合作课题与NIH申请书的书写

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1、 课题分担：课题承担量大，需多实验室合作；研究资源互补：人力资源、现场资源或动物资源优势与技术资源互补；研究能力互补：细胞学、分子生物学、新型技术与实验方法 Significance: The CIPRA cohort offers a unique population infected at about the same time with a uniform HIV strain. Determining immunologic parameters that differentiate progression of disease from non-progression can be

2、 quite significant.Approach: This application from a group of investigators in China aims to evaluate two cohorts of HIV infected patients from the CIPRA project to determine functionality of CD8 epitope-specific immune responses during HIV-1 infection and correlate these with progression or contain

3、ment of HIV replication. This cohort contains patients who were infected with HIV about 10 years ago through contaminated blood products. All were infected by the Thailand B virus.Innovation: The study of CD8 responses to specific viral epitopes and correlation with Treg function in progressor vs. n

4、on-progressor populations is innovative.Grant Application: Five components from each reviewer Investigators: The PI, Dr. Xu, is experienced in HIV immunology research. His research team has relevant experience in biostatistics and molecular virology; however, the responsibilities of each team member

5、 are not described. Environment: The PIs laboratory is well equipped to carry out the proposed work. Clinical resources critical to the project are demonstrated in the preliminary Data, but apparently are quite distant from the laboratory, requiring delivery of specimens by aircraft, which may be pr

6、oblematic.Five components from each reviewer Innovation: The study of CD8 responses to specific viral epitopes and correlation with Treg function in progressor vs. non-progressor populations is innovative.Innovation: The proposed project will address a critical barrier to progress in the field. Afte

7、r more than 20 years we still do not completely understand the immunopathogenesis of HIV infection. It is thought that information gained by comparing immune, viral, and genetic differences between progressors andlong-term non-progressors will be useful in defining the hosts response to HIV infectio

8、n which is crucial for the development of an HIV vaccine. The proposed studies will expand the breadth of research support and advance the development of local scientific expertise in Beijing as well as provide supportfor new Chinese investigators.Innovation: The level of innovation is low; the proj

9、ect proposes to use established techniques, although these are state-of-the-art in HIV immunology and appropriate for the research objectives. Different comments from different reviewers for the identical application Investigators: The PI, Dr. Xu, is experienced in HIV immunology research. His resea

10、rch team has relevant experience in biostatistics and molecular virology; however, the responsibilities of each team member are not described. Investigators: The investigators are appropriately trained and well suited to conduct this research. Dr. Jianqing Xu was trained at the Research Institute fo

11、r Genetic and Human Therapy in Washington, D.C., from 1997-2004 and has a number of publications from this training. It appears that Dr. Xu has beenable to transfer much of this technology to the Chinese CDC in Beijing.Environment: The PIs laboratory is well equipped to carry out the proposed work.

12、Clinical resources critical to the project are demonstrated in the preliminary Data, but apparently are quite distant from the laboratory, requiring delivery of specimens by aircraft, which may be problematic.Environment: The PI and collaborating team has a strong track record and the use of the CIP

13、RA cohort for several years makes for an excellent environment for these studies. Facilities are adequate. Different comments from different reviewers for the identical application THE FOLLOWING RESUME SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW ADMINISTRATOR TO SUMMARIZE THE OUTCOME OF DISCUSSI

14、ONS OF THE REVIEW COMMITTEE ON THE FOLLOWING ISSUES:PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE (30). Informed consent seems adequate; privacy protection is in place; options for treatment are well defined. However, the study procedures and potential risks are not described. The text should al

15、so address plans to “collect additional blood if necessary”.INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE (G1A). However, the specifics related to recruitment of women are lacking.INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE (M5A). However, the specifics related to recruitment of minorities are

16、lacking.INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE (C1A).BIOHAZARD COMMENT: Protection against blood-borne pathogens should be addressed.FOREIGN INSTITUTION: The proposed project utilizes a unique subject cohort at the foreign location, and supports the activities of local researchersCOMMITTEE

17、BUDGET RECOMMENDATIONS: The budget was recommended as requested. 核心思维：目的明确，假说有力面面俱到：含所有的必需元件路标意识：研究思路清晰具体，具有可操作性初次相见：简略介绍相关背景 Significance: The significance of this research must be given the highest possible rating. Approach: Taken together, these proposed studies are to put it mildly rather ambiti

18、ous. The proposal lacks critical detail, focus and interpretive precision needed to precisely define what comparisons are to be made. Innovation: Most of the data are descriptive, however, they have the potential to lead to highly relevant and important issues in HIV immunopathogenesis. Investigator

19、: One concern is the fact that Dr. XXXX will devote only 10% of his time to this expansive project. Dr. YYY is still relatively inexperienced in guidance of such a complex project, and Dr. XXXs scientific guidance will likely be needed at a higher level than 10%. Environment: The coalition of the XXX and YYY with the ZZZ and SSS Hospital is an ideal situation for clinical studies of HIV biology in 2005. How could the comments be for the application from one of the best investigator in the world?