ADVANCED RESEARCH COOPERATION FOR ENVIRONMENTAL HEALTH
RELEASE DATE: June 19, 2003
RFA: ES-03-009
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
93.113, 93.114, 93.115
LETTER OF INTENT RECEIPT DATE: October 21, 2003
APPLICATION RECEIPT DATE: November 21, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The mission of the National Institute of Environmental Health Sciences (NIEHS)
is to reduce the burden of human illness and dysfunction from environmental
exposures. The NIEHS achieves its mission through multidisciplinary
biomedical research programs, prevention and intervention efforts, and
communication strategies that encompass training, education, technology
transfer, and community outreach. An important element of the NIEHS mission
is to develop the research capacity of minority-serving institutions that have
research scientists who are committed to understanding the impact of
environmental exposures on human health. To address this need, the NIEHS has
developed a Thematic Program Project Grant (S11) that focuses on establishing
research partnerships between investigators at Research Intensive Universities
(RIUs) with significant biomedical health sciences research and at Minority
Serving Institutions (MSIs) with graduate and/or professional schools
conferring doctoral degrees. MSIs for the purposes of this solicitation are
academic institutions, either medical or non-medical, that have a minority
enrollment greater than 50 percent. This includes Historically Black Colleges
and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal
Colleges and Universities. The purpose of this grant is to establish a
research infrastructure and a hypothesis-driven research program at a Minority
Serving Institute that develops a cadre of investigators that will
successfully compete for Research Project Grant (RPG) support.
RESEARCH OBJECTIVES
Background
Research programs in environmental health science at MSIs have not been
extensively pursued or realized. NIEHS believes there is a critical need for
a focused program to increase the participation of minority schools and
investigators in the health research mission of the NIEHS. To address the
need for increased minority participation the NIEHS has developed this
program, which focuses on establishing research partnerships between
investigators at RIUs with significant environmental health sciences research
and investigators at MSIs with graduate/professional schools with a strong
interest in such research. The low level of involvement of minority serving
institutions in environmental health science and the lack of sufficient
training opportunities for minority scientists represent two major obstacles
to developing an effective cadre of investigators at MSIs engaged in research
efforts aimed at addressing environmental health issues. One way of meeting
these challenges is to increase the pool of well-trained investigators,
especially in minority groups where the proportion of biomedical investigators
is strikingly lower than the percentage of minority U.S. citizens.
Currently, there are four collaborative ARCH programs that are supported by
the NIEHS. Awards were made to Southern University Baton Rouge, Xavier
University, Florida A&M University, and Florida International University. RIU
partners are the University of Texas Medical Branch at Galveston (UTMB),
Tulane University Medical Center, Wayne State University, and the University
of Miami, respectively. The Southern-UTMB collaboration scientific thematic
focus is on the molecular mechanisms of butadiene toxicity. The Xavier-Tulane
collaboration focuses on xenobiotic regulation of transcription. The Florida
A&M-Wayne State collaboration focuses on signal transduction and Florida
International-Miami ARCH project addresses marine and freshwater toxics and
arsenic speciation. All of these projects feature unique scientific
partnerships that allow for faculty development at the MSIs while supporting
sound scientific research at both institutional partners. (See ARCH website:
http://www.niehs.nih.gov/translat/arch/arch.htm)
The most recent ARCH RFA solicitation, ES-00-006, utilized a two-tiered award
program for either ARCH I or ARCH II programs. Key differences between ARCH I
and ARCH II programs were the number of research projects allowed and
requirement of a Faculty recruitment component. The current initiative has
some significant differences with regards to what an ARCH award will support.
There will only be one type of ARCH award available, as in the initial ARCH
RFA (ES-98-005), eliminating opportunities for ARCH I or ARCH II designations.
Additionally, there will be a greater emphasis placed on the pilot project
component allowing for collaborative pilot projects at both the MSI and RIU.
Further, only one research project will be funded at the MSI, however there
will be an increase in resources allocated for that project to allow more
opportunities for collaboration. There will not be a faculty recruitment
component for ARCH awards made in response to the current RFA.
