and Human Services (HHS)
EXPIRED
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: [email protected]
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
[email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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) 710-0267,
Email: [email protected].
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: [email protected]
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
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