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and Human Services (HHS)
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INTERNATIONAL COOPERATIVE BIODIVERSITY GROUPS (ICBG)
RELEASE DATE: October 26, 2004
RFA Number: RFA-TW-04-004 (Reissued as RFA-TW-08-003)
EXPIRATION DATE: February 16, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
Fogarty International Center (FIC)
(http://www.fic.nih.gov)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/default.htm)
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/index.htm)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute on Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov/)
Office of Dietary Supplements (ODS)
(http://dietary-supplements.info.nih.gov/)
National Science Foundation (NSF)
(http://www.nsf.gov)
USDA Foreign Agricultural Service (FAS)
(http://www.fas.usda.gov/)
USDA Forest Service (FS)
(http://www.fs.fed.us/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.989 (FIC); 93.395
(NCI); 93.855, 93.856 (NIAID); 93.859 (NIGMS); 93.837, 93.838, 93.839,
93.233 (NHLBI); 93.279 (NIDA); 93.242 (NIMH); 93.213 (NCCAM); 47.074
(NSF). The Office of Dietary Supplements (ODS) was mandated by
Congress in 1994 and established within the Office of the Director,
National Institutes of Health (NIH). The Dietary Supplement Health and
Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the
Federal Food, Drug, and Cosmetic Act "to establish standards with
respect to dietary supplements." This law authorized the establishment
of the ODS.
LETTER OF INTENT RECEIPT DATE: January 18, 2005
APPLICATION RECEIPT DATE: February 15, 2005
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Composition of Groups
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements, including Terms and Conditions of Award
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
o Principles for Access, Intellectual Property and Benefit-Sharing
o Definitions
PURPOSE OF THIS RFA
The National Institutes of Health (NIH), the National Science Foundation
(NSF) and the U.S. Department of Agriculture (USDA) (hereafter "the
Government" or "the Participating Agencies") invite applications for the
establishment of "International Cooperative Biodiversity Groups" (ICBG)
to address the interdependent issues of biodiversity conservation,
economic capacity, and human health through discovery and development of
therapeutic agents for diseases of importance in developing countries,
as well as those important to developed countries. Eligibility for this
competition is limited to groups that are currently funded by ICBG R21
planning grant awards issued in 2003. Innovative and integrated
approaches to access to genetic resources and benefit-sharing with host
country stakeholders and participants is an important component of the
overall program. Particularly relevant disease areas and health needs
include HIV-AIDS and its opportunistic infections and associated
malignancies, tuberculosis, malaria, other emerging diseases, mental
disorders of adults and children, cancer, drug abuse and cardiovascular
and pulmonary diseases. Applicants are encouraged to consider marine
coral reef organisms as well as new sources of previously unexplored or
under explored microorganisms, including but not limited to those
arising from symbiosis, extreme environments such as thermovents, and
deep sea microbes. Applications that propose to work primarily with
plants for pharmaceutical drug discovery are encouraged to propose
research and training related to phytomedicine analysis. Research and
capacity building toward the development of agricultural agents is
permissible as a secondary activity where it complements work on human
health agents.
For the purposes of this program, the NIH will be allocated funds from
the NSF, the USDA Foreign Agricultural Service (FAS) and the USDA Forest
Service (FS). The Fogarty International Center (FIC) of the NIH will
administer this program under the authority and regulations of the
Public Health Service (PHS).
The unifying theme underlying the ICBG program is the concept that the
discovery and development of pharmaceutical and other useful agents from
natural products can, under appropriate circumstances, promote economic
opportunities and enhanced research capacity in developing countries
while conserving the biological resources from which these products are
derived. This RFA calls for the development of interdisciplinary
programs through the establishment of International Cooperative
Biodiversity Groups (ICBGs), with active and substantial participation
by U.S. and developing country scientists and institutions. It is the
intent of this RFA to promote the conservation of biological diversity
through the discovery of bioactive agents from natural products, and to
ensure that benefits accruing from both the research process and any
discoveries are shared with the country of origin. The RFA is seeking
applications that will build institutional relationships with developing
countries that will continue to grow beyond the life of the RFA and will
serve as effective models for others to develop similar relationships.
This fourth RFA of the International Cooperative Biodiversity Groups
program represents a maturation of the eleven-year-old program and
includes several changes originally incorporated into the third RFA,
including increased emphasis on drug development and increased
integration of conservation and development activities. Some
information about previous ICBG activities and a list of answers to
frequently asked questions about this competition may be found at
http://www.fic.nih.gov/programs/ICBGFAQS.html.
RESEARCH OBJECTIVES
1. Pertinent background that establishes the need for this research
Natural products that hold promise for the development of pharmaceutical
agents, as well as those that form the basis for many traditional
botanical remedies, are often found in ecosystems that are seriously
threatened. These include terrestrial as well as marine ecosystems that
are rich in biological diversity. For example, tropical forests cover
only seven percent of the earth's surface, but they are thought to
contain at least one-half of all plant and animal species. Tropical
deforestation is currently proceeding at a rate of 16 million hectares
per year. Marine coral reefs support at least 25,000 described species
from 32 of the 33 recognized animal phyla. At least ten percent of the
world's coral reefs are already degraded and another 20 percent are
likely to decay during the next 20 years. Despite these rates of loss,
our knowledge of the world's biological diversity is so incomplete that
for many groups we do not even know, within an order of magnitude, the
number of species at risk of extinction. Cultural diversity is also
seriously threatened by habitat conversion and the loss of biological
resources on which many traditional societies depend.
Diverse plant, microbial and animal resources contain a wealth of
potentially useful compounds. The clinical importance of the Vinca
alkaloids, camptothecin analogues, and taxol in treatment of cancers,
the artemisinin derivatives for malaria, the statins for heart disease,
Acetyl Choline Esterase inhibitors for hypertension, and galantamine for
Alzheimer's Disease underline the continuing need to explore natural
products sources. New natural products in pharmaceutical or dietary
supplement form are possible sources of effective therapies for these
diseases and others including diarrheal disorders, HIV/AIDS and its
associated opportunistic infections and cancer, respiratory diseases,
mental disorders, narcotic dependency, and other serious illnesses
prevalent in developing and/or developed countries.
Perhaps even more urgent than the losses of genetic and chemical
diversity as sources of potential pharmaceutical agents, are the
immediate repercussions of biodiversity loss in many developing
countries where botanical and other remedies based on crude materials
from diverse biota are a primary source of health care. While much of
the world's populations still rely on such traditional medicines, few of
these have been scientifically evaluated for safety or efficacy.
Standards for the composition of these materials are generally non-
existent. Lastly, the scale and methods of harvest of these materials
from the wild are often unsustainable in the context of today's growing
local and international markets. Thus, decreasing availability of raw
materials that derive from unsustainable exploitation and other forces
that affect biodiversity and inadequate scientific understanding of the
botanical medicines are significant public health concerns.
Simultaneous with the pressure on biological diversity are accelerating
losses of traditional knowledge associated with the biota. This
knowledge of the identity and utility of specific organisms for
medicinal and other uses has intrinsic value as part of our cultural
patrimony, is critically important as a source of health care for many
people, and may offer important leads for future treatments of numerous
human ailments.
Advances in genomics and analytical methods have enabled more effective
use of molecular diversity by identifying important targets,
understanding mechanisms of action and enabling optimization of small
molecules for therapeutic purposes, as well as optimizing the use of
botanicals as health-promoting agents. Similarly, advances in chemical
ecology and ethnobiology have expanded our ability to identify source
organisms based on their interactions with nature and human societies.
Finally, the molecular, statistical and computational tools that support
the sciences of systematics and biological inventory have made enormous
strides in recent years. The unfortunate irony is that, as advances in
biology expand our ability to use genetic diversity to combat diseases,
the raw material is being lost due to ecosystem degradation and species
extinction.
The underlying causes of biodiversity loss are many and involve
interwoven social, economic, and political elements. In developing
countries struggling to meet the most basic human needs, efforts to
protect biological diversity will succeed only if implemented in the
context of promoting sustainable economic opportunities. To be
effective, efforts to protect biological diversity must include the
active participation of national institutions and affected local
communities, which ultimately will determine the success or failure of
those efforts. Biological resources must benefit national institutions
and local populations if the resources are to be conserved.
Consequently, the sustainable economic potential of biological
resources, such as developing pharmaceuticals or validated botanicals
from natural sources, can be used to promote biodiversity conservation
by providing an economic return from sustainable use of the resources
while improving quality of life through better human health. The
development of significant conservation incentives is most likely when
both near- and long-term benefits accrue to stakeholders.
