ALZHEIMER’S DISEASE CLINICAL SCIENTIST DEVELOPMENT AWARD 

RELEASE DATE:  August 9, 2004
 
RFA Number:  RFA-AG-05-003 (This RFA has been reissued, see RFA-AG-06-006) 

EXPIRATION DATE:  January 25, 2005

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Aging (NIA)
 (http://www.nih.gov/nia/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866
 
LETTER OF INTENT RECEIPT DATE:  December 22, 2004
APPLICATION RECEIPT DATE:  January 24, 2005  
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms 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 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) will accept applications for the 
Mentored Clinical Scientist Development Award (K08) or Mentored Research 
Scientist Award (K01) in the area of Alzheimer’s disease and related 
dementias research. NIA will offer the K08 or K01 award to support the 
development of outstanding academic physician scientists to continue or 
to focus their research effort in Alzheimer’s disease related to 
clinical practice.  These mechanisms provide support for a period of 
supervised research and study for either clinically trained 
professionals with little research experience but who have the 
commitment and the potential to develop into productive, independent 
Alzheimer’s disease investigators (K08) or for clinically trained 
professionals with substantial research experience who wish to redirect 
their career to concentrate on Alzheimer’s research (K01).  The award 
period is three years and must include a plan to obtain didactic 
training and supervised training experience in order to ground the 
applicant in the field of neurodegenerative disease and integrate a 
fundamental and theoretical understanding of dementia with clinically 
oriented and/or laboratory research.  The proposed research should have 
both scientific importance and be a suitable vehicle for learning the 
skills necessary to become an independent physician-scientist 
concentrating on dementia research and practice.  The scope and nature 
of the proposed research should also be suitable for potential 
development into an independently funded research endeavor. The research 
program should be designed to elicit results that can be translated into 
clinical practice.

This award will support developmental experiences in either clinical or 
laboratory research. Because of the focus on progression to independence 
as a researcher, the prospective candidate for the K08 or K01 award 
should propose a period of training consistent with this goal and his or 
her previous research and clinical experience.  For example, a candidate 
with limited experience in dementia research may need a designated 
period of didactic training and closely supervised research experience 
for a longer period as the most efficient means of attaining 
independence.  A candidate with substantial previous research 
experience, such as an investigator in another field redirecting his/her 
career focus into dementia research, may require a shorter didactic 
training period appropriate for the transition to independence.  In all 
cases, the candidate must provide evidence of either having attained a 
broad understanding of theoretical aspects of the relevant clinical or 
basic science related to Alzheimer’s disease and related dementias, or 
that s/he will attain the same during the course of this award.

You are strongly encouraged to contact NIA staff listed below to 
discuss issues of eligibility and the specific provisions of this award 
as it pertains to NIA programmatic interests. While NINDS is not a 
sponsor of this RFA, the Institute has strong interest in research in 
Alzheimer's disease and related dementias (see: 
http://www.ninds.nih.gov/about_ninds/clusters/neurodegeneration.htm)

NIH encourages applications for educational loan repayment from 
qualified health professionals who have made a commitment to pursue a 
research career involving clinical, pediatric, contraception, 
infertility, and health disparities related areas.  The LRP is an 
important component of NIH's efforts to recruit and retain the next 
generation of researchers by providing the means for developing a 
research career unfettered by the burden of student loan debt.  Note 
that an NIH grant is not required for eligibility and concurrent career 
award and LRP applications are encouraged.  The periods of career award 
and LRP award may overlap providing the LRP recipient with the required 
commitment of time and effort, as LRP awardees must commit at least 50% 
of their time (at least 20 hours per week based on a 40 hour week) for 
two years to the research.  For further information, please see: 
http://www.lrp.nih.gov

RESEARCH OBJECTIVES

A.  Environment: The institution must have well-established research 
programs in Alzheimer’s disease research including clinical facilities 
and basic laboratories similar to those of an NIA-sponsored Alzheimer’s 
Disease Center.  The institution must have experience with clinical 
career development programs and qualified faculty in clinical and basic 
research related to Alzheimer’s disease and other neurodegenerative 
diseases to serve as mentors.  The institution must be able to 
demonstrate a commitment to the development of the candidate as a 
productive, independent investigator.  You, your mentor and your 
institution must be able to describe an in-depth, broadly based career 
development program that will maximize the use of relevant research and 
educational resources.

