NIAID INSTITUTIONAL PREDOCTORAL RESEARCH TRAINING PARTNERSHIP AWARD

RELEASE DATE:  July 24, 2002

PA NUMBER: PAR-02-135

RECEIPT DATES:  September 10, 2002, 2003, 2004

EXPIRATION DATE: September 10, 2004, unless reissued.

National Institute of Allergy and Infectious Diseases (NIAID)  
 (http://www.niaid.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Terms and Conditions of Award
o Required Federal Citations

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID) invites 
applications from academic institutions granting doctoral degrees to establish 
research training partnership programs with our institute's intramural 
research programs. The purpose of this program is to broaden the opportunities 
available to pre-doctoral students, provide them with a unique research 
setting and outstanding resources, and more importantly, to expose them to the 
state-of-the-art research opportunities available at NIAID.  Our intramural 
programs in the Division of Intramural Research and the Dale and Betty Bumpers 
Vaccine Research Center offer a rich research environment as well as a cadre 
of outstanding investigators who may serve as mentors.  In addition, NIAID 
laboratories present a wealth of opportunities for multidisciplinary 
collaboration with the extramural academic community.

MECHANISM OF SUPPORT 

This PA will use the Collaborative Institutional Training Grant award (TU2) 
mechanism.  The total requested project period for an application submitted in 
response to this PA shall not exceed five years.  NIAID expects to make 1-3 
partnership awards per year, subject to the availability of funds.

These Institutional Pre-doctoral Research Training Partnership Awards will be 
carried out in two phases:  

o  Phase I will support the didactic training of pre-doctoral students at the 
applicant academic institutions through the (TU2) training grant.

o  Phase II will support the trainees and their pre-doctoral research in NIAID 
intramural laboratories through the Intramural Research Training Awards 
(IRTA).  

Under this Partnership program, NIAID intramural scientists will collaborate 
closely with the sponsoring academic institution to establish the appropriate 
training program leading to a student's doctoral degree.  The university may 
define the requirements for the Ph.D. degree, but there should be consultation 
and agreement on the scope and duration of the students' research at NIAID.  
Where appropriate, NIAID intramural researchers may be granted faculty status 
by the partnering academic institution while they serve as research mentors 
for the students.  In addition, the academic institution is encouraged to 
involve participating NIAID scientists in teaching, curricula design, and 
other activities of the pre-doctoral training program, as needed.  The nature 
and extent of the collaboration will be determined by the partners and must be 
described in the application.

ELIGIBLE INSTITUTIONS 

o Domestic
o Non-profit 
o Public or private universities, and academic institutions that offer Ph.D.
and/or equivalent health professional degrees

The applicant institution must have a strong research program in the area 
proposed for training as well as the requisite resources to carry out the 
proposed program.  In order to further strengthen an application, the 
applicant institution may also include collaborations with other universities, 
if appropriate.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The Principal Investigator of each partnership must be from the applicant 
academic institution and will serve as its Program Director.  This individual 
will be responsible for the overall direction, management, and administration 
of the program.  If the application includes other academic entities, faculty 
from the collaborating institutions should also be established researchers.  
The Principal Investigator shall be responsible for identifying the NIAID 
intramural laboratories willing to participate in the program. In addition, 
the Principal Investigator will establish a strong working relationship with 
the lead scientist who will serve as the intramural research training program 
director (IRTPD). In certain cases, such as when the training program proposed 
is broad in scope, more than one NIAID laboratory may be involved in this 
partnership program, and it may be appropriate to have more than one IRTPD.  
However, a primary IRTPD should be named to oversee the Phase II IRTA.

The applicant must describe the roles and responsibilities of the university 
and the participating NIAID laboratories as well as provide evidence that 
these entities and the IRTPD(s) have agreed to collaborate.

The IRTPD will be responsible for the overall direction, management, and 
administration of the NIAID-based part of the program, although this will be 
done by consultation and consensus with the Principal Investigator at the 
academic institution.  

