Transcript NIH Update (without notes) - Spring 2008

NIH Update – Spring 2008
Office of Policy for Extramural Research Administration
Marcia Hahn, Director
Division of Grants Policy
Office of Policy for Extramural Research Administration
OPERA
NIH Budget News
and Priorities
OPERA
Final NIH Appropriations
FY 2008
• NIH received a total of
$29.457 billion
• Increase of $329 million from
FY2007
• Average competing 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
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html
FY2008 NIH Budget
$29.457 Billion
10%
11%
53%
$15.61 B
6%
3%
2%
Research Project Grants (53%)
R&D Contracts (11%)
Training (3%)
Research Mgmt & Support (5%)
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5%
10%
Research Centers (10%)
Other Research (6%)
Intramural Research (10%)
All Other (2%)
Quick and Easy Search:
New Tools to Search NIH Funding
• Prototype reports, data and analyses website now
available at: http://report.nih.gov/
• Will replace the current Award Information and Data
web page and will provide:
– Quick access to “Frequently Requested Reports”
– FAQs 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)
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President’s 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 Project
Grants
• Approximately 14 less
than FY2008 and 566
less than FY2007
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More at: http://officeofbudget.od.nih.gov
President’s Budget Request
FY 2009
Areas of Focus:
– Bolster funding to new investigators especially in
novel and recently emerging areas of opportunity – Goal
of sustaining 1,500 new investigators 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, Tuberculosis and Malaria
– NRSA Funding Policy – Proposed 1% stipend increase
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More at: http://officeofbudget.od.nih.gov/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-engineering 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!
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More at: http://nihroadmap.nih.gov
NIH Priority: Blueprint for
Neuroscience 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.
• Available neuroscience resources include: animal
models; imaging tools; neuroinformatics
(computational biology); core facilities; cells, tissue,
and DNA; gene and protein expression; and
training.
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More at: http://neuroscienceblueprint.nih.gov
NIH Priority: Continued Focus
on New Investigators
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Available at: http://grants.nih.gov/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 most research grants.
– R03, R13/U13, R15, R21, R25, R34, R36, 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/PI’s who did not initially compete for a major research
grant but were later designated as PD/PI are still considered
“new”.
• All PD/PIs must meet the new investigator definition to receive
special consideration on multi/PI grants.
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Available at: http://grants.nih.gov/grants/new_investigators/resources.htm
NIH/CSR Shortens Review
for New Investigators
• New investigators unsuccessful in a R01 grant submission who
are 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).
• Policies 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).
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More at: http://grants.nih.gov/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 talented, 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 independent research position.
• Standard K Submission Dates (February 12, June 12,
October 12)
• Program Announcement PA-07-297
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Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm
NIH Director’s
New Innovator Award (DP2)
• Stimulates highly innovative research and supports
promising new investigators.
• 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).
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More at: http://grants.nih.gov/grants/new_investigators/innovator_award
NIH Director’s 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 receive one-year of funding up to $500,000
DC + applicable F&A (increased from $333,000)
• Cannot apply, cannot self-nominate! Criteria:
– Must have < $400,000 in other support (total costs) from
all sources to fund research (increased from $200,000)
– A1s and only the most meritorious A2s are now eligible
– Applications submitted in FY2007 that are still being
considered for funding & FY2008 submissions
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-037.html
New Scientific and Grants
Management Policies
OPERA
Enhancing Peer Review at NIH
The Charge: “Fund the best science, by the
best scientists, with the least administrative
burden…”
• Initial Public Consultation Period
– RFI for public comment period in Summer, 2007
– Regional Consultation Meetings held Fall, 2007
• Final Draft Report submitted to Dr. Zerhouni in
February 28, 2008 and available for public comment
until March 17, 2008.
• NIH will formally announce the new initiatives it
plans to implement in Spring, 2008.