B.  Program: The goal of this program is to train junior and mid level 
physicians to focus their careers on Alzheimer’s disease research and to 
apply basic knowledge of the disease process to clinical care of 
patients. There is a critical need to build better bridges between 
Alzheimer’s laboratory research and cutting edge new methods of 
diagnosis, treatment and prevention of the disease. Well-trained 
physician scientists are needed to provide the next generation of 
leadership for research and treatment of Alzheimer’s disease and the 
related dementias.

The award provides for three consecutive 12 month appointments. At least 
75% of full-time professional effort must be devoted to this 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 help you develop the necessary 
knowledge and research skills in scientific areas relevant to your 
career goals. (See DETERMINING FULL-TIME PROFESSIONAL EFFORT FOR CAREER 
AWARDS at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html)

C.  Mentor(s): You must receive appropriate mentoring throughout the 
three-year program. You must name a primary mentor, who together with 
you is responsible for the planning, direction, and execution of the 
program. Your mentor(s) must have expertise in Alzheimer’s disease and 
related dementias, have a funded research program, have a track record 
of success in training  independent investigators, and demonstrate 
his/her availability and commitment to a clearly delineated training 
program. Where feasible, women and minority individuals and individuals 
with disabilities should be involved as mentors to serve as role models.

D.  Allowable Costs:

1.  Salary:  NIA will provide salary for you at a maximum of $ 100,000 
per year plus fringe benefits.

The institution may supplement the NIA contribution up to a level that 
is consistent with the institution's salary scale. 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. 
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. 

2.  Research Development Support: NIA will provide up to $50,000 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.

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

4.  Facilities and administrative costs: These costs will be reimbursed 
at 8 percent of modified total direct costs, or at the actual indirect 
cost rate, whichever is less.

E.  Evaluation:  In carrying out its stewardship of human resource 
related programs, the NIA may request 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.

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

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

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

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

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

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.

G.  Special Leave: Leave to another institution, including a foreign 
laboratory, may be permitted if directly related to the purpose of the 
award. Only local, institutional approval is required if such leave does 
not exceed three months.  For longer periods, prior written approval of 
NIA is required.  To obtain prior approval, you must submit a letter to 
NIA describing the plan, countersigned by your department head and the 
appropriate institutional official.  A copy of a letter or other 
evidence from the institution where the leave is to be taken must be 
submitted to assure that satisfactory arrangements have been made.  
Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave 
requires the prior written approval of 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.

H.  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 you are 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.

MECHANISMS OF SUPPORT

This RFA will use the NIH K01 
http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html and K08 
http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html
award mechanisms. As an applicant, with advice from your mentor(s), 
you will be responsible for planning, directing, and executing the
proposed project. This RFA is a one-time solicitation although NIA
intends to re-issue this RFA if funds are available. The anticipated
award date is September 15, 2005. The project period is limited to
three years. Awards are not renewable.

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.

This program does not require cost sharing as defined in the current 
NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

The NIA intends to commit approximately $1 Million in FY 2005 to fund  
six new grants in response to this RFA. You may request a project 
period of up to three years and a salary of up to $100,000 per year 
(plus fringe benefits) and $50,000 for research development. Although 
the financial plans of the NIA provide support for this program, awards 
pursuant to this RFA are contingent upon availability of funds and 
receipt of a sufficient number of applications of outstanding 
scientific and technical merit. 