2. Objectives of this research and development program
The overall goals of the ICBG Program are drug discovery, biodiversity
conservation, and economic development. The following cross-cutting
approaches should guide the research and capacity-building efforts
toward these goals: a) assisting with the discovery and development of
drugs that address priority health needs of the participating developing
country(ies) and of the United States; b) assisting with research on
other natural products-based materials, such as locally used botanical
medicines; c) developing biological inventories of native species and,
where relevant, indigenous knowledge; d) training targeted toward
achieving the research goals of this RFA and meeting the needs of the
participating country; and, e) enhancing the scientific infrastructure
within the host country. Specifically, the program objectives are to:
a) Conduct pre-clinical research to discover, isolate, evaluate and
develop agents from natural sources to treat or prevent diseases of
importance to developing countries, as well as those primarily important
in developed countries. Particularly relevant disease areas and health
needs include HIV/AIDS-associated malignancies, HIV/AIDS and associated
complications and co-infections, tuberculosis, malaria and other
emerging infectious diseases, mental disorders of adults and children,
cancer, drug abuse and cardiovascular and pulmonary diseases. The scope
of this RFA does not include the conduct of clinical trials. Source
organisms may include any group found in nature that is likely to yield
pharmaceutically useful molecules. While plants from both the temperate
and tropical ecosystems have been and continue to be an important
resource and focus of attention, applicants are also encouraged to
consider marine coral reef organisms and new sources of previously
unexplored or under-explored microorganisms, including but not limited
to those arising from symbiosis (for example endophytic fungi and
symbionts of marine organisms), extreme environments, deep sea
organisms, and other less understood groups. Original field collections
should be the predominant source of sample organisms for testing.
b) Conduct pre-clinical research to evaluate, validate and standardize
locally important botanicals or other remedies based on crude biological
materials, and develop ecologically-sustainable means of harvest or
cultivation for local supply of high quality materials. Alternatively,
a group may choose to include discovery of other natural-product based
entities such as crop protection agents, animal veterinary medicines, or
other useful products with the potential to provide economic benefits to
local communities and other developing country partners through product
earnings or stimulation of local industries. It is probable that in
many cases research in these alternative areas can be conducted in
parallel with drug discovery work with minimal additional cost by
incorporating academic, governmental or commercial partners with the
appropriate scientific resources.
c) Undertake inventories of biological diversity and produce
documentation of all collected material in the form of museum
catalogues, published works, and/or databases, reporting specific
locality and all features of biology relevant to standard botanical and
zoological collections; assure accessibility of inventory specimens to
the public in both the partner countries and in the United States by
housing them in public institutions (such as universities and national
museums), and accessibility to all inventory databases through
publication on the Internet. All taxonomic groups are relevant and
those proposed for inventory do not necessarily have to be the same as
those being analyzed for drug discovery purposes. However, applicants
should give careful thought to the potential synergies in expertise,
data and cost-effectiveness if they overlap. Similarly, the choice of
organisms and areas to study should reflect not only scientific value
but their relevance to conservation planning.
d) Support research training targeted to meet the needs of the
developing country represented within the Group and related to the scope
of work of the RFA, and to augment field experience and training of U.S.
scientists in areas of knowledge unique to the developing country.
Examples of relevant areas of training could include systematics,
geographic information science, ethnomedicine, natural product
chemistry, pharmacology, biotechnology, production methods, quality
control in botanical production, data management, statistics, grant
writing, scientific manuscript preparation, grants administration and
bioethics. Where possible, projects should plan to advance the level of
training of developing country scientists beyond initial efforts to
include advanced field and laboratory work such as the development and
conduct of locally appropriate bioassays, isolation and analytical
chemistry, database development, ecology and biodiversity analysis and
management techniques.
Research training supported through this award may take place in the
host country or in the United States and may be linked to degree-earning
programs. Training may include, but is not limited to: i) practical
and applied short-term courses or workshops for professionals or
technicians; ii) course work, laboratory, or field training in essential
research skills for technical assistants, graduate degree candidates, or
professionals; and iii) fellowships for one or more years for degree
candidates or post-doctoral trainees to conduct research related to the
goals of the Group. Training costs and plans must be specified in the
text of the application and in the application's budget request.
e) Assist in enhancing the scientific environment within the
participating developing country(ies) to enable ongoing drug discovery
and biodiversity science and an understanding of the economic context in
which they may operate. Enhancing the scientific environment could
include social, policy and technological instruments. The social
environment might be enhanced through strengthening of networks of
scientists or local healers. Groups are strongly encouraged to provide
technical support for local and national governments interested in
developing policy related to access and benefit-sharing for genetic
resources. Physical infrastructure support could include assistance for
herbaria, museums, and laboratories, the supply of necessary equipment
in these facilities, and the enhancement of collecting and screening and
analysis capabilities in the host country. Limited renovation of
existing facilities, but not construction of new facilities, is
allowable under this RFA. All renovation of facilities must be strictly
relevant to the research objectives of the Group and requires prior
approval of FIC.
Successful applications will most likely include some element of all
five approaches (a-e). Without a comprehensive and multi-disciplinary
approach, it would be difficult to meet the requirement that drug
discovery, biodiversity conservation, and sustainable economic
development be addressed.
Applications for funding as an ICBG should stress creative, synergistic
approaches to biodiversity conservation, drug discovery, and sustainable
economic development. Synergy among these goals is more likely when the
varied activities of the ICBG have significant geographical overlap than
when they are widely dispersed among different regions and countries.
However, legitimate scientific or other considerations may lead to less
geographically-localized programs. Applicants are encouraged to develop
a plan that integrates the diverse activities above as tightly as
possible.
MECHANISM OF SUPPORT
This RFA will use the NIH U01 award mechanism (Cooperative Agreement)
and will support awards of up to $600,000 per year in direct costs for
up to four years to carry out the full spectrum of ICBG research and
development activities in this RFA. Under the NIH U01 cooperative
agreement mechanism the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a
partner with the Principal Investigator. The nature of the U.S.
Government's assistance is described under "Terms and Conditions of
Award."
An award will be made only to the Group Leader's institution, which will
subcontract with the other participating institutions. All Group
activities will be coordinated through the Group Leader's institution.
Applicants must comply with NIH policies concerning allowable costs.
Note that foreign institutions are eligible for facilities and
administrative (F&A) costs of up to eight percent. Questions about
allowable costs may be directed to Mr. Bruce Butrum, Grants Management
Officer, FIC.
Under the Cooperative Agreement, a relationship between the awardee and
the Government is established in which the Group is responsive to the
requirements and conditions set forth in the RFA. Specifically, the
Group Leader defines the details for the project in response to the RFA,
retains primary responsibility for the performance of the Group, and
agrees to coordinate with the assistance of the Government in all
aspects of scientific and technical management of the project in
accordance with the terms and conditions outlined under "Terms and
Conditions of Award."
Awards pursuant to this RFA are contingent upon availability of funds.
Subsequent to receiving awards and with pre-approval, awardees may
request supplemental support from the Government to expand their
activities. Funding for such expansion should be administered through
the FIC if they originate from one of the agencies sponsoring this RFA.
Complementary funds could also be supplied, for example, from a non-
governmental organization or a U.S. Governmental agency, not currently
participating in this RFA. Applicants are encouraged to apply for funds
from corporate partners or non-profit foundations to further enhance
health, conservation and development activities in the host countries,
perhaps utilizing trust funds in those countries for management of such
resources. Regardless of the source, any supplemental support for Group
activities must be reported to FIC.
This funding opportunity uses the just-in-time budget concepts. It also
uses the non-modular budget format described in the PHS 398 application
instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The anticipated award date is September 15, 2005.
Future UNSOLICITED, competing continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary NIH peer review procedures.
At the present time FIC does not consider unsolicited applications but
other components of the NIH do.
FUNDS AVAILABLE
The participating organizations intend to commit approximately $1.5
million in FY 2005 to fund two new U01 awards in response to this RFA.
An applicant may request a project period of up to four years and a
budget for direct costs of up to $600,000 per year.
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)
Because the nature and scope of 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 ICs
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.
All currently funded R21 ICBG Planning Grants that wish to be eligible
for ICBG funding beyond their second year of support must apply under
this RFA.
COMPOSITION OF GROUPS
Groups should be multi-disciplinary, including individuals and
organizations with expertise in various relevant disciplines of the
biological and physical sciences, as well as areas such as economics and
sociology, and may include those who have not collaborated in programs
of this type in the past.
Groups will be international in scope with participation of developing
country institutions to the greatest extent possible. Since it is
unlikely that all of the required capabilities will be located within
one institution, Groups likely will be multi-institutional as well.
