and Human Services (HHS)
EXPIRED
DEVELOPMENTAL INFRASTRUCTURE FOR POPULATION RESEARCH
RELEASE DATE: August 11, 2004
PA NUMBER: PAR-04-138
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date. The
non-AIDS portion of this funding opportunity expires on the date indicated below.
A replacement R21 (PAR-06-362) funding opportunity announcement has been issued
for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865
APPLICATION RECEIPT DATES: December 15, 2004
November 23, 2005
November 22, 2006
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Child Health and Human Development (NICHD), through
the Demographic and Behavioral Sciences Branch (DBSB), Center for Population
Research (CPR), invites applications for developmental infrastructure grants
in support of population research relevant to the DBSB mission. Applicants may
request funds to support infrastructure development designed to: (1) enhance
the quality and quantity of population research conducted at an institution;
and (2) develop new research capabilities to advance population research
through innovative approaches. A central goal of this program is to facilitate
interdisciplinary collaboration and innovation in population research while
providing essential and cost-effective core services in support of the
development, conduct, and translation of population research based in centers
or comparable administrative units.
This is one of two announcements inviting applications under the Population
Research Infrastructure Program. This announcement invites applications for
Developmental Infrastructure Awards. A separate announcement, RFA-HD-04-022,
invites applications for Research Infrastructure Awards. A table summarizing
the differences between the Research Infrastructure Award and the
Developmental Infrastructure Award is available at:
http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm.
Developmental Infrastructure Awards are intended to support the development
and demonstrate the feasibility of programs that have high potential for
advancing population research, but have not yet fully developed the necessary
resources and mechanisms to be competitive for a full-fledged Research
Infrastructure Award.
RESEARCH OBJECTIVES
Background
The Demographic and Behavioral Sciences Branch (DBSB) is one of three programs
in the Center for Population Research of the NICHD. The mission of the Branch
is to foster research on the processes that determine population size, growth,
composition, and distribution, and on the determinants and consequences of
those processes. This mission translates into a research portfolio that looks
intensively at the demographic processes of fertility, mortality, and
migration and at their broad interrelationships with larger social, economic,
and cultural processes. Areas of supported research include fertility and
family planning, sexually transmitted disease, family and household
demography, mortality and health, population movement, population and
environment, and population composition and change. Research supported by the
Branch uses a broad spectrum of scientific approaches in the clinical,
behavioral, and social sciences.
During the years 1972-2000, NICHD provided infrastructure support for
population research through the Center Core Grant (P30) and Specialized
Research Center Grant (P50) mechanisms. In 1999, DBSB undertook a
comprehensive review of this program to determine whether its structure and
guidelines best served the future needs of population research. A report
summarizing the results of this review is available at
http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program
contact named under WHERE TO SEND INQUIRIES, below. As a result of the review,
DBSB is phasing out the P30 and P50 mechanisms in favor of the R24 and R21
mechanisms. This announcement uses the R21 mechanism. A corresponding
announcement (RFA-HD-04-022) uses the R24 mechanism.
Objectives and Scope
The primary purposes of the Population Research Infrastructure Program are to
provide resources to support and advance research that will improve
understanding of the antecedents and consequences of population structure and
change, facilitate interdisciplinary collaboration among investigators
conducting population-related research, and promote innovative approaches to
population research questions. An additional goal is to facilitate interaction
among scientists in locations throughout the United States that contributes to
the integration and coordination of population research.
The Infrastructure Grant retains some of the characteristics of traditional
P30 and P50 grants. It funds infrastructure to support a portfolio of
population research housed in or coordinated by a center or other research
unit (hereafter, "research unit" or "unit") at an institution. However, it is
designed to move beyond the traditional center grant mechanism to allow
institutions to aggressively pursue scientific opportunities appearing at the
boundaries between traditional population research and allied fields, and to
facilitate partnerships among diverse scientists and institutions. The
Infrastructure Grant allows units to use funds to address not only the core
support needs of existing projects, but to develop new directions and
approaches to population research. It asks applicants to design and propose
infrastructure programs that will advance the interdisciplinary reach,
innovation, and impact of their research programs, in addition to serving the
existing needs of researchers.
