12 Golden Gcp Rules for Investigators

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12 Golden Gcp Rules for Investigators Powered By Docstoc
					                               Grants 101


                      Charles van der Horst, MD
                         Professor of Medicine
                      University of North Carolina
                           Visiting Professor
                     University of the Witwatersrand
University of North Carolina      1/12/2011
                               Outline
         Some basic facts
         Research idea
           – Group work: decide on idea and significance
             (groups of 3 to 6 people), 2 groups present
         Study proposal structure & specific aims
           – Group work: develop specific aim, 2 groups present
         Research design and methods
           – Group work: develop study design and methods
         Limitations, Background and preliminary studies
           – Group work: develop study limitations and alternative
             approaches
         Why study proposals succeed or fail?
         What we want from your proposals
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              The Golden Age of Research

        NIAID Payline 12th percentile
        Patents and Biotech Companies
        Medical Advances




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         Research is Not for Everyone
        Requires more than 9 to 5 work
        Attention to detail
        Patience
        Ability to write




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            What you need for research
    Time: Can’t be a clinician 24/7
    Patience: Rarely do you have immediate
     gratification
    Space: lab and clinical
    An IRB: human subjects committee
    A supportive boss, hospital director,
     government, etc

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           What you bring to your boss
     Prestige
     Indirect costs (8% currently in Africa)
     More faculty
     Renovation money
     Patient care costs




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         Three Types of Research Grants

     Request for Proposals (RFP)-They tell
      you what they want
     Independent ideas
     Contracts
          – Don’t forget small business grants




University of North Carolina   1/12/2011
         Charlie’s Simple Rules #1: Keep
                 your eyes open!
         – NIH www.niaid.nih.gov
         – CDC www.cdc.gov
         – Wellcome Trust www.wellcome.ac.uk
         – USAID www.usaid.gov
         – Elizabeth Glaser Pediatric AIDS Foundation
           www.pedaids.org
         – Doris Duke Charitable Foundation www.ddcf.org
         – European and Developing Countries Clinical Trials
           Partnership www.edctp.org
         – Pharmaceutical companies (Pfizer, Tibotec)


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               Charlie’s Simple Rules #2
       Get into bed with others….
         – Senior authors of great papers (PubMed)
         – Meet them at international meetings
         – Ask them if they want to collaborate
       Find friends (many hands make light work!)
         – Establish collaborative working groups (Acute
           HIV, Genital Secretions, Prison)


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               Charlie’s Simple Rules #3
       Brag with unabashed enthusiasm
         – Key points of grant up front
               • what sets you apart from your competitors
         – If no room, put in appendix
         – Tables and graphs are easy to read
         – Show you are good people, not just vampires
               • capacity building, infrastructure development,
                 training, black empowerment



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              Charlie’s Simple Rules #4
        Follow the rules
          – Letter of Intent
          – Due Date
          – Page length
          – Font and type, margins
          – Budget Cap and indirects
          – For RFA/RFP read what they want both in
            requirements section and the review criteria
            section and REPEAT IT BACK TO THEM!!!
          – If they ask for 6 things, give them 6 things
            even if you have to create it on the spot
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               Charlie’s Simple Rules #5
           Letters of support
             – Scientific Advisory Board (good place for
               nasty people as well)
             – Community Advisory Board
             – Your institution (cost sharing!)
             – Government




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               Charlie’s Simple Rules #6
           Dress for success
             –   Readable, not boring, talk to reviewer
             –   Clear
             –   Easy to follow
             –   Good English (read out loud)
             –   Index
             –   No redundancies unless crucial
             –   No bullshit (be familiar with literature)!
             –   Know your weaknesses and address them

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               Charlie’s Simple Rules #7
         Budget needs to be realistic and well
         justified
          – Do you really need a full time data manager?
          – What will the person be doing to justify it?