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 Domestic institutions only

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

You must have an M.D. degree or its equivalent, must have completed 
postgraduate clinical training in a clinical area pertinent to the goals 
of this RFA such as Geriatric Medicine, Neurology, Psychiatry or 
Neuropathology and must have secured a faculty appointment in an 
appropriate research-intensive environment with established facilities 
for Alzheimer’s disease research comparable to an NIA-sponsored 
Alzheimer’s Disease Center, must identify a mentor with extensive 
Alzheimer’s disease research experience, and must be willing to spend a 
minimum of 75 percent of full-time professional effort conducting 
research and research career development related to Alzheimer’s disease 
and related dementias. Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

At the time of the award, you must be a U.S. citizen or a non-citizen 
national, or must have been lawfully admitted for permanent residence 
and possess an Alien Registration Receipt Card (I-551) or have 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.

Former principal investigators on NIH research project (R01), FIRST 
Awards (R29), most former NIH career development (K) awardees, sub-
projects of program project (P01) or center grants (P50), or the 
equivalent, are not eligible for the K08 award but may apply for the 
K01 award. If you apply for these K awards, then you may not 
concurrently apply for any other PHS award that duplicates the 
provisions of this award nor have another application pending award.  
Former principal investigators of NIH Small Grants (R03) or 
Exploratory/Developmental Grants (R21) remain eligible. Both K08 and 
K01 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. Specifically mentored career award recipients in the last 
two years of their support period will be permitted to reduce the level 
of effort required for the career award and replace that effort with an 
NIH research grant or subproject provided they remain in a mentored 
situation. Further details can be found at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html

SPECIAL REQUIREMENTS 

You and your primary mentor should commit to attending one meeting a 
year designated as the annual Markey Meeting as a condition of 
accepting the award. The location of the meeting will be determined by 
NIA and may vary from year to year. Therefore, funds should be 
requested to travel both individuals to and from the meeting for each 
year of the award.  For budget purpose assume that the meeting will be 
in Bethesda, Maryland.
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Such contact should 
occur early in the planning phase of the application preparation and 
will help insure that the applications are responsive to the career 
development goals and policies of NIA. 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:

Creighton H. Phelps, Ph.D.
Program Director, Alzheimer's Disease Centers 
Neuroscience and Neuropsychology of Aging
National Institute on Aging 
Gateway Building, Suite 350
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email: phelpsc@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
Bethesda, MD  20892-9205
Telephone: (301) 496-9666
FAX: (301)402-0066
Email: NekolaM@nia.nih.gov

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

Deborah Stauffer
Grants Management Specialist
National Institute on Aging
7201 Wisconsin Ave., Suite 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 492-3672
Email: stauffed@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 
o Names of all key personnel including proposed mentor(s)
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:

Creighton H. Phelps, Ph.D.
Program Director, Alzheimer's Disease Centers 
Neuroscience and Neuropsychology of Aging
National Institute on Aging 
Gateway Building, Suite 350
Bethesda, MD  20892-9205
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email: phelpsc@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 D&B number can be obtained by calling (866) 
705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The D&B number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 document 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.
 
SUPPLEMENTARY INSTRUCTIONS:

The application must address the following:

Candidate

o Describe your commitment to a career in clinical or laboratory-based 
biomedical research related to Alzheimer’s disease and related 
dementias.

o Provide evidence of your potential to develop into an independent 
investigator.

o Describe your immediate and long-term career objectives, explaining 
how the award will contribute to their attainment. If you are a K01 
applicant, outline previous research experience and the rationale for 
redirecting your research interests to Alzheimer’s disease.

o Include three sealed letters of recommendation addressing your 
potential for a research career. The mentor’s statement (see below) must 
not be included as one of the letters of recommendation. A co-mentor who 
is not your primary mentor may write a letter of references for you.

