Current Issues at NIH
Joe Ellis, OPERA Director
Pam Gilden, Grants Policy Analyst
Office of Policy for Extramural Research Administration
NIH Budget News
Final NIH Appropriations
• NIH received a total of
• Increase of $329 million from
• Average competing award
expected to increase by 1%
• Average noncompeting
award also increases by 1%
but implementation will vary
• No change to NRSA stipend
levels or funding policies
3 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html
FY2008 NIH Budget
Research Project Grants (53%) Research Centers (10%)
R&D Contracts (11%) Other Research (6%)
Training (3%) Intramural Research (10%)
Research Mgmt & Support (5%) All Other (2%)
(Research and Training)
Extramural Funding = 83% of Total Budget
Extramural Funding Research Mgmt & Support
Intramural All Other
Extramural Funding = 83% of Total Budget
13% Research and Training Grants (87%)
R&D Contracts (13%)
Quick and Easy Search:
New Tools to Search NIH Funding
• New reports, data and analyses website released in
• Replaces 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
– Links to funding estimates for certain research areas,
conditions, and diseases.
• Foundation for broader NIH-wide Research Portfolio
Online Reporting Tool (RePORT)
More at: http://report.nih.gov
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; not “set-asides” or “allocations”.
• Meets requirements of the NIH Reform Act of 2006.
Research/Disease Area FY 2006 FY 2007 FY 2008
(Dollars in Millions and Rounded) Actual Actual Estimate
Acute Respiratory Distress Syndrome $74 $48 $48
Agent Orange and Dioxin 17 18 18
Aging 2,431 2,462 2,461
Alcoholism 511 521 521
Allergic Rhinitis (Hay Fever) 4 5 5
8 View the site at: http://www.nih.gov/news/fundingresearchareas.htm
President’s Budget Request for
• Requested a total of
$29.457 billion for NIH
• Same as FY2008
• Estimated 9,757 new
and competing renewal
• Approximately 14 less
than FY2008 and 566
less than FY2007
9 More at: http://officeofbudget.od.nih.gov
President’s Budget Request
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
10 More at: http://officeofbudget.od.nih.gov/ui/HomePage.htm
NIH Priority: Roadmap for
• “Version 1.5” Builds on Success of Original
• 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
• RFI for new research areas closed June 2, 2008
and review is ongoing. – Stay Tuned!
11 More at: http://nihroadmap.nih.gov
NIH Priority: Blueprint for
• Cooperative effort among 16 ICs to accelerate
• RFAs in 2007-2009 will focus on three themes,
– 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
12 More at: http://neuroscienceblueprint.nih.gov
NIH Priority: Continued Focus
on New Investigators
13 Available at: http://grants.nih.gov/grants/new_investigators/index.htm
Updated Definition of
• 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, 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
• PD/PI’s who did not initially compete for a major research
grant but were later designated as PD/PI are still considered
• All PD/PIs must meet the new investigator definition to receive
special consideration on multi/PI grants.
14 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
• 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
– New Investigators who do not choose this option may use
the standard resubmission dates for subsequent
submissions (March 5, July 5, or November 5).
15 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html
Pathway to Independence
• 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
• 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,
• Program Announcement PA-07-297
16 Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm
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). - PASSED
17 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
18 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-037.html
New Scientific and Grants
Enhancing Peer Review at NIH
The Charge: “Fund the best science, by the
best scientists, with the least administrative
• 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.
• Implementation plan presented to Advisory
Committee to the NIH Director on June 6, 2008.
20 More at: http://enhancing-peer-review.nih.gov
Enhancing Peer Review: Selections
from the Draft Implementation Plan
• Core Priorities for Enhancing Peer Review
– Recruit, train and reward the best possible
– Align structure of applications, review criteria,
summary statements, and rating process to
improve quality and transparency of reviews.
– Ensure balanced and fair reviews across scientific
fields and career stages while reducing
unnecessary burden on applicants.
– Implement system for continuous review and
improvement of peer review.
