REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS
DISEASES RESEARCH (RCE)
RELEASE DATE: August 1, 2002 (see amendment NOT-AI-02-051)
RFA: AI-02-031
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
LETTER OF INTENT RECEIPT DATE: November 15, 2002
APPLICATION RECEIPT DATE: January 15, 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
The National Institute of Allergy and Infectious Diseases (NIAID) invites
applications (U54) for funds to develop Regional Centers of Excellence (RCE)
in areas related to Biodefense and Emerging Infectious Diseases Research
(see page 9 for regions). The NIAID will also be releasing another RFA for P-
RCE Planning Grants (U56) soon. This program will provide funds for start up
and developmental activities that will lead to RCE applications. The overall
goal of the RCE Program is to develop and maintain strong infrastructure and
multifaceted research and development activities that will provide the
scientific information and translational research capacity to make the next
generation of therapeutics, vaccines and diagnostics against the CDC Category
A-C Agents (http://www.bt.cdc.gov/agent/agentlist.asp#catagoryadiseases),
with particular emphasis on Category A. To accomplish this goal, the Centers
will be provided with support 1) to develop and conduct programs of
investigator-directed research, 2) to train researchers and other personnel
for biodefense research activities, 3) to develop and maintain comprehensive
core facilities to support the research and training activities of the RCE,
4) to develop translational research capacity for testing and validating
vaccine, therapeutic and diagnostic concepts for biodefense and emerging
infectious diseases, 5) to maintain and make available core facilities and
other support to approved investigators from academia, biotech companies, the
pharmaceutical industry, and other appropriate entities in the region for the
purpose of performing basic research and for testing and evaluating vaccines,
therapeutics and diagnostics for CDC Category A-C Agents, 6) to be ready and
available to provide facilities and scientific support to first-line
responders in the event of a national biodefense emergency.
This Request For Applications (RFA) invites research institutions and groups
of investigators to form consortia and develop applications for programs to
address the fundamental research and development questions that will provide
the information needed to counter the threat of bio-terrorism. Diverse
research and development approaches are encouraged, as long as they include
the following essential features: a biodefense research focus on CDC Category
A-C Agents, particularly Category A, which incorporates a translational
component with the long term goal of developing testable products.
Additionally, the consortium must document: institutional commitment,
organizational capabilities, ability to develop and expand facilities, plans
for training of new investigators and other participants in the national
biodefense effort, and interdisciplinary coordination and collaboration,
particularly linkages to federal, state, and local agencies. The consortium
must have a lead team of individuals responsible for the overall management
and direction of the RCE. A group of Center member researchers, with
expertise in Biodefense and emerging infectious diseases research, is
required to lead the research thrust which underlies all the other activities
of the RCE. In addition, the RCE should designate specific platforms and
technologies that will serve as the basis for the Center"s development
programs. Platforms are cross-cutting technologies or experimental
approaches that integrate the research and development activities. Examples
of platforms include: genomics, proteomics, animal models, pre-clinical
development, but others are welcome.
The overall direction and scope of activities of the RCE Program and its
participant Center sites will be centrally coordinated and monitored by a
Management and Oversight Committee that is run through the RCE Program Office
at NIAID to ensure that the RCE program contributes maximally and effectively
to the biodefense and emerging infectious diseases effort.
PUBLIC BRIEFING DATE: August 8, 2002
An informational session for investigators representing groups planning to
submit applications in response to this RFA will be held August 8, 2002 at
the Marriott Washingtonian Center Hotel in Gaithersburg, MD. Representatives
from the NIAID extramural research programs and Division of Extramural
Activities will be available to provide information and to answer questions
relevant to preparing applications in response to this RFA. Questions and
Answers from discussions at the meeting will be available on the NIAID
website for those unable to attend.
RESEARCH OBJECTIVES
Background
As identified by the recently convened NIAID Blue Ribbon Panel on
Bioterrorism and Its Implications for Biomedical Research, there is a
critical need for the establishment of highly developed research and
development infrastructure with strong translational research capacity to
implement the Biodefense Research Agenda of NIAID
(http://www.niaid.nih.gov/dmid/bioterrorism/).
To facilitate this initiative, the NIAID is establishing The Regional Centers
of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE)
Program. Each Center will serve a geographical region and will be comprised
of investigators at one or more participating universities and/or research
institutions. The overall activity of the Centers will be research in
support of the NIAID Biodefense and Emerging Infectious Diseases mission.
The center member researchers will be encouraged to collaborate with other
NIH-funded investigators within and outside the Center region. In addition,
the Center will serve as a focal point to organize and promote linkages with
pharmaceutical and biotech companies, with federal, state, and local agencies
and with other qualified investigators to foster translational research and
promote maximal use of the core facilities by a broad range of qualified
scientists. In times of national biodefense emergency the RCEs will
rapidly realign their activities to assist local response efforts within
their region. This includes making the their core facilities and other
resources available to assist in the implementation of biodefense plans.
Objective and Scope
This initiative supports the establishment of Regional Centers of Excellence
for Biodefense and Emerging Infectious Diseases Research (RCE). The program
is established for the purpose of developing and maintaining research and
development capacity that is needed to evaluate and counter bioterrorism or
emerging infectious disease events. To accomplish this the Centers will
receive support to: 1) to develop and conduct programs of investigator-
directed research, 2) to train researchers and other personnel for biodefense
activities, 3) to develop and maintain comprehensive core facilities to
support the research and training activities of the RCE, 4) to develop
translational research capacity for testing and validating vaccine,
therapeutic and diagnostic concepts for biodefense and emerging infectious
diseases, 5) to maintain and make available core facilities and other support
to qualified investigators from academia, biotech companies, the
pharmaceutical industry, and other appropriate entities in the region for the
purpose of performing basic research and for testing and evaluating vaccines,
therapeutics and diagnostics for CDC Category A-C Agents, 6) to be ready and
available to provide facilities and scientific support to first-line
responders in the event of a national biodefense emergency.