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More at: http://enhancing-peer-review.nih.gov
Enhancing Peer Review: Selections
from the Draft Final Report
• Challenges identified in 7 broad areas:
– Reducing administrative burden on applicants,
reviewers, and NIH staff
– Enhancing the rating system
– Optimizing support at different career stages
– Optimizing support for different types of science
– Reducing stress on the support system of science
– Meeting the need for continuous review of NIH
peer review
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More at: http://enhancing-peer-review.nih.gov
Enhancing Peer Review: Select
Challenges and Recommendations
• Recommendations under consideration for pilot
testing and community feedback include:
– Shortening the length of applications
– Providing unambiguous feedback by scoring all
applications and including a “Not Recommended for
Resubmission” option
– Eliminating “Special Status” of amended applications by
considering all applications as “New”
– Linking potential review service to most prestigious NIH
awards
– Employing an editorial board model for review of
interdisciplinary research
– Instituting a minimum effort requirement for investigators
on RPGs
– Pilot ranking early-career investigators against each other
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More at: http://enhancing-peer-review.nih.gov
Continuous Submission Process
for NIH Study Section Members
Appointed members of chartered Study Sections may
submit applications as they are developed and NIH
will review within 120 days of receipt.
• Chartered Study Section member must be the
PD/PI. Multi-PI applications are eligible if one or
more PD/PI is an appointed Study Section member.
• Limited to R01, R21 and R34 (including AIDSrelated) applications submitted for standard due
dates.
• Not available for temporary or ad hoc reviewers, or
reviewers for other Federal agencies.
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-26.html
Clarification of NIH Policy on Late
Application Submission
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
– Permission is not granted in advance
– Must be accompanied by a cover letter with compelling reasons for
the delay (including timing and nature of the cause of the delay)
– Regular Standing Submission dates – Late applications must be
received within two weeks of standing submission date
– Expedited Standing Submission dates – Late applications must be
received within one week of standing submission date.
• NIH will not consider accepting late applications for the
Special Receipt Dates for RFAs and PARs
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-027.html
Centralized NIH Database
of Human Genome Data
•
•
Facilitates rapid and broad access to Genome-Wide
Association Study (GWAS) datasets
Policy addresses:
–
–
–
–
–
–
•
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Principles governing the repository
Data sharing procedures and requirements
Research participant protection and privacy
Data Access Committees
Intellectual property and publication rights
Oversight and governance of repository
Implementation guidance now available at:
http://grants.nih.gov/grants/guide/notice-files/NOTOD-08-013.html
GWAS Website: http://grants.nih.gov/grants/gwas
FY 2008 Legislative Mandates
• Most provisions identical to existing requirements in
Appropriations from FY 2005-2007
• Ban on False and Deliberately Misleading Scientific
Information
– Similar to existing research integrity, fraud and false
claims restrictions
– No significant changes expected for grantees.
• Restriction on Employment of Unauthorized Alien Workers
– Similar to existing Immigration and Nationality Act
requirements
– No significant changes expected for grantees
• NIH Public Access Policy
– No longer optional – compliance mandated by law
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-041.html
Revised Public Access Policy
All investigators funded by NIH must submit to PubMed
Central an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication.
• Applicable to peer-reviewed articles accepted for publication
on or after 4/7/08, and arising from direct or indirect grant or
contract funds active in FY 2008, and beyond.
• Starting May 25, 2008, all applications and progress reports
must include the PMC or Manuscript Submission reference
number when citing NIH-funded articles
• Compliance mandated by Public Law 110-161
• Full-text articles to be made publicly available on NLM’s
PubMed Central no later than 12 months after date of
publication
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html
How to Comply
• Address copyright issue: Institutions and
investigators are responsible for ensuring that
publishing/copyright agreements allow submission.
• Submission of articles to NIH: Upon acceptance
for publication, deposit final manuscript in NIH
Manuscript Submission (NIHMS) system. Many
journals will submit articles on behalf of author.
• Citing Articles in Applications & Progress
Reports: Beginning with 5/25/08 submission date,
when citing articles authored or co-authored by the
applicant(s) that fall under the Policy, include the
PubMed Central ID or NIH MS ID number for each
article.
