and Human Services (HHS)
EXPIRED
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: 301/710-0267, 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.
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NIH Funding Opportunities and Notices
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