UCRC SPECIAL CASE STUDY PROTOCOL

该方案的目的是为UCRC提供机制，以更详细地评估似乎具有独特疾病过程、已识别疾病的独特亚群、对药物治疗的独特反应等的患者的特征。偶尔，UCRC会被一名教职员工致电，询问看似独特的患者或家庭。作为第一步，最好是在有控制的环境中研究这类患者，例如UCRC提供的环境，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连续采集血液进行各种检测。偶尔，这样的患者可以“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病例研究方案。通过这个方案，可以获得初步信息，如果确实显示患者具有独特的特征并需要进一步研究，则产生的数据可以用于开发后续方案。希望使用此方案的研究人员必须向UCRC和IRB提交患者独特特征的简短书面描述，并说明建议使用UCRC的理由和要执行的程序。此表格必须附有同意书。在进行这项研究之前，必须获得UCRC项目主管和IRB的批准。预计该方案将在任何一年内仅适用于少数患者或家属。

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.