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More at: http://publicaccess.nih.gov/FAQ.htm
Registration of Clinical Trials
The FDA Amendments Act (P.L. 110-85) mandates
registration and results reporting at ClinicalTrials.gov
by sponsors of applicable clinical trials.
• Expansion of existing ClinicalTrials.gov registry.
• Includes Phase II-IV clinical trials of drugs and devices
subject to FDA regulation.
• Increased number of data elements that must be submitted.
• Not limited to trials for serious or life threatening diseases.
• Competing applications and progress reports grants with NIHfunded trials must include a certification of submission.
• NIH encourages registration in ClinicalTrials.gov of ALL
clinical research trials funded by NIH, whether required under
the law or not.
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
Registration of Clinical Trials
(continued)
Detailed Requirements:
• Effective December 26, 2007, all ongoing trials of drugs and
devices for serious or life-threatening diseases are to be
registered in ClinicalTrials.gov database
• All other trials are to be registered within 1 year
• New trials are to be registered within 21 days after the first
patient is enrolled
• Registration information must be posted publicly within 30
days of submission for drug trials, or 30 days of FDA
approval for device trials
• Civil penalties to be levied for noncompliance if trials are not
properly registered.
• NIH will verify registration before funds are released. See
requirements for competing applications and noncompeting
progress reports at NIH Guide Notice NOT-OD-08-023.
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FY 2008 NIH Salary Cap
Effective January 1, 2008, salary and wages on
NIH grants limited to an annual rate of $191,300
(equal to Executive Level I).
• An individual's base salary is NOT constrained by the
legislative provision for a limitation of salary. An institution
may pay an individual's salary amount in excess of the
salary cap with non-federal funds.
• Grantees should provide information on full salary needs
(if more than the cap) so NIH can adjust based on future
limits.
• Salary Cap Summary (Historical Information):
http://grants.nih.gov/grants/policy/salcap_summary.htm
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html
Multiple Principal Investigators
Supporting Team Science
Goal: Encourage collaboration among equals when
that is the most appropriate way to address a
scientific problem, a “Team Science” approach.
• NIH Implementation Plans for Recognition of Multiple PIs on
Federally-Funded Research Projects
– http://rbm.nih.gov/NIH_Multi_PIs.doc
• Multiple Principal Investigator website and FAQs:
– http://grants.nih.gov/grants/multi_pi/index.htm
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Elimination of Paper Notification of
Award Letters (NoAs)
• As of January 1, 2008, NIH is no longer
providing paper notification of NoA letters.
• NoAs are sent solely by e-mail and award
letters are accessible through the eRA
Commons.
• All award recipients must be e-mail enabled!
– Edit your institutional profile in the eRA
Commons.
– If already enabled, confirm that the address is
correct.
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html
Electronic FSR
Submission Required
• As of October 1, 2007, NIH requires all
Financial Status Reports (FSRs) to be
submitted using the electronic FSR
system in the eRA Commons.
• Applies to both domestic and foreign
grantees.
• Does not apply to other Federal
agencies.
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-078.html
Federal Funding Accountability
and Transparency Act (FFATA)
Public Law 109-282 requires information on every
grant, including 1) the amount, 2) descriptive purpose
of the grant, and 3) name and location of recipient of
primary performance location. This includes data on
all subawards over $25,000.
• Prepare for potential increased attention and scrutiny when
data is made publicly available.
• NIH is actively involved with a variety of Federal-wide
committees to implement the act and is tailoring processes to
meet its requirements.
