CAREER DEVELOPMENT IN AGING AND GENETIC EPIDEMIOLOGIC RESEARCH METHODOLOGY

Release Date:  September 23, 2002

RFA: AG-03-001

National Institute on Aging  (NIA) 
 (http://www.nih.gov/nia/)

Letter of Intent Receipt Date:  November 18, 2002
Application Receipt Date:  December 18, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE

The National Institute on Aging (NIA) invites applications for the Mentored 
Clinical Scientist Development Award (KO8) or the Mentored Research Scientist 
award (KO1) for career development in study design, data collection, and 
analytical methods for genetic epidemiologic research that focuses on aging-
related topics. The purpose of this Request for Applications (RFA) is to 
develop expertise in genetic epidemiologic methods and techniques that can 
aid in identifying effects of genetic factors and elucidating gene-
environment dynamics, such as gene-environmental interactions, gene-
environment correlations, and age-related changes in gene expression on: 
rates of age-related behavioral, physiologic and pathologic changes, 
differences in age of onset of diseases and disabilities, and/or broader 
outcomes not encompassed by disease diagnoses, such as exceptional longevity, 
in human populations. These award mechanisms provide support for a period of 
supervised research and study for either clinically trained junior 
investigators without substantial research experience, but with commitment 
and potential to become productive, independent researchers in aging and 
genetic epidemiology (KO8), postdoctoral research scientists who wish to 
substantially expand their knowledge and capabilities into aging and genetic 
epidemiologic research (KO1), or experienced investigators in genetics, 
epidemiology, biostatistics, or related fields who wish to develop their 
research approaches by learning aging and genetic epidemiologic methods that 
can be applied to their substantive areas of investigation (KO1).

RESEARCH OBJECTIVES

Background

Genetic epidemiology in age-related research is gaining importance with the 
increasing number of research questions focusing on age-related outcomes. 
Paralleling this is the growing demand for expertise in study design, data 
collection and analytic outcomes. With this growth of the field, it is 
essential to develop an enriched pool of qualified scientists with expertise 
in a variety of related research areas. The expected expansion of the field 
requires an increased emphasis on training in methods unique to population-
based research on age-related diseases and survival outcomes such as age of 
disease onset and disability, age-related rates of change, and exceptional 
survival phenotypes, i.e., unusually long survival before the occurrence of 
significant morbidity (health span), or disability (active life expectancy).

Objectives of Career Development

The objective of this career development initiative is to produce, through 
comprehensive research training, a well-qualified cadre of investigators in 
the genetic epidemiology of aging, capable of successfully competing for NIH 
and other research support for studies that focus on the identification of 
genetic factors that contribute to aging-related outcomes such as rates of 
age-related behavioral, physiologic and pathologic changes, differences in 
age of onset of diseases and disabilities, and/or broader outcomes not 
encompassed by disease diagnoses, such as exceptional longevity, in human 
populations. Identification of potential genetic and environmental factors, 
and their interactions, that act protectively against development of diseases 
and disability and that help to promote healthy aging and prolonged survival 
in the absence of morbidity are of interest. Investigators supported under 
this RFA will be expected to develop the experience and expertise necessary 
to direct population- and family-based studies in these areas. Candidates are 
expected to attain the skills to develop well-formulated, hypothesis-driven 
approaches. They are also expected to attain the skills to develop and carry 
out longitudinal data analyses, advanced statistical and analytical 
approaches to the study of complex age-related traits, identify biomarkers 
and endophenotypes, and develop new methodologic approaches to address gene-
gene and gene-environment interactions affecting age-related outcomes.  

Candidates should develop skills to test hypotheses in broad multi-level 
contexts, and the ability to test and develop appropriate genetic 
epidemiologic and behavior-genetic models in order to pinpoint fruitful areas 
for preventive interventions. Candidates should aim to gain expertise in the 
determination of appropriate assessment measures and epidemiologic databases 
as well as alternate designs that can accelerate the understanding of age-
related survival outcomes. 