21 More at: http://enhancing-peer-review.nih.gov
Enhancing Peer Review: Select
• Select recommendations under consideration
for pilot testing and community feedback:
– Providing individual scores for each of five review criteria (1-7)
and a preliminary global score. After initial scoring, all proposals
within relevant categories will be discussed as a group and
– Limiting R01 Research Plans to 12 pages
– Rewarding outstanding and sustained review service by
allowing applications for administrative supplements of up to
$250,000 in total costs
– Improving training and mentoring of all study section chairs,
peer reviewers, and SROs.
– Expanding use of Pioneer, EUREKA and New Innovator awards
to encourage transformative research.
22 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 AIDS-
related) applications submitted for standard due
• Not available for temporary or ad hoc reviewers, or
reviewers for other Federal agencies.
23 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-026.html
Clarification of NIH Policy on Late
NIH expects grant applications to be submitted
• 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
24 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:
– 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:
25 GWAS Website: http://grants.nih.gov/grants/gwas
Revised NIH Parental Leave Policy for
Trainees on institutional training grants and individual
fellowships may receive stipends for up to 60
calendar days (equivalent to 8 work weeks) for
parental leave per year.
• NRSA programs affected: F30, F31, F32, F33, T32, T34,
T35 and NRSA portion of T90 awards.
• Applies to adoption or birth of a child when those in
comparable training positions at the grantee organization
have access to this level of paid parental leave.
• Either parent is eligible for leave.
• The use of parental leave must be approved by the training
26 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-064.html
Revised Policy on Concurrent Support
from K Awards and Research Grants
Recipients of mentored career development (K)
awards may reduce effort on their K award in its final
two years when they successfully compete for a peer-
reviewed research grant from any Federal agency.
• Effort may be reduced to no less than 6 person-months (or
50% full-time professional effort) and replaced with effort
from the research award so the total research effort
commitment remains at 9 person-months (75% effort).
• K awardee must be one of the named PIs on a competing
research grant application or sub-project director on multi-
component research or center grant or cooperative
27 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html
FY 2008 Legislative Mandates
• Most provisions identical to existing requirements in
Appropriations from FY 2005-2007
• Ban on False and Deliberately Misleading Scientific
– Similar to existing research integrity, fraud and false
– No significant changes expected for grantees.
• Restriction on Employment of Unauthorized Alien Workers
– Similar to existing Immigration and Nationality Act
– No significant changes expected for grantees
• NIH Public Access Policy
– No longer optional – compliance mandated by law
28 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.
• Compliance mandated by Public Law 110-161
• Applicable to:
– Peer-reviewed articles,
– Accepted for publication on or after 4/7/08, and
– Arising from direct grant or contract funds active in FY
2008, and beyond.
• Full-text articles to be made publicly available on NLM’s
PubMed Central no later than 12 months after date of
29 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
30 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 NIH-
funded 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.
31 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
Registration of Clinical Trials
• 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
• 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.
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
• Salary Cap Summary (Historical Information):
33 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
• Multiple Principal Investigator website and FAQs:
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
• All award recipients must be e-mail enabled!
– Edit your institutional profile in the eRA
– If already enabled, confirm that the address is
35 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html
• 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
• Does not apply to other Federal
36 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
37 More at: www.FederalSpending.gov
Highlights of New and
Existing Grant Requirements
Financial Conflict of Interest
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
• 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 (FCOICompliance@mail.nih.gov)
• NIH Guide Notices
39 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
40 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:
– Guide Notice: http://grants.nih.gov/grants/guide/notice-
41 FCOI questions for NIH? FCOIcompliance@mail.nih.gov
• 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
Entire report available at:
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
• An Investigator is not just the Principal Investigator or
Senior/Key Personnel conducting the PHS-sponsored
• Recipient institutions are encouraged to broadly
consider an individual’s role, rather than title, and their
degree of independence when applying the definition.
FCOI Summary of
1. At the time of application: Investigators must
submit known significant financial interests to
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.
44 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
– 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.
Information to be Reported
• All FCOI reports should include the
– 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
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.
