and Human Services (HHS)
EXPIRED
COOPERATIVE REPRODUCTIVE SCIENCE RESEARCH CENTERS AT MINORITY INSTITUTIONS
Release Date: November 20, 2000
RFA: HD-00-019
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
Office of Research on Minority Health
(http://ncmhd.nih.gov/)
Office of Research on Women’s Health
(http://www4.od.nih.gov/orwh/)
Letter of Intent Receipt Date: February 16, 2001
Application Receipt Date: March 29, 2001
PURPOSE
The National Institute of Child Health and Human Development (NICHD), in
collaboration with the NIH Office of Research on Minority Health (ORMH) and
the Office of Research on Women’s Health (ORWH), invites new and established
basic science, translational, and clinical investigators to submit grant
applications for Cooperative Reproductive Science Research Centers at
Minority Institutions. Applications for these centers are sought from
investigators willing to participate with the NICHD under a Cooperative
Agreement (U54) mechanism in a multicenter cooperative research program.
Center investigators will be expected to work with NICHD staff in
facilitating research collaborations and interactions within and between
centers.
The purpose of this new initiative is to form a cooperative program that will
augment and strengthen the research infrastructure and research capabilities
of faculty, students, and fellows at minority institutions by supporting the
development of new, and/or the enhancement of ongoing, basic science,
translational, and clinical research that focuses on topics deemed to be of
high priority and significance because of their critical importance to
reproductive health. Applications are encouraged that address priority areas
in reproductive science that include, but are not limited to, the following
broad topics: (1) reproductive biology, physiology, and genetics; (2)
reproductive endocrinology; and (3) reproductive medicine encompassing
infertility, gynecology, and andrology.
The overall focus of the initiative is intended to stimulate the development
of a competitive research environment in reproductive science at minority
institutions. Reproductive scientists at minority institutions are invited
to establish a collaborative partnership with NICHD-designated reproductive
science research institutional programs, thereby benefiting from a broader
range of resources, experienced leadership, and exposure to ongoing research
projects. Such centers would bring together strong teams of experienced and
new investigators, around a reproductive science theme, to share essential
facilities, services, knowledge, and other resources. Long-term
comprehensive affiliation can be expected to lead to the development of a
stable relationship between the minority institution and the NICHD
reproductive science program that can build and foster independent and
competitive research capabilities at the minority institution. It is
envisioned that each center will ultimately become a training and mentoring
resource for developing and strengthening the research capacity of the nation
by expanding opportunities for minority scientists, particularly those
underrepresented within the scientific workforce.
This solicitation embraces the NICHD Research Agenda for identifying and
characterizing the factors and potential avenues of treatment related to
priority areas of reproductive science, represents an extension of ongoing
efforts, and demonstrates the Institute’s emphasis on expanding research
support for reproductive sciences. Finally, a major hallmark of the
initiative is its inclusiveness in addressing research across the
reproductive life span among diverse populations of women and men, thereby
improving the health of all citizens.
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) is related to one or more of the priority areas.
Potential applicants may obtain Healthy People 2010 at
http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by minority, for-profit and non-profit
organizations, public and private, such as universities, colleges, and
academic institutions that offer Ph.D., M.D., and/or equivalent health
professional degrees, at which 50 percent or more of the students enrolled
are from racial/ethnic minority groups and a significant proportion of
minority students are underrepresented in the biomedical sciences (e.g.,
African Americans, Hispanics, Native Americans, Alaskan Natives, Native
Hawaiians, and Pacific Islanders). To be responsive to this RFA, each
applicant institution must identify a collaborative affiliation with an
NICHD-designated reproductive science research institutional program. The
collaboration should be for the purpose of facilitating and addressing the
scientific objectives of the proposed center. A list of the designated NICHD
programs may be obtained at http://www.nichd.nih.gov/RFA/HD-00-019/HD-00-
019.htm and from the program staff listed under INQUIRIES, below.
The Principal Investigator from the minority institution, who serves as the
Center Director, must be an experienced researcher and be able to provide
both administrative and scientific leadership. The Co-director, from the
collaborating institution, must be an established investigator from an NICHD-
supported reproductive science program. Participating collaborating
investigators must be designated NICHD grantees (supported by grant
mechanisms such as the U-series, R01, P01, or K12).
The need for continuous and active communication among sites dictates that
only minority institutions in the United States, its possessions or its
territories are eligible to apply. Ideally, the collaborating institutions
should be in close proximity to one another. However, if this is not
possible, applicants should describe procedures and/or processes that will be
used to overcome any potential problems associated with the geographical
separation. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
Only one application will be accepted per eligible minority institution and
each NICHD-designated reproductive science research institutional program may
participate in no more than one application in response to this RFA.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) specialized
cooperative research center (U54) award mechanism, an assistance mechanism
(rather than an acquisition mechanism) in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated during the
performance of the research development activities. Under the cooperative
agreement, the NIH staff support and stimulate the recipients activities by
involvement in the activity and otherwise working jointly in a partner role,
but do not assume direction, prime responsibility, or a dominant role in the
activity. Details of the responsibilities, relationships, and governance of
the activities to be funded under the cooperative agreements awarded for this
program are discussed below under Terms and Conditions of Award.
The total project period for applications submitted in response to this RFA
is five years. The anticipated award date is September 30, 2001.
FUNDS AVAILABLE
The NICHD, ORWH, and ORMH intend to commit approximately $3 million in total
costs (Direct plus Facilities and Administrative [F & A] costs) in FY 2001 to
fund up to three new centers in response to this RFA. An applicant may
request a project period of up to five years and a budget for direct costs of
up to $1 million per year, including F & A costs on consortium arrangements.
Because the nature and scope of the research proposed may vary, it is
anticipated that the size of awards also will vary. Although the financial
plans of the NICHD, ORWH, and ORMH provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.
RESEARCH OBJECTIVES
Background
There has been increased focus on addressing health disparities and improving
the health status of all Americans. The increasing ethnic and racial
diversity of the U.S. population heightens the need to understand the impact
of health disparities over the reproductive life span of the American public.