A list of research areas that are considered relevant for this U54 RFA
follows. This list is not all-inclusive, and prospective applicants are
encouraged to discuss program relevance issues with program staff cited under
INQUIRIES. The scope of acceptable areas includes research from basic, to
the basic/clinical interface, to clinical, spanning the range of inquiry
needed to establish a comprehensive national program for these agents:
The following are examples of research within the scope of the RCE program.
For a more detailed list of NIAID Biodefense research priorities applicants
are encouraged to consult the strategic plan.
Basic biology of category A-C agents, with particular emphasis on category A
Mechanisms of pathogenesis of A-C agents
Application of genomic and proteomic strategies to category A-C agents
Basic aspects of the innate and adaptive immune responses to category A-C
agents
Rapid, sensitive, and specific approaches for detection and identification of
category A-C agents
Target identification for diagnostics, therapeutics, and vaccines, including
assay development
Development of new animal models for pathogenesis studies, for therapeutics
and vaccine evaluation, and for rapid diagnostic studies.
Testing through Phase I clinical trials of drugs, diagnostics and vaccines.
Strategic Plan
As part of the preparing an application, the consortium organizers should
undertake the following planning process, and document the steps taken in the
application. The purpose of the strategic plan is to identify the
significant opportunities and needs within our current knowledge base and in
the resources currently available to the consortium that can be addressed by
having a RCE. The plan should include both short and long term goals, and
must include descriptions of objective milestones that will be used to
measure success or failure. The following process framework is suggested for
developing the strategic plan:
1) Strengths - Identify and describe the strengths of the proposed consortium
including a brief summary of the research and development experience and
expertise of RCE participants as well as the current facilities and resources
available. Outline the major biodefense studies to be assisted by RCE
funding and describe how these research efforts will translate into vaccines,
therapeutics and/or diagnostics for CDC Category A- C Agents.
2) Opportunities - Identify and evaluate the potential opportunities to
establish high quality research, training and development programs using RCE
funds. The NIAID strongly encourages the RCE to form associations with other
federal agencies, such as intramural NIH, CDC, DoD, Dept of Agriculture, DOE
National Laboratories, and state and local health departments. As part of
the planning process the RCE leadership should determine which collaborations
with the institutions in their region will be further developed and target
opportunities that can utilize the unique strengths within the consortium and
that will also address the goals of the NIAID Biodefense Research Agenda.
3) Action Plan - Choose the highest priority opportunities and develop a
detailed plan for the first year of funding and broader goals for subsequent
years of funding. Elements of an action plan include determining what
research projects will be pursued and which cores will be established or
expanded, identifying possible projects for support as developmental
projects, defining development goals for specific products that the RCE
decides to pursue, establishing career development plans for new and existing
faculty and staff by the consortium, establishing policies and procedures for
access to and handling of CDC Category A-C Agents, establishing overall
policies and procedures for management of cores and Center resources.
Specific thematic areas will probably emerge from this strategic planning
process, and the action plan should capitalize on such programmatic themes.
4) Outcome Measurements - Determine how progress on action plans will be
measured. Include qualitative and quantitative criteria for measuring how
the RCE provides "added value" and for assessing the unique contributions of
the Center that cannot be provided by other research awards. Define measures
for assessing long-term goals for the entire funding period, and specific,
detailed milestones for the first year.
5) Emergency Response Plan- Determine who the partners and contacts are in
the case of a local, regional or national biodefense crisis. This should
include an evaluation of the potential partners, and establishment of a plan
to define a regional research role for the P-RCE to assist in the response.
Application/Center Organizational Structure
An application that includes the following elements is required:
1. Overall Research Theme
The intent of the RCE Program is to support any substantial range of
research, training and development activities as long as the plan involves
vibrant, multi-disciplinary approaches that transcend customary thinking and
organizational structures to address critical questions related to the CDC
Category A-C Agents from very basic to clinical. The theme and the range of
activities being pursued should be clearly defined as a result of the
strategic planning process.
2. Research Projects
Each application must include at least five Research Projects, which together
will enable the RCE to contribute substantially to the NIAID biodefense
mission. The range of research that may be proposed is outlined above. A
significant amount of work on category A agents is an essential component of
the research plan. A project may be similar in scope and design to an R01
application, or it may be more extensive and resemble a P01.
Each application must highlight research platforms representing cross-cutting
approaches that will be integrated throughout the Research Projects and
integrate them. Examples of platforms are: animal models, immune response,
proteomics, and genomics, how the platforms apply to the individual Research
Projects must be clearly described.
3. Career Development Projects
The RCE must include a consistent and significant commitment to career
development with the goal of increasing the availability of researchers for
biodefense. This may focus on advanced post-doctoral candidates, junior
faculty, or established investigators who wish to develop or refocus their
careers on biodefense research. RCE career development programs are not
intended for predoctoral candidates.
Each application should include at least two career development projects, it
is recommended that one be focused on basic research and one involving
translational and/or clinical activities, others may be added at the
discretion of the consortium leadership. The training must be an integral
part of the strategic plan, and complement the research activities. The
long-range goal of the training component is development of an expanded cadre
of new researchers, clinicians, and technical personnel who can help lead the
national biodefense mission into the future. This may include continuing
education for current health professionals and faculty/staff interested in
starting and pursuing research in the areas of biodefense and emerging
infectious diseases. The description of these plans should include the
policies, criteria, and processes fro selecting candidates, including special
efforts to recruiter qualified women and minorities.
