Investigator-Initiated Research Grants at the NIH: Something - NIH ...Presentation Transcript
Introduction to Clinical Research Understanding the Essentials for Starting a Study
December 4, 2003 Henry P. Parkman, MD
Investigator-Initiated Grants at the NIH: Something for Everyone.
December 11, 2003 Steve Houser, PhD
Planning a Successful NIH Research Grant
December 18, 2003 Bill Hirschhorn, MS
Investigator-Initiated Clinical Studies Funded by Industry: Applying for Research Support
Investigator-Initiated Research Grants at the NIH: Something for Everyone Henry P. Parkman, MD With help from Judith Podskalny, Ph.D. Program Director, NIDDK, NIH NIH Funding Opportunities for Young Investigators
Overview of Important Points
Decide which NIH Institute or Center
bests suits your research.
Know the different types of grants
for your career stage.
Subscribe to NIH Guide for Grants and Contracts.
Where To Go at the NIH
Decide where you ‘fit’.
Go to http:// www.nih.gov
Identify the several most likely Institutes for funding based on your specialty/scientific interests
Become familiar with those Institutes’ websites
Contact appropriate staff early in the process of applying for any grant
National Institutes of Health -1 (Institutes or Centers)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of General Medical Sciences (NIGMS)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health -2 (Institutes or Centers)
National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Eye Institute (NEI)
National Institutes of Health -3 (Institutes or Centers)
National Heart, Lung and Blood Institute (NHLBI)
National Human Genome Research Institute (HGRI)
National Institute on Aging (NIA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health -4 (Institutes or Centers)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Research Resources (NCRR)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center on Minority Health and Health Disparities (NCMHD)
Types of Grant Support
Consider your career stage
Career progression for MDs in research --
Finish clinical training
Do postdoctoral research (mentored) (1 – 3 years) Advance/nurture your career (3 - 5 years) Become an independent investigator Fellowships (F,T) Career Development Awards (K) Research grants (R)
“ Typical” NIH-funded Research Career Pathway
Medical Postgraduate Junior Experienced
School (Post-fellowship) Faculty Faculty
T32 T32 K01 R01
F31 F32 K08, K23 K24
T35 K25 R03, R21
Ruth L. Kirschstein National Research Service Awards (NRSA) T32 = NRSA Institutional Training Grant F32 = NRSA Individual Fellowship Award This category of training support provides a stipend, or 'living expenses' allowance, to predoctoral students while they work toward their research degree, or to postdoctoral fellows while they obtain additional research experience in a mentor's laboratory. Applicants must be U.S. citizens or permanent U.S. residents.
A senior mentor is PI
Pre- and/or Post-doc ‘slots’ awarded
Appointments left up to PI at institution
Grant is 5 years, renewable
Fellow is PI
Funding 6-9 months later
NRSA (i.e. T32 & F32) ‘features’:
U.S. citizen or permanent residents ONLY
Must be ‘full-time’ training
3 year limit on postdoctoral support
Stipend, not salary
First 12 months of support subject to payback
MDs can usually get a ‘waiver’
‘ supplementation’ and ‘compensation’ allowed
2 nd year pays back 1 st year
MDs only 75-80%
Institutional Training Grants (T32s)
all NIH-supported training grants can be found at:
all NIDDK-supported training grants can be found at:
Career development awards provide salary and laboratory support for individuals who have completed their postdoctoral training, or who merely need 'protected time' at critical periods of their research careers.
NIH Clinical Research Career Development programs of help maintain a cadre of biomedical researchers in the US.
These grant programs are designed to attract talented medical students, physicians, dentists, and similar professionals to the challenges of clinical research or to help clinical investigators transition to independent research careers.
NIH Director's Panel on Clinical Research (CRP) 1997 Report
The Panel's three-part definition "clinical research” is:
(a) 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. This area of research includes:
Mechanisms of human disease
Development of new technologies
(b) Epidemiologic and behavioral studies
(c) Outcomes research and health services research.
Recommendations Concerning Training and Support for Clinical Investigators
Recommendation #3. The NIH should initiate training programs that will enhance the attractiveness of careers in clinical research to medical students .