University of North Carolina   1/12/2011
               Charlie’s Simple Rules #8
           Let other knowledgeable people read
            your grant




University of North Carolina   1/12/2011
               Charlie’s Simple Rules #9
     If at first you don’t succeed, try, try try
      again
     Call the program officer
     Read the review sheet




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            Charlie’s Simple Rules # 10
           Now you have it, what should you do?
             – No weak links, communicate as a group weekly
             – Be generous with staff
                   • Pay them what they are worth
                   • Acknowledge their work frequently
                   • Don’t hog papers
             – Get rid of the mean spirited
             – Delegate, you can’t do everything
             – Nurture junior investigators


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                Remember: research involves
                     a long process
        The proposal document itself is not the
         first, not the last, and not the most
         important point of the research process
        It can takes months to years from an
         idea to start of the study (and many
         more years from idea to publication)
        Use the proposal writing as a learning
         process and relationship building
         exercise
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             An Example of a New RFP
        NIAID International Research in Infectious
     Diseases including AIDS (IRIDA) Program (R01)

                       PA Number: PAR-08-130
              National Institute of Allergy and Infectious
                            Diseases (NIAID)
              (http://grants.nih.gov/grants/guide/pa-
                       files/PAR-08-130.html)

        APPLICATION RECEIPT DATE: December 16,
           2010 (non AIDS September 16, 2010)
University of North Carolina     1/12/2011
                               IRID Contents
           Purpose of this Program            Where to Send Inquiries
            Announcement                       Application Materials
           Mechanism of Support               Submitting an
           Funds Available                     Application
           Eligible Institutions              Peer Review Process
           Individuals Eligible to            Review Criteria
            Become Principal                   Receipt and Review
            Investigators                       Schedule
                                               Award Criteria
                                               Required Federal
                                                Citations


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    •NIAID intends to commit approximately $800,000 annually
    to fund up to 10 new grants.

    •Budgets for direct costs of up to $100,000 per year and a
    project duration of up to four years may be requested for a
    maximum of $400,000 direct costs over a four-year project
    period.

    •80% of funds must be in foreign country

    •Foreign PI’s who already have an NIH RO-1 are not
    eligible




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                               What the RFP Wants
    •     To conduct collaborative infectious diseases research at
          international sites where NIAID has significant investment
    •     To build independent research capacity in investigators who do not
          currently have NIAID funding
    •     Topics of interest include emerging infections that are of the
          greatest public health significance within the applicant country
          (e.g. tuberculosis; malaria; HIV/AIDS; sexually transmitted
          diseases; diarrheal, respiratory, and enteric diseases; viral
          hemorrhagic fevers; viral encephalitides; parasitic diseases; and
          vector-borne diseases).
    •     Development of immunological, microbiological, biostatistical,
          epidemiological, and clinical research capacity is encouraged.
    •     To extend NIAID international programs by expanding the breadth
          of research supported at international sites and by providing
          support to new researchers.


University of North Carolina            1/12/2011
    Direct your questions about scientific/research non-AIDS issues to:
    Polly R. Sager, Ph.D.
    Division of Microbiology and Infectious Diseases, NIAID
    Room 6005, MSC-6603
    6610 Rockledge Drive
    Bethesda, MD 20892-6603
    Telephone: (301) 496-1884
    FAX: (301) 480-4528
    Email: ps31g@nih.gov

    For AIDS research:
    Opendra Sharma, Ph.D.
    Division of AIDS, NIAID
    Room 4151, MSC-7626
    6700 B Rockledge Drive
    Bethesda, MD 20892-7626
    Telephone: (301) 496-9041
    FAX: (301) 402-3211
    Email: osharma@niaid.nih.gov

University of North Carolina         1/12/2011
               The research idea, its
            presentation and justification




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             Elements of a Successful study
                       proposal

                                    Idea
                                    Science
                                    Presentation : ―grantsmanship‖




    A good proposal is a good idea, well expressed, with a clear
    indication of methods to pursue the idea and evaluate the findings

University of North Carolina        1/12/2011
                          Idea or presentation?
        No amount of grantsmanship can disguise
         a weak idea…

    BUT
     It is not enough to have a good idea
     Poor grantsmanship can kill a good idea
     Nobody can write this as a last minute job

University of North Carolina     1/12/2011
                               Good Ideas
        Should be able to be tested (i.e. hypotheses)
        Are scientifically important
        Are relevant, address a significant problem
        Are based on existing knowledge/data or fill
         existing gaps in specific areas of knowledge
        Do not need to be sophisticated to be relevant
        Are focused, feasible and answerable



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                         Good and bad ideas
           Avoid grand sweeping questions
             – Why do we have the largest AIDS epidemic in
               Africa?
           Avoid questions that are too focused
             – Why are 35 year old males living in Northern Malawi
               less likely to be married and have HIV than 35 year
               old males in central Malawi?
           Aim for ―middle range questions‖
             – What is the impact of ARVs given to the mother or
               the breastfeeding infant in preventing HIV infection
               for 6 months post partum?



