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NIH Update Spring 2005

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Title: NIH Update Spring 2005


1
NIH UpdateSpring 2005
2
Where are We Going?How are We Going to Get
There?Rules of the Road!Safety First!Signs
Along the Way!Compliance!Stopping for
Directions!
3
WHERE ARE WE GOING?
4
Imperatives for NIH
  • Accelerate pace of discoveries in life sciences
  • Enable deeper understanding of pathobiology of
    disease prior to irreversible damage
  • Translate research more rapidly from laboratories
    to patients and back
  • Explore novel biomedical strategies orders of
    magnitude more effective than current ones
  • NIH Roadmap

5
What is the NIH Roadmap?
  • A framework of priorities the NIH as a whole must
    address in order to optimize its entire research
    portfolio.
  • A set of initiatives that are central to
    extending the quality of healthy life for people
    in this country and around the world.
  • A vision for a more efficient and productive
    system of biomedical and behavioral research.

6
Three Themes of the Roadmap
7
NIH Roadmap Trans-NIH teams manage
Re-engineering the Clinical Enterprise
New Pathways to Discovery
Research Teams of the Future
8
New Pathways to DiscoveryGenomic era offers
unprecedented opportunities
  • Building Blocks for Biological Pathways, Networks
  • Molecular Libraries and Imaging
  • Structural Biology
  • Bioinformatics and Computational Biology
  • Nanomedicine

9
Research Teams of the FuturePromoting innovation
  • Interdisciplinary Research Teams
  • Centers
  • Training
  • Out-of-the-Box Thinkers
  • Directors Pioneer Award
  • Public-Private Partnerships
  • Central point of contact at NIH

10
Re-engineering the Clinical Research Enterprise
  • Translational Research through
  • Regional Centers
  • Core Services
  • Harmonize and Simplify Clinical Research
    Regulatory Processes
  • Integrate Clinical Research Networks
  • Strengthen Clinical Research Workforce
  • Regional Centers of Excellence for Training
  • National Clinical Research Corps

11
NIH Roadmap Goals
  • Accelerate basic research discoveries and speed
    translation of those discoveries into clinical
    practice
  • Explicitly address roadblocks that slow the pace
    of medical research in improving the health of
    the American people

12
Additional Information on the NIH Roadmap
  • Roadmap website
  • http//nihroadmap.nih.gov/
  • RFAs and PAs posted in the NIH Guide for Grants
    and Contracts
  • http//grants1.nih.gov/grants/guide/index.html

13
HOW ARE WE GOING TO GET THERE?
The NIH Budget
14
FY 2005 Budget 28.59 Billion
Research Project Grants 53 15.3 billion
Training 3 761 million
15
FY 06 Presidents Budget Request
  • 28.740 billion
  • .5 increase over FY 2005
  • Approximately 9,463 competing RPG awards
  • 247 over FY 2005
  • Major initiatives
  • NIH Roadmap
  • Biodefense
  • Neuroscience Blueprint
  • AIDS

16
Salary Cap
  • Restricts the amount of direct salary under a
    grant or contract to Executive Level I of the
    Federal Executive Pay Scale
  • Executive Level I increase effective January 1,
    2005

180,100
175,700
January 7, 2005 NIH Guide Notice http//grants.nih
.gov/grants/guide/notice-files/NOT-OD-05-024.html
17
RULES of the ROAD!
18
Public Access to NIH Research Information
19
New Public Access Policyto Publications
Resulting from NIH-funded Research
  • NIH-funded investigators are requested to submit
    to the NIH National Library of Medicine's (NLM)
    PubMed Central (PMC) an electronic version of the
    author's final manuscript upon acceptance for
    publication, resulting from research supported,
    in whole or in part, with direct costs from NIH.

Effective May 2, 2005
NIH Guide, February 3, 2005 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-022.html
20
Why Public Access?
  • ACCESS Provide electronic access to NIH-funded
    research publications for patients, families,
    health professionals, teachers, and students.
  • ARCHIVE Keep a central archive of NIH-funded
    research publicationsfor now and in the future,
    preserving vital medical research results and
    information for years to come.
  • ADVANCE SCIENCE Create an information resource
    that will make it easier for scientists to mine
    medical research publications, and for NIH to
    better manage its entire research investment.