Some examples of topics to be incorporated into a career development plan 
that would be responsive to this RFA include, but are not limited to the 
following: 

o Selection and definition of appropriate qualitative and quantitative aging-
related phenotypes, including, but not limited to, age of onset of diseases 
and/or disabilities, rates of age-related physiologic and pathologic changes, 
survival time in the absence of one or more diseases or disabilities, and/or 
exceptional longevity. Selection of appropriate study designs (e.g., 
association and linkage approaches) for assessment of genetic and 
environmental factors that contribute to aging-related outcomes and expansion 
of analyses to understudied populations. 

Elements of various phenotypes and study designs should take into account 
issues unique to aging populations (e.g., missing parental data, ease of 
locating living relatives of older study subjects, ease of collecting 
detailed health histories and genetic information on study subjects and their 
family members retrospectively, selection of appropriate unrelated controls 
in the absence of available family members, the potential to follow offspring 
of older subjects to examine familial patterns of aging-related outcomes 
prospectively). Power considerations and cost effectiveness of optimal 
designs should be addressed.

o Application and development of methods (e.g., survival analysis, frailty 
models, multivariate models) to analyze age-related data (e.g., life table 
data) including those derived from other pertinent fields such as demography 
and gerontology should be included. Benefits of combining some current 
methods (e.g., linkage and association methods), and the development of new 
approaches to analyzing aging-related data should be included. Problems 
common to studies of older persons (e.g., missing parental genetic 
information, age misreporting, accurate age ascertainment), or longitudinal 
designs (sample attrition, missing data points) the effect of secular trends 
(e.g., cohort and gender effects), and frequent confounders (e.g., population 
admixture), including current methods, and the development of new methods to 
deal with them should be addressed. Benefits of pooling data (e.g., 
subdividing large heterogeneous samples into homogenous groups) and results 
(e.g., meta-analysis) should also be covered.

o Identification of appropriate target populations (e.g., genetically 
homogenous populations, unrelated individuals, relative pairs, extended 
pedigrees) and advantages and disadvantages of using each for studies of 
aging-related outcomes should be discussed with emphasis on sampling 
strategies, statistical power, and ease of subject recruitment. A review of 
existing data (current and historical) sources that include information on 
older persons and their family members for selecting study subjects (e.g., 
existing longitudinal studies, family studies, twin registries and genealogic 
registries that include information on older-aged individuals) should be 
included. Methods to collect additional data, where appropriate, on older 
subjects and their family members should be incorporated.

o Collection and storage methods, for clinical (e.g., health history), 
genetic (e.g., blood samples from study subjects and family members), 
environmental, demographic, familial (e.g., family structure), and other 
relevant data, focusing on data management and quality control should be 
covered and include attention to IRB issues regarding research protocols, 
including the types of information that can be collected (e.g., family names, 
blood samples from family members), proper guidelines for obtaining informed 
consent, proxy consent, data and biological sample sharing issues, and other 
ethical, legal and social issues.

o Strengths and limitations of various genetic approaches (e.g., candidate 
genes, genome-wide scans), including a review of evolving methodologies from 
laboratory and statistical analysis perspectives including SNP (single 
nucleotide polymorphism) mapping and gene expression (e.g., microarray) 
analysis that can be used to identify genetic contributions (e.g., 
heritability, familial aggregation) to aging-related outcomes should be 
included. A review of candidate genes currently hypothesized to contribute to 
aging-related pathologies, approaches to identifying polymorphisms relevant 
to aging-related phenotypes, and ways to test the nature and strength of 
their relationships should be covered.

Some candidates may have significant research experience in some areas within 
these topics and may choose to focus on other relevant areas as a means to 
expanding their expertise. 

Scope of Career Development

The award period may be up to five years and must include a career 
development plan that incorporates didactic instruction and mentoring in 
genetic epidemiologic methods, relevant study design and analytical methods 
that cover issues specific to the study of older populations. The plan should 
be consistent with the goal of focusing on progression to independence as a 
researcher and with his or her previous research experience. For example, a 
candidate with limited research experience in aging and genetic epidemiology 
may need a designated period of didactic training and closely supervised 
research experience for a longer period as the most efficient means of 
achieving independence. Each candidate must have access to ongoing research 
projects that focus on aging-related issues in genetic epidemiology. The 
primary focus of candidate research questions on these projects with their 
mentor(s) must be on aging-related topics. The primary mentor must have 
expertise in genetic epidemiologic methods. Candidates are strongly 
encouraged to develop the substantive areas of their plan with an additional 
mentor with expertise in aging-related research.

