and Human Services (HHS)
EXPIRED
INTERNATIONAL COLLABORATIVE GENETICS RESEARCH TRAINING PROGRAM
Release Date: November 19, 2001
RFA: RFA-TW-02-001
Fogarty International Center
(http://www.nih.gov/fic)
National Institute of Mental Health
(http://www.nimh.nih.gov/)
National Institute on Aging
(http://www.nih.gov/nia)
National Institute of Environmental Health Sciences
(http://www.niehs.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism
(http://www.niaaa.nih.gov/)
National Institute of Neurological Disorders and Stroke
(http://www.ninds.nih.gov/)
National Human Genome Research Institute
(http://www.nhgri.nih.gov/)
National Institute on Drug Abuse
(http://www.nida.nih.gov/)
Letter of Intent Receipt Date: January 25, 2002
Application Receipt Date: March 25, 2002
PURPOSE
The Fogarty International Center, in partnership with the National Institute
of Mental Health, National Institute on Aging, National Institute of
Environmental Health Sciences, National Institute on Alcohol Abuse and
Alcoholism, National Institute of Neurological Disorders and Stroke, National
Human Genome Research Institute and National Institute on Drug Abuse, invites
applications from nonprofit, private or public, domestic or international
educational and research institutions in developed countries to establish
research-training programs that contribute to the capacity of developing
country investigators and institutions to conduct human genetics research
relevant to the health needs of the country. Applications are solicited to
create innovative research training programs within existing scientific
collaborations between developed and developing country researchers to begin
to build a critical mass of scientists, health professionals and academics
with human genetics expertise and a sustainable research environment at the
collaborating developing country institution.
The International Collaborative Genetics Research Training programs will
enhance and promote equitable international collaborations between
investigators in the developed world and those in developing countries where
a base level of institutional infrastructure for the advancement of
sustainable genetic science is already established. Each proposed program
should provide opportunities to generate the combined expertise at the
developing country institution that could contribute to the long-term goal of
harnessing new genetic knowledge and skills to diagnose, prevent or
ameliorate morbidity and mortality related to a disease with a significant
genetic component that occurs with substantial public health cost in that
country and is relevant to the sponsoring NIH institutes. Programs should
include training in one or more of the following areas: genetic
epidemiology, population genetics, molecular genetics, clinical genetics,
statistical genetics, and bioinformatics. Expertise should be developed
simultaneously on the ethical, social and legal implications of human
genetics research in each program. The training programs supported will
begin to address and reduce the growing disparity in genetic sciences between
those nations that have been at the forefront of the human genome research
revolution and those with a limited but growing capacity in genetic science
in developing regions of the world.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This Request for
Applications (RFA), International Public Health Genetics Research Training
Program, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign developed country, for-
profit and non-profit public and private organizations, such as universities,
health professional schools, research institutions capable of meeting the
objectives of the RFA. Faith-based organizations are eligible to apply for
these awards.
Applicants must be the principal investigator or project director on an NIH
"parent" research grant from one of the sponsoring NIH institutes in the
human genetics area proposed for training, as outlined in the Research
Training Objectives Section, with at least 18 months of active research
support remaining at the time of application. NIH sponsored research project
grants (R series) or center grants, program project grants or cooperative
agreements (P and U series) from one of the co-sponsoring NIH institutes or
centers qualify as "parent" research grants. Equivalent research grants from
other sources may qualify as "parent" research grants if approved by the FIC
program officer before submission of the application. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
Principal Investigators.
The applicant training institution must demonstrate either an ongoing
collaborative research relationship or high potential for development of
collaborative research with the human genetics researcher named as the
primary foreign collaborator from a single institution. The foreign
collaborators should be from Africa, Russia and Eastern Europe, Asia (except
Japan, Singapore, South Korea and Taiwan), the Pacific Island region (except
Australia and New Zealand), the Middle East (except Israel), Latin America
and the Caribbean. The primary foreign collaborator must either hold a full
time faculty research position or should have a full-time faculty position
with a strong research commitment. The individual may be based at a public
or private university, health professional school or research institution
that will allow him or her adequate time and provide appropriate facilities
and resources to participate in the proposed human genetics research training
program.