The Developmental Infrastructure Award is intended to support the development
of research units that have high potential for advancing population research.
The award provides such units the opportunity to further develop the
mechanisms and resources required to support and facilitate significant new
contributions to the field, continue to build a substantial interdisciplinary
portfolio of population research, and demonstrate their feasibility as full-
fledged population research units. Applicants for Developmental Awards are
expected to demonstrate the potential for becoming competitive for a
Population Research Infrastructure Program Award (R24) within three to five
years.
Applicants must articulate a clear vision for their research unit and its
current and future contributions to population research. Applicants must
identify the signature population-related themes of the unit and these must be
relevant to the DBSB mission. Signature themes are defined as research topics
that exemplify the applicant program's most significant current and/or
anticipated contributions to population research. The themes should reflect
major strengths of the program and need not encompass all research topics
covered by program researchers. Applicants must also articulate a vision for
the potential future contributions of the program.
Population Research Topics:
A description of the DBSB mission is available at
http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Illustrative examples of
population research topics that fall within the DBSB mission include, but are
not limited to, the list that follows. Applicants may consult with program
staff listed under WHERE TO SEND INQUIRIES to discuss the relevance of other
topics to the DBSB mission.
1. Research on the antecedents and consequences of changes in population size,
structure, and composition, including the documentation, analysis, and/or
projection of population composition with respect to demographic, economic,
social, and geographic characteristics; economic and social mobility; the
relationship of economic, social, and cultural factors to population change;
and the interrelationship between population and the physical environment.
2. Research on families and households, including studies of the determinants
of trends in marriage, divorce, and cohabitation; the formation of and changes
in household structures, fatherhood, patterns of child support and visitation
with absent parents; the use of child care services; the relationship between
changing fertility and family patterns and the well-being of children;
intergenerational demography; and the implications of welfare and health
policies on families.
3. Fertility research, including research on individual, social, economic, and
cultural determinants and consequences of fertility and fertility trends, on
the interrelationship between fertility patterns and education, work, union
formation and dissolution, family structure, and health; and on contraceptive
use, abortion, and sexual behavior.
4. Research on population movement and distribution, including studies of the
determinants and consequences of international and internal migration and
residential mobility, assimilation and adaptation of migrants; migrant
selectivity; residential segregation; and spatial demography.
5. Demographic aspects of health, morbidity, disability, and mortality,
including research on infant mortality and low birth weight; health
disparities; research that relates demographic and social processes to
mortality and health across the life course; and the health and well-being of
children (see http://www.nichd.nih.gov/cpr/dbs/dbsb_mission.htm for more
information).
6. Behavioral research on the sexual transmission of HIV, including
demographic studies of sexual behaviors related to HIV transmission; studies
of the interrelationships between social, institutional, economic, and
cultural contexts and sexual behavior; studies of the interrelationships among
pregnancy, pregnancy prevention, and HIV prevention; theoretically grounded
intervention studies within these areas; and related methodological studies
(see http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html).
Infrastructure Support
Applicants for the Developmental Infrastructure Award may request support in
two categories: (1) Research Support Cores and (2) Developmental
Infrastructure. Applicants are not required to request support in both
categories; rather, they should request types and levels of support that best
suit their needs and objectives. The NICHD expects that the amount and
allocation of infrastructure support that applicants request will vary.
For both categories of support, applicants must justify the types and amounts
of support requested in terms of: (1) the scope, objectives, and current and
potential impact of the applicant's research program; (2) the potential of the
requested infrastructure to develop the resources and mechanisms required to
build a substantial interdisciplinary portfolio of population research and
facilitate significant new contributions to the field; and (3) the cost-
effectiveness of the requested support. Applicants are expected to define
guidelines for determining the eligibility of researchers and research
projects to access resources provided under this program, and guidelines and
procedures for allocating such resources. No restrictions on access (e.g., by
students, investigators lacking research support, investigators in fields
other than population research) are imposed under this announcement.
