MULTIDISCIPLINARY CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS

Request for Applications
RFA-RM-05-016

http://grants2.nih.gov/grants/guide/rfa-files/RFA-RM-05-016.html

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. This is a re-issuance of a previously released RFA, RM-04-006.

Important Dates

• Letter of Intent Receipt Date: February 25, 2005
• Application Receipt Date: March 25, 2005
• Pre-Application Meeting: February, 2, 2005, 1:30pm - 4:30pm (EST), NIH,
  Building 31, Conference Room 9A 22

For those of you who are unable to make it to the NIH campus, you may e-mail you questions up until the day of the broadcast to Robert_Star@NIH.gov
Go to http://videocast.nih.gov/ (TO VIEW THE MEETING)

Contact Information

• For questions about GENERAL PROGRAMMATIC issues:

• For questions about PEER REVIEW issues:

• For questions about FINANCIAL OR GRANTS MANAGEMENT matters:

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 in response 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 five 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.



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?
    
    NIH Definition of Clinical Research is as follows:
    (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
    
    
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 plan 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.

Pre-Application National Meeting

A Pre-Application National Meeting/Webcast will be held on February 2, 2005, 1:30 - 4:30 pm at the National Institutes of Health, Building 31, Conference Room 9A22.

Format for Application

Applicants should refer regularly to those sections of this announcement that delineate "content and form of application submission" 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 (prorated for 6 months for the initial implementation phase for 5-8 CR Scholars)

E. Budget for Entire Proposed Period of Support that escalates the number of scholars to 11-14 in the second year and to 18-23 in the third, fourth and fifth years

F. Biographical Sketches

• For Program Director, Co-director(s), Advisory Committee Members, Mentors, and Other Faculty of this Program

G. Other Support

• For the Program Director, Co-director(s), MAC members, Mentors, and Other Faculty of this Program

H. Multidisciplinary Clinical Research Career Development Program (no more than 60 pages)

(1) Overall Aims

• Approach/Meeting the Intent of this Initiative
• Institutional Commitment
• Innovation
• Collaborations

• Clinical Research Capability and Infrastructure
  - Include plans for Shared Clinical Research Support Facility
• Program Leadership/Management
• Multidisciplinary Advisory Committee,
  - Include plans for matching CR scholar to mentor
  - Include policies and procedures for the Research Project Support Program
• Program Mentors/Team Leaders
• Description of Didactic Core Requirements and Practicum research experience
• Interactions

I. Human Subjects

J. Vertebrate Animals

K. Checklist

L. Appendices and Tables.

Suggested Format for Tables to be Included in Application

These are suggested formats for presenting tabular information in the application. Please include tables in the body of the application.

Please sign up for the Research Careers Program Listserve
(http://list.nih.gov/archives/clinrescareers.html) to be notified of any updates.

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	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

b.     Existing Funded Clinical Research Support. This should include a representative sample
        (up to 25 studies) of the clinical research currently being conducted in the Institution(s).

TABLE B. Examples of Current Funded Clinical Research Support by type (up to 25 clinical studies)

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)	Project Period(mm/yy-mm/yy)	Annual TOTAL Costs
Epidemiology Jane Doe, MD
Translational John Smith, PhD
Intervention Studies ("clinical trials")
Health Services Research
Outcomes Research

c.     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	Project Period(mm/yy-mm/yy)	Annual TOTAL Costs
K30
GCRC
Centers
Shared Cores

d.     Expertise and Training Track Record of Program Director, Co-directors(s), MAC and
        Mentors. This list should include a representative sample of mentors (at least 25 but
        not more than 40). For each person, please include a list of 5-10 recent trainees, in
        the past 10 years (Trainee Name, degree, research project, current position, current
        research area if known).

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

Names of Mentorand 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.