Recommendation #4. The NIH should improve the quality of training for clinical researchers by requiring grantee organizations to provide formal training experiences in clinical research and careful mentoring by experienced clinical investigators.
Recommendation #5. The NIH should initiate substantial new support mechanisms for young and mid-term clinical investigators , if possible in collaboration with the private sector.
Recommendation #6. A loan repayment program for clinical investigators should be instituted.
“Career Development Awards” or K-series Awards
designed to “protect” time, i.e., free up time currently spent in clinic or on administrative duties
most are for early career development
provide ‘salary’ not ‘stipend’
meant to train U.S. citizens/permanent residents
limited to U.S. research/clinical institutions
K01 – Mentored Research Scientist Development Award
K08 – Mentored Clinical Scientist Development Award
K23 – Mentored Patient-oriented
Research Career Development Award
K24 – Mid Career Investigator Award in Patient-oriented Research
PhD, non-clinical MD MD, bench research MD, ‘clinical’ research
K23 Mentored Patient-Oriented Research Career Development Award
Provide physicians with up to 5 years of support to pursue more clinically oriented research careers directly involving patients. For early career physicians who have made a commitment to clinical/patient-oriented research.
The three to five years of supervised study and research supported by this award provide clinically trained professionals with an opportunity to develop independent research skills and to gain experience in advanced methods and experimental approaches needed to carry out patient-oriented research.
An eligible candidate must have (1) an M.D., D.D.S., or equivalent; (2) a mentor; (3) a career development plan.
Mentored Clinical Scientist Development Awards (K08)
Provide physicians with up to 5 years of support to pursue research careers. Generally to work in a basic science laboratory , not for clinical research.
The Small Grant Program for NIDDK K08/K23 Recipients allows NIDDK K08-holders to apply for up to $50,000 per year of extra research support in the final 2 years of their K08 to help in their transition to independence.
K24 Midcareer Investigator Award in Patient-Oriented Research
Provides support to established clinical investigators who are actively engaged in patient-oriented research and who serve as mentors for new clinical investigators.
Allows them protected time to (1) devote to clinical/patient-oriented research, (2) enhance their clinical research skills in order to conduct meritorious patient-oriented research, and (3) mentor beginning clinical investigators.
Target candidates are outstanding clinical scientists who are engaged in patient-oriented research, are within 15 years of their specialty training, can demonstrate the need for a period of intensive-research focus as a means of enhancing their clinical research careers, and committed to mentoring.
Elements Reviewed in K applications
Qualifications of candidate (prior training, letters of recommendation, publications)
Mentors (previous mentoring experience, expertise in area of research)
Research project (hypothesis driven, preliminary data, reasonable in time frame, logical sequence of studies, appropriate safeguards)
Career development plan and Environment (‘enrichment’, training, future plans)
R01s – Research project grants unsolicited and in response to PAs and RFAs
R21s – Exploratory/Developmental grants usually only in response to PAs or RFAs
R03s – Small grants only in response to PAs or RFAs
R34s – Clinical trials planning grants
New Funding Opportunities
Sign up to receive the NIH Guide for Grants and Contracts. Join the List Serve at:
Once a week receive the Table of Contents with active links to all
Request for Applications (RFA), and
Program Announcements (PA, PAR)
NIH Loan Repayment Program (LRP)
Seeks to retain an adequate national pool of physicians and dentists who are trained to be independent clinical investigators.
Provides for repayment of the educational loan debt of physicians and dentists.
Individuals must hold peer-reviewed research funding and have educational debt that exceeds 20% of their salary.
NIH Budget Growth: 1993 to 2003 2003E = $27.0 billion 1.98 fold 1998: start of doubling of NIH Budget = $13.7 billion 1 2 3 4 5
A final take home message --
If you don’t apply , you can’t be funded
Contact the NIH before you start preparing application
AND while writing it
AND after you submit
Loan Repayment Programs
Two new programs began in 2002:
for Clinical Researchers
(Public Health Act of November 2000)
for Pediatric Research
(Children’s Health Act of 2000)
Provides up to $35,000 per year for 2 years to pay principal and interest on educational debt
NIH pays the taxes on this amount directly to the IRS
Institutes prioritize their own applications
Dependent upon indebtedness
Owe more than 20% of annual income
Must be an educational loan –
Engaged in research at least 50% of the time for at least
2 years (concurrent with loan repayment)
U.S. citizen or permanent resident
DO NOT refinance or combine loans
LRP – Time-line for 2003 (~2004)
November – application forms available on NIH homepage
January 31 – applications due at LRP office
February – applications sent to ICs
April – applications peer-reviewed and then IC staff develop pay plans
May/June – results reported to Advisory Councils
July – contracts issued
Why should you apply for LRP?
