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NIH Flashcards

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1
Q

of NIH Institutes and Centers

A

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Each awarding Institute/Center (I/C) has its own mission and priorities, budget and funding mechanisms

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2
Q

NIH Scientific Review Officer

A

Responsible for scientific and technical review

Point of contact for applicants during the review process

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3
Q

NIH Program Official

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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

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4
Q

NIH Grants Management Officer

A

Responsible for completion of business management requirements

  • evaluates applications for administrative content and compliance with policy
  • negotiates awards
  • interprets grants admin policies
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5
Q

Types of NIH Funding

A

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

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6
Q

NIH Research Project Grant Program (R01)

A
  • 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
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7
Q

NIH Small Grant Program (R03)

A
  • 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
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8
Q

NIH Support for Conferences and Scientific Meetings (R13 and U13)

A
  • 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
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9
Q

NIH Academic Research Enhancement Award (AREA or REAP) (R15)

A
  • 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
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10
Q

NIH Exploratory/Developmental Research Grant Award (R21, R33)

A
  • 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
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11
Q
  • 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
A

NIH Clinical Trial Planning Grant (R34)

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12
Q

NIH Small Business Technology Transfer (STTR) (R41/R42)

A
  • 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
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13
Q

NIH Small Business Innovative Research (SBIR) (R43/R44)

A
  • 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
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14
Q

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.
A

NIH Resource-Related Research Projects (R24)

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15
Q

NIH Education Projects (R25)

A
  • 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.
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16
Q
  • Invites eligible institutions to seek access to NIH research resources
  • Also categorized as a resource grant
A

NIH Resource Access Program (X01)

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17
Q

NIH K01

A
  • 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.

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18
Q

NIH K99/R00

A
  • “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
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19
Q

Ruth L. Kirschstein National Research Service Awards for Individual Fellowships (F series) and Training Grants (T series)

A 
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
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20
Q

Research Project Cooperative Agreement (U01)

A
  • 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
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21
Q

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

A

Research Program Project Grant (P01)

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22
Q

Often used to support planning activities associated with large multi-project program project grants

A

Exploratory Grants (P20)

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23
Q

Center Core Grants (P30)

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A

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

24
Q

FOA Types

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A

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

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NIH Budget Types
R&R Detailed Budget Modular Budget
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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
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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
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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"
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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
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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) ```
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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)
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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)
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Type 1 Application
New
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Type 5 Application
Non-competing continuation
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Type 3 Application
Competing Supplemental
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Type 4 Application
Funded Extension Award (R21 to R33, K99 to R00)
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Type 8 Application
Change of sponsoring IC within NIH for non-competing continuation
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Type 2 Application
Competing Continuation
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Type 7 Application
Transfer from one grantee institution to another
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Type 9 Application
Change of sponsoring IC within NIH for competing renewal
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NIH Grants Policy Statement
> Terms and conditions for all NIH grant awards > Explicitly defines roles, responsiblities
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> 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
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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
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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
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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.
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How many phases of NSF award cycle?
3
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NSF Phase 1
- starts when finding opp is released - 90 days *** - proposal prep and submission - ends w submission
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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
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NSF phase 2
- proposal review and processing - 6 months *** - peer review from EXTERNAL reviewers - program officer review and recommendation - division director review
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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
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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
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NIH Grants Policy Statement
- trumps UG - terms and conditions of award - incorporates applicable grant regulations that apply to NIH awards
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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
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P Series
Program Project / Program Centers
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U Series
Cooperative agreements
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R Series
Research
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