The NIAID supports a variety of training and career development
opportunities, including various T, K, and F awards, and applicants are
encouraged to supplement RCE activities by applying for direct training
support. For information see: NIH Guide Notice NOT-AI-02-024.
4. Developmental Projects
Every RCE must identify and support Developmental Projects that take
advantage of developing technology and new research opportunities, from basic
to clinical. These projects may involve scientists within the RCE, or extend
to appropriate regional scientists outside the Center. The RCE application
must propose an institutional review process for selecting the most promising
Developmental Projects for funding, consistent with the strategic plan and
the overall RCE Program goals. A key goal is expanding the scope and range
of research, investigators, and institutions involved in biodefense research.
While the specific number of developmental projects to be proposed is at the
discretion of the applicant, funding for all of the developmental studies may
not exceed $500,000 any one year, with no more than $100,000 for any one
study. Individual Developmental Projects are expected to have small budgets
since the Cores will likely provide significant support. It is anticipated
that some developmental projects will begin during the first year while
others will be phased in during the life of the award. The overall success
of the RCE will, in part, be determined by the choices of developmental
projects and the growth of successful developmental studies into new NIAID
grants to advance specific vaccines, therapeutics, diagnostics or basic
science/clinical studies. These funds are intended to remain flexible and to
support studies of a limited duration, e.g., two years or less. The use of
developmental projects permits maximal flexibility to proceed in the
directions that seem most scientifically fruitful, successful developmental
projects may also grow and replace full projects that are no longer
contributing significantly to the objectives of the RCE. As a result, the
scientific members of the RCE may change during the course of the award. The
plan for selection and phasing in and out of projects as well as for
management of developmental funds must be spelled out in the application, and
if the plan is approved, it will be incorporated into the terms of award of
the RCE.
5. Administrative and Facilities Cores
An Administrative Core must be included. The RCE PI must be director of the
Administrative Core and must commit at least 20% effort to these
responsibilities, in addition to his/her own RCE research activities. The
Administrative Core director and staff are responsible for managing,
coordinating, and supervising the entire range of Center activities,
monitoring progress and making sure the strategic plan is carried through.
This includes making sure appropriate systems are in place to provide for
biosafety and security of materials, data, and facilities. Institutions
must be in compliance with U.S. laws and regulations and DHHS and NIH
policies in effect at the time of grant award and during the period of
performance of the research. The management plan for the RCE must include
procedures for continually evaluating and selecting the most promising
research, with the end goal being development of clinically useful biodefense
vaccines, therapeutics or diagnostics. The RCE concept is intended to promote
flexibility, with the discontinuance of research projects with little
translational potential and the initiation of new projects with greater
potential expected as the program evolves and matures.
The RCE plan must include development and maintenance of core
resources/facilities that are essential for the Center"s success. Cores may
include resources that are currently available at the institution, as well as
new or expanded ones. The cores need to facilitate and add to the research
and training plans, and lead to new regional biodefense capacity. The cores,
their use for the research, and why they are needed must be described in the
application. As part of the application, a detailed plan for ensuring that
core facilities can be accessed in a timely way by RCE investigators, other
NIAID funded investigators from outside the center, and other qualified
investigators in the region must be provided. In addition, cores must be
available and integral to the RCE emergency response plan.
A necessary component of the Center"s success will be the availability of
adequate access to BSL3/4 biocontainment facilities. A pre-solicitation
notice for the Regional Biocontainment Facilities has been announced at
https://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-038.html for
construction of and operation of BSL3/4 facilities. Applicants must describe
in detail their research and training plans that will require high level
containment facilities, and provide a description of what they have available
currently. If plans and arrangements have made at the time of application
for linkages to groups that are applying to be RBL contractors or with other
planned or existing containment facilities these should be described.
Finally, applicants should discuss what resources they will need to arrange
with the help of NIAID staff if an award is made, and once the RBL
contractors have been selected.
MECHANISM OF SUPPORT
This RFA will use the U54 award mechanism. The NIH U54 is a cooperative
agreement award mechanism in which the Principal Investigator retains the
primary responsibility and dominant role for planning, directing, and
executing the proposed project, however, substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during the
performance of the activities. Under a cooperative agreement, the NIH"s
purpose is to support and stimulate the recipient"s activities by involvement
in and otherwise working jointly with the award recipient in a partner role.
This interaction is further described under the section "Cooperative
Agreement Terms and Conditions of Award". The U54 mechanism may support any
part of a full range of research and development activities from very basic
to clinical.
FUNDS AVAILABLE
For FY2003 the NIAID intends to commit approximately $40 million to fund up
to 4 RCEs in response to this RFA. An applicant may request a project period
of up to five years. Because the nature and scope of the proposed research
will vary from application to application, the size and duration of each
award may also vary. Although current NIAID plans include 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 the NIAID is planning a second receipt date for applications to
be funded from FY2004 funds. However, this competition is dependent on
availability of funds and future decisions about NIAID Biodefense priorities.
Another RFA that describes the P-RCE program, a U56 cooperative agreement
program, will appear soon. That program will provide funds for start up and
developmental activities that will lead to RCE applications.
REGIONAL DEFINITIONS
To achieve nationwide distribution of the RCEs, the NIAID has divided the
United States into 10 regions.