47 Full report available at: http://oig.hhs.gov/oei/reports/oei-03-06-00460.pdf
FY 2008 OIG Audit Work Plan
• 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)
48 FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1
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
Summary of Audit Requirements
Grantee Type Source of Audit Where to Submit Audit Reports
State & Local OMB Circular A-133 Federal Audit Clearinghouse
Governments 1201 E. 10th Street
Colleges & Jeffersonville, IN 47132
National External Audit Review Center
For-Profits HHS Office of Inspector General
45 CFR Part 74.26 (d) HHS Office of Audit Services
1100 Walnut Street, Suite 850
Kansas City, MO 64106-2197
Foreign NIH Grants Policy
Statement (same as (same as For-Profits)
Closeout Final Reports
Grantees are strongly encouraged to submit
closeout documents electronically through the eRA
• Documents are due within 90 days of
project period end date
– Final Financial Status Report (now required
– Final Inventions Statement & Certification
– Final Progress Report
• Failure to submit timely reports may
affect future funding to the organization!
51 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-051.html
NIH Centralized Processing Center
• NIH encourages electronic submission of closeout
documents through the eRA Commons.
• Centralized office accepts receipt of all non-financial,
paper-based 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
Bethesda, MD 20817 (for other courier/express mail
Renewed Focus on Protecting
Sensitive Data in Research
• Federal Information Security Management Act (FISMA)
requires that all information systems which contain Federal
data, electronic or hard copy, must be protected from
unauthorized access. – Public Law 107-347
– Access to data should be limited through password
protection and other appropriate means.
– Personally identifiable, sensitive and confidential
information should not be housed on portable electronic
devices, but if they must be used the data should be
• FISMA applies to grantees but only when they collect, store,
process, transmit, or use information on behalf of HHS.
All other grantees still have responsibility to protect
personally identifiable, sensitive and confidential data.
53 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-066.html
Protecting Confidentiality in the
NIH Peer Review Process
• NIH is now password-protecting data on the
compact disks sent to peer reviewers prior to
study section meetings. This includes:
– Grant application information
– Previous summary statements
– Appendix materials
– Additional materials (“eAdditions”) in the grant
• Specific instructions for accessing data will
be sent to reviewers with the CDs
54 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-071.html
Requirements and Compliance
Assistance for OHRP / OLAW
• “What Investigators Need to Know About the Care and Use of
– Brochure explains the requirements for using animals in
– 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.
– September 13, 2008: Fort Collins, CO
– September 23, 2008: San Francisco, CA
56 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
– 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@example.com or 301-594-2061)
– Institute/Center (IC) supporting the award
57 More at: Notice NOT-OD-07-044 at http://olaw.nih.gov
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)
58 GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
Public Outreach Materials from
• Call OHRP at
(800) 447-4777 for
up to 50 free
• Now available in
59 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:
60 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html
Application Forms and
Changes to NIH Application Forms
• New PHS 398 forms mandatory for all paper-
based grant applications.
– The new PHS 2271 form is currently available and
must be used for appointments made on/after May
– 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.
62 All Forms Available at: grants.nih.gov/grants/forms.htm
NIH Transition to Adobe Forms
• Begin posting with Adobe in PHS 398
December ‘08 Changes
– Pilot with couple FOAs in late
• Includes upcoming form
changes to minimize impact
on applicant community
After Adobe Transition…
– Fellowship (F) – Career Dev (K)
– Training (T) – Complex
5% Paper 20%
80% competing grant apps now electronic
F, K and T Transition Plans
February 12 – Research Career Development (K)
April 8 - Individual National Research Service Awards (F)
September 25 - Institutional National Research Service
Awards and Other Training Grants (T)
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
K F T
Avoid Common Errors
• 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
• R&R Budget form - Senior/Key Person effort must be
greater than zero
• Clicking “Submit” is not the last step! Applicant is
responsible for tracking it through the submission
66 More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
• Responded to applicant
– Reduction of correction window
in eRA Commons from 5 days
to 2 days.