While not mandatory, the active participation of the private sector is
encouraged because it: 1) will allow this segment of the scientific
community to contribute its considerable intellectual and material
resources; 2) will promote private sector participation in local health
and conservation issues; and 3) will facilitate efforts to negotiate
conditions for the equitable distribution of profits and other benefits
to all parties, including developing country institutions involved in
conservation and sustainable resource use. The interaction of academic
and non-profit institutions with industry and Government will encourage
the creation of novel, interdisciplinary approaches that may not
otherwise develop. Private sector pharmaceutical partners may include
companies, large and small, non-profit drug development organizations or
a combination of these.
A version of this RFA is available on the internet at
http://www.fic.nih.gov/programs/icbg.html. That version includes a
diagram representing some possible relationships among scientists that
might form an International Cooperative relationship to the Funding
agencies. It depicts some of the scientific Biodiversity Group and the
disciplines that may be included. No specified number of associate
programs should be inferred by this sample. However, it should be noted
that fewer three associate programs may be insufficient to accommodate a
project of such complexity and more than 6 may lead to unnecessary
administrative complexity. Furthermore, different ICBGs will vary
considerably with respect to the number and kinds of scientific
disciplines required.
1. The composition of an ICBG is envisioned as follows:
a) A Group Leader who is likely to also head an associate program.
b) Associate Programs, each headed by an Associate Program Leader, in
diverse scientific disciplines, such as ecology, microbiology, cell
biology, ethnobiology, sociology, anthropology, botany, zoology,
entomology, pharmacology or chemistry, that may be appropriate to the
realization of Group objectives. Associate Programs will be composed
primarily of developing country and U.S. institutions. At least one of
the Associate Programs must be located in a developing country and
directed by a scientist or program administrator in a developing country
institution. Developing country scientists must be substantially
involved in the overall program design.
c) The U.S. Government Coordinator (Advisory Committee Chairperson)
appointed by the Technical Advisory Group to provide assistance to the
Group.
2. The Group Leader, in addition to providing scientific and
administrative leadership, may head an Associate Program. Associate
Program Leaders will be directly responsible to the Group Leader. The
formation of the Group, submission of the application in response to
this RFA, the overall management of the Group, and the allocation of
funds to the various Associate Programs based on anticipated needs, past
performance and the overall Group needs at any given time will be the
responsibility of the Group Leader and the Group Leader's institution in
accordance with PHS policies. The Group Leader will also be responsible
for maintaining an integrated relational database of all the significant
research and capacity-building activities of the Group as outlined under
SPECIAL REQUIREMENTS.
3. The composition of the Group and its Associate Programs should
depend on the talents required to accomplish its scientific and
technical objectives as perceived by the Group Leader and Associate
Program Leaders. The major consideration in structuring an ICBG should
be the maximum utilization of intellectual, physical, and financial
resources to carry out the proposed research and capacity-building. If
the Group includes more than one Associate Program on a specific topic,
each should be capable of contributing high quality, necessary, and non-
overlapping talents.
4. An individual scientist or a single institution may be proposed as a
Group Leader in only one application. However, an individual scientist
may be an Associate Program Leader in more than one application, or a
Group Leader and an Associate Program Leader on separate applications.
If a scientist appears on more than one application, it is the
responsibility of the Group Leader to demonstrate in their applications
that there are no scientific or budgetary overlaps or proprietary
conflicts with each individual's proposed activities. Likewise,
individuals currently receiving funding via contracts, grants, gifts,
commercial arrangements, or Cooperative Agreements may be funded under
this RFA providing that there is no scientific or budgetary overlap or
proprietary conflict in funded activities.
Any Associate Program Leader must complete their portion of the overall
application in detail even if no funds are requested for his or her
specific project. NSF Staff or intramural scientists at the NIH or the
Department of Agriculture may participate in an ICBG as collaborators or
consultants, but may not submit a formal application as an Associate
Program Leader, assist in developing other portions of the application,
or receive funds from this program. Such a government scientist must
provide in the application a letter of commitment, a current curriculum
vitae, and documentation of the required clearances from their Division,
Institute or Agency director, as appropriate. The Group Leader must
incorporate into the application, in the usual grant format, a full
description of the project, including technical details and methodology.
The participation of an intramural scientist is independent of and
unrelated to the role of the Advisory Committee or the U.S. Government
Scientific Coordinator as described under "Terms and Conditions of
Award."
5. More than one Associate Program of a Group might be derived from a
single institution. However, the varied talents and technologies
required for the effective attainment of the objectives described in
this RFA are not likely to be present in an individual institution. It
is anticipated that the Associate Program Leaders within a Group will
therefore likely be derived from several institutions.
6. No prescribed number of Associate Programs per Group is stipulated.
However, the Group Leader could experience difficulty in providing the
desirable level of guidance, and Group members might communicate and
collaborate less efficiently, if the Group were to contain more than
five or six Associate Programs. In addition, to ensure the most
effective use of resources and management of data, the number of
institutions collaborating in a Group should be considered carefully.
7. In forming Groups, potential Group Leaders should remain cognizant
of the need for communication, including regular meetings of members,
and transfer in a timely manner of data and materials to Group members
located in all the participating countries. A plan for communication
and material transfer, including all permits and other legal documents
required to assure this transfer, must be supplied.
8. Under the provisions of assistance via a Cooperative Agreement, the
U.S. Government Scientific Coordinator will assist the ICBG and
participate in the Group in a manner specified in "Terms and Conditions
of Award," and carry out the scientific responsibilities required. The
U.S. Government Scientific Coordinator will not conduct Associate
Program activities.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o Non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Eligible agencies of the Federal government
o Domestic institutions
o Faith-based or community-based organizations
The Group Leader must be located in a public or private non-profit
institution of the United States. Components of the sponsoring
agencies, including NIH, the NSF, the FAS and the FS of the USDA are not
eligible either as Group Leaders or Associate Programs. If you are from
a U.S. Government agency and are interested in participating in an
application contact the Program Director for guidance on eligibility.
Foreign and for-profit institutions may and are encouraged to
participate in an ICBG as Associate Programs.
Only one application may be submitted per institution.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals who currently hold R21 ICBG awards may be Principal
Investigators on applications under this RFA. Within that framework,
any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups, as well as individuals with
disabilities, are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
1. Award Monitoring and Evaluation
Progress of each funded Group will be monitored and evaluated using bi-
annual technical progress reports prepared by the Group. Detailed
reporting instructions will be provided to grantees upon receipt of
award or by request. Part of this reporting process will rely on
grantee cooperation with an ICBG Global Data Center that is supported
under a contract from the Government. Evaluation of productivity and
accomplishments of Groups will utilize diverse criteria including, but
not limited to, scientific publications, new species, new compounds, new
analytical or production methods and approaches including those that
increase the efficiency of natural products drug discovery, patents,
trainees, courses, local income-generating activities, institutional
capacity development and conservation or health policy impacts.
The U.S. Government Scientific Coordinator or the ICBG Program Director,
with advice from the Advisory Committee, may also elect to conduct site
visits or enlist the technical assistance of external consultants to
review progress and work with investigators to suggest mid-course
changes or recommendations for non-competitive renewal of awards.
2. ICBG Global Data Center
To ensure the integrity of collaboration within groups and the ability
of the Government to monitor and facilitate progress of the ICBGs
minimum data elements, formats and standards for a subset of data will
be developed in consultation with grantees. Grantees will be required
to maintain an integrated relational database for bioinventory (e.g.
species name and collection site) and drug discovery (e.g. bioactive
compounds isolated) and to provide a subset of these data on a regular
basis to a Global Data Center serving all groups. All grantee data will
be treated as proprietary and confidential except where otherwise
indicated by the grantees. The Global Data Center will also serve a
variety of data analysis, data management, literature access, outreach
and training needs of the funded groups. The Government will use the
Natural Products Information System (NAPIS™) to consolidate these data
and applicants are encouraged to use this or a compatible system to
collect and store the relevant subset of their data. Every group will
be expected to have a qualified Data Manager who will be responsible for
the Database and can serve as a Coordinator with the Global Data Center.
3. Genetic Resources Access, Intellectual Property and Benefit-Sharing
Because the discovery of bioactive agents from natural products is one
objective of this effort, along with ensuring an equitable economic
benefit accrues to developing country organizations or communities
associated with ICBG research, it is essential that applicants develop
appropriate plans for access to genetic resources and contractual
agreements for the treatment of intellectual property and benefits that
may arise. Carefully planned and executed approaches to access and
benefit-sharing are integral to the goals of this program and must
anticipate the rapidly changing regulatory environment in many countries
as they respond to the U.N. Convention on Biological Diversity. The
development of these plans and agreements is frequently complex and
challenging because multiple institutions and countries are involved,
often with very different objectives, perceptions and expectations, and
occasionally from very different legal environments.
