UCRC SPECIAL CASE STUDY PROTOCOL

UCRC 特殊案例研究协议

• 批准号: 6121141
• 负责人: James T. Willerson
• 金额: $ 1.51万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6121141
• 关键词: cardiovascular disorder; clinical research; human subject; patient /disease registry

The aim of this protocol is to provide the mechanism on the UCRC to assess in more detail the characteristics of patients who appear to have unique disease precesses, unique subsets of an already identified disease, unique responses to drug therapy, etc. Occasionally, the UCRC is called by a faculty member concerning a patient or family who appears to be unique. As a first step, it would be desirable to study such patients in a controlled environment such as that offered by the UCRC with a rigidly controlled diet, quantitative collection of urine and feces, and serial sampling of blood for a variety of determinations in either routine or special laboratories. Occasionally such patients can be ""fit"" into already approved protocols, but if they cannot, they can be entered into this special case study protocol. Through this protocol, preliminary information can be gained, and if it does indeed appear that the patient has unique characteristics and warrants further studies, the data generated can be used to develop subsequent protocols. An investigator wishing to utilize this protocol must submit to the UCRC and to the IRB a brief written description of the patient's unique characteristics, with a justification of the proposed use of the UCRC and procedures to be performed. This must be accompanied by a consent form. Approval from both the UCRC Program Director and the IRB must be obtained before the study can be conducted. It is anticipated that this protocol will be applicable to only a few patients or families within any given year.

本协议的目的是提供UCRC的机制，以更详细地评估具有独特疾病进展的患者的特征，已经确定的疾病的独特亚群，对药物治疗的独特反应等。偶尔，教员会给UCRC打电话，询问一个病人或家庭，这似乎是独一无二的。作为第一步，最好在UCRC提供的受控环境中对这类患者进行研究，严格控制饮食，定量收集尿液和粪便，并在常规或特殊实验室进行一系列血液采样，以进行各种测定。偶尔这样的病人可以“适合”已经批准的方案，但如果他们不能，他们可以进入这个特殊的案例研究方案。通过该方案，可以获得初步信息，如果确实显示患者具有独特的特征，值得进一步研究，则生成的数据可用于制定后续方案。希望使用此方案的研究者必须向UCRC和IRB提交一份关于患者独特特征的简短书面描述，并说明建议使用UCRC和将要执行的程序的理由。这必须附有同意书。在进行研究之前，必须获得UCRC项目主任和IRB的批准。预计在任何一年内，这项议定书将只适用于少数病人或家属。