IRB与参与研究监督的UTHealth组件的协调beplay苹果手机能用吗
POLICY
人类研究保护计划的各个组成部分相互紧密合作，以确保遵守监管，道德和安全标beplay苹果手机能用吗准。Uthealth具有审查计划的研究，演示和开发项目以及培训补助金的程序。beplay苹果手机能用吗对研究的适当审查使大学能够维持安全的beplay苹果手机能用吗环境，保持公众的信心，并保留联邦和其他研究资金来源。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的政策和程序。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。（HOOP 200 - 研究回顾）beplay苹果手机能用吗
The various components of the human research protection program are:
Executive Vice President and Chief Academic Officer:Leadership for UTHealth’s research enterprise is provided by the Executive Vice President and Chief Academic Officer (EVP&CAO), Michael Blackburn, PhD. The EVP&CAO has administrative and budgetary responsibility for the HRPP. The EVP&CAO is also responsible for keeping the UTHealth President and executive leadership informed about the HRPP’s priorities, and needs. The EVP&CAO is responsible for the human research protection program including the Institutional Review Boards, conflict of interest program and clinical research education.
Institutional Review Board:副总裁HRPP，医学博士Anne Dougherty是Uthealth的机构官员。Dougherty博士还是CPHS执行委员会主席，该委员会由四个IRB小组的主席和副主席组成。机构官员负责IRB政策和程序，IRB的数量和组成，处理研究人员和研究人员的不当影响和投诉的报告。beplay苹果手机能用吗
Research Conflict of Interest Program- 利益冲突计划由EVP＆CAO的主持下的利益冲突办公室管理。该办公室支持两个教师LED委员会 - 研究冲突（RCOI）委员会，该委员会负责审查与研究和机构冲突有关的重beplay苹果手机能用吗大财务利益（ICOI）委员会，该委员会负责管理机构利益冲突。在审查涉及人类受试者的研究时，beplay苹果手机能用吗委员会采用可驳斥的推定标准，假设具有重大财务利益的个人可能不会进行研究，除非有令人信服的情况可以批准。The Committee’s recommendations for these studies are forwarded to the EVP & CAO and the CPHS before the protocol receives final CPHS review and approval, and the CPHS may request revision of the recommended management plan if it feels the conflict cannot be managed or the proposed plan is insufficient. The CPHS makes the final determination as to whether the research should be approved.
Research Compliance, Education and Support Services –Research compliance staff assist researchers with regulatory processes – IND/IDE submissions, clinicaltrials.gov registration, DSMB coordination. Several basic, intermediate, and advanced training courses in good clinical practice (GCP) for researchers and research staff are coordinated by this group. Research compliance group also helps coordinate educational programs for IRB members and staff. Research compliance staff conduct routine post approval study reviews and for cause audits as directed by the IRB.
临床研究部门 -beplay苹果手机能用吗The mission of the Clinical Research Unit is to facilitate clinical research by providing investigators with specialized facilities, personnel, and advice. The UTHealth CRU at Memorial Hermann—Texas Medical Center offers 6 outpatient and 4 inpatient rooms; skilled nursing assistance; assistance with processing of laboratory samples; scheduling diagnostic tests and procedures; a research dietician; a chart room; and a physician charting area. The Brownsville CRU is in the Professional Building of the Valley Baptist Hospital-Brownsville, adjacent to the main hospital buildings. The unit is dedicated for outpatient services, and includes a waiting room, 4 examination rooms, a laboratory area for sample processing and storage, an area for charting by staff and investigators, office space for patient scheduling and follow-up, and an interview/conference room for long patient interviews, staff in-services, and investigator meetings.
Office of Institutional Compliance– The mission of the Office of Institutional Compliance is to pro-actively promote compliance with all applicable legal and regulatory requirements. The compliance program strives to foster and help ensure ethical conduct and provide education, training, and guidance to all faculty and staff members. The office manages the compliance hotline. The office also manages mandatory institution training including HIPAA and data security. The Chief Compliance Officer works very closely with the EVP&CAO on research related matters. The Institutional Compliance Office is responsible for coordinating the Executive Compliance Committee.