Additionally, significant interaction and cooperation with researchers with 
expertise in methods on aging-related research (e.g., gerontologists, 
geriatricians) and researchers from other areas related to genetic 
epidemiology (e.g. epidemiologists, demographers, geneticists and 
biostatisticians) must be clearly presented in the application. Mentors must 
also have participated in funded, peer-reviewed research programs in the 
areas of genetic epidemiology and aging-related research. 

The application must address the following issues:

Candidate

o The candidate's commitment to a career in aging and genetic epidemiologic 
research must be described;

o The candidate's potential to develop into a successful independent 
investigator must be established;

Mentor(s)

The recipient must receive appropriate mentoring throughout the duration of 
the program. Where feasible women, minority individuals, and individuals with 
disabilities should be involved as mentors and serve as role models. Mentors 
must be recognized as accomplished investigators in the proposed research 
areas and have track records of success in training independent 
investigators. Candidates must name a primary mentor, with expertise in 
genetic epidemiology, who together with the applicant is responsible for the 
planning, direction, and execution of the career development plan. The mentor 
should have sufficient independent research support to cover the costs of the 
proposed career development plan in excess of the allowable costs in the 
award. Candidates are strongly encouraged to develop the substantive areas of 
their plan with an additional mentor with expertise in aging-related 
research. Both mentors may be from the candidate's institution, or one mentor 
can be from the candidate's institution and the other from another 
institution due to the rarity of combined genetic epidemiology and aging 
expertise.

Statement (see instructions in PHS 398 Application Form)

Environment and Institutional Commitment (see instructions in PHS 398 
Application Form)

Career Development Plan

Applicants must provide detailed plans for:

o Didactic instruction (i.e., a full description of the coursework to be 
covered) and the research components (i.e., a full description of research 
project(s) and research question(s) on which candidate will work) of the 
career development plan. 

o Means by which candidate needs and goals will be developed and addressed. 
Ongoing program evaluation and mechanisms to improve course content, 
mentoring, and supervised research experiences must be included. 

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 Candidates must describe the research plan and the use of a genetic 
epidemiologic approach to an aging-related biomedical problem. 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 consult with 
the mentor(s) regarding the development of this section. 

Data Sharing Plan 

Most projects will not involve the generation of independent data. However, 
for projects where the candidate will be generating independent data, a 
detailed plan for sharing data and biological samples must be included.

The KO8/KO1 awards focus on progression to independence as a researcher. 
Thus, the prospective candidate should propose a period of training that is 
consistent with this goal and his or her previous research experience. For 
example, a candidate with limited research experience in aging and genetic 
epidemiology may need a designated period of didactic training and closely 
supervised research experience for a longer period as the most efficient 
means of achieving independence. A candidate with substantive previous 
research experience, such as an investigator in another field redirecting 
his/her career focus into aging and genetic epidemiology, may require a 
shorter didactic training period appropriate for achieving independence. 

Applicants are strongly encouraged to contact the NIA staff listed below in 
this document to discuss issues of eligibility and the specific provisions of 
the application as it pertains to NIA programmatic interests.

Financial and Administrative Requirements

The award provides funds for five consecutive 12-month appointments.  At 
least 75 percent of the recipient's full-time professional effort must be 
devoted to the program. The remainder may be devoted to other clinical and 
teaching pursuits consonant with the objectives of the award. Both the 
didactic and basic science components must be designed to develop the 
necessary knowledge and research skills in scientific areas relevant to the 
career goals of the candidate.

Allowable Costs:

Salary: NIA will provide salary for the K08 or K01 recipient at a maximum of 
$100,000 per year.