• FFATA may require form changes in the 424 (R&R) and PHS
398 to capture performance site information. - Stay Tuned
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More at: www.FederalSpending.gov
Highlights of New and
Existing Grant Requirements
OPERA
Financial Conflict of Interest
(FCOI) Activities
NIH continues to enhance and promote compliance with
the FCOI Regulation (42 CFR Part 50, Subpart F)
• NIH system-wide review of FCOI policies, procedures, and
guidance
• eRA Commons FCOI module/reporting tool for grantees
(implementation expected 10/08)
• Updated FAQs and an online tutorial
– For grants, cooperative agreements, and contracts
• Articles in NIH Extramural Nexus
• Web based reporting and tracking tool for NIH staff
• Pilot Compliance Program on FCOI
• NIH Targeted Site Reviews
• FCOI mailbox ([email protected])
• NIH Guide Notices
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Web Postings and Resources at: grants.nih.gov/grants/policy/coi/index.htm
Pilot FCOI Compliance Program
• NIH selected a number of institutions for review
of their FCOI policy and related information.
– Assess compliance with 42 CFR Part 50 Subpart F
– An outgrowth of the NIH Targeted Site Reviews
– Desk reviews, not site visits
• Results of the pilot program will be shared with
the grantee community for educational
purposes to enhance and improve FCOI
compliance.
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-010.html
FCOI Targeted Site Reviews
• Targeted Site Reviews are an initiative to determine
whether grantee institutions have:
– Fully implemented the FCOI regulations as they pertain to
grants and cooperative agreements (42 CFR Part 50
Subpart F), and;
– Complied with reporting requirements.
• Eighteen site reviews completed in FY 2006
– “Observations from NIH’s FY 2006 Targeted Site Reviews
on Financial Conflict of Interest” have been posted on the
OER Conflict of Interest page:
http://grants.nih.gov/grants/policy/coi/index.htm
– Guide Notice: http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-07-048.html
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FCOI questions for NIH?
[email protected]
AAMC-AAU Report
• Protecting Patients, Preserving Integrity, Advancing Health:
Accelerating the Implementation of COI Policies in Human
Subjects 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 human subjects research
– Implementation of COI policies
• Report includes practical resource information in its
Appendices
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Entire report available at:
http://www.aamc.org/newsroom/pressrel/2008/080228.htm
FCOI
Definition of Investigator
Investigator – Principal Investigator (PI) and any
other person who is responsible for the design,
conduct, or reporting of research funded by PHS, or
proposed for such funding. The term “Investigator”
includes the Investigator’s spouse and dependent
children.
• An Investigator is not just the Principal Investigator or
Senior/Key Personnel conducting the PHS-sponsored
research.
• Recipient institutions are encouraged to broadly
consider an individual’s role, rather than title, and their
degree of independence when applying the definition.
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FCOI Summary of
Reporting Requirements
1. At the time of application: Investigators must
submit known significant financial interests to
the institution.
2. 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.
3. 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.
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More at: http://grants.nih.gov/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 steps to ensure compliance by
requiring either:
– Subrecipient Investigators to comply with the grantee
institution’s 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. Grantee institution reports to NIH.
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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
research from bias (e.g., managed, reduced, or
eliminated).
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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 routinely 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 OER’s database includes
all FCOI reports provided by grantee institutions.
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Full report available at: http://oig.hhs.gov/oei/reports/oei-03-06-00460.pdf
FY 2008 OIG Audit Work Plan
Selected Highlights
• Colleges’ and Universities’ Compliance with Cost Principles
– Cost transfers, effort reporting, and other areas
• University Administrative and Clerical Salaries
• Are salary 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 NIH’s oversight
• Grantee Management of Financial Conflicts of Interest in
Research Funded by the NIH
– Monitoring of FCOIs, nature of FCOIs, and how FCOIs
managed (for FCOIs reported to NIH in FY 2006)
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FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1
Audit Requirements
All NIH Grantees that expend $500,000 or
more within a year in Federal awards are
subject to an audit requirement.
• Audits are due within the earlier of 30 days after
receipt of the auditor’s report(s) or 9 months after
the end of the grantee’s audit period.
• Grantees delinquent in submitting audits risk the
imposition of sanctions and potential loss of
Federal funds.