The following list shows the participating NIAID intramural programs and the 
contact person(s) for each laboratory:

DIVISION OF INTRAMURAL RESEARCH (DIR) LABORATORIES 
(See http://www.niaid.nih.gov/dir/labs.htm for addresses, phone numbers and e-
mail addresses)

Laboratory of Allergic Diseases (LAD)
Contact: Dean Metcalfe, M.D.
LAD conducts basic and clinical research on immunologic diseases (emphasis on 
disorders of immediate hypersensitivity, including the spectrum of classic 
allergic diseases). Basic research efforts are directed at studying the growth 
and differentiation of mast cells, the interactions of mast cell surface 
receptors, and signal transduction pathways in inflammation. Clinical research 
involves the pathogenesis of allergic inflammation and the role of T 
lymphocytes and their cytokines in this process.

Laboratory of Cellular and Molecular Immunology (LCMI)
Contact: Ronald Schwartz, M.D., Ph.D.
Senior Investigators: B.J. Fowlkes, Ph.D., Polly Matzinger, Ph.D.
LCMI research projects currently focus on lineage commitment in the thymus, 
the role of danger and costimulatory signals in initiating an immune response, 
the molecular basis of costimulation, molecular and cellular aspects of T cell 
anergy, the cloning of genes from thymic epithelial cells, dissection of in 
vivo models of CD4+ T cell tolerance, and the cloning of genes involved in T 
cell receptor activation-induced cell death.

Laboratory of Clinical Investigation (LCI)
Contact: Stephen Straus, M.D.
Senior Investigators: Warren Strober, M.D., John Bennett, M.D., Jeffrey Cohen, 
M.D., Joshua Farber, M.D., June Kwon-Chung, Ph.D.
Major current emphases include studies of recurrent herpes simplex virus, 
varicella-zoster virus, Epstein-Barr virus, HIV infection, invasive 
aspergillosis, cryptococcosis, candidiasis, histoplasmosis, Lyme borreliosis, 
leishmaniasis, and tuberculosis. LCI investigators identify and characterize 
microbial virulence genes; cellular, cytokine, and chemokine responses to 
microbial pathogens; and the genetic, cellular, and biochemical bases for 
immune dysregulation leading to chronic autoimmune and inflammatory diseases 
and immune deficiency states 

Laboratory of Host Defenses (LHD)
Contact: John Gallin, M.D.  
Senior Investigators: Harry Malech, M.D., Steven Holland, M.D., Thomas Leto, 
Ph.D. Philip Murphy, M.D., Helene Rosenberg, Ph.D.
The LHD studies mechanisms of host defense against bacterial and fungal 
infections, with particular emphasis on the biochemistry, function, and 
structure of phagocytic cells. The program integrates laboratory studies with 
clinical trials to develop new diagnostic and therapeutic approaches to 
patients in whom inherited defects in host defense affect phagocytic cells. 

Laboratory of Human Bacterial Pathogenesis (LHBP)
Contact: James Musser, M.D., Ph.D. 
Senior Investigators: Tom Schwan, Ph.D., Patricia Rosa, Ph.D., Frank 
Gherardini, Ph.D.
Research projects currently focus on the molecular basis of pathogen-arthropod 
vector interaction using pathogenic Borrelia spp.-tick and Yersinia pestis-
flea model systems; the role of high-frequency genetic and antigenic variation 
in the pathogenesis of Neisseria gonorrhoeae infections; the genetic basis of 
antimicrobial agent resistance, host susceptibility, and disease specificity 
in Mycobacterium tuberculosis; and the molecular basis of epidemic waves and 
human-pathogen interactions in group A Streptococcus. 

Laboratory of Immunogenetics (LIG)
Contact: Susan Pierce, Ph.D. 
Senior Investigators: Eric Long, Ph.D., Peter Sun, Ph.D., Clifton Barry III, 
Ph.D.
LIG research is focused on the cellular and molecular mechanisms that underlie 
the signaling functions of immune cell receptors. Studies encompass a wide 
spectrum of experimental approaches from the structural determination of 
immune receptors to live cell image analysis of the behavior of chemotactic 
receptors.  

Laboratory of Immunology (LI)
Contact: William Paul, M.D. 
Senior Investigators: Ronald Germain, M.D., Ph.D., John Inman, Ph.D., Michael 
Lenardo, M.D., Rose Mage, Ph.D., David Margulies, M.D., Ph.D., Ethan Shevach, 
M.D., Michail Sitkovsky, Ph.D.
Specific areas of current investigation include early lymphocyte development; 
T and B cell receptor gene rearrangement; MHC molecule structure and function; 
antigen processing; T cell and cytokine receptor signal transduction; 
apoptotic cell death; regulation and activity of cytokines; mechanisms of 
cytotoxicity; and control of autoimmune responses.

