PAUL B. BEESON CAREER DEVELOPMENT AWARDS IN AGING

RELEASE DATE:  September 8, 2003

RFA Number:  RFA-AG-04-004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH)
 (http://www.nih.gov/)
The John A. Hartford Foundation 
 (http://www.jhartfound.org/)
The Atlantic Philanthropies 
 (http://www.atlanticphilanthropies.org)
The Starr Foundation 
 (http://fdncenter.org/grantmaker/starr/)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.866

LETTER OF INTENT RECEIPT DATE:  November 17, 2003

APPLICATION RECEIPT DATE:  December 17, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanisms of Support 
o  Funds Available
o  Allowable Costs
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Program Considerations
o  Special Requirements 
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations:

PURPOSE OF THIS RFA

The National Institute on Aging (NIA), the John A. Hartford Foundation, 
Atlantic Philanthropies, and the Starr Foundation are collaborating on 
this initiative to sustain and promote the research careers of 
clinically trained individuals who are pursuing research careers in 
aging. (The Hartford Foundation, Atlantic Philanthropies, and the Starr 
Foundation are collectively identified as "the participating 
foundations" later in this document). The program is named after Dr. 
Paul B. Beeson. Dr. Beeson was Chairman of Medicine at Emory and Yale 
Medical Schools, Nuffield Professor at Oxford University and Professor 
and distinguished VA Physician at the University of Washington. He 
chaired the first Institute of Medicine study on "Aging and Medical 
Education" in 1978. His leadership as an editor of the Cecil Textbook 
of Medicine greatly influenced medical education. From his research and 
patient care base, he grew increasingly interested in the process of 
aging, and this interest led to a commitment that included his 
editorship of the Journal of the American Geriatrics Society. He has 
profoundly influenced the career paths of many young physicians, 
including several who now form the core leadership in geriatric 
medicine.

The aims of the Paul B. Beeson Career Development Awards in Aging 
(BCDA) program are:

To encourage and assist the development of future leaders in the field 
of aging by supporting faculty members early in their careers to gain 
additional research training as needed and to establish independent 
programs in aging research.

To deepen the commitment of research institutions to academic research 
in aging and to translating research outcomes to geriatric medicine by 
involving mentor and recipient in establishing and advancing the 
recipient's career in aging research.

To expand medical research on aging broadly defined as including the 
biology of aging, maintenance of health and independence in old age, 
diseases and disabilities of old age and issues in their clinical 
management, and systems of care for the elderly.

Overall the program will foster the independent research careers of 
clinically trained investigators whose research will enhance the health 
and quality of life of Americans, particularly older people.

RESEARCH OBJECTIVES

Despite multiple efforts and programs sponsored by the National 
Institutes of Health, other agencies, and private foundations, the 
numbers of clinically-trained individuals who are committing to and 
sustaining independent research careers in the biomedical sciences 
remain inadequate to address the opportunities for translational 
research, interdisciplinary collaboration, and groundbreaking basic 
research being generated by advances in genetics, biomedical 
engineering, and other life sciences. Within the field of clinical 
aging research the small numbers of individuals receiving training in 
geriatrics, and the smaller numbers pursuing clinical research remain 
wholly inadequate to address the burgeoning needs of the rapidly 
growing older population. The aging of the American population requires 
a substantial investment in current and future faculty who will devote 
their careers to advancing knowledge of effective prevention and 
management of illness and disabilities, and to inspire successive 
generations to do the same.

This program provides support to junior to mid-career faculty members 
in strong research environments to enable them to gain skills and 
experience in clinical aging research and to establish an independent 
program of research in this field. If you are such a faculty member and 
wish to apply for this program you must identify a mentor. This 
individual should be a senior researcher in aging and/or geriatrics who 
agrees to commit time to supervising and guiding you during the period 
of the award. Mentors are encouraged to request limited support from 
the career development award to reflect their commitment to you (see 
below under Allowable Costs).