Career Development Plan

o Describe your career development plan incorporating consideration of  
your goals and prior experience.  Where necessary, the application must 
describe a systematic plan to obtain both the necessary didactic 
training and research experience to launch an independent research 
career related to Alzheimer’s disease and other dementias of aging.  If 
you are interested in clinical research you must describe the 
availability of courses such as research design, biostatistics, 
epidemiology, and ethical and regulatory issues at your institution and 
the integration of these studies into your career development plan.
If you have limited research training you may require a phased 
developmental period including didactic training during the first year 
of the award while gradually phasing in a period of intense, supervised 
research experience. If you have more experience at the time of 
application you may need a shorter developmental period and may already 
have an adequate theoretical background. In any case, the career 
development plan must be tailored to your particular needs and your 
ultimate goal of achieving independence as a researcher.

Research Plan

o Describe the research plan and the use of a clinical science or 
laboratory approach to a research project that will likely lead to 
increased knowledge or better treatment of Alzheimer’s disease and/or 
related dementias. To describe the research plan follow 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. However, the proposed research should derive from your 
own background, research interests, and career goals. The proposed 
research should also be suitable for development into a project capable 
of generating independent funding.

Mentor's Statement

o The application must include a statement from your mentor(s) and any 
co-mentor(s)) including information on his or her research 
qualifications and previous experience as a research supervisor for 
training scientists in Alzheimer’s disease, related dementias, or other 
neurodegenerative diseases. The application must also include a clear 
statement of commitment from your mentor(s) describing the nature and 
extent of supervision that will occur during the proposed award period.

Environment and Institutional Commitment

o Your sponsoring institution must document a strong, well-established 
research and training program related to Alzheimer’s disease and other 
neurodegenerative disease including a high quality research environment 
comparable to a NIA-sponsored Alzheimer’s Disease Center with staff 
capable of productive collaboration with you.  Your sponsoring 
institution also must provide a statement of commitment to your 
development into a productive, independent investigator.  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. The statement should 
indicate that the institution sponsoring you must treat you as a faculty 
member.

Training in the Responsible Conduct of Research

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.

Budget

o Budget requests must be provided according to the instructions in 
form PHS 398 and must be consistent with the amounts described under 
Allowable Costs in this announcement.  The request for tuition and 
fees, books, travel, research development support, etc., must be 
justified and specified by category.

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, 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 and 
all copies of the appendix material must be sent to:

Chief of Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD 20892-9205
 
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 the 
applicant 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 the NIA. Incomplete and/or 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 the 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 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: 

Candidate

o Quality of academic and clinical record;

o Potential through this award to develop as an independent clinical or 
laboratory based researcher in the field of Alzheimer’s disease; and

o Commitment to a career in Alzheimer’s research and clinical practice.

Career Development Plan

o Likelihood that the career development plan will contribute 
substantially to your scientific development;

o Probability of development of a competitive independent research 
program;

o Documentation of local expertise in Alzheimer’s disease and other 
neurodegenerative diseases and appropriateness of the content and 
duration of the proposed didactic and research phases of the award;

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

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

Training in the Responsible Conduct of Research

o Appropriateness and quality of the proposed training in the 
responsible conduct of research.

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 dementia research in which you propose 
to establish independence;

o 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 dementia research;

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

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

Mentor

o Appropriateness of mentor's statement of support and research 
qualifications in Alzheimer’s disease and related dementias;

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

o Previous experience in fostering the development of Alzheimer’s 
researchers; and

o History of research productivity and support; and

o Adequacy of support for the proposed research.

Environment and Institutional Commitment

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 Adequacy of research facilities (comparable to those of an NIA-
sponsored Alzheimer’s Disease Center) and availability of appropriate 
educational opportunities;

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

o Your institution's commitment to an appropriate balance of research 
and clinical responsibilities including the level of 75 percent effort 
proposed by you. 

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).

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: December 22, 2004
Application Receipt Date:  January 24, 2005
Peer Review Date: May 2005
Council Review: August 2005
Earliest Anticipated Start Date: September 15, 2005

AWARD CRITERIA

Award criteria that NIA will use to make award decisions include:

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

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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 PLAN: 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).  

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.healthypeople.gov/.

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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NIH Funding Opportunities and Notices


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