Laboratory of Immunopathology (LIP)
Contact: Herbert Morse III, M.D.
Major current emphases of the LIP research include studies of murine 
retrovirus-induced immunodeficiency syndrome, termed MAIDS, and analyses of 
leukemia and lymphoma including model systems for chronic myelogenous leukemia 
and B cell lineage lymphomas.

Laboratory of Immunoregulation (LIR)
Contact: Ann Mastradone, Lab Mgr.
Senior Investigators: Anthony Fauci, M.D., John Kehrl, M.D., H. Clifford Lane, 
M.D., Thomas Quinn, M.D., Ulrich Siebenlist, Ph.D.
LIR research is focused on the regulation of the human immune system in health 
and disease, with particular emphasis on the study of immunopathogenic 
mechanisms of human immunodeficiency virus (HIV) infection and disease 
progression. Additional studies seek to understand the role of dysregulated 
immunity in the vasculitic syndromes in order to design and execute rational 
therapeutic strategies for these disease states.

Laboratory of Infectious Diseases (LID)
Contacts: Brian Murphy, M.D., and Robert Purcell, M.D.
Senior Investigators: Peter Collins, Ph.D., Suzanne Emerson, Ph.D., Albert 
Kapikian, M.D., Ching Juh Lai, Ph.D., John Patton, Ph.D., Yasutaka Hoshino, 
D.V.M.
Studies in the LID focus primarily on viruses that play an important role in 
disease of the respiratory and gastrointestinal tracts, the liver, and the 
reticuloendothelial system. Currently, the LID employs the techniques of viral 
genetics and molecular biology to elucidate pathogenesis of disease, and to 
express protective viral antigens and attenuate viral mutants that may prove 
useful as vaccines for prevention of disease.

Laboratory of Intracellular Parasites (LICP)
Contact: Harlan Caldwell, Ph.D.
Senior Investigators: David Hackstadt, Ph.D.
Ongoing work within the LICP focuses on basic immunology and cell biology 
studies aimed at understanding host defenses and host-parasite interactions in 
Chlamydia trachomatis and C. pneumoniae infections. Mucosal host immunity to 
infection of the female genitalia is being investigated in a murine model. 

Laboratory of Molecular Microbiology (LMM)
Contact: Malcolm Martin, M.D.
Senior Investigators: Vanessa Hirsch, D.V.M., D.Sc., Kuan Teh Jeang, M.D., 
Ph.D., Christine Kozak, Ph.D., Klaus Strebel, Ph.D., Eric Freed, Ph.D.
The LMM conducts research on primate (HIV, SIV, HTLV) and murine retroviruses, 
with emphasis on HIV. Research programs focus on viral capsid and envelope 
proteins and their use to generate potentially useful antivirals or vaccines; 
exploration of the structure and function relationship of retroviral accessory 
proteins; and development of animal models for investigations of viral 
pathogenesis and identification of potentially useful antiviral agents.

Laboratory of Parasitic Diseases (LPD)
Contacts: Thomas Wellems, M.D., Ph.D., and Alan Sher, Ph.D.
Senior Investigators: Louis Miller, M.D., Robert Gwadz, Ph.D., Dennis Dwyer, 
Ph.D., Theodore Nash, M.D., Franklin Neva, M.D., Thomas Nutman, M.D., Jose 
Ribeiro, Ph.D., David Sacks, Ph.D.
LPD conducts basic and applied research on the prevention, control, and 
treatment of a variety of parasitic diseases, with emphasis on malaria. 
Biochemical and molecular studies are used to identify the stages and manner 
in which functional immune responses occur, the structure of functional 
proteins, the response of parasites to drugs, and the pathogenesis of 
parasitic diseases. Investigations of factors that influence vector capacity 
and insect physiology and its influence on vector capacity are new areas of 
focus.