21
Updated Criteria for Evaluating Research Grant
Applications
22
Updated Review CriteriaEffective Jan 2005
  • Significance. Does this study address an
    important problem? If the aims of the application
    are achieved, how will scientific knowledge or
    clinical practice be advanced? What will be the
    effect of these studies on the concepts, methods,
    technologies, treatments, services, or
    preventative interventions that drive this field?
  • Approach. Are the conceptual or clinical
    framework, design, methods, and analyses
    adequately developed, well integrated, well
    reasoned, and appropriate to the aims of the
    project? Does the applicant acknowledge potential
    problem areas and consider alternative tactics?

23
Updated Review Criteria (cont)
  • 3. Innovation. Is the project original and
    innovative? For example Does the project
    challenge existing paradigms or clinical
    practice address an innovative hypothesis or
    critical barrier to progress in the field? Does
    the project develop or employ novel concepts,
    approaches, methodologies, tools, or technologies
    for this area?
  • 4. Investigators. Are the investigators
    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? Does the
    investigative team bring complementary and
    integrated expertise to the project (if
    applicable)?

24
Updated Review Criteria (cont)
  • 5. Environment. Does the scientific environment
    in which the work will be done contribute to the
    probability of success? Do the proposed studies
    benefit from unique features of the scientific
    environment, or subject populations, or employ
    useful collaborative arrangements? Is there
    evidence of institutional support?

NIH Guide Notice, October 12, 2004
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-05-002.html
25
NIH Policy on Late Submission of Grant
Applications
26
NIH Policy on Late Submission of Grant
Applications
  • NIH expects grant applications to be submitted on
    time
  • Late applications
  • Generally are not accepted, except in rare
    instances
  • Unaccepted late applications will be returned
    without review
  • Are only considered for standing receipt dates
  • Permission is not granted in advance
  • Must be accompanied by a cover letter with
    compelling reasons for the delay
  • Window of consideration for late applications is
    two weeks
  • NIH will not consider accepting late applications
    for the Special Receipt Dates for RFAs and PARs

NIH Guide, January 27, 2005 http//grants2.nih.gov
/grants/guide/notice-files/NOT-OD-05-030.html
27
Model Organisms
28
New NIH Policy on Sharing of Model Organisms for
Biomedical Research
Investigators submitting an NIH
application/proposal beginning with the October
1, 2004 receipt date are expected to include a
specific plan for sharing and distributing unique
model organism research resources generated using
NIH funding in the application/proposal OR state
appropriate reasons for why such sharing is
restricted or not possible.
  • NIH Guide Notice, May 7, 2004 http//grants.nih.go
    v/grants/guide/notice-files/NOT-OD-04-042.html
  • FAQs and sample sharing plans available at
    http//grants.nih.gov/grants/policy/model_organism
    /index.htm

29
Sharing Model Organisms (cont.)
  • Applicants should specify
  • A reasonable time frame for periodic deposition
    of material and associated data
  • If, or how, they will exercise their intellectual
    property rights
  • Investigators may request funds in their
    application/proposal to defray reasonable costs
  • Reviewers will review the plan and may comment in
    an administrative note
  • Reviewers will generally not include their
    assessment in the overall priority score.
  • Failure to comply with NIH research resource
    sharing policies, guidelines, and the accepted
    plan may be considered by NIH staff in future
    funding decisions.

30
National Science Advisory Board for Biosecurity
(NSABB)
31
National Science Advisory Board for Biosecurity
(NSABB)
New Board to provide advice and guidance
regarding biological research that has the
potential for misuse and could pose a biologic
threat to public health or national security
  • Will advise heads of Federal entities that
    conduct/support life sciences research
  • Managed by NIH
  • Further information and updates available at
    http//www.biosecurityboard.gov

32
FY 2005 Kirschstein-NRSA News
33
FY 2005 Kirschstein-NRSA News
  • 1,000 increase in Institutional Allowance for
    Individual Postdoctoral Fellowships only
  • No stipend increase this year
  • Revising the Individual Fellowship Application
    and Progress Report Form Pages and Instructions.
    Expect new version to be available by Fall 2005.

