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Office of Extramural Research, Education and Priority Populations (OEREP) Grantsmanship Session

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Grantsmanship Session Overview: Francis Chesley, MD OEREP Director Prepare a Grant Application: Debbie Rothstein, PhD, Senior Advisor to the Director - OEREP – PowerPoint PPT presentation

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Title: Office of Extramural Research, Education and Priority Populations (OEREP) Grantsmanship Session


1
Office of Extramural Research, Education and
Priority Populations (OEREP) Grantsmanship
Session
  • Overview Francis Chesley, MD OEREP Director
  • Prepare a Grant Application Debbie Rothstein,
    PhD, Senior Advisor to the Director - OEREP
  • AHRQ Peer Review Process Kishena Wadhwani, PhD,
    MPH Div. Scientific Review Director, OEREP
  • Human Subjects Protections and Inclusions
    Patrick McNeilly, PhD AHRQ IRB Official, OEREP

2
Preparing a Grant Application Steps to Success
  • Debbie Rothstein, Ph.D.
  • Senior Advisor, Extramural Research
  • Office of Extramural Research,
  • Education and Priority Populations
  • Agency for Healthcare Research and Quality
  • September 9, 2008

3
Getting Started
  • Internet is funding gateway
  • AHRQ and NIH use essentially the same application
    processes and grant mechanisms
  • Keep abreast of open solicitations and Agency
    research priorities

4
AHRQs Website www.ahrq.gov
   AHRQ Research Agenda
   Funding Announcements
   Research Policies
   Grants Process
   Grant Application Basics
   Training and Education
   Contracts
5
AHRQ and NIH Grant Application Similarities
  • Application forms SF 424(RR), PHS 398
  • Application submission dates
  • Use of internet as the funding gateway to keep
    abreast of research priorities and open
    solicitations, staff can provide technical
    assistance
  • Announcement publication NIH Guide for Grants
    http//grants1.nih.gov/grants/guide/index.html
    and Grants.Gov www.http//grants.gov

6
AHRQ and NIH Grant Application Similarities
(contd)
  • Receipt and referral of grant applications
  • Application review procedures
  • Grant mechanisms e.g., R01, R03, R13, R36, K01,
    K02, K08
  • Transition to electronic submission of
    applications
  • Some common Policy Notices and Funding
    Opportunity Announcements

7
AHRQ and NIH Grant Application Differences
  • Detailed budget vs. modular budget
  • Conference grants AHRQ has small and large
    opportunities
  • AHRQ doesnt allow multiple PIs
  • Budget limitations
  • Large grants (R01, R18) - 300K vs. 500K
  • Small grants (R03) - 100K vs. 50K
  • Fewer grant mechanisms used at AHRQ

8
AHRQ Grant Opportunities
  • AHRQ announces availability of grants in a
    Funding Opportunity Announcement (FOA)
  • FOAs are published in the NIH Guide for Grants
    (http//grants.nih.gov/grants/guide/index.html)
    and posted on Grants.gov (http//www.grants.gov/
  • Program Announcement (PA)
  • Describes broad research interests
  • Open over a period of time
  • Request for Applications (RFA)
  • More well defined area, specific program
    objectives
  • Single application receipt date and amount of
    funds

9
Common AHRQ Grant Opportunities
  • R01 large research grants
  • Feb 5, June 5, Oct 5 application receipt dates
  • up to 300K/yr
  • R18 research demonstration grants
  • Jan 25, May 25, Sept 25 application receipt dates
  • up to 300K/yr
  • R03 small research projects
  • Feb 16, June 16, Oct 16 application receipt dates
  • up to 100K in total costs
  • Large and small conference grants (R13)
  • Large Apr 12, Aug 12, Dec 12 receipt up to
    100K/yr in total costs
  • Small Feb 20, Apr 20, Jun 20, Aug 20, Oct 20,
    Dec 20 receipt up to 50K

