managing a niaid grant: a grantee experience
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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. - PowerPoint PPT PresentationTRANSCRIPT
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Managing a NIAID Grant: a grantee experience
Dr Mina John
Centre for Clinical Immunology & Biomedical Statistics
Royal Perth Hospital & Murdoch University
Western AustralianHIV Cohort Study
Western AustralianHIV Cohort Study
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The Centre for Clinical Immunology & Biomedical Statistics Royal Perth Hospital & Murdoch University
Centre research scientists, employees and visiting research fellows July 2005
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WA HIV COHORT
STUDY est. 1987
BIOSTATISTICS COMPUTING
HLA GENOTYPING SERVICES
MHC RESEARCH
Simon Mallal & Ian JamesThe Centre for Clinical Immunology &
Biomedical Statistics
Royal Perth Hospital & Murdoch University
GENOMICS LAB
TECHNOLOGY
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HLA & HIV co-evolution
HLA-BHLA-BCodingCoding Coding (minus Exons 1-3)Coding (minus Exons 1-3)
0.005
0.005
0.02
WA White
ACTG Hispanic
Black
ACTG White
HIV NEF (clade B)HIV NEF (clade B)
Host gene HIV gene
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AcuteInfection
AIDSTIME
HLA-restricted T cell response Viral load
Escapes from current host RCReversions from previous host(s) RC
HIV adaptation to HLA in-vivo to optimise fitnessHIV adaptation to HLA in-vivo to optimise fitness
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HLA associations identify sites of immune recognition & selection1
TAFTIPSI non-adapted/revertantTAFTIPSV adapted/escapedTAFTIPST adapted/escaped2
C Moore et al, Science 2002, 296; 1439
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C Moore et al, Science 2002, 296; 1439
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“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
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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
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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”
Preparing the application:
The ACTG
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Targeting an R01 announcement
Letter of intent
Establishing dialogue with the Scientific Review Administrator (SRA)
Preparing the application:preliminary communications
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The submission
The two-stage scientific review
Just in Time Concepts
Submission
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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
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•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
Key Ingredients: The applicant team
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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
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NIAID Foreign Organization
System Review
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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.
Local IRB considerations
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Annual reporting
Electronic submission – 1. Progress report2. Annual Financial Status Report 3. Annual Report of Possible Research Misconduct
Obtain ethics renewal documentation
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Other thoughts…..
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Acknowledgements• 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
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