In the application, each applicant Group must, therefore, provide a
detailed description of its approach to prior informed consent,
intellectual property and the sharing of benefits from ICBG-sponsored
research. Descriptions should encompass both the conduct of
collaborative research activities and the nature of contractual
agreements among the collaborators. The research plan and contractual
agreements among Group members must be designed such that they address
the ICBG "Principles for Access, Intellectual Property and Benefit-
Sharing" detailed in this RFA. Applicants may wish to consult the newly
formed Public Interest Intellectual Property Advisors (PIIPA)
(http://www.piipa.org) for advice in developing their plans.
Prior to receiving an award, locally appropriate evidence of prior
informed consent and formal agreements specifying the rights and
responsibilities of each Group member institution (See Principles for
Access to Genetic Resources, Treatment of Intellectual Property and the
Sharing of Benefits) must be signed and dated by the organizational
official authorized to enter into such arrangements, and must be on file
at the Fogarty International Center. The FIC may issue restricted
awards to allow a Group to complete negotiations or finalize
documentation of informed consent. (See the section "MINIMUM
REQUIREMENTS FOR APPLICATION.") The above applies to all research
carried out under this RFA, including any that may involve U.S.
Government laboratories.
4. Terms and Conditions of Award
The following terms and conditions will be incorporated into the award
statement and provided to the Principal Investigator (Group Leader) at
the time of award. The "Terms and Conditions of Award" described in
this section are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant
administration policy statements.
a) Awardee Rights and Responsibilities
Assistance via Cooperative Agreements differs from that of grants in
that, in addition to programmatic and administrative stewardship
responsibilities, the U.S. Government, in awarding the Cooperative
Agreement, anticipates substantial scientific involvement during
performance of the project. However, the Group must define its
objectives and its approaches to attain these objectives in accord with
its own interests, scientific creativity, capabilities and perceptions.
In this process, Groups are invited to use novel and effective
approaches to the interdependent program areas of drug development,
biodiversity conservation and development of scientific and economic
capacity. The Group must develop the details of the program design
following the guidance given in this RFA. It is the primary
responsibility of the Group Leader to state clearly the objectives of
the Group, to direct the research and other activities stipulated in the
application, and to ensure that the results obtained are properly
disseminated and published. It is anticipated that decisions will be
reached by consensus of the Group under the leadership of the Group
Leader and that the U.S. Government Scientific Coordinator will have the
opportunity to offer input to this process.
Each project is expected to contribute to the achievement of three
classes of benefits: health benefits through the discovery of natural
products which may lead to new pharmacologic agents, benefits in the
understanding and conservation of biological diversity, and enhanced
scientific and economic capacity of the host country. The following
three sections describe responsibilities of the awardee relating to the
realization of these benefits.
i. Drug Discovery
o One principal end product of the ICBG is the identification of
bioactive natural products with potential for biomedical use. Grantees
will actively pursue pre-clinical development of promising leads with
support from the ICBG grant, industrial partners, NIH pre-clinical
contract resources or other means. Additional health-related end
products may include data, methods and local capacity toward development
of botanicals of local importance. Research related to agricultural
agents and other natural product-based materials may be included if the
work requires modest support from the grant.
o Grantee organizations and their domestic and foreign partners retain
custody and rights to all proprietary data and intellectual property
that emerge from their research, as outlined in the section, "Principles
for Access, Intellectual Property and Benefit-sharing." Currently
proposed modifications to NIH rules governing foreign intellectual
property from grants (NIH Guide: NOT-OD-02-039) will not apply to the
ICBG program.
o The Government will retain the option to cross-file or independently
file an application for investigational clinical trial [e.g. an
Investigational New Drug Application (INDA) or an Investigational New
Device] to the United States Food and Drug Administration of any
invention resulting from these Government-supported Cooperative
Agreements. It is the responsibility of the Group Leader to submit to
the U.S. Government Scientific Coordinator, upon request, reports of
data generated by the Group or any of its members required for cross-
filing purposes. Such reports will include background information,
methods, results, and conclusions. They will be subject to approval and
revision by Government staff and may be augmented with test results from
other Government-sponsored projects prior to submission to the
appropriate regulatory agency.
o The awardee will retain custody of and rights to the data.
Significant findings emerging from ICBG-funded research must be
published in a timely fashion in peer-reviewed scientific journals
except in cases in which clear proprietary concerns are present.
Publications or oral presentations of work done under this agreement
will require appropriate acknowledgment of joint support from the NIH,
NSF and the USDA under this RFA.
ii. Biodiversity Conservation
o The primary products of biodiversity conservation efforts should
include:
1) the establishment of spatially explicit biotic inventories and
collections of preserved or living specimens of plants, animals and
microbes; 2)enhanced host country technical capabilities to implement
sustainable resource use policies and programs; and 3) enhancement of
the value of biodiversity to communities affected by conservation
efforts through benefit-sharing activities, educational programs,
sustainable use income opportunities, or other approaches. All projects
focused on biodiversity conservation outcomes must be clearly related to
the other scientific and development objectives of the program.
Isolated or seemingly haphazard efforts must be avoided.
o Projects must comply with all national and international regulations
regarding collection, import/export and use of biological specimens.
All requisite permits for inventory collections and for drug discovery
collections from the relevant government organizations will be procured
in advance of collection activities and copies must be provided to the
Program Director. Requests to collect species that have been declared
threshold or endangered by the Convention on International Trade in
Endangered Species (CITES) must be particularly well-justified, and all
regulations regarding these species must be scrupulously followed.
o Collection of biological materials for inventories, assays, chemical
analyses or commercial development must be conducted with close
attention to the potential impact of collection on natural populations
of target or associated organisms.
o Voucher specimens should be made for all collections. These must be
preserved in a manner suitable to allow subsequent identification and
scientific analysis of the specimens. Specimen collections must be
placed in appropriate depositories, such as major natural history
museums and living organism stock collections. It is especially
important to deposit specimens in the host country in addition to the
United States, and plans for the eventual deposition of all collections
made during the life of the proposed ICBG should be included in the
application.
o Floral and faunal lists and identification keys should be published
in English and in the major language(s) of the host country. When
ethnobiological studies are involved, results should also be published
in the language(s) of the subject population where possible.
o The development of biodiversity databases, such as computerized keys,
inventory lists, and geographic information systems, is strongly
encouraged. Where possible, these databases should be located at the
host country institution where collections from ICBG activities are
deposited. In all cases, the institutions where collections are housed
and organizations with biodiversity management responsibilities in the
host country must have ready access to the data. If these databases are
linked to drug discovery databases with proprietary information,
appropriate attention to security of those data is expected. However,
it is anticipated that drug discovery collections would form only a part
of inventory data and the entirety of the data related to taxonomy and
location of species should be made public via the internet and/or other
publicly available formats, except in extremely unusual and well-
justified cases.
iii. Scientific and Economic Development
o ICBG efforts must provide for both near- and long-term benefits to
the source country and communities from the research process and any
discoveries that emerge from it. It is important to recognize that a
commercially successful pharmaceutical from a given research project is
a relatively rare and much delayed outcome.
o End products of special concern for economic development may include:
1) training targeted to the specific needs of the research program and
the participating country; 2)enhancement of the scientific
infrastructure of the participating country; and 3)identification of
natural products suited for sustainable micro-enterprise development
and/or health promotion in the participating country. Enhanced
technical capacity to evaluate, standardize and sustainably harvest
locally important botanical remedies is one means of integrating these
goals. Scientific and technical support to the national process of
policy formulation for access and benefit-sharing, for regulation of
botanical products, for conservation of nature, or for investments in
research represent other options. Whatever approach is taken, economic
development strategies should be clearly related to the other goals of
the ICBG and should be integrated with these activities.
o ICBGs must present a strategic plan with benchmarks for years one,
four, and ten for the major capacity building, conservation and
development goals of the project. The plan will address sustainability
of initiatives following the end of the grant period (e.g. ten year
benchmarks). The plan is expected to evolve and be updated periodically
during the course of the project.
o Relevant host country governmental, non-governmental and community
organizations should be consulted at the planning stage to ensure that
research and development plans support national and local objectives,
and to identify potential barriers to implementation early on. It is
strongly recommended that Groups hold a public meeting or workshop in
the host country during the very early developmental stage of the
project. Such fora involving individuals from local communities as well
as from university, government, and community organizations in a single
meeting is a valuable means of gaining early feedback on working plans
and broad-based support for future project efforts.