10
AHRQ Grant Opportunities Training/Career
Development
  • Pre and Postdoctoral Training
  • Institutional Training Programs (T32)
  • Individual Pre-doctoral Fellowships to Promote
    Diversity (F31)
  • Individual Post-doctoral Fellowships (F32)
  • Dissertation Grants (R36)
  • Career Development Awards
  • Mentored Scientist Awards (K01)
  • Independent Scientist Awards (K02)
  • Mentored Clinical Scientist Awards (K08)
  • Detailed information at
  • http//www.ahrq.gov/fund/training/trainix.htm
  • Send questions to training_at_ahrq.hhs.gov

11
AHRQ Staff Involved in Grants Process
  • Referral Officer
  • Review Staff Scientific Review Officer and
    Grants Management Specialist
  • Program Staff Project Officer (PO)
  • Grants Management Staff

12
Electronic Application and Submission
  • Transition to Electronic Receipt began Dec, 2005
  • Vast majority of all competing applications to
    AHRQ are now submitted electronically using SF
    424 (RR) application
  • All major mechanisms used by AHRQ have
    transitioned except for the training grants

13
What is Grants.gov?
  • Federal governments single, online portal to
    electronically
  • Find Grant Opportunities
  • Apply for Grants
  • A cross-agency initiative spanning 900 grant
    programs from the 26 grant-making agencies, and
    over 350 billion in annual awards.

14
Electronic Submission of Grant Applications
  • With this new process, its critical to read and
    follow all instructions in the announcement and
    application guide
  • Applicant must prepare for e-submission by
    completing mandatory registrations
  • Grants.gov registration for organization
  • ERA Commons registration for organization and
    the PI

15
SF424 (RR) Application Form
  • Provides a consistent electronic submission
    process through Grants.gov
  • Consists of common data elements, arranged in
    components
  • Not all components will be used for every Funding
    Opportunity Announcement (FOA)
  • Each FOA will have the appropriate application
    package attached
  • From data files, application image is generated
  • Applicant should view and verify the application
    image

16
Electronic Application and Submission -
General Information and Help Links
  • SF424 (RR) Application and Electronic Submission
    Information
  • http//grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of
    Grant Applications
  • http//era.nih.gov/ElectronicReceipt/
  • Finding Help
  • http//era.nih.gov/ElectronicReceipt/support.htm

17
Paper No More, Use 424 (RR) OLD
NEW
18
What Determines Which Awards Are Made?
  • Scientific merit
  • Significance and originality
  • Methods
  • Program / Agency considerations
  • What is uniquely AHRQ
  • Existing research portfolio balance
  • Anticipated IMPACT of research
  • Availability of funds

19
Ingredients of a Successful Grant Application
  • Good Idea
  • Good Science
  • Good Application
  • Fits Agency Research Priorities

