and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
INTERNATIONAL COOPERATIVE BIODIVERSITY GROUPS (ICBG)
RELEASE DATE: October 17, 2002
RFA: TW-03-004
Fogarty International Center (FIC)
(http://www.nih.gov/fic)
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 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 Institute on Child Health and Human Development (NICHD)
(http://www.nichd.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/)
LETTER OF INTENT RECEIPT DATE: January 20, 2003
APPLICATION RECEIPT DATE: February 19, 2003
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, the National Science Foundation and the
U.S. Department of Agriculture (hereafter "the Government" or "the
Participating Agencies") invite applications for the establishment or
continuation of "International Cooperative Biodiversity Groups" 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. 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 cancer, HIV-AIDS and its opportunistic
infections, tuberculosis, malaria, and other emerging diseases, mental
disorders of adults and children, drug abuse and cardiovascular and pulmonary
diseases. Applications that propose to work on marine coral reef organisms,
endophytic fungi, extremophilic bacteria and other poorly understood groups
are particularly encouraged. 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 National Institutes of Health (NIH) will
be allocated funds from the National Science Foundation (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 International Cooperative Biodiversity
Groups (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 or
continuation 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 third RFA of the International Cooperative Biodiversity Groups program
represents a maturation of the ten-year-old program and includes several
changes from the previous RFAs, to now include 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
the following URL: http://www.nih.gov/fic/programs/icbg.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 disappearing 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 the recently approved 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, 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 affected local communities
and national institutions, which ultimately will determine the success or
failure of those efforts. Biological resources must benefit local populations
and national institutions 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
cancer, AIDS associated malignancies, HIV/AIDS and associated complications
and co-infections, tuberculosis, malaria, and other emerging infectious
diseases, mental disorders of adults and children, 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 reefs organisms, endophytic fungi,
extremophilic bacteria 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, authenticate 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 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. Incumbent Groups 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 R21 award mechanism for two year PLANNING GRANTS and
the NIH U01 award mechanism (Cooperative Agreement) for COMPREHENSIVE AWARDS
(up to five years).
Planning grants (R21)
Planning grants (R21) will provide support for up to $150,000 per year direct
costs for up to two years for developing the partnership plans, access and
benefit-sharing framework, specific aims, and preliminary data for a project
to compete for a COMPREHENSIVE AWARD. The participating organizations intend
to issue another RFA in approximately two years. It is likely that only
recipients of R21 PLANNING GRANTS will be eligible to submit an application
for COMPREHENSIVE AWARDS under that RFA.
Note that the R21 mechanism is specifically intended to support innovative
ideas where preliminary data, as evidence of feasibility, are sparse or do not
exist. R21 grants are not intended for large-scale undertakings or to support
or supplement ongoing research. Rather, R21-supported projects are intended
to serve as a basis for planning and strengthening future applications for a
COMPREHENSIVE AWARD (U01 Cooperative Agreement). Successful responses to this
solicitation must clearly outline how the work conducted during the two-year
period of this award would inform, enhance, and lead to a longer-term (up to
four-year) research project.
A planning grant application should describe your plan to consolidate
partnerships, permits, contract elements and to develop preliminary data in
preparation for an application for a full award. It must also clearly explain
why the two-year award is necessary to the successful implementation of the
envisioned research project. As an applicant, you will be solely responsible
for planning, directing, and executing the proposed project.
Applications for planning grants should use the modular budget pages available
in the PHS-398 Application forms and described below under SUBMITTING AN
APPLICATION.
Comprehensive awards (U01)
Comprehensive ICBG awards (U01) will support awards of up to $600,000 per year
direct costs for up to five years to carry out the full spectrum of ICBG
research and development activities in this RFA. These awards will use the
NIH U01 cooperative agreement mechanism in which 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.
Applications for Comprehensive Awards are anticipated to exceed $250,000 and
therefore SHOULD NOT USE modular budget formats in the PHS-398 application
form. Supplemental instructions for these applications are below under
SUBMITTING AN APPLICATION.
The anticipated award date is September 1, 2003.
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 parts of the NIH do.
FUNDS AVAILABLE
The participating organizations intend to fund four to six new and/or
competing continuation grants for COMPREHENSIVE AWARDS and up to four PLANNING
GRANTS in response to this RFA. For a COMPREHENSIVE AWARD, an applicant may
request a project period of up to five years and a budget for direct costs of
up to $600,000 per year. For a PLANNING GRANT, an applicant may request a
project period of two years and a budget up to $150,000 direct costs.
PLANNING GRANT recipients that successfully compete for COMPREHENSIVE AWARDS
in response to the anticipated follow-up RFA (September 2004) will be able to
request direct costs of up to $600,000 per year for up to four years.
