MENTORED PATIENT-ORIENTED RESEARCH CAREER DEVELOPMENT AWARD WITH EMPHASIS ON 
THE APPLICATION OF GENOMIC OR PROTEOMIC TECHNOLOGIES (K23)

RELEASE DATE:  July 1, 2003

RFA:  HG-03-006 (Modified, see RFA-HG-05-013)
                (Inactive per NOT-HG-04-004)

National Human Genome Research Institute (NHGRI)
 (http://www.genome.gov/)
Office of Rare Diseases (ORD), NIH 
 (http://rarediseases.info.nih.gov/)
National Institute of Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
 
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.172 (NHGRI), No. 
93.172(ORD), and No. 93.279(NIDA) 

APPLICATION RECEIPT DATES: October 20, 2003; October 20, 2004; and 
October 20, 2005 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
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 Required Federal Citations

PURPOSE OF THIS RFA

The purpose of the Mentored Patient-Oriented Research Career Development Award 
(K23) is to support the career development of clinicians who intend to engage in 
patient-oriented research that involves the application of the knowledge, tools, 
technologies and approaches of genomics and proteomics to the study of diseases 
in an effort to develop effective therapeutic interventions.  This award will 
provide support for three to five years of supervised study and research for 
clinically trained professionals who plan to become independent, productive 
clinical investigators focusing on patient-oriented research.  

This K23 award has several important features: (1) it requires an integrated 
clinical-laboratory research project that directly involves patients affected by 
the disease being studied so that awardees can develop skills in both clinical 
research and basic science, i.e. bench-to-bedside research; (2) it emphasizes 
career development and a research program that focuses on developing effective 
therapeutic interventions; projects that involve pre-therapeutic research will 
also be considered if the applicant can make a strong case that the knowledge 
gained from the study will provide a clear pathway toward the development of 
therapeutic interventions; and (3) it requires significant utilization of 
genomic and proteomic tools and technologies in the research project.

NHGRI:  This initiative is consistent with the NHGRI's new vision for the future 
of genomics research (http://www.genome.gov/11006873) which includes translating 
the information and resources generated by the Human Genome Project into medical 
value and is responsive to the recommendations of the NIH Director's panel on 
Clinical Research (http://www.nih.gov/news/crp/97report/) and the Institute of 
Medicine's Committee on Addressing Career paths for Clinical Research 
(http://www.nap.edu/books/0309048907/html/).

ORD:  Under the Rare Diseases Act of 2002, the office has a legislative mandate 
to support training in clinical research in rare diseases.  

NIDA:  The institute is interested in the application of genomic and proteomic 
tools and technologies in pursuit of therapeutic interventions in drug addiction 
and drug abuse.

The NHGRI's Division of Intramural Research in Bethesda, MD, has a companion 
program, Physician Scientist Development Program, for clinicians who wish to 
conduct their research at the National Institutes of Health.  To learn more 
about this program, please visit this website: 
http://www.nhgri.nih.gov/Intramural_research/PSDP/index.html.  

Individuals with a clinical degree who are interested in further career 
development in biomedical research that is not patient-oriented, should refer to 
the NIH-wide Mentored Clinical Scientist Career Development (K08) Award (see 
http://grants.nih.gov/training/careerdevelopmentawards.htm on the NIH website 
for details).  Individuals who are interested in patient-oriented research and 
wish to 1) study the mechanisms of human disease, 2) conduct clinical trials, 
3) develop new technologies, or 4) develop therapeutic interventions that do 
not use genomic or proteomic technologies should refer to the Mentored Patient-
Oriented Research Career Development (K23) Award (see 
http://grants.nih.gov/grants/guide/PA-files/PA-00-004.html).

RESEARCH OBJECTIVES

There are several events that make this an opportune time for clinically trained 
investigators who are interested in incorporating genomic and proteomic 
approaches to develop new therapeutic approaches to disease problems.  As of 
April 2003, the finished sequence of the human genome is available.  Draft 
sequences of the mouse and rat genomes are also available, as are finished 
genome sequences of several other important model organisms (yeast, fly and 
roundworm).  Genomics has emerged as a new approach to conducting research, and 
has already provided a variety of powerful tools and methods to assist in the 
elucidation of genomic information and the application of such information to 
address important health problems.  The ultimate goal of biomedical research is 
to improve our overall ability to prevent, diagnose, treat and cure diseases.  
Thus, the effective and efficient translation of the basic research findings 
coming out of the Human Genome Project into understanding and treating diseases 
is now a major challenge.  An important way to facilitate the translation of the 
findings into improved medical care is through the training of clinicians 
interested in patient-oriented research.  Therefore, the objectives of the 
Mentored Patient-Oriented Research Career Development Award (K23) are to: (1) 
develop clinician researchers who are able to utilize genomic and proteomic 
knowledge, approaches, tools and technologies to develop therapeutic 
interventions for human diseases; and (2) increase the pool of independent 
clinical researchers who can conduct patient-oriented studies that capitalize on 
the discoveries of genomics and proteomics and effectively translate them into 
clinical settings.