20
AHRQ PEER REVIEW PROCESS Kishena C.
Wadhwani, Ph.D., M.P.H. Director, Division of
Scientific Review (DSR) Kishena.wadhwani_at_ahrq.h
hs.gov Phone (301) 427-1556 Office of
Extramural Research, Education and Priority
Population (OEREP) Agency for HealthCare
Research and Quality (AHRQ) Department of Health
and Human Services (DHHS)
10/09/2008
21
ORGANIZATIONAL CHART Office of Extramural
Research, Education and Priority Populations
(OEREP) Division of Scientific Review
(DSR) Current Study Review Group (SRG) Clusters
and the Corresponding SRO/GMS
OEREP Director Dr. Francis Chesley
Committee Management
Receipts Referrals
DSR Director Dr. Kishena Wadhwani
Study Section Clusters
Health Care Quality Effectiveness Research
(HCQER)
Health Care Technology and Decision Sciences
(HCTDS)
Health Care Research Training (HCRT)
Health Care System Research (HSR)
SRO Dr. Carl Ohata GMS Maureen Gallagher
SRO TBD GMS Ms. Carmen Colston
SRO Dr. Boris Aponte GMS Ms. Rebecca Trocki
SRO Ali Azadegan GMS Ms. Diane Manuel
22
AHRQ HEALTH SERVICES RESEARCH SRG AND ITS PRIMARY
RESEARCH FOCI
Health Care Systems Research (HSR) Health Care Technology and Decision Sciences (HCTDS) Health Care Quality Effectiveness Research (HCQER) Health Care Research Training (HCRT)
Translational Research Translational Research Translational Research Translational Research
Implementation Research Implementation Research Implementation Research Implementation Research
Access and Utilization Technology/HIT Assessment Healthcare Quality Effectiveness Training Career Development
Cost/Finance/Markets Information Sciences Dissemination Cost-effectiveness Research Training-related Conferences/Workshops
Qualitative Quantitative Methods Qualitative Quantitative Methods Qualitative Quantitative Methods Qualitative Quantitative Methods
Delivery Systems Clinical/Translational Decision-making Evidence-based Medicine Institutional Training Career Development
Organizational Studies Patient Utilities, Morbidity Function Quality of Care Research Demonstrations Evaluations
Infrastructure Building Research Outcome Research Access to Utilization of Care Outcome Research
Provider Workforce Healthcare Quality Cost Improvement Clinical Outcome Research Healthcare-related IT Training
23
SCHEDULE OF STUDY SECTION MEETINGS, FY08-FY09
(TENTATIVE) (Updated 09/01/2008)
Study Section ( Meeting Dates) October 2008 Meeting March 2009 Meeting June 2009 Meeting
HSR Ohata/Gallagher October 24, 2008 March 5-6, 2009 June 24-25, 2009
HCQER TBD/Colston October 30, 2008 February 23-24, 2009 June 18-19, 2009
HCTDS Aponte/Trocki October 29, 2008 February 24, 2009 June 18-19, 2009
HCRT Azadegan/Manuel October 23-24, 2008 March 5-6, 2009 June 24-25, 2009
24
Process of Review for New Individual Research
Project Grant Applications
  • Three overlapping cycles per year
  • Submit in February (June, October)
  • - Review in June July (Oct -
    Nov, February - March)
  • SLT in July - August (December, May -
    June)
  • Earliest award in December (April, August -
    September)

25
Peer Review at NIH/AHRQ Types of Committees
(Study Sections)
  • Standing Committees
  • - Chartered multi-year commitment
  • - Temporary members added as needed
  • - Roster posted on NIH/AHRQ websites
  • Special Emphasis Panels (SEPs)
  • - All Temporary (Ad-hoc) members

26
Purpose of Peer Review
  • To evaluate the scientific and technical
  • merit of grant applications, providing
  • information (Recommendations) used by the
    Agencies/Institutes and Centers to make funding
    decisions.

27
Reviewers consider
  • Scientific and technical merit of proposed
    research/training
  • Qualifications of Principal Investigator(s) and
    research team
  • Availability of resources (Labs, Institutions)

28
Reviewers also consider (Cont.)
  • Reasonableness of requested budget for work
    proposed
  • Other factors (e.g., human subjects, animal
    welfare, inclusion policies/plans)

29
Reviewers do not consider
  • Program relevance (Except if stated in FOA)
  • Policy issues
  • Funding levels
  • Anticipated budget reductions
  • Comparisons with other applications

30
Review Criteria
  • For all R01, R03, R15, R21, and P01 subprojects
  • Significance and Originality
  • Approach Methods and Data
  • Innovation
  • Organization of the Project
  • Investigators
  • Environment Facilities and Resources

31
Sole Basis of Review Review Criteria
(The NIH 5 as an example)
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? 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? 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?
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)? 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 the unique features of the
scientific environment or employ useful
collaborative arrangements? Is there evidence of
institutional support?
32
Also...
  • Reviewers evaluate
  • Protection of human subjects, the environment,
    and animal welfare
  • Inclusion of women, minorities, and children
  • Inclusion of AHRQ Priority Populations
  • Budget