The institution may supplement the NIA contribution up to a level that is 
consistent with the institution's salary scale; however, supplementation may 
not be from Federal funds unless specifically authorized by the Federal 
program from which such funds are derived.  In no case may PHS funds be used 
for salary supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the 
purpose of this award.  Under Institution authorities, however, institutions 
may rebudget funds within the total costs awarded to cover salaries 
consistent with the institution's salary scale.

The total salary requested must be based on a 100%, 12-month staff 
appointment.  It must be consistent both with the established salary 
structure at the institution and with salaries actually provided by the 
institution from its own 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.

Research Development Support: NIA will provide up to $25,000 per year for: 
(a) research expenses such as supplies, equipment and technical personnel; 
(b) statistical services including personnel and computer time;(c) travel to 
research meetings or training; (d) tuition, fees, and books related to career 
development.

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

Facilities and Administrative Costs: F&A costs will be reimbursed at 8 
percent of modified total direct costs, or at the actual F&A cost rate, 
whichever is less.

Evaluation:  In carrying out its stewardship of human resource related 
programs, the NIA may begin requesting information essential to an assessment 
of the effectiveness of this program.  Accordingly, recipients are hereby 
notified that they may be contacted after the completion of this award for 
periodic updates on various aspects of their employment history, 
publications, support from research grants or contracts, honors and awards, 
professional activities, and other information helpful in evaluating the 
impact of the program.

Other Income: Fees resulting from clinical practice, professional 
consultation, or other comparable activities required by the research and the 
career award recipient may not retain research-related activities of this 
award.  Such fees must be assigned to the grantee institution for disposition 
by any of the following methods:

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.

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

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, Division of Financial 
Management, NIH, Bethesda, Maryland 20892.  Checks must identify the relevant 
award account and reason for the payment.

Awardees may retain royalties and fees for activities such as scholarly 
writing, service on advisory groups, or honoraria from other institutions for 
lectures or seminars, provided these activities remain incidental and 
provided that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

Usually, funds budgeted in an NIH supported research or research training 
grant for the salaries or fringe benefits of individuals, but freed as a 
result of a career award, may not be rebudgeted. NIA will consider approval 
for the use of released funds only under unusual circumstances.  Any proposed 
retention of funds released as a result of a career award must receive prior 
written approval of NIA.

Special Leave: Given the highly specialized nature of aging-related genetic 
epidemiologic research, it may be appropriate for a candidate to take leave 
to go to another institution where research experience may be valuable to the 
purpose of the award. For example, if a co-mentor or collaborator 
specializing in an aging related field is located at a different institution 
than the primary mentor in genetic epidemiology at the applicant institution, 
special leave may be permitted. Only local, institutional approval is 
required.  However, NIA must be notified, in writing that this leave will 
occur, one month prior to such leave. A detailed research plan for this 
period of time must be included with the written notification.

Leave Without Award Support: Such leave may not exceed 12 months and requires 
the prior written approval of NIA 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.

Termination or Change of Institution: When a grantee institution plans to 
terminate an award, NIA must be notified in writing at the earliest possible 
time so that appropriate instructions can be given for termination.  If the 
individual is moving to another eligible institution, career award support 
may be continued provided:

The new institution submits an application to transfer the award, complete 
with the requisite information concerning all aspects of the career 
development plan, mentoring, and institutional support (as described 
elsewhere in this RFA);

The period of support requested is no more than the time remaining within the 
existing project period; and

The application to transfer an award is submitted at least 60 days prior to 
the requested start date at the new institution to allow time for review by 
NIA staff.

The Director of the NIH may discontinue an award upon determination that the 
purpose or terms of the award are not being fulfilled.  In the event an award 
is terminated, the Director of the NIH shall notify the grantee institution 
and career award recipient in writing of this determination, the reasons 
therefore, the effective date, and the right to appeal the decision.

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.