REGION I: CT, ME, MA, NH, RI, VT
REGION II: NJ, NY, PR, VI
REGION III: DE, D.C., MD, PA, VA, WV
REGION IV: KY, MS NC, TN, AL, FL, GA, SC
REGION V: IL, IN, MI, MN, OH, WI
REGION VI: AR, LA, NM, OK, TX
REGION VII: IA, KS, MO, NE
REGION VIII: CO, MT, ND, SD, UT, WY
REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions
REGION X: AK, ID, OR, WA
It is the long-range goal of this program, contingent upon the availability
of funds, to establish at least one RCE within each region.
ELIGIBLE INSTITUTIONS
A group of collaborating investigators at one institution or a consortium of
investigators at more than one institution, who are working together to
pursue basic and applied research and development activities with a common
theme that focuses on countering the threat of category A-C agents, with
emphasis on at least one category A agent, may apply. An application must
contain several interactive research projects that constitute an
interdisciplinary, multi-platform-based, approach to these agents and that
will lead to the development of therapeutics, vaccines, or diagnostics for
them. Applications will not be accepted that focus exclusively on clinical
research or exclusively on basic research, or that are limited to
epidemiological or large scale clinical trials. The consortium must also be
able to conduct appropriate training activities, and is dependent on
availability of needed facilities, including BSL3/4 capacity, although no
group is expected to have all required facilities at the time of application.
NIAID staff will work with successful applicants to provide access to BSL3/4
facilities. Broadly based applicant groups are encouraged.
Applicant organizations that may respond to this RFA include:
o For-profit or non-profit organizations
o Public or private research institutions, such as universities, colleges,
hospitals, and laboratories
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to form a consortium as described above,
and develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
Foreign organizations are not eligible to serve as grantees and may not be
part of domestic applications. Principal Investigators must be United States
citizens. All investigators in RCE activities who handle CDC Category A
Agents must be United States citizens.
SPECIAL REQUIREMENTS
Cooperative Agreement Terms and Conditions of Award
The administrative and funding instrument used for this program is a
cooperative centers agreement (U54), an "assistance" mechanism (rather than
an "acquisition" mechanism) in which substantial NIH scientific and
programmatic involvement with the awardee is anticipated during the grant
award. Cooperative agreements are subject to the same administrative
requirements as grants. The following Terms and Conditions of Award are in
addition to, and not in lieu of, otherwise applicable OMB administrative
guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92 and
administered under the NIH Grants Policy Statement.
1. Awardee Rights and Responsibilities:
a. Awardees will have primary responsibility for the project as a whole,
including research design and conduct, data collection, data quality control,
data analysis and interpretation and preparation of publications, as well as
collaborations with other awardees. Awardees will retain primary custody of
and have primary rights to the data developed under these awards, subject to
government rights of access consistent with current HHS, PHS, and NIH
policies. However, awardees must be committed to making the therapeutic,
vaccine and diagnostic products and other research tools and research
materials they develop available to the biodefense and emerging infectious
disease research community through the NIAID Biodefense and Emerging
Infectious Diseases Research Resources Program.
b. Awardees agree to participate in projects identified by the Management
and Oversight Committee that include common research interests that address a
specific problem or threat.
c. The Principal Investigator must attend and participate as a voting member
in regular meetings of the NIAID RCE/RBL Management and Oversight Committee
to discuss progress and directions of research and to ensure that overall
Program goals are being met.
d. The Principal Investigator must coordinate and participate in regular,
local meetings of the RCE to discuss progress and directions of research and
to ensure that the necessary interdisciplinary interactions are taking place.
Additionally the Principal investigator must ensure that the core facilities
of the RCE are utilized to the fullest extent possible and that procedures
remain in place to make core facilities available to qualified users in the
region from outside the RCE.
e. The Principal Investigator and appropriate other RCE investigators will
attend an RCE Program Annual Meeting to be organized by NIAID staff in
Washington, D.C. Each RCE will submit semi-annual progress reports to the
NIAID that describe activities and accomplishments during the previous
funding/reporting period.
An NIH intramural scientist (IMS) may not serve as the Principal Investigator
but may participate as a member researcher of the RCE. The participation of
an IMS is independent of and unrelated to the role of the NIAID Program Staff
as described below. An IMS who is one of the Center"s member scientists will
have the same programmatic rights and responsibilities as other
investigators.
f. All Awardees must adhere to the Principles and Guidelines for Recipients
of NIH Research Grants and Contracts on Obtaining and Disseminating
Biomedical Research Resources (64 Federal Register 72090). The Principles
and Guidelines can be accessed electronically at: (http://ott.od.nih.gov/).
g. Intellectual Property Plan. In order to encourage timely presentation
and publication of results, the RCEs are encouraged to file patent
applications in a timely manner, according to an approved implementation
plan.
Applicants shall include in their application the following terms concerning
intellectual property rights, or provide an alternative plan. In no event
will an award be made absent incorporation of either the RCEs terms below, or
the applicant"s own plan.
"Each institution participating in the RCE agrees to grant to commercial
collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free,
world-wide license to all RCE Inventions for research purposes only, and (ii)
a time-limited first option to negotiate an exclusive, world-wide royalty-
bearing license for all commercial purposes, including the right to sub-
license, to all inventions on terms to be negotiated in good faith by the
collaborator and Institution. The collaborator shall notify Institution, in
writing, of its interest in obtaining such an exclusive license to any
Institution Invention within six (6) months of the collaborator"s receipt of
notice of such Institution Invention(s). In the event that a collaborator
fails to so notify Institution, or elects not to obtain an exclusive license,
then the collaborator"s option shall expire with respect to that Institution
Invention, and Institution will be free to dispose of its interests in such
invention in accordance with participating Institution"s policies. If the
participating institution and collaborator fail to reach agreement within
ninety (90) days, (or such additional period as collaborator and Institution
may agree) on the terms for an exclusive license for a particular Institution
Invention, then for a period of six (6) months thereafter Institution shall
not offer to license the invention to any third party on materially better
terms than those last offered to collaborator without first offering such
terms to collaborator, in which case collaborator shall have a period of
thirty (30) days in which to accept or reject the offer.