Laboratory of Persistent Viral Disease (LPVD)
Contact: Bruce Chesebro, M.D.
Senior Investigators: Marshall Bloom, M.D., Byron Caughey, Ph.D., John Portis, 
M.D., Richard Race, D.V.M.
LPVD research is focused on persistent virus infections of the hemopoietic and 
lymphoid systems and of the central nervous system and the role of persistent 
infection in the development of immune system disease. Models being examined 
include HIV; murine and equine retroviruses; rabies virus; Aleutian disease 
virus of mink; and transmissible spongiform encephalopathies (TSEs or prion 
diseases) such as scrapie, bovine spongiform encephalopathy (BSE or mad cow 
disease), and Creutzfeldt-Jakob disease.

Laboratory of Viral Diseases (LVD)
Contact: Bernard Moss, M.D., Ph.D.
Senior Investigators: Jack Bennink, Ph.D., Edward Berger, Ph.D., Jonathan 
Yewdell, M.D., Ph.D., Thomas Kristie, Ph.D., Alison McBride, Ph.D.
Current topics of basic research include the mechanisms of entry of viruses 
into cells, regulation of viral gene expression, viral DNA replication, 
assembly and transport of viral proteins and particles, viral virulence, and 
humoral and cellular immunity. Applied areas of investigation include 
development of recombinant expression vectors, candidate vaccines and 
antiviral agents. These studies involve a variety of DNA and RNA viruses. 

DALE AND BETTY BUMPERS VACCINE RESEARCH CENTER (VRC) LABORATORIES
(See http://www.niaid.nih.gov/vrc/labs.htm for addresses, phone numbers, and 
e-mail addresses)

Human Immunology Section
Contact: Daniel Douek, M.D., Ph.D.  
Understanding the induction, maintenance and reconstitution of immunity in 
humans.  Study of HIV disease and vaccination against HIV to establish 
correlates of effective and protective immunity. 

Vaccine Production Program
Contact: Phil Gomez, Ph.D.  
Development of manufacturing processes and release tests that provide material 
for Phase I/II clinical trials, with particular emphasis on techniques 
suitable for eventual large-scale manufacture of vaccines.  Preparation of 
regulatory submissions and development of appropriate pre-clinical testing for 
vaccine products.

Viral Pathogenesis Laboratory
Contact: Barney Graham, M.D., Ph.D.
Study of viral immunity and development of animal models of viral 
immunopathogenesis. 

Clinical Trials Core
Contact: Barney Graham, M.D., Ph.D.
Advancement of the most promising vaccine candidates into human clinical 
trials. Study of the natural history of HIV infection and evaluation of basic 
aspects of pathogenesis, antigen presentation, and immune response. 

Immunology Laboratory
Contact: Rick Koup, M.D.
Advancement of methods to translate immune responses to HIV into practical 
applications in clinical trials of prophylactic and therapeutic vaccines.  
Analysis of the strength, breadth, plasticity, phenotype, and functional 
characteristics of the cellular immune response to HIV during natural 
infection. 

Structural Biology Section
Contact: Peter Kwong, Ph.D.
Creation and application of the tools of atomic resolution structural analysis 
-- primarily X-ray crystallography -- to design of an effective HIV vaccine.  
Investigation into the mechanisms by which viruses evade the humoral immune 
response.  Deciphering and exploiting the virological, immunological, and 
biological implications of atomic structures.  

BSL3 Virology Laboratory
Contact: John Mascola, M.D.
Understanding protective immune responses to SIV and HIV with an emphasis on 
humoral immunity and vaccine induced immunity. Areas of investigation include 
studies of mechanisms of antibody-mediated neutralization of HIV with a focus 
on primary virus strains and physiologically relevant target cells. 

Virology Laboratory
Contact: Gary J. Nabel, M.D., Ph.D.
Understanding immune correlates and mechanisms of protection against primary 
HIV infection; the cellular and molecular regulation of viral gene expression; 
entry into the cell; and correlates of immune protection.  Utilization of 
genetic mutations and immunologic assessment in order to develop immunogens 
that elicit broadly neutralizing antibodies to HIV with the goal of developing 
safe and effective AIDS vaccines. Areas of study involve the human 
immunodeficiency virus (HIV), emerging viruses such as Ebola, mechanisms of 
viral gene regulation, and regulation of eukaryotic gene expression.

