1 / 28

Managing a NIAID Grant: a grantee experience

Managing a NIAID Grant: a grantee experience. Dr Mina John Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University. The Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University.

charde-alexander
Download Presentation

Managing a NIAID Grant: a grantee experience

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Managing a NIAID Grant: a grantee experience Dr Mina John Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University

  2. The Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University Centre research scientists, employees and visiting research fellows July 2005

  3. HLA GENOTYPING SERVICES WA HIV COHORT STUDY est. 1987 MHC RESEARCH GENOMICS LAB TECHNOLOGY BIOSTATISTICS COMPUTING Simon Mallal & Ian James The Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University

  4. HLA & HIV co-evolution HIV NEF (clade B) ACTG White HLA-B Coding Coding (minus Exons 1-3) ACTG Hispanic Black WA White Host gene HIV gene

  5. HIV adaptation to HLA in-vivo to optimise fitness Viral load HLA-restricted T cell response Escapes from current host  RC Reversions from previous host(s) RC Acute Infection AIDS TIME

  6. HLA associations identify sites of immune recognition & selection1 TAFTIPSI non-adapted/revertant TAFTIPSV adapted/escaped TAFTIPST adapted/escaped2 C Moore et al, Science 2002, 296; 1439

  7. C Moore et al, Science 2002, 296; 1439

  8. “HIV 1 adaptation to HLA-restricted immune responses: viral and host determinants and implications for HIV-1 vaccines”2004 - 2009 • Large, ‘representative’ national population to study • Reflect contemporary viral diversity • Pre-treatment plasmas available stored at -80 • Source of DNA • Contemporaneous viral load/CD4 count • Good epidemiologic and clinical data collection & retrieval • Centralized specimen and DNA repositories • Potential synergies with therapeutics and drug resistance research

  9. About the AACTG • Largest HIV clinical trials organization in the world • Highly influential in setting standards of care for HIV/AIDS in the US and the developed world. • Broad scientific, therapeutic, and pathogenesis-based research agenda • Well established infrastructure for data and sample management • Directed by clinical scientists in HIV/AIDS therapeutic research. • Funded by the DHHS, NIH through the NIAID

  10. Preparing the application: The ACTG Protocol 5142: “A phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonovir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection” Co-enrolled in Protocol 5128: “A multi-investigator/institutional DNA bank for AIDS related human genetic studies”

  11. Preparing the application:preliminary communications Targeting an R01 announcement Letter of intent Establishing dialogue with the Scientific Review Administrator (SRA)

  12. Submission The submission The two-stage scientific review Just in Time Concepts

  13. The submission: Key Ingredients • Pressing research question – consistent with NIAID priorities • Capability for conducting the research does not exist in the US • Long term collaborators/research colleagues in the US or international • Key people identified as investigators

  14. Key Ingredients: The applicant team • A dedicated administrative person within research group who can: coordinate the submission and liaise with all parties involved • Sound understanding of the ethical principles - how to address them in the application. • Communication with the Grants Administrator

  15. Key Ingredients: the FWA Local IRB registration with the Office of Human Research Protections (OHRP) FWA: Federalwide Assurance Number: required for all documents pertaining to HREC processes Ongoing communication with local IRB

  16. NIAID Foreign Organization System Review

  17. Local IRB considerations These are typically under resourced and burdened by pharmaceutical trials Provide ‘complete’ cover letters and lay descriptions using plain language Ongoing reporting requirements – provide draft documentation especially if ‘expert’ knowledge of the grant/research is required.

  18. Annual reporting Electronic submission – 1. Progress report 2. Annual Financial Status Report 3. Annual Report of Possible Research Misconduct Obtain ethics renewal documentation

  19. Other thoughts…..

  20. National Institutes of Health National Health and Medical Research Council American AIDS Clinical Trials Group Centre for Clinical Immunology and Biomedical Statistics Royal Perth Hospital Department of Medical Illustrations: Brydon Dunstan Royal Perth Hospital Art Collection: Curator of Artwork, Lancelot Hyde Acknowledgements

More Related