o For projects that will have substantial interactions with indigenous
and local communities, Groups are advised to develop formal, well-
documented consultations with indigenous community leaders and respected
local Non-Governmental Organizations during project planning and
periodically thereafter. In many areas identifying appropriate
representation of indigenous groups for the purposes of ICBG-type
research is difficult, and researchers are advised to make minimal
assumptions in this regard. Seeking the advice or participation of
social scientists and development organizations with local expertise is
also advisable during this process.
o In the enhancement of scientific infrastructure, project managers
must specifically consult with participating country officials to assure
that the enhanced research capabilities can be sustained after
completion of the project, using locally available resources. Equipment
procured will be of U.S. source and origin. Major equipment
procurements that are not from U.S. sources or origins must be justified
in writing and are subject to U.S. Government approval.
o Where information is generated that would be useful to developing
countries in meeting development objectives, such as information useful
in establishing sustainable natural products-based industries or novel
and important approaches to partnership frameworks, such information
will be made available to the Government of the developing country
partners and to the U.S. Government. Moreover, within the application,
a plan to disseminate this information should be developed and
implemented. The dissemination plan may include such elements as
publication of results in appropriate scientific or technical journals,
presentations at conferences, the transfer of relevant information to
agricultural and industrial extension services, and direct publication
and extension efforts by the collaborators.
o In the licensing of a product for advanced development and/or
commercial production, the licensee must be required to use the
participating country and/or communities as the first source of raw or
processed material, subject to the negotiation of mutually acceptable
terms.
b) Nature of U.S. Government Assistance
The U.S. Government shall assist in the activities of the ICBG
principally through the U.S. Government Scientific Coordinator and the
FIC Biodiversity Program Director. Both the Program Director and the
Coordinator are members of the Interagency Technical Advisory Group
(TAG). This body of scientists representing the participating agencies
meets regularly to discuss progress of funded ICBGs and make
recommendations regarding technical, policy and funding issues. The
Program Director shall be the primary Government contact with the Group
Leader for issues relating to program administration, funding and
policy. The Coordinator will be the primary Government contact with the
Group Leader for scientific and technical issues.
The Coordinator and two to four advisors (Advisory Committee) from the
TAG with relevant expertise will be appointed by the Government to
provide assistance to your ICBG. During performance of the award, the
Coordinator may provide appropriate assistance in the design of
activities, in the identification of scientific resources, and in the
collection of materials or information. In all cases, the role of the
Coordinator will be to assist and facilitate, and not to direct
activities.
The U.S. Government Scientific Coordinator, as well as any other Group
member, may assist in research planning; may suggest studies within the
scope of the Group's objectives; may present to the Group findings from
published sources or from grant or contract projects in support of these
suggestions; may participate in the design of project activities and
experiments as agreed to by the Group; and may participate in the
analysis, reporting and publication of results.
When appropriate and with prior knowledge of the Advisory Committee to
the Government Scientific Coordinator, U.S. Government laboratories or
contractor laboratories may be available for training related to the
specific research efforts of the ICBG. Prior written approval from the
laboratory director must be obtained. With the exception of training
provided by the ICBG Global Data Center, funding for this training must
be within the ICBG's approved budget.
The in vitro human cancer cell line screen of the National Cancer
Institute (NCI) will be available for testing of all ICBG materials,
including extracts, either in the form of a primary prescreen or for
confirmatory secondary testing, as appropriate.
The Group is encouraged to utilize NIH contract-based resources to
facilitate development of important lead compounds that are not of
interest to industrial collaborators. The intent is to help grantees
further develop lead agents. It is not anticipated that NIH would
retain any intellectual property rights from the work except as
specified in the "Terms and Conditions of Award, a) Awardee Rights and
Responsibilities." Upon recommendation of the U.S. Government
Scientific Coordinator, and with appropriate prior mutual agreement,
other Institutes of the NIH, including NCI, NHLBI, NIAID, NIGMS, NIMH,
NIDA, NCCAM, may use their contract resources in support of Group
research activities. The following is a list of resources that may be
available. It cannot be assumed that any specific resource will be
provided, and accordingly they should not be included as part of the
application unless formally agreed upon prior to submission, and
documentation of such a commitment is provided with the application.
All compounds and information exchanged between the awardee and the
Government will be governed by confidentiality agreements among the
parties involved. These resources include:
i. Reference compounds for standardization of test systems, as
analytical standards, and for related purposes.
ii. Needed resources such as test materials and research results and
other information that may not otherwise be available to the Group.
iii. Laboratory testing capacity, whenever appropriate and possible, in
the current contract-based pre-clinical therapy-related laboratory
testing programs of several of the participating NIH Institutes. The
Group is expected to provide sufficient test material for such testing.
iv. Searches of government computer databases of materials, chemical
structures and biological activity, if requests for such searches are
sufficiently focused to avoid excessive costs. Information given to an
ICBG will be restricted by any standard confidentiality agreements
between the Government and suppliers of test material to the Government.
v. Experimental animals and other biological resources (e.g. cell
cultures), if available, to Groups whose main research activities do not
require these materials on a regular basis, and if fully justifiable.
Note: in all cases, Groups whose experimental approach involves studies
that require animals must 1) meet all PHS animal protection requirements
(see below), and 2) budget for anticipated associated costs in their
application.
A current list of resources potentially available for project support
through the NIH and other participating agencies will be available
through the FIC ICBG website:
http://www.fic.nih.gov/programs/icbg.html.
These "Terms and Conditions of Award" require that the U.S. Government
Scientific Coordinator approve the following: reports intended for
inclusion in INDAs and Clinical Brochures; redistribution, outside the
ICBG, of biological and chemical materials received from the U.S.
Government; and dissemination of research or project findings resulting
from the use of such materials to assure conformity to existing
confidentiality agreements with suppliers.
c) Data Access and Standards
The Government will have access to all data generated under this
Cooperative Agreement and will periodically review the data for program
management purposes. The Government may elect, following consultation
with grantees, to publish summary results from program activities to
fulfill its responsibility to disseminate lessons learned from the
program.
Minimum data quality and format standards will be developed in
consultation with awardees. Awardees will be required to maintain an
integrated relational database of inventory and drug discovery
activities and to provide these data on a regular basis to an ICBG
Global Data Center serving all groups. Grantee data will be treated as
proprietary and confidential except where otherwise agreed upon between
the Government and the Awardees.
d) Collaborative Responsibilities
The Group Leader is responsible for organizing meetings of all Group
members, including the Government Scientific Coordinator and the ICBG
Program Director, at least once per year, to review progress, plan and
design research and technical activities, and establish priorities.
In addition, Group Leaders from each ICBG will meet every year at the
NIH Campus to share findings and lessons with each other and the ICBG
Technical Advisory Group. For at least two of these meetings during the
five-year duration of awards under this RFA, all Associate Program
Leaders from each Group and all available TAG members will attend a
joint meeting to share important information, to review the overall
progress of the program and establish future priorities. Applicants
should budget for these meetings from grant funds.
e) Arbitration
Disagreements pertaining to approval by the U.S. Government Scientific
Coordinator on scientific and technical programmatic matters will be
arbitrated by a panel composed of one Group designee, one Government
designee assigned by the Government Scientific Coordinator, and a third
designee with expertise in the relevant area chosen by the other two.
This arbitration procedure in no way affects the awardee's right 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
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:
Joshua Rosenthal, Ph.D.
Deputy Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: rosenthj@mail.nih.gov
o Direct your questions about peer review issues to:
Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7843
Bethesda, MD 20892-7843
Telephone 301-435-1021
Fax: 301-480-1677
Email: duperes@csr.nih.gov
o Direct your questions about financial or grants management matters
to:
Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2C29, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1670
Fax: 301-594-1211
Email: butrumb@mail.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 NIH 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:
Dr. Joshua Rosenthal
Deputy Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: ronsenthj@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance, contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR ICBG (U01) APPLICATIONS: This RFA requires
the submission of a single application for each proposed International
Cooperative Biodiversity Group. Applicants should follow the
instructions given in the Form PHS-398 (Rev. 5/2001) package unless
otherwise indicated in this announcement or in supplemental
instructions. Because of the multi-institutional nature of an ICBG and
the special requirements in this RFA, additional instructions regarding
format and some modifications are given to guide the writing of a
comprehensive application.
The application will be reviewed as a whole; however, each Associate
Program will receive an individual critique. Therefore, the application
should contain separate sections for each Associate Program, preceded by
an integrated Group Plan section. However, it is not necessary to
repeat background information in each Associate Program section. Try to
avoid repetition wherever possible. Note that the Group plan and the
plan for each Associate Program must not exceed 25 pages each.
