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Ni hhottopics Ni hhottopics Presentation Transcript

  • NIH Fundamentals and Hot Topics!
    David Curren
    Office of Policy for Extramural Research Administration
  • FDR Dedicates NIH Campus
    October 31, 1940
  • NIH Campus Today
  • NIHEXTRAMURALSites
    Executive Plaza
    South and North
    Rockledge 1 & 2
    Neuroscience Center
    NIEHS Campus
    Research Triangle Park, NC
    Democracy 1 & 2
  • U. S. Dept. of Health and Human Services
    Secretary of Health and Human Services
    Administration for
    Children and Families
    (ACF)
    Food and Drug
    Administration
    (FDA)
    Health Resources
    and Services
    Administration
    (HRSA)
    Administration on
    Aging
    (AoA)
    Center for Medicare & Medicaid Services
    (CMS)
    Indian Health
    Services
    (IHS)
    National Institutes
    of Health
    (NIH)
    Agency for
    Healthcare Research and Quality
    (AHRQ)
    Centers for
    Disease Control
    and Prevention
    (CDC)
    Substance Abuse and
    Mental Health Services
    Administration
    (SAMHSA)
    Agency for Toxic
    Substances and
    Disease Registry
    (ATSDR)
  • NIH is organized into:
    NIGMS
    International Center
    Clinical Center
    27 Separate Institutes & Centers (IC) each with different:
    • missions & priorities
    • budgets
    • ways of deciding which grants to fund
  • New NIH Director
    Francis S. Collins, M.D., Ph.D., was officially sworn in on Monday, August 17, 2009 as the 16th director of the National Institutes of Health (NIH).
    Served as Director of the National Human Genome Research Institute (NHGRI), NIH from 1993-2008.
  • Fundamentals of the NIH Grants Process
  • What’s the Difference Between Grants and Contracts?
    GRANT
    CONTRACT
    $
    $
    $
    $
    $
    $
    $
    $
    $
    $
    $
    $
    $
    • Assistance
    • Acquisition
    • Government is Patron or Partner
    • Government is Purchaser
    • Purpose: support and stimulate research
    • Purpose: acquire goods or services
    • Benefit a public purpose
    • Benefit and use of the government
    • Investigator initiated
    • Government initiated
  • How Does NIH Solicit Applications?
    • Funding Opportunity Announcements (FOA) published through
    • the NIH Guide (http://grants.nih.gov/grants/guide/)
    • at grants.gov
    • Parent Announcements cover basic mechanisms
    • investigator-initiated applications
    • Special Opportunities to fill gaps
    • Requests for Applications (RFA), a one-time call with set aside funds
    • Program Announcement (PA) highlights areas of focus
    • Program Announcement with Special Review (PAR) for special consideration and “protected” review
    • Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates
  • Award Activity Codes:Research Project Grants
    • Traditional – R01
    • Small Research – R03
    • Exploratory Development Grants – R21/R33
    • Program Project – P01
    • Research Center Grants – P50
    • Small Business – R41, R42, R43, R44
    • Cooperative Agreements – Us
    • Substantial NIH staff involvement in program and science
    • Typically initiated by NIH
  • Research Training and Research Career Development Awards
    • Training Grants – T
    • Institutional
    • Predoctoral and Postdoctoral
    • Trainees must be U.S. citizens
    • Fellowships (U.S. Domestic only) – F
    • Individual
    • Fellows must be U.S. citizens
    • Predoctoral – F31
    • Postdoctoral – F32
    • Career Development Awards – K
  • Writing a Grant Application
    Research plan answers 4 essential questions
    What do you intend to do?
    Why is the work important?
    What has already been done?
    How are you going to do the work?
    Successful applications typically are:
    Well-focused and explicitly written
    Not overly ambitious
    Understandable by a naïve reader
  • Getting to the Top:Writing Great Grants
    Components of successful applications
    Strong Idea
    Strong Science
    Strong Team
    Strong Presentation
    Match idea/science to the NIH Institute
    Every IC has specific mission
    Hone high-quality grant writing skills
    Communicate scientific content compellingly
    Follow all the instructions
  • NIH Budget and Recovery Act News
  • NIH Budget FY 2010 & 2011
    NIH 2010 Budget $31.2 billion
    Strategic priorities include: Cancer Research; Autism Research; Nanotechnology-related Environment, Health and Safety Research; NIH Common Fund; Bioethics; Oversight
    President’s 2011 Budget Request $32.2
    Increase of 3.2% from FY 2010
    Increase will support Innovative high throughput technologies, including DNA sequencing, imaging, and computational biology
    Director’s Bridge Award program (R56) temporarily suspended (because of ARRA).