Participating institution agrees that notwithstanding anything contained
herein to the contrary, any inventions, discoveries or innovations, whether
patentable or not, which are not Subject inventions as defined in 35 USC
201(e), arising out of any unauthorized use of the collaborator"s agent
and/or any modifications to the agent, shall be the property of the
collaborator (hereinafter "Collaborator Inventions"). Institution will
promptly notify the collaborator in writing of any such Collaborator
Inventions and, at collaborator"s request and expense, participating
institution will cause to be assigned to collaborator all right, title and
interest in and to any such collaborator inventions and provide collaborator
with assignment or other documents). Participating institution may also be
conducting other research using the agent under the authority of a separate
Material transfer Agreement (MTA) with the collaborator. Inventions arising
there under shall be subject to the terms of the MTA, and not to this
clause." 35 USC.
h. Protection of Proprietary Data
Raw and primary data may be provided exclusively to the NIAID, industrial
collaborators, and the FDA, as appropriate. This provision shall not affect
the investigators" right to disseminate their research findings through
publications or presentations.
2. NIAID Program Staff responsibilities:
a. The role of NIH staff in the cooperative agreement arrangement is to
support and stimulate the recipient"s activities by substantial involvement
as facilitators in the process without assuming responsibilities that remain
with the PI. The RCE Program Director from the Division of Microbiology and
Infectious Diseases and Program Staff Scientists assigned to each RCE will
work closely with the PI and other RCE member scientists to facilitate
collaborations with other NIAID-funded research groups and to leverage the
resources available to the Program. Other NIAID staff will be responsible
for normal program stewardship and monitoring of award.
b. The NIAID Program Staff Scientist will monitor the progress of the RCE,
helping coordinate research approaches between Centers, and contributing to
the adjustment of research projects or approaches as warranted. The NIAID
Project Staff Scientist will assist and facilitate this process and not
direct it. This individual will also provide assistance with all major
transitional changes of an individual RCE"s activities prior to
implementation to assure consistency with the overall goals of the RCE
Program and the NIAID biodefense mission. When necessary issues may be
brought to the Management and Oversight Committee for advice.
d. The NIAID Program Staff Scientist will keep the RCE informed about other
ongoing studies supported by NIAID to avoid duplication of effort and to
encourage sharing and collaboration in the development of new clinically
useful reagents and methodologies for biodefense and emerging infectious
diseases research. The NIAID Program Staff Scientist will coordinate access
for the RCE to other resources from NIAID, including NIAID sponsored agents
for preclinical and clinical testing, drug screening, preclinical toxicology
testing, and assistance in IND filing, etc. NIAID Program Staff Scientists
assist the research efforts of the RCEs by facilitating access to fiscal and
intellectual resources provided by industry, private foundations, NIH
intramural scientists and other federal government agencies.
e. NIAID RCE Program Staff Scientists will help organize an annual meeting
of investigators from all funded RCEs to share progress and research insights
that may benefit all of the projects. The RCE Program Director will be
responsible for conducting semi-annual meetings of the Management and
Oversight Committee.
f. The RCE Program Staff Scientist may assist, where warranted, in data
analyses, interpretations, and the dissemination of study findings to the
research community and health care recipients, including co-authorship of the
publication of results of studies conducted by the RCEs, subject to NIH
publication policies.
3. Collaborative responsibilities:
The Management and Oversight Committee (MOC) will provide overall scientific
coordination of the RCE Program, RCE Principal Investigators, Directors of
the RBLs (BSL3/4 facilities), and the NIAID RCE Program Director will be
voting members. Additional NIAID Program Staff and scientists other than PIs
may attend as non-voting members of the committee, where additional expertise
may be required. The NIAID RCE Program Director will serve as chairperson.
The Management and Oversight Committee will meet twice yearly or as needed in
the event of a bio-terrorism emergency event. The purpose of these meetings
is to share scientific information, to assess scientific progress, to
identify new research and development opportunities and potential avenues of
collaborations such as with industry, private foundations NIH intramural
scientists, and other federal government agencies and to establish priorities
that will accelerate the translation of preclinical findings into clinical
applications, reallocate resources and conduct other business of the RCE
Program.
The Committee may determine the need to redirect certain efforts in RCEs when
results and data suggest that the proposed research is no longer feasible or
progressing toward desired goals. Some RCEs will develop common research
interests, research focus groups may be formed to pursue coordinated research
activities identified by this Committee. The Committee will be called upon
to make recommendations regarding approaches to specific threat agents and
emerging diseases that require new attention as the need arises. The
Committee will also seek input from the scientific research communities, and
help the NIAID determine initiatives that will have an impact on the health
and safety of the nation. The MOC will also provide a forum for
coordinating RCE activities that require a liaison function with other
federal agencies such as FDA, USDA, and CDC.
4. Arbitration:
When agreement between an awardee and NIAID staff about
scientific/programmatic issues that may arise after the award cannot be
reached, an arbitration panel will be formed. The panel will consist of one
person selected by the awardee, one person selected by NIAID staff, and a
third person selected by the two. The decision of the arbitration panel, by
majority vote, will be binding. This special arbitration procedure in no way
affects the right of an awardee to appeal an adverse action in accordance
with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45
CFR Part 16.