In order to develop skills necessary to apply genomic tools, methods, 
technologies and approaches to understanding disease and to develop new 
therapeutic interventions, the candidate should propose a plan that includes the 
following:

o  Training:  

A didactic training program that provides a thorough understanding of the basic 
knowledge underlying the research problem.  Such a program may include courses 
in the biological, quantitative and informational sciences.  

o  Research:  

NHGRI and ORD are interested in research that focuses on the application of 
modern genomic and proteomic tools and technologies to the development of 
effective interventions based on an understanding of the disease process.  There 
are, generally speaking, two ways to approach therapeutic intervention. One is 
gene-based therapy, meaning an intervention that is based on knowledge about how 
the gene or encoded protein functions normally and malfunctions in the case of 
disease.  This will be the focus of this K23 program, i.e. on using genomic and 
proteomic tools and information about the properties of genes, gene functions, 
and gene products to develop new therapeutic approaches.  The types of diseases 
that might lend themselves to this type of approach are: (a) diseases associated 
with variations in a single known gene; (b) diseases that are designated as rare 
diseases (http://ord.aspensys.com/asp/diseases/diseases.asp); and (c) common 
diseases that have a genetic component and for which at least some of the genes 
have been identified.  The other approach to therapeutic intervention, gene 
therapy, defined here as the replacement, manipulation, or supplementation of 
genes that are not fully functional with ones that are more functional, will not 
be supported.  This area already receives significant research and training 
support from other sources.  

NIDA is interested in research that focuses on: (a) the application of modern 
genomic and proteomic tools and technologies to identify target molecules, 
pathways or profiles that will identify target genes/proteins or 
diagnostic/prognostic indicators involved in the mechanisms of drug addiction 
and treatment of drug addiction including, but not limited to, addiction to 
nicotine (tobacco), benzodiazepines, cocaine, marijuana, and methamphetamine.   
Research in which the proteomic or genomic data will be integrated with 
epidemiological data are of particular interest. (b) proteomic or genomic 
studies looking at the effects of drugs of abuse on the progression and/or 
treatment of human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) are 
also of interest.

It is expected that the research program proposed by the applicant will involve 
a tight integration with clinical investigation directly involving patients 
affected by the disease or condition being studied.

MECHANISM OF SUPPORT

Awards made in response to this request for applications will use the K23 
mechanism.  Planning, direction, and execution of the program will be the 
responsibility of the candidate and her/his mentor on behalf of the applicant 
institution. The project period may be up to five years, with a minimum of three 
years. 

Awards will not be renewable.  This RFA uses the just-in-time concept, but does 
not use the modular budget format.  
This program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/PArt_i_1.htm.  

FUNDS AVAILABLE

The participating institutes intend to commit approximately $700,000 in FY2004 
in response to this RFA and make approximately four to six awards per year. The 
actual number of awards to be made will vary and will be dependent upon the 
number and quality of applications submitted and the funds available. 

ELIGIBLE INSTITUTIONS

Applications may only be submitted from domestic, non-Federal institutions that 
have any of the following characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as medical, dental, or nursing schools or 
other institutions of higher learning 
o Units of State and local governments
o Eligible agencies of the Federal government

Foreign institutions are not eligible to apply.

To be eligible, an institution must have a well-established clinical and 
genomics or proteomics research program and have a qualified faculty of clinical 
researchers to serve as mentors.  General Clinical Research Centers (GCRC) are 
considered ideal environments for patient-oriented clinical research.  The 
candidate, mentor and institutional representative must be able to propose an 
appropriate research/career development program that will maximize the use of 
relevant research and educational resources.  The institution must be able to 
demonstrate a commitment to the development of the research careers of patient-
oriented clinical researchers.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The candidate must have a clinical doctoral degree or its equivalent.  
Illustrative examples include, but are not limited to: M.D., D.D.S., D.M.D., 
D.O., or Ph.D. (nursing, clinical psychology or clinical genetics). 