NIH Guide, February 4, 2005 http//grants1.nih.gov
/grants/guide/notice-files/NOT-OD-05-032.html
34
Revised PHS 398 and 2590 Forms
35
PHS 398 (rev. 9/04)
  • Revised PHS 398 forms are accepted for
    submission/receipt dates on or after 12/1/04.
  • All applications received on or after May 10,
    2005 must use the new instructions and forms.
  • Applications using the old forms received after
    May 9 will be returned.

NIH Guide, Novemeber 2, 2004 http//grants1.nih.go
v/grants/guide/notice-files/NOT-OD-05-006.html Rev
ised instructions and forms http//grants.nih.gov
/grants/forms.htm
36
PHS 398 (rev. 9/04)
  • Reorganized into 3 Parts
  • Part I Instructions (now are truly just
    application instructions)
  • Part II Supplement Instructions for Preparing
    the Human Subjects Section of the Research Plan
  • Part III Policies, Assurances, Definitions
    Other Information

37
Changes of Note to the PHS 398 (rev. 9/04)
Instructions
  • Font Size Requirement NIH now requires the use
    of Arial-11 or Helvetica-11 point font.
  • Face Page Added Clinical Trials Indicator.
  • Form Page 2
  • Description now includes separate instruction for
    PI to clearly describe public health relevance.
  • Created designated area for Stem Cell
    information.
  • Added new section for Other Significant
    Contributors.

38
Changes of Note to the PHS 398 (rev. 9/04)
Instructions
  • Significant Revisions, particularly in Part II,
    Human Subjects Research Supplement, to address
    NIH implementation of OHRP Guidance on research
    involving coded private information or biological
    specimens.
  • Instructions for Modular and Non-Modular Budgets
    and have been revised to implement the new policy
    on Direct Cost Limitations.
  • The modular budget format no longer applies to
    SBIR/STTR grant applications.

39
Change in Calculation of Direct Costs for
Applications with Consorium FA Costs
All applications that involve consortium/contractu
al facilities and administrative (FA) costs are
to exclude the facilities and administrative
(FA) costs requested by consortium participants
from the total direct cost request.
Effective for all applications that have
submission/receipt dates on or after Dec 1, 2004
NIH Guide notice, November 2, 2004
http//grants1.nih.gov/grants/guide/notice-files/
NOT-OD-05-004.html
40
New PHS 398 Modular Budget Format Page
  • Added 2 new rows (DC less Consortium FA and
    Consortium FA) and 1 new column (Sum Total)

41
New PHS 398 Budget Page - Form Page 4
  • Separated Consortium DC FA Costs
  • Instructions revised to use Subtotal for Face
    Page Item 7a

42
PHS 2590 (rev. 9/04)
  • Revised PHS 2590 forms may be used now
  • All progress reports received on or after May 1,
    2005 must use the new version.

NIH Guide, Novemeber 2, 2004 http//grants1.nih.go
v/grants/guide/notice-files/NOT-OD-05-007.html Rev
ised instructions and forms http//grants.nih.gov
/grants/forms.htm
43
Changes of Note to the PHS 2590 Instructions
  • Grantees need only submit a signed original and
    one copy.
  • Uses new definition of Key Personnel
    implemented in the NIH Grants Policy Statement
    (rev. 12/03)
  • Other Significant Contributors introduced in
    the PHS398 (rev. 9/04) has been incorporated
  • The SNAP progress report instructions for the
    first 2 SNAP questions have been modified as
    follows
  • SNAP Question 1 - requires submission of
    complete Other Support information with any
    change
  • SNAP Question 2, Reworded so level of effort
    question only applies to the PI and other
    personnel named on the Notice of Grant Award.