ImmunoTechnology Section
Contact: Mario Roederer, Ph.D.
Definition of the functional roles of uniquely identifiable leukocyte subsets 
in the healthy immune system, and understanding how perturbations in the 
balance of these subsets lead to disease.  Development and application of 
highly sophisticated technologies for clinical medicine and vaccine trials.

Cellular Immunology Section
Contact: Bob Seder, M.D.
Understanding the cellular and molecular mechanisms by which various cytokines 
and costimulatory molecules regulate cellular immunity in vivo.  Development 
of vaccines for infectious diseases in which the cellular immune response is 
required to mediate protection (e.g., Leishmania major, Mycobacterium 
tuberculosis, HIV).
 
Structural Virology Laboratory
Contact: Richard Wyatt, Ph.D
Utilizing virological, immunological, structural, and biophysical information 
on the HIV-1 envelope glycoproteins to rationally design subunit vaccine 
candidates.  Testing envelope glycoprotein vaccines for their ability to 
elicit neutralizing antibodies in animal models.  Characterization and 
development of broadly neutralizing vaccine candidates. 
  
ROLE OF THE GRADUATE PARTNERSHIPS PROGRAM, NIH:  The Graduate Partnerships 
Program (GPP), Office of the Director, NIH will assist NIAID partnership 
programs established under this Program Announcement as follows:

1.  Tracking of student progress,
2.  Assistance in the recruitment of students (if appropriate),
3.  Mentoring of partnership graduate students at NIH,
4.  Helping establish appropriate student benchmarks of graduate student 
progress, and
5.  Assistance in partnership programs.

In addition, the Director, GPP, has established an advisory committee of 
IRTPDs to assist with the coordination of these programs throughout NIH. NIAID 
IRTPDs will be expected to participate in the activities of this committee.

Trainees appointed to this award: 

1.  Must be citizens or non-citizen nationals of the United States or must 
have been lawfully admitted for permanent residence (i.e. possession of a 
currently valid Alien Registration Receipt Card I-1551, or some other legal 
verification of such status).  Non-citizen nationals are generally persons 
born in outlying possessions of the United States (e.g., American Samoa and 
Swains Island).  Individuals on temporary or student visas are not eligible.

2.  Must be assured of the opportunity to carry out supervised biomedical 
research in the NIAID intramural program with the primary objective of earning 
a Ph.D. or equivalent degree, and developing or extending their research 
skills and knowledge in preparation for a research career.

3.  Are required to pursue their research training on a full-time basis, 
devoting at least 40 hours per week to the program.  Within the 40 hours per 
week training period, research trainees who are also training as clinicians 
must devote their time to the proposed research training and must confine 
clinical duties to those that are an integral part of the research training 
experience.

4.  Will not incur any payback obligations.

SPECIAL REQUIREMENTS 

Stipends and Other Allowable Costs

Applicants are encouraged to determine the appropriate number of trainee slots 
based on (1) their present pool of trainees, and (2) the number of trainees 
NIAID laboratories are able to accommodate.

Students will receive a stipend, at the NRSA level, while in training at their 
academic institution.   The stipend levels for NRSA funds are at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html. When the 
students are in residence at the NIAID laboratories, they will be supported by 
an IRTA at the salary levels at 
http://www1.od.nih.gov/ohrm/pay/2002/NIH2002.htm.

The stipend is provided as a subsistence allowance to help trainees defray 
living expenses during the research training experience.  This IRTA stipend 
does not indicate any commitment of future employment with either the NIAID, 
Federal Government or the grantee institution.  

Tuition, Fees, and Health Insurance  
The partnership program will support tuition and fees of the academic 
institution for the trainee at the following rate: 100 percent of all costs up 
to $3,000 and 60 percent of the remainder, for the tenure of the trainee on 
the Phase I of this grant.  Medical insurance coverage is also included in 
this category for the trainee and family members (if applicable).  Costs 
associated with tuition, fees and health insurance are allowable only if they 
are required for all individuals in a similar research training status at the 
institution regardless of the source of support. 

Other Trainee Costs  

Trainee travel, including attendance at scientific meetings that the 
institution determines to be necessary to the individual's research training, 
is an allowable cost.  While the student is supported by the NIAID IRTA 
mechanism, the host laboratory will provide supplies.