WHERE TO SEND INQUIRIES
Written and telephone inquiries from potential applicants to clarify any
issues or questions about the RCE Program and responding to the RFA are
welcome.
Direct inquiries regarding programmatic issues and address the letter of
intent to:
Dr. Rona Hirschberg
RCE Program Director
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infections Diseases
6700B Rockledge Drive, Room 3129, MSC 7630
Bethesda, MD 20892-7630
Zip code for express couriers: 20817
Telephone (301) 496-1884
Fax: (301) 480-4528
e-mail: rhirschberg@niaid.nih.gov
Direct inquiries regarding review issues to:
Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov
Direct inquiries regarding fiscal matters to:
Linda Shaw
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Disease, NIH
6700-B Rockledge Drive, MSC 7614
Room 2125
Bethesda, MD 20892-7614 (Express Zip 20817)
Email: ls15k@nih.gov Tel: (301) 402-6611
Fax: (301) 480-3780
Lesia A. Norwood
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Disease, NIH
6700-B Rockledge Drive, MSC 7614
Room 2117
Bethesda, MD 20892-7614 (Express Zip 20817)
Email: ln5t@nih.gov Tel: (301) 402-7146
Fax: (301) 480-3780
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Number and title of this RFA
o Descriptive title of the proposed application
o Region (see list above)
o Names of Institution(s) participating in the RCE application
o Name, address and telephone number of the Principal Investigator
o Names of other key personnel
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information that it
contains allows NIAID 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:
Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: es170m@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. The total application may not exceed 300 pages,
and no more than 200 pages of appendix material may be included.
Applications exceeding these limits will be returned without review.
In addition, applicants must consult and use "Instructions for Applications
for Multi-Project Awards" (http://www.niaid.nih.gov/ncn/grants/multibron.htm )
with the following additional instructions specific to this RFA.
Table of Contents: Organize the application and table of contents as
described below:
Face Page
Description, performance sites and key personnel
Table of contents
Detailed Budget for Initial Budget Period:
Administrative core
Research Projects
Developmental projects
Training projects
Facilities cores
Budget for entire project period
Budgets pertaining to consortium/contractual arrangements
Biographical sketch of the Principal Investigator (not to exceed two pages)
Biographical sketch of the Research Project Investigators (not to exceed two
pages each)
Biographical sketch of other Key Personnel including Core Directors(not to
exceed two pages each)
List of all participating members of the Center
A. Introduction (15 pages)
Background and objectives
Letter of commitment from Institution(s)
Chronological review of planning and priority setting processes
B. Strategic Plan (20 pages)
Strengths
Opportunities
Action Plan
Outcome Measures
Emergency Response Plan
C. Research Projects (25 pages (sections A-D of the 398 form) or less each,
maximum of 150 pages total)
Use standard R01 sections and budget pages for each
D. Career Development Projects (10 pages or less each, maximum of 30 pages)
Basic Science
Translational/clinical
Other
Budget
E. Developmental Projects (maximum of 20 pages total)
Process for review and award
Assessment process, including termination or promotion
Proposals for first years" awards (2-3)
Budget
F. Cores and Facilities (15 pages or less each, maximum of 70 pages)
Administrative Core with detailed budget
Other Cores with budgets
Discussion/documentation of need for BSL3/4 facilities, including
renovation plans, if planned
SUPPLEMENTAL INSTRUCTIONS:
A collaborating NIH Intramural Scientist (IMS) may not receive salary,
equipment, supplies, or other remuneration from this RFA. The IMS must obtain
approval of his/her NIH Institute Scientific Director to allocate resources
to the project. This letter must specify that no more than $600,000 direct
costs of intramural resources will be allocated to the project and provide
assurance that the conduct of the project will comply with the DHHS
regulations for research involving human subjects (if applicable) and with
the PHS policy of vertebrate animal research.).
Each applicant RCE must provide in the application a detailed description of
the approach to be used for obtaining patent coverage and for licensing where
appropriate, in particular where the invention may involve investigators from
more than one institution, and a signed agreement between all parties must be
included. Procedures must be described for resolution of legal problems
should they arise. Your attention is drawn to P.L. 96-517 as amended by P.L.
98-620 and 37 CFR Part 401. Instructions were also published
in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 19, No. 23, June
22, 1990).)
NIAID acknowledges that some commercial collaborators that are members of
applicant RCEs, or who provide material to applicant RCEs, may require that
Institution agree to grant to them certain intellectual property rights, as
described by the terms above. If Institution voluntarily agrees to the
described terms, then they should appear in the RCE application. NIAID
recognizes that Institutions" and consortia of Institutions" ability to
access agents from commercial collaborators for this effort may be limited in
the absence of such a voluntary agreement, or a substantially similar
independent agreement between Institution and commercial collaborators
providing agents. However, in no event will the award of cooperative
agreement be dependent upon the described terms" being part of an RCE
application. Rather, the consortia and the Institution"s application may
provide Institution"s own plan for accessing agents from commercial
collaborators.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01)
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
(20817 FOR EXPRESS SERVICE)
At the time of submission, two additional copies and all copies of appendix
material for the application must also be sent to:
Edward W. Schroder, Ph.D.
Chief, Microbiology and Immunology Review Branch
NIAID Scientific Review Program
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov
APPLICATION PROCESSING: Applications must be received by the receipt date
listed. 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. Applications must
meet all eligibility requirements as described above and must address all
programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES WILL NO LONGER BE ACCEPTED. This policy does
not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.)
