ALZHEIMER'S DISEASE CLINICAL RESEARCH AND TRAINING PROGRAM:
MENTORED SCIENTIST DEVELOPMENT AWARDS (K08 and K01)
RELEASE DATE: April 17, 2002
RFA: AG-02-006
National Institute on Aging (NIA)
(http://www.nih.gov/nia/)
LETTER OF INTENT RECEIPT DATE: June 17, 2002
APPLICATION RECEIPT DATE: July 16, 2002
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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE 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 and integrate a
fundamental and theoretical understanding of dementia with a period of
intensive clinically oriented and/or laboratory research. The proposed
research should have both intrinsic 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. Whenever possible the research program should be designed to
elicit results that can be translated into clinical practice.
These awards 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.
All applicants 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)
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. The candidate, mentor and
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 percent of the recipient"s full-time professional effort must
be devoted to the program. The remainder may be devoted to other
clinical and teaching pursuits consonant with the objectives of the
award. Both the didactic and basic science components must be designed
to develop the necessary knowledge and research skills in scientific
areas relevant to the career goals of the candidate.
C. Mentor(s): The recipient must receive appropriate mentoring
throughout the three-year program. The mentor(s) must have expertise in
Alzheimer"s disease and related dementias, have a funded research
program, and demonstrate his/her availability and commitment to a
clearly delineated training program. Where feasible, women and minority
mentors should be involved as role models.
D. Allowable Costs:
1. Salary: NIA will provide salary for the K08 or K01 recipient at a
maximum of $100,000 per year.
The institution may supplement the NIA contribution up to a level that
is consistent with the institution"s salary scale, however,
supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived.
In no case may PHS funds be used for salary supplementation.
Institutional supplementation of salary must not require extra duties
or responsibilities that would interfere with the purpose of this
award. Under Institution authorities, however, institutions may
rebudget funds within the total costs awarded to cover salaries
consistent with the institution"s salary scale.
The total salary requested must be based on a 100%, 12-month staff
appointment. It must be consistent both with the established salary
structure at the institution and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned.
If full-time, 12-month salaries are not currently paid to comparable
staff members, the salary proposed must be appropriately related to the
existing salary structure.
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. Indirect costs: Indirect 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 begin requesting information essential to
an assessment of the effectiveness of this program. Accordingly,
recipients are hereby notified that they may be contacted after the
completion of this award for periodic updates on various aspects of
their employment history, publications, support from research grants or
contracts, honors and awards, professional activities, and other
information helpful in evaluating the impact of the program.
F. Other Income: Fees resulting from clinical practice, professional
consultation, or other comparable activities required by the research
and research-related activities of this award 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:
The funds may be expended by the grantee institution in accordance with
the NIH policy on supplementation of career award salaries and to
provide fringe benefits in proportion to such supplementation. Such
salary supplementation and fringe benefit payments must be within the
established policies of the grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury.
Checks should be made payable to the Department of Health and Human
Services, NIH and forwarded to the Director, Division of Financial
Management, NIH, Bethesda, Maryland 20892. Checks must identify the
relevant award account and reason for the payment.
Awardees may retain royalties and fees for activities such as scholarly
writing, service on advisory groups, or honoraria from other
institutions for lectures or seminars, provided these activities remain
incidental and provided that the retention of such pay is consistent
with the policies and practices of the grantee institution.
Usually, funds budgeted in an NIH supported research or research
training grant for the salaries or fringe benefits of individuals, but
freed as a result of a career award, may not be rebudgeted. NIA will
consider approval for the use of released funds only under unusual
circumstances. Any proposed retention of funds released as a result of
a career award must receive prior written approval of NIA.
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 3 months. For longer periods, prior written approval
of NIA is required. To obtain prior approval, the award recipient must
submit a letter to NIA describing the plan, countersigned by his or her
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 the individual is moving to another eligible
institution, career award support may be continued provided:
The new institution submits an application to transfer the award,
complete with the requisite information concerning all aspects of the
career development plan, mentoring, and institutional support (as
described elsewhere in this RFA),
The period of support requested is no more than the time remaining
within the existing project period, and
The application to transfer an award is submitted at least 60 days
prior to the requested start date at the new institution to allow time
for review by NIA staff.
The Director of the NIH may discontinue an award upon determination
that the purpose or terms of the award are not being fulfilled. In the
event an award is terminated, the Director of the NIH shall notify the
grantee institution and career award recipient in writing of this
determination, the reasons therefore, the effective date, and the right
to appeal the decision.
A final progress report, invention statement, and Financial Status
Report are required upon either termination of an award or
relinquishment of an award in a change of institution situation.
MECHANISMS OF SUPPORT
This RFA will use the NIH K01 and K08 award mechanisms. Planning,
direction, and execution of the program will be the responsibility of
the candidate and his/her mentor on behalf of the applicant
institution. The project period is limited to three years. Awards are
not renewable.