Training-Related Expenses  

During Phase I at the academic institution, an allowance of up to $2200 (in 
FY'2002) per trainee may be requested to defray the costs of other research 
training related expenses, such as staff salaries, consultant costs, 
equipment, research supplies, and staff travel. 

During Phase II, while the trainee is supported by the NIAID IRTA mechanism, 
the host NIAID laboratory will provide equipment, research supplies, and 
travel related to the research experience.

Facilities and Administrative Costs
  
A facilities and administrative allowance (indirect costs) based on 8 percent 
of total allowable direct costs (this excludes amounts for tuition, fees, and 
health insurance) may be requested by the academic institution. See NRSA 
policy Guidelines on the NIH Website at: 
http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.  

Prior to developing budgets, applicants are strongly encouraged to contact 
NIAID staff listed under INQUIRES.

Special Program Considerations. The primary objective of this Institutional 
Predoctoral Research Training Partnership initiative is to prepare qualified 
individuals for future careers in biomedical research by providing 
collaborative training opportunities that would not otherwise be possible at 
either institution alone.  The ultimate objective is to significantly impact 
the Nation's research agenda through the collaborative involvement of NIH 
intramural researchers and laboratories at academic institutions.  

Because of the underrepresentation of racial or ethnic groups underrepresented 
in the biomedical sciences applicants should make strong efforts to include 
trainees from these groups in their pool of trainees.  The following groups 
have been identified as underrepresented in the biomedical sciences 
nationally: African Americans, Hispanic Americans, Native Americans, Alaskan 
Natives, and Pacific Islanders.  Use of the term minority in this announcement 
will refer to these populations.

In addition, NIAID encourages the submission of applications from minority 
serving institutions.  Applicants from non-minority institutions are 
encouraged to include minority-serving institutions in collaborative 
arrangements as a means of including adequate numbers of minority students in 
their pool of trainees.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Milton J. Hernandez, Ph.D. 
Office of Special Populations and Research Training 
National Institute of Allergy and Infectious Diseases 
Room 2133, MSC-7610
6700-B Rockledge Drive
Bethesda, MD 20892-7610 
Telephone: (301) 496-3775 
FAX: (301) 496-8729 
Email: mh35c@nih.gov

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

Barbara Huffman 
Office of Special Populations and Research Training
National Institute of Allergy and Infectious Diseases 
Room 2132, MSC-7610 
6700-B Rockledge Drive
Bethesda, MD 20892-7610 
Telephone: (301) 496-3821 
FAX: (301) 496-8729
Email: bh23q@nih.gov
SUBMITTING AN APPLICATION

Applications  must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applicants should use the section on 
Institutional National Research Services Awards 
http://grants.nih.gov/grants/funding/phs398/phs398.html).   The version of the 
PHS 398 is available in an interactive, searchable PDF format.  For further 
assistance contact GrantsInfo, Telephone: 301/435-0714, email: 
GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR INSTITUTIONAL PREDOCTORAL RESEARCH TRAINING 
PARTNERSHIP AWARD:  Applicants are encouraged to utilize the appropriate 
tables included at the following website: 
http://www.niaid.nih.gov/ncn/training/t32tables/default.htm in their submission.

A.  Biographical Sketch

Applicants should include the standard NIH biographical sketches for the 
Principal Investigator and all key faculty members from the academic 
institution and NIAID laboratories. 

B.  Resources

Describe the resources of the university that support the proposed training 
program.

C.  Budget

All requests for funds should be justified and must be within the allowable 
costs for NRSA awards.  

D.  Specific Aims
  
Describe: (1) scientific content of the proposed Ph.D. (or equivalent) program 
with specific areas of knowledge considered core for each graduate student 
trained; (2) the expected outcome(s) of the training program; and (3) how the 
partnership with the NIH intramural programs and faculty to be involved in the 
partnership supports and uniquely enhances the content matter and research 
training for the program's graduate students.

E.  Research Training Program (Phase I)

1.  Background.  Summarize the research training activities of major 
participating units with current training activities of departments and 
organizations represented in the proposed program.  Emphasis should be placed 
on the general rationale for the partnership and mutual benefits that the 
institution(s) expect to derive from the NIH training affiliation that could 
not otherwise be achieved outside this partnership award.  Include a 
discussion of potential opportunities that the partnership may consider as the 
relationship and affiliation evolves.  