LRP in 2002
Goal in 2002 was 250 contracts NIH-wide, $28 million
minimum of 20% for pediatric, the rest for clinical researchers
NIDDK was allocated 15 contracts ($1.5 mill)
NIDDK Director allocated more funds to award 20 ($2 mill)
NIDDK received 66 LRP applications
We issued 58 contracts
Success rate = 87%
LRP – 2003 changes
Open to non NIH-grantees – as long as engaged at least 50% of the time in research
NIH obtained waiver to delay payback obligation for NRSA recipients so they can apply
LRP – 2003 current status
NIH received ≈1700 applications
NIDDK assigned 166
Sign up to receive information
GCRC Mentored Medical Student Clinical Research Program
NCRR provides supplemental funding to the General Clinical Research Centers (GCRCs) that it already supports so the GCRCs can establish institutional programs that will introduce medical students to potential careers in clinical research.
GCRCs are the focal point of this award program because they provide the necessary infrastructure and environment to expose medical students to both didactic training and the clinical practice of patient-oriented research.
Short-term Institutional Training Grants (T35)
Awarded to medical or other health professional schools to support summer research experiences for students between the first and second years of school.
Individual Postdoctoral Fellowships (F32)
Provide up to three years of support for qualified individuals who have received a Ph.D., M.D., or equivalent degree.
The award supports supervised research to enable biomedical scientists and clinicians to broaden their scientific backgrounds and expand their potential for research in health-related areas.
Prior to submission, an applicant must arrange for an appointment to an appropriate institution and acceptance by a sponsor who will supervise the training and research experience.
The institutional setting may be a domestic or foreign nonprofit, private or public institution, including the NIH. The postdoctoral fellow is the applicant on the application and award, and must participate in the planning of the research project proposed.
Individual Predoctoral Fellowships (F31) for Minority Students and for Students with Disabilities
Provide up to 5 years of support for research training leading to the Ph.D., or equivalent, research degree.
The intent of both programs is to encourage students from these groups to seek graduate degrees and thus increase the number of minority investigators and of persons with disabilities who are prepared to pursue careers in biomedical and behavioral science research.
Institutional Training Grants (T32)
Awarded to institutions with strong research programs to support a designated number of pre- or postdoctoral fellows, appointed by the training director at the institution.
K12 Mentored Clinical Research Scholar (CRS) Award
Provides support to institutions to establish career development for physicians and dentists so they may develop the research skills necessary to become independent, clinical/patient-oriented investigators.
Candidates for the program are selected from among the recently trained physicians and dentists. Funds may be used to support full or partial completion of an advanced degree such as an MS, PhD, MPH.
The program must include activities that will provide candidates with a comprehensive understanding of clinical research approaches that are fundamental and not necessarily disease-specific.
The lead mentor, an established clinical researcher who holds a faculty position, will work closely with the candidate to develop a tailored career development plan.
Individual Senior Fellowships (F33)
Provide the opportunity for experienced scientists to make major changes in the direction of their research careers, to broaden their research capabilities, or to enlarge their command of an allied research field.
Candidates must have received a doctoral (Ph.D., M.D.), or equivalent degree, and must have had at least 7 subsequent years of relevant research or professional experience by the time the award is made.
The total period of the award will not exceed 24 months, although 12 months is more usual.
These awards are not made for study leading to any of the professional degrees (M.D., O.D., D.D.S., etc.) or for residency or other clinical training.
Mentored Research Scientist Development Awards (K01)
Provide Ph.D., or other comparable researchers, with support for up to 3-5 years following postdoctoral training to transition into independence and obtain regular research grant (R01) funding.