Applications that exceed the page limit will be returned to the
applicant unread.
a) Group Plan
This section should contain the following portions of the PHS-398: Face
Page; Description, Performance Sites, Key Personnel; Research Grant
Table of Contents, Budget for Entire Period of Proposed Support, and
Research Plan; Checklist. The 25-page limit described in the PHS-398
applies to this Group Plan section.
Complete the FACE PAGE for the application as in a regular research
grant application.
For the Group Plan section, KEY PERSONNEL should list the Associate
Program Leaders for the whole Group. The TABLE OF CONTENTS should
number pages for the entire application consecutively, with the FACE
PAGE as page one.
The BUDGET page in this section (Form Page 5) should reflect the
consolidated TOTAL DIRECT COSTS, by category, of the entire proposed
ICBG. A summary page of the TOTAL DIRECT COSTS, by Associate Program,
by year, must be included on a separate page. The Group Plan section
should also provide, from the applying institution, a Detailed Budget
for the first twelve-month period and a budget for the entire proposed
project period for direct costs for the management and coordination of
Group activities through a Central Operations Office and all travel,
including the cost of annual Group meetings.
Often the various research tasks necessary to reach the Group's goals
may need to be phased in, at least in part, in sequential fashion. For
example, isolation chemistry will not likely begin until samples have
been collected and samples with biologically-active constituents have
been identified and verified. In such cases, the budgets for the
individual Associate Programs should, logically, reflect an appropriate
change in relative emphasis among tasks until an operational steady
state situation is attained. Justification for phase-in budgets also
should be provided.
Applicants must describe, in five pages or less, the progress they have
attained during the planning grant period, including a list of
publications, workshops and any other accomplishments.
Inasmuch as the Group Leader may also function as an Associate Program
Leader for his/her Associate Program, detailed budget information that
duplicates information provided in the section describing the Group
Leader's Associate Program need not be included in the Group Plan
Section.
The RESEARCH PLAN in the GROUP PLAN section should summarize and
synthesize the associate programs to illustrate a coherent Group effort,
e.g., how the projects are mutually reinforcing and how collectively
they will further the goals of the proposed research. This should
include a description of the interrelationships among members of the
Group and organizational charts in accordance with Sections H and I of
this RFA and how the data from the various associate programs involved
in drug discovery and biodiversity inventory will be integrated into a
single relational database. It is important to discuss any prior
collaborative efforts among the investigators as evidence of the ability
to work together in multi-disciplinary and/or international projects.
The Group Plan section should not repeat details that are provided in
the Associate Program sections, however, it should contain any
additional information about the proposed Group Leader or his/her
institution that is evidence of the capability to carry out the
scientific and administrative duties required in this RFA and the
functions of the Central Operations Office.
The Group Plan Section must include the following elements to be
considered responsive to minimum requirements:
i. A statement assuring compliance with the ICBG Program Principles for
Access, Intellectual Property and benefit-sharing detailed in this RFA.
ii. An outline of the steps necessary to achieve prior informed consent
of appropriate host country institutions, communities and individuals to
carry out the proposed research and development activities.
iii. A statement of acceptance of the provisions of "Terms and
Conditions of Award," as described in that section of the RFA.
iv. A plan to assure maintenance of close collaboration and effective
communication among members of the Group.
b) Associate Programs
Each of the Associate Programs, including the Associate Program (if any)
of the proposed Group Leader, should be numbered consecutively (i.e., AP
1, AP 2). Use Form PHS-398 for each Associate Program, but omit the
face page and checklist for the individual program. The 25-page
limitation stipulated in the PHS-398 application package applies to each
of the individual Associate Programs.
Each Associate Program section should begin with its own TITLE PAGE.
The Associate Program Title or Topic, Associate Program Leader, and the
Associate Program number within the group should be at the top of the
page. The TITLE PAGE should also state "International Cooperative
Biodiversity Groups," the overall project title, and the Group Leader at
the bottom of the page. The second page of the PHS-398 should follow
with the abstract ("Description") of the Associate Program and the list
of sites and key personnel.
The TABLE OF CONTENTS (Form Page 3) for each Associate Program section
should be consistent with the GROUP PLAN TABLE OF CONTENTS, and should
be detailed enough to enable reviewers to find specific information
readily.
The remaining parts of the PHS-398, including the budget pages, except
the CHECKLIST for each Associate Program section, should be completed as
in a normal grant application, detailing the proposed work of the
Associate Program, and where relevant, the interactions with other
Associate Programs within the Group.
c) Appendices should follow the Group Plan, except where exclusively
relevant to the activities of one Associate Program and should be listed
individually in the Table of Contents:
i. If internal or external advisory groups will be used in addition to
those specified in this RFA, list their membership and describe their
roles.
ii. Include in one appendix all letters of support from Associate
Program Leaders, Government officials, community leaders, as well as a
list of documents or actions that will be required to fulfill local
institutional and governmental regulations in order to carry out work.
iii. List in a separate table all consultants, both paid and unpaid.
Include a signed letter of agreement from each consultant.
This RFA uses "Just in Time" procedures outlined in the PHS-398
instructions. Questions concerning use of human subjects in research
should be referred to the Office for Human Research Protections of the
Department of Health and Human Services (Telephone: (301) 496-7005,
Office for Human Research Protections, Department of Health and Human
Services, The Tower Building, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852). Questions concerning the use of animal subjects
in research should be referred to the Office of Laboratory Animal
Welfare, National Institutes of Health (Telephone:(301) 594-2289, Office
of Laboratory Animal Welfare, National Institutes of Health, Rockledge
One, Suite 360, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 20892-7982,
for express or hand-delivered mail, use zip code 20817).
MINIMUM REQUIREMENTS FOR APPLICATION
Applications to the International Cooperative Biodiversity Groups must
meet a set of minimum requirements, listed below, in order to be
considered by the peer review panel. These requirements are each
described elsewhere in this RFA and should be addressed in the relevant
portions of the application or as detailed below.
1. Identify a single Group Leader from a U.S. non-profit institution
who will be responsible for the application, for Group research and
technical activities, and for the disbursement of funds in support of
Group activities.
2. Structure the Group to include at least one Associate Program
located within and led by a developing country institution.
3. Identify the Group Leader's institution that will assume legal and
financial responsibility and accountability for the use and disposition
of funds awarded on the basis of this RFA; show availability of
personnel and facilities capable of performing and supporting the
administrative and scientific functions of this ICBG including data
management.
4. Present, for each Associate Program, research, technical approaches,
and budget requirements.
5. Describe the ways in which the Group Leader and the Associate
Program Leaders possess the outstanding scientific and technical skills
and leadership qualities to conduct the proposed research successfully,
including past and current involvement in relevant research programs,
experience, unique competencies, and pertinent publications, peer
recognition or other evidence of accomplishment.
6. Describe how each component Associate Program is required for the
attainment of the Group's objectives and that each has available the
professional and technical personnel to permit efficient and successful
conduct of the proposed research. Documentation should include
curricula vitae for all key personnel involved in the Group.
7. Provide a description of the Group's plan for assuring adequate
protection of intellectual property and sharing of benefits that may
result from Government funding of the proposed work. The application
requires an outline for the basic framework of an agreement or
agreements among all Group members and their institutions, including
local community organization representatives, signed and dated by the
organizational official authorized to enter such arrangements for each
Group member and member institution. The outline or plan need not list
specific terms of agreements, but must indicate correspondence of the
basic plan with relevant national and international laws and the program
principles described in this RFA. Draft agreements among all Group
members must be submitted to the FIC for review prior to award, and
finalized, signed agreements must be in place before any research
materials are collected or transferred among collaborators.
8. Provide a clear, concise plan in narrative and diagrammatic form
that depicts the interrelationships among the members of the Group and
the contribution of each to the fulfillment of Group objectives; provide
an organizational chart of the Group showing the name, organization, and
scientific discipline of the Group Leader and Associate Program Leaders;
provide an organizational chart for each Associate Program within the
Group showing relationships among the key personnel.
9. Provide a plan to assure the maintenance of close collaboration and
effective communication, and exchange and maintenance of data among
members of the Group and between the Group and host country government
and community leaders. The application must include letters of
commitment to the plan by all Associate Program Leaders (place in an
appendix to Group Plan).
10. The application should include a letter of support for the project
from the relevant developing country Government agency(ies),
acknowledging the multiple objectives of the program. The application
must include a list of the documents that will ultimately be necessary
to satisfy local institutional and governmental requirements (place in
an appendix to Group Plan). Copies of all permits and legal documents
and certifications of governmental authorizations required to assure
collaborations must be provided before an award is made.