Objectives and Scope
The ARCH grant is a mechanism for the support of a broadly based research
program involving investigators at an MSI and established investigators at an
RIU sharing knowledge and common resources. The goal of the ARCH grant is to
establish a group of investigators at an MSI that can successfully compete for
National Institutes of Health (NIH)/NIEHS Research Project Grant (RPG)
support, typically R01/R15 grants, or awards from other agencies that use the
peer review mechanism, for example, U.S. Environmental Protection Agency, the
National Science Foundation, or the American Cancer Society. To achieve this
goal an ARCH grant will provide support for a broadly based multidisciplinary
research program that has a well-defined central research focus or objective.
The NIEHS envisions the support received from the ARCH grant as the foundation
necessary for achieving the above stated goal. It is anticipated that the MSI
scientists will compete for other types of NIH/NIEHS and peer reviewed grants
during the period of ARCH funding as part of the overall strategy for this
effort. Thus, as the ARCH program develops at the MSI institution, it is
expected that the MSI investigators will compete for other types of grants in
areas relevant to the NIEHS mission (K01, R15, R03, R01, P01, F31/32, T32,
etc.) that will provide research support after the ARCH award support ends.
Information on the mission and program interests of NIEHS is available on the
web site: http://www.niehs.nih.gov/dert/programs/special/special.htm.
MECHANISM OF SUPPORT
This RFA will use the NIH S11 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. The anticipated award date is
July 1, 2004.
This RFA uses just-in-time concepts. This RFA uses the non-modular budgeting
format. Applicants must use the forms for regular research grants, follow the
specific instructions in the PHS 398 application kit, and provide a complete
detailed budget (Forms Pages 4 & 5) with narrative justifications. This
program does not require cost sharing as defined in the current NIH Grants
Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm
FUNDS AVAILABLE
The NIEHS intends to commit approximately $3,000,000 in FY 2004 to fund three
new and/or competitive continuation grants 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 $750,000 per year. Because of the nature and scope the
proposed research will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the
financial plans of the NIEHS 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. At this time, it is not known
if this RFA will be reissued.
ELIGIBILE INSTITUTIONS
As described below, there are specific eligibility criteria for the partner
institutions that must be met in order to apply for this RFA. Potential
applicants are strongly encouraged to contact the NIEHS program administrator
listed under WHERE TO SEND INQUIRIES.
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, women and individuals with disabilities are always
encouraged to apply for NIH programs. The Principal Investigator must have
his or her primary appointment at the applicant MSI institution.
SPECIAL ELIGIBILITY REQUIREMENTS
Applicant Organization and Investigators
For this RFA, the applicant organization must be a Minority Serving
Institution (MSI). The MSI must have a graduate or professional school that
offers at least one doctoral degree (Ph.D., M.D., D.V.M., D.D.S., etc.) The
Principal Investigator must have his/her primary appointment at the applicant
MSI, and have a strong interest in environmental health sciences. The ARCH
application must also include a Research Intensive University (RIU) with
significant research support in environmental health sciences, and an RIU
leader (co-investigator) who has demonstrated interests in environmental
health sciences. Applications that include RIU investigators who are current
NIEHS grantees are strongly encouraged, but not required. Only one
application will be accepted per eligible minority serving institution and
each RIU may participate in no more than one application in response to this
RFA.
MSI and RIU Collaboration
The MSI/RIU collaboration must be between an MSI with a strong interest in
environmental health sciences and RIU investigators with a significant
research base in peer reviewed environmental health sciences-related research
support such as R01, P20/30, P42, etc. Environmental health has been defined
as "those aspects of human health, including quality of life, that are
determined by physical, chemical, biological, social and psychosocial factors
in the environment (World Health Organization, 1993)." Thus, collaborations
may focus on any component of environmental health science-research as defined
by the preceding definition of environmental health. ARCH awards will support
research that utilizes state of the art methodologies in the conduct of
environmental health sciences research.
The need for continuous and active communication among sites dictates that
only MSIs 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, less than 100 miles apart. However, if the distance
between institutions exceeds 100 miles, 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.
ARCH programs will: (1) help minority institutions develop state-of-the-art
environmental health science research programs; (2) create more opportunities
for researchers employed by minority serving institutions to establish
research collaborations and professional networks with NIH grantees employed
by research intensive institutions; (3) increase the role of ongoing research
in maintaining a vigorous, stimulating academic and intellectual milieu that
will inspire and prepare students and fellows to pursue research careers in
environmental health sciences; and (4) provide support for pilot research.