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              Justification of your idea is the
               first and most essential step
     The problem or needs statement is the disparity between what is
     and what should be, that created the gap which your proposed
     project will attempt to close or diminish.

          What Exists Now                      What Should Be


          What Is                              What Ought To
                                                 Be
                                 GAP
          Present Level of
           Knowledge                            Desired State of
                                                 Knowledge
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                           All research is……

                      Hypothesis driven:
               What question are you asking?
                 What result do you expect?
         Is it an interesting question to you and to
                            others?

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                Check your hypotheses and
                 background literature in…
        The literature, discussion sections of
         already published peer-reviewed papers
        NIH, WHO or CDC Workshop Results
        NIH or CDC Webpages
        PubMed www.ncbi.nlm.nih.gov/PubMed/




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               NIAID Web Page
               www.niaid.nih.gov
         Research Funding Opportunities
         Chance to see what areas of science are of
          special interest to the Institute.
         Familiarity with concepts gives you a
          heads up for future initiatives
         See whether your research relates to any of
          these high-priority areas and if not change
          with the times. HIV investigators become Bio-
          defense Experts!
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                 Rationale and significance
           Points to the gap between ―what is‖ and ―what
            should be‖. Document the need and express
            it in human terms.
           Summarizes why this issue is important to
            answer the question and what we will learn
            from your study
           Tells others why this project matters and why
            this project should be carried out now


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                               Break
     Groups of 6 people
     Develop some research ideas in
      prevention of TB, diagnosis of TB and
      treatment of TB
     What is the significance of the idea
     Present to group
     Everyone is a critic


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     Example: What is the impact of ARVs given to
     the mother or the breastfeeding (BF) infant in
     preventing HIV infection for 6 months post
     partum?
        ARVs prevent HIV transmission if given antenatally and
         immediately postpartum by decreasing viral load in the
         mothers
        BF accounts for up to 50% of MTCT of HIV(> 200,000/yr)
        In Africa most women breastfeed for 2 years
        Formula is expensive ($1/ day)
        Formula fed babies have a 5% mortality the first 6
         months vs 0.5% BF babies
        In Africa, there is an urgent need to find methods to
         prevent transmission through breastmilk

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                  Study proposal structure
                       Specific aims




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                    Study proposal structure :
                        the NIH example
           Abstract
           Budget, Biographical Sketches, Resources
           Research Plan
             – A. Specific Aims (and hypotheses)
             – B. Background and Significance
             – C. Preliminary Studies / Progress Report
                   • (includes background of investigators)
             – D. Research Design and Methods
             – E. Human Subjects Research
             – G. Literature cited


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                               Specific aims
       The framework for the entire proposal
         – The problem/needs statement
         – The long range goals of the overall program and this
           particular application
         – The central hypothesis to be examined: testable and
           not predetermined
         – Rationale for the project
         – Specific aims
         – Anticipated results

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                               Specific aims
        What are the specific answers you plan to study
          – Aim for 2 – 5 brief, focused and limited questions
          – Each aim should link logically into the next aim
          – For each aim, briefly expand upon the data and type
            of methods used
        Be realistic
          – Don’t overestimate your abilities/capabilities to finish
          – Don’t underestimate the time needed to complete



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                               Specific aims
        End with
          – What will be the significance or impact of
            solving this problem or addressing this issue?
          – Why is the study innovative
          – Why should they fund you – your institution?
                • Creditable organization
                • Creditable PI
                • Unique organization for the proposed research



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                               Break # 2
           Write 3 to 5 specific aims for each
            research idea
             – Explain significance
             – Explain innovation




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        Example: ARVs for PMTCT via Breast
                       Milk
        To decrease HIV transmission over 28 weeks post partum using
         maternal HAART
          – Millions children infected with HIV
          – 50% HIV transmission through BM
          – Formula while effective in decreasing transmission is expensive,
            dangerous to infants first 6 months
          – Suppression of viral replication antenatal and perinatal decreases
            transmission
          – BM viral load correlates with plasma viral load
          – No randomized trials looking at HAART given to mothers while BF
        To decrease HIV transmission over 28 weeks post partum using
         daily infant NVP
          – Ditto
          – Post exposure prophylaxis works peri-natally, in animal models, in
            nosocomial needle exposures
        To compare the toxicities of the ARVs given to the mothers or the
         infants