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Summary of Audit Requirements
Grantee Type
State & Local
Governments
Colleges &
Universities
Non-Profits
Source of Audit
Requirement
OMB Circular A-133
Where to Submit Audit Reports
Federal Audit Clearinghouse
1201 E. 10th Street
Jeffersonville, IN 47132
Questions:
1-800-253-0696
Hospitals
For-Profits
45 CFR Part 74.26 (d)
Foreign
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NIH Grants Policy
Statement (same as
For-Profits)
National External Audit Review Center
HHS Office of Inspector General
HHS Office of Audit Services
1100 Walnut Street, Suite 850
Kansas City, MO 64106-2197
Phone: 800-732-0679/816-426-7725
(same as For-Profits)
Closeout Final Reports
Grantees are strongly encouraged to submit
closeout documents electronically through the eRA
Commons!
• Documents are due within 90 days of
project period end date
– Final Financial Status Report (now required
electronically)
– Final Inventions Statement & Certification
– Final Progress Report
• Failure to submit timely reports may
affect future funding to the organization!
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-051.html
NIH Centralized Processing Center
• Announced in NIH Guide 4/2/2008:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08061.html
• NIH strongly encourages electronic submission of closeout
documents through the eRA Commons.
• Centralized office accepts receipt of all non-financial, paperbased closeout documents
– Final Progress Report
– Final Invention Statement and Certification
• 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 delivery only)
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NIH Policy on Data Sharing
Investigators submitting a research application
requesting $500,000 or more of direct costs, in any
single budget period to NIH, must include a plan for
sharing final research data for research purposes, or
state why data sharing is not possible.
Applicant Resources:
• Data Sharing Chart: Quick guide for identifying data sharing
regulation/policy/guidance documents applicable to NIH
funding http://grants.nih.gov/grants/policy/data_sharing/data_sharing_chart.doc
• Data Sharing Main Page: http://grants.nih.gov/grants/policy/data_sharing
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
NIH Policy on Sharing of Model
Organisms
Investigators submitting an NIH application/proposal
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.
Applicant Resources:
• Data Sharing Main Page available at:
http://grants.nih.gov/grants/policy/model_organism/index.html
– Frequently Asked Questions
– Sample Sharing Plans
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More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
Requirements and Compliance
Assistance for OHRP / OLAW
OPERA
OLAW
Compliance Assistance
• “What Investigators Need to Know About the Care and Use of
Laboratory Animals”
– Brochure explains the requirements for using animals in
PHS-supported research
– Contact OLAW to request multiple copies
• FAQs on “PHS Policy on Humane Care and Use of
Vertebrate Animals” available on the OLAW website
• IACUC 101 is a series of workshops on the roles and
responsibilities of IACUCs, including federal policies and
regulations regarding animal welfare.
– March 26, 2008: Atlanta, GA
– April 15, 2008: Galveston, TX
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More at: http://olaw.nih.gov
Policy on UnAllowable Costs for
Activities Involving Animals
Institutions are not permitted to charge grants or
contracts for animal activities when terms and
conditions are not upheld.
• Absence/suspension of valid Assurance filed with OLAW
• Absence/suspension of valid IACUC approval of the animal
activity:
– Failure to obtain IACUC approval for animal activity.
– Continuing animal activities after IACUC approval has expired.
– Continuing animal activities after suspension of IACUC approval.
• Institutions must report noncompliant situations to:
– OLAW ([email protected] or 301-594-2061)
– Institute/Center (IC) supporting the award
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More at: Notice NOT-OD-07-044 at http://olaw.nih.gov
Consortium Agreements:
Subawards and Animals (Cont.)
• Prime grantee is accountable to NIH and must confirm
Assurance and IACUC approval (dated within 3 years)
• Animal welfare requirements apply to all consortium
participants and sub-projects
– Inter-Institutional Assurance is needed:
• Prime grantee has no animal program; animal work is
being conducted at an Assured performance site
– Foreign Assurance is needed:
• Direct support to a foreign institution
• Domestic prime grantee with a foreign performance
site using animals (Domestic grantee’s IACUC
approves animal activities performed at foreign site)
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GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
Public Outreach Materials from
OHRP
• Informational
pamphlets on
becoming a
research volunteer.