However, applicants must demonstrate that their proposed guidelines and
procedures for controlling access to core resources are consistent with the
goal of effectively advancing the scientific program of the unit and the goals
of this announcement.
Definitions of Infrastructure Support Categories:
1. Research Support Cores provide shared resources that support the
applicant's research program. Examples include:
o Administrative Core, providing for coordination of research, editorial
services, and/or assistance with grant application development and fiscal
management of grants.
o Computing Core, providing equipment and/or services supporting shared
computing needs.
o Information Core, providing support for retrieving information, materials,
and data commonly used in population research.
o Methodology Support Cores, providing support for specific methodologies
employed in population research (e.g., GIS, statistical methods, biomarkers,
survey methodologies).
Research Support cores should be designed to advance the applicant's research
program while providing essential, cost-effective services to support on-going
research activities. Cores should be designed to facilitate and promote
innovation in the science conducted by program researchers in addition to
responding to researcher needs. Equipment and support services that are
specific to individual research projects or researchers are not allowable.
2. Developmental Infrastructure refers to activities that promote the
development of new research capabilities. Such activities may lead to outcomes
such as innovative projects and approaches, new interdisciplinary
collaborations, the scientific development of junior researchers, or the
integration of experienced researchers from other fields into population
research. Examples of potential developmental infrastructure activities
include:
o Seed grant programs, providing funds for the development of new research
projects. Institutions proposing seed grant programs must develop guidelines
and eligibility requirements appropriate to the goals of this PA, and
procedures and policies for administration of the program. Issues that may be
addressed include (but need not be limited to): (1) priorities for allocating
funds (e.g., junior researchers, specified areas of research,
interdisciplinary work, etc.); (2) procedures for reviewing applications; (3)
requirements for leveraging funds or preparing research proposals to continue
or expand the research project; (4) size of awards; (5) length of award
periods; (6) number of awards permitted to an individual researcher; (7)
mentoring arrangements; and (8) support for the program from the parent
institution or other funding sources.
o Faculty development, providing for partial salary support or other support
for the recruitment of new faculty in scientific areas critical to the
development of innovative and/or interdisciplinary research directions.
Support for any one individual may not exceed three years in duration.
o Activities that foster the development of new core services. For example,
applicants may propose to hire consultants to assist with the design of GIS
services, or conduct pilot studies to evaluate the cost-effectiveness of
alternative modes of core service delivery.
o Workshops, conferences, seminar series, and visiting scholar programs that
lay the groundwork for new substantive work or foster new research
collaborations.
Applicants may propose to cooperate with other institutions in undertaking any
of the above-mentioned infrastructure activities. Cooperative activities may
include the development of research partnerships involving scientists in the
applicant's program and colleagues in other institutions, and/or joint
ventures with other institutions to provide research, developmental, or public
infrastructure services. Proposed research partnerships must be justified in
terms of the scientific advances to be gained through collaboration across
institutions relative to those likely to emerge from within-institution
partnerships. Examples of allowable activities include travel for project
development and coordination and use of research support core, seed project,
and research project funds. Applicants also may propose cooperative research
support or developmental services in which the applicant and a Population
Center or similar unit in another institution participate in joint funding and
administration of a common service or resource. Examples might include a
shared library, data archive or outreach effort. Partners in a cooperative
venture need not be another funded applicant or Center. Applicants must
clearly describe the rights and responsibilities of each proposed partner in
the funding, administration, and use of shared resources.
MECHANISM OF SUPPORT
This PA will use the NIH Exploratory/Developmental Grant (R21) award
mechanism. As an applicant you will be solely responsible for planning,
directing, and executing the proposed project.
For this announcement, an applicant for an R21 award may request a project
period of up to five years and a budget for direct costs of up to $150,000 per
year. Developmental Infrastructure Awards are not renewable.
This PA uses just-in-time concepts. It also uses the modular budgeting format
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Faith-based or community-based organizations
o Domestic institutions
Foreign institutions are not eligible to apply.
