330或电话713-500-8100。可以通过环境健康与安全网站

E.化学安全委员会

任何使用被分类为剧毒,致癌性,热情毒素,毒素,毒气,抗肿瘤,农药,爆炸性或纳米颗粒的化学物质,必须经过审查和批准Chemical Safety Committeebefore any procedure is initiated. The researcher must submit forms for research procedure; information on the chemical to be used; and a protocol with references for the laboratory procedures to be followed when using the chemical, including details of the safety practices to be followed for addressing losses of containment and methods for handling wastes.

EHS协助研究人员确定哪beplay苹果手机能用吗些化学药品被归类为急性毒性和保证委员会审查。寻求帮助,联系EHS在OCB 1.330或电话713-500-8100。可以通过环境健康与安全网站

F.研beplay苹果手机能用吗究冲突委员会

All proposed research must include a completedResearch Conflicts of Interest (“RCOI”) Certification Formfor all individuals responsible for the design, conduct, or reporting of the proposed research (“covered individuals”). The Principal Investigator is responsible for ensuring that all covered individuals submit the form. The RCOI Certification Form indicates whether covered individuals have significant financial interests (defined inHOOP Policy 94 Research Conflicts of Interest)与拟议的研究有关。beplay苹果手机能用吗RCOI认证表必须与所有申请一起提交给赞助项目办公室(“ OSP”),CPHS或AWC。此外,所有建议的研究都由内部资金资助(beplay苹果手机能用吗例如。, gifts designated for a covered individual’s research, department startup funds) must include RCOI Certification Forms for all covered individuals and must be submitted to the department, school, or other responsible area performing the funding review.

If a covered individual has a significant financial interest related to the proposed research, he/she must submit anRCOI披露表。RCOI披露表s are submitted directly to the EVP/CAO/Conflict of Interest Program Office, which will initiate the required review.

Disclosures of significant financial interests related to proposed research will be reviewed by the RCOI Committee. The RCOI Committee advises the EVP/CAO if the significant financial interest represents a financial conflict of interest in the research and, if so, whether the conflict can be managed. The EVP/CAO makes the final decision about whether any conditions or restrictions are required to resolve or manage conflicts. The review must be completed and any required management plan implemented before any research funds may be expended.

如果在奖励期内获得新的可报告利益,或者在财务利益发生变化或研究中,则还必须在奖励/合同期内提交更新的披露。beplay苹果手机能用吗更新的披露必须在变更后的30天内提交给EVP/CAO/利益冲突计划办公室。

g .人类干细胞研究监督委员会(SCRbeplay苹果手机能用吗O)ttee

所有涉及beplay苹果手机能用吗人类胚胎干细胞(HESC)或人类诱导的多能干细胞(HIPSC)的研究必须由人类干细胞研究监督(SCRO)审查和批准。)委员会在开始之前。AWC,Ibeplay苹果手机能用吗BC和/或CPHS的一些涉及hESC或HIPSC的研究可能需要额外批准。有关申请流程的更多信息,请通过scro@uth.tmc.edu与SCRO办公室联系。

H. Institutional Anatomical Oversight Review Committee

All deceased human bodies and anatomical specimens entering, in possession of, utilized, or leaving the university must do so as part of an activity, program or protocol that is registered with theInstitutional Anatomical Oversight Review Committee (“IAORC”)

The IAORC has delegated to the Director of the Human Structure Facility (“HSF”) responsibility for reviewing and approving requests for use of anatomical specimens. Requests must be reviewed and approved by the IAORC before specimens may be used. The Review and Approval form used by the Office of Sponsored Projects must include the IAORC approval number.

Necessary forms and additional information are available on theIAORC website。HSF staff members are available to assist with questions about use of anatomical material and the process of obtaining IAORC review and approval (713-500-6154). See alsoHOOP 97 Deceased Human Bodies and Anatomical Specimens

iii。联系人

    • Office of the Executive Vice President & Chief Academic Officer
    • 713-500-3082
    • //www.tjghsg.com/index/research.htm
    • Committee for Protection of Human Subjects
    • 713-500-7943
    • //www.tjghsg.com/cphs/
    • 环境健康与安全
    • 713-500-8100
    • //www.tjghsg.com/safety/
    • Research Conflict of Interest
    • 713-500-3082
    • //www.tjghsg.com/evpara/rcoi/
    • Animal Welfare Committee
    • 713-500-3625
    • //www.tjghsg.com/animal-research/awc.htm
    • 人类结构设施
    • 713-500-6154
    • https://med.uth.edu/nba/administrative/human-scrupture-facility/

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