University of North Carolina             1/12/2011
       Research design and methods




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                               Good Science
     Rationale for experimental methods
      selected
     Appropriate controls
     Limitations and alternative approaches
     Statistical design must be sound and
      complete


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             Good Written Presentation
     Gives just enough information
     Gives info where reviewers expect it
     Is clear, concise, readable the first time
     Persuades and justifies:
          – Why me?
          – Why this project?
          – Why now?
        Is organized and nicely presented


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           Research design: organization
     Restate each Specific Aim and for each,
      provide:
          1. Introduction and rationale
          2. Hypothesis tested
           – what you propose to do
          3. Methods of approach:
           – how you plan to do it
           – why you are doing it that way
          4. Anticipated findings or result
           – What the result will mean to the overall project
          5. Potential pitfalls/alternative approaches
           – What problems you might encounter
           – How you will cope with those problems

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               Research design: methods
           For each specific aim, develop method
            and then question
             – Can this method be used to address the
               research question?
             – Can this method test the hypothesis?
             – Will this method lead to results that are
               valid and reliable?


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        Research design: data collection
        Carefully think which variables you need to
         collect. Avoid collecting everything and at
         the time of analysis go for a fishing
         expedition
        Consider and discuss all variables that will
         impact the outcome. That is, which ones
         need to be controlled, which ones don’t, and
         how this will affect the outcome.
        For all variables:
          –   Provide rationale for collection
          –   Discuss validity reliability
          –   Present operational definitions of variables
          –   Discuss data collection procedures: when, where,
              how
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            Research design: statistical
                     issues
           Data analysis plan
             – Discuss primary and secondary analysis
             – Lay out dependent and independent
               variables
             – Discuss confounding and bias
           Sample size:
             – how many subjects or samples and why?
             – Sufficient for primary analysis or primary
               and secondary analysis?
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              Research design: timeline and
                organizational structure
        Plan of work over the life of the project:
          – What will be done when
          – Break down the work in subtasks
          – How do tasks and subtasks relate to each
            other
        Organizational structure
          – Expertise of key personnel
          – Why have you chosen these people?
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                               Break # 3
           Develop study design and methods




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                   BF and PMTCT: Maternal
                    HAART and Infant NVP
           Enroll HIV pos pregnant women in
            Lilongwe, Malawi
             – CD4 > 250, Hgb > 7, no prior ARVs, > 18 yo
             – All receive sdNVP + 7 days AZT/3TC
             – Randomize post partum randomize to
               maternal HAART, infant daily NVP or neither
               for 28 weeks (no placebo)
             – BF counseling, weaning

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    Timeline BAN Study
    Anticipated start date: July 2003.
       Phase 1 Formative research with target                   8 weeks
               population
       Phase 2 Training and pilot test of instrument            6 weeks
       Phase 3 Recruitment of participants and                  54 months
               initiation of study
       Phase 4 Continuing follow-up of participants             12 months
               and infants
       Phase 5 Data analysis and report writing will continue
               after completion of Participant and infant
               follow-up


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    Activity            2003        2004   2005        2006   2007   2008   2009
    Ethics                 x
    Train                      x
    Pilot                      x
    Recruit                             xxxxxx xxxxxxxxxxxx
    Follow                              xxxxxx xxxxxxxxxxxxxxxx
    QA/QC                               xxxxxx xxxxxxxxxxxxxxxx
    Analyze
    Write                          xxxxxxxx xxxxxxxxxxxxxxxxx
    Feedback                        x      x          x       x      x      x      x


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                 Organizational Structure
           PI-Dr. van der Horst, clinical trials since 1982,
            HIV care since 1981, research since 1986
           Biostatistician-Dr. Hudgens, randomized
            clinical trial design and monitoring since X
           Data Manager
           Laboratory Director
           Pediatrician
           Obstetrician
           Pharmacologist

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          Background, preliminary studies
               and study limitations




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                               Background
         Establish a solid foundation on which to build
          your proposal.
         Is not to impress others with your
          comprehensive knowledge of the field
         Needs to demonstrate your familiarity with the
          literature
         Is a focused, critical review of the literature to
          indicate what we know, the gap, what you will
          add
         Gives a clear conceptual framework or
          theoretical approach
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                      Preliminary Studies
        Describe your published studies in limited detail
        Avoid describing methodology in text
        Explain in most important figures/tables
        Describe unpublished studies in more complete
         detail, including newer data.
        Do not duplicate the preliminary studies with the
         proposed studies.
        Summarize qualifications of investigators


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                          Preliminary Studies
           Include the results of your recent work
            that have direct relevance to the studies
            proposed in your grant application.