The ultimate goal of reproductive science research supported by the NICHD is
to strengthen the science base and develop new knowledge leading to clinical
applications that will foster improved reproductive health. One way to
support this effort is to increase the cadre of new and experienced minority
investigators in ongoing and emerging areas of reproductive science.
Research in reproductive science remains relatively unexplored at minority
institutions. Some minority institutions have had difficulties developing
and sustaining independent programs in biomedical research, and there is a
dearth of minority scientists who are pursuing successful biomedical research
careers. The low level of involvement of minority institutions in
reproductive science and the lack of sufficient training opportunities for
minority scientists represent two major obstacles to developing an effective
research effort aimed at addressing significant health disparities. This
initiative will support the development of an enhanced research
infrastructure in reproductive science at these institutions. Creating
collaborations among minority institutions and other ongoing NICHD
reproductive science research programs would integrate and take advantage of
their respective expertise and experience. The Cooperative Reproductive
Science Research Centers at Minority Institutions would bring together strong
teams of experienced and new investigators, around a reproductive science
theme, to share essential facilities, services, knowledge, and other
resources.
It is not the intent of this RFA to focus only on studying disease processes
and disorders that disproportionately affect the reproductive health of
minority groups, but to encourage and foster the development of an
infrastructure at minority institutions needed to support the NIH research
agenda. State-of-the-art reproductive science research centers at minority
institutions would accomplish the following objectives: (1) create
professional opportunities for minority investigators; (2) cultivate an
academic and research milieu that would stimulate interest among students and
fellows to pursue research careers in reproductive science; and (3)
contribute to providing an environment in research excellence that would
increase the competitiveness of minority institutions and investigators for
traditional research project grants. It is envisioned that increasing the
diversity among investigators and institutions would strengthen the
scientific research conducted at these institutions, and participating in
research supported by this initiative would enhance the experience, training,
and career development of minority students and investigators associated with
these institutions.
NICHD’s strategic framework, From Cells to Selves
(http://www.nichd.nih.gov/strategicplan/cells/), highlights selected
scientific themes for future exploration and development that emphasize the
importance of fostering training opportunities for basic science,
translational, and clinical investigators, supporting the research
infrastructure of institutions, and translating science to meet the needs of
special populations and eliminate health disparities. The framework
acknowledges that for innovative and creative scientific projects to succeed,
the appropriate infrastructure, resources, and technologies need to exist.
The Cooperative Reproductive Science Research Centers at Minority
Institutions initiative represents an expansion of research opportunities at
minority institutions by creating strong reproductive science programs,
stimulating partnerships with research-intensive institutions, enhancing the
careers of underrepresented minority scientists, exposing graduate and
undergraduate students to meritorious research, and stimulating long-term
interest in reproductive science research careers among qualified
underrepresented minority students.
The Institute has demonstrated a long-term commitment to support reproductive
science institutional programs that have the framework to stimulate
multidisciplinary and interdisciplinary interactions among basic science,
translational, and clinical investigators interested in establishing quality
research projects in reproductive science. This RFA is specifically designed
to encourage the reproductive science research community to form partnerships
and support research-based centers at minority institutions, and to form a
cooperative network with NICHD that fosters communication, innovation, and
excellence. Thus, the major goals of this initiative are to support
specialized reproductive science programs of distinction and to facilitate
the development of a competitive research environment at minority
institutions.
Research Scope
The Cooperative Reproductive Science Research Centers at Minority
Institutions Program is composed of research-based center grants designed to
support interactive groups of research projects and supporting administrative
core units. The research activities included in these center grants must
comprise, by definition, a multidisciplinary approach to the specific
research topic areas announced in this RFA. These centers may have more than
one theme, focus or emphasis, but all of the projects involved must be
responsive to one or more of the designated reproductive science research
areas supported by NICHD.
There are a number of relevant research themes that would lend themselves to
a cooperative center approach and are considered important for the potential
development of new leads in reproductive science. Examples of the scope of
research deemed responsive to this RFA include, but are not limited to, the
following topics:
(1) Reproductive Biology, Physiology, and Genetics
o Biology of male or female gonads and reproductive tract, including
genetic, cellular, molecular, physiologic, hormonal, developmental, and
immunologic aspects of production and function of sperm and oocytes, and
their union to form an embryo.
o Gametogenesis, gamete maturation, gonadotropin regulation, role of gonadal
somatic cells, ovulation, gamete transport, acquisition of fertilization
potential, and function of corpus luteum.
o Fertilization: in vitro and in vivo, abnormal and normal.
o Blastocyst-uterus interaction in normal and abnormal implantation, pre-
and peri-implantation embryo development.
o Genetics of susceptibility to reproductive diseases and disorders.
(2) Reproductive Endocrinology
o Mechanisms of action of male or female steroid, protein, and peptide
hormones and other compounds important for reproduction, including target
cells of the hypothalamic pituitary-genital tract.
o Studies on the biosynthesis, secretion, and metabolism of hormones and
other compounds involved in reproductive processes.
o Modulation, signal transduction, and intermediary action of reproductive
hormones by secondary messengers, receptor modulators (e.g., selective
estrogen receptor modulators/SERMs and selective androgen receptor
modulators/SARMs), and co-activators/co-repressors.
o Establishment of cell lines and bioassays as models of reproductive
endocrine activity.
o Targeted genetic animal models of reproductive function and dysfunction.
o Reproductive neuroendocrinology, including positive and negative feedback
systems that influence reproductive processes, defining signal pathways.
o Interactions among the nervous, immune, and endocrine systems in
regulating reproductive processes.