2.  Preliminary Data.  The previous training experience of the university 
regarding the applicant pool to graduate programs and number of matriculated 
students each academic year should be described.  Describe the training record 
of all university faculty members in the program.

3.  Outline the curriculum of the proposed program and the individuals who 
will be involved in the teaching.  If applicable, describe how NIH intramural 
staff's involvement will enhance the didactic training.

4.  Describe how and when trainees will transition from their didactic 
training at the university to their research training at the NIH intramural 
program.  List benchmarks to note progress of students during the training 
leading to the doctoral degree.

5.  Describe how and when trainees will identify a research dissertation 
advisor or co-advisor.

6.  Document institutional and departmental commitment to support this 
cooperative study and staff dedicated to this program.  A letter of commitment 
from a senior official (e.g., President or Dean) at the applicant institution 
should outline the commitment for faculty and resources to sustain and support 
the training program throughout the period of funding.  

7.  Describe specific recruitment plans for the program, including sources and 
availability of candidates and proposed admissions criteria for candidates.  

8.  Include a detailed recruitment plan for individuals from underrepresented 
racial/ethnic populations.  Describe the department's previous efforts in 
recruiting underrepresented minorities.

9.  Describe how students will be instructed in the responsible conduct of 
research at the university.

10. Provide a plan for evaluating the overall progress and success of the 
partnership training program and describe the benchmarks that will be used to 
note and evaluate progress of students during the training leading to the 
doctoral degree.

F.  The Role of the NIH Intramural Program (Phase II)

The application should include documentation, signed off by the NIAID 
intramural Program Director, including the following: 

1.  Documentation about the roles and responsibilities of the IRTPD and 
participating members from NIAID's intramural program in the overall training 
program.

2.  A letter from the Director, Division of Intramural Research, or the 
Director, Vaccine Research Center, assuring that NIAID scientists will be 
given time and funds to teach and travel to the university for the purposes of 
training predoctoral students in the program. 

3.  A plan for evaluating the overall progress and success of the partnership 
training program and describe the benchmarks that will be used to note and 
evaluate progress of trainees during the training leading to the doctoral 
degree.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, 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: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. Applications must 
be received by the date listed above.  If an application is received after 
that date, it will be returned to the applicant without review.  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 NIAID.  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 National Institute of Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

(1) Objectives, design, and direction of the research training program with 
attention to recruitment, course offerings, research experiences, mentoring, 
and expected competencies of students, and program oversight.

(2) Qualifications of the university program director to provide leadership, 
oversight and management of the research training program.

(3) Qualifications of the preceptors at the university and the collaborating 
NIAID intramural scientists and mentors.

(4) Adequacy of the training environment, including the institutional 
commitment of the university and the collaborating NIAID intramural research 
program.

(5) Adequacy of the recruitment and selection plans and the availability of 
high quality candidates.

(6) Demonstration that the collaboration is one that will enhance the research 
training of graduate students.

(7) Quality of the plan for evaluating the progress and success of the 
partnership as a whole and the progress of the individual trainees using 
measurable indicators.

Recruitment Plan for Underrepresented Minorities 

The NIH remains committed to increasing the participation of individuals form 
underrepresented minority groups in biomedical research.  Applications must 
include a specific plan to recruit and retain underrepresented minorities in 
the training program.  If an application is received without a plan the 
application will be considered incomplete and will be returned to the 
applicant without review.  Additional information on this requirement was 
published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, 
July 16, 1993 
(see http://grants.nih.gov/grants/guide/notice-files/not93-188.html).  

The minority recruitment plan will be discussed after the overall 
determination of merit.  The review panel's evaluation will not be a factor in 
the determination of the priority score but will be included in an 
administrative note in the summary statement.  If the minority recruitment 
plan or if the record of recruitment of minorities is judged to be 
unacceptable, funding will be withheld until a revised plan that addresses the 
deficiencies is received.  Staff within the NIH awarding component, with 
guidance from the appropriate national advisory committee, will determine 
whether amended plans and reports submitted after the initial review are 
acceptable.