RESEARCH TRAINING OBJECTIVES
Background
The exploration of molecular mechanisms and widespread use of genetic
methodology is rapidly becoming a fundamental component of biomedical
research globally. Due to the rapid pace and expense of human genome
research, however, the disparity in genetic science capabilities continues to
widen between the developed and developing world. If the power and promise
of human genome research to improve health is to come to fruition for most of
the world"s population, it is essential for biomedical researchers and health
professionals in developing countries to:
1) better understand how these scientific advances might be utilized to
diagnose, prevent or ameliorate infectious and chronic diseases prevalent in
their countries,
2) participate fully in human genetics research to meet the health needs of
their country, and
3) guide the conditions under which human genetics research is conducted in
their country.
Low- and middle-income nations suffer over ninety percent of the world"s
burden of premature mortality as measured in lost years of life. These
countries, constituting three-quarters of the world"s population, now share a
double burden: the persistent cluster of infectious diseases and
malnutrition with a growing incidence of chronic disease and disabilities due
to increased life spans and new risk exposures that accompany this
demographic transition. It is essential to integrate advances in the field
of genetics into the conduct of research, medical education and health
services in developing countries, in order to maximize the impact of this
progress on the health of people globally. While pockets of excellence in
research genetics are present in some countries in the developing world, the
numbers of individuals who have the expertise to perform this work are few.
Increasing capacity in terms of both proficiency and numbers of trainees is
essential in order to promote sustainable efforts to address global and local
disease challenges.
A number of middle-income and some low -income developing countries support
ongoing human genetics research efforts and some include basic medical
genetics services. Studies suggest that developing countries that attain an
infant mortality rate of 50/1000 live births are those able to initiate
genetics services within their health care systems. With limited resources,
and scientific infrastructure, however, developing country geneticists have
few opportunities to work in collaboration with colleagues abroad or with
primary health care professionals in their own countries. In addition, in
many settings, insufficient attention is given to the legal, social and
ethical protections for the conduct of international genetic research. As
U.S. scientists and their counterparts around the world work to incorporate
genetics technologies into sustainable and collaborative research
partnerships, a range of activities should be supported in developing country
institutions.
Training Objectives
It is expected that each human genetics research-training program supported
will:
o substantially increase the expertise of trainees from developing countries
in human genetics-related research and thereby strengthen sustainable human
genetics research within the developing country institutions by providing a
crucial level of human genetics expertise and building an integrated
biomedical genetics and research training environment for future generations
of developing country scientists and health professionals,
o simultaneously increase trainee expertise in the legal, ethical and social
implications of genetics research. This expertise might include but should
not be limited to issues surrounding informed consent for individuals
participating in genetics research, the role of ethics review committees in
dealing with international genetics research, the cultural implications of
policies related to effectively maintaining privacy and confidentiality of
genetic information, questions raised by the commercialization of the
products from human genetics research (e.g. ownership of tissue and tissue-
derived products, patents, copyrights, and accessibility of data and
material),
o expand collaborative human genetics research interactions between
developed and developing country scientists and health professionals at the
collaborating developing country institution,
o generate data for research-based decision making in genetic disease
clinical treatment and prevention programs, for creating guidelines and
procedures for conducting human genetics research and for informing national
health care policy in the collaborating developing country, and,
o stress an interdisciplinary approach that integrates behavioral and basic
human genetics research with clinical training and public health priorities.
Examples of research and training priorities include, but are not limited to:
o Application of genetic epidemiologic methods in family-based association
and linkage designs, population-based studies that correlate genetic
variation with disease risk and studies of gene-environment interactions,
o Design and implementation of genetic epidemiologic studies of complex
diseases, including cancer, cardiovascular disease, diabetes, mental
disorders, alcoholism and drug abuse, neurological diseases and asthma, as
well as individual variation in drug response (pharmaco-genomics),
o Assessments of the population impact of gene variation, disease, death and
disability including surveillance systems,
o Development of tools, models and algorithms which could facilitate
assessment, utility and priority for genetic services in developing
countries,
o Assessing the genetic susceptibility to environmental exposures, including
nutritional factors, pollutants, chemical toxins and substance abuse, on the
initiation and progression of disease, or,
o Research on the ethical, legal and social implications of performing human
genetic research (as an adjunct to the other research training).
