# Presentation: 487155

## Judith Podskalny, Ph.D.
NIDDK, NIH

- NIDDK, NIH

**Overview of the ****National Institutes of Health**

## Why do this?

- Get you up to speed
- ‘NIH- 101’ based on first meeting of NMRI
- 2 day meeting (now condensed into 1 hour)

## Topics from 1st meeting:

**Overview of NIH**
**Roles of different NIH staff (program, review, grants management)**
**Funding mechanisms**
*Grant-writing*
*Budgets (modular vs non-modular, NGAs, terms and conditions)*
**Review Process**
*Career advice – from mentors and from peers*
*Regulatory issues  (HS, FDA regulations) *

## Preamble: 

- First –
-    don’t let me, or anyone else at these     meetings, talk in acronyms

- Second – see list of acronyms

- Third – 	ask questions

## Topics:

- Who\when to contact
- How to navigate the NIH grants process
- What type of grant
- Loan Repayment Programs

** ****Where to start**

## NIH ‘fact sheet’:

- Part of the Dept. of Health and Human Services (DHHS)
- Budget for 2004 ≈ $28 billion
- 27 Institutes or Centers (ICs)
- ~18,000 employees
- > 60,000  extramural grantees

##  National Institutes of Health (Institutes or Centers)

- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute on Aging (NIA)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- National Cancer Institute (NCI)

- National Institute of Child Health and Human Development (NICHD)
- National Institute on Drug Abuse (NIDA)
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- National Institute of  Dental and Craniofacial Research (NIDCR)
- National Institute of Environmental Health Sciences (NIEHS)
- National Eye Institute (NEI)
- National Institute of General Medical Sciences (NIGMS)

- National Heart, Lung and Blood Institute (NHLBI)
- National Human Genome Research Institute (HGRI)
- National Institute of Mental Health (NIMH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institute of Nursing Research (NINR)
- National Center for Complementary and Alternative Medicine (NCCAM)
- National Center for Research Resources (NCRR)
- National Library of Medicine (NLM)

## Therefore --

- You may have interests that could be funded by more than just NIDDK
- Identify the *several* most likely Institutes for funding based on your specialty/scientific interests
- Become familiar with those Institutes’ websites
- Contact appropriate staff early in the process of applying for any grant

## If you do NOTHING else ---

***	***Sign up for the *NIH GUIDE ListServe*
- _http://grants1.nih.gov/grants/guide/listserv.htm_

- once a week receive a Table of Contents with ‘links’ to PAs, Notices, and RFAs

## Topics:

**Who\when to contact**
**How to navigate the NIH**

## “Grants Process”

## Program staff:

- aka  ‘Program Director’ or ‘Program Administrator’ or ‘Project Officer’
- Work for an Institute or Center
- Handle pre-application questions
- Manage portfolio of grants
- Develop RFAs and PAs
- Observers at study section meetings
- Handle post-review issues
- Send out summary statements
- Initiate funding plans
- Review yearly progress reports

**A**

- 		(see handout)

## Scientific Review Administrators

- Equivalent to program staff on the referral and review side (some SRAs are also ‘referral officers’)
- Work *either* for the CSR or for an Institute (most ICs have their own Review Branch)
- Manage study sections:
- Recruit members
- Assign applications
- Responsible for meetings
- Prepare summary statements

**B**

## Grants Management staff:

- Grants Management Specialists (non-scientific staff)
- Review budgets AND Administrative notes/codes in summary statements in preparation for issuing awards
- Work with applicants, program staff, and OER to resolve issues
- Prepare Notice of Grant Awards

**C**

- 		(see handout)

## Schedule

- Jan-April
- May-Aug	Receipt Dates
- Sept-Dec
- June-July
- Oct-Nov	Review Dates
- Feb-Mar
- Sept-Oct
- Jan-Feb	National Advisory Council Board Dates
- May-June
- Dec 1
- Apr 1		Earliest Possible Beginning Date
- July 1

## Review Outline

- Applications received by Center for Scientific Review  (CSR)

- Assigned to (1) Institute and, often, (2) Study Section

- SRA assigns reviewers and mails out applications

- Copies sent to IC

- IC assigns application to a Program

- Letter mailed to applicant with ‘assignment’

- Copies sent to SRA

- ....4-6 weeks later....

- ~ 3 months

## Review Outline -- continued

- Study Section meets and reviews & scores applications

- Letter mailed to applicant with priority score (& Program Director name)

- SRA enters score into computer

- SRA generates Summary statement

- IC Program staff notified

- Program staff sends summary statement to applicant

- Second level review

- Funding decision

- 1 week

- 2-8  weeks

- Questions?

## Topic:

**What type of grant**

## Types of support (extramural):

- Grants
-  Cooperative Agreements
-  Contracts
-  Interagency agreements

- 	** Grants are by far the major 	     mechanism used --

- 118

- 86

**Notes:**
i.e how we get money to investigators/students/universities

## Sample Application Number

-                      **1  R01  DK  123456 - 01****	****A1**

- Type :  1 = new
-            2 = renewal
-            5 = progress  report

- Institute

- Grant Year

- Mechanism = Activity Code

- Identifying number

- Amended

## Activity code groups:

- F = Fellowships (all levels)
- G = Resource programs
- K = Research Career
- M = M01 = GCRCs
- P = Research Program Projects & Centers
- R = Research Projects
- S = Research-related
- T = Training Programs
- U = Cooperative Agreements

## R-series awards:

- R01s – regular research project grant
- R03s – **only** in response to PAs or RFAs
- R21s – **only** in response to PAs or RFAs
- R34s – **only** in response to PAs or RFAs