Program:
The BCDA is intended to provide you with the resources and time to 
establish yourself as an independent and funded investigator whose 
research focuses on clinically-relevant topics in aging. It is targeted 
primarily at individuals who have had some prior training in research 
coursework, methods, and resources related to aging research. Therefore 
the didactic plan is expected to be a relatively small part of the 
overall program and be tailored closely to the particular targeted aims 
of the research. Nevertheless candidates with limited prior research 
training and research experience will need longer periods of support on 
the BCDA than those with more research training and experience. Also, 
exceptionally, some candidates may require more extended periods of 
didactic training if changing areas or acquiring additional research 
skills. To accommodate these differences in prior experience or 
intended direction the initial BCDA award may be from three to five 
years. In addition, clinically-trained candidates with limited research 
experience are eligible for an up to two year competing continuation of 
the BCDA following completion of the initial award. Candidates who have 
a research doctorate earned prior to receiving the BCDA are not 
eligible for this competing continuation. Your program must be tailored 
to your individual needs and ensure that you will gain the experience, 
knowledge and skills necessary to carry out high quality clinically-
relevant aging research.  You and your mentor are jointly responsible 
for the preparation of the plan for this program. 

At least 75% of your full-time professional effort must be devoted to 
the goals of this award. The remainder may be devoted to pursuits 
consistent with the purpose of the award which must be designed to 
allow you to develop the necessary experience, knowledge and skills to 
become an independent researcher in a clinically-relevant field of 
aging. The BCDA program allows support for your salary, additional 
limited support for mentors, and for research/research development 
expenses to be used for research and training. 

The proposed training and research must focus on clinically-relevant 
research on aging and/or the aged. Your research project may be in the 
basic sciences, use animal models, or employ secondary data analysis as 
well as clinical and patient-focused methods.  The full range of 
research methods is encouraged provided that the application makes clear 
the clinical-relevance of the proposed work.

Mentor(s): You must name a primary mentor, who together with you is 
responsible for the planning, direction, and execution of the program. 
Your mentor should be recognized as an accomplished investigator in the 
proposed research area and have a track record of success in training 
independent investigators. You may also nominate co-mentors as 
appropriate to the goals of the program.  Where feasible, women, 
minority individuals and individuals with disabilities should be 
involved as mentors to serve as role models.

In addition your institution must have a well-established research and 
clinical career development program with an emphasis or specialty in 
geriatrics and/or other areas of aging-related research. It must have 
faculty qualified in aging research to serve as mentors. Your 
institution must be able to demonstrate a commitment to your 
development as a productive, independent investigator in aging-related 
research.

MECHANISMS OF SUPPORT

This RFA will use the NIH Patient-Oriented Research Career Development 
Award mechanism (K23); and the NIH Mentored Clinical Scientist 
Development Award mechanism (K08).  As an applicant you will be solely 
responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation although NIA and the 
participating foundations intend to re-issue this announcement if funds 
remain available.  The anticipated award date is July 1, 2004. 
Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated NIH mentored 
career development award applications using the standard receipt dates 
for NEW applications described in the instructions to the PHS 398 
application.

Competing Continuations. You may be able to seek a competing 
continuation following your initial award if you have limited research 
training and experience at the time of initial application. Clinically-
trained applicants with no prior NIH career development or similar 
award from other sources prior to the initial BCDA may seek support for 
one competing continuation of the BCDA. This continuation may not 
request support for more than two additional years. However, if you 
possess a research doctorate you are not eligible for the two-year 
continuation.

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.

If you are seeking to pursue patient-oriented research you should seek 
a K23 BCDA. If your own research project focuses on research in the 
basic sciences, uses animal models or secondary data-analysis with no 
direct contact with human participants, then you should seek a K08 
BCDA.

