Full Text PAR-97-011
 
PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES
 
NIH GUIDE
 
PA NUMBER:  PAR-97-011
 
P.T. 34

Keywords: 
  Aging/Gerontology 
  Epidemiology 

 
National Institute on Aging
 
PURPOSE
 
The National Institute on Aging (NIA) will provide grant support for
planning and protocol development of biomedical epidemiologic and
intervention studies in research areas supported by the Geriatrics
Program (see Research Objectives section of this program
announcement).
 
The planning grant application and review process is intended to
provide a mechanism for peer review of the rationale and basic design
of an epidemiologic or intervention study which would require
extensive detailed protocols and/or complex organization for proper
implementation.  The planning grant itself is intended  to provide
support for the development of a refined study design, organizational
plan, detailed protocol, Manual of Procedures, and budget, for
implementation of studies whose rationale and basic design are
considered sufficiently meritorious.  After these are completed,
planning grant awardees may submit applications to conduct the
full-scale study.  These applications will also be peer-reviewed.
 
Thus, the planning grant mechanism is intended to facilitate careful
and detailed protocol development and peer review of proposed complex
intervention and epidemiologic studies through a two-stage process
(rationale and basic design first, detailed protocol and organization
second), in order to minimize  unnecessary effort by applicants and
reviewers, and allow careful scrutiny of the methods proposed for
projects whose basic rationale and design have been judged to be of
high quality.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas. This PA is
related to the priority area of chronic diseases and disabling
conditions of older persons. Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report:  Stock No.017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic for-profit and
nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
 
Applicant institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may
wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC Program
Director or Principal Investigator should be included with the
application.
 
MECHANISM OF SUPPORT
 
The mechanism of support will be the NIA Planning Grant (R21), which
will provide up to $100,000 in direct costs for one year. The award
cannot be renewed.
 
Applicants should note that NIA funding of a planning grant does not
imply a commitment by NIA to fund the proposed full-scale study, nor
even to accept a subsequent application for such a study.  NIA
decisions on acceptance of applications for projects whose proposed
direct costs are $500,000 or more per year are determined by
availability of funds and other programmatic considerations.  Persons
considering submitting an application for a planning grant to develop
a project whose annual direct costs are likely to equal or exceed
$500,000 per year are strongly encouraged to contact Geriatrics
Program staff  (see the "Research Objectives" section of this
announcement)  before writing the planning grant application, in
order to obtain information on current program priorities and
projected availability of funds.
 
RESEARCH OBJECTIVES
 
The NIA Geriatrics Program supports biomedical research on
clinically-oriented aging topics. More detailed information on the
range of research topics for which the Geriatrics Program provides
support is available on the Geriatrics Program's section of the NIA
Home Page http://www.nih.gov/nia/.  Additional information regarding
specific topics may be obtained from the staff contacts listed for
specific research areas on the Home Page. Persons without access to
the NIA Home Page may obtain the information from:
 
Ms. Wanda Solomon
Geriatrics Program, NIA
Gateway Building, Suite 3E327
7201 Wisconsin Avenue
Bethesda MD 20892-9205
Phone: (301) 435-3047
Fax: (301 402-1784
E-Mail: SolomonW@gw.nia.nih.gov
 
Applicants for planning grants may request funds for activities such
as:
 
o  Preparation of detailed protocols and a Manual of Procedures.
These protocols and the Manual must be included in the Final Report
for this award.
 
o  Analyses of existing data needed for refinement of study design
and protocols (e.g., power calculations, dosage or intensity of
intervention, budget estimates).
 
o  Preliminary studies to guide selection of,  and/or refine, study
procedures and instruments, and estimate recruitment and retention
potential.
 
o  Travel expenses of individuals from multiple sites to planning
meetings for the project.
 