(3) Reproductive Medicine
o Etiology, pathophysiology, prevention, diagnosis, and treatment aspects of
male or female infertility and reproductive diseases and disorders.
o Clinical studies and clinical trials.
o Efficacy and safety of assisted reproductive technologies and other drugs,
devices, and surgical treatments for infertility.
o Andrology, including endocrine disorders, sperm production, maturation,
transport, and function.
o Endocrine dysfunction, including central, hypothalamic, pituitary, and
target organ abnormalities of reproductive hormone production and action.
o Benign gynecological conditions such as endometriosis, leiomyomata uteri,
disorders (and normal function) of the pelvic floor and external genitalia.
o Follicular maturation, ovulation and corpus luteum formation, egg quality,
and uterine markers.
o Mechanisms underlying hypothalamic, pituitary, and reproductive tract
dysfunction in such conditions as gonadotropin deficiency, amenorrhea,
polycystic ovary syndrome, and premature ovarian failure.
o Female sexual function and dysfunction.
o Nutrition, body weight, and exercise as determinants affecting
reproductive function and fertility.
(4) Risk Factors for Reproductive Disorders
o Determination of the influence and role of risk factors such as race,
ethnicity, culture, and co-morbid medical conditions or previous surgery
associated with the occurrence of male or female reproductive disorders
(including pathophysiology, etiology, diagnosis, treatment outcomes, and
complications).
Research proposals involving human in vitro fertilization and/or embryo
transfer must be in compliance with NIH policies for such research and should
not, therefore, include efforts or activities that create human embryos
solely for research purposes.
Prospective applicants are encouraged to consider relevant topics other than
those listed here and to discuss their ideas with the program staff listed
under INQUIRIES, below.
Guidance and Management Structures
The Principal Investigator/Center Director affiliated with the applicant
institution and the Co-director associated with the NICHD-supported
reproductive science collaborating institution will be responsible for the
scientific and administrative leadership of each center. The management of
the Centers Program includes two committees (the Steering Committee and
Scientific Advisory Board) as described below in Terms and Conditions of
Award.
o Each Center Director and Co-director will participate as members of a
Steering Committee that will assist in the coordination of all centers. A
Chairperson will be chosen by a majority of the Committee members. The NICHD
Project Coordinator will participate as a voting member and a member of the
NICHD grants management staff will serve as a nonvoting advisor to the
Committee. The Steering Committee will employ a consensus decision process
to guide the centers in evaluating the progress of member center programs,
their proposed new research initiatives within the general scope of the
approved programs, and the need for collaboration either within or outside
the center. The Steering Committee will meet at least once a year.
o An independent Scientific Advisory Board will advise the Steering
Committee in identifying and prioritizing research topics appropriate for
study. The Scientific Advisory Board, chosen by the NICHD with the advice of
the Steering Committee, will consist of consultants with appropriate research
expertise. A Chairperson will be chosen by a majority of the Board members.
The Board will (1) review the broad goals and accomplishments of the centers,
including any mentoring, career development, and training activities; (2)
assess interim progress of all scientific projects and their relevance to the
broad objectives of this initiative; and (3) assist in identifying,
prioritizing, and reviewing proposed research projects that emerge during the
course of the grant. The NICHD program staff will serve as ex officio
member(s) of the Board. The Scientific Advisory Board will meet annually and
must submit a written report to the NICHD that summarizes its evaluation and
recommendations.
SPECIAL REQUIREMENTS
Center Characteristics
The minimal requirements for a Center described in this RFA are as follows
(see sections on Review Procedures and Award Criteria below):
1. Center Description. The applicant institution must offer Ph.D., M.D.,
and/or equivalent health professional degrees, 50 percent or more of the
students enrolled must be from racial/ethnic minority groups, and a
significant proportion of the minority students must be underrepresented in
the biomedical sciences (e.g., African Americans, Hispanics, Native
Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders). Each
center consists of the applicant minority institution and the collaborating
NICHD-designated reproductive science research institutional program. The
Center Director is from the minority institution and is the Principal
Investigator. The Co-director is from the collaborating reproductive science
program. Joint research projects may be in basic science, translational or
clinical research specifically addressing targeted areas in reproductive
science.
o Each center will represent a consortium consisting of the grantee
institution and the required collaborative partnership with one of the NICHD-
designated reproductive science institutional programs (as defined in this
solicitation) that should have the flexibility to identify new opportunities
through formalized planning, evaluation, and priority-setting activities.
The applicant institution will be expected to support research activities and
should have evidence of an existing research infrastructure.
o The application should include letters of commitment from leadership
within the minority institution and the identified collaborating institution
that are fully supportive of this activity and that commit the additional
resources necessary to ensure that these partnerships will have the maximum
chance of success. Institutions comprising each consortium should be
selected to facilitate attainment of the scientific objectives of the center.
Each application must justify the specific pattern of collaboration in light
of the scientific aims of the center and the resources that the participating
institutions have to contribute, and should outline the mutual benefits to be
gained as a result of the affiliation. Research partnerships are also
encouraged between departments, divisions, and schools within a single
institution to facilitate attainment of the scientific goals of the center.
2. Center Administration. The Principal Investigator/Center Director
affiliated with the applicant institution and a Co-director affiliated with
the NICHD reproductive science collaborating institution will be responsible
for the scientific and administrative leadership of the center.
o Each center partnership should develop a planning and evaluation component
to assure the progress of the collaboration, and procedures should be in
place for reviewing internal research proposals, enhancing infrastructure,
and recruiting new investigators on the basis of their merit and potential to
contribute effectively in achieving stated goals and objectives.
o Each Center Director and Co-director will participate as members of a
Steering Committee that will assist in the coordination of all centers. A
Chairperson will be chosen by a majority of the Committee members. The NICHD
Project Coordinator will participate as a voting member, and a member of the
NICHD grants management staff will serve as a nonvoting advisor to the
Committee. The Steering Committee will employ a consensus decision process
to guide the centers in evaluating the progress of member center programs,
their proposed new research initiatives within the general scope of the
approved programs, and the need for collaboration either within or outside
the center. The Steering Committee will meet at least once a year.
o An independent Scientific Advisory Board will advise the Steering
Committee in identifying and prioritizing research topics appropriate for
study. The Scientific Advisory Board, chosen by the NICHD with the advice of
the Steering Committee, will consist of consultants with appropriate research
expertise. A Chairperson will be chosen by a majority of the Board members.