The candidate also must have completed clinical training, including specialty 
and, if applicable, subspecialty training prior to receiving an award.  However, 
the candidate may submit an application prior to the completion of clinical 
training.  The candidate must identify a mentor with extensive research 
experience in clinical research and genomics or proteomics.  If the mentor does 
not have the expertise or experience in genomics or proteomics, this aspect of 
the training may be provided by others (individuals or committee) who will work 
collaboratively with the candidate and the mentor.

During the award period, the candidate must be willing and able to spend a 
minimum of 90% of full-time professional effort in support of this award.  This 
90% effort is meant to encompass: (1) didactic training; (2) laboratory research 
activities; and (3) clinical research activities related to the project.  It is 
anticipated that the primary activity of the awardee will be spent on the 
laboratory research activities; in no case should the awardee plan to spend more 
than half of the supported time on the clinical research activities.  Such a 
time commitment in the initial two years of the program is considered essential.  
After completion of the didactic training period, it may be possible, upon 
approval from the awarding unit, to reduce the minimum effort devoted to the 
award from 90% to 75% of full-time professional effort.

At the time of the award, a candidate must be a citizen or non-citizen national 
of the United States, or have been lawfully admitted to the United States for 
permanent residence (i.e., in possession of a currently valid Alien Registration 
Receipt Card I-551, or other legal verification of such status).  Non-citizen 
nationals, although not U.S. citizens, owe permanent allegiance to the United 
States.  They are usually born in lands that are not states but are under US 
sovereignty, jurisdiction or administration.  Individuals on temporary or 
student visas are not eligible for this award.  Minorities, women and 
individuals with disabilities are encouraged to apply.  

Ineligible individuals include current and former principal investigators on 
NIH research projects (R01), FIRST Awards (R29), comparable career development 
awards (K01, K07, or K08), sub-projects of program project (P01) or center 
grants (P50), and the equivalent.  Former principal investigators of NIH Small 
Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.  

SPECIAL REQUIREMENTS

A. Mentor:  The mentor must be a clinician-researcher and have expertise in 
genomics or proteomics tools and technologies.  The mentor must ensure that the 
candidate will obtain the didactic training and clinical research expertise 
necessary to become an independent investigator.  The applicant must name a 
mentor who, together with the applicant, is responsible for the planning, 
direction, and execution of the program.  The mentor should be recognized as an 
accomplished investigator in the proposed research area and have a record of 
success in training independent investigators.  The mentor should have 
sufficient independent research support to cover the costs of the proposed 
research project in excess of the allowable costs of this award.  If the mentor 
is not the appropriate researcher experienced in genomics or proteomics, the 
candidate may get access to this expertise from another faculty member or small 
committee.  Where feasible, women, minority individuals and individuals with 
disabilities should be involved as mentors to serve as role models. 

B. Program:  The award provides up to five consecutive 12-month awards.  At 
least 90% of the recipient's full-time professional effort must be devoted to 
the goals of this award.  The remainder may be devoted to clinical duties, 
teaching, or other research pursuits consistent with the objectives of the 
award. Both the didactic and the research phases of an award period must be 
designed to develop the necessary knowledge and research skills in scientific 
areas relevant to the career goals of the candidate.  The candidate must 
demonstrate that s/he has taken or will take during the award period, (a) 
relevant courses in genetics and genomics that provide a basic understanding of 
these areas and (b) courses that provide a basic understanding of experimental 
design and interpretation, such as: statistics, data management, epidemiology, 
study design, hypothesis development, etc., as well as the legal and ethical 
issues associated with research on human subjects.

Because of the focus on progression to independence as a researcher, a candidate 
for the K23 should propose a period of study and career development consistent 
with her or his previous academic background and research and clinical 
experiences.  For example, a candidate with limited experience in a given field 
of research may find a phased developmental program that includes a designated 
period of didactic training followed by a period of closely supervised research 
experience to be the most efficient means of attaining independence.  On the 
other hand, a candidate with previous research experience and training may not 
require extensive additional didactic preparation, and a program that focuses on 
an intensive, supervised patient-oriented research experience may be 
appropriate.  The proposed program must be tailored to meet the individual needs 
of the candidate to ensure that s/he will gain the skills and knowledge 
necessary to carry out high quality patient-oriented research.  The candidate 
and the mentor are jointly responsible for the preparation of the plan for this 
program.  The mentor may form an advisory committee to assist with the 
development of the genomics or proteomics component of the research program or 
to monitor the candidate's progress through the career development program.  The 
didactic and research components of both phases must develop new knowledge and 
research skills in scientific areas relevant to the career goals of the 
candidate.  It is critical that there is a laboratory research component 
directly related to the patient-oriented research proposed in the application.