33
Research Involving Human Subjects
  • Important Considerations that must be addressed
    in the application because they impact on
    priority score - considered to be part of the
    Approach
  • Are there any risks to the human subjects?
  • Are the protections adequate?
  • Are there potential benefits to the subjects and
    to others?
  • What is the importance of the knowledge to be
    gained?
  • Are the plans for inclusion of minorities, both
    genders and children adequately addressed?
  • Is the proposed study exempt from human subject
    review?
  • No page limits

Risks include the possibility of physical,
psychological, social injury or safety resulting
from research.
34
AHRQ Requirement Inclusion of Priority
Populations
  • Inclusion of Children? - Rationale?
  • Inclusion of Elderly? - Rationale?
  • Inclusion of Rural? - Rationale?
  • Inclusion of Inner City? - Rationale?
  • Inclusion of Low Income? - Rationale?
  • Inclusion of Disabled? - Rationale?
  • Inclusion of Chronic Care? - Rationale?
  • Inclusion of End of Life? - Rationale?

35
Review Criteria (Cont.)
  • For FOAs (RFAs or PAs) , modified or additional
    criteria may be specified
  • For other mechanisms, specific criteria apply

36
Peer Review Process
  • Each application assigned to 3 reviewers for
    written comments
  • Streamlined Review may be used
  • Group discussion of each application, including
    budget recommendation
  • Recommended score range
  • Reviewers privately assign priority score

37
Peer Review Group Actions
  • Unscored (Streamlined Review)
  • Scientific Merit Rating (Priority Score)

38
Priority Scores/ Percentiles
  • Priority scores range from
  • 100 (Best) to 500
    (Worst)
  • 100 x (1.0 5.0)
  • In Streamlined Review, those in lower half are
    eliminated (unscored)
  • Percentiles calculated to normalize scoring
    behavior across review groups

39
Priority Scores Assigned by Reviewers
  • SCORED (stronger) 1.0 ? 1.4
    (Outstanding)

  • 1.5 ? 2.0 (Excellent) (25)

  • 2.0 ? 3.0 (25)
  • UNSCORED (weaker ) 3.0 ? 4.0
  • 4.0
    ? 5.0 (50)

40
HINTS PREPARING AN APPLICATION
  • Start early
  • Read and follow instructions
  • Clarify any confusing instructions early
  • Do not assume staff or reviewers will know what
    you mean
  • Include well designed tables and figures
  • Format - consider the reviewers
  • Proofread and check before sending

41
PREPARING AN APPLICATION (cont.)
  • Explicitly state the purpose of the proposed work
  • Refer to the literature thoroughly but
    thoughtfully
  • Present an organized, lucid write-up
  • Be mindful of the review criteria to be used
  • Get advice from colleagues

42
Art of Persuasion Assumptions
  • that the reviewers are knowledgeable and
    committed to doing a thorough job of evaluating
    each application
  • that the reviewers have less time to complete
    the task than desirable
  • that good formatting will assist reviewers to
    remember your organization and the thrust of your
    arguments


43
Strategies to Strengthen Applications The Short
List
  • Ask scientist with AHRQ support to critically
    review your application prior to submission
    more than once
  • Talk with an Agency (AHRQ, etc.) program
    officer(s)

44
Strengthening Applications - The Long List
  • Significance of problem Best if transparent yet
    not insultingly obvious
  • Scientific Rationale New /or original ideas
    clearly identified
  • Include a plan for acquiring needed expertise,
    if needed
  • Discuss the limitations of the chosen approach
  • Include abundant detail about the methodology
  • Scope of work midway on the trivial grandiose
    continuum
  • Describe the participants their involvement in
    the study in detail
  • Include pilot or preliminary data
  • Describe future research directions

45
Help Reviewers See the Merits
  • Think like a reviewer
  • Learn as much as possible about The System (e.g.,
    figure out the likely review group)
  • Preempt criticism
  • Include collaborators who can compensate for your
    deficiencies
  • Learn as much as possible about what research
    projects in your area that have been funded by
    the NIH/AHRQ/HRSA/CDC/etc.
  • CRISP Database
    (http//crisp.oit.nih.gov)