• Call OHRP at
(800) 447-477 for
up to 50 free
copies.
• Now available in
Spanish!
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More at: http://www.hhs.gov/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 those 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:
– http://phrp.nihtraining.com/users/login.php
55
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html
Application Forms and
Electronic Submission
OPERA
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. Grants.gov 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.
57
All Forms Available at: grants.nih.gov/grants/forms.htm
Upcoming eSubmission
Form Changes
Transition to Adobe-based 424(R&R) forms continues
but no firm dates set yet.
Things we are trying to coordinate into a single
transition:
• Transition of current PureEdge-based 424 (R&R) applications
• FFATA will 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
• F, T, and K transition still on hold
• Transition of Complex Mechanisms still on hold.
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Stay Tuned!
Helpful Hint:
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 the federal-wide
form that are required by NIH
59
More at: http://grants.nih.gov/grants/funding/424/index.htm
Helpful Hint:
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 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
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More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
Helpful Hint:
Track Your Application
• Clicking “Submit” is NOT the last step!
– It is the applicant’s 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 can’t view your application in eRA
Commons – we can’t review it!
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More at: http://era.nih.gov/ElectronicReceipt/
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
62
More at: http://era.nih.gov/ElectronicReceipt/
eRA Commons
OPERA
Servicing Other Agencies
• Continuing to service HHS 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)
– Veteran’s Health Administration (VA)
64
Enhanced eRA Commons
Features – 10/2007
• Electronic Streamlined 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 submission of
reference letters
65
More at: http://grants.nih.gov/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
Grants.gov tracking number.
– Reorganized application/grant data to separate
applications requiring further action in the
submission process from all others.
• While the screens may look different, all the
information you’re used to seeing is still
available (plus more!)
66
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-007.html
Coming Soon: X-Train
• X-Train is a new system to 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
training grants at 9 universities.
• Full production release expected Spring 2008
67
Reminder:
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)
– Degrees
– Position Titles
– Addresses - e-mail & postal
68
Technical Assistance and
Training Resources
OPERA
SBIR/STTR
Pipeline 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.
70
More at: http://www.ott.nih.gov/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 visitor
feedback
– New search tools
– Comprehensive glossary and acronyms list
– New content walks through the NIH grantmaking process
• Also improved & updated eRA web site
71
Visit at: http://grants.nih.gov/grants/oer.htm
72
OER web site located at http://grants.nih.gov/grants/oer.htm
Redesigned eRA Web Site
• Services for Applicants - 'plain language' fact
sheets on eRA services
• Commons - overview, quick link to system,
user guides, release notes, FAQs and other
resources
• NIH & Grantor Agencies - highlights services
and system modules available for NIH staff and
other Federal agencies
• News & Events - eRA updates and info on
upcoming workshops/seminars
73
Visit at: http://era.nih.gov/
Summary of
Helpful NIH Web Pages
• 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 – Bimonthly newsletter for the extramural
community
http://grants.nih.gov/grants/nexus.htm
• Electronic Submission of Grant Applications Homepage
http://era.nih.gov/ElectronicReceipt/index.htm
• CRISP database - Search to analyze an Institute’s portfolio of
funded projects, research areas, and more
http://crisp.cit.nih.gov/crisp/crisp_querty.generate_screen
• Grant Application Basics
http://grants.nih.gov/grants/grant_basics.htm
74
New OER Outreach Webpage
New OER Outreach Webpage
• NIH Regional Seminars on Program Funding and Grants
Administration
– Funding Opportunities for New Investigators
– Application Preparation and the Review Process
– Grant Administration Issues, Hot Topics, and More…
• National Animal Welfare Workshops
• Office of Human Research Protections Workshops
• NIH Small Business Research Workshops
• Office of Research Integrity Workshops and Conferences
75
Visit at: http://grants.nih.gov/grants/outreach.htm
NIH Regional Seminars on Program
Funding and Grants Administration
2008 Regional Seminars:
March 25-26, 2008 in San Antonio, TX
June 19-20, 2008 in Chicago, IL
NIH electronic research administration labs
offered in conjunction with the two-day seminar.