11. Indicate that all key personnel have the time available for this
project and show for all key professional personnel: 1) title,
identifying number, percentage of effort devoted to the project, direct
costs, and project period of all awarded and pending grants, contracts,
Cooperative Agreements, and industrial commitments regardless of source
of funding; and 2) identify and explain areas of potential scientific
and/or budgetary overlap with active and pending grants, contracts, and
Cooperative Agreements and what support would be relinquished if this
Cooperative Agreement award is made.
12. Describe for each component Associate Program and the Group as a
whole, the facilities available for conduct of the proposed research.
Funds will be provided for alteration or renovation only for facilities
in developing countries under this RFA.
13. Provide a research training plan for each relevant Associate
Program which includes types of training, numbers of long-term trainees,
in-country courses and workshops, if any. Evidence of the facilities to
conduct the training should be included. Costs associated with training
activities must also be specified in the Budget section of the
application.
14. Submit a strategic plan (in the Group Plan section) that outlines
the schedule of activities and expected products of the Group's work
with benchmarks for years one, four and ten of the initiative. The
strategic plan must include not only activities for the funded period
under the ICBG grant (e.g. year ten benchmarks) but plans to provide for
long-term sustainability of segments of the program beyond this period.
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:
http://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 five 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)
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 eight 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 from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the FIC. Incomplete applications will not be
reviewed.
If the application is not responsive to the RFA, NIH staff may contact
the applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
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 National Institutes of Health in accordance
with the review criteria stated below. As part of the initial merit
review, all applications will:
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 written critique
o Receive a second level review by the FIC Advisory Board
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application's overall score, weighting them as
appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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? What is the potential impact of the
project on human health, biodiversity conservation, and sustainable
economic opportunities? Will it measurably advance the scientific
capacity of the host country(ies)?
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? Is there likely to be strong
multidisciplinary cooperation among associate programs and potential for
synergy of activities toward the three goals of the program? Are the
plans for intra-Group communication and data-sharing adequate and do
they account for the special requirements of an international
collaboration? Is the plan to build capacity for biodiversity and
biomedical research adequate and appropriate to local and international
scientific needs beyond the specific targets of the proposed work? Is
the extent and level of developing country participation and
documentation of local community involvement and support appropriate and
sufficient?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
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?
Do the Principal Investigator and the members of the group have the
experience, competence, commitment, and time availability? Do the
Principal Investigator and the Associate Program leaders have a track
record of success relevant to this RFA and demonstrated past support
from NIH, NSF or other sources? Does the Principal Investigator have
the ability and commitment, as measured by previous success, to
cooperate with and train developing country nationals in the scientific
and technical disciplines considered critical to meeting the objectives
of the proposed programs? Does the Group Leader have administrative
experience and competence in the development, implementation, and
management of comprehensive domestic and international research programs
and has the Group Leader's institution demonstrated commitment to
support these activities?
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 the unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support? Does the proposed work take place in
a country or region that is a priority for biodiversity conservation and
economic development efforts, and does it take advantage of the unique
biological and intellectual resources of that country or region? Are
the physical facilities and research and training resources available
adequate? Is there sufficient evidence of the availability and
competence of the institutions involved to carry out all required legal,
fiscal and policy responsibilities?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o 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.)
o 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 included in the
section on Federal Citations, below)
ADDITIONAL REVIEW CONSIDERATIONS
o DATA SHARING: The scientific review group will evaluate the adequacy
of the proposed plans for sharing and access to data. Comments on the
plan and any concerns will be presented in an administrative note in the
Summary Statement.
NIH policy requires that the grant awardee recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (see the
NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and
http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators
responding to this funding opportunity should include a sharing research
resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan will be considered by the
Program staff of the funding organization when making recommendations
about funding applications. Program staff may negotiate modifications
or the data and resource sharing plans with the Principal Investigator
before recommending funding of an application. The final version of the
data and resource sharing plans negotiated by both will become as part
of the administrative review of each non-competing Grant Progress Report
(PHS 2590).
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
o OTHER REVIEW CRITERIA: Progress/accomplishments made during the term
of the previous ICBG planning grant.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 18, 2005
Application Receipt Date: February 15, 2005
Peer Review Date: May 2005
Council Review: August 2005
Earliest Anticipated Start Date: September 15, 2005
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, including unique research opportunities,
geographic considerations, and interests of co-funding organizations.
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.
SHARING RESEARCH DATA: Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are expected
to include a plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing. Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the reasonableness of the data sharing plan, or the
rationale for not sharing research data, but will not factor the plan
into the determination of the scientific merit of the priority score.
SHARING OF MODEL ORGANISMS: NIH is committed to support efforts that
encourage sharing of important research resources including the sharing
of model organisms for biomedical research (see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html).
At the same time, the NIH recognizes the rights of grantees and
contractors to elect and retain title to subject inventions developed
with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants
Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All
investigators submitting an NIH application or contract proposal,
beginning with the October 1, 2004 receipt date, are expected to include
in the application/proposal a description of a specific plan for sharing
and distributing unique model organism research resources generated
using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the
resources developed with public funding. The inclusion of a model
organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of
model organisms is anticipated.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to00 provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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).
Decisions about applicability and implementation of the Privacy Rule
reside with the research and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can
be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-
025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This 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 287b) and under Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or
early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from
qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an
important component of NIH's efforts to recruit and retain the next
generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note
that an NIH grant is not required for eligibility and concurrent career
award and LRP applications are encouraged. The periods of career award
and LRP award may overlap providing the LRP recipient with the required
commitment of time and effort, as LRP awardees must commit at least 50%
of their time (at least 20 hours per week based on a 40 hour week) for
two years to the research. For further information, please see
http://www.lrp.nih.gov/.
PRINCIPLES FOR ACCESSING GENETIC RESOURCES, THE TREATMENT OF
INTELLECTUAL PROPERTY AND THE SHARING OF BENEFITS ASSOCIATED WITH ICBG-
SPONSORED RESEARCH
In developing both research plans and intellectual property agreements,
it is important that all involved understand the differences between
patent coverage and benefit-sharing agreements. While legal protection
of the right to commercialize an invention is generally accomplished
through the patent system, agreements among collaborators are generally
required to designate the terms of partnerships including, among other
things, the licensing of an invention and the sharing of any financial
or other benefits that accrue from it.
The conduct of ICBG-sponsored research and the agreements among the
collaborators must address the following principles to be eligible for
funding.
1. Disclosure to and informed consent of host country stakeholders
a) Plans to collect samples for drug discovery should be vetted with
the national government authorities of the host country and with any
other national or local organizations they, you or your partners deem
appropriate at the earliest stage of planning and once again, formally,
before any collections take place.
b) Where national governments do not have clear regulations to guide
informed consent procedures, activities should follow a two phase
approach to distinguish basic and commercial research. Basic research
intended primarily for publication, including collecting and analyzing
biodiversity, as well as bioassay and chemistry work, may be considered
"basic" research. If, at any time, researchers intend to file a patent
application based on this work or to send a sample for testing to an
industrial partner, the research immediately enters the commercial realm
and must follow all the requisite permit and contract standards.
c) Arrangements for the use of traditional knowledge or the collection
of samples from the lands of local peoples should be based upon full
disclosure and informed consent of those peoples. Under best practices
such arrangements develop as a partnership with early and ongoing full
participation of appropriate community representatives in project
design.
d) Indigenous concepts of intellectual property should be respected.
If, for instance, cooperating indigenous groups, on the basis of
religious or other concerns, object to specific uses, widespread
dissemination or other treatments of the knowledge they provide, these
concerns should be respected in the conduct of ICBG projects.
e) The process of disclosure and informed consent should be as
inclusive and formal as is possible and culturally appropriate. The
best practice is the development of written agreements with a community
following complete and formal mutual agreement on the Group's goals and
methods. Presentations by scientists to host country stakeholders
should provide realistic descriptions of the type, amounts and
probabilities of benefits, as well as any costs or risks that may accrue
to cooperating communities or organizations. Arrangements with
individuals who cooperate or provide information should be based upon
prior community-level agreements whenever possible or appropriate.