The Board will (1) review the broad goals and accomplishments of the center,
including any mentoring, career development, and training activities; (2)
assess interim progress of all scientific projects and their relevance to the
broad objectives of this initiative; and (3) assist in identifying,
prioritizing, and reviewing proposed research projects that emerge during the
course of the grant. The NICHD program staff will serve as ex officio
member(s) of the Board. The Scientific Advisory Board will meet annually and
must submit a written report to the NICHD that summarizes its evaluation and
recommendations.
3. Research Development Core. The function of the core is to strengthen,
stabilize and consolidate interaction and cooperation between the minority
institution and the affiliated NICHD reproductive science program. All
research projects will be part of the Research Development Core. Each center
will consist of at least three research projects that thematically address
one or more research areas listed under Research Scope, above. All of the
research projects must be of sufficient scientific merit to warrant
independent support and must be an integral part of the center. It is
required that at least three research projects be maintained at all times for
the duration of the award.
o Applicants are required to propose at least three meritorious reproductive
science research projects and must describe the nature and scope of the
proposed scientific research collaborations. Qualified investigators from
the applicant minority institution or the collaborating institution should be
selected to propose and lead research projects suited to their respective
reproductive science expertise. A co-investigator from the other institution
must be involved in the project.
o Each of the proposed projects should effectively use the scientific and
technical strengths of collaborating investigators, and investigators must
clearly define the nature and extent of the research collaboration,
addressing administrative, fiscal, and scientific matters in the application.
All projects must include experienced investigators at identified NICHD
reproductive science programs as collaborators.
o At least two of the projects must be traditional R01-type research
projects. Each project will involve participation by accomplished co-
investigators from the collaborating institutions. Each R01-type research
project may not exceed $250,000 in direct costs per year.
o Each center may include, in addition to the two traditional research
projects, one or more short-term research pilot projects. The total project
period may not exceed two years, and each pilot project may not exceed
$100,000 direct costs per year. The purpose of the short-term project(s) is
to support pilot or feasibility studies that can lead to a traditional
research project(s) funded as part of the center grant. Each project will
involve participation by accomplished co-investigators from the collaborating
institutions. The expectation is that successful pilot projects will become
traditional R01-type research projects.
4. Administrative Core. Core resources supporting center development
activities, educational activities, administrative services, salaries of key
personnel, biostatistical and computer services, a planning and evaluation
component, and shared equipment should be included. The function of the core
is to strengthen, stabilize, and consolidate interaction and cooperation
between the minority institution and the affiliated NICHD reproductive
science program. The level of support for core resources must be
commensurate with the level of research proposed and funded. The
administrative core should include support for meetings (workshops and
seminars) or other activities to explore new and expanded collaborative
research, research training, and career development activities. Travel for
the Center Director and key investigators to an annual meeting of NICHD
Center Directors must be budgeted in the administrative core. This budget
must also include travel for the Center Director and Co-director to the
Steering Committee meetings.
Allowable Costs
Items fundable under an NICHD U54 grant include:
a. Direct support of individual research projects.
b. Research Development Core (research projects) and Administrative Core
activities used by these research projects.
c. Salaries and support for a limited number of administrative and clerical
personnel, such as the Center Director, Co-director, Center Administrator,
secretaries, and clerical support staff. The criteria defined under revised
OMB Circular A-21 will be used by NICHD staff to determine if funding of
administrative and clerical support staff is allowable.
d. Administrative support services, including supplies, duplication,
telephone, and maintenance contracts for equipment when not covered by
institutional Facilities and Administrative (F&A) charges.
e. At the discretion of the NICHD Centers Program, and as described in the
RFA, travel to meetings to confer with other NICHD Center Directors and
Administrators or to visit other center facilities pursuant to the
administration of the center.
f. Travel of Center Director, Co-director, and other investigators to
scientific meetings.
g. Travel of technical staff for training that would enhance the quality of
the research projects supported by the U54 grant.
h. Seminars or meetings designed to promote interdisciplinary interaction,
education, or center cohesiveness.
i. Consultants providing specific scientific and/or technical support to
center projects or cores.
j. Costs related to Steering Committee and NICHD Center Directors meetings.
Research Career Development and Training Opportunities
While formal research training cannot be supported by this solicitation, it
is understood that participation in research supported by this initiative can
have significant impact on the career development of underrepresented
minorities in the scientific workforce. Successful applicants are encouraged
to use existing research training and/or career development programs to
encourage qualified and interested underrepresented minorities to participate
in research funded under this RFA.
Terms and Conditions of Award
The following Terms and Conditions of Award are in addition to, and not
instead of, otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and
NIH grant administration policies. Cooperative Agreements are subject to the
administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH
guidelines, with particular emphasis on HHS regulations at 42 CFR Part 52 and
45 CFR Part 74. Indirect costs are calculated and awarded for cooperative
agreement awards the same as for grants.
The purpose of these cooperative agreements is to support a coordinated
research program of centers pursuing high quality reproductive science
research at minority institutions. Consistent with the cooperative agreement
mechanism, the dominant role and prime responsibilities reside with the
awardees for the project as a whole, although specific tasks and activities
in carrying out the studies will be shared among the awardees and the NICHD
program staff, as described in this announcement.
1. Awardee Rights and Responsibilities
The responsibilities and authorities of the awardees will be as follows:
o Primary authority and responsibility remain with the awardee: to define
the scientific objectives and pursue research approaches; to plan and conduct
experiments; to collect and analyze resulting data; and to publish results,
interpretations, and conclusions of the studies. The nature and scope of
research on common protocols must be adequately documented and must ensure
participation, sharing of methods and data among collaborating organizations.
o The awardee will agree to (1) participate cooperatively and accept the
coordinating role of the Steering Committee, which includes evaluating
objectives and research goals of the centers and recommending modification,
deletion or addition of protocols within the centers; (2) follow any common
protocols in which they participate and any multicenter projects that are
approved by the Steering Committee; (3) accept the advisory role of the
Scientific Advisory Board, which includes providing guidance and
recommendations; and (4) support the cooperative nature of the group process.
o Each collaborating partnership should plan regular communications to
discuss the progress and direction of its activities and to confirm that
necessary interactions within the center are taking place.
o The awardee will retain custody of and primary rights to the data and
intellectual property developed under the award, subject to current
Government policies regarding rights of access consistent with current HHS,
PHS, and NIH policies.