Support of pilot projects is intended to bolster the skills and abilities of
investigators, to obtain preliminary data, and to publish in peer reviewed
journals that can help ensure successful competition for traditional research
grants and awards.
The purpose of this 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 and
translational research that focuses on topics deemed to be of high priority
and significance because of their critical importance to environmental health.
ESSENTIAL CHARACTERISTICS OF ARCH GRANTS
Overall Characteristics
The ARCH grant will support a broadly based multidisciplinary research and
development program that is a collaborative effort between an MSI and an RIU.
The program focus should be on establishing a group of investigators at the
MSI that can compete for NIH Research Project Grant (R03, R21, R01 or R15 if
R15 eligible) support. Key factors for an ARCH grant are as follows:
o There be should be a unifying, well-defined goal or problem area of research
to which each project relates and contributes. This may be a specific disease
outcome, e.g., asthma, diabetes, cancer, low birth weight or children=s
health, autoimmune disorders, etc. or a more general area, such as, gene-
environment interactions, xenobiotic gene regulation, molecular mechanisms of
toxicity.
o There must be the participation of established investigators from the RIU
and MSI, and all investigators must contribute to, and share the
responsibilities for, fulfilling the program objectives. The program should
include enough participation to make a collaborative effort successful, and
yet not so diverse in scope as to make program collaboration and communication
ineffective.
o The RIU investigators included in this project must have significant peer-
reviewed research project grant support that is relevant to the NIEHS mission
(see NIEHS web site: http://www.niehs.nih.gov/external/intro.htm)
o There must be a demonstrated commitment of the MSI and RIU institutions to
the support and encourage the ARCH program. Such support usually involves
release time of faculty, capital improvements that will facilitate the
research, and assistance in the acquisition of scientific equipment and
supplies. A letter of support from the Chancellor or President of the
applicant institution will be required to demonstrate support for the ARCH
program from the highest level of institutional administration.
o All MSI ARCH investigators must spend a sabbatical period in the laboratory
of their RIU collaborator. This sabbatical period must consist of a minimum
of one semester and can include summer research experiences. It is
anticipated that during the sabbatical period, the MSI ARCH investigator will
further hone his/her research skills and write and submit a grant application
under the tutelage of his/her RIU collaborator.
Administrative and Planning Core
There must be strong leaders at both the MSI and RIU who are substantially
committed to the project, are capable of scientific leadership and are willing
to accept responsibility for the administration and integration of the
program. Assessment of the ability of the program Principal Investigator
(ARCH Director) and RIU leader to develop a tightly integrated program of
collaborative research will be a significant consideration in evaluation of
the application.
The administrative/planning core must provide the support of administrative
and research development infrastructure for the entire program and should not
be duplicated within any other components or within support normally provided
by the MSI or RIU institutions. The responsibilities and activities for the
administrative and planning core include:
o Appropriate and adequate organization and facilities for conduct of the
research and development activities such as seminars, workshops, reference
collection, computer support, etc. Specifically the administration and
planning core must develop and support a grants writing course (not a seminar)
that is available to all MSI ARCH grant investigators and other MSI faculty.
Additionally this core must also subscribe and provide access to electronic
library services that allow MSI ARCH grant investigators to remain current
with scientific literature relevant to their research pursuits.
o An Internal Steering Committee formed of the individual project leaders (RIU
and MSI investigators) that will assist the Principal Investigator in making
scientific and administrative decisions in the operation of the program.
o An External Advisory Committee, comprised of at least three members who are
outside both the MIU and RIU and are recognized leaders in the biomedical
sciences related to the scientific theme of the program, that will provide
overall guidance and advice to the Principal Investigator and program
investigators on program direction.
o A Senior Scientific Advisor (SSA) who is on the faculty of the MSI and has
been successful in attracting RPGs (R01, P01, etc.) from the NIH. This
individual will assist the ARCH Director in the overall development of the MSI
research infrastructure and advise the MSI investigators on the preparation of
research grant applications. The SSA must have affiliation with the MSI and
serve as a liaison between ARCH grant investigators and administration.