C. Environment:  The institution must have both a well-established clinical and 
genomics or proteomics research programs.  It must also have faculty qualified 
in clinical research with an emphasis on patient-oriented research to serve as 
mentors.  The institution must be able to demonstrate a commitment to the 
development of the candidate as a productive, independent investigator.  The 
candidate, mentor, and institution must be able to describe an in-depth, multi-
disciplinary career development program that will utilize the relevant research, 
genomics, proteomics, and educational resources.  

D. Research Grant Application:  The purpose of this award is to provide the 
training and research experiences that will facilitate the awardee becoming an 
independent investigator.   Therefore, awardees will be strongly encouraged to 
submit a grant application to the National Institutes of Health 12 to 18 months 
before the termination of the K23 award.  The purpose of this will be to give 
the awardee experience in writing a research grant application, an opportunity 
to become familiar with the NIH peer review process, and the opportunity to 
obtain guidance from the mentor and other experts in the institution regarding 
grantmanship.

E. Salary:  The NIH will provide 100% of the Principal Investigator's 
institutional base annual salary in any given year, as long as the salary is not 
in excess of Executive Level I of the Federal Executive Pay Scale (for FY 2003, 
$171,900/year; (see 
http://odoerdb2.od.nih.gov/gmac/topics/awards_salcap_2003_email.html). 

The total salary requested must be based on a full-time, 12-month staff 
appointment and must be consistent both with the established salary structure at 
the grantee institution and with salaries actually provided by the institution 
from its own or other non-federal funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned.  If 
full-time, 12-month salaries are not currently paid to comparable staff members, 
the salary proposed must be appropriately related to the existing salary 
structure.

The grantee institution may supplement the NIH contribution up to a level 
consistent with the institution's salary scale.  Supplementation may not be from 
Federal funds unless specifically authorized by the Federal program from which 
such funds are derived.  Because the salary amount provided by this award is 
based on the full-time institutional salary, no other NIH funds may be used for 
salary supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with or detract 
from the purpose of the award.

F. Research Support:  The NIH will provide up to $50,000 per year for the 
following expenses:  (a) tuition, fees, and books related to career development; 
(b) research expenses, such as supplies and technical personnel; c) travel to 
research meetings or training; (d) travel to annual meetings of K23 awardees in 
Bethesda, MD; and (e) research support services including personnel and computer 
time.  It is expected that the mentor will have sufficient resources to support 
the remainder of the awardee's research program.

G. Ancillary Personnel Support:  Salary for the mentor, secretarial and 
administrative assistance, etc., is not allowed.

H. Facilities and Administrative Costs:  These costs will be reimbursed at 8% 
of modified total direct costs.

I. Loan Repayment Program: Awardees under this program may be eligible to apply 
to the NIH Extramural Loan Repayment Program (LRP) for Clinical Researchers.  
The purpose of the LRP is to recruit and retain highly qualified health 
professionals as clinical investigators by providing for repayment of the 
educational loan debt of qualified health professionals who agree to conduct 
clinical research.  The program provides for the repayment of up to $35,000 of 
the principal and interest of the educational loans of extramural grantees or 
awardees for each year of obligated service.  NIH also covers the Federal taxes 
on the loan repayments, which are considered taxable income to program 
participants. Information regarding the eligibility requirements and benefits 
for the program may be obtained via the LRP website: http://www.lrp.nih.gov. 

J. Other Income:  Awardees may retain royalties and fees for activities such as 
scholarly writing, service on advisory groups, honoraria from other institutions 
for lectures or seminars, fees resulting from clinical practice, professional 
consultation or other comparable activities, provided these activities remain 
incidental, are not required by the research and research-related activities of 
this award, and provided that the retention of such pay is consistent with the 
policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as 
retainable, may not be retained by the career award recipient.  Such fees must 
be assigned to the grantee institution for disposition by any of the following 
methods:

o  The funds may be expended by the grantee institution in accordance with the 
NIH policy on supplementation of career award salaries and to provide fringe 
benefits in proportion to such supplementation.  Such salary supplementation and 
fringe benefit payments must be within the established policies of the grantee 
institution.

o  The funds may be used for health-related research purposes.

o  The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks 
should be made payable to the Department of Health and Human Services, NIH and 
forwarded to the Director, Office of Financial Management, NIH, Bethesda, 
Maryland 20892.  Checks must identify the relevant award account and reason for 
the payment.