2. NICHD Program Staff Involvement
The role of the NICHD program staff will be to assist the awardees, the
Steering Committee, and the Scientific Advisory Board in the following ways:
o Participate in the overall coordination of the program with the Steering
Committee. This includes efforts to improve and strengthen inter- and intra-
center cooperation among the research projects of the centers; facilitate
interactions between the awardee and collaborating investigators; and retain
scientific/programmatic involvement during the award performance period by
contributing to planning and assessment activities, providing technical
assistance, advice and coordination beyond typical program stewardship for
grants.
o Provide technical advice and expertise regarding scientific direction and
program management to help shape a comprehensive framework for the
development of the center; interact with each individual center grant awardee
evaluating objectives and research goals of the particular center, deciding
optimal research approaches and protocol designs, and contributing to the
adjustment of research protocols or approaches, as warranted. The Project
Coordinator will assist and facilitate this process and not direct it.
o Assist research efforts by facilitating access to fiscal and intellectual
resources; recommend additional research endeavors within the approved
research and negotiated budgets; participate, where warranted, in data
analysis, interpretation, and dissemination of study findings; and assist
through review, comment, analysis and, where appropriate, co-authorship, in
reporting results to investigators and health care recipients.
o Reserve the authority to recommend reductions in budget, withhold support,
suspend and/or terminate the award if technical performance falls below
acceptable standards for quality and timeliness. The program staff will, as
required, help reprogram research efforts, including options to modify or
terminate them, by mutual consent between the center and NICHD. This
includes identifying jointly with participants of the Steering Committee and
Scientific Advisory Board the need to add additional research projects to
centers or to phase out a center project or core when performance standards
are not met.
o Serve as an ex officio member of the Scientific Advisory Board.
Participate as a voting member of the Steering Committee and all active
subcommittees.
o The Program Official will, as required, maintain primary responsibility
for stewardship of the award and overall responsibility for monitoring the
conduct, progress, and fiscal management of the research program; provide
assistance in reviewing and commenting on all major transitional changes of
an individual center’s activities prior to implementation to assure
consistency with required goals of the program; and reserve the right to
include selected NIH extramural and intramural staff as consultants/experts
on scientific issues during the performance periods of the award.
The NICHD reserves the right to negotiate additional awardee terms and
conditions based on recommendations from the Scientific Review Group and the
National Advisory Child Health and Human Development Council.
3. Collaborative Responsibilities
Overall coordination of the program, consistent with the stated intent of the
RFA, will be managed by a Steering Committee, Scientific Advisory Board, and
the NICHD program staff.
o The center partnership must have a planning and evaluation component in
place for reviewing internal proposals for pilot and traditional research
projects based on their merit and potential to contribute effectively to
achieving high priority goals and objectives. The center partnership will
have responsibility for directing the research projects and flexibility to
discontinue and start new projects based on the regular evaluation of
progress and identification of new opportunities through formalized and
priority setting activities. Beyond this, the center should develop
opportunities for information exchange, seminar presentation, and research
training opportunities for students and fellows.
o An independent Scientific Advisory Board will advise the Steering
Committee in identifying and prioritizing research topics appropriate for
study. The Scientific Advisory Board, chosen by the NICHD with the advice of
the Steering Committee, will consist of consultants with appropriate research
expertise. A Chairperson will be chosen by a majority vote of Board members.
The Board will (1) review the broad goals and accomplishments of the center,
and identify areas of new opportunity based on continuing evaluation; (2)
assess interim progress of all scientific projects and their relevance to the
broad objectives of this initiative; and (3) assist in identifying,
prioritizing, and reviewing proposed research projects that emerge during the
course of the grant period. The NICHD program staff will serve as ex
officio member(s) of the Board. The Scientific Advisory Board will meet
annually and must submit a written report to the NICHD that summarizes its
evaluation and recommendations for improvement.
o The Steering Committee will be composed of the Center Directors and Co-
directors from the collaborating institutions, and the NICHD Project
Coordinator. A Chairperson will be chosen by a majority vote of the
Committee members. The purpose of these meetings is to share scientific
information, assess scientific progress, identify new research opportunities
and potential avenues of collaboration, establish priorities, reallocate
resources, and conduct the business of the cooperative research program. The
Committee will have the responsibility for monitoring the progress of the
research projects. The NICHD Project Coordinator will participate as a
voting member of the Committee and any subcommittees. A member of the NICHD
grants management staff will serve as a nonvoting advisor on the committee.
The Steering Committee will meet at least once a year.
4. Arbitration
When agreement between an awardee and NICHD staff cannot be reached on
scientific/ programmatic issues that may arise after the award, an
arbitration panel will be formed. The panel will consist of one person
selected by the Principal Investigator, one person selected by NICHD, and a
third person selected by these two members. The decision of the arbitration
panel, by majority vote, will be binding. The process to resolve
programmatic differences described above in no way affects the rights of a
recipient of a cooperative agreement assistance grant to appeal an adverse
determination in accordance with PHS regulations at 42 CFR Part 50, Subpart
D, and HHS regulations at 45 CFR Part 16.
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 sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-
048.html); a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH-defined Phase III clinical trials and require: a)
all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subject research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
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, published in the NIH Guide for Grants and
Contracts, March 6, 1998, and available at:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
PREAPPLICATION WORKSHOP
An information/technical assistance preapplication workshop addressing the
scientific and administrative issues associated with this initiative will be
held during the Fall 2000. The purpose of the workshop is to (1) familiarize
the potential applicant with established NIH guidelines and criteria for
review, (2) discuss the areas of NICHD programmatic emphasis, and (3) respond
to potential applicants technical questions about application format,
procedures, etc. Logistic information, including date, time and location,
will be posted at http://www.nichd.nih.gov/RFA/HD-00-019/HD-00-019.htm and
may be obtained from program staff listed under INQUIRIES, below. For those
who cannot attend the workshop, a written summary will be posted at that
website.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the 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 NICHD staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent to Dr. Estella Parrott, by February 16,
2001, at the address listed under INQUIRIES.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research, on the Internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-710-0267, E-mail: [email protected].
