Department Review for Clinical Research
人类受试者法规要求IRB实体ure that risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and that Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. The department review process provides the IRB with information to help determine if the proposed research meets all the regulatory criteria for approval.
The department review should assess scientific validity of the proposed research. The department review should also include a feasibility assessment with particular attention to the feasibility of meeting enrollment targets. (example -可行性问卷) In addition to conducting a review of proposed research, a robust departmental oversight mechanism should also be able to assess whether the research is progressing well and help the research team resolve any problems during the course of the research.
Suggested goals of the department oversight mechanism:
- Facilitate research that meets the department research goals.
- 就拟议方案的科学有效性提供建议。
- Assess the feasibility of proposed protocol:
- 研究人员是否通过经验，教育和培训来进行研究，beplay苹果手机能用吗
- 研究人员是否可以获取包括设施和研究人员在内的足够资源，beplay苹果手机能用吗
- Whether the recruitment plan will be able to meet target accrual.
- 当有多个具有相似资格标准的开放协议时，请确定招聘的优先级。
- Assist researchers to conduct research according to the good clinical practice guidelines.
- 在德监督各个项目的进展partment’s research program.
Department Representative Signature within iRIS Routing:
All new protocols must have department approval before they are reviewed by the IRB. Protocols from School of Dentistry, Cizik School of Nursing, School of Public Health, School of Biomedical Informatics and Graduate School for Biomedical Sciences and others (not from McGovern Medical School) may be routed within iRIS for departmental representative signature. Instructions for routing to departmental representative can be found on the虹膜导航page。
临床研究表（McGovern医学院）的部门审查：beplay苹果手机能用吗
McGovern医学院的协议，有资格获得全面董事会审查的部门审查，并完成临床研究表的部门审查beplay苹果手机能用吗must be submitted with initial application in iRIS under 'Other Study Documents'. CPHS does not require department review in the following situations:
- Protocols that meet exemption criteria (see policy豁免)
- 通过加急程序有资格进行审查的协议（请参阅政策Expedited Review)
- Federally funded protocols (grants that have already been awarded by NIH or other federal agencies)
Department review is required for industry sponsored clinical trials being submitted to the UTHealth IRB for review and approval. It is highly recommended that protocols being reviewed by commercial IRBs undergo department review, but this is not required by the IRB.
部门审查流程：向您部门协调部门审查的人员提交协议和其他研究文件。我们强烈建议该表格由部门审阅者完成，而不是由研究团队预先填写。您应该收到签名临床研究表的部门审查beplay苹果手机能用吗after the review has been completed. If there are comments and suggestions on the form, you are highly encouraged to incorporate the comments and suggestions into the study protocol before submitting to the IRB for review. Submit the signed form in 'other study documents' section with the initial application in iRIS. If you do not agree with any comments and suggestions provided by the department review, include a cover letter with justification along with your iRIS application. You do NOT have to route for department signature when you submit the initial application within iRIS.
Frequently Asked Questions:
Which protocols require departmental research review?All initial submissions from Medical School that require a full board review (i.e. not eligible forexemption或通过expedited程序）必须接受部门研究审查。beplay苹果手机能用吗CPHS不需要部门审查商业IRB或NIH等联邦机构审查的协议。但是，您的部门可能需要提交所有项目以进行审查。
How can I determine whether my protocol is exempt or expedited?通常，在完整的董事会会议上审查了临床试验。临床试验是研究参与者的研究，将参与者前瞻beplay苹果手机能用吗性分配给一种或多种干预措施，以评估这些干预措施对健康相关的生物医学或行为结果的影响。这些协议应接受部门审查，并且必须在IRIS的初始申请中提交签名的部门审查表。大多数涉及与参与者接触的研究（例如图表审查，去识别数据或样本的分析等）符合标准exemption。Protocols that are no greater than minimal risk may meet criteria for review by加急程序。您可以通过713-500-7943与CPHS办公室联系或cphs@uth.tmc.edu为了澄清。
What outside peer review will be accepted in lieu of departmental review?Protocols for grant applications that have already been reviewed and funded by NIH will not require departmental review. Do attach evidence of funding in lieu of the completed departmental research review form.
提交给外部IRB的协议是否需要部门审查？The IRB does not require department review for industry sponsored protocols being reviewed at an external IRB, including commercial IRBs. However, your department might require review. Department reviewers should be mindful that it might not be possible for investigators to request for changes to industry protocols. Department review might focus on the feasibility of conducting the trial at UTHealth including feasibility of meeting enrollment target, qualifications of the research team and competing trials at UTHealth etc.
如何在IRIS中提交签名的部门审查表格？The临床研究表的部门审查beplay苹果手机能用吗should be uploaded in the Study Document section in iRIS, under the Departmental Research Review category. The attachment process is the same as for any other study document. For instructions visit基本虹膜。
Who is responsible for the department review in my department?Each department has established its own procedure. Please consult within your department to determine the appropriate process. Refer to this部门审稿人名单to find the person to contact within your department.
如果我不同意部门同行评审怎么办？We encourage you to work with your department reviewer and make changes to your protocol based on the department review and resolve any differences before submitting to CPHS for review. If there are issues that you are unable to resolve with the department reviewer, you may submit to CPHS with a cover letter explaining the differences and providing your justification.
Links:
- 部门研究审查表beplay苹果手机能用吗(请下载表格并在Adobe中打开以启用数字签名）
- 建立部门研究审查过程的指南beplay苹果手机能用吗
- 部门审稿人名单
其他资源：
- Scientific Partners Advancing Research Kickoff (S.P.A.R.K.)
- Biostatistics Epidemiology and Research Design (BERD)
- Clinical Trials Resource Center (CTRC)
- Protocol Templates
CPHS求助热线713-500-7943
iRIS HELPLINE 713-500-7960
Uthealth的合规性热线（1-888-472-9868）
Committee for the Protection of Human Subjects IRIS Support713-500-7960 |
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