Research Program Development Core
The function of the core is to strengthen, stabilize and consolidate
interaction and cooperation between the Minority Serving Institution and the
collaborating RIU=s environmental health science program. All research
projects will be part of the Research Development Core. Two types of projects
(Pilot and Research) will be supported as part of the ARCH program and both
types must be present. It is of paramount importance that each project (Pilot
and Research) be of sufficient scientific merit to warrant independent support
and that each project is an integral part of the ARCH program. To be funded,
an ARCH program must have at least three Pilot projects and one Research
project that are judged to have significant and substantial scientific merit
on their own.
Research projects are R01-type projects that have as the project leader either
RIU or MSI faculty who have been Principal Investigators on R01 grants from
the NIH in the past three years. A faculty member from the other
collaborating institution is required to be included in the project. The
maximum project period for a Research project is five years. One research
project will be funded by an ARCH award. The roles of both the MSI and RIU
collaborators must be clearly described in the ARCH grant application.
Pilot projects are intended to provide an MSI investigator an opportunity to
develop his/her research skills and/or for the MSI investigator to obtain the
preliminary research data needed for the submission of a peer reviewed
research grant application. Additionally pilot projects may provide RIU
collaborators/mentors an opportunity to develop/pursue new research activities
that generate preliminary data to be used in subsequent traditional grant
submissions. Pilot projects can also be developed in the RIU investigators
established area of research.
Pilot projects are established between an MSI investigator and an RIU
mentor/collaborator. The maximum project period for a Pilot project is 36
months. Pilot project leaders may be either MSI or RIU investigators.
In order to assess the success of the Pilot projects and to provide for new
Pilot projects, the application must include a provision for:
o The scientific merit review of new Pilot projects that may be submitted by
MSI or RIU investigators. Copies of all proposals, with documentation of
their reviews, relative ranking, and final action must be retained by the ARCH
Director.
o The tracking of the results of each Pilot project (abstract, peer reviewed
grant applications, publications, presentations, etc.). These records must be
available to NIEHS program staff.
A. Facilities Core may be proposed provided it meets the criteria listed
below:
o The Core must provide service, on a continuing basis to two or more Research
or Pilot projects. This support may be directed to different projects as the
scientific program advances.
o The Facility Core should utilize state-of-the-art techniques and equipment
in order to maximize the efficiency of the entire ARCH program.
o Core support funded by this grant should provide service for only Research
and Pilot projects. Service provided to other projects may be done on a fee-
for-service basis or there must be some reciprocal service provided to the
program that is substantially of the same value.
o The Facilities Core(s) must be located on the MSI campus.
ALLOWABLE COSTS
The ARCH award will provide multiple components of support that in total will
provide funds for the establishment of research and development collaboration
between groups of investigators at an MSI and an RIU. The general budget
categories and dollar levels that can be supported by this award are listed
below. However, the specifics for each budget category are the responsibility
of the Principal Investigator. The total direct cost that may be requested
for an ARCH program is limited to $750,000 per year. Indirect costs for the
subcontract to the RIU that are included as a part of the MSI direct costs are
not included in the $750,000 per year budget limit.
A. Administrative/Planning Core
1. The ARCH grant will provide up to $150,000 (direct cost) per year for
administrative/planning support. These funds are intended to support the
research infrastructure necessary to provide MSI investigators an adequate
opportunity to develop competitive research applications. Funds for the
conduct of Pilot and Research projects including salary are to be included in
the Research Program Development Core budget. The MSI Principal Investigator
and the RIU leader are responsible for development of the
Administrative/Planning Core budget. A listing of some of the items that may
be included in this core is provided below.
Budget Item and Maximum Allowable Support:
o Principal Investigator - 25 percent effort
o RIU Leader - 15 percent effort
o MSI or RIU Senior Scientific Advisor - 10 percent effort
o Administrative Assistant at MSI - 50 percent effort
o Administrative Assistant at RIU - 25 percent effort
o Computer network support/Office supplies - as justified
o Seminars/Program enhancement/courses - as justified
o Travel for ARCH investigators - as justified
o Travel for external advisory committee - as justified
2. An additional request of up to $100,000 for major equipment items for MSI
investigators may be included in the Administrative/Planning Core budget in
the first two years. This equipment may be in addition to equipment that is
requested for the Research/Pilot projects or the Core facility. These
equipment items must be well justified and be an integral part of the research
program the MSI investigator(s) plan to develop. These funds are in addition
to the $150,000 for the administrative/planning core budget items identified
above.