MECHANISM OF SUPPORT

This RFA will use the NIH KO8 and KO1 award mechanisms. Planning, direction, 
and execution of the program will be the responsibility of the candidate and 
his/her mentor on behalf of the applicant institution. The project period can 
last up to five years. Awards are not renewable. This RFA is a one-time 
solicitation. Future unsolicited, competing continuation applications based 
on this project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures. The 
anticipated award date is July 2003. This RFA uses just-in-time concepts.  
FUNDS AVAILABLE

The NIA intends to commit approximately $500,000 in total costs [direct plus 
Facilities and Administrative (F&A) costs] in FY 2003 to fund up to five 
awards. Although the financial plans of the NIA provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Domestic institutions only

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Candidates for the KO8 Mechanism 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., D.C., O.D., N.D. (Doctor of Naturopathy), D.V.M. or Pharm.D. 
Individuals with the Ph.D. or other doctoral degrees in clinical disciplines 
such as clinical psychology, nursing, clinical genetics, speech-language 
pathology, audiology and rehabilitation are also eligible.  Individuals 
holding the Ph.D. in a non-clinical discipline but are certified to perform 
clinical duties should contact the NIA concerning their eligibility for a KO8 
award.  The candidate must be able to identify a mentor with extensive 
research experience.  The candidate must be willing to spend a minimum of 75 
percent of full-time professional effort conducting research and research 
career development.  NIA does not require completion of postgraduate clinical 
training by the time of award

Candidates for the KO1 mechanism must have a research or a health-
professional doctorate or its equivalent, and must have demonstrated the 
capacity or potential for highly productive independent research in the 
period after the doctorate.  The candidate must identify a mentor with 
extensive research experience.  The candidate must be willing to spend a 
minimum of 75 percent of full-time professional effort conducting research 
and research career development during the entire award period.  The 
candidate must clearly describe the need for intensive research supervision 
for a period lasting three, four, or five years leading to research 
independence.   All potential applicants are strongly encouraged to contact 
the prospective NIH awarding component regarding their eligibility for the 
K01.

Candidates for the KO1, under some circumstances, may have been principal 
investigators on NIH research or career development awards, provided the 
research experience proposed in this application is in a fundamentally new 
field of study or there has been a significant hiatus in their research 
career because of family or other personal obligations.  Also, under some 
circumstances, current principal investigators on NIH research grants may be 
eligible if the proposed research experience is in a fundamentally new field 
of study.  Current principal investigators on NIH career awards are not 
eligible.  A candidate for the K01 award may not have pending nor 
concurrently apply for any other career development award. K01 recipients are 
encouraged to apply for independent research grant support during the period 
of this award.

Minorities, women, and individuals with disabilities are encouraged to apply.  
Candidates must be U.S. citizens or non-citizen nationals, or must have been 
lawfully admitted for permanent residence by the time of award.  Individuals 
admitted for permanent residence must be able to produce documentation of 
their immigration status such as an Alien Registration Receipt Card (I-551) 
or some other verification of legal admission as a permanent resident.  Non-
citizen nationals, although not U.S. citizens, owe permanent allegiance to 
the U.S.  They are usually born in lands that are not states but are under 
U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary 
or student visas are not eligible for this award.
 
Both KO8 and KO1 recipients are encouraged to apply for independent research 
grant support during the period of this award.  Recipients would be allowed 
to maintain the award if other PHS support is procured, as long as the new 
support does not interfere with the ability to meet the K08 or K01 
requirements.

SPECIAL REQUIREMENTS

Sponsors and awardees will meet as a group once a year, each year of the 
award period, in Bethesda, Maryland with NIH program staff to exchange 
information on the progress of the career development programs. Applicants 
should allow sufficient funds in their application budgets to support travel 
and lodging expenses to attend these meetings. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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 scientific/research issues to:

Winifred K. Rossi, M.A.
Special Assistant for Planning
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E327, MSC 9205
Bethesda, MD  20892-9205 (Express: 20814)
Telephone:  (301) 496-3836
Email: rossiw@nia.nih.gov

o Direct your questions about peer review issues to: 

Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office 
National Institute on Aging 
7201 Wisconsin Avenue, Room 2C212, MSC 9205
Bethesda, MD  20892-9205 (Express: 20814)
Telephone:  (301) 496-9666
Email: nekolam@nia.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205 (Express: 20814)
Telephone:  (301) 496-1472
Email: whippl@nia.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document. The letter of intent should be sent to:

Winifred K. Rossi, M.A.
Special Assistant for Planning
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E327, MSC 9205
Bethesda, MD  20892-9205 (Express: 20814)
Telephone:  (301) 496-3836
Email: rossiw@nia.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 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: GrantsInfo@nih.gov.