K. Special Leave:  Leave to another institution, including a foreign 
laboratory, may be permitted if directly related to the purpose of the award.  
Only local, institutional approval is required if such leave does not exceed 
three months.  For longer periods, prior written approval of the NIH funding 
component is required.

To obtain prior approval, an awardee must submit a properly routed e-mail or 
letter to the NIH describing the plan, countersigned by the department head and 
the appropriate institutional official.  A copy of a letter or other evidence 
from the institution where the leave is to be taken must be submitted to assure 
that satisfactory arrangements have been made.  Support from the career award 
will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the 
prior written approval of the NIH funding component and will be granted only in 
unusual situations.  Support from other sources is permissible during the period 
of leave.  Such leave does not reduce the total number of months of program 
support for which an individual is eligible.  Parental leave will be granted 
consistent with the policies of the NIH and the grantee institution.

L. Termination or Change of Institution:  When a grantee institution plans to 
terminate an award, the NIH funding component must be notified in writing at the 
earliest possible time so that appropriate instructions can be given for 
termination.

If the awardee plans to relocate, s/he must submit to the NIH funding component, 
in advance of the move, a written request for transfer, countersigned by the 
appropriate institutional business official, describing the reasons for the 
change and including the new sponsor's name and biosketch.  The request must 
establish that the specific aims of the research program to be conducted at the 
new institution are within the scope of the original peer reviewed research 
program.  Additionally, the new mentor must have the appropriate research 
expertise to supervise your program and sufficient research support to ensure 
continuation of the research program to the end of the award.  Staff within the 
NIH funding component will review this request and may require a review by an 
initial review group and/or the appropriate National Advisory Council or Board.  
Upon approval of the request, the new institution, on the awardee's behalf, must 
submit a new career award application far enough in advance of the requested 
effective date to permit review.  The period of support requested in the new 
application must be no more than the time remaining within the existing award 
period.

If the awardee plans to change mentor, the institution must submit a letter from 
the proposed mentor and awardee documenting the need for substitution, the new 
mentor's qualifications for supervising the program, and the level of support 
for your continued career development.  The letter must also document that the 
specific aims of the research program will remain within the scope of the 
original peer reviewed research program.  The NIH must also receive a letter 
from the original mentor relinquishing sponsorship of the awardee. Staff within 
the NIH funding component will review the request and will notify your 
institution of the results of the evaluation.

A final progress report, invention statement, and financial status report are 
required upon either termination of an award or relinquishment of an award in a 
change of institution situation.

Questions about any of these issues should be addressed to the appropriate NIH 
program staff person listed under "WHERE TO SEND INQUIRIES."

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this Request for applications and welcome the 
opportunity to answer questions from potential applicants.  Inquiries may fall 
into three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about NHGRI's and ORD's scientific interests to:

For scientific/program issues:
Bettie J. Graham, Ph.D.
Program Director
National Human Genome Research Institute
Building 31, Room B2B07
Bethesda, MD  20892-2033
Telephone:  (301) 496-7531
Fax:  (301) 480-2770
e-mail: bettie_graham@nih.gov

o Direct your questions about NIDA's scientific interests to:

Christine Colvis, Ph.D.
Program Director
Genetics and Molecular Neurobiology Research Branch
Division of Neuroscience & Behavioral Research
National Institute on Drug Abuse/NIH
6001 Executive Blvd.
Room 4260, MSC 9555
Bethesda, MD  20892-9555
301-435-1323
301-594-6043 fax
ccolvis@nida.nih.gov

NHGRI will conduct the reviews of this RFA for all participating NIH components.  

o Direct your questions about peer review issues to:

Rudy Pozzatti, Ph.D.
Scientific Review Administrator
Division of Extramural Research, NHGRI
Building 31, Room B2B37
Bethesda, MD  20892-2032
Telephone:  (301) 402-0838 
FAX:  (301) 435-1580
Email: pozzattr@mail.nih.gov

o Direct your questions about NHGRI's financial or grants management issues to:

Ms. Jean Cahill
Grants Administration Branch
National Human Genome Research Institute 
Building 31, Room B2B34
Bethesda, MD  20892-2031
Telephone:  (301) 402-0733
Fax:  (301) 402-1951
e-mail:  jean_cahill@nih.gov

o Direct your questions about NIDA's financial or grants management issues to:

Gary Fleming, J.D., M.A.
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd.
NSC Building, Suite 3131, MSC 9541
Bethesda, MD 20892-9541
Phone: (301) 443-6710
FAX: (301) 594-6849
E-mail: gf6s@nih.gov
OVERNIGHT DELIVERY ADDRESS: 
6001 Executive Blvd., Suite 3131
Rockville, MD 20852

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application form, 
using Section IV "Research Career Award" instructions and forms (rev. 5/01 and 
updated 6/28/02). The PHS 398 form is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

Applicants who will be using the resources within a General Clinical Research 
Center (GCRC) during the course of the award should include a letter of 
agreement from either the GCRC program director or the principal investigator 
for the application.

SUPPLEMENTAL INSTRUCTIONS

Candidate

o  A description of the candidate's commitment to a clinical research career 
developing therapeutic interventions utilizing genomics and protemics tools and 
technologies.

o  Evidence of the candidate's interest in conducting patient-oriented research 
that involves the application of the knowledge, tools, technologies and 
approaches of genomics and proteomics to the study of diseases in an effort to 
develop effective therapeutic interventions.  

o  Evidence of the candidate's potential to develop into a successful 
independent investigator.  Usually this is evident from publications, prior 
research interests and experience, and letters of recommendation.

o  A description of the candidate's immediate and long-term career objectives, 
explaining how the award will contribute to their attainment. 

o  A commitment of at least 90 percent effort (includes didactic training, 
laboratory research activities, and  clinical research activities related to the 
project) to this research program.  The mentor or department chair must agree 
that this amount of the candidate's time will be protected.

o  Letters of recommendation:  Three sealed letters of recommendation addressing 
the candidate's potential for a clinical research career in which genomics and 
protemics tools and technologies are utilized to develop therapeutic 
interventions.  The mentor's statement (see below) should not be included as one 
of the letters of recommendation, although the mentor(s) may submit a separate 
letter(s) of recommendation.

Career Development Plan

o  A description of the career development plan, incorporating consideration of 
the candidate's goals and prior experience.  A systematic plan to obtain the 
necessary theoretical and conceptual background and research experience to 
launch an independent clinical research career in the application of genomics or 
proteomics tools and technologies to therapeutic interventions.

o  A list of the specific course of study in which the candidate will engage, 
including specific coursework, which is essential to gaining the required 
theoretical and conceptual understanding of genetics, molecular biology, 
statistics, bioinformatics, genomics, and proteomics and is important to the 
candidate's short- and long-term research interests.

o  The career development plan must be tailored to the needs of the individual 
candidate and the ultimate goal of achieving independence as a patient-oriented 
clinical researcher who employs genomic and proteomic tools and technologies to 
develop effective therapeutic interventions.  Less experienced candidates may 
require a phased developmental period in which the first one to two year(s) of 
the award are largely of a didactic nature followed by a period of intense, 
supervised research. Candidates with more experience at the time of application 
may need a shorter developmental period and may already have an adequate 
theoretical background. 

Training in the Responsible Conduct of Research

o  Candidates must describe plans to receive instruction in the responsible 
conduct of research. These plans must detail the proposed subject matter, 
format, frequency, and duration of instruction.  No award will be made if an 
application lacks this component.

Research Plan

o  The research plan must be described as outlined in form PHS 398, including 
sections on the Specific Aims, Background and Significance, Progress 
Report/Preliminary Studies, and Research Design and Methods.  The candidate 
should confer closely with the mentor(s) regarding the development of these 
sections.

Mentor's Statement

o  The application must include a statement from the mentor(s), including 
information on his or her: (a) clinical research qualifications; (b) research in 
the area proposed by the candidate; and (c) previous experience as a research 
supervisor.  The application must also include information to describe 
the mentor's research support relevant to the candidate's research plan and the 
nature and extent of supervision that he/she will provide during the period of 
the award.  The primary mentor must agree to provide annual evaluations of the 
trainee's progress for the duration of the award.  If the proposed mentor does 
not have expertise in genomics or proteomics, s/he must make arrangements for 
the applicant to receive such mentoring.  In such case, the application must 
describe this arrangement.

o  Each co-mentor must provide similar information.  When more than one mentor 
is proposed, the respective areas of expertise and responsibility of each should 
be described.