B. Research Program Development Core
The ARCH grant will provide up to $550,000 in direct costs per year for the
research program development core at the ARCH to include: 1) At least three
collaborative pilot projects between ARCH (MSI and RIU) investigators; and 2)
one collaborative Research project between MSI and RIU investigators [most
likely will be at RIU] [Describe Facility Cores separately from the Research
Program Development Core].
1. Pilot Projects
Items that may be included are MSI and RIU investigator salaries, technical
support, supplies, small equipment items, travel and other items that are
necessary for the conduct of the Pilot Project. The maximum direct cost for
each Pilot Project is $100,000 per 12-month period, and the maximum length of
a Pilot Project is 36 months. At least three Pilot Projects must be
recommended by the Special Emphasis Panel (SEP) in order to be eligible for an
ARCH award. Pilot Projects may be located on either the MSI or RIU campus and
each Pilot Project will be a collaborative effort between MSI and RIU
investigators.
2. Research Projects
Research Projects are to be conducted by RIU and MSI investigators. The
maximum direct cost for a Research Project is $150,000 per year, and funding
may be requested for up to five years. One Research Project will be supported
per ARCH award.
C. Facility Core
The Principal Investigator may request up to $100,000 per year (direct cost)
for the Facility Core.
The Facility Core unit is a resource for the Research/Pilot projects that
provides centralized services or equipment to several projects. At a minimum,
a Facility Core must provide service or equipment for at least one Pilot
Project and one Research Project. The Facility Core must be located at the
MSI and the support may be directed to different component research projects
as the scientific program advances.
The ARCH program is not intended to provide support for graduate students.
Such support should be obtained through competitive training programs of the
NIH/NIEHS such as the Individual (F31), Institutional (T32) National Research
Service Awards or through supplements to ongoing RPGs.
D. Supplemental Funds for Additional MSI Investigators or Postdoctoral
Trainees
As the program develops, supplemental funds may be requested for support of
additional MSI/RIU faculty and postdoctoral trainees on RIU Research projects.
This includes Research Supplements for Underrepresented Minorities
(https://grants.nih.gov/grants/guide/pa-files/PA-01-079.html) and is restricted
to the RIU Research Projects. Other types of administrative supplement
requests will require approval of NIEHS staff prior to submission, and is
contingent upon availability of funds.
ADDITIONAL CRITERIA
A. Mid-Program Evaluation Criteria for ARCH Awardees.
In addition to the usual review of the non-competing application each year,
there will be an in-depth review of the progress of each ARCH award toward
meeting the program goal at the end of the third year of the grant period.
The criteria to be used for the evaluation are the following:
o Number of peer reviewed publications with an MSI author/co-author.
o Number and type of peer reviewed grants submitted and awarded.
o Quality and efficacy of mentoring activities provided by the RIU.
o Status of the MSI research infrastructure, and plans for sustaining and
nurturing it after the ARCH grant funding ends.
The in-depth mid-program evaluation will be used as a basis for awarding the
fourth and fifth year of funds.
B. Pre-application Phase.
Communications between a potential Principal Investigator and program staff of
the NIEHS at the pre-application planning phase will serve to (1) advise the
applicant concerning the areas of program interests of the NIEHS; (2)
facilitate the receipt of a well-organized, tightly-focused application; and
(3) ensure that the application conforms to established guidelines and
criteria for an S11 application. The initial contact with NIEHS program staff
is the responsibility of the potential applicant and should be made as early
as possible. This interaction may take the form of correspondence, such as a
letter of intent, telephone conversations, etc. The program staff are
particularly cognizant of the scope of their programs and the S11 guidelines
and are especially qualified to advise applicants concerning the preparation
of a complete and well-developed application. This communication will enable
the program staff to discuss issues such as the need for integration of all
projects into the theme of the overall program, the established review
guidelines, the proper format of the applications, and the necessary relevancy
of the proposal to the programs supported by the NIEHS.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
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:
Frederick L. Tyson, Ph.D.