    More at: http://officeofbudget.od.nih.gov/br.html
  • Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion
    $16.4 B
  • NIH Priority 2010
    Identifying and Attracting New Biomedical Researchers
    Assistance to New and Early Stage Investigators (ESIs)
    NIH commits to identify ESIs so appropriate consideration of their career stage can be applied during review and award selection.
    ESIs are identified by data in Personal Profile section of eRA Commons.
    Investigators who enter degree and residency completion dates will be notified of their ESI status by email.
    ESI Definition: A new or first time investigator who is within 10 years of completing his/her terminal research degree or medical residency (or equivalent).
    More athttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html.
    More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html
  • NIH FY 2010 Fiscal Policy for Grant Awards
    Non-Competing Research Awards: each IC will use its own discretion to implement compliance with the 2% inflation allowance provided in FY10.
    Competing Research Awards: each IC will manage its own portfolio, with average increase of 2% over FY09.
    New Salary Cap Summary (equal to Executive Level I) is $199,700http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-041.html
    New NRSA Stipend levelshttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-047.html
    More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-039.html
  • American Recovery and Reinvestment Act (ARRA)
    Purpose
    Stimulate the economy; preserve/create jobs
    Support NIH’s biomedical, behavioral, and clinical research agenda
    Funding
    $10.4 billion in funding: Scientific Research ($8.2 billion); Shared Instrumentation ($300 million); Extramural Construction ($1 billion) & Intramural Buildings/Facilities ($500 million)
    13,674 ARRA Grants Funded in 2009
    Current Opportunities
    Global Health, Comparative Effectiveness Research, NIH Basic Behavioral and Social Science Opportunity Network (OppNet), Research and Research Infrastructure, Research On Biosamples
    More at: http://www.grants.nih.gov/recovery/
  • ARRA Recipient Reporting
    Reports entered at www.FederalReporting.gov and publicly available at www.recovery.gov
    Includes web based form, MS Excel template and XML schema options for report submission
    OMB Data Model v.3.0
    OMB released the Recipient Reporting Data Model v3.0 for ARRA, Quarter Ending December 31, 2009.
    Includes a Data Dictionary describing the data elements specifically required for recipient reporting
    Additional NIH guidance (based on the OMB Data Model) has not yet been updated. Use OMB guidance.
  • ARRA Recipient Reporting
    NIH FAQs address ARRA recipient reporting NIH-specific concerns: http://grants.nih.gov/recovery/faqs_recovery.html
    ARRA Quarterly Report Sample Templates: http://grants.nih.gov/recovery/sample_quarterly_reports.html
    ARRA Data Reports: http://report.nih.gov/recovery/index.aspx
    (includes most data needed for quarterly reports)
    More at http://grants.nih.gov/recovery
  • ARRA Reminders
    Standard NIH Terms of Award apply in addition to ARRA specific terms.
    Grantee has authority to extend project period end dates up to 12 months. (This is separate from the non-ARRA parent.)
    Additional (prior approval) extensions will only be considered in limited circumstances
    Reporting for ARRA Supplements
    Progress should be addressed separately in the annual progress report (Type 5); if no T-5 address in final progress report
    Separate closeout documents are required for each supplement and competitive revision
  • New Scientific and Grants Management Policies
  • Enhancing Peer Review:Summary of Recommendations
    More at:http://enhancing-peer-review.nih.gov
  • Restructured Application Forms/Instructions must be used for due dates after January 25, 2010
    To implement changes for Peer Review initiative and changes to the SF 424 R&R new application packages were posted in December, along with new Parent Announcements, and updated active FOAs
    Resubmissions must use new application forms and instructions (and shorter page limits)
    More at: http://enhancing-peer-review.nih.gov
  • NIH Guidelines on Human Stem Cell Research – 7/7/09
    Established criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be included in new Registry as eligible for use in NIH funding
    Centralize processes and procedures for NIH reviews of hESCs
    Organizations submitting information about hESCs for potential inclusion in the Registry must use NIH Form 2890 (web-based form)
    More at: http://stemcells.nih.gov
  • NIH hESC Registry
    Grantees may only use lines listed on the new Registry
    Old cell lines are not grandfathered into the new Registry
    First 13 lines approved 12/2/09
    43 lines are currently approved
    97 lines are currently pending NIH review
    More at: http://grants.nih.gov/stem_cells/registry/current.htm
  • NIH hESC Registry
    As of 12/02/2009 approved cell lines are in Registry: http://grants.nih.gov/stem_cells/registry/current.htm
    Applicants should review approved hESCs
    If any of the approved lines are appropriate, the Registry number should be cited in application/correspondence (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-020.html )
    If no approved lines are appropriate, applicant should include statement that one from the Registry will be used (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-123.html )
    Progress Report form updated to capture hESC information
    More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-020.html
  • Highlights of New and Existing Grant Requirements
  • Important FCOI Reminders: Summary of Reporting Requirements
    At the time of application: Investigators must submit known significant financial interests to the institution.
