NATIONAL INSTITUTES OF HEALTH ROADMAP INITIATIVE

MULTIDISCIPLINARY CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS

Request for Applications
RFA-HD-04-006

Please go to http://www.nichd.nih.gov/RFA/rm-05-016/roadmap.htm for update information on the re-issuance of this RFA, RM-05-016.

The purpose of this RFA is to support the early career development of clinical researchers from a variety of disciplines engaged in all types of clinical research, including patient-oriented research, translational research, small- and large-scale clinical investigation and trials, and epidemiologic and natural history studies. These individuals would be expected to achieve excellence in their ability to design and oversee research in multidisciplinary team settings, and have a high potential to become leaders of various fields of clinical research critical to the overall mission of the National Institutes of Health (NIH). To accomplish this aim, the NIH invites institutions with well-established clinical research infrastructures to submit applications for the establishment of Multidisciplinary Clinical Research Career Development Programs.

Important Dates

Contact Information

Robert Star, M.D.
Senior Scientific Advisor
National Institute of Diabetes and Digestive and Kidney Diseases
Building 31, Room 9A-19C, MSC 2560
31 Center Drive
Bethesda, MD 20892-2560
Telephone: (301) 594-7717
E-mail: Robert.Star@nih.gov

Joan Davis M.D., M.P.H.
Program Director
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
E-mail: jd372m@nih.gov

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
E-mail: stretch@nih.gov

Ms. Annette Hanopole
Chief, Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5001
FAX: (301) 480-4782
E-mail: hanopola@mail.nih.gov

Frequently Asked Questions

Multidisciplinary Clinical Research Career Development Program

  1. If my institution already has another K12 program, are we eligible to apply for this RFA?

    Yes. However, you will need to explain how the addition of this Trans-NIH K12 will enhance clinical research training at your institution. You will also need to document that you have sufficient resources (mentors, pool of potential CR Scholars, clinical research infrastructure) to support concurrent K12 programs. You should also address how the K12 programs interact. How are the programs different? How will you decide who (i.e., mentors, Scholars) is in which program? Will the programs be separate and distinct programs that avoid overlap in terms of research topics? Will other K12 trainees be enrolled in the Core courses that are developed under this RFA? Note: this is allowed. Will there be overlap of mentors?

    We expect a broad representation of disciplines in the Programs developed under this RFA. All applicants are encouraged to describe the multidisciplinary clinical investigations/topic areas that will make up their proposed programs.

    A multidisciplinary approach brings experts from diverse disciplines for example, clinicians from different specialties (pediatrician and an infectious disease specialist, epidemiologist, clinical trialist and a pharmacologist) to address collectively a common complex problem.

  2. If my institution has a K30 program, are we eligible to apply for this RFA?

    Yes. You will need to explain how the K30 will interact with the Trans-NIH K12. Will the two programs be distinct? Will you use some of the K30 courses in the K12 program, then use K12 funds to develop new courses?

  3. If we have existing curriculum that will serve the Trans-NIH K12 program, can we still apply?

    Yes. You would need to explain how this will be utilized in the Trans-NIH K12 program. Will you then use the Trans-NIH K12 funds to develop new courses?

  4. Can the application focus on a single disease entity or must it be broad in scope?

    The program must not be restricted to a single problem or disease (e.g. cardiovascular disease, cancer, diabetes, etc.), but rather should be dispersed across multiple health conditions. During the practicum phase, we expect that an individual CR scholar's research projects may be focused on a single disease or health problem. However, the program should have a broad focus and representation from multiple disciplines and specialties.

  5. Do scholars apply?

    This is an institutional award. Individual scholar candidates do not apply to the RFA. They wait to see what institutions are funded, then apply to a Program directly, not to NIH.

  6. If a potential scholar is already studying under an existing K12, is he/she eligible for this program?

    Yes. However, the cumulative length of time under NIH-sponsored K12 programs should be no more than 5 years. Since the minimum amount of time any one Scholar may spend in this Trans-NIH K12 program is two years, he/she may not have had more than three years of support under the previous K12 program. Furthermore, the applicant would need to justify additional mentored research training or training in a team context.

  7. Are scholars under this program eligible to apply for individual K awards such as the K08 and K23?

    Yes, but to apply for a K08 or a K23 application after being supported on this K12 would require a very strong justification to convince peer reviewers of the need for additional mentored training. CR scholars, after completing their training on the K12, would more likely be prepared to submit a K22, R-type or U-type grant application (e.g. R03, R21, R01, U01, etc.).

  8. If I hold a K23 or K08, am I eligible for this RFA?

    No. See the Eligible Scholars section of the RFA.