FUNDS AVAILABLE
The NIA has set aside $1 million in order to fund at least five awards.
Awards 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(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Domestic institutions only
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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. You 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.
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), 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.
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.
WHERE TO SEND INQUIRIES
We strongly 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 ensure 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:
Elisabeth Koss, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Ave., Suite 3C307
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: kosse@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
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 of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows 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:
Elisabeth Koss, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Ave., Suite 3C307
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: kosse@nia.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, three sealed
letters of recommendation, and three signed, photocopies, in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
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 by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIA.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIA in accordance with the review criteria
stated below. As part of the initial merit review, all applications:
o Will receive a written critique.
o May undergo a process in which only those applications deemed to
have the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score.
o Will receive a second level review by the National Advisory Council
on Aging.
The application must address the following issues:
1. Candidate
Describe your commitment to a career in clinical or laboratory-based
biomedical research related to Alzheimer"s disease and related
dementias.
Establish your potential to develop into an independent investigator.
Describe your immediate and long-term career objectives, explaining how
the award will contribute to their attainment. For K01 applicants,
outline previous research experience and the rationale for redirecting
research interests to Alzheimer"s disease.
Career awards are full-time awards. At least 75% effort must be on
research and career development activities. The remainder of the effort
should be on clinical, teaching duties, or other duties that are
consistent with the award goals. You may receive compensation from
other than PHS sources for the time on the career award that is not
allocated to research.
Letters of recommendation. Three sealed letters of recommendation
addressing your potential for a research career must be included as
part of the application.
2. Career Development Plan
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.
You 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.
3. Research Plan
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. Describe the research plan as outlined 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, but 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.
4. Mentor"s Statement
The application must include information on your mentor(s) including
information on research qualifications and previous experience as (a)
research supervisor(s) for training scientists in Alzheimer"s disease,
related dementias, or other neurodegenerative diseases. The application
must also include information describing the nature and extent of
supervision that will occur during the proposed award period. There
must be a clear statement of commitment from your mentor(s) describing
the extent of his/her/their availability and effort to your training.
5. Environment and Institutional Commitment
The 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 statement
should indicate that the institution sponsoring you must treat you as a
faculty member.
6. Budget
Budget requests must be provided according to the instructions in form
PHS 398. The request for tuition and fees, books, travel, research
development support, etc., must be justified and specified by category.
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:
o Candidate
o Career Development Plan
o Research Plan
o Mentor
o Environment and Institutional Commitment
o Budget
1. Candidate
Quality of your academic and clinical record,
Potential to develop as an independent clinical or laboratory based
researcher in the field of Alzheimer"s disease, and
Commitment to a career in Alzheimer"s research and clinical practice.
2. Career Development Plan
Likelihood that the career development plan will contribute
substantially to your scientific development,
Probability of development of a competitive independent research
program,
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,
Consistency of the career development plan with your career goals and
prior research experience, and,
Quality of the proposed training in responsible conduct of research.
3. 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:
The significance of the area of dementia research in which you propose
to establish independence,
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,
Scientific and technical merit of the research question, design and
methodology and its likelihood to advance dementia research,
Relevance of the proposed research to your career objectives, and
Adequacy of the plan"s attention to gender and minority issues
associated with projects involving human subjects.
4. Mentor
Appropriateness of mentor"s statement of support and research
qualifications in Alzheimer"s disease and related dementias,
Quality and extent of commitment of your mentor"s proposed role in
providing you with guidance and advice,
Previous experience in fostering the development of Alzheimer"s
researchers, and
History of research productivity and support, and
Adequacy of support for the proposed research.
5. Environment and Institutional Commitment
Your institution"s commitment to your scientific development and
assurances that your institution intends you to be an integral part of
its research program,
Adequacy of research facilities (comparable to those of an NIA-
sponsored Alzheimer"s Disease Center) and availability of appropriate
educational opportunities,
Quality and relevance of the environment for your scientific and
professional development, and
Your institution"s commitment to an appropriate balance of research and
clinical responsibilities including the level of 75 percent effort
proposed by you.
6. Budget
Justification of the requested budget in relation to career development
goals and research aims.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: June 17, 2002
Application Receipt Date: July 16, 2002
Peer Review Date: Fall, 2002
Council Review: January 2003
Earliest Anticipated Start Date: April 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
o Research environment of the applicant institution.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a
complete copy of the updated Guidelines are available at
https://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.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://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
https://grants.nih.gov/grants/stem_cells.htm and at
https://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 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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This Request for Applications (RFA), Alzheimer"s Disease
Clinical Research and Training Program, is related to one or more of
the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.866, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and administered under NIH grants policies described
at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.