(https://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)
This change in practice is effective immediately.
This policy is similar to and consistent with the policy for applications
addressed to Centers for Scientific Review as published in the NIH Guide
Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAID. Incomplete 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 Division of Extramural Affairs (DEA) at NIAID, 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 selection process in which only those applications deemed to have
the highest scientific merit will be discussed and assigned a priority score
o Receive a second level review by the National Institute Allergy and
Infectious Diseases Advisory Board.
REVIEW CRITERIA
o Overall evaluation and scoring
The overall application score will be based on review and merit of the
individual components as well as the merit of the application taken as a
whole. A single numerical priority score will be assigned to the whole
application after consideration of all of the review elements listed below.
The Strategic Plan, the individual Research Projects, the career development
projects as a whole, and the developmental projects as a whole, will be
assigned numerical priority scores, while the Administrative and Facilities
Cores will be rated acceptable or unacceptable without numeric scores.
The overall score will be based on the scientific merit of the individual
components as well as the overall synergy, the effectiveness and adequacy of
plans for sharing resources, the overall program organization and capability
of the associated personnel and the extent to which having a RCE would
contribute to the overall NIAID Biodefense mission.
Criteria and factors to consider for evaluation of the application
components:
1. Overall strategic plan, management and goals of the Center
a. Strategic Plan
(1) Feasibility of the proposed strategic plan to achieve goals that
are appropriate to the mission of the RCE.
(2) Scientific / technical merit and innovation of the proposed goals
of the RCE.
(3) Potential for the proposed plans for the RCE to enhance regional
research and development capabilities.
(4) Potential for the proposed RCE to develop critical, new knowledge
about biodefense and emerging infectious diseases.
(5) Potential for the proposed research goals to lead to vaccines,
diagnostics and therapeutics for category A-C agents.
(6) Feasibility of the proposed research to span basic as well as
translational / clinical issues.
b. Communications, Collaborations, and Interactions
(1) Strength, merit and feasibility of plans to foster synergistic
interactions among the participants of the proposed Center.
(2) Strength, merit and feasibility of plans for Center interactions
with federal, state and local agencies or with industrial partners.
(3) Strength, merit and feasibility of plans for rapid and effective
communication among the proposed participants and with the broader
constituency of the Center.
c. Monitoring and Evaluation
(1) Scientific and technical merit and feasibility of the proposed
milestones.
(2) Appropriateness and feasibility of the proposed means to measure
and assess productivity.
(3) Appropriateness and feasibility of plans to add research projects
and / or cores in response to emerging opportunities or to delete
unproductive projects and/or cores.
d. Institutional Commitment
(1) Merit and appropriateness of the documented institutional support
to the goals of the Center, including the commitment of additional
resources.
(2) Strength, merit and feasibility of documented plans to leverage
additional scientific and technical resources to increase the impact
of NIAID funds.
(3) Merit and feasibility of the documented capacity and interest of
the proposed institution(s) to serve as a regional biodefense first
responder.
(4) Appropriateness and feasibility of plans to rapidly develop the
Center.
2. Administrative Core
a. Adequacy of the training, experience, level of commitment,
availability and qualifications of the Principal Investigator to
successfully lead and manage the proposed Center.
b. Adequacy of the training, experience, levels of commitment,
availability and qualifications of key personnel who represent the
leadership team proposed for the Center.
c. Appropriateness and clarity of plans for organizing the Center"s
activities for prioritization of competing needs.
d. Appropriateness and clarity of the organizational structure and lines
of authority as well as plans for lines of authority in the Principal
Investigator"s absence.
e. Appropriateness of plans to make the Center and its resources
available to investigators and institutions throughout the region.
f. Appropriateness of the management plan for fiscal accountability and
communications within the Center.
3. Evaluation of research projects
The following review criteria for research projects will be applied in the
context of how the project supports the strategic plan and advances the
overall program of the Center.
SIGNIFICANCE: appropriateness of the research proposed in advancing the
biodefense mission of the NIAID, contributing to the RCE strategic plan,
and in inclusion of an appropriate representation of category A-C agents.
APPROACH: appropriateness of the conceptual framework, design, methods, and
analyses to the aims of the project and the RCE program. An effective
strategy for selecting approaches and platforms within the RCE to address
the research questions should be evident. Where appropriate,
investigators should include approaches that will translate into safe,
feasible and useful therapeutics, vaccines, and diagnostics.
INNOVATION: novelty of concepts, approaches or methods. Project leaders
should seek to advance, extend or challenge existing paradigms, or to
develop new methodologies or technologies for biodefense.
INVESTIGATOR: appropriateness of the training, qualifications, experience,
accomplishments of the project leader to carry out the proposed project.
The project leader is expected to allocate sufficient effort to RCE
activities. The application should provide documentation that project
leaders have the ability and willingness to function as part of an RCE
team.
ENVIRONMENT: adequacy of the availability of personnel at the institution(s)
who are experienced with CDC Category A-C Agents consistent with the
proposed research. Adequate, appropriate facilities must be available.
For projects that include translational and clinical studies, there should
be adequate support and expertise available for the successful pursuit of
the proposed work. Projects should include a plan to take advantage of
Center resources and for integration of the project into Center
activities.
When appropriate, individual projects may be grouped as programs within the
Center to address overarching scientific aims. Such programs will be further
evaluated for cohesiveness, the suitability of plans for collaboration and
exchange of ideas among participants, and for evidence that program
components will bring synergy and added value to overall Center activities.