  9. Can two hospitals (or entities) from the same university apply separately to this program?

    No. See the Eligible Institutions section of the RFA. The intent of this RFA is to develop an identifiable Clinical Research Career Program that integrates existing clinical research training/career development programs and infrastructure within a university. The program should perform effectively as one activity across institutional boundaries. An eligible institution (e.g., university) may submit only a single application in response to this RFA, although the application may come from any division, faculty, center, school, or hospital affiliated with the university. Collaborating institutions may be included to supplement training activities in needed areas. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH. This includes any related not-for-profit organizations.

  10. What if a potential program director is involved in other clinical research activities and does not have 40% effort available for this project?

    The site may wish to split the duties between a Program Director and a Co-Program Director. However, you will need to document that together, the two individuals have sufficient effort, time and expertise to oversee a program of this magnitude. How the responsibilities will be divided should be clearly demarcated.

  11. What is the definition of clinical research in this RFA?

    The NIH defines Clinical Research as patient-oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.

  12. What do you mean by disciplines?

    We expect the scholars to come from a broad representation of disciplines, specialties, and sub-specialties. Medicine, nursing, pharmacology, statistics, informatics, and behavioral science are different disciplines. Internal medicine, surgery, pediatrics, and radiology are different specialties of medicine. Cardiology, infection disease, nephrology, and oncology are different sub-specialties of internal medicine. Thus, a pediatrician, a PharmD, a statistician, and an informatician would be considered four disciplines. However, four types of internal medicine sub-specialties would not meet the multidisciplinary criteria required in this program. In addition, a mathematician or chemist would need to be performing translational research. We want scholars who are working on clinical research not on "nanoscience".

  13. What career stage should potential CR Scholars be at?

    CR Scholars must hold a doctoral level degree. We are seeking individuals at an early stage of their career, even while they are in subspecialty training. We expect that CR scholars will be postdoctoral level trainees or junior faculty who plat to conduct, or are conducting, clinical research. Some CR Scholars may be at the tenure-track/assistant professor level when they enter the program, but we hope most CR Scholars will be at a much earlier stage. We expect that CR Scholars will become assistant professor or tenure-track clinical research faculty either during or after they progress through the program.

  14. Are fellows eligible to apply to be scholars in this program?

    Yes. We want to make it easy to access this program. We want to attract doctoral level clinical researchers even during subspecialty training e.g. during their research years.

  15. Can we request an administrative assistant during the planning phase?

    Yes. During the planning phase you may request up to 1/2-1 FTE for an administrative assistant.

  16. After the 40% effort in the planning phase ends, can the 20% effort still be split between two people?

    Yes.

  17. NIH Definition of Clinical Research. For clarification, the full definition is as follows:

    NIH defines human clinical research as (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies
    (2) Epidemiologic and behavioral studies
    (3) Outcomes research and health services research

Clarifications to the RFA

  1. Radiology is a medical specialty not a discipline.

  2. NIH Definition of Clinical Research. For clarification, the full definition is as follows:

    NIH defines human clinical research as (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies
    (2) Epidemiologic and behavioral studies
    (3) Outcomes research and health services research

  3. The 20% effort for the program director(s) after the planning/recruitment phase ends may be split between two individuals.

  4. Administrative support
    For the first year of the grant, you may request up to 0.5 - 1.0 FTE for an administrative assistant. During year two, you may request up to 0.75 -1.25 FTE for an administrative assistant. During year 3 onward, you may request up to 1.0 - 1.5 FTE for an administrative assistant.

  5. Review Criteria - the review criteria listed in the RFA have been grouped into five major categories for the peer review.

Pre-Application National Meeting

The Pre-Application National Meeting/Webcast will be held on December 11, 2003 at the National Institutes of Health, Building 31, 6th floor, Conference Room 10, from 2:30 PM - 4:30 PM.

Format for Application

Applicants should refer regularly to those sections of this announcement that delineate "special programmatic requirements" and "review criteria". The grant application should be organized as follows:

A. Face Page

B. Description, Performance Sites, and Key Personnel

C. Table of Contents

D. Detailed Budget Page for Initial Budget Period, separating the budget for the first 6 months (i.e., Planning Phase) from the second 6 months (i.e., initial implementation phase for 5-8 CR Scholars)

E. Budget for Entire Proposed Period of Support that escalates the number of scholars to 12-15 in the second year and to 20-25 in the third, fourth and fifth years

F. Biographical Sketches (not to exceed two pages per individual)

G. Other Support

H. Multidisciplinary Clinical Research Career Development Program (no more than 40 pages)

(1) Overall Aims

(2) Major Program Elements

(3) Candidate Pool and Recruitment Plans

(4) Evaluation/Tracking

(5) Planning Phase and Milestones

I. Human Subjects

J. Vertebrate Animals

K. Checklist

L. Appendices and Tables.

Suggested Format for Tables to be Included in Application

These suggested formats for presenting tabular information required in the application are not yet available. Please sign up for the Research Careers Program Listserve (http://list.nih.gov/archives/clinrescareers.html) to be notified when these formats become available. The information should include:

  1. Funded Training and Career Development Programs Relevant to Clinical Research. This should include all programs within the institution that are relevant to the purpose and objectives of the Program. (e.g., K30s, T32s, R25Ts, K12s, GCRCs, School of Public Health, Degree Programs, etc.). The table should be organized following headings: Principal Investigator, Source of Support (e.g., Institution, NIH, Other Federal agencies, non-federal support, Industry), Title, Health Focus (e.g., heart disease, child health, aging, mental health, cancer), number of trainees, and Description (no more than two sentences)

    TABLE A. Training And Career Development Programs Relevant To Clinical Research Training

    Clinical Research Program Type, Title, Program Director Source of Support,(Institution, NIH, CDC, AHRQ, HRSA, non-federal support, industry grants) and grant number Type of research (Epidemiology, POR, Clinical trials, methodology, ethics, biostatistics) Health Focus
    (disease)     		Number of Trainees
    Current Total for the Past 5 Years
    Post-doc Junior Faculty Post-doc Junior faculty

    K30

    John Smith, M.D., Ph.D., PI, Chair Molecular Biology, Dir, Cancer Center, Assistant Professor

    		             
    K12 programs













    School of Public Health













    GCRC

    		             
    T32 with Clinical research slot















  2. Existing Funded Clinical Research Support. This should include the overall total (for example, by type and Phase of research), and a table summarizing a representative sample (including at least 50 studies) of the clinical research currently being conducted in the Institution(s). The table should include: Principal Investigator, Source of Support (e.g., Institutional, NIH, other Federal, non-federal, Industry), Title, Research Emphasis (e.g., epidemiology, therapy, diagnosis, nutrition, behavior); Health Focus; Disciplines involved, Dates, Length, Total Costs.

    TABLE B. Current Funded Clinical Research Support (by type and phase of research: Epidemiology, Translational, Patient Oriented Research, Phase 1, Phase 2, Phase 3, Outcomes Research, Health Services Research)

    Department, Principal Investigator/Co-Investigator Source of Support (Institutional, NIH, CDC, AHRQ, HRSA, Industry) and grant number Research Title (and disease focus if not obvious from title) Disciplines Involved Project Period
    (mm/yy-mm/yy)     		Annual
    TOTAL Costs
    Epidemiology
    Jane Doe, MD









    Translational
    John Smith, PhD









    Patient Oriented Research









    Phase 1









    Phase 2









    Phase 3









    Health Services Research











    Outcomes Research











  3. Clinical Research Infrastructure. This should include all shared clinical research facilities within the institution(s) (e.g., GCRC's, incubators, statistical expertise, etc.).

    TABLE C. Clinical Research Infrastructure - Shared Facilities/Resources

    Name of Facility Source of Support (Institutional, NIH, CDC, AHRQ, HRSA, Industry) and grant number Facilities/Resources Primary Department Project Period
    (mm/yy-mm/yy)     		Annual
    TOTAL Costs
    K30









    GCRC










    Centers









    Shared Cores











  4. Expertise and Training Track Record of Program Director, Co-directors(s), MAC members, Mentors, and Other Faculty. This should include Name, rank, department/division, area of expertise, and other relevant information for the Program Director, Co-directors(s), and MAC members, as well as a representative sample of mentors (include at least 25 mentors) and other faculty members included in this Program. For each person, please include a list of recent 5-10 trainees (Trainee Name, degree, research project, current position, current research area, basic or clinical research).

    TABLE D. Training Track Record of Key Program Staff (Including Mentors and Advisory Committee Members)

    Names of Mentor
    and Traineesa
    ( Status while in Training)     		Training Period Degree Title of Research Project
    While Training With This Mentor     		Current or Last Known Position Current or last known research type and topic; Sources of Support
    Jane Doe MD

    Mitchell Jones, Young Faculty


    Maxine Kingston, post-doc

    John Smith, post-doc

    10/02-12/04



    10/99-1/02


    6/96-9/99




    ...............................


    ...............................

    Still in training


    Assistant Professor, UCLA


    Asst. Prof, Cal Tech,




    Clinical Research, Epidemiology

    Basic research, cardiovascular diseases (two NIH R01, AHA)

    Clinical Research, Nephrology


    John Smith PhD

    Michael Doe














    a List individuals in decreasing order of the end dates of their appointments.

  5. Clinical Facilities, Patients, and Specialized Populations. This should include all hospitals and in-patient and out-patient clinics; a numerical distribution of patients relative to disease and/or health issues; and specialized populations that are served by the institutions in this Program.

    TABLE E. Clinical Facilities, Patients and Specialized Populations

    Clinical Research Training Activity of the Major Units and Department Participating in the Proposed Training Program

    Hospital/Department/Unit Specialized Populations served by the Clinical Research Program Numerical distribution of patients relative to Health Conditions/Major Clinical Research Activities
    Park Hospital    
    Parkland Clinic    
    University Hospital