Priority will be given to programs that include research objectives for the
proposed training related to the creation of low-cost diagnostic methods that
might facilitate the recognition of specific diseases (where applicable)
endemic to a particular country or region, and the development of preventive
or ameliorative treatment options.
The design of human genetics research training programs must demonstrate that
the critical mass of genetics expertise at the collaborating developing
country institution will increase over time. This must include activities,
including research and a support structure to encourage trainees to return to
their home countries on completion of training. In addition, since genetics
is a multidisciplinary field, in order to build a critical mass of genetics
expertise at the developing country institution it is expected that trainees
supported in each program will represent diverse academic backgrounds.
Trainees may include pre- and post-doctoral behavioral or biomedical
scientists, physicians, or individuals from a variety of other academic
disciplines.
Training Plan
1. Applicants should design a training plan that attempts to fill specific
gaps in human genetics research expertise and expertise in the ethical, legal
and social implications of this research at the collaborating developing
country institution. The end result should be a critical mass of scientists
and health professionals who will be able to conduct genetic research,
understand the patho-physiology and prevent or treat a high priority disease
with a genetic component in their country while simultaneously addressing the
ethical, legal and social issues of associated with these activities.
Proposals may incorporate a wide range of long- or short-term research
training opportunities or a mixture of training possibilities that can be
offered to a wide range of possible developing country participants. The
purpose will be to achieve the creation of or expansion to a scientifically
autonomous and sustainable human genetics research group capable of equal
partnership in international collaborative efforts. A proposed training plan
should include developed country grantee institution-based research training.
However, applicants are also strongly encouraged to provide some support and
mentored research training that will be conducted at the trainees" home
institution in the developing country. This should take place to the
greatest extent possible in order to promote sustainable and ongoing
collaborative research once the training is complete. Applicants are also
strongly encouraged to include women and developing country ethnic minorities
as trainees.
2. Long-term training (usually a minimum of two years) may include studies
leading to an advanced degree or a mentored post-advanced degree experience.
Applicants should describe how the long-term training proposed would combine
the acquisition of specific expertise to successfully answer a hypothesis-
based human genetic research question with the opportunity to acquire
multidisciplinary knowledge about the biomedical and public health impact and
the related ethical, legal and social implications of performing human
genetics research to the greatest extent possible. Long-term training should
include academic genetics courses taken at the grantee institution, as well
as instruction in the responsible conduct of research, laboratory safety,
computational biology, bioinformatics, technical writing and English as a
second language, if necessary.
3. Applicants are expected to develop, promote and facilitate short-term
training opportunities targeted toward the specific genetic research needs of
their developing country collaborators, which will directly enhance their
research capabilities. Short-term training may be offered on such topics as
new laboratory, clinical or behavioral research methods, medical informatics,
genetic counseling, biostatistics, data management and intervention trial
protocol development or in areas which support research efforts such as
institutional review board (IRB) and biosafety procedures, proposal writing
and research administration skills. When a short training course or workshop
is given by one human genetics research training program, it is expected that
this activity will be open to trainees from the other training programs
supported by this RFA to the extent that this is feasible.
Training activities should be coordinated, facilitated and monitored by a
Training Advisory Committee, comprised of grantee institution human genetics
research training program faculty and collaborating developing country
faculty that should meet at least annually.
Types of Training
1. Long-term pre-doctoral training in human genetics research associated
with a human genetics research study leading to a masters or Ph.D. or
equivalent degree for individuals with or without previous research
experience in this field. Research training should relate directly to the
PI"s or a co-investigator"s collaborative research in human genetics at the
developing country institution and may range from two to four years.
2. Long-term post-advanced degree human genetics research associated with a
human genetics research study for developing country scientists and health
professionals including human genetics-related clinical training for
approximately two years duration.