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 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)
 
At the time of submission, two additional copies of the application must be 
sent to:

Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office 
National Institute on Aging 
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD  20892-9205, (Express: 20814)
Telephone:  (301) 496-9666
Email: nekolam@nia.nih.gov 
 
APPLICATION PROCESSING: 

Applications must be received by 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 Review (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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

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

Incomplete and/or non-responsive 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 the NIA in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o Receive a written critique

o May undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score

o Receive a second level review by the National Advisory Council on Aging

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

(1) CAREER DEVELOPMENT PLAN

o The integration of aging and genetic epidemiologic topics in didactic 
instruction and in mentored research experience provided to candidates

o The Appropriateness of the interaction and cooperation with researchers 
with expertise in methods on aging-related research (e.g., gerontologists, 
geriatricians) and researchers from other areas related to genetic 
epidemiology (e.g. epidemiologists, demographers, geneticists and 
biostatisticians).

o Likelihood that the career development plan will contribute substantially 
to the candidate's scientific development;

o Probability of development of a competitive independent research program;

o Consistency of the career development plan with the candidate's career 
goals and prior research experience; and,

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

(2) RESEARCH PLAN

Reviewers recognize that applicants will have variable amounts of previous 
research experience and that an individual with limited research experience 
is less likely to be able to prepare a research plan with the breadth and 
depth of that submitted by a more experienced investigator.  Although it is 
understood that K08 and K01 applications do not require the level of detail 
necessary in regular research grant proposals, a fundamentally sound research 
plan must be provided.  In general the plan for the first year should be 
spelled out in detail while less detail is expected with regard to research 
planned for the later years of the award. The application should outline the 
general goals for years two and three.  The following details should be 
provided:

o The significance of the area of aging and genetic epidemiologic research in 
which the candidate proposes to establish independence;

o The appropriateness of the research plan to the stage of research 
development and as a vehicle for developing the research skills as described 
in the career development plan;

o Scientific and technical merit of the research question, design and 
methodology and its likelihood to advance aging and genetic epidemiologic 
research;

o Relevance of the proposed research to the candidate's career objectives; 
and

o Adequacy of the plan's attention to gender and minority issues associated 
with projects involving human subjects.

(3) CANDIDATE

o Quality of the candidate's academic record

o Potential to develop as an independent researcher

o Commitment to a research career

(4) MENTOR(S)

o Appropriateness of mentor(s) research qualifications in genetic 
epidemiology and/or aging-related research

o Quality and extent of mentor(s) proposed role in providing guidance and 
advice to the candidate

o Previous experience in fostering and development of researchers

o History of research productivity

o Adequacy of support for the proposed research project

(5) ENVIRONMENT AND INSTITUTIONAL COMMITMENT

o Adequacy of research facilities and training opportunities

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

o Applicant institution's commitment to the scientific development of the 
candidate and assurances that the institution intends the candidate to be an 
integral part of its research program

o Applicant institution's commitment to an appropriate balance of research 
and other professional responsibilities including the level of 75% effort 
proposed by the candidate

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS: The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent that they may be adversely affected by the 
projects proposed in the application.

o INCLUSION: The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups) as appropriate for the scientific 
goals of the research. Plans for the recruitment and retention of subjects 
will also be evaluated. (See Inclusion Criteria included in the section on 
Federal Citations below).

o DATA SHARING: The adequacy of the proposed plan to share data. (Most 
projects will not involve the generation of independent data. However, for 
projects where the candidate will be generating independent data, a detailed 
plan for sharing data must be included in the application.)

o BUDGET: The reasonableness of the proposed budget and the requested period 
of support in relation to career development goals and research aims. 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    November 18, 2002
Application Receipt Date:         December 18, 2002
Peer Review Date:                 March 2003
Council Review:	                  May 2003
Earliest Anticipated Start Date:  July 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

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.

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, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 RFA 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.

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 RFA 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: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.866, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and to 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.

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