NIH Flashcards
of NIH Institutes and Centers
27
Each awarding Institute/Center (I/C) has its own mission and priorities, budget and funding mechanisms
NIH Scientific Review Officer
Responsible for scientific and technical review
Point of contact for applicants during the review process
NIH Program Official
Responsible for the programmatic, scientific and/or technical aspects of the grant
Provides scientific guidance to investigators pre- and post- award
Develops initiatives
Provides post-award oversight
NIH Grants Management Officer
Responsible for completion of business management requirements
- evaluates applications for administrative content and compliance with policy
- negotiates awards
- interprets grants admin policies
Types of NIH Funding
Research Award Programs (R-Series) - R01, R03, R15, R21, R56
Resource Grants - R24, R25, X01
Research Training Grants and Fellowships (T and F) - T32, T35, F31, F32, F33
Cooperative Agreements (U Series) - U01, U13
Program Project / Center Grants (P Series) - P01, P20, P30, P50
NIH Research Project Grant Program (R01)
- NIH’s most commonly used grant program
- No specific dollar limit unless specified in FOA
- Advance permission required to request $500k or more (direct costs) in any year
- Generally 3-5 years
- All ICs utilize
- Typically uses a modular budget
NIH Small Grant Program (R03)
- Limited funding for short periods for projects aimed at collecting data, developing new technology
- Limited to 2 years of funding
- Direct costs up to $50k per year
- Utilized by ~ half of ICs
NIH Support for Conferences and Scientific Meetings (R13 and U13)
- Support for high quality conferences/meetings that are relevant to NIH’s scientific mission and public health
- Requires advance permission
- Award amounts vary by IC
- Up to 5 years
NIH Academic Research Enhancement Award (AREA or REAP) (R15)
- Supports small-scale research projects at educational institutions that provide baccalaureate or advanced degrees but have not been major recipients of NIH support
- Direct costs limited to $300k over entire project period
- Project period limited to 3 years
NIH Exploratory/Developmental Research Grant Award (R21, R33)
- Provides support in early stages of development; sometimes used for pilot and feasibility studies
- Limited to 2 years
- Combined direct costs for 2 year project period usually cannot exceed $275k total
- The R33 is the 2nd phase of support for research initiated under the R21
- Designed to permit early peer review of the rationale for the proposed clinical trial and support development of essential elements of a clinical trial
- Usually 1 year, cannot exceed 3 years
- Direct costs cannot exceed $100k per year
- Modular budget required
- Only used by select ICs
NIH Clinical Trial Planning Grant (R34)
NIH Small Business Technology Transfer (STTR) (R41/R42)
- 3 phase structure (know the phases)
- Eligibility limited to U.S. small business concerns
- PD/PI may be employed by the SBC or the participating non-profit research institution as long as he/she has a formal appointment with SBC
- Multiple PDs/PIs allowed
NIH Small Business Innovative Research (SBIR) (R43/R44)
- 3 phase structure (know phases)
- Eligibility limited to U.S. small business concerns
- Primary employment of PD/PI must be with the small business concern.
- Multiple PDs/PIs allowed
- All ICs utilize except FIC
NIH
Used in a wide variety of ways to provide resources for problems where multiple expertise is needed to focus on a single complex problem in biomedical research or to enhance research infrastructure.
- Also classified as a resource grant.
NIH Resource-Related Research Projects (R24)
NIH Education Projects (R25)
- To promote an appreciation for and interest in biomedical research, provide additional training in specific areas, and/or to develop ways to disseminate scientific discovery into public health and community applications
- Also classified as a resource grant.
- Invites eligible institutions to seek access to NIH research resources
- Also categorized as a resource grant
NIH Resource Access Program (X01)
NIH K01
- Most common early career award
- PI must be a U.S. citizen or non-citizen national of U.S. or permanent resident of U.S.
NIH K99/R00
- “Pathway to Independence (PI) Award”
- Provides up to 5 years of support consisting of 2 phases:
Phase 1 - provides 1-2 years of mentored support for highly promising, postdoctoral research scientists
Phase 2 - provides up to 3 years of independent support contingent on securing an independent research position - Award recipients are expected to compete successfully for independent R01 support from NIH during the career transition period
- Foreign institutions are not eligible to apply
- For K99/R00: PI can be a non-U.S. citizen
Ruth L. Kirschstein National Research Service Awards for Individual Fellowships (F series) and Training Grants (T series)
Predoctoral - F31 and T01, T32, T35 Postdoctoral - F32 and T32 Senior Fellows - F33 Stipends are determined each year by NIH For K and T grants F&A is usually limited to 8% For F grants no F&A
Research Project Cooperative Agreement (U01)
- Used when substantial programmatic involvement is anticipated between the awarding Institute and Center
- One of the many types of Cooperative agreements
- No funding limit unless specified in FOA
Support for broadly based, multidisciplinary, often long-term research programs with a specific objective or theme
Involve a number of independent investigators who share knowledge and common resources
No specific dollar limit unless specified in FOA
Research Program Project Grant (P01)
Often used to support planning activities associated with large multi-project program project grants
Exploratory Grants (P20)
Center Core Grants (P30)
The core grant is integrated with the Center’s component projects or program projects, though funded independently from them.