3. Short-term training in either the grantee or developing country
institution of up to four weeks in specific research methods or other
laboratory, clinical, field or administrative skills related to human
genetics research associated with human genetics research study efforts at
the collaborating developing country institution for technicians, health care
professionals and research administrative staff.
4. Short-term training of three to six months duration for individuals with
advanced degrees or health care professionals conducted in the grantee
institution in research methods or other skills, in order to support specific
collaborative human genetics research efforts at the developing country
institution.
5. Advanced research training support ("re-entry" funding), generally for
one to two years, to enable trainees with advanced degrees or health care
professionals to continue mentored human genetics research in their home
country or to initiate independent human genetics research projects related
to ongoing collaborative research at the developing country collaborating
institution.
SPECIAL REQUIREMENTS
Training in the Ethical, Legal and Social Implications of Genetic Research
Applicants must include plans for training in the ethical, legal and social
implications of genetics or genomics research. An award will not be made
unless a description of such training is included. The description should
include the topics, format, faculty participation, instructional materials
and the frequency and duration of the training provided.
Training in Responsible Conduct of Research
Applicants must include plans for training in responsible conduct of research
for long-term trainees and short-term trainees. An award will not be made
unless a description of such training is included. The description should
include the topics, format, faculty participation, instructional materials
and the frequency and duration of the training provided.
Recruitment and Selection Plan
The applicant institution must include a detailed plan describing the
recruitment criteria and selection procedures for trainees and what criteria
will be used to demonstrate that trainees will be reintegrated into their
institution of origin upon return. Degree candidates must meet all entrance
requirements of the grantee degree-granting institution.
If applicable, proposals should describe the mechanism for internal peer
review of re-entry funding applications by a committee composed of grantee
and developing country investigators from participating institution(s) to
support human genetics research projects at the developing country
institution relevant to a genetics-related health problem in that country to
be conducted by returning trainees.
Trainee Tracking System
Applicants should describe their plan to track their trainees with respect to
the short- and long-term impact of both human genetics training and training
in the ethical, legal and social implications related to genetics research
studies on their trainees. Awardees will be required to track and document
the long-term impact of this training program on: (1) the careers of all
trainees, (2) the research capacity at the collaborating developing country
institution from which the trainees originated in the developing world, (3)
positions trainees assume upon completion of training, (4) the contributions
of trainees to future international human genetics research and intervention
trial efforts supported either by NIH or by other granting institutions.
Examples of training impact might include data on (1) how training may have
enabled participants to assume more responsible positions upon returning
home, (2) how collaborations with former trainees resulted in the funding of
human genetics intervention trials or (3) collaborative research projects on
which trainees were either PIs or co-investigators, and (4) research
publications authored by trainees supported by this program. The evaluation
and impact of training resulting from each program will be considered an
important criterion during any recompetition of this RFA.
This RFA is co-sponsored by the World Health Organization. The WHO Genetics
Collaborating Centres http://www.who.int/ncd/hgn/collcentres.htm are eligible
and encouraged to apply for funding under the terms of reference of this RFA.
The WHO will participate in the annual network meeting of awardees, co-
funding agencies and selected international genetics trainees outlined in
this RFA.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) international
research training grant (D43) award mechanism that limits facilities and
administrative (F&A) costs to eight percent of allowable direct costs. F&A
costs up to eight percent can be requested in applications submitted by
foreign institutions or for a subcontract to a foreign institution (see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. The
applicant organization must provide the necessary management for the transfer
of funds and material to the collaborating developing country institution.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. The total project period for
an application submitted in response to this RFA may not exceed five years.
Continued support during this period depends on satisfactory performance as
judged by: annual progress reports, institution visits, participation in
periodic meetings of program directors, career progress of trainees,
continued "parent" research grant funding and the long term development of
sustainable human genetics research capacity at the collaborating developing
country institution. The International Collaborative Genetics Research
Training awards will provide up to $400,000 per year in direct costs for up
to five years of support. The anticipated award date is September 30, 2002.
Although the intent of this RFA is to facilitate long-term scientific
research capacity development at participating developing country
institutions, the FIC and its partners have not determined at this time
whether this solicitation will be continued beyond this RFA.
