INNOVATION GRANTS FOR RESEARCH IN HUMAN IMMUNOLOGY

RELEASE DATE:  March 7, 2002

PA NUMBER: PA-02-073

EXPIRATION DATE:  February 4, 2003, unless reissued. (Expiration date extended, see NOT-AI-02-055) 

National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA) is a new initiative for Innovation Grants for 
Research in Human Immunology. The purpose of this PA is to bring new, 
scientifically challenging and untested ideas into the exploration of the 
human immune system.  There are a number of critical questions in human 
immunology that remain unanswered, and new ideas and fresh approaches are 
needed.  It is anticipated that furthering understanding of human immunology 
will have ultimate impact on better understanding of immunologic and 
infectious diseases in man, the latter including those caused by HIV, agents 
of bioterrorism, and emerging and re-emerging infections. Applications are 
especially welcome from new investigators. 

RESEARCH OBJECTIVES

Significant progress has been made in our understanding of the human immune 
system, much of it through animal model systems for exploring the immune 
response in health and disease. Research efforts directed toward elucidating 
the pathogenic mechanisms involved in the development and progression of 
human diseases have resulted in greater understanding of human immunology.  
Nonetheless, there are many unresolved questions concerning the behavior and 
biology of the human immune system. Through this PA, the National Institute 
of Allergy and Infectious Diseases of the National Institutes of Health in 
collaboration with the Institutes and Centers listed above seeks to encourage 
research projects that will take a fresh approach at tackling these 
questions.  Specifically we are seeking applications that propose to test 
novel and significant hypotheses for which there is scant precedent or 
limited preliminary data, and which, if confirmed, would have a substantial 
impact on current thinking and understanding of human immunology. Increased 
comprehension of human immune processes should lead to increased knowledge of 
immunologically mediated or infectious diseases, including those caused by 
HIV, agents of bioterrorism and emerging or re-emerging infections.   

Examples of topics appropriate for this PA include but are not limited to the 
following areas of human immunology:

o development of innovative techniques or methodologies to study cells of the 
human immune system in situ
o characterization of novel immune cell populations such as T regulatory 
cells and intraepithelial lymphocytes in humans 
o the role of non-adaptive/innate immune mechanisms in the afferent and 
efferent human immune response
o influence of the environment - internal and external, micro and macro - on 
cells of the human immune system, including tissue-specific factors
o age and gender-related differences in the human immune response
o genomic and proteomic approaches to defining specific human immune 
responses 
o determinants of human immune cell lineage commitment and homeostasis
o use of complex data sets and genetic screens to discover relevant human 
immune modifier genes
o characterization of functional diversity of antigen-specific clonal human T 
cells
o characterization of human mucosal immune responses, especially those in the 
oral, gastrointestinal and genitourinary tracts
o novel uses of animal models, including non-human primates, to explore 
issues critical to understanding the human immune system, providing that the 
research cannot be directly performed in humans

MECHANISM(S) OF SUPPORT 

This PA will use the National Institutes of Health (NIH) research project 
grant (R21) award mechanism. Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant. 
Applicants may request up to two years of support and up to $150,000 per 
annum in direct costs.  With compelling justification, exceptions can be made 
if specific costly reagents or animals are needed to perform these studies.  
Program staff may be able to advise prospective applicants concerning 
alternative NIH-sponsored resources that may be available to them. Contact 
the program staff listed under INQUIRIES for further information.

This award is non-renewable.  However, it is hoped that successful grantees 
funded through this exploratory phase program will elect to seek continuing 
support for further developed research areas through the R01 or P01 grant 
mechanisms.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:	

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs

When clinical studies are a component of the research proposed (note: 
clinical trials will not be supported under this announcement), NIH policy 
requires that studies be monitored commensurate with the degree of potential 
risk to study subjects and the complexity of the study.  Terms and Conditions 
of Award will be included with awards.  NIAID policy was announced in the NIH 
Guide on February 24, 2000 and is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.  The full 
policy including terms and conditions of award is available at:  
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:
 
Dr. Susan F. Plaeger 
Division of AIDS
National Institute of Allergy and Infectious Diseases 
Room 4134, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626 
Telephone: (301) 402-9444 
FAX: (301) 402-3211 
Email: SPlaeger@niaid.nih.gov

Dr. Helen Quill
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5140, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640 
Telephone: (301) 496-7551 
FAX: (301) 402-2571 
Email: hquill@niaid.nih.gov

Dr. Irene B. Glowinski
Division of Microbiology and Infectious Disease
National Institute of Allergy and Infectious Diseases
Room 3145, MSC-7630
6700-B Rockledge Drive
Bethesda, MD 20892-7630
Telephone: (301) 496-1884
FAX: (301) 480-4528
Email: Iglowinski@niaid.nih.gov

Dr. John F. Finerty
Cancer Immunology Branch
National Cancer Institute
Room 5060, Executive Plaza North
6130 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 496-7815
FAX: (301) 480-2844
Email: fin@nih.gov

Dr. Allan Lock
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Room 4B01, Building 61E 
6100 Executive Boulevard
Bethesda, MD 20892-7510
Telephone: (301) 496-5541
FAX: (301) 402-4083
Email: al39o@nih.gov 

Dr. Dennis Mangan
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-18
Bethesda, MD  20892-6402
Telephone: (301) 594-2421
FAX: (301) 480-8318
Email: Dennis.Mangan@nih.gov

o Direct your questions about financial or grants management matters to:

Mary Ledford
Division of Extramural Affairs, Grants Management Branch 
National Institute of Allergy and Infectious Diseases 
Room Number, MSC-7614 
6700-B Rockledge Drive
Bethesda, MD 20892-7614 
Telephone: (301) 402-6446 
FAX: (301) 480-3780 
Email: ml28g@nih.gov

William Powell
National Institute of Dental and Craniofacial Research 
Room 4AN-44 MSC-6402
45 Center Drive 
Bethesda, MD  20892-6402  
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  wp43y@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the application deadlines for standard 
receipt dates as well as AIDS-related research depending on the focus of the 
application.  All receipt dates are available at the following link: 
http://grants.nih.gov/grants/dates.htm.  Application deadlines 
are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications must be 
submitted in a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  
Section C of the research grant application instructions for the PHS 398 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR A EXPLORATORY/DEVELOPMENTAL (R21) GRANT 
APPLICATION.

The research plan (items a-d) for an R21 application is limited to 15 pages. 
The total number of pages in all appendix material is limited to 25.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist and any appendices and five signed 
photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING 

The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for 
scientific and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate Institute"s Advisory 
Council
	
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  Note that the R21 grant mechanism does not 
require extensive Preliminary Data.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople 

AUTHORITY AND REGULATIONS:  This program is described in the Catalogue of 
Federal Domestic Assistance in the following citations: No. 93.855, 
Immunology, Allergy, and Transplantation Research Awards, No. 93.856, 
Microbiology and Infectious Diseases Research Awards, and No. 93.121, Oral 
Diseases and Disorders Research Awards. Awards are made under authorization 
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 
241 and 284) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm.  This document includes 
general information about the grant application and review 
process, information on the terms and conditions that apply to NIH Grants and 
cooperative agreements, and a listing of pertinent offices and officials at 
the NIH.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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