NIH UPDATE Spring .ppt

1、NIH Update Spring 2008,NCURA Region VI/VII Regional Meeting Portland Office of Policy for Extramural Research Administration Joe Ellis, Director OPERA,NIH Budget News and Priorities,Final NIH AppropriationsFY 2008,NIH received a total of $29.457 billion Increase of $329 million from FY2007 Average c

2、ompeting award expected to increase by 1% Average noncompeting award also increases by 1% but implementation will vary by IC. No change to NRSA stipend levels or funding policies,More at: /grants/guide/notice-files/NOT-OD-08-036.html,FY2008 NIH Budget $29.457 Billion,$15.61 B,Ext

3、ramural Funding (Research and Training),Extramural Funding,Quick and Easy Search:New Tools to Search NIH Funding,New reports, data and analyses website released in March, 2008. Replaces the current Award Information and Data web page and will provide: Quick access to “Frequently Requested Reports” F

4、AQs on how success rates are computed and questions on the NIH budget Search tools for locating data and reports quickly and easily Links to funding estimates for certain research areas, conditions, and diseases. Foundation for broader NIH-wide Research Portfolio Online Reporting Tool (RePORT),More

5、at: ,NIH Award Funding Estimates for Various Diseases and Conditions,New web site combines data from NIH ICs explaining research spending and priorities to Congress and the public in approximately 360 research areas. Reports actual and estimated spending figures for FY 2004-2009;

6、 not “set-asides” or “allocations”. Meets requirements of the NIH Reform Act of 2006.,View the site at: /news/fundingresearchareas.htm,Presidents Budget Request for FY 2009,Requested a total of $29.457 billion for NIH Same as FY2008 Estimated 9,757 new and competing renewal Research

7、 Project Grants Approximately 14 less than FY2008 and 566 less than FY2007,More at: ,Presidents Budget RequestFY 2009,Areas of Focus: Bolster funding to new investigators especially in novel and recently emerging areas of opportunity Goal of sustaining 1,500 new invest

8、igators each year achieved in FY 2007. Encourage established investigators through investigator-initiated research projects, which remain the workhorse of NIH research. Roadmap/Common Fund Incubator for new ideas and initiatives that accelerate the pace of discovery Global Fund for HIV/AIDS, Tubercu

9、losis and Malaria NRSA Funding Policy Proposed 1% stipend increase,More at: /ui/HomePage.htm,NIH Priority: Roadmap for Medical Research,“Version 1.5” Builds on Success of Original Roadmap NIH is Focusing on Three Roadmap “Themes”: Research Teams of the Future Re-engine

10、ering the Clinical Research Enterprise New Pathways to Discovery Includes two recently added pathway areas, the Human Microbiome Project and New Initiative in Epigenomics. New Roadmap programs to be selected in Spring, 2008 Stay Tuned!,More at: ,NIH Priority: Blueprint for Ne

11、uroscience Research,Cooperative effort among 16 ICs to accelerate Neuroscience research. RFAs in 2007-2009 will focus on three themes, respectively: Neurodegeneration during disease and aging; Neurodevelopment throughout the lifespan; and Neuroplasticity, from molecular to behavioral levels. Availab

12、le neuroscience resources include: animal models; imaging tools; neuroinformatics (computational biology); core facilities; cells, tissue, and DNA; gene and protein expression; and training.,More at: ,NIH Priority: Continued Focuson New Investigators,Available at:

13、/grants/new_investigators/index.htm,Updated Definition of “New Investigator”,Definition updated to provide more detailed guidance “New” investigators cannot have successfully competed as a PD/PI for an NIH-supported research project other than R03, R13/U13, R15, R21, R25, R34, R3

14、6, R41, R43 R55, or R66 grants F05, F03, F31, F32, F34, F37, or F38 grants K01, K08, K22, K23, K25, or K99/R00 grants G07, G08, G11, G13, G20, S10, S15, X01, X02, C06, or UC6 grants. PD/PIs who did not initially compete for a major research grant but were later designated as PD/PI are still consider