    Prior to the expenditure of funds: The institution must report a financial conflict of interest to the NIH and assure that it has been managed, reduced, or eliminated.
    FCOI identified after the initial report: The institution must report within 60 days of identification and assure that it has been managed, reduced, or eliminated.
  • Closeout Final Reports
    Grantees are strongly encouraged to submit closeout documents electronically through the eRA Commons!
    • Failure to submit timely reports may affect future funding to the organization.
    • Documents are due within 90 days of project period end date
    • Final Financial Status Report (must be submitted electronically)
    • Final Inventions Statement & Certification
    • Final Progress Report
    • Grantees must ensure that there are no discrepancies between the final Financial Status Report (SF-269 or 269A) and the Payment Management System’s Federal Financial Report (SF-425)cash transaction data elements
  • NIH Centralized Processing Center
    Centralized office accepts receipt of all non-financial, paper-based closeout documents
    Final Progress Report
    Final Invention Statement and Certification
    If not using eRA Commons, mail to the Central NIH unit at:
    NIH Centralized Processing Center
    6705 Rockledge Drive, Room 2207, MSC 7987
    Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail)
    Bethesda, MD 20817 (for other courier/express mail only)
  • Non-Competing Continuation Progress Reports
    Failure to submit timely progress reports may affect future funding to the organization
    Annual progress reports are due two months prior to the anniversary date
    Electronic SNAP progress reports
    (e-SNAP) are due 45 days prior to the anniversary date
    All grantees have access to a searchable list to determine which progress reports are due at: http://era.nih.gov/userreports/pr_due.cfm
  • Requirements and Compliance Assistance for OLAW
  • Humane Animal Research
    Grantees are responsible for the humane care and treatment of animals
    NIH Office of Laboratory Animal Welfare (OLAW) oversees policies for humane animal care and use.
    grants.nih.gov/grants/olaw
  • http://olaw.nih.gov
    OLAW Educational Outreach
    • OLAW Online free quarterly webinars
    • OLAW IACUC Staff Outreach http://grants.nih.gov/grants/olaw/e-seminars.htm
    • OLAW IO Outreachhttp://grants.nih.gov/grants/olaw/outreach.htm
    • Recordings of past webinarshttp://grants.nih.gov/grants/olaw/educational_resources.htm
    • New FAQs at http://olaw.nih.gov
    • IACUC review at time of grant award
    • DMR subsequent to FCR
  • OLAW-supported Workshops
    http://grants.nih.gov/grants/olaw/workshop.htm
    OLAW SUPPORTED WORKSHOPS
  • Adobe Application Forms and Electronic Submission
    Changes to electronic applications have arrived.
  • Electronic Submission: Update
    Jan. 25, 2010: transition to shortened and restructured applications
    including the transition from ADOBE-FORMS-A to ADOBE-FORMS-B.
    Career Development Awards (Ks), Individual Fellowship Awards (Fs) and Training Grants (Ts and Ds) have all successfully transitioned to electronic submission
    Ts and Ds transitioned as of Jan. 2010.
    NIH has successfully transitioned all grant programs to electronic submission, with the exception of Complex, Multi-project Applications.
    Accommodated new activity codes as needed.
    New eSubmission Web site to be launched this spring.
  • Sample Changes to Application Forms
    PHS398 Changes
    Peer Review Changes
    FFATA Changes
    SF424 (R&R) Renewal
    R&R SF 424 Cover
    • Added Agency Routing Identifier
    • Added SFLL or other Explanatory Documentation Attachment
    PHS 398 Cover Page Supplement
    • Removed New Investigator checkbox
    PHS 398 Career Development Award Supplemental Form
    • Accommodated changes for Enhancing Peer Review
    PHS Fellowship Supplemental Form
    • Accommodated changes for Enhancing Peer Review
    • Removed Degree Earned as collected on the Senior/Key form
    SBIR/STTR Information
    • Added Anticipated Number of personnel field
    More at: http://grants.nih.gov/grants/forms.htm
  • Available Resources
    Resources for the transition to shortened and restructured applications can be found on these Web sites:
    Enhancing Peer Review at NIH:
    http://enhancing-peer-review.nih.gov/index.html
    NIH Electronic Submission of Grant Applications:
    http://era.nih.gov/ElectronicReceipt/index.htm
  • Obtain Compatible Software
    Adobe Reader:
    Only specific Adobe Reader versions are compatible with Grants.gov forms
    PDF conversion program:
    Attachments must be converted to PDF
    Grants.govDownload Software page:
    http://www.grants.gov/help/download_software.jsp
  • Support
    Contact Grants.gov Contact Center for questions on form functionality or submission of the forms to Grants.gov. 