• Yearly seminars to educate research administrators,
investigators new to NIH, and trainees.
• Due to the popularity of these seminars and availability
of space - Early Registration is Highly
Recommended!
Interested in hosting?
• Seminar and Registration Information:
http://grants.nih.gov/grants/seminars.htm
76
Contact us!
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-076.html
NIH OER Listserv Addresses
and Instructions
•
Office of Biotechnology Activities (OBA):
– https://list.nih.gov/archives/oba_news.html
• Office of 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
77
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 awarding
Institute/Center
• Review Questions - Contact the assigned
Scientific Review Officer
78
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: [email protected]
– Phone: 301-435-0949
• Compliance Issues:
– E-Mail: [email protected]
– Phone: 301-435-0949
79
Grants Information:
Who to Contact!
• General Application Questions: (e-Submission guidelines,
resources & referrals, application review & award process,
etc.)
– E-Mail:
– Phone:
[email protected]
301-435-0714
• Customer Support for Grants.gov: (navigating forms, aspects
of submitting through the system, resources available, etc.)
– E-Mail: [email protected]
– 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)
80
Enter your own
help ticket!
Thank You!
Any Questions?
OPERA
Frequently Asked
Questions
OPERA
#1 – How do I prepare for
eSubmission?
• Grants.gov requires a three-step registration
process for the organization to submit electronically
• eRA Commons registration is also required for both
the organization and the PI
– These are separate processes that can be done
simultaneously.
• All registrations must be completed prior to
application submission.
It is critical for institutions to begin these registrations
at least 2 – 4 weeks before applications are due!
83
More at: http://era.nih.gov/ElectronicReceipt/preparing.htm
#2 – How do I submit a
multiple-PI application?
• Applications
– NIH Grant Applications Forms (PHS 398 and SF424 R&R) accommodate
more than one PI
– Leadership Plan required describing roles, responsibilities, and the working
relationship of the identified PIs.
• Principal Investigators
– The Contact PI will be responsible for communication between the NIH and
the leadership team (and will be listed first on the application)
– All PIs share the responsibility and authority for leading and directing the
project.
• New Investigator Policies
– New Investigator box on the application may only be checked when all PIs
are classified as New Investigators.
• Review Criteria
– Standard NIH review criteria have been modified accordingly.
• Awards Involving More than One Institution
– PIs from different institutions will be managed though subcontracts for now.
84
More at: http://grants.nih.gov/grants/multi_pi/
#3 – Are there any fellowship programs for
individuals from minority or disadvantaged
groups?
Yes.
However, note that a revised FOA includes
the following changes:
•
•
•
85
Effective January 1, 2007: Now 3 submission dates--April
13, August 13, and December 13.
Added new bullet in “Content and Form of Application
Submission” section to require information that must be
submitted by applicant Institution in a letter certifying the
applicant’s eligibility (See FOA for further details.)
Updates information on Tuition/Fees and Institutional
Allowance, published in the NIH Guide: NOT-OD-06-093.
FOA at: http://grants.nih.gov/grants/guide/pa-files/PA-07-106.html
#4 - Does NIH still accept
unsolicited grant applications?
Yes. Use Parent Announcements (available on
Grants.gov and NIH web pages) for “unsolicited”
or “investigator-initiated” applications.
Other funding opportunity announcements include:
• Program Announcements
– Statement of new or ongoing NIH interest in a certain
research area.
• Requests for Applications (RFAs)
– Statement soliciting applications in a well-defined
scientific area to accomplish specific program objectives.
86
All Available at: http://grants.nih.gov/grants/guide/index.html
#5 – Can foreign applicants
submit modular budgets?
No.