Training in the Responsible Conduct of Research

Every predoctoral trainee supported by an institutional training grant must 
receive instruction in the responsible conduct of research.  (For more 
information on this provision, see the NIH Guide for Grants and Contract, 
Volume 21, Number 43, November 27, 1992, see 
http://grants.nih.gov/grants/guide/notice-files/not92-236.html).  Applications 
must include a description of a program to provide formal or informal 
instruction in scientific integrity or the responsible conduct of research. 
Application without plans for instruction in the responsible conduct of 
research will be considered incomplete and may be returned to the applicant 
without review.

Plans must address the subject matter of the instruction, the format of the 
instruction, the degree of faculty participation, trainee attendance, and the 
frequency of instruction. The rational for the proposed plan of instruction 
must be provided.

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 and educational merit of the proposed project as determined by 
peer review
o Availability of funds 
o Relevance to program priorities
o Balance among types of research training supported by the awarding component
o Acceptability of the plan for minority recruitment
o Acceptability of the proposal for instruction in the responsible conduct of 
research

NIAID staff will notify the applicant of the final action shortly after the 
second level of review has taken place.

TERMS AND CONDITIONS OF AWARD

Terms and Conditions of Award 

The following terms and conditions will be incorporated into the award 
statement and will be provided to the University Research Training Program 
Director, as well as the appropriate institutional official, at the time of 
award.  The following special terms of award are in addition to, and not in 
lieu of, otherwise applicable OMB administrative guidelines, HHS grant 
administration regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable 
when State and local Governments are eligible to apply], and other HHS, NIH, 
and NIH grant administration policies: 

1.  The administrative and funding instrument used for this program will be 
the Collaborative Institutional Training Grant (TU2).  The Principal 
Investigator has the primary responsibility for carrying out the activities 
proposed in the application. However, specific tasks and activities may be 
shared with the participating NIAID DIR and VRC staff and the IRTPD.

2.  Awardee's Rights and Responsibilities: 

The Principal Investigator will have the primary responsibility for the 
oversight, administration and management of the NRSA-supported part of the 
research training program within the guidelines of the PA. The Principal 
Investigator will agree to accept close coordination, cooperation, and 
participation of participating NIAID intramural research training program 
director.
 
The Principal Investigator will: 

Recruit graduate students for the program, with special attention to 
increasing the number of underrepresented minority trainees;

Ensure that there are adequate faculty with appropriate mentoring skills and 
research experience to participate in the training program;

Ensure that the didactic portion of the research training program is 
appropriately rigorous so that students are grounded in fundamentals of the 
sciences appropriate to their research interests;

Establish a steering committee to monitor the students' progress and to 
evaluate the effectiveness of the partnership and the research training 
program; 

Ensure that the research interests of the students are matched with the 
research interests of the participating NIAID intramural faculty; 

Ensure that the roles and responsibilities that are agreed to by the IRTPD are 
 communicated to the university faculty and that there is adequate 
communication between the program directors regarding when students will 
transition from the didactic program to the dissertation research program.
  
3. NIAID IRTPD responsibilities: 

Oversight of the research in support of the students' dissertations;

Work collaboratively with the Principal Investigator to ensure that there are 
acceptable procedures to recruit and select graduate students to participate 
in the research programs of the NIAID intramural program;

Work with the Principal Investigator to ensure a smooth transition from the 
didactic part of the training program to the dissertation research part of the 
program;
 
Be informed about and in compliance with the institution's requirements for 
doctoral degrees; 

Ensure that every graduate student selected for participation in the NIAID 
intramural research program will pursue a research project that will result in 
a doctoral dissertation, will receive appropriate mentoring, and will be 
provided with the resources to pursue the research.

Set up an internal advisory group to develop policies for graduate students 
under this program, to monitor students' progress and to evaluate the 
university partnership and the research training program.

Attend Steering Committee Meetings and accept and implement the guidelines and 
procedures approved by the Steering Committee; 

4. Annual Meetings 

All participants (students and faculty) in the Institutional Predoctoral 
Research Training Partnership Award will meet once a year to review 
procedures, roles and responsibilities of the university and NIH intramural 
participants, and to monitor the progress of the students. 

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 and No. 93.856, Microbiology and Infectious Diseases Research. 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. 


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.