Support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide MULTIDISCIPLINARY APPROACH to a joint research effort OR from the SAME DISCIPLINE who focus on a common research problem
FOA Types
Parent Announcements (PA) - Investigator initiated for basic mechanisms
Program Announcements (PA, PAR, PAS) - Highlights area of focus
Requests for Application (RFA) - A one time call for apps
NIH Budget Types
R&R Detailed Budget
Modular Budget
Modular Budget
- For proposals under $250k direct costs per year
- Direct costs in each year must be in $25k increments
- Requires only bottom line direct and indirect costs. Not detailed by category.
- Requires budget justification for personnel on project
- Additional justifications required in following scenarios if applicable:
> Total direct costs increase or decrease from yr to yr
> Consortium justification required for subcontractors
Cosortiums
- For applications involving multiple institutions, the parties choose a lead and others will be subs
- All subs include their budgets in lead institution app
- NIH does not include consortium indirect costs in the lead institution’s direct costs
Consortiums Multi-Project Proposals
- Parties choose a lead, all others are subs
- Typically there is an Overall component (lead), Administrative component (lead), and various component/research project proposals (led by subs or the overall lead)
- Subs leading a component complete component proposal and budget in ASSIST (not included in lead app)
- To capture $25k in F&A costs on each sub, lead completes the “PHS Additional Indirect Form”
NIH Review Process (sequence of events)
- Application submitted
- Center for Scientific Review: Assigns to IC & IRG / Study Section
- Study Section: Reviews for Scientific Merit
- Institute: Evaluates for Relevance
- Advisory Councils & Board: Recommends Action
- Institute Director: Makes Funding Decision
1 T32 GM129176-01
"1" is the application type - new competing "T32" is the grant mechanism "GM" is the IC "129176" is the award # "-01" is the year (budget pd)
5 R01 CA198421-03S1
“5” is the application type - non competing continuation
“R01” is the grant mechanism
“CA” is the IC
“198421” is the grant #
“03” is the year (budget pd)
“S1” is for supplement (could be “A1” for amendment)
Types of Applications
> New (Type 1)
> Competing Continuation (Type 2)
- Request for funding to renew, by one or more budget periods, a project that otherwise would expire
> Competing Supplemental (Type 3)
- Request for increase in support for current budget period for SOW expansion
> Funded Extension Awards (Type 4)
- Request for additional years of support beyond the years previously awarded (R21 to R33, K99 to R00)
- Used for select programs only
> Non-Competing Continuation (Type 5)
> Transfer from one grantee institution to another (Type 7)
> Change of sponsoring IC within NIH for non-competing continuation (Type 8)
> Change of sponsoring IC within NIH for competing renewal (Type 9)
Type 1 Application
New
Type 5 Application
Non-competing continuation
Type 3 Application
Competing Supplemental
Type 4 Application
Funded Extension Award (R21 to R33, K99 to R00)
Type 8 Application
Change of sponsoring IC within NIH for non-competing continuation
Type 2 Application
Competing Continuation
Type 7 Application
Transfer from one grantee institution to another
Type 9 Application
Change of sponsoring IC within NIH for competing renewal
NIH Grants Policy Statement
> Terms and conditions for all NIH grant awards
> Explicitly defines roles, responsiblities
> Affects certain types of awards (F, K, R25, R36, T)
> Applies to all trainees, fellows, students and post docs who work on these projects
> Must incorporate formal and informal training and mentoring
NIH Responsible Conduct of Research Training
When are annual reports due?
- RPPRs are due between 45 and 60 days prior to the end of the current budget period
- For “multi-year” awards (where the entire competitive segment - aka project period - is funded upfront), RPPRs are due by the anniversary of the date of the award.
- Cooperative agreements, NRSA training grants and a few others require annual SF-425s (FFRs) to be filed
> requirement is noted in NoA
> due within 90 days after end of each budget period
NIH Public Access Policy
NIH requires a PDF copy of all publications for research sponsored by them to be publicly available for free within 12 months of publication
PubMed Central
No Cost Extension
First NCE can be requested in eRA Commons. Must be submitted before the current project period end date.
A second NCE requires approval from NIH. Request is filed through eRA Commons.
How many phases of NSF award cycle?
3
NSF Phase 1
- starts when finding opp is released
- 90 days ***
- proposal prep and submission - ends w submission
Reasons why NSF can return proposal without review
1) duplicate or too similar to existing
2) doesn’t follow guidelines
3) missed deadline
4) required proposal sections missing
NSF phase 2
- proposal review and processing
- 6 months ***
- peer review from EXTERNAL reviewers
- program officer review and recommendation
- division director review
NSF phase 3
- award processing
- 90 days ***
- starts when division director has signed off and selected proposals to go through business review by grants and agreement officer
- biz office can still reject proposal at this stage
level 2 NIH Peer review
- institute and center (IC) national advisory council/board review
- scientific + non-scientific members w necessary expertise, chosen by IC, approved by DHHS
- IC Director makes final funding decision based on advisory Board/council recommendation
NIH Grants Policy Statement
- trumps UG
- terms and conditions of award
- incorporates applicable grant regulations that apply to NIH awards
What actions require NIH prior approval? (9)
- change in scope
- change to approved protocols
- application of new technology
- significant rebudgeting (greater than 25%)
- equipment purchase over $25k
- change of key personnel status
- adding foreign sun after NOA received
- greater than 25% carry forward
- second NCE
P Series
Program Project / Program Centers
U Series
Cooperative agreements
R Series
Research