Environment and Institutional Commitment

o  The institution must have strong, well-established  clinical and 
genomics/proteomics research programs related to the candidate's area of 
interest, including a high-quality research environment with staff capable of 
productive collaboration.  The institution also must provide a statement to 
document the level of commitment to the candidate's development into a 
productive, independent investigator during the period of the award.  This must 
include an indication of support for the proposed level of effort (at least 90 
percent), commitment to the necessary release time from other duties (e.g. 
clinical responsibilities), as well as the availability of 
support and supervision during the award period.

Budget Instructions

o Budget information must be provided according to the instructions in the PHS 
398, including information on the mentor(s)' pending and current research 
support as stipulated.  This award does not use the modular budget.  The total 
direct costs requested must be consistent with this K23 request for applications 
and the award limits of the NIH funding component. 

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:

Submit a signed, typewritten original of the application, including the 
reference letters, the checklist, and three 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)

NHGRI will arrange for the review of all applications submitted to this RFA.  
Therefore, at the time of submission, two additional copies of the application 
must be sent to:

Rudy Pozzatti, Ph.D.
Scientific Review Administrator
Division of Extramural Research, NHGRI
Building 31, Room B2B37
Bethesda, MD  20892-2032
Telephone:  (301) 402-0838 
FAX:  (301) 435-1580
Email: pozzattr@mail.nih.gov

The number and title of this request for applications should be typed in item 2 
on the face page of the application, and the "Yes" box should be checked.

APPLICATION PROCESSING: Applications must be received by or mailed on or before 
the receipt date specified for this RFA. Applications must be received on or 
before the application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review. 

The Center for Scientific (CSR) will not accept any application in response to 
this RFA that is essentially the same as one currently pending initial review 
unless the applicant withdraws the pending application.  However, when a 
previously unfounded application, originally submitted as an investigator-
initiated application, is to be submitted in response to an RFA, it is to be 
prepared as a NEW application.  That is the application for the RFA must not 
include an Introduction describing the changes and improvements made, and the 
text must not be marked to indicate the changes.  While the investigator may 
still benefit from the previous review, the RFA application is not to state 
explicitly how.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 
eight weeks of the application receipt date.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NHGRI.  

Incomplete and/or nonresponsive applications will be returned to the applicant 
without further consideration.  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NHGRI or NIDA in accordance with the review criteria 
stated below.  

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 NHGRI's or NIDA's national advisory council.

REVIEW CRITERIA

(1) Qualifications of the Candidate

o Quality and breadth of the candidate's academic and/or clinical record, 
research experience, including publications, as a foundation for developing as 
an independent patient-oriented clinical researcher;

o Commitment of the candidate to an independent research career in terms of 
effort and future plans that will be focused on problems clearly relevant to the 
development of  therapeutic interventions of human diseases utilizing genomic or 
proteomic resources and technologies;

o Appropriateness of the dedicated 90% effort to the successful development as a 
patient-oriented clinical researcher; 

o Ability of the candidate to interact and collaborate with other scientists; 
and

o Recommendations of three well-established scientists attesting to the special 
potential of the individual to pursue an independent career in patient-oriented 
clinical research.

(2) Career Development Plan

o Appropriateness of the content, the phasing, and the proposed duration of the 
candidate's career development plan in relation to his/her experience, 
background, and stated career goals;

o The need for the proposed research experience;

o Likelihood that the plan will contribute substantially to the scientific 
development of the candidate and the achievement of scientific independence;

o Conformity of the plan to 90 % effort devoted to research training, clinical 
responsibilities related to the research and research program;

o Adequacy of prior or proposed training in the responsible conduct of research;

o Likelihood of successful planning, writing and submitting traditional grant 
applications.

(3) Research Plan

Reviewers should recognize that clinicians are likely to have variable degrees 
of research experience.  Those with more limited experience are less likely to 
prepare a plan with the breadth and depth of that submitted by more experienced 
investigators unless the mentor plays a significant role.  All plans must 
include fundamentally sound research approaches but reviewers should consider 
the applicant's research experience and the mentor's commitment to and 
involvement in the career development of the candidate (See Mentor section 
below).