44
Centralized Receipt of Non-Competing Progress
Reports
  • Effective with non-competing progress reports due
    on/after October 1, 2004
  • Does NOT change the mailing address used for all
    new and competing grants nor that process
  • Only for NIH progress reports
  • Goal of improving efficiency

NIH Guide Notices, July 23 and September 2,
2004 http//grants.nih.gov/grants/guide/notice-fil
es/NOT-OD-04-054.html http//grants1.nih.gov/grant
s/guide/notice-files/NOT-OD-04-063.html
45
Applications and FormsQuestions?
  • Dedicated e-mail address for questions on
    format
  • format_at_mail.nih.gov
  • Frequently asked questions on format
  • http//www.format.nih.gov

46
New Grant Mechanism
47
New High Priority, Short-term Project Award (R56)
  • Funding high-priority new or competing renewal
    R01 applications that fall just outside the
    funding limits of the participating NIH
    Institutes and Centers
  • One or two years of funding
  • INVESTIGATORS MAY NOT APPLY FOR AN R56 GRANT -
    Recipients of R56 awards will be selected by IC
    staff
  • Awarded beginning in Fiscal Year 2005
  • Additional information is available at
    http//grants.nih.gov/grants/funding/r56.htm

NIH Guide, June 15, 2004 http//grants1.nih.gov/gr
ants/guide/notice-files/NOT-OD-04-047.html
48
Career Development Awards
49
Mentored career awardees (K awardees) may now
hold concurrent support from an NIH career award
and as a PI an NIH research grant or project
leader on a multi-project grant.
Policy on Concurrent Support for Mentored Career
Awardees
NIH Guide, November 14, 2003 http//grants.nih.gov
/grants/guide/notice-files/NOT-OD-04-007.html Inf
ormation About Career Development
Awards http//grants.nih.gov/training/careerdevelo
pmentawards.htm
50
New Policy on Concurrent Support for Mentored
Career Awardees
  • May reduce level of effort on career awards in
    last two years of support and replace with an NIH
    research grant or subproject -- awardee must
    remain in mentored situation
  • Awardee must serve as a PI or subproject Director
  • Effort required on career award may be reduced to
    no less than 50 and be replaced by effort from
    the research award so total level of research
    commitment remains at gt75 for the duration of
    the mentored career award
  • Applies to K01, K07, K08, K22, K23, and K25, and
    individuals mentored through institutional K12
    awards
  • Policy effective for competing research
    applications submitted on or after February 1,
    2004

51
Revised Definition of Full Time Appointment for
Career Awards
  • Require 75 commitment of full-time professional
    effort
  • Revised policy allows recipient to meet required
    commitment of total professional effort as long
    as
  • the individual has a full-time appointment with
    the applicant organization
  • the minimum percentage of the candidates
    commitment required for the proposed Career award
    experience is covered by that appointment
  • Applies to all existing Career Development Award
    announcements for all applications and
    resubmissions submitted on/after October 1, 2004

NIH Guide Notice, August 3, 2004 http//grants1.ni
h.gov/grants/guide/notice-files/NOT-OD-04-056.html
52
SBIR/STTR(Small Business Research)
53
SBIR/STTR
  • Use the "SBIR/STTR Supplementary Instructions for
    Completing the Newly Revised (09/04) PHS 398
    Forms
  • SBIR/STTR may no longer use modular budget format
  • FDA Resources and useful websites provided in
    SBIR/STTR solicitation
  • Type 2 competing Phase II awards
  • NIH SBIR Conference in Bethesda, MD on July 28
    29, 2005
  • Technical Assistance Program for NIH Awardees

NIH Small Business Funding Opportunities web
page http//grants.nih.gov/grants/funding/sbir.ht
m
54
SAFETY FIRST!
Protecting Research Subjects
55
New Guidance for Protecting Research Subjects
from Possible Harm Caused by Financial Conflicts
of Interest
  • New guidance entitled, "Financial Relationships
    and Interests in Research Involving Human
    Subjects Guidance for Human Subject Protection,"
    published May 12, 2004
  • Applies to all human subjects research conducted
    or supported by HHS agencies or regulated by the
    FDA
  • Intended for
  • Institutional Review Boards (IRBs)
  • Investigators
  • Research institutions
  • Other interested parties
  • Federal Register notice http//ohrp.osophs.dhhs.g
    ov/humansubjects/finreltn/finalguid.pdf
  • HHS press release http//www.hhs.gov/news/press/
    2004pres/20040512.html

56
NIH Implementation of OHRP Guidanceon Research
Involving Coded Private Information or Biological
Specimens
  • NIH added definitions and clarifications relevant
    to the OHRP Guidance to the PHS 398 (rev. 9/04)
    instructions.
  • All grant applications and progress reports
    involving coded private information or biological
    specimens submitted on or after January 10, 2005
    should follow the revised instructions.
  • Although use of the 9/04 version of the PHS 398
    is not mandatory until May 10, 2005, this version
    includes instructions to help applicants apply
    the OHRP guidance.