The planning grant proposal should describe:
 
o  The principal hypotheses to be tested, and the rationale for doing
so.
 
o  Basic study design, estimated sample size, and time course.
 
o  The intervention(s) (if any), populations (including general
eligibility and exclusion criteria), and outcomes to be studied, and
the rationale for their selection.
 
o  Outline of strategies for recruitment, retention, and maintenance
of subjects' adherence to study protocols.
 
o  Outline of methods for outcome measures and other measurements.
 
o  Outline of methods for data management and analysis.
 
o  The study elements to be planned or refined if the planning grant
is awarded. These must be included in the protocol and draft Manual
of Procedures to be produced by the awardees upon or before the end
of the planning grant award period: e.g., number and identity of
sites; power and sample size calculations; protocol elements;
external data and safety monitoring procedures; quality assurance of
data and study protocols; external data and safety monitoring;
liaisons with industry (if any); data coordination and
standardization; and planned staffing, organization, and budget.
 
Applicants for planning grants for human intervention studies should
review the NIA document "Implementation of Policies for Human
Intervention Studies" (NIH Guide to Grants and Contracts: Volume 25,
No. 33; October 4, 1996).  This is available in the "Grants and
Contracts" section of the NIH Home Page (http://www.nih.gov). Persons
without access to the NIH Home Page may obtain copies of the policy
from: Office of Extramural Affairs, National Institute on Aging;
Gateway Building, Suite 2C218; Bethesda, MD 20892-9205. Phone (301)
496-9322)
 
o  Proposed preliminary analyses of existing data needed for
refinement of study design and protocols (e.g., power calculations,
dosage or intensity of intervention, budget estimates).
 
o  Proposed preliminary studies to guide selection of,  and/or
refine, study procedures and instruments, and estimate recruitment
and retention potential.
 
o  The participants in the planning process, their roles in the
development of the plan, and their experience in related studies.
 
o  The organizational approach and timetable to be followed in
developing the protocol and draft Manual of Procedures over the
course of the planning grant award.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
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) and supersedes and strengthens the previous policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the February 1, June 1, and
October 1 application deadlines as indicated in the application kit.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Grants Information
Office, Office of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, Email:
ASKNIH@odrockm1.od.nih.gov.  The title and number of this program
announcement must be typed in Section 2 on the face page of the
application.
 
The completed original application and three legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)
 
At the same time, two additional copies should be sent to:
 
Chief, Scientific Review
National Institute on Aging
Gateway Building, Suite 2C212
7201 Wisconsin Avenue, MSC 9205
Bethesda MD 20892-9205
(20814 for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be evaluated for scientific
and technical merit by study sections of the NIH Division of Research
Grants or by the National Institute on Aging, NIH, convened in
accordance with the standard NIH peer review procedures.  As part of
the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of applications under review, will be discussed, assigned a priority
score, and given a second level review by the appropriate National
advisory council or board.
 
Review Criteria
 
In evaluating a Planning Grant application, the initial review group
will consider the criteria outlined below. NIA strongly encourages
applicants to address these criteria.
 
o  Scientific, technical, or medical significance and originality of
the proposed research.
 
o  Appropriateness and adequacy of the overall approach and
methodology proposed to carry out the proposed research
 
o  Qualifications and research experience of the Principal
Investigator and staff in the area of the proposed research.
 
o  Availability of resources necessary to perform the research
 
o  Appropriateness of the proposed budget for the planning activities
proposed.
 
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
 
o  Validity of rationale for the study, including scientific, public
health, and ethical aspects.
 
o  Quality and feasibility of basic study design; recognition of
possible problems inherent in the design and the adequacy of plans
for dealing with them.
 
o  Appropriateness of outcomes to be studied, and the methods used to
measure them.
 
o  Appropriateness of population, sample size, and eligibility and
exclusion criteria.
 
o  Appropriateness and effectiveness of overall strategies for data
management and analyses.
 
o  Feasibility and appropriateness of general strategies for
recruitment, retention, and maintenance of subjects' adherence to
protocol.
 
o  Rationale for, and quality of proposed preliminary analyses and
studies.
 
AWARD CRITERIA
 
NIA decisions on funding are determined by scientific merit of
proposed projects as determined by peer review,  availability of
funds, and NIA program needs and balance.
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
 
Geriatrics Program
National Institute on Aging
Gateway Building, Suite 3E327
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
FAX:  (301) 402-1784
E-mail: EH21f@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email: JE14j@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.866 and 93.846.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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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