Application Instructions
General Format:
o All essential information for the evaluation of the center application
must appear in the body of the application rather than in an appendix. The
instructions accompanying form PHS 398 must be followed as completely as
possible, but some modification, outlined below, will be necessary. For
example, in lieu of the preprinted Table of Contents outline on Form Page 3
of PHS 398, a Table of Contents should be prepared listing all of the major
sections described below and paginated to enable reviewers to find specific
information readily. Pagination must be consecutive throughout the
application. The Abstract should consist of a description of the composite
research program, indicate the emphasis of the component research projects,
and identify the purpose of the proposed core units.
o The Table of Contents should contain the types of information suggested
below:
Section I - General Information, Section II - Research Plan, and Section III
Appendix, if applicable. The following guidelines will provide directions
and descriptions for preparing each section. Major areas to be listed and
paginated in the Table of Contents are underlined.
Section I - General Information
A. Face Page
o Complete all items on the application's face page. This is Form Page 1 of
the application; number succeeding pages consecutively.
o On line 2, enter the RFA number (HD-00-019) and title ( Cooperative
Reproductive Science Research Centers at Minority Institutions ), and mark
the YES box.
B. Description and Personnel
o On Form Page 2, describe briefly the overall research program, indicate
the emphasis of the component research projects, and identify the purpose of
the proposed core units.
o List scientific and technical personnel participating in the Cooperative
Research Center. Use continuation pages as necessary, numbering
consecutively.
C. Table of Contents
o Prepare the Table of Contents as noted above. The major areas to be
listed are enumerated in these instructions.
D. Budget Estimates
o Prepare a series of composite Budget Tables for the Cooperative Research
Center Grant as requested below. A separate detailed budget is required for
each research project and for each core unit.
1. Composite Budget
a. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS
398 to present the total direct cost budget for all requested support for
the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc.,
list the amount requested for each research project and for each core
unit.
If consortium arrangements have been made involving other institutions or
organizations, include total costs (direct and F&A) associated with such
third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category.
Costs for purchased services should be itemized under "OTHER EXPENSES."
b. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS
398 to prepare a budget, by category, that provides direct cost totals for
each year of requested support.
2. Individual Project and Core Budgets
a. First year (use Form Page 4 of PHS 398 for each)
b. Total project period (use Form Page 5 of PHS 398 for each)
o Consortium Budgets (if applicable) should be presented as described in
Item 1 (Composite Budget), including a budget for the entire proposed project
period. Total Direct and F & A costs of sub-awardees are to be shown under
"CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets
and a detailed consortium budget is to be inserted following the appropriate
research project or core budgets.
o Budget Justifications: Describe the specific functions of key scientific
and technical personnel, consultants, collaborators, and support staff. For
all years, explain and justify any unusual items such as major equipment or
alterations and renovations. For future years of support requested, justify
any significant increases in any category over the first 12-month budget
period. Identify such significant increases with asterisks against the
appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER
EXPENSES" is anticipated, give the percentage.
E. Biographical Sketch
o Biographical sketches are required for all key scientific and technical
personnel participating in the research projects and core units as listed on
Form Page 2.
o Beginning with the Principal Investigator/Center Director, and following
in alphabetical order, submit biographical sketches as described in the
"Instructions for Form PHS-398," using Form Page 6. Do not exceed two pages
for each person.
F. Summary of Other Support
o To aid in the review of your application, information on all current and
pending research support of key personnel may be presented in tabular form.
Please indicate by an asterisk research support that overlaps with projects
proposed in this application. For all key personnel named on Form Page 2
(except consultants), beginning with Principal Investigator and in
alphabetical order thereafter. Identify other support in the following
categories:
1. Current Active Support; and
2. Applications Pending Review or Funding.
G. Resources
o Complete the "RESOURCES" section on Form Page 8 of the PHS 398 for the
overall center. Briefly describe the features of the institutional
environment that are or would be relevant to the effective implementation of
the proposed program. As appropriate, describe available resources, such as
clinical and laboratory facilities, participating and affiliated units,
patient populations, geographical distribution of space and personnel, and
consultative resources. Use continuation pages as needed.
Section II - Research Plan
o A proposed five-year research plan that is responsive to the objectives
set forth in this RFA and presents the organization and component functions
of the center must be included. The research plan must contain the
description of at least three collaborative research projects that will be
mutually beneficial to participating investigators through coordinated,
cooperative interactions. The plan should demonstrate the applicant’s
knowledge, ingenuity, and commitment to developing productive, competitive
reproductive science research.
o Include a detailed Table of Contents with pagination (numeric only) at the
beginning of Section II. Identify each research project or core unit by
title, and assign each research project a number (I, II, III) and each core
unit a capital letter (A,B,C) that reflects the order in which the research
projects and core units are presented in the application research plan. For
each research project and core unit, provide the names of the Principal
Investigator/Co-Principal Investigator or Core Director/Co-director, and
biographical sketches for personnel not identified previously.
A. Introductory Overview
o Although there is no page limitation for this section, applicants are
encouraged to present a concise and succinct overview. Discuss the
objectives of the center and general plans for the proposed grant period.
1. Center Description/Management
o A description of and justification for the proposed research development
core, which consists of the individual research projects, and the
administrative core unit should be included. This should include the
capabilities to meet or exceed the minimal requirements for a center, as
stated in this RFA. List by title and investigator the component research
projects and core units, showing the interrelationship between the research
projects, the core units, and their relationship to the central theme.