– Enhanced application guide
– Extended application viewing
times through Federal holidays
67 More at: http://era.nih.gov/ElectronicReceipt/
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
– Veteran’s Health Administration (VA)
Enhanced eRA Commons
Features – 10/2007
• Electronic Streamlined Non-competing Award
– 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
• Ability to monitor the electronic submission of
• Updated Status screens
70 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-064.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 testing is expanding to all FDP
institutions in June 2008.
• Full production release expected Fall 2008
• 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,
– Position Titles
– Addresses - e-mail & postal
Helpful NIH Technical
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
– New search tools
– Comprehensive glossary and acronyms list
– New content walks through the NIH grant-
• Also improved & updated eRA web site
74 Visit at: http://grants.nih.gov/grants/oer.htm
75 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
• NIH & Grantor Agencies - highlights services
and system modules available for NIH staff and
other Federal agencies
• News & Events - eRA updates and info on
76 Visit at: http://era.nih.gov/
Helpful NIH Web Pages
• NIH Searchable Database of RFAs, PAs, and Guide Notices
• NIH Grants Policy Statement (Rev. 12/03)
• NIH Extramural Nexus – Bimonthly newsletter for the extramural
• Electronic Submission of Grant Applications Homepage
• CRISP database - Search to analyze an Institute’s portfolio of
funded projects, research areas, and more
• Grant Application Basics
New OER Outreach Webpage
New OER Outreach Webpage
• NIH Regional Seminars on Program Funding and Grants
– 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
78 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 - Past
June 19-20, 2008 in Chicago, IL – Today!
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: Contact us!
79 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-076.html
NIH OER Listserv Addresses
• Office of Biotechnology Activities (OBA):
• Office of Human Research Protections (OHRP):
• Office of Laboratory Animal Welfare (OLAW):
– Separate listservs available for scientists and administrators
• NIH Guide for Grants and Contracts:
– The official publication for NIH medical and behavioral research
Grant Policies, Guidelines and Funding Opportunities
Who to Contact!
• Institutional Resources – First, utilize the
expertise of your organization’s Office of
Application Specific Questions
• Administrative - Contact the Grants Management
Specialist at the awarding Institute/Center
• Scientific/Programmatic - Contact the designated
Program Official/Director at awarding
• Review Questions - Contact the assigned
Scientific Review Officer
Who to Contact!
• Grants Administration individuals at all NIH ICs:
• NIH Chief Grants Management Officers:
• 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
Who to Contact!
• General Application Questions: (e-Submission guidelines,
resources & referrals, application review & award process,
– 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: firstname.lastname@example.org
– 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/ Enter your own
– Phone: 301-402-7469 (Toll Free: 866-504-9552) help ticket!
#1 – How do I prepare for
• 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
• All registrations must be completed prior to
It is critical for institutions to begin these registrations
at least 2 – 4 weeks before applications are due!
86 More at: http://era.nih.gov/ElectronicReceipt/preparing.htm
#2 – How do I submit a
– 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
• 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.
87 More at: http://grants.nih.gov/grants/multi_pi/
#3 – Are there any fellowship programs for
individuals from minority or disadvantaged
However, note that a revised FOA includes
the following changes:
• 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.
88 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
• Requests for Applications (RFAs)
– Statement soliciting applications in a well-defined
scientific area to accomplish specific program objectives.
89 All Available at: http://grants.nih.gov/grants/guide/index.html
#5 – Can foreign applicants
submit modular budgets?
• 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.
90 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.
91 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
92 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html
#8 – How do I calculate person-
months 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
• 10% of a 12 month calendar appointment equals
1.2 months (12 x .10 = 1.2 person months)
93 More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm
#9- 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:
– Site also includes available training opportunities.
94 More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-067.html
#10 – Does NIH have a cap on
No. There is no cap on consultant fees and the
NIH salary cap does not apply.
• Grantees must have written policies for paying
– 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.
#11 – 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.
#12 – 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
• Transfer approval is not automatic and requires
approval from both NIH and the original grantee
• Contact your GMO before moving to initiate the
• Grants to individuals may not be transferred but
individual fellowships may transfer to a new