Allowable costs
All budget items related to trainee participation in the program should be
itemized on the PHS Form 398 NRSA substitute budget pages OO and PP in the
categories indicated in parentheses. All budget items related to faculty
participation in the program should be itemized on the PHS Form 398 budget
pages DD and EE in the categories indicated in parentheses. The totals for
Form 398 budget pages DD and EE should be placed in the "Other" category on
Form 398 NRSA substitute budget pages OO and PP listed as "Totals from budget
pages DD and EE." Form 398 NRSA substitute budget pages OO and PP will be
the composite budget showing all the funds requested.
Trainees Stipends
Trainees (developing country graduate students and post-advanced degree
participants) studying at the developed country grantee institution may be
paid a stipend comparable to their professional experience similar to other
equivalent trainees but not exceeding $45,000 per year in accordance with the
grantee institutional policies while involved in long-term training at the
grantee institution. Applicants may wish to refer to the NRSA stipend levels
described on the web site http://grants.nih.gov/training/nrsa.htm. (NRSA
substitute pages, pre- or postdoctoral stipends)
Salary for Developing Country Faculty
Professional and clerical support staff at the grantee developed country
institution who provide major program administration or extended long-term
training or conduct collaborative research with trainees at the developing
country institution may receive salary and fringe benefits. The total amount
of salary and fringe benefits requested for all grantee faculty may not
exceed $100,000 of direct costs per year in the budget request. The
administrative, training or teaching responsibilities and time commitment for
personnel receiving salary should be thoroughly described in the budget
justification. (Form 398 budget pages, personnel)
Consulting Fees for Developing Country Faculty
Developing country institution faculty who provide major program
administration at the developing country institution or participate in long-
term training of participants at the developing country institution and
grantee faculty or developing country faculty who teach short courses may
receive a consulting fee not to exceed $3,000, in accordance with their
institution"s policies. No more than $40,000 of the direct costs per year
may be requested for consultant fees. The administrative, training or
teaching responsibilities and time commitment for personnel receiving
consulting fees should be thoroughly described. (NRSA substitute pages-
training related expenses)
Tuition, Fees and Insurance for Trainees
Funds for tuition, academic fees and self-only or family medical insurance
for developing country trainees at the grantee institution may be requested.
Programs are encouraged to seek cost sharing arrangements with the grantee
institutions in order to provide reduced tuition for long-term trainees and
tuition-free short courses. (NRSA substitute pages, tuition, fees,
insurance)
Travel for Trainees
o Funds may be requested for one round trip economy class airfare per year
(on U.S. carriers to the maximum extent possible) and local ground
transportation for each long-term developing country trainee to travel to the
grantee institution or for developing country trainees to participate in
short courses or to attend scientific conferences. Funds may also be
requested for developing country trainees and developed country grantees to
present their results at an annual NIH network meeting for all grantees. FIC
program staff must approve additional travel. (NRSA substitute pages,
trainee travel)
o Funds may be requested for per diem and lodging for developing country
trainees to participate in short courses or attend scientific conferences to
present their results. (NRSA substitute pages, trainee travel)
Training related expenses
o Funds to support developing country participant training or research
related costs at the grantee developed country may be requested. (NRSA
substitute pages, training related expenses)
Faculty Travel for Developed Country Staff
o Funds may be requested for one round trip economy airfare per year (on
U.S. carriers to the maximum extent possible) for each grantee faculty
participant providing extended training or participating in collaborative
research to go to the developing country institution or teach short courses
at the developing country institution. FIC staff must approve additional
travel. (PHS 398 pages, travel)
o Funds may be requested for per diem and lodging for grantee faculty to
teach short courses at the developing country institution. (PHS 398 pages,
travel)
o Funds should be requested for airfare, per diem and lodging comparable to
U.S. government rates (see
http://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for the
Program Director and the primary foreign collaborator to attend an annual
network meeting in Bethesda, Maryland. Inclusion of funds for trainees and
other key personnel to attend these meetings is at the request of the
applicant and at the discretion of FIC. (PHS 398 pages, travel)
FUNDS AVAILABLE
It is anticipated that approximately $3,000,000 will be available for the
first year of the initial awards under this program from the FIC and
collaborating partners. The National Institute on Nursing Research will
consider supporting meritorious applications that are relevant to its
mission. This will support an estimated seven to eight new awards. Because
the nature and scope of the research proposed may vary, it is anticipated
that the size of each award may also vary. Although the financial plans of
the FIC and its partners provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
Research Involving Human Subjects
Applicants must inform the FIC program staff that approval of research
protocols involving human subjects has been obtained from U.S. and developing
country ethics review committees registered under Institutional assurances
with the Office of Human Research Protection and required U.S. and foreign
government agencies before research involving human subjects is initiated.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing 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
It is the policy of NIH 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. This was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
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. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) 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.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of the RFA in
response to which the application may be submitted. 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 IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent to Dr. Barbara Sina as listed under
INQUIRIES by the letter of intent receipt date listed in the heading of this
RFA.