Applicants must also provide a detailed description of the process involved
in selecting projects included in the center grant application as well as the
process that will be used in evaluating their outcomes, and in selecting a
new set of projects based on their merit and potential for meeting the
objectives of the partnership.
o Discuss the general rationale for the partnership and mutual benefits that
the minority institution and collaborating institution expect to derive from
the affiliation. Include a discussion of potential opportunities that the
partnership may consider as the relationship and affiliation evolves.
o The goals of the center must be described and background and significance
of the topics being addressed discussed. In addition, each research project
and core unit must be fully explained in light of how they contribute to
achieving these goals. The organizational and administrative structure, the
responsibilities of the Center Director, the Co-director, and the individual
investigators, and the proposed mechanism for monitoring scientific progress
must be addressed. Describe the organizational framework and provide an
organizational chart.
o A description of the qualifications and experience of the Center Director
and Co-director in terms of their ability to provide scientific and
administrative leadership, and how they plan to promote the collaboration and
cooperation needed to achieve the center objectives.
o The center must be prepared to participate in a cooperative manner.
Document institutional and departmental commitment to support this
cooperative study and staff dedicated to this program.
o Clearly outline the chain of responsibility for decision making and
administration, beginning at the level of the institution’s President or
other senior official and including all key staff (e.g., Sponsored Program
Administrator, Department Chair, and Dean). Describe the plans for day-to-
day administration of the center, including program coordination, planning,
and evaluation. Describe the proposed relationship of the center to existing
research activities and, in detail, how the center will augment and
strengthen the existing research infrastructure.
o Include information on the use of the steering and advisory committees,
and the method of determining core access and space assignment.
o The applicant must identify and outline plans for support staff (e.g.,
grants management, administrative, and technical) to ensure the timely
ordering of research supplies, equipment, and other resources essential to
the scientific productivity of the research award.
o Describe the availability of existing resources (e.g., clinical and
laboratory facilities, patient populations, geographic distributions of space
and personnel) and collaborative resources that can support a research
program.
o Briefly describe how the proposed activities will enhance the scientific
capabilities of faculty, students, and fellows in reproductive science and
strengthen the reproductive science curriculum.
2. Institutional Commitment/Supporting Infrastructure
o A letter of commitment from a senior official (e.g., President or Dean) at
the applicant institution should outline the commitment for resources and
facilities to sustain and support the center throughout the period of funding
and beyond the performance of this award; document institutional and
department commitment and the availability of technical resources and
facilities for the long-term support of the center; delineate features of the
institutional environment that are relevant to the overall success of the
reproductive science program; provide evidence that senior leadership has
addressed issues such as tenure, promotion, research release time, and other
personnel matters pertaining to the scientific success of the center.
o A letter of commitment from a senior official (e.g., President or Dean) at
the collaborating NICHD reproductive science institutional program should
outline the commitment for resources and facilities to sustain and support
the center throughout the period of funding; document institutional and
department commitment and the availability of technical resources and
facilities; and delineate features of the institutional environment that are
relevant to the scientific success of the center.
3. Assurances and Collaborative Agreements.
o Any arrangements for collaborative and cooperative endeavors or
subcontracting should be highlighted. Letters of Intent to Collaborate and
Letters of Agreement from consultants should be referenced here and included
at the end of the appropriate research project or core unit. (This is
usually covered under each research project and core.)
B. Research Development Core Description
o It is required that at least three research projects be maintained at all
times for the duration of the award. These research projects must
thematically address one or more research areas listed under Research Scope.
o At least two of the research projects must be in the format of an R01-type
application. One or more research project may be a short-term pilot project.
The maximum direct costs for each R01-type project is $250,000 per year and
for each pilot project is $100,000 per year.
o Selection of qualified investigators from the applicant minority
institution or collaborating institution to propose and lead meritorious
research projects suited to their reproductive science expertise must be
identified. A co-investigator from the other institution must be involved in
the project. Each of the proposed projects should effectively use the
scientific and technical strengths of collaborating investigators, and
investigators must clearly define the nature and extent of the research
collaboration, such that they fully explain the necessary administrative,
fiscal, and scientific focus in the application. These projects must involve
established investigators at affiliated NICHD-designated institutions as
collaborators.
o Each of the research projects and the core units proposed for inclusion in
the center should be described using the PHS 398 application format.
However, additional face pages are NOT necessary for each research project.
Each research project description should include an abstract depicting the
purpose and objectives of the research. Another paragraph should include a
description explaining how the project relates to the overall priorities and
objectives as described in the application.
o Identify each project by a Roman numeral (I, II, III ) and a title.
o For each component research project, a full description is to be provided
following the format presented in Form PHS 398. A 25-page limitation will
apply for each of the R01-type projects and a 10-page limitation will apply
for the short-term pilot project(s). Unless stated otherwise in this RFA,
the page limitations for each section provided in the PHS 398 instructions
are to be used. Begin the presentation of each component research project on
a separate page. For each project, include the following information:
1. Introductory Information
a. Indicate:
o Project Title
o Project Principal Investigator, title, location
o Other investigators, consultants, and collaborators, titles (Associate
Professor, Postdoctoral Fellow, student).
a. Abstract of Research Plan (use Form Page 2 of PHS 398)
2. Research Project Information:
Discuss the purpose and nature of the project and its relevance to the
application's overall theme. Address the following:
a. Specific Aims
b. Significance
c. Preliminary Studies. Describe the research project's use of core unit
services, including need for the services, and the advantages and cost
effectiveness of core unit usage for the project.
d. Research Design and Methods. For research involving human subjects, this
section must address the inclusion of women, minorities and their subgroups,
and children as research subjects, following relevant policy announcements.
e. Human Subjects
f. Vertebrate Animals
g. Consultants
h. Collaborative arrangements, including pertinent letters of assurance and
intent.
i. Literature Cited
C. Administrative Core Description
o A full description is to be provided following the format presented below.