- NIH issued ******45,000** awards in FY2003

**Notes:**
R01 = Research project
R21 = Exploratory/Development grant
R03 = Small Research Grants
R15 = Academic Research Enhancement Awards (AREA)

## ‘Features’ of R01s:

- Major grant mechanism
- Renewable
- Budget requested is up to investigator
- Must get prior approval if >$500,000 in any 1 year

- Budget **awarded** is up to the NIH (peer review, Institute policy, funds available)

*Remember ---*

## ‘Features’ of R21s:

- Exploratory grants
- Institute-specific
- Not renewable
- Budgets limited to no more than $275,000 for a 2 year period
- Reviewed in standard study sections in CSR

## ‘Features’ of R03s:

- Small grants
- $50,000 per year for 2 years*
- Not renewable
- Reviewed (usually) in Institute study sections
- * some Institutes use $100,000 for some R03s

## ‘Features’ of U01s:

- Big awards
- Only in response to RFAs
- Need special internal NIH clearance
- NIH staff is involved
- Multiple sites – large scale clinical trials

## Cooperative Agreements

- R01

- U01

- NIH staff

## Request for Applications (RFA)

- One receipt date
- Money is ‘committed’ AND amount is indicated in RFA
- Review usually organized by Institute
- Scores not percentiled
- Often:
- More than one Institute involved (i.e. more chances, more money)

## Program Announcement (PA)

- Multiple receipt dates
- Active for 3 years (unless otherwise stated)
- Shows Institute has an interest in area
- Funds are not ‘set-aside’, but PA is considered when making funding decisions
- Review usually in CSR study sections
- Sometimes – more than one Institute

## Program Announcement(PAR)

- the ‘R’ means additional Referral guidelines – USUALLY it means the review is in the Institute study sections

## Definitions:

- Unsolicited applications
- Solicited applications

-  submitted for one of the “standard” receipt dates
- everything else

## Definitions:

- Unsolicited applications
- Solicited applications

-  most R01s
-     most PAs
-  RFAs
-     some PAs

- Every application submitted to the NIH should include a COVER LETTER....

## Application cover letter:

- Request an Institute –MORE THAN ONE
- Request a study section
- Indicate areas of expertise needed to review your application
- Indicate any individual or group with a *major* conflict of interest
- NEVER--
- Name desired reviewers

## Assignment Considerations:

- Institute guidelines
- IRG guidelines and Competency roster of study section
- if amended application, previous assignment history
- conflict of interest
- workload balance in CSR
*APPLICANT REQUESTS (cover letter)*
** ****ARAs (**_**A**_**waiting **_**R**_**eceipt of **_**A**_**pplication)**

**Notes:**
Add info about ARAs

## Review of Research Grants

- REVIEW CRITERIA:
-   Significance
-   Approach
-   Innovation
-   Investigator
-   Environment

## Review Criteria (continued)

- Significance: Does the study address an important problem?  How will scientific knowledge be advanced?
- Approach: Are design and methods well-developed and appropriate?  Are problem areas addressed?
- Innovation: Are there novel concepts or approaches?  Are the aims original and innovative?
- Investigator: Is the investigator appropriately trained?
- Environment: Does the scientific environment contribute to the probability of success?  Are there unique features of the scientific environment?

- Other mechanisms have different review criteria.......

## Elements reviewed in K applications:

**Qualifications of candidate** (prior training, letters of recommendation, publications)
**Mentors** (previous mentoring experience, expertise in area of research)
**Research project** (hypothesis driven, preliminary data, reasonable in time frame, logical sequence of studies, appropriate safeguards)
**Career** **development plan** and **Environment **(‘enrichment’, training, future plans)

## Resources

- NIH Guide for Grants and Contracts
- Institute web pages
- Grants Net (_[http://www.grantsnet.org](http://www.grantsnet.org/)__)_
- Mentors and colleagues
- NIH staff
- Also.....

## Who else is working in my area of research?

## Do a search ...

- Using ----
**C**omputerized **R**etrieval of **I**nformation on **S**cientific **P**rojects (CRISP)
- _[http://crisp.cit.nih.gov](http://crisp.cit.nih.gov/)_

- Abstracts of funded grants

## Topic:

**Loan Repayment Programs**

## LRP ‘features’:

- Up to $35,000 per year for 2 years
- NIH pays the taxes on this amount directly to IRS
- Institutes prioritize their own applications

## Several Programs:

- Clinical Research
- Clinical Researchers from Disadvantaged Backgrounds
- Contraception and Infertility Research
- Health Disparities
- Pediatric Research

## LRP Eligibility: 2003

- DO NOT refinance

-  Bona fide educational loan

-  Dependent upon indebtedness

-  Recipient agrees to complete                                   	2 years of research

*(concurrent with loan repayment)*

- Debt > 20% of yearly income

-  Engaged in research **** 50%

- Verified 4x a year

-   NIH-funding *NOT* a prerequisite

## LRP information

- _[www.lrp.nih.gov](http://www.lrp.nih.gov/)_

-   Sign up to receive information

**NIDDK in 2002** :
- 	63 applications
- 	55 contracts

- 87%

**NIDDK in 2003** :
- 	171 applications
- 	 89+  contracts

- ≈52%

## If you do NOTHING else ---

***	***Sign up for the *NIH GUIDE ListServe*
- _http://grants.nih.gov/grants/guide/listserv.htm_

- once a week Table of Contents with ‘links’ to PAs, Notices, and RFAs

## Take home messages --

- Sign up for the GUIDE List Serve
- Keep your program director’s phone number and email address handy
- Your goal is to be FUNDED – AND
- You have to be persistent to succeed!

**Judith Podskalny, Ph.D.**
**	****301 594-8876**
**	****jp53s@nih.gov**