15、ed “new”. All PD/PIs must meet the new investigator definition to receive special consideration on multi/PI grants.,Available at: /grants/new_investigators/resources.htm,NIH/CSR Shortens Review for New Investigators,New investigators unsuccessful in a R01 grant submission who are

16、 readily able to address the concerns and issues identified in the Summary Statement may shorten the time to the next review. Available for all CSR study sections reviewing new investigator R01 applications submitted for standard receipt dates (not including RFAs and PARs with special dates). Polici

17、es and practices include: Resubmission applications to be considered at the next cycle must be submitted by March 20, July 20, or November 20. New Investigators who do not choose this option may use the standard resubmission dates for subsequent submissions (March 5, July 5, or November 5).,More at:

18、 /grants/guide/notice-files/NOT-OD-07-083.html,Pathway to Independence(K99/R00),Facilitates timely transition from mentored postdoctoral research to independent research position at earlier stage. Primary, long-term goal is to increase and maintain strong cohort of new and talent

19、ed, NIH-supported independent investigators. Provides up to 5 years of support consisting of two phases: Initial phase (K99): 1-2 years of mentored support for highly promising, postdoctoral research scientists. 2nd Phase (R00): Up to 3 years of independent support contingent on securing an independ

20、ent research position. Standard K Submission Dates (February 12, June 12, October 12) Program Announcement PA-07-297,Qs and As at: /grants/new_investigators/QsandAs.htm,NIH DirectorsNew Innovator Award (DP2),Stimulates highly innovative research and supports promising new investi

21、gators. Awards provide up to $1.5 million in direct costs for (up to) a 5 year project period. Highly Popular: NIH received nearly 2,200 applications in FY2007 and funded 29. Program continues with applications due March 31, 2008 (RFA-RM-08-114).,More at: /grants/new_investigator

22、s/innovator_award,NIH Directors Bridge Award (R56) Updated and Expanded,Continued, limited funding for new and established PIs who have submitted a competing renewal, who just miss the nominal funding payline for the IC. Additional funded time for PIs to strengthen a resubmission. Selectees will rec

23、eive one-year of funding up to $500,000 DC + applicable F Complied with reporting requirements. Eighteen site reviews completed in FY 2006 “Observations from NIHs FY 2006 Targeted Site Reviews on Financial Conflict of Interest” have been posted on the OER Conflict of Interest page: http:/grants.nih.

24、gov/grants/policy/coi/index.htm Guide Notice: /grants/guide/notice-files/NOT-OD-07-048.html,FCOI questions for NIH? FCOI,AAMC-AAU Report,Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Sub

25、jects Research (February 2008) Calls on medical schools and major research universities to develop and implement institutional FCOI policies within the next two years and to refine individual FCOI standards Policies on individual FCOI in human subjects research Policies on institutional FCOI in huma

26、n subjects research Implementation of COI policies Report includes practical resource information in its Appendices,Entire report available at: /newsroom/pressrel/2008/080228.htm,An Investigator is not just the Principal Investigator or Senior/Key Personnel conducting the PHS-spons

27、ored research. Recipient institutions are encouraged to broadly consider an individuals role, rather than title, and their degree of independence when applying the definition.,FCOIDefinition of Investigator,Investigator Principal Investigator (PI) and any other person who is responsible for the desi

28、gn, conduct, or reporting of research funded by PHS, or proposed for such funding. The term “Investigator” includes the Investigators spouse and dependent children.,FCOI Summary of Reporting Requirements,At the time of application: Investigators must submit known significant financial interests to t

29、he 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 th

30、at it has been managed, reduced, or eliminated.,More at: /grants/guide/notice-files/NOT-OD-05-013.html,FCOI - Subrecipients,If the grantee institution performs NIH-funded research through “subgrantees, contractors, or collaborators,” the grantee institution must take reasonable s