Unless stated otherwise in this RFA, the page limitations for each section
provided in the PHS 398 instructions are to be used.
o Briefly summarize the overall objectives of core unit; present the
organizational framework or chart; highlight the decision-making process for
use of core unit services described.
o Explain the core facility in light of how it will contribute to achieving
the goals of the center, and the ability to provide administrative oversight
and coordination. Provide a description of key personnel, space, physical
resources and projected use. Describe specific functions of the
administrative core, such as the daily oversight, travel and logistic
services needed to support the center. This should include organizing
meetings, workshops, and seminars, documenting the results of activities,
providing critical secretarial services, biostatistical and computer
services, etc. Describe the planning and evaluation component and procedures
for internal review of research proposals.
o Include the following information:
a. Objective(s)
b. Staffing: Description of key professional and support staff functions
c. Resources: Description of space and physical resources
d. Services Provided: Describe projected services to other core units and
research projects, and the center as a whole
D. Checklist - As required in Form PHS 398
Section III Appendix, if applicable
o Include materials as appropriate (see PHS 398)
Submission Instructions
The RFA label available in the PHS 398 (rev. 4/98) application form must be
stapled to the bottom of the face page of the application and must display
the RFA number HD-00-019. A sample RFA label is available at
http://www.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is
in the pdf format. 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.
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 should be
sent to:
L. R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
[email protected]
Applications must be received by March 29, 2001. 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.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
for responsiveness to the RFA by NICHD. 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 NICHD in accordance with the review criteria stated below. Site
visits will not be conducted in the review of these applications. As part of
the initial merit review, all applications will receive a written critique
and may undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed, assigned a priority score, and
receive a second level review by the National Advisory Child Health and Human
Development Council.
Review Criteria
The scientific and technical merit peer review focuses on three areas: (1)
review of the overall center as an integrated effort; (2) review of the
administrative core, and (3) review of the component research projects that
make up the research development core.
1. Overall Center Evaluation Criteria
o Strengths of the center in terms of the combined focus of the research
projects and core units, and the significance of the application to the
objectives of the program, as outlined in this RFA. The importance and
relevance of each collaborative project to the achievement of the center
program objectives. Feasibility of achieving the priorities and objectives
of this collaboration within the five-year period.
o Qualifications and experience of the Principal Investigator/Center
Director and Co-director to provide scientific and administrative leadership,
and the ability to meet the center’s demands of time and effort.
Specifically stated and described willingness of the Principal
Investigator/Center Director and Co-director to work and cooperate with other
centers and with the NICHD in the manner summarized in this RFA. For key
personnel from both collaborating institutions: the adequacy of the
qualifications and experience to successfully plan for and achieve the
objectives of center.
o Appropriateness of the minority institution and NICHD-designated
reproductive science research program collaboration with respect to the
scientific aims of the center, including the use of partnerships to access
scientific expertise from inter- and intra-institutional affiliations.
Multidisciplinary scope of the center; its cohesiveness, coordination, and
synergistic potential among the center and its projects.
o The strength of the relationship of the applicant, key investigators and
the collaborating researchers, particularly the academic qualifications,
research experience, expertise and research productivity, as well as
administrative and fiscal relationship.
o Appropriateness of the structure and plans for the administration of the
grant and center. An appropriate organizational and administrative structure
for effective attainment of center objectives that considers arrangements for
internal quality control of ongoing research, the solicitation of funds, day-
to-day management, contractual agreements, and internal communication among
center investigators.
o Demonstrated institutional commitment to the center and its objectives in
terms of providing research facilities and management support. The plans for
the establishment and utilization of support structure (grants management,
administrative, technical) to provide resources essential to carry out the
scientific projects.
o Documentation of institutional endorsement of the proposed five-year plan,
including letters of commitment from senior institutional officials from both
collaborating institutions. The degree to which the letters of commitment
fully address and support the priorities and objectives of the center.
o The institutional environment in which the research will be conducted,
including the availability of space, equipment, and subjects, if proposed;
adequacy of administrative, clinical and technical capabilities to conduct
the research proposed; and the physical proximity of investigators or, if
geographically separated, the plans to ensure a successful collaborative
effort. Features of the institutional environment that are relevant or
unique in assuring the success of the program.
o Existing research infrastructure (laboratory space, equipment, clinical
facilities, animal housing, and computer resources) and its commitment to the
center that would facilitate and support the reproductive science research
program. The relationship of the proposed program to already existing
reproductive science programs, if applicable.
o The degree to which this center, if fully successful, would enrich the
academic and intellectual milieu for reproductive science research at the
minority institution, and the feasibility and potential for underrepresented
minority investigators to gain research experience and independence.
2. Administrative Core Evaluation Criteria
o Quality and availability of core resources, and the appropriateness of the
use of the administrative core services. The adequacy of the structure and
organization for effective attainment of center priorities and objectives.
Evidence that the core will provide the necessary administrative support,
such as oversight and management, biostatistical and computer services,
planning and evaluation component, contractual agreements, support, travel,
and logistic services, and internal communications among investigators
required for the successful completion of the research projects.
o Qualifications, experience and commitment of co-Investigators and key
personnel designated to support the administrative core.
3. Research Development Core: Research Project Evaluation Criteria
Each research project (as defined in this solicitation) will be individually
evaluated for its scientific and technical merit using the standard NIH
review criteria.
o Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
o Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
o Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
o Investigators: Are the key investigators and collaborative investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the key investigators and
other collaborative researchers? Are the key investigators and collaborative
investigators committed to devote the required time and effort to the
research project and the center? Are the key investigators and collaborative
investigators willing to cooperate, as appropriate, with NICHD assistance in
the manner summarized in this RFA.
o Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications also will be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects also will be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
SCHEDULE
Letter of Intent Receipt Date: February 16, 2001
Application Receipt Date: March 29, 2001
Peer Review Date: June/July 2001
Council Review: September 2001
Earliest Anticipated Start Date: September 30, 2001
AWARD CRITERIA
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.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
FAX: (301) 496-0962
E-mail: [email protected]
Direct inquiries regarding fiscal matters to:
Diane Watson
Chief, Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: 301) 496-5001
FAX: (301) 402-0915
E-mail: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.864, Population Research. 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 and Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. 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 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS) |
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NIH... Turning Discovery Into Health® |
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