FUNDS AVAILABLE

The National Institute on Aging and the participating foundations 
intend to commit (in combination) approximately $2.5 million in FY 2004 
to fund 10 to 12 new grants in response to this RFA. You may request a 
project period of three, four or five years (note considerations under 
Program above) and a budget for direct costs of up to $200,000 per 
year. The maximum allowable direct costs across all years are $800,000 
for five year awards, $700,000 for four year awards and $600,000 for 
three year awards. Budgets for competing continuations will be limited 
to $300,000 across the two years with no more than $200,000 allowed in 
any one year. Although the financial plans of NIA and the participating 
foundations provide support for this program, awards pursuant to this 
RFA are contingent on the availability of funds and the receipt of a 
sufficient number of meritorious applications. NIA and the 
participating foundations also intend to reissue this RFA in future 
years contingent on the continuing availability of funds and receipt of 
meritorious applications.

ALLOWABLE COSTS

1.  Salary:  The NIA and the participating foundations will provide 
salary and fringe benefits for you. The total salary requested must be 
based on a full-time, 12-month staff appointment.  It must be 
consistent both with the established salary structure at your 
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. Note that the maximum salary support that NIA may 
provide is limited by the NIH legislative limit. Information on the 
current legislative limit is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-034.html. 
Foundation funds are not restricted in this way and therefore total 
salary may be above the NIH legislative limit if consistent with the 
salary structure of the institution, and if the NIA contribution is no 
more than the prevailing legislative limit.

At least 75% of full-time effort must be devoted to the goals of this 
award.  Because the salary amount provided by this award is based on 
your full-time institutional salary, you may not use other PHS funds to 
supplement the salary. However, you may use foundation funds in this 
way with the permission of the sponsoring foundation.  Institutional 
supplementation of salary must not require extra duties or 
responsibilities that would interfere with the purpose of the BCDA.  
Under expanded authorities, however, institutions may rebudget funds 
within the total costs awarded to cover salaries consistent with the 
institution's salary scale.

2.  Research Development Support: These expenses include: (a) tuition, 
fees, and books related to career development; (b) research expenses, 
such as supplies, equipment and technical personnel; c) travel to 
research meetings or training; (d) statistical services including 
personnel and computer time.

3.  Ancillary Personnel Support: Salary for secretaries and 
administrative assistants is not allowed. Funding for mentors is 
encouraged but is limited to no more than 5% effort for mentors for up 
to three years.

4.  Facilities and Administrative Costs: These costs, will be 
reimbursed at 8 percent of modified total direct costs and only on the 
NIA portion of the BCDA. The NIA portion to which F&A costs may be 
applied should be calculated at $100,000 per year for the purpose of 
calculating these amounts.

ELIGIBLE INSTITUTIONS

You may submit an application 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  Units of State and local governments
o  Eligible agencies of the Federal government
o  Foreign institutions are not eligible to apply

Also note the institutional requirements described under Research 
Objectives and under Review Considerations.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

You must have a clinical doctoral degree (e.g., MD, DO, DDS) or its 
equivalent. Note that, under some circumstances, individuals with 
doctoral degrees that require a dissertation or thesis as the final 
(non-clinical) stage of the doctoral program may apply for the BCDA 
program. These may include individuals holding both MD and PhD degrees 
as well as individuals with PhDs in clinical fields (such as clinical 
psychology, nursing or physical therapy). However, such individuals are 
not eligible for a competing continuation of the BCDA. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

You also must have completed your clinical training, including 
specialty and, if applicable, subspecialty training prior to receiving 
an award.  However, you may submit an application prior to the 
completion of clinical training.  You must identify a mentor with 
extensive research experience, and must be willing to spend a minimum 
of 75 percent of full-time professional effort conducting research 
career development and research on aging.

At the time of award, you must be a citizen or noncitizen 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).  Noncitizen nationals are generally persons born in outlying 
possessions of the United States (i.e., American Samoa and Swains 
Island).  Individuals on temporary or student visas are not eligible.