31、teps to ensure compliance by requiring either: Subrecipient Investigators to comply with the grantee institutions policy OR Subrecipient institutions to provide assurances to the grantee institution that will enable it to comply,Subrecipients should report identified FCOIs to grantee institution. Gr

32、antee institution reports to NIH.,FCOI Information to be Reported,All FCOI reports should include the following information: Grant number; Name of Principal Investigator (PI) or contact PI if multiple PI award; Name of Investigator with the FCOI; and Distinguish which method was used to protect the

33、research from bias (e.g., managed, reduced, or eliminated).,OIG Report - NIH: Conflict of Interest in Extramural Research,Recommendations in January 2008 report Increase oversight of grantee institutions to ensure their compliance with Federal FCOI regulations. Require grantee institutions to routin

34、ely provide details regarding the nature of FCOI and how they are managed, reduced or eliminated. Require Institutes to forward to the Office of Extramural Research (OER), NIH, all FCOI reports received from grantee institutions and ensure OERs database includes all FCOI reports provided by grantee

35、institutions.,Full report available at: /oei/reports/oei-03-06-00460.pdf,FY 2008 OIG Audit Work PlanSelected Highlights,Colleges and Universities Compliance with Cost Principles Cost transfers, effort reporting, and other areas University Administrative and Clerical Salaries Are sal

36、ary costs appropriately charged? Use of Data and Safety Monitoring Boards in Clinical Trials NIH Monitoring of Extramural Conflicts of Interest How NIH monitors extramural grantees FCOI and the effectiveness of NIHs oversight Grantee Management of Financial Conflicts of Interest in Research Funded b

37、y the NIH Monitoring of FCOIs, nature of FCOIs, and how FCOIs managed (for FCOIs reported to NIH in FY 2006),FY 08 Work Plan: /publications/workplan.html#1,Audit Requirements,Audits are due within the earlier of 30 days after receipt of the auditors report(s) or 9 months after the e

38、nd of the grantees audit period. Grantees delinquent in submitting audits risk the imposition of sanctions and potential loss of Federal funds.,All NIH Grantees that expend $500,000 or more within a year in Federal awards are subject to an audit requirement.,Summary of Audit Requirements,Closeout Fi

39、nal Reports,Documents are due within 90 days of project period end date Final Financial Status Report (now required electronically) Final Inventions Statement animal work is being conducted at an Assured performance site Foreign Assurance is needed: Direct support to a foreign institution Domestic p

40、rime grantee with a foreign performance site using animals (Domestic grantees IACUC approves animal activities performed at foreign site),GPS Page 224 at: /grants/policy/nihgps_2003/index.htm,Public Outreach Materials from OHRP,Informational pamphlets on becoming a research volun

41、teer. Call OHRP at (800) 447-477 for up to 50 free copies. Now available in Spanish!,More at: /ohrp/outreach/,New Online Tutorial on Protecting Human Research Participants,Free, on-line tutorial now available that satisfies the NIH human subjects training requirement Designed for th

42、ose involved in the design and/or conduct of research involving human participants. Replaces the NCI Human Participant Protections Education for Research Teams Course previously available for this requirement. Available at: ,More at: /grants/guide/notice-files/NOT-OD-08-054.html,

43、Application Forms and Electronic Submission,Changes to NIH Application Forms,New PHS 398 forms approved for optional use until May 24, 2008. Use will be mandatory for submission dates after May 25. Changes will also be incorporated into PHS 398 components used in the SF424 (R&R) form set. G

44、 development of these forms is pending. The new PHS 2271 form is currently available and must be used for appointments made on/after May 1, 2008. The PHS 3734 and HHS 568 forms have also been renewed and are now available. New PHS 2590 forms available and required for all progress reports.,All Forms