4. Evaluation of Career Development Plans
a. Quality and appropriateness of the technical and scientific expertise,
mentoring experience and availability of the faculty and staff to
conduct the proposed training.
b. Strength of the documented available training infrastructure such as
laboratories, clinics, etc.
c. Merit, feasibility and level of creativity of the proposed approaches
to increase the human resources available for biodefense.
d. Relevance of the proposed training to, and integration with, the goals
of the strategic plan.
e. Feasibility and strength of plans to recruit sufficient qualified
students and trainees and adequacy of plans for the inclusion of women
and minorities.
f. Appropriateness of the proposed training within the current education
framework of the involved institution(s).
g. Potential contribution of the specific training proposed to the overall
RCE mission.
h. Suitability of plans for evaluation of the training and documenting
success.
5. Evaluation of Developmental Project plan
a. Strength, feasibility and appropriateness of the proposed plans and
criteria to select developmental projects and monitor their long term
success.
b. Scientific merits of the sample developmental projects provided, and
their suitability to the overall goals and priorities of the Center.
c. Inclusiveness and feasibility of the developmental project plan for
bringing new investigators into the biodefense research area.
d. Adequacy of the proposed procedures and criteria for the phase-in and
phase-out of developmental projects and for the promotion of promising
developmental projects to full research status.
e. Adequacy of the plans of the leadership for selecting developmental
projects that leverage resources and complement the Center"s strengths.
f. Appropriateness and clarity of plans to manage the budgets of
developmental projects.
g. Appropriateness and feasibility of recruitment strategies to ensure a
broad pool of applicants and scientific topics for the development
projects.
6. Evaluation of core facilities plans
a. Appropriateness of the proposed core facilities in the context of the
overall strategic plan and the proposed research and training
activities.
b. Feasibility and clarity of plans for prioritizing the use of
facilities and for allocating availability to the proposed research
projects.
c. Qualifications, experience and commitment of key personnel for running
the core facilities.
d. Documented importance of the core proposed in the context of existing
facilities in the Center and region.
e. Adequacy and feasibility of plans to ensure that the core facilities
are used to fullest extent including access by non-RCE investigators
and institutions.
f. Adequacy and feasibility of plans to ensure that during a time of
National biodefense emergency the cores will re-align their activities
to assist in the local response through research activities.
g. Appropriateness of the schedule of user fees set to ensure broad
accessibility and utilization by regional partners, particularly those
with limited resources.
7. BSL3/4 Utilization plans
a. Clarity of documentation of the need for BSL3/4 facilities.
b. Adequacy and feasibility of plans to establish linkages to exisiting
BSL3/4 facilities.
c. Collective experience of Center participants in the use biocontainment
facilities and ability to provide training for proposed biocontainment
facilities.
d. Adequacy and feasibility of the phase in plans providing a mechanism
for research to proceed until new BSL3/4 capacity is on-line.
ADDITIONAL REVIEW CRITERIA: In addition each of the research projects, as
well as planned developmental projects, and the project as a whole will be
evaluated with respect to the following:
o PROTECTIONS: 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.
o INCLUSION: 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
included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The initial review group will also examine the reasonableness of
the proposed budget and the requested period of support in relation to the
proposed research. The support for attendance at Management and Oversight
Committee meetings can be provided through the Team"s award as part of the
travel budget.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 15, 2002
Application Receipt Date: January 15, 2003
Peer Review: May 2003
Earliest Anticipated Award Date: August 2003
AWARD CRITERIA
If multiple applications from a single region are reviewed and scored, the
NIAID reserves the right to negotiate the merging of the two into a single
RCE. This will be done based upon the peer review-identified strengths and
weaknesses of each application, and programmatic need. NIAID may also
negotiate prior to award to expand/change the scope of the proposed research
to meet overall program needs.
Additional award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
o Coverage of desired research scope
o Regional distribution of meritorious applications
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NIAID require special
considerations. It is anticipated that the RCEs will run very limited proof
of concept trials, and limited safety studies of new agents. Activities
beyond this will require approval by the full Management and operations
committee.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
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. A
continuing education program in the protection of human participants in
research in now available online.
RECOMBINANT DNA AND HUMAN GENE TRANSFER RESEARCH
The National Institutes of Health Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines) apply to NIH-funded and non-NIH-
funded gene transfer projects that are conducted at or sponsored by an
institution that receives NIH support for recombinant DNA research. As
defined by the NIH Guidelines, recombinant DNA molecules are either: (1)
molecules which are constructed outside living cells by joining natural or
synthetic DNA segments to DNA molecules that can replicate in a living cell,
or (2) DNA molecules that result from the replication of those described in
(1). The NIH Guidelines set forth principles and standards for safe and
ethical conduct of recombinant DNA research and apply to both basic and
clinical research studies. Specific guidance for the conduct of human gene
transfer studies appears in the appendix of the document (Appendix M.) The
NIH Guidelines should be carefully reviewed to ensure compliance with all
other requirements for the conduct of projects involving recombinant DNA
research and human gene transfer. Failure to comply with the NIH Guidelines
may result in suspension, limitation, or termination of NIH funds for
recombinant DNA research at the organization or a requirement for NIH prior
approval of any or all recombinant DNA projects at the organization. A copy
of the NIH Guidelines is posted at the following URL:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html and may be
obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892, 301-496-9838.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov/). It is the responsibility of the applicant to provide
the official NIH identifier(s)for the hESC line(s)to be used in the proposed
research. Applications that do not provide this information will be returned
without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People
2010," a PHS-led national activity for setting priority areas. This 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 No. 93.3393 and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies described at https://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.