Program Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive, MD EC-21
P.O. Box 12233
Research Triangle Park, NC 27709
Tel: (919) 541-0176
Fax: (919) 316-4606
Email: tyson2@niehs.nih.gov
Direct your questions about peer review issues to:
Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
Direct your questions about financial or grants management matters to:
Ms. Lerlita Dingle Garcia
Grants Management Specialist
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
Telephone: (919) 316-4638
Fax: (919) 541-2860
Email: garcia1@niehs.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating Institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIEHS staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, telephone (301) 710-0267,
Email: GrantsInfo@nih.gov
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Leroy Worth, Jr., Ph.D.
Scientific Review Administrator
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
111 T.W. Alexander Drive
(79 T.W. Alexander Drive, 4401 Building, 3rd Floor)(Express/Courier Service)
Research Triangle Park, NC 27709
Telephone: (919) 541-0670
Fax: (919) 541-2503
Email: worth@niehs.nih.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an application
is received after that date, it will be returned to the applicant without
review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIEHS. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIEHS in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Environmental Health
Sciences Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. The application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.
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?
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?
INNOVATION: Does the project employ novel concepts, approaches or method? Are
the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the Principal Investigator and other researchers (if any)?
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?
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:
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 will also 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.
The following is a listing of items considered by the review committee.
A. Overall Program
1. A program cohesiveness that clearly indicates that the presence of the
ARCH program will make a difference in the research infrastructure and
capacity of the MSI.
2. The likelihood that the collaboration between the RIU and MSI will be
successful.
B. Administrative and Planning Core
1. Scientific and administrative leadership ability and experience of the MSI
Principal Investigator and the RIU leader, and their commitment and ability to
devote adequate time to the effective management of the ARCH program.
2. Appropriateness and adequacy of multidisciplinary teams constituting the
program's members.
3. Academic environment and resources in which the research will be conducted,
including availability of space, equipment, human subjects, animals, or other
resources as required, and the potential for interaction with scientists from
other departments.
4. Administrative organization to foster the scientific development of the
investigators and institution.
5. Institutional commitments to the program including provision of space,
technical resources, personnel, equipment, release time and salary for
faculty. In addition, fiscal responsibility and management capability of the
institutions to assist the MSI Principal Investigator and the RIU leader in
following DHHS, PHS, and NIH policies.
6. Appropriateness of the budget in relation to the proposed program.
7. Human subjects protection, animal welfare, and biohazard issues.
8. Appropriateness of first year equipment requested, if any, for the program.
9. External advisory committee composition and arrangements to provide ongoing
direction and guidance.
10. Demonstration of effective collaboration between MSI scientists and RIU
scientists to achieve programmatic goals, such as to help minority
institutions develop state-of-the-art biomedical research programs; create
more opportunities to establish research collaborations and professional
networks with NIH grantees employed by RIUs; to provide support for the pilot
research needed to show the skills and abilities of investigators by obtaining
the preliminary data and publications that can help ensure successful
competition for traditional research project grants during the performance
period of the grant.
11. The nature, scope, and effectiveness of the plans for coordination and
cooperation among research project investigators.
C. Research Program Development Core: Facility Core
1. Utility/benefit of the Facility Core to the program.
2. Qualifications, experience, commitment of the personnel involved in the
core.
3. Appropriateness of the budget.
D. Research Program Development Core: Scientific Projects
The review of the individual Research Projects is similar to the review of
individual project grant applications (R01/R15) for the Research and Pilot
Projects. These projects must have substantial scientific merit and, in
essence, be of sufficient quality to be supported if they were submitted as
individual projects. Research Project proposals that are not at this level of
quality will not be funded. The review criteria are intended to focus more on
the global picture of each project and the program overall rather than
concentrating on the details of each experiment in their critiques.
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. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below.)
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 21, 2003
Application Receipt Date: November 21, 2003
Peer Review Date: February 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
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 involving
human subjects 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 read the AMENDMENT "NIH
Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research B Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001, https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are
available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
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.
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 that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and
Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
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). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/
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 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
https://grants.nih.gov/grants/policy/policy.htm.
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.