45、 Available at: /grants/forms.htm,Upcoming eSubmission Form Changes,Transition to Adobe-based 424 forms continues but no firm dates set yet. F, T, and K transition from PHS 398 to Adobe 424 (R&R) Transition of current PureEdge-based 424 (R&R) applications Transition of Complex Mechanism

46、s still on hold. FFATA may require form changes in the 424 (R&R) to capture performance site information. Other 424 (R&R) changes also possible during OMB renewal. A few OMB-approved changes to the PHS 398 components NIH is attempting to coordinate all these changes into a single transition to minim

47、ize impact on the community. Stay Tuned!,Read & Follow All Instructions!,Avoid having to submit corrected applications read and follow all application guide and announcement instructions Look for the HHS logo in the application guide for any special instructions or fields not marked as mandatory on

48、the federal-wide form that are required by NIH,More at: /grants/funding/424/index.htm,Avoid Common Errors,NIH-specific requirements: Use PDF format for text attachments R&R Senior/Key Person Profile(s) form Include eRA Commons Username in the “Credential, e.g. agency login” field

49、 for all individuals assigned a PD/PI role. Include the Organization Name for all Senior/Key Persons listed R&R Budget form - Senior/Key Person effort must be greater than zero,More at: /ElectronicReceipt/avoiding_errors.htm,Track Your Application,Clicking “Submit” is NOT the last s

50、tep! It is the applicants responsibility to track the application through the submission process Use eRA Commons to check for submission errors/warnings and to view your assembled application If you cant view your application in eRA Commons we cant review it!,More at: /ElectronicRec

51、eipt/,Recent Changes,Responded to applicant feedback Reduction of correction window in eRA Commons from 5 days to 2 days. Enhanced application guide instructions Extended application viewing times through Federal holidays,More at: /ElectronicReceipt/,Future Changes,G Adobe

52、eForms Platform Independent (PC and Mac compatible) Advanced Search Features Will have the same look & feel as current forms to ease the transition No firm transition date set,More at: /aboutgrants/program_status.jsp,eRA Commons,Servicing Other Agencies,Continuing to service HHS

53、partners Agency for Healthcare Research & Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Food & Drug Administration (FDA) Substance Abuse & Mental Health Services Administration (SAMHSA) Veterans Health Administration (VA),Enhanced eRA Commons Features 10/2007,Electronic Streamlined

54、 Non-competing Award Process (eSNAP) Changes to Institutional Profile Assurances/Certifications Updated to include changes to multi-PI Leadership Plan and research with Select Agents Delegation of PI status to assistant for reviewing electronic applications Ability to monitor the electronic submissi

55、on of reference letters,More at: /grants/guide/notice-files/NOT-OD-07-064.html,Enhanced eRA Commons Features (cont.),Updated Status screens. Added ability to search and track applications by G tracking number. Reorganized application/grant data to separate applications r

56、equiring further action in the submission process from all others. While the screens may look different, all the information youre used to seeing is still available (plus more!),More at: /grants/guide/notice-files/NOT-OD-08-007.html,Coming Soon: X-Train,X-Train is a new system to

57、 improve the administration of NIH Training Grants. Allows PIs and staff to electronically submit appointment forms and termination notices Allows institutional staff to track status and timing of appointment actions Will be available through eRA Commons Pilot begun December 2007 with over 90 traini

58、ng grants at 9 universities. Full production release expected Spring 2008,Profile Maintenance,PIs have an obligation to keep information in their Personal Profile current and need to update it regularly Profile data used in other electronic processes (e.g., Summary Statements, eNotifications) Degree

59、s Position Titles Addresses - e-mail & postal,Technical Assistance and Training Resources,SBIR/STTRPipeline to Partnerships,Showcase of SBIR/STTR grantee technology available to potential strategic partners and investors for development opportunities. Searchable index organized by technology and stage of development.,More at: /p2p/p2p_writeup.html/,Redesigned OER Web Site,Office of Extramural Research home page Links to funding opportunities, grants policy, application and forms, awarded grant data Redesign based on focus groups and v