2. Clear designation of the rights and responsibilities of all
partners.
a) This is principally done through the design of adequate contractual
agreements. Agreements should be among all collaborating organizations,
whether or not they are recipients of government funds. These may
include commercial drug developers, source country and U.S. research
institutions, and indigenous and local peoples whose resources,
biological or intellectual, are utilized in the research process.
b) It is strongly recommended that all parties to agreements have
separate, competent legal counsel to represent their interests.
c) Useful contractual tools for the designation of rights and
responsibilities include material transfer agreements, research and
development agreements, license options agreements, know-how licenses,
benefit-sharing agreements, and structured trust funds.
d) Unless stipulated otherwise in agreements among source country
institutions and their collaborators, biological samples and associated
information collected under ICBG-sponsored research is the property of
the source country institutions. The Government retains "march-in"
rights to require licensing if the inventing organization(s) fail to
pursue development of the process or invention, as described in the
"Terms and Conditions of Award."
e) The ownership and compensation terms of first generation and
subsequent inventions based upon a lead discovered in ICBG work should
be clearly stipulated in agreements.
f) Agreements should specify that the basic goals of the collaboration
include drug discovery, economic opportunities, and the conservation and
sustainable use of biological diversity.
g) Agreements should also indicate how a sustainable source of
materials for follow-up analysis of a lead compound will be developed,
and should preferentially use the participating country and/or
communities as the first source of raw or processed materials.
3. Protection of inventions using patents or other legal mechanisms.
a) Non-profit organizations (including universities) and small business
firms retain the rights to any patents resulting from U.S. Government
contracts, grants, or Cooperative Agreements. PL 96-517, through
regulation, extends to businesses of any size the first option to the
ownership of rights to inventions made in the performance of a
federally-funded contract, grant, or Cooperative Agreement. All group
members, therefore, including businesses of any size, might be full
partners in the research of the Group and in rights to file patents for
any inventions resulting therefrom as specified in the Group's research
agreement(s). This includes communities organized into or represented
by an appropriate legal entity.
b) The specific intellectual property arrangements among the
institutions may vary and could include joint patent ownership,
exclusive licensing arrangements, etc. Valuable intellectual resources
that cannot or will not be patented, such as novel assays or traditional
medicinal techniques, may require alternative protection methods, such
as trade secrets. Applicants are encouraged to develop an arrangement
that best suits the particular circumstances of their Group.
4. Sharing of benefits with the appropriate source country parties.
a) Equitable distribution of benefits should accrue to all those who
contribute to a commercialized product, whether they are members of the
consortium or not, including research institutions and local or
indigenous people who provide useful traditional knowledge.
b) Benefits should flow back to the area in which the source plant,
animal or microorganism was found, in such a way that they at least
indirectly promote conservation of biological diversity.
c) The selection of beneficiaries must be justified in terms of program
goals, as well as local and international laws and customs.
d) Benefits should be structured such that they are appropriate to the
needs of the communities and the resources of the other collaborators.
For example, trust funds managed by a community or community-project
board may be more effective in support of conservation and health or
education services than cash payments to a single individual or
authority. Note that direct cash compensation may even have injurious
effects on non-money economies.
e) Ideally, compensation begins flowing early in the collaboration
through initial payments, training, equipment or services, to provide
near-term conservation incentives.
5. Information flow that balances proprietary, collaborative and public
needs.
a) Agreements and research plans should anticipate the tension between
the traditional scientific ethic of public access to information,
including publication of results, and the understandable desire of
indigenous or commercial partners for confidentiality of information
with potential commercial value, pending protection through patenting or
other means.
b) Sharing of information among collaborating organizations should be
an ongoing and regular process and should be as complete as possible to
maximize efficiency of research and equity in partnerships while
recognizing the proprietary concerns of those partners. Reporting back
to collaborating communities, where relevant, on significant project
developments should be a regular and expected component of the project.
6. Respect for and compliance with relevant national and international
laws, conventions and other standards.
a) Relevant international conventions, such as the United Nations
Convention on Biological Diversity and national laws regarding study,
use and commercialization of chemical, biological and cultural
resources, should be observed rigorously in the development of
agreements and the conduct of research.
b) An essential goal of this program is to develop models for
sustainable and equitable commercial use of biodiversity-rich
ecosystems. As such, ICBG research agreements and activities should,
wherever possible, go beyond the minimum legal standards regarding
international research collaborations, looking to best practices and
other standards for guidance.
DEFINITIONS
ADVISORY COMMITTEE: A subset of two or more U.S. Government scientific
advisers from the Technical Advisory Group (TAG) to assist the work of
the Group by providing advice and assistance and through the Scientific
Coordinator (Committee Chair), to the Group. The Advisory Committee
assists in such matters as reviewing the Group's progress reports and
suggesting mid-course corrections and future directions for the Group.
The Advisory Committee assembled for each Group is determined by the
TAG. Each committee, including the Scientific Coordinator, attends
groups meetings, where possible, meets separately at least once per
year, and maintains ongoing communication regarding group progress.
ASSOCIATE PROGRAM: A component of the overall Group with a separate,
detailed program plan and budget, that brings to the Group a unique
resource, capability or expertise.
ASSOCIATE PROGRAM LEADER: The director of one of the Associate Programs
of the ICBG.
BOTANICAL: A preparation of plant-based materials used as a form of
healthcare in its whole or extracted form, including various chemical
constituents, rather than as a single isolated compound. For the
purposes of this RFA, botanicals include "phytomedicines" and may also
include preparations of non-plant biological materials used similarly
but derived from terrestrial or marine sources including fungal,
bacterial or animal origin.
CENTRAL OPERATIONS OFFICE: An administrative unit located at the Group
Leader's institution, which is responsible for coordinating and/or
providing administrative support for all Group activities including
budgets from the Group's associate programs.
COOPERATIVE AGREEMENT: An assistance mechanism in which substantial
Government scientific and programmatic involvement with the recipient is
anticipated during performance of the planned activity.
CONTRACTUAL AGREEMENT: Any formal written agreement negotiated among
participating institutions in an ICBG, or between the ICBG and other
organizations, that stipulates the rights and responsibilities of the
parties with respect to the research process, the access to genetic
resources, treatment of intellectual property and the sharing of
benefits.
DEVELOPING COUNTRY: Low- and middle-income countries as listed at:
http://www.worldbank.org/data/countryclass/classgroups.htm. Note that
this economic criterion is a minimal criterion of eligibility. High
indices of biodiversity and other scientific features of potential host
country sites that enable ICBG research and development activities are
an important part of the peer review. If you have questions about the
eligibility or competitiveness of a given country or region you are
encouraged to contact program staff.
FIC BIODIVERSITY PROGRAM DIRECTOR: A representative of the Fogarty
International Center, a member of the TAG, and the Government program
administrator for all funded Groups. The Program Director has lead
responsibility for day-to-day funding and policy decisions in
coordination with the Director of the FIC and the TAG. In conjunction
with the Government Scientific Coordinator for each ICBG, the Program
Director supports the activities of the Groups, where possible, through
policy and program functions.
GROUP LEADER: The Principal Investigator identified in the application
who assembles the ICBG, submits the single application in response to
this RFA, and who is responsible for the performance of the Group as a
whole and of each Associate Program Leader. The Group Leader will
coordinate Group activities both scientifically and administratively
and, in addition, may lead one of the Associate Programs of the Group.
The Group Leader's institution is legally and fiscally accountable for
the disbursement of funds awarded. The Group Leader's institution must
be a not-for-profit institution in the US.
INTERNATIONAL COOPERATIVE BIODIVERSITY GROUP: A consortium of Associate
Programs, at least one of which is located in a developing country
institution, representing diverse scientific disciplines and
organizations which join together under guidance and direction of a
single Group Leader (Principal Investigator) and which function as a
unit with a common goal: to promote, through multidisciplinary
approaches, drug development, biodiversity conservation, and sustainable
scientific and economic development. In this RFA, the terms
International Cooperative Biodiversity Group, ICBG, and "Group" are used
synonymously.
NATURAL PRODUCT: In the context of the ICBG, a term used broadly to
encompass any naturally occurring bioactive agent selected for pre-
clinical evaluation against a disease or for another medical,
agricultural, cosmetic or industrial need. This, of course, excludes
materials which are synthesized de novo, as well as any semi-synthetic
derivatives which do not require the collection of material from nature.
PATENTABLE INVENTION: Any new and useful process, machine, manufacture
or composition of matter, or any new and useful improvements thereof, as
defined under the U.S. Patent Statute (35 USC 101).
TECHNICAL ADVISORY GROUP (TAG): A committee of advisors with relevant
expertise from the Participating Agencies and Institutes, including the
Director of the Fogarty International Center (FIC). The TAG reviews
applications to make funding recommendations following the initial peer
review, and meets several times per year, as necessary, to review
developments in the ICBG program as a whole and progress of individual
Groups.
U.S. GOVERNMENT SCIENTIFIC COORDINATOR: A representative of the TAG
who assists a specific ICBG, attends Group meetings, interacts
scientifically with the Group, and facilitates the role of the
Government as a participant in the Group. The U.S. Government
Scientific Coordinator serves as the chair of his or her respective
Advisory Committee.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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