           Exclude any studies in which the
            relationship to your proposed study is
            not relevant.

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                               Graphs and figures

       Anything that is vital to understanding your
        project should be in both graphic and text form
       Graphs should be uncomplicated...the simpler,
        the better.
       Clearly label your graphs
       Each table or figure should be designed to
        convey a single point or idea.
       Show people you have spent time on collecting
        preliminary data. Show all data, not only those
        that fit the hypothesis

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                          Potential problems

             Be realistic about the strengths and limitations
             Anticipate potential problems, and discuss
              them but do not overemphasize them.
             Offer alternative strategies.
             Reconcile the results of differing approaches.




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         Why think about potential problems
         and not just deal with them later?
         Problems are mainly related to confounding,
          bias and ethics
         One needs to identify as many potential
          problems before you start the study to ensure
          you correct them and you can deal with them in
          the analysis of the data
         Consider potential problems for each specific
          aim you have listed for your study and try to
          optimize each aim and its method to limit the
          limitations
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                What are the most common
                problems with study design?
    Is this the most optimal study design?
    What are the pro’s and con’s of
     alternative designs?
    Does the study design lead to ethical
     problems?
         – example is a placebo justified on the basis
           of equipoise?
         – Would another study design have the same
           risk-benefit ratio?
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              What are the most common
            problems with study population?
           Generalizability of results:
             – Is the study population representative for
               the population of interest for the study?
             – Would another study population provide a
               better answer to the research question ?
             – Does the study population represent the
               different perspectives/problems related to
               the research question?

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          What are the most common
        problems with study population?
           Participation bias
             – Is possible that the decision to participate
               can be linked to the outcome or exposure?
             – If yes, how can I design the study better to
               avoid this?
             – If yes, what data do I need to collect on
               non-participants to afterwards assess this
               issue?

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                What are the most common
                 problems with methods?
        Will the measurement methods selected
         give me a valid and reliable answer to the
         research question?
        Is the frequency of measurement
         optimal?
        Do I have the correct measurements for
         control data?


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                   What are the most common
                    problems with methods?
           When using novel methods
             – What are the chances that the method will
               work or fail?
             – What will you do when it fails?
                   • Suggestions for adaptation of technique
                   • Suggestions for alternative technique




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       Review: Steps in proposal writing
        Step 1 : idea
        Step 2: prepare yourself
             – Set timelines
             – Read one or more successful proposals
             – Read to refine your thinking
             – Formulate 2 to 3 specific research questions
             – Check if you can do the research (data,
               materials, institution, collaborations,…)

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           Steps 3 -5 in writing a research
                       proposal
        Step 3: Prepare a 3 page summary of the project
          – Get advice on this document with experienced
            colleagues
        Step 4: Do you need preliminary data ?
          – Objections vanish if you can show you have done it
        Step 5: Prepare proposal draft and get started
         on administrative issues (paperwork, budget)



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                               Final steps
     Step 6: Get experienced colleagues to
      read the proposal and critique proposal
     Step 7: Revise proposal several times
     Step 8: Proofread and finalize
      administrative issues
     Step 9: Aim to have everything ready
      before the deadline
     Step 10: Get your grant to the right study
      section and submit a cover letter
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           Cover Letter and Study Section
           Go to CSR website to look for study section
            descriptions Biology Development Aging (Fogarty
            initiatives) ICP-1 and 2 are the key committees for
            Fogarty, also special emphasis panels every cycle
           Contact the program officer as well
           Cover letters requests study section and gives one
            sentence description of project. Can also put in
            people with potential conflicts whom you do not want
            to review. Do not suggest reviewers by name but can
            suggest areas of expertise
           If you are unhappy with the initial committee
            assignment you can call and request reconsideration


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                Review criteria
        Why study proposals succeed and
                      fail




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                               Review Criteria
        Significance
        Approach
        Innovation
        Investigator
        Environment




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                               Significance
        Does this study address an important
         problem?
        If the aims of the application are
         achieved, how will scientific knowledge
         be advanced?
        What will be the effect of these studies
         on the concepts or methods that drive
         this field?