APPLICATION PROCEDURES
The PHS 398 research grant application forms (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in
applying for these grants. Applicants should follow the instructions for the
Institutional NRSA found at the end of the PHS 498 instructions to construct
their application. This version of the PHS 398 is available in an
interactive, searchable format. For further assistance contact GrantsInfo,
Telephone 301/710-0267, Email: [email protected].
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.
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)
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.
REVIEW CONSIDERATIONS
Upon receipt, CSR will review applications for completeness and the Fogarty
International Center will review applications for responsiveness. 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 Center for Scientific Review in accordance with the review
criteria stated below. As part of the initial merit review, all applications
will receive a written critique with an assigned priority score, and receive
a second level review by the Fogarty International Center Advisory Board and
other participating ICs.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research training will have a substantial impact on the pursuit of these
goals. Each of these criteria will be addressed and considered in assigning
the overall score, weighting them as appropriate for each application. Note
that the application does not need to be strong in all categories to be
judged likely to have major scientific training and research capacity
building impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important research training that by its
nature is not innovative but is essential to move a field forward.
Applicants must demonstrate specific relevant research support from NIH
(eligible parent grant) or another funding source that will serve as the
foundation for the research training proposed. The scientific evaluation of
each application will include an assessment of linkage between the proposed
training and human genetics research support for the PI and other co-
Investigators and developing country collaborators. Evidence of support for
initiating the proposed human genetics research-training program from the
collaborating developing country institution must be submitted with the
application.
Significance
1. The need for the specific human genetics research training proposed to
fill the identified gaps in human genetics research expertise at the
collaborating developing country institution.
2. The expected public health and scientific contributions related to the
proposed human genetics research training to address major health issues in
the collaborating developing country.
3. The potential to achieve independent and sustainable molecular or
clinical human genetics research capacity at the developing country
institution through the proposed training efforts.
Approach
1. The clarity and feasibility of the research training objectives,
2. Adequacy of the research training plan to achieve the proposed research
training objectives including:
o A trainee recruiting, application and selection process that captures the
most qualified individuals with the appropriate variety of professional
backgrounds from the developing country who could most benefit from the
training proposed (the proposed qualifications of potential candidates should
be well described in terms of academic status and previous accomplishments
and experience),
o The process for determining appropriate trainee skill development plans,
research project participation and mentorship,
o For proposed long-term research training, the adequacy of the training
opportunities to provide a breadth of knowledge in either academic-based
molecular or clinical studies including the legal, ethical and social
implications of human genetics research, while providing disease-specific
human genetics research training to fill recognized gaps in expertise at the
collaborating developing country institution,
o If short courses or non-degree training are proposed, the adequacy of the
mixture of long- and short-term training opportunities within the program as
a means to achieve the overall objectives stated,
o Appropriate assessment and enhancement of background skills through
training in research-related areas such as laboratory safety, technical
writing, statistical methods, good clinical practice, medical informatics,
English as a second language (if necessary), etc, and
o Process for periodic evaluation of short- and long-term trainee progress
and mentoring activities
o Methods to monitor the long-term impact of the human genetics research
training experience on the subsequent careers of the trainees and on the
capacity for human genetics research in the collaborating developing country.
o Plans to include an adequate representation of women and ethnic minorities
in the collaborating developing country among the developing country
trainees.