NIH Guide, December 30, 2004 http//grants1.nih.go
v/grants/guide/notice-files/NOT-OD-05-020.html OHR
P Guidance, August 10, 2004 http//www.hhs.gov/oh
rp/humansubjects/guidance/cdebiol.pdf
57
SIGNS ALONG THE WAY
And Other Important Reminders!
58
Data Sharing
59
NIH Policy on Data Sharing
Reminder
  • Investigators submitting a research application
    requesting 500,000 or more of direct costs in
    any single budget period to NIH on or after
    October 1, 2003 must include a plan for sharing
    final research data for research purposes, or
    state why data sharing is not possible.

February 26, 2003 NIH Guide Notice
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-03-032.html NIH Guide, October 16, 2001
http//grants.nih.gov/grants/guide/notice-files/N
OT-OD-02-004.html
60
Applications and FormsRestriction on Submission
Reminder
  • Prior approval is required for competing
  • applications that request 500,000 total direct
    costs or more for any budget period. (This limit
    is now exclusive of any consortium FA costs.)
  • NIH Guide, October 16, 2001
  • http//grants.nih.gov/grants/guide/notice-files/N
    OT-OD-02-004.html

61
Graduate Student Compensation
Reminder
  • Ties compensation on research grants to the zero
    level NRSA postdoc stipend in effect at the time
    of award
  • Compensation continues to include salary or
  • wages, fringe benefits and tuition remission
  • No adjustments will be made to noncompeting award
    levels or future years
  • Grantees may rebudget to accommodate the higher
    level
  • This policy was effective with awards issued on
    or after 12/10/2001
  • See NIH Guide, 12/10/2001
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-02-017.html

62
Other Support
Reminder
  • NIH requires complete and up-to-date other
    support information before an award can be made
  • Complete means all sources of research support
    (including outside the applicant organization)
  • Grantees must report changes in other support as
    part of the annual progress report
  • NIH Guide, February 13, 2003
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-03-029.html

63
Financial Conflict of Interest
Reminder
  • When a conflict of interest is identified, the
    grantee must
  • Notify Chief GMO to assure that the conflict of
    interest is being managed, reduced, or eliminated
  • Provide additional information, if requested
  • FCOI requirements must be addressed in consortium
    agreements
  • See the following NIH Guide Notices for
    additional information
  • http//grants2.nih.gov/grants/guide/notice-files/N
    OT-OD-00-040.html
  • http//grants2.nih.gov/grants/guide/notice-files/n
    ot95-179.html

64
Closeout Final Reports
Reminder
  • Documents are due within 90 days of project
    period end date
  • Final Financial Status Report (FSR)
  • Final Inventions Statement Certification
  • Final Progress Report
  • Failure to submit timely reports may affect
    future funding to the organization

65
Revised Policy on Amended Applications
Reminder
  • No longer time limit on submission of revised
    applications
  • Limit of 2 revisions remains in effect
  • Applies to all NIH extramural funding mechanisms
  • NIH Guide Notice May 7, 2003
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-03-041.html

66
Revised Policy on Application Resubmissions
Reminder
  • Unfunded RFA applications--resubmit as NEW
    investigator initiated apps
  • Previously unfunded investigator-initiated
    applications submitted in response to an RFA
    should be prepared as NEW applications
  • Unfunded applications reviewed for a particular
    grant mechanism then submitted for a different
    grant mechanism--prepare as NEW applications
  • NIH Guide Notice, January 16, 2003
  • http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-03-019.html

67
Non-Competing Continuation Progress Reports
  • REMINDERDont Be Late! A recent OIG study
    concluded that major contributing factors to late
    awards were late and/or incomplete progress
    reports.
  • An annual progress report is due two months prior
    to anniversary date
  • New Business Process Beginning 10/1/2004
    Centralized Receipt of ALL NIH Progress Reports
    http//grants.nih.gov/grants/guide/notice-files/NO
    T-OD-04-054.html