• Receiving detailed budgets from foreign
applications allows NIH staff to assist applicant
community with applicable regulatory and policy
requirements for grant funding expenditure.
• However, domestic (U.S.) institutions with
subawards to foreign (non-U.S.) institutions may
use modular budgets.
87
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html
#6 – Are fellowship candidates
required to register in eRA Commons?
Yes. Applicant organizations should
register any individual fellows submitting
applications to NIH and AHRQ
• PI Role in the Commons does not provide special
status – only a record in the system that provides
administrative authority to see pertinent application
documents (e.g. summary statements, scores,
submission status, etc.)
• Individual Fellows registered by any organization
other than the sponsoring organization should not
have more than one eRA Commons account.
88
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html
#7- Are consortium F&A costs included
as part of an applicant’s direct costs?
No. Applicants are to exclude the facilities and
administrative (F&A) costs requested by
consortium participants when determining if the
budget exceeds a direct cost limit.
• This policy applies to:
– $250K direct cost calculation for modular budgets
– $500K direct cost calculation for NIH data sharing
policy and requirement to contact IC staff for
unsolicited applications requesting over $500K
• This policy does not apply to:
– Small Business Innovation Research (SBIR) grants
– Small Business Technology Transfer (STTR) grants
89
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html
#8 – May I reduce my level of
effort on a K award?
Yes. Recipients may reduce their commitment of
total professional effort in some circumstances.
Requirements:
• Individual has a full-time appointment with their institution.
• The minimum percentage of effort commitment required
for the K award is covered by that appointment.
Alternatively:
• In the last two years of support individuals may reduce the
level of effort on most K awards and replace with an NIH
research grant or subproject.
–
Awardee must serve as a PI or subproject Director
–
Effort may be reduced to no less than 50% and be
replaced by effort from the research award so total
effort commitment remains at or above 75%.
90
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html
#9 – How do I calculate personmonths in a 9-month academic year?
• Person months are the metric expressing
amount of effort faculty and other
senior/key personnel devote to a project
• How are person-months calculated?
– Multiply the percentage of effort by the number
of months of the appointment. For example:
• 10% of a 9 month academic year appointment
equals .9 person months (9 x .1 = .9 person
months)
• 10% of a 12 month calendar appointment equals
1.2 months (12 x .10 = 1.2 person months)
91
More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm
#10- What are the requirements
for recombinant DNA research?
• Institutional Biosafety Committees must review and
certify proposed recombinant DNA research.
• Serious adverse events in human gene transfer
research must be reported promptly!
– Usually within 15 days, but
– Within 7 days if life threatening or fatal.
– Annual reporting is also required.
• Full text of the guidelines are available:
– http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.
– Site also includes available training opportunities.
92
More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-067.html
#11 – Does NIH have a cap on
consultant fees?
No. There is no cap on consultant fees and the
NIH salary cap does not apply.
HOWEVER,
• Grantees must have written policies for paying
consultants that:
– Are consistently applied regardless of fund source.
– Include conditions for paying consultant fees.
• Consultants must be properly classified.
– Consultants are defined as individuals who provide
professional services or advice for a fee, but normally are
not employees of the organization. This also includes
firms that provide advice or services.
93
#12 – How different does a “new
application” have to be?
“New applications” are expected to be
substantially different in content and scope
• More significant differences than normally
encountered in resubmission applications.
– Rewording the Title and Specific Aims is not sufficient.
– Incorporating minor changes in response to reviewer
comments is not sufficient
• Research Plan changes should produce a
significant change in direction and approach. All
research plan sections should have substantial
changes, particularly the Specific Aims and
Research Design and Methods sections.
94
#13 – As PI, what happens if I
change institutions mid-grant?
Prior, written approval is required for transferring
legal and administrative authority for a grant to a
different organization.
• Transfer approval is not automatic and requires
approval from both NIH and the original grantee
organization.
• Contact your GMO before moving to initiate the
transfer process.
• Grants to individuals may not be transferred but
individual fellowships may transfer to a new
sponsoring institution.
95