Office of Sponsored Projects Administration——赞助项目办公室负责for reviewing and approving all research contracts and grants submitted by UTHealth faculty and trainees and for verifying that UTHealth can meet the terms and conditions of grants/contracts awarded to the institution. If the research involves human subjects or human derived materials and requires CPHS approval, the principal investigator must provide the Office a copy of the CPHS approval letter before a research account can be set up and funds expended to support the proposed research. The clinical trial contract team ensures that clinical trial contracts have appropriate language on research related injury, publication, dissemination of results, and sharing of data safety monitoring board reports. The Clinical Research Finance team works with the research staff to develop coverage analysis for clinical trials. The preliminary and final coverage analysis are sent to the IRB staff and uploaded in iRIS.
Human Embryonic Stem Cell Research Oversight Committee– This Committee addresses ethical, scientific, and regulatory issues related to human embryonic stem (hES) cell research. Its responsibilities include reviewing research protocols involving hES cells, monitoring approved studies as appropriate and maintenance of registries research involving hES that are conducted at UTHealth. This Committee is also responsible for recommending training requirements for UTHealth investigators involved in hES cell research.
Institutional Biosafety Committee– This Committee addresses ethical, scientific and regulatory issues related to infectious diseases and biological agents. Research involving biological agents must be reviewed by the Institutional Biosafety Committee.
Radiation Safety Committee– This Committee formulates and recommends policy for the use of radioactive materials and other sources of radiation. Research involving use of radioactive materials in humans must be reviewed by the Radiation Safety Committee.
Chemical Safety Committee– This Committee recommends policy for the use of chemicals that may be hazardous in the research, clinical and educational activities at UTHealth. Research involving hazardous chemicals in humans must be reviewed by the Chemical Safety Committee.
Pathology Review Process –病理部门所需文档a proposed study will not compromise pathologic evaluation of tissues required for current or future clinical care as biopsies are becoming smaller so there is less tissue available. Any research study involving tissues collection or request for specimen stored in Pathology requires review by the Pathology department. The IRB office checks for this approval letter before proceeding with IRB review.
Radiology Review Process -诊断干预和成像部（DII）需要批准进行研究成像，以确保可以使用成像资源并适当地进行计费。beplay苹果手机能用吗beplay苹果手机能用吗研究人员必须寻求DII的批准，用于使用诊断成像程序的所有研究项目，无论是由DII教职员工发起还是由其他部门，学校或机构的成员进行的研究。外围beplay对于涉及使用放射学和医学物理服务的任何研究（例如，解释，报告，处理，建立成像设备性能/合规性等），需要获得事先批准beplay苹果手机能用吗。任何涉及非常规使用放射学的研究（例如，在评估新植入物或设备时），非常规成像方法或新/改进的对比度方法也需要部门批准。与标准的护理成像一样，对MHHS成像设备进行的所有研究成像都需要由Utheabeplay苹果手机能用吗lth放射科医生阅读。
PROCEDURE
The CPHS submission packet for each research study requires key study personnel to declare if they have any related financial interests at initial and continuing review. The CPHS application includes screening questions for Institutional Biosafety Committee, Radiation Safety Committee and Chemical Safety Committee. If the investigator indicates that the research involves a substance or agent that needs review by any of these Committees, the investigator is given directions to obtain approval from these Committees. The human embryonic stem cell oversight committee has representation from the IRB to ensure that human subjects research protocols involving hES obtain the necessary approvals.
调查人员可以同时向委员会提交研究建议，以保护人类受试者和其他委beplay苹果手机能用吗员会。对于不涉beplay苹果手机能用吗及赠款或合同的研究建议，在获得所有必要的批准之前，IRB工作人员可以持有CPHS批准。
The Office of Sponsored Projects Administration requires Review and Approval forms within the UT Start grants and contracts management system. R&A forms are internal forms required for all sponsored research projects. R&As must be submitted to SPA for all grant proposals and applications, and for all industry-sponsored projects. The R&A form has questions about human subjects research, safety committees and conflict of interest. Research accounts are not opened until all institutional approvals are complete. IRB staff have access to the UT Start system.
APPLICABLE REGULATIONS
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REFERENCES TO OTHER POLICIES
1. HOOP Policy 90 – Review of Research
ATTACHMENTS
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If you find errors in this document, contact cphs@uth.tmc.edu
文件号码： |
101-A01 |
Document Name: |
Components of the Human Research Protection Program |
审核者： |
Executive Director, Research Compliance |
Effective: |
2008年8月1日 |
Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
Committee for the Protection of Human Subjects IRIS Support713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY |
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