68
Non-competing Continuation Grant Progress Reports
Reminder
  • It is important that progress reports be complete
    and timely
  • All grantees have access to searchable list of
    due progress reports at http//era.nih.gov/userre
    ports/pr_due.cfm
  • NIH e-mails 2 progress report reminders to the PI
  • Two months prior to the due date
  • Two weeks after the due date for overdue reports
  • NIH Guide, August 5, 2003
  • http//grants1.nih.gov/grants/guide/notice-files/N
    OT-OD-03-054.html

69
Intellectual Property
70
Invention Reporting Requirements of
Grantee/Contractors per the Bayh-Dole Act
Administrative Requirements (per 37CFR, 401.14)
Reminder
  • Implement Employee Agreements ? at employment
  • Disclose Each Invention ? within 60 days
  • Resolve Election or Waive of Title ? within 2
    years
  • File Patent ? within 1 yr. of election
  • Provide License to the Govt. ? upon title
    election
  • Indicate Govt. Support on Patent ? with patent
    appl.
  • Share Royalties With Inventor ? when available
  • License Small Businesses ? where feasible
  • Product Manufacturing in U.S. ? required
  • Report on Invention Utilization ? annually

71
Intellectual Property
  • Information on reporting requirements and policy,
    as well as electronic systems to fulfill
    reporting requirements, may be found at
    Interagency Edison, http//www.iedison.gov.
  • All foreign grantees, contractors, consortium
    participants and/or subcontractors are reminded
    that they must comply with Bayh-Dole invention
    reporting requirements

72
COMPLIANCE
73
Common Institutional Compliance Issues
  • Misuse of funds
  • Unallowable costs
  • Misallocation of costs
  • Excessive cost transfers
  • Inaccurate effort reporting
  • Incomplete other support
  • Inadequate subrecipient monitoring
  • Large unobligated balances

74
Common Contributors to Compliance Problems
  • Inadequate resources
  • Lack of understanding of roles and
    responsibilities of institutional staff
  • Inadequate staff training and education
  • Outdated or nonexistent policies and procedures
  • Inadequate management systems (e.g., effort
    reporting, financial management)
  • Perception that internal control systems are not
    necessary

75
What Can You Do?Elements of an Effective
Compliance Program
  • Formalized compliance function
  • Current, written policies and procedures
  • Defined roles and responsibilities
  • Ongoing training and education program
  • Effective communication
  • Effective management systems and internal
    controls
  • Enforcement of compliance standards
  • Appropriate and prompt response to non-compliance

76
(No Transcript)
77
eRA StatisticsNIH Commons
78
Commons Capabilities
  • Administration
  • Create and maintain institutional profiles (IPFs)
  • Create and maintain user accounts and
    professional profiles (PPFs)
  • Status
  • Display summary and detail grant info, notice of
    grant award and other documents, progress report
    face page, NIH staff contact info
  • Link to study section dates and rosters
  • Submit Just-in-Time (JIT) info
  • Submit request for No-Cost Extension

79
Commons Capabilities (cont)
  • Electronic Simple Non-Competing Award Process
    (eSNAP)
  • Review simple, non-competing grant info
  • Submit simple, non-competing progress report
  • Financial Status Report (FSR)
  • Submit FSR
  • Internet Assisted Review (IAR)
  • Submit critiques and scores prior to review
    meeting
  • Review all critiques prior to meeting
  • Generate summary statement body
  • Demo Facility
  • Try out most Commons capabilities in a simulated
    session

80
Benefits of Electronic Submissions
  • Just-in-Time Info
  • Enter IACUC and IRB approval dates, other support
    and education info for key personnel involved
    with human subjects
  • Request for No-Cost Extensions
  • Automatically updates end dates
  • Generates notifications
  • Eliminates 10-day window for hardcopy requests