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                               Approach
        Are the conceptual framework, design,
         methods, and analyses adequately
         developed, well-integrated, and
         appropriate to the aims of the project?
        Does the applicant acknowledge
         potential problem areas and consider
         alternative tactics?


University of North Carolina     1/12/2011
                               Innovation
        Does the project employ novel
         concepts, approaches or methods?
        Are the aims original and innovative?
        Does the project challenge existing
         paradigms or develop new
         methodologies or technologies?



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                               Investigator
        Is the investigator appropriately trained
         and well-suited to carry out this work?
        Is the work proposed appropriate to the
         experience level of the principal
         investigator and other researchers (if
         any)?



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                               Environment
     Does the scientific environment in which
      the work will be done contribute to the
      probability of success?
     Do the proposed experiments take
      advantage of unique features of the
      scientific environment or employ useful
      collaborative arrangements?
     Is there evidence of institutional support?


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               Additional Review Criteria
        Protection of Human Subjects
        Inclusion of women, minorities and
         children
        Data sharing
        Budget




University of North Carolina   1/12/2011
                          Why proposals fail?
           Rationale and significance not sufficient
             – No rationale
             – Lack of significance
             – Only local significance
           Unlikely to produce new or useful information
           Hypothesis
             –   Based on insufficient evidence
             –   Doubtful
             –   Unsound
             –   Lacking - fishing expedition
             –   Lacking - pure descriptive

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                         Why proposals fail?
        Problem more complex than
         investigator appears to realize
        Problem is scientifically immature and
         warrants at most a pilot study
        Unrealistically large amount of work –
         don’t promise more than you can deliver
        Lack of original or new ideas
        Project too diffuse and lacks focus

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                         Why proposals fail?
        Background lacks critical references
        Lack of preliminary data
        Preliminary data do not support
         feasibility
        Preliminary data: not clear which were
         obtained by the investigator and which
         by others

University of North Carolina    1/12/2011
                           Why proposals fail?
        Methods not appropriate for hypothesis
        Insufficient methodological details –
         lacking in clarity to permit adequate
         evaluation
        No potential problems identified and no
         alternative approaches
        Sample size too small


University of North Carolina      1/12/2011
                          Why proposals fail?
          Lack of expertise of investigators or resources
          Investigator wrote disorganized, rushed
           proposal
          Investigator unfamiliar with recent pertinent
           literature
          Investigator unfamiliar with recent methodology
          The investigator’s published work does not
           inspire confidence


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                               References
    1.      UNAIDS and WHO, AIDS Epidemic Update.
            UNAIDS/05.19Eed, World Health Organisation,
            Geneva (2005).
    2.      H Coovadia, Antiretroviral agents—how best to protect
            infants from HIV and save their mothers from AIDS, N
            Engl J Med 2004; 351:289–292.
    3.      Nduati R; John G, Mbori-Ngacha D, et al, Effect of
            breastfeeding and formula feeding on transmission of
            HIV-1: a randomized clinical trial, JAMA 2000;
            283:1167–1174.
    4.      Miotti P, Taha T, Kumwenda N, et al.. HIV
            transmission from breastfeeding: a study from Malawi.
            JAMA 1999;282:744-749

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          What to do to be successful?
          Balance between something ―sure‖ and
           something new and innovative, risky
          Be persuasive and clear
          State clearly what is novel
          Make your proposal pleasant, attractive and a
           joy to read
          Aim for both an expert and a general reader
          Don’t irritate the reviewer
            – Follow directions
            – Don’t be sloppy : a sloppy application = a sloppy
              scientist
            – Don’t be make spelling mistakes or write tiny
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                               Magic in research
                                 proposals?
        Study proposals are the opposite of magic.
        ―Magicians don’t tell people what they are going to do
          and they don’t like to repeat a trick. You should be
          sure to tell people what you are going to do, and be
          sure you repeat things often.‖
        Research proposal writing is hard work.
        Read, read, read;
          write, revise, rewrite,
               work, and work, and be ready to work some
                       more…especially at night and in the
                              weekend

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                               Product of Good
                               Grantsmanship
           Is a clear and lucid application that allows
            others to understand the train of thought
            that guided the development of
            scientifically good ideas.
           An application where the proposed
            research is innovative and focused.