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 IC(s) 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 Groups that wish to be eligible for funding beyond their
fifth year of support under their current ICBG award 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.nih.gov/fic/programs/icbg.html. That version includes a diagram
representing some possible relationships among scientists that might form an
International Cooperative Biodiversity Group and the relationship to the
Funding agencies. It depicts some of the scientific disciplines that may be
included. No specified number of associate programs should be inferred by
this sample, nor is a requisite inclusion of a particular discipline implied.
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 organization
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Eligible agencies of the U.S. Government
o Domestic
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 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.
The NIH will review ONLY ONE APPLICATION FROM ANY ONE INSTITUTION. Therefore,
you are encouraged to consult within your institution about other individuals
who maybe considering applying before developing one yourself.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with 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 semi-
annual technical reports progress 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
Data Coordinating Center that will be 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, 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 Data and Coordinating 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 Data and Coordinating
Center serving all groups. All grantee data will be treated as proprietary
and confidential except where otherwise indicated by the grantees. The Data
and Coordinating 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 Product 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.
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. The importance of
carefully planned and executed approaches to access and benefit-sharing is a
function of both their integral relationships with the goals of this program
and 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
founded Center for the Management of Intellectual Property
(MIHR)(http://www.mihr.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"). Applications that represent continuation from
previous ICBG awards must also provide updated, revised or new evidence of
prior informed consent and agreements prior to receiving an award. 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, herbaria, and
living organism stock collections. It is especially important to deposit
specimens in the host country, 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, three,
five and ten for the major capacity building, conservation and development
goals of the project. The plan will address sustainability of their
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 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, NIAID, NICHD, 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 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.nih.gov/fic/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 Data and Coordinating 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:
Dr. Joshua Rosenthal
Deputy Director,
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 CENTER DRIVE, MSC 2220
BETHESDA, MD 20892-2220
Telephone: 301-496-1653
FAX: 301-402-0779
Email: joshua_rosenthal@nih.gov
o Direct your questions about peer review issues to:
Dr. Donald Schneider
Center for Scientific Review
Division of Molecular and Cellular Mechanisms
6701 Rockledge Drive, Room 5160
Bethesda, MD 20892-7842
Telephone: 301-435-1727
FAX: 301-480-1988
Email: schneido@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
Bldg. 31, Room B2C29
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 MSC 2220
BETHESDA, MD 20892-2220
Telephone: 301-496-1653
FAX: 301-402-0779
Email: joshua_rosenthal@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
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 MODULAR GRANT APPLICATIONS (R21 PLANNING GRANTS
ONLY): Applications requesting up to $250,000 per year in direct costs must
be submitted in a modular grant format. The modular grant format simplifies
the preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398 (rev.
5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes
step-by-step guidance for preparing modular grants. Additional information on
modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
The research plan of Planning Grant applications must not exceed the 25 page
limit specified in the PHS-398.
SPECIFIC INSTRUCTIONS FOR COMPREHENSIVE AWARD (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, and in addition 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. 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 or Planning Grant 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.
Incumbent Groups must describe, in ten pages or less, the progress they have
attained toward the original goals of their program, including a list of
publications, workshops and any other accomplishments of the Group.
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. A 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 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.
PLANNING GRANTS (R21) and COMPREHENSIVE AWARDS (U01)
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.
COMPREHENSIVE AWARDS ONLY
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, three, five 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 by 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.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an Introduction addressing the previous critique.
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the FIC. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the National Institutes of Health in accordance with the review criteria
stated below. As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the 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 discuss the following aspects
of your application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your 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, you may propose to carry out
important work that by its nature is not innovative but is essential to move a
field forward.
(1) SIGNIFICANCE: What is the potential impact of your project on human
health, biodiversity conservation, and sustainable economic opportunities?
Will it advance scientific knowledge? What will be the effect of these
studies on the concepts or methods that drive this field? Will it measurably
advance the scientific capacity of the host country(ies)?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you 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?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you and your Group appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to your
experience level as the Principal Investigator and to that of other
researchers? Do you and your group have the experience, competence,
commitment, and time availability? Do you and your Associate Program leaders
have a track record of success relevant to this RFA and demonstrated past
support from NIH, NSF or other sources?
Do you 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?
Do you as the Group Leader have administrative experience and competence in
the development, implementation, and management of comprehensive domestic and
international research programs and has your institution demonstrated
commitment to support these activities?
(5) ENVIRONMENT: 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 PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
o OTHER REVIEW CRITERIA: Progress/accomplishments of incumbents made during
the term of the previous ICBG grant, if applicable.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 20, 2003
Application Receipt Date: February 19, 2003
Peer Review Date: May 2003
Council Review: August 2003
Earliest Anticipated Start Date: September 1, 2003
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 and
interests of co-funding organizations.
REQUIRED FEDERAL CITATIONS
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This RFA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.989. Awards are made under authorization
of the Public Health Service Act 42 USC 241 and 287b and administered under
NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
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.
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