81
Benefits of Electronic Submissions (Cont)
  • eSNAPs
  • Due 45 days before budget start date (vs. 60 days
    for paper)
  • IRB and IACUC approval dates not required with
    submission
  • Image stored in electronic grant folder for
    online viewing
  • Reviewer Critiques
  • Laptops (PC and Mac) are easier to use than paper
    at meetings
  • Reviewers come to the table prepared for
    discussion, resulting in shorter and more
    productive meetings
  • Study section chairperson/SRA creates better
    meeting schedule by knowing in advance which
    applications need the most discussion
  • Electronic critiques facilitate the generation of
    summary statements

82
Update on Electronic Competing Application
Process (eCGAP)
  • More than 30 research institutions were early
    adopters during pilots
  • In January 2005, NIH opened access to electronic
    submission for
  • modular non-consortia R01, R03 and R21
    applications
  • new, competing continuation and revised
    applications
  • Grantee institutions work with Service Providers
    to transmit system-to-system

83
Collaboration with Grants.gov
  • NIH Pioneer Award applications submitted via
    Grants.gov
  • eRA and Grants.gov completed initial
    system-to-system tests
  • eRA and Grants.gov preparing for joint pilot in
    spring 2005
  • eRA mapped SF 424 RR to eRA data elements
  • Grants.gov completing PHS 398 NIH-specific forms
    to supplement SF 424
  • eRA defined business validations for applications
    thru Grants.gov
  • eRA integrating Grants.gov Web service calls with
    eRA eXchange

84
Why e-Applications
  • To satisfy the requirements of the Government
    Paperwork Elimination Act (Public Law 105-277) as
    well as Public Law 106-107 and the Presidents
    Management Agenda, which mandates improving
    access to federal grants via the Internet.
  • To save 200,000,000 pieces of paper per year and
    countless hours of human effort. These savings
    mean more money and more time to dedicate to
    scientific discovery.
  • To create a comprehensive electronic repository
    of eRA data that can be mined with intelligent
    tools to promote health research and accelerate
    discoveries.

85
OPDIV Integration with eRA
  • New DHHS Enterprise Grants Management System
    Board oversees integration of all Department
    research grants processing under eRA.
  • Benefits of Integration
  • streamline work processes to provide improved
    services to citizens
  • capitalize on existing advanced technology and
    best practices
  • create an opportunity for cost-effective,
    intra-agency sharing
  • provide a single point-of-interface with
    Grants.gov and the HHS Unified Financial
    Management System
  • maintain reliable and common data across
    Operating Divisions
  • simplify the implementation of new policies and
    regulations
  • Status of Migration (January 2005)- AHRQ is
    performing 100 of its research grant
    transactions using eRA CDC, 95 FDA, 30, HRSA,
    15 and SAMHSA, 15

86
Plans for 2005
  • Pilot e-applications with full budgets,
    supplements and possibly addenda
  • Implement One View, to achieve a consistent
    look and feel for data input, processing and
    reporting throughout the grant lifecycle
  • Release new version of X-Train
  • Develop complex, electronic non-competing
    application process (eNAP)
  • Create infrastructure for electronic notification
  • Implement organizational hierarchy, a new Commons
    security scheme that will accommodate each
    institutions unique structure (i.e.,
    schools/divisions/departments) and the many
    roles/rights required by large institutions

87
Commons User Support


88
Outreach and Resources
STOPPING FOR DIRECTIONS
89
NIH Regional Seminars on Program Funding and
Grants Administration
  • NIH holds 2 Regional Seminars a year to educate
    research administrators, investigators new to
    NIH, and trainees
  • 2005 seminars
  • April 7-8, 2005 in Albuquerque, NM
  • June 23-24, 2005 in West Lafayette, IN
  • Seminar information http//grants.nih.gov/grants/
    seminars.htm

90
Workshops and Seminars http//grants1.nih.gov/gra
nts/outreach.htm
91
Webpage for New Investigators
http//grants1.nih.gov/grants/new_investigators/in
dex.htm
92
  • Grants Information
  • http//grants.nih.gov/grants/oer.htm
  • Phone 301-435-0714
  • E-Mail GrantsInfo_at_nih.gov

93
NIH Preserving public trust while supporting
discoveries to improve human health.
94
Office of Policy for Extramural Research
Administration301-435-0938GrantsPolicy_at_mail.nih
.gov

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