o Degree of relevance of the research plan to developing an independent research 
program as it relates to the utilization of genomic or proteomic resources and 
technologies to develop effective and efficient therapeutic interventions for 
human diseases;

o A sound research project that is consistent with the development plan for an 
independent career in patient-oriented clinical research and commensurate with 
the candidate's level of research development;

o Usefulness of the research project as a vehicle for enhancing existing 
research skills as described in the career development plan;

o The originality and quality of the research hypothesis/question, design and 
methodology, judged in the context of the candidate's previous training and 
experience;

o Attention to and implications of what aspects of the project will remain with 
the candidate as an independent investigator, especially since the submission of 
a grant application to a funding agency prior to the termination of the career 
development award is a program requirement; and

o Adequacy of plans for the provisions for the protection of human and animal 
subjects and the safety of the research environment and conformance with the NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research and Inclusion of Children participating in Research Involving Human
Subjects

(4) Qualifications and Appropriateness of the Mentor/Co-Mentor

The application must include a signed statement from the mentor including 
information on research qualifications and previous experience as a research 
supervisor.  The applications must also include information to describe the 
mentor's research support related to the candidate's research plan and nature
of the supervision that will occur during the mentored phase of the proposed 
award period.  The application will also be assessed for the following:

o Evidence that the mentor has participated in the development of the career 
development plan;

o Appropriateness of the mentor's research qualifications as a clinician 
researcher; 

o Appropriateness of the qualifications of the mentor or a committee to provide 
the requisite expertise in genomics or proteomics;

o Appropriateness of plans to ensure that the candidate will receive adequate 
training in genomics or proteomics as applied to the development of therapeutic 
interventions for diseases;

o Quality and extent of the mentor's proposed role in providing guidance and 
advice to the candidate during the entire period of the award;

o Previous experience in fostering and developing patient-oriented clinician 
researchers;

o History of research productivity and peer reviewed support;

o Adequacy of existing support for the proposed research project;

o Adequacy and clarity of the mentor's statement describing what aspects of the 
Research Plan will remain with the candidate when his/her transition is made to 
an independent position. This statement should also specifically describe 
whether all or parts of the research project being conducted by the candidate 
will go with the candidate when the transition to an independent position is 
made or whether the candidate will be expected to develop an entirely new 
project in the independent position.

(5) Environment and Institutional Commitment

o Adequacy of research facilities and the availability of appropriate 
educational opportunities;

o Quality and relevance of the environment for scientific and professional 
development of the candidate; and

o Appropriateness of the applicant institution's commitment to ensuring that 90% 
of the candidate's time is dedicated to research career development and not to 
other activities unrelated to research, as evidenced by a clear listing of 
activities expected of the candidate within the 90% research effort and other 
activities that will be included in the remaining 10% effort.

(6) Training in the Responsible Conduct of Research

o Quality of the proposed training in the responsible conduct of research.

(7) Budget

o Justification of the requested budget in relation to career development goals 
and research aims and plans.

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, the following items will be considered in the 
determination of scientific merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section on 
Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the research 
will be assessed.  Plans for the recruitment and retention of subjects will also 
be evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.

RECEIPT AND REVIEW SCHEDULE: 

Application Receipt Date: October 20, 2003; October 20, 2004; and October 20, 
2005
Peer Review Date: February 2004; February 2005 and February 2006
Council Review: May 2004; May 2005; and May 2006
Earliest Anticipated Start Date: July 2004; July 2005; and July 2006

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making decisions:

o Scientific merit of the proposed project as determined by peer review;

o Results of the secondary review by national advisory council of the funding 
institute;

o Availability of funds;

o Relevance to program priorities;

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

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 (Revised August 25, 2000) at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in research 
in now available online at: http://cme.nci.nih.gov/.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research in 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Guidance 
for investigators and institutional review boards regarding research involving 
human embryonic stem cells, germ cells, and stem cell-derived test articles can 
be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
"Standards for Privacy of Individually Identifiable Health Information", the 
"Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health information, and 
is administered and enforced by the DHHS Office for Civil Rights (OCR). Those 
who must comply with the Privacy Rule (classified under the Rule as "covered 
entities") must do so by April 14, 2003  (with the exception of small health 
plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a 
complete Regulation Text and a set of decision tools on "Am I a covered entity?"  
Information on the impact of the HIPAA Privacy Rule on NIH processes involving 
the review, funding, and progress monitoring of grants, cooperative agreements, 
and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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:  The NHGRI program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under the authorization of Sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) No. 93.172 
(NHGRI), No. 93.172 (ORD), and No. 93.279 (NIDA) and under Federal Regulations 
42 CFR 52 and 45 CFR parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the NIH 
Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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


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