    Contact eRA Help Desk at NIH for technical issues that threaten NIH’s on-time receipt of your application.
    Work with Grants.gov Contact Center to document the issue and provide the tracking number you receive from Grants.gov Contact Center to the eRA Help Desk.
  • Helpful NIH Technical Assistance Resources
  • Web Page on NIH Extramural Response to Natural Disasters
    Part of NIH’s commitment to the health of the biomedical community in the impacted areas, and concern for the health and safety of people and animals in the programs we oversee.
    Includes:
    Links to Recent Guide Notices and event-specific web page
    Links to other Federal web sites for disasters
    NIH Emergency Contact Information
    Examples of extramural assistance provided to previous natural disasters and emergencies
    Frequently Asked Questions
    Available at: http://grants.nih.gov/grants/natural_disasters.htm
  • Summary of Helpful NIH Web Pages
    Office of Extramural Research (OER) Web Page
    http://grants.nih.gov/grants/oer.htm
    NIH Searchable Database of RFAs, PAs, and Guide Notices http://grants.nih.gov/grants/guide/index.html
    NIH Grants Policy Statement (Rev. 12/03) http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
    NIH Extramural Nexus – Monthly newsletter (previously bimonthly) for the extramural community
    http://grants.nih.gov/grants/nexus.htm
    RePORTER - Search to analyze an Institute’s portfolio of funded projects, research areas, and more http://projectreporter.nih.gov/reporter.cfm
    Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm
    Intellectual Property Policy
    http://grants.nih.gov/grants/intell-property.htm
  • NIH OER Listserv Addresses and Instructions
    Office of Biotechnology Activities (OBA):
    https://list.nih.gov/archives/oba_news.html
    Office for Human Research Protections (OHRP):
    http://www.hhs.gov/ohrp/news/distributionlist.html
    Office of Laboratory Animal Welfare (OLAW):
    http://grants.nih.gov/grants/olaw/references/list.htm
    eSubmission:
    http://era.nih.gov/ElectronicReceipt/listserv.htm
    Separate listservs available for scientists and administrators
    NIH Guide for Grants and Contracts:
    http://grants.nih.gov/grants/guide/listserv.htm
    The official publication for NIH medical and behavioral research Grant Policies, Guidelines and Funding Opportunities
    NIH Regional Seminars on Program Funding & Grants Administration:
    http://grants.nih.gov/grants/seminars.htm
    Held twice each year around the country, these seminars offer an opportunity to meet, share with & learn from approximately 30 NIH/HHS policy, review, grants management, & program experts. (April 15-16, 2010: Philadelphia, PA) & (June 24-25: Portland, OR)
  • Grants Information:Who to Contact!
    Institutional Resources – First, utilize the expertise of your organization’s Office of Sponsored Programs
    Application Specific Questions
    Administrative - Contact the Grants Management Specialist at the awarding Institute/Center
    Scientific/Programmatic - Contact the designated Program Official/Director at awardingInstitute/Center
    Review Questions - Contact the assigned Scientific Review Officer
  • Grants Information:Who to Contact!
    Grants Administration individuals at all NIH ICs:
    http://grants.nih.gov/grants/staff_list_grants_admin.htm
    NIH Chief Grants Management Officers:
    http://grants.nih.gov/grants/stafflist_gmos.htm
    Grants Policy Interpretation & Consultation:
    E-Mail: GrantsPolicy@mail.nih.gov
    Phone: 301-435-0949
    Compliance Issues:
    E-Mail: GrantsCompliance@mail.nih.gov
    Phone: 301-435-0949
  • Grants Information:Who to Contact!
    General Application Questions: (e-Submission guidelines, resources & referrals, application review & award process, etc.)
    E-Mail: GrantsInfo@nih.gov
    Phone: 301-435-0714
    Customer Support for Grants.gov: (navigating forms, aspects of submitting through the system, resources available, etc.)
    E-Mail:support@grants.gov
    Webpage:http://grants.gov/
    Phone:1-800-518-4726
    eRA Commons Help Desk: (Commons registration help, application verification, Commons functionality questions, etc.)
    Webpage: http://ithelpdesk.nih.gov/era/
    Phone: 301-402-7469 (Toll Free: 866-504-9552)
    Enter your own help ticket!
  • Thank You!
    Any Questions?