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

You cannot hold the BCDA concurrently with another NIH career 
development award or similar award. You must terminate the other career 
development award in order to receive the BCDA. Normally support from 
the prior career development award and support from the BCDA should add 
to no more than five years.

We encourage you to apply for independent research grant support during 
the period of this award.

PROGRAM CONSIDERATIONS

Evaluation:  In carrying out their stewardship of human resource 
related programs, NIA or the participating foundations may request 
information essential to assess the effectiveness of this program.  
Accordingly, you are hereby notified that you may be contacted after 
the completion of this award for periodic updates on various aspects of 
your 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: You may not retain fees resulting from clinical practice, 
professional consultation, or other comparable activities required by 
the research and research-related activities of this award. Such fees 
must be assigned to your grantee institution for disposition by any of 
the following methods:

o  The funds may be expended by your 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.

o  You 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 your grantee institution.

If you currently receive salary and fringe benefit support from an NIH-
supported research or research training grant, the salary funds from 
the BCDA will replace your current support. Under most circumstances 
the funds that are released will be returned to the Institute that 
supports the other award. However, under unusual circumstances the 
principal investigator of the other grant may seek approval from that 
Institute to use the funds for research within the scope of the prior 
award.

G. Special Leave: Leave to another institution, including a foreign 
laboratory may be permitted if the experience that you propose is 
directly related to the purpose of your award.  Only local, 
institutional approval is required if such leave does not exceed 3 
months.  For longer periods, prior written approval of NIA and the 
participating foundations is required.  To obtain prior approval, you 
must submit a letter to NIA and the participating foundations 
describing the plan, countersigned by your department head and 
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 BCDA will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave 
requires the prior written approval of NIA and the participating 
foundations 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 you are eligible.

Under unusual and pressing circumstances, you may submit a written 
request to NIA and the participating foundations, requesting a 
reduction in professional effort below 75 percent.  Such requests will 
be considered on a case-by-case basis during the award period.  In no 
case, will it be permissible to work at a rate of less than 50 percent 
effort.  The nature of the circumstances requiring reduced effort might 
include medical conditions, disability, or pressing personal or family 
situations such as child or elder care. Permission to reduce the level 
of effort will not be approved to accommodate other sources of funding, 
job opportunities, clinical practice, or clinical training.  In each 
situation, your grantee institution must submit documentation 
supporting the need for reduced effort along with assurance of a 
continuing commitment to your scientific development.  Further, you 
must provide written assurance of your intent to return to full- time 
professional effort (at least 75 percent) as soon as possible.  During 
the period of reduced effort, the salary and other costs supported by 
the award will be reduced accordingly.

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. The Director of the NIA together with the 
leadership of the participating foundations 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 NIA and the 
participating foundations shall notify both you and your institution in 
writing of this determination, the reasons for it, the effective date, 
and the right to appeal the decision.

If you plan a change of institution, you must submit to NIA and the 
participating foundations in advance of the change 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. You must establish in this request 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 sponsor must have the appropriate 
research expertise to supervise the program and sufficient research 
support to ensure continuation of the research program to the end of 
the award (initial award).  Staff at NIA and the participating 
foundations 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 this request, a new BCDA application must be 
submitted by the new institution 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.

When a mentor at your grantee institution is to be replaced, the 
institution must submit a letter from the proposed mentor documenting 
the need for substitution, the new mentor's qualifications for 
supervising the program, and the level of support for your 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.  Staff within NIA, and the participating 
foundations will review the request, and will notify the grantee 
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 when an 
institution relinquishes an award.

SPECIAL REQUIREMENTS 

You and your primary mentor should commit to attending one annual 
meeting a year as a condition of accepting a BCDA. You should budget 
funds for your individual travel to and from the annual Beeson meeting 
for one meeting a year. (The location of the meeting will vary from 
year to year.)

