Analysis of Stored Samples Collected Using Previously Expired Protocols

在这些研究的原始方案结束后，本方案将作为从特定的LIR临床试验中获得的存储的、编码的标本和数据的研究使用的一揽子方案。当临床试验的所有受试者参与结束且初步分析完成时，LIR将与NIAID机构审查委员会（IRB）终止原始临床方案。将在原始方案终止备忘录中说明是否有保存的样本和/或仍在使用的数据将继续遵循本一揽子方案下的人类受试者保护问题。获得标本和/或数据的特定LIR方案清单将保存在本方案的附录A中。将要求NIAID IRB批准在附录A中添加新的研究。

This protocol will serve as a blanket protocol for the research use of stored, coded specimens and data obtained from specific otherwise completed LIR clinical trials after the original protocols for these studies have been closed. When all subject participation in a clinical trial ends and the primary analyses are complete, the LIR will terminate the original clinical protocol with the NIAID Institutional Review Board (IRB). It will be stated in the original protocols termination memo whether there are stored specimens and/or data remaining in use that will continue to be followed for human subject protection issues under this blanket protocol. A list of specific LIR protocols from which specimens and/or data are obtained will be maintained in Appendix A to this protocol. The NIAID IRB will be requested to approve the addition of new studies to Appendix A. The objective of this protocol is to continue to have human subjects protection oversight by the NIAID IRB while making stored specimens and/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol. In 2015-2017 data and samples from the following protocols were transferred to this project: 04-I-0086 Evaluation of Clinical, Virological, and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis B and C and their Complications, PI: Colleen Hadigan, MD. 13-I-0066 A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients, PI: Henry Masur, MD. 14-CC-0065 Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, with or without BMS-791325, in Subjects Coinfected With HIV-HCV, PI: Henry Masur, MD No new protocols were transferred to this project in 2016-2020. Samples were used for the following since the prior report 04-I-0086 Evaluation of Clinical, Virological, and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis B and C and their Complications, PI: Colleen Hadigan, MD. 10 serum samples were pulled 14-CC-0065 Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, with or without BMS-791325, in Subjects Coinfected With HIV-HCV, PI: Henry Masur, MD 6 serum samples were pulled Samples are available for further analysis