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      Playing Nice in the Sandbox:
     Working as a Collaborative Group
        Bring in experts to fill in your gaps in
         knowledge/ability
        Listen to them
        Make sure everyone signs off the final
         draft of proposals, abstracts, papers
        Don’t exclude people as authors or
         participants if they have helped you

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                               References
   “A Grant Writing Primer” by Hinda Zlotnik, MARC/MBRS Program, NIGMS
   “Writing a grant proposal”, by Malcolm Gordon, Ph.D., National Institute of
     Mental Health, 1999
   “Leaping the hurdles &navigating the maze: how to get funding from
      DBSB/NICHD” by Rebecca L Clark, 2004
   “Developing and writing successful proposals”. UMKC Sponsored
      Programs & Research Support, 2001
   “A beginners guide to the world of research grants for sociologists” by
      Stew Tolnay, 2001
   “Why proposals are rejected” by Don Thackrey, University of Michigan
   “Introduction to NIH: Grant Fundamentals” Anthony M. Coelho, Jr.,
      Ph.D.Review Policy Officer.Office of the NIH Director Office of
      Extramural Research


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     THE SATABAT DEVELOPMENTAL AWARD
                   APPLICATION
        Front/Title page of grant response

                Title of project (descriptive) font size 18.
               SATBAT TB Research Proposal. July 2010
        Name, title, position and full contact details of Principal
                   Investigator (tel, cell fax and email)
         Full name and postal address of institution that will be
                            receiving the grant
        Name and title of academic supervisor or Department or
                   Unit head and their contact details.
         Name, title and contact details of recipient’s institution
                           grants administrator.

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       ―One time advanced in-country research
         support‖




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                    Abstract/Executive Summary

       This should be one page and include a short rationale for
      the study, study objectives and specific aims, location and
        institution(s) involved, study design and methods and
      estimated time frame. For the remainder of the document
                    use a font size not less than 11.




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                 Objective, aims and hypotheses

        Provide an overall objective (what the study hopes to
     achieve) of the study and if applicable your primary aim and
       not more than two secondary aims. Please state your
                         primary hypothesis.




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                               Background

     Provide a one to two page detailed referenced rationale for
        your study. Explain the size and scope of the clinical
     problem you will address, a summary of prior relevant work
     reported with results and, if available, preliminary data that
     you or your group have. This section should be directed at
           making a strong case for your research project.




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                               Methods
        This section should be not more than 3 pages of text.
       Using appropriate sub headings, outline your proposed
     project, including the following: study design; population to
       be studied and their locations or where samples will be
          obtained from; eligibility criteria; study procedures;
       statistical methods and sample size calculations; ethical
        considerations. Make sure that the methods section is
       clearly linked to your aims. If a sampling frame is to be
      used describe how participants or their specimens will be
     selected. List the possible shortcomings/limitations of your
           study. In addition, make sure the study design is
                   appropriate for the budget offered.


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                                     Study Team
    Write a 2-3 paragraph narrative resume of each study member
    (including yourself) that will contribute the success of the project clearly
    stating their role. List up to 5 relevant peer-reviewed publications of
    each study member.
                       Institutional Research Environment
    Include at least two paragraphs describing the facilities supportive of
    research that you will use at your institution
                         Budget and Budget Justification
    Tabulate anticipated study expenses using line items that are
    commonly used by your institution. For any expense over ten thousand
    rand, write a sentence or two justifying the expense. This section
    should be not more than one page.
                                     References
    All references should be in the style of the journal AIDS
    (http://www.aidsonline.com).

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   •Please make sure each page is numbered at the bottom of the page
   centralized in the format current page/total pages.

   •Include your name and an abbreviated study title as a header on each
   page (including the title page).

   •Before you submit your response to tb@hivsa.com, make sure you
   attach the letter of support from you academic supervisor or head of unit
   or department or fax it to 0119899762 - clearly marked SATBAT.

   •Get someone else to critically read and comment on your penultimate
   draft. Even if it is a lay person who will correct grammar and spelling.
   The more people that read and comment on your work prior to
   submission the better.

   •Anyone who submits a response that has any merit –even if it is not
   selected as one that should be funded - will be offered a free GCP
   course in their nearest major city.

University of North Carolina        1/12/2011

				
DOCUMENT INFO
Description: 12 Golden Gcp Rules for Investigators document sample