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:

Robin A. Barr, D. Phil.
Office of Extramural Affairs
7201 Wisconsin Avenue, Room 2C218, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9322
FAX: (301) 402-2945
Email: BarrR@nia.nih.gov

o  Direct your questions concerning peer review issues to:

Mary Nekola, Ph.D.
Chief, Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C212
Bethesda, MD  20892-2292
Telephone:  (301) 496-9666
FAX:  (301) 402-0066
Email: nekolam@nia.nih.gov

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

Linda Whipp
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, MD  20892-2292
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippL@nia.nih.gov

LETTER OF INTENT

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

o  Descriptive title of the proposed research
o  Your name, address, and telephone number
o  Names of all key personnel including proposed mentors
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 NIA 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:

Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging 
Gateway Building, Room 2C212
Bethesda, MD  20892-9205
Telephone:  (301) 496-9666
FAX: (301)402-0066 
Email: nekolam@nia.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at http://www.dunandbradstreet.com. 
The DUNS number should be entered on line 11 of the face page of the 
PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov.

This initiative is a collaboration among NIA and the participating 
foundations. Submission of an application is explicit approval for NIA 
to share the application and the written results of its review (the 
summary statement) with the collaborating partners. NIA and the 
foundations will jointly consider the applications to determine 
responsiveness to the RFA (see below under PEER REVIEW PROCESS) and 
jointly consider the results of review in order to develop a funding 
plan (see below under AWARD CRITERIA).

SUPPLEMENTARY INSTRUCTIONS:

The instructions provided here are in addition to the instructions in 
the PHS 398 (rev. 5/2001 section on career development awards (Section 
IV). Please refer to that section in preparing your application.

If you intend to use the resources within a General Clinical Research 
Center (GCRC) during the course of your award include a letter of 
agreement from either the GCRC program director or the principal 
investigator with the application.

The application must contain the following:

Candidate

o  A description of your commitment to a career in clinically-relevant 
aging research

o  Evidence of your potential to develop into an independent 
investigator.

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

o  A commitment of at least 75 percent effort to the BCDA program.

o  Three sealed letters of recommendation addressing your potential for 
a career in clinical aging research. The mentor's statement (see below) 
must not be included as one of the letters of recommendation.

Career Development Plan

o  Describe a plan for your career development that integrates your 
goals and prior experience.  It must show how you will obtain, or that 
you have obtained, the necessary theoretical and conceptual background, 
in addition to the research experience and skills, necessary to launch 
an independent career in clinically relevant aging research. You must 
describe available and appropriate courses on aging, including ethical 
and regulatory issues and integrate these studies into your career 
development plan.  It is expected that most candidates will already 
have completed relevant coursework on aging and on aging-related 
research methods and resources. Therefore the didactic period will be 
brief and the bulk of the awards will consist of intensive supervised 
research experiences staged towards increasing independence for the 
candidate. In exceptional cases, 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 experience. The career 
development plan must be specifically tailored to your individual needs 
and the ultimate goal of achieving independence as a researcher on 
aging.

Mentor's Statement

o The application must include a statement from the mentor including 
information on his or her qualifications in your proposed research area 
and previous experience as a research supervisor.  The application must 
also include information to describe the nature and extent of 
supervision that will occur during the proposed award period.

o  Similar information must be provided by any co-mentor.  If more than 
one mentor is proposed, the respective areas of expertise and 
responsibility should be described. A co-mentor who is not your primary 
mentor may write a letter of reference for you.

Research Plan 

o  Describe the research plan following the instructions in form PHS 
398 including sections on the Specific Aims, Background and 
Significance, Progress Report/Preliminary Studies, Research Design and 
Methods.  You should consult with your mentor regarding the development 
of this section.