Applicant institutions must have an established research center or other
administrative unit (referred to as the "research unit" or "unit") that serves
as a focal point for or coordinates population research across the
institution. This unit must have a defined governance structure.
The research conducted at the unit should reflect scientific benefits and
cost-efficiencies resulting from cooperation and interaction among a pool of
scientists with shared interests in population research. Applicants should
have in place (or propose in their applications) effective mechanisms for
fostering the development of an intellectual community that bridges
investigators from different disciplines and different projects and promotes
innovation in population research.
To be eligible to apply, the unit must have at least three researchers who
hold permanent (tenured or non-tenured) appointments with the applicant
institution and can present evidence of research activity related to the
mission of DBSB in all three of the following categories: (1) externally
funded research grants or contracts in the past three years; (2) publications
in peer-reviewed journals during the past three years; (3) papers in
preparation and future plans for research. Because their association with the
unit can be expected to be temporary, trainees, post-doctoral fellows, and
visiting professors should not be counted toward this requirement. The "past
three years" refers to the 36-month period preceding the application
submission date for this announcement. "Externally funded" means funding is
received from sources outside the institution; it may include funding from
NIH, NSF, other federal agencies, state and local governments, and private
foundations. Include only projects on which the individual has served as
Principal Investigator or had substantial involvement, comparable to that
indicated by identification of an investigator as "key personnel" on an NIH-
funded grant.
Note that the criterion used for unit eligibility above (at least three
researchers with evidence of research activity in all three categories)
differs from the criteria used to define page limitations under the
Application Guidelines at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm.
In latter case, the criterion of an "active researcher" is evidence of
research activity in at least two of the three categories defined above.
If your institution has held a P30, P50, or R24 grant from NICHD related to
population research in the three years prior to the application date, you may
not apply for a Developmental Infrastructure Award. Developmental awards are
nonrenewable and institutions may not simultaneously hold a Developmental
Award and a Population Research Infrastructure Program Award.
Potential applicants may contact staff listed under WHERE TO SEND INQUIRIES,
below, to discuss eligibility prior to submission of an application.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with his/her institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
The Principal Investigator should be a scientist or science administrator who
can provide effective administrative and scientific leadership.
SPECIAL REQUIREMENTS
Because the Infrastructure Program is expected to enhance the unit's
competitiveness for NIH funding, the institution and pertinent departments are
expected to show a strong commitment to the unit by providing additional
infrastructure support at a level appropriate to the resources of the
institution and the scope of the proposed program activities. Such commitment
may be demonstrated by the provision of dedicated space, faculty appointments
in subject areas relevant to the goals of the unit's research program, salary
support for investigators or core staff, dedicated equipment, or other
financial support for the proposed program. Applicants may consult with
program staff listed under WHERE TO SEND INQUIRIES to discuss this
requirement.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this announcement and welcome the
opportunity answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Christine Bachrach, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-9485
FAX: (301) 496-0962
Email: [email protected]
o Direct your questions about peer review issues to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Rashawn Farrior
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-5482
FAX: (301) 402-0915
Email: [email protected]
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
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo, Telephone
(301) 710-0267, Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS: Applications for Infrastructure Development
Awards (R21) should be prepared according to the Application Guidelines
available at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm and from
program staff listed under WHERE TO SEND INQUIRIES. All instructions and
guidelines accompanying the PHS 398 are to be followed, with the exception of
the sections modified by these guidelines.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
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:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates listed in the heading of this PA.
The CSR will not accept any application in response to this PA 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 a substantial revision of an application
already reviewed, but such application must include an Introduction addressing
the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned to NICHD. An appropriate
scientific review group convened by the NICHD in accordance with the standard
NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of 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 Child Health and
Human Development Council.
REVIEW CRITERIA
Reviewers will evaluate each application for overall scientific merit
according to the criteria provided below. Reviewers will also evaluate the
merit of proposed Infrastructure Support Components.