46
http//crisp.oit.nih.gov
47
HCRT Grant Applications Reviewed and Funded in FY08 HCRT Grant Applications Reviewed and Funded in FY08 HCRT Grant Applications Reviewed and Funded in FY08 HCRT Grant Applications Reviewed and Funded in FY08
Types Reviewed Funded Sucessful
F31 2 0 0
F32 8 2 25
K02 5 3 60
K08 12 6 50
R36 39 11 28
R01 1 1 100
R13 1 0 0
Total 68 23 34
48
In God We Trust. All Others Must Bring Data.
Olivia Bartlett, Ph.D. Chief, Research Programs
Review Branch Division of Extramural Activities,
NCI
49
BEST WISHES TO YOUR EDUCATION AND PROFESSIONAL
ENDEAVORS! ANY QUESTIONS?
50
Human Subjects Protections
  • Overview for Applicants
  • Patrick McNeilly, Ph.D.
  • September 2008

51
Background
  • Belmont Report
  • - Respect for Persons
  • - Beneficence
  • - Justice
  • Common Rule (45 CFR 46)
  • http//www.hhs.gov/ohrp/humansubjects/guidance/45c
    fr46.htm

52
Common Rule Requires
  • IRB Review
  • Informed Consent
  • Evaluations of all applications and proposals
    involving human subjects (45 CFR 46.120)

53
Peer Review vs IRB
  • Peer review
  • - Evaluate the application
  • - Identify human subjects concerns in any
    portion of the
    application
  • - Justification of exemption
  • IRB
  • - Initial and continuing review of research
  • - Approve modifications to research

54
Human Subjects Concern
  • Any actual or potential unacceptable risk, or
    inadequate protection against risk, to human
    subjects as described in any portion of the
    application.
  • - Captured in Summary Statement
  • - Administratively coded

55
Common Peer Review Issues
  • No human subject protection plan
  • Unidentified subjects
  • Unidentified risks
  • Informed consent issues

56
Resolution of Issues
  • Written response from Principal Investigator to
    all human subjects concerns
  • AHRQ Program Official will consult with human
    protections administrator on adequacy of response

57
Exemption from HHS Regulations
  • Six categories of exemption
  • Not all health services research is exempt
  • Is there an appropriate justification of
    exemption?

58
Inclusion of Women Minorities
  • Women and members of minority groups must be
    included
  • Unless a clear and compelling rationale to
    exclude
  • http//grants.nih.gov/grants/funding/women_min/wom
    en_min.htm

59
Priority Populations
  • Inner-city rural low income minority women
    children elderly special health care needs
  • Studies should consider including one or more
    AHRQ priority populations
  • AHRQ specific requirement
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-HS-03-010.html

60
Example 1
  • The proposed study will provide a screening tool
    in the form of a Bruising Clinical Decision Rule
    (BCDR) for discriminating bruises caused by
    physical child abuse vs. accidental trauma.
    Success will result in a BCDR to function as a
    screening tool to identify children and infants
    with bruising who are at high risk for physical
    abuse and require further evaluation.

61
Example 1 (contd)
  • The proposed study is a prospective
    observational study of bruising characteristics
    in children over 4 years of age. Data on
    bruising characteristics will be collected by
    pediatric emergency medicine physicians and child
    abuse experts on 1,000 children with bruising.

62
Example 2
  • In an application focusing on the differences in
    treatment of prostate cancer for whites compared
    to non-whites.

63
Example 2 (contd)
  • Reviewers Commented
  • Given the applications focus, prostate cancer,
    the exclusion of women is appropriate. However,
    the low minority representation and poor
    recruitment strategies for minorities (85 White,
    7 Hispanic, 8 African American) would make it
    difficult for comparisons of treatment methods by
    racial and ethnic categories to be made .

64
  • Questions?
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