Environment and Institutional Commitment

o  Your sponsoring institution must document a strong, well-established 
research and training program related to your area of interest 
including a high-quality research environment with staff capable of 
collaborating with you. Your institution must provide a statement of 
commitment to your development into a productive, independent 
investigator in clinically-relevant aging research.  The institutional 
statement also must commit to provision of release time from normal 
clinical, teaching or administrative duties necessary to meet the 75% 
effort requirement of this award.

Training in the Responsible Conduct of Research

o  You must either (a) describe plans to receive instruction in the 
responsible conduct of research, or (b) provide evidence that you have 
completed such a course in the past three years, or (c) show that you 
are teaching such a course. These plans or description of the course 
must detail the subject matter, format, frequency, and duration of 
instruction.  No award will be made if an application lacks this 
component.

Budget

o  The total direct costs requested must be consistent with the amounts 
described under Allowable Costs in this BCDA announcement. 

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/labels.pdf.

SENDING AN APPLICATION TO THE NIH: Submit a signed 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 and 
all copies of the appendix material must be sent to:

Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging 
Gateway Building, Room 2C212
Bethesda, MD  20892-9205
Telephone:  (301) 496-9666
FAX: (301)402-0066 
Email: nekolam@nia.nih.gov
 
APPLICATION PROCESSING: 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 you 
without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

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.  However, when a previously unfunded 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 from the previous unfunded 
version of the application.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIA and the participating foundations. Incomplete 
and nonresponsive applications will not be reviewed. 

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 NIA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o  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 written critique
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 evaluate the 
application in order to judge the likelihood that the proposed goals of 
the career development award will enable the candidate to have a 
substantial impact on clinically-relevant aging research. The 
scientific review group will address and consider each of the following 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.

o  Candidate
o  Career Development Plan
o  Training in the Responsible Conduct of Research
o  Research Plan
o  Mentor(s)
o  Environment and Institutional Commitment

Candidate

o  Quality of your academic and clinical record,

o  Your potential through this award to develop as an independent 
researcher focusing on clinically-relevant aging research. Reviewers 
will consider the proposed duration of support along with the quality 
of the proposed career development and research activities. 

o  Your commitment to a career in clinically-relevant aging research.

Career Development Plan

o  Likelihood that the career development plan will contribute 
substantially to your scientific development and lead to your 
establishing and advancing an independent research career in clinical 
aging research;

o  Appropriateness of the content and duration of the proposed didactic 
and research phases of the award; and

o  Consistency of the career development plan with your career goals 
and prior research experience.

Training in the Responsible Conduct of Research

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

Research Plan

Reviewers recognize 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.  
Nevertheless, a fundamentally sound research plan must be provided.  
For candidates who require substantial didactic training as part of 
their program, the research plan may cover less than the full period of 
the award.

o  Scientific and technical merit of the research question, design and
methodology;

o  Relevance of the proposed research to your career objectives; and

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

Mentor/Co-Mentor

o  Appropriateness of mentor(s) research qualifications in the area of 
this application;

o  Quality and extent of mentor's proposed role in providing guidance 
and advice to you;

o  Previous experience in fostering the development of more junior 
researchers;

o  History of research productivity and support; and

o Adequacy of support for the proposed research project.

Environment and Institutional Commitment

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

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

o  Your institution's commitment to your scientific development and 
assurances that your institution intends you to be an integral part of 
its research program; and

o  Your institution's commitment to an appropriate balance of research 
and clinical responsibilities including the commitment of 75 percent of 
your effort to research and research related activities.

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, AND MINORITIES IN RESEARCH: The adequacy of plans 
to include subjects from both genders, and 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 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.

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: November 17, 2003
Application Receipt Date: December 17, 2003
Peer Review Date: March 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 2004

AWARD CRITERIA

Award criteria that NIA and the participating foundations will use to 
make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Program balance.

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 

DATA AND SAFETY MONITORING: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III). The establishment of 
data and safety-monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety 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 "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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on 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.  
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, in the project description and elsewhere in the application as 
appropriate, 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 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.

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 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 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 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.


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