The size and scope of applicant programs are not a review criterion. NICHD
believes that investments of infrastructure resources in small centers of
excellence with focused scientific programs may be highly cost-efficient for
the field. Reviewers are encouraged to take the number of researchers involved
in a program into account in applying the additional review criteria below,
particularly when evaluating current and potential program impact. While both
larger and smaller programs are expected to demonstrate research activity of
high quality, programs with fewer researchers would not be expected to
demonstrate the same quantity of research productivity and program impact as
programs with a greater number of researchers.
OVERALL PROGRAM:
One primary criterion will be used to evaluate the overall scientific merit of
an application for a Developmental Infrastructure Award:
The potential future contributions of the applicant program to population
research: Reviewers will base their assessment of potential on such factors
as the current level and trajectory of research productivity, innovation,
quality, and significance; the significance of the applicant's central
scientific objectives and signature population-related themes and the plan for
advancing them; the program's plan for encouraging synergy and interaction
among population researchers; and the applicant's success in contributing to
the development of junior researchers. Applicants rated favorably on this
criterion will have high potential for becoming competitive for a Research
Infrastructure Award within three to five years.
Three secondary criteria will also be used to assess the overall scientific
merit of applications:
o Quality and potential impact of proposed infrastructure program: Reviewers
will examine the overall quality, scientific merit, and innovation of the
activities to be supported. Reviewers will consider the likelihood, based on
existing capabilities and proposed activities, that the proposed program will
develop the resources and mechanisms required to build a substantial
interdisciplinary portfolio of population research and facilitate significant
new contributions to the field.
o Research competence of key personnel: Reviewers will consider the
capability and scientific credentials of the Principal Investigator to direct
the program and maintain high standards of research collaboration; the
specific technical qualifications of core directors; and the scientific
accomplishments of all participating investigators.
o Institutional commitment and environment: Reviewers will assess the nature
and level of resource commitment from the institution in which the center is
housed and any cooperating institutions, taking into account the institutional
context. Reviewers also will consider the academic and physical environment
as it bears on research opportunities, space, equipment, and the potential for
interaction with scientists from various departments, institutions or
disciplines.
INFRASTRUCTURE SUPPORT COMPONENTS:
Each individual element of the proposed infrastructure program will be
evaluated separately based on the criteria below.
Research Support Cores
o Potential or actual contribution of the proposed core to advancing research
within the applicant unit, by enhancing the productivity of the existing
scientific program; fostering new scientific advances; facilitating
interactions across disciplines and substantive areas of study; and/or
advancing theoretical or technical approaches.
o Appropriateness to the size and characteristics of the applicant's existing
research program and the vision for the potential future contributions.
o Qualifications, experience, and commitment to the program of the
investigators responsible for the cores or activities and their ability to
devote the required time and effort to the program; and
o Cost-effectiveness of services or activities and appropriateness of cost-
sharing arrangements with the institution, relevant departments, and other
external infrastructure support programs.
Developmental Infrastructure
o Potential of the proposed activity to advance research within the
applicant's unit by stimulating innovation in population research and/or
fostering the development of junior researchers.
o Appropriateness to the size and characteristics of the applicant's existing
research program and the vision for the potential future contributions.
o Qualifications, experience, and commitment to the program of the
investigators responsible for the activities and their ability to devote the
required time and effort to the program; and
o Cost-effectiveness of services or activities and appropriateness of cost-
sharing arrangements with the institution, relevant departments, and other
external infrastructure support programs.
o For seed grant programs proposed under "Developmental Infrastructure," the
appropriateness and quality of procedures and policies for administering the
program, such as guidelines for reviewing applications, priorities for
allocating funds, requirements for leveraging funds, and size and length of
awards, and other program guidelines. In the review of a subsequent
application for R24 funding, seed grant programs will be reviewed for their
success in developing funded research projects relevant to the mission of
DBSB.
Collaborations
Applications proposing to undertake any infrastructure activity in cooperation
with another institution will be evaluated for the value added by the
involvement of other institutions and the appropriateness and adequacy of
plans for the sharing of rights and responsibilities among proposed partners
with respect to the funding, administration, and use of shared resources.
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, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below.)
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
o Relevance of the applicant's research program to the DBSB mission.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 is 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.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
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
http://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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA 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 PA 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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