Innovation
1. Innovation in strategies for trainees to become actively involved in
human genetics laboratory, clinical or public health research, development of
ethical, legal and social guidelines and procedures for conducting human
genetics research or intervention trials conducted at the developing country
institution.
2. Innovation in training strategies to produce a critical mass of
independent human genetics researchers and build a sustainable human genetics
research training environment at the developing country collaborating
institution during the course of the program.
3. Creativity of plans to use modern information technology training to
facilitate trainee access to electronic information resources, distance
learning and collaborative interaction.
Investigators
1. Qualifications of the program director to lead and other faculty from the
grantee and the collaborating developing country to participate as mentors in
the proposed research training program. (The human genetics research
experience and training accomplishments should be included in addition to
Biographical Sketches and Other Support forms for each faculty participant.)
2. Qualifications of the program director or other faculty to provide
research training and, if proposed, mentorship in research on the ethical,
legal and social implications of performing human genetics research in
developing countries.
3. Adequacy of the ongoing collaboration between the grantee and developing
country investigators and their institutions to provide a suitable framework
in which the proposed training will occur.
4. Commitment to building a long-term partnership with the developing
country institutions to build a sustainable genetics research capacity.
Environment
1. The adequacy of the teaching and research facilities and other resources
and the overall training environment at the grantee and developing country
institutions.
2. The grantee and developing country institutional commitments to
international human genetics research and training in the ethical, legal and
social implications related to the genetics research. (Letters of commitment
from the appropriate institutional officials should be included in the
application.)
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The reasonableness of the proposed budget and duration in relation to the
proposed research training program.
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research involving human subjects. Plans for the recruitment and retention
of subjects will also be evaluated.
o The adequacy of the proposed protection for participants, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
Schedule
Letter of Intent Receipt Date: January 25, 2002
Application Receipt Date: March 25, 2002
Peer Review Date: July 2002
Council Review: September 2002
Earliest Anticipated Start Date: September 2002
AWARD CRITERIA
In addition to the outcome of the initial scientific peer review, the
following may also be considered in making funding decisions:
o The extent to which proposed training programs support and complement FIC
and other NIH international human genetics research efforts.
o The availability of funds.
o Program balance among critical research and public health training areas
of emphasis, including the scientific interests of the co-funding NIH
partners in this program.
o The geographic distribution among countries included in applications under
consideration, including the strength of the rationale for a given program to
be carried out in a specific country.
INQUIRIES
Written and telephone inquiries concerning this RFA are strongly encouraged.
The opportunity to clarify any issues or questions from potential applicants
is welcome.
Direct inquiries regarding research/training program issues to:
Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email: [email protected]
Direct inquiries regarding review issues to:
Dr. Camilla Day
Genetics Sciences Integrated Review Group
Center for Scientific Review
6701 Rockledge Drive MSC 7890
Bethesda, MD 20892
Telephone: (301)-435-1037
FAX: 301-480-2067
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Mr. Bruce Butrum
Office of the Director
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1670
FAX: (301) 402-0779
Email: [email protected]
Direct inquiries regarding the specific scientific interests of the
participating NIH Institutes to:
Steven Moldin, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Blvd., Room 7189, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-2037
Fax: (301) 443-9890
Email: [email protected]
Jennifer Harris, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Ave., Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 496-3138
Fax: (301) 402-0051
Email: [email protected]
Jose Velazquez, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 Alexander Drive, P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-4998
Fax: (919) 316-4606
Email: [email protected]
Samir Zakhari, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd., Suite 402
Bethesda, MD 20892-7003
Telephone: (301) 443-0799
Fax: (301) 594-0673
Email: [email protected]
Robert Finkelstein, Ph.D.
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2142
Bethesda, MD 20892-9527
Telephone: (301) 496-5745
Fax: (301) 402-1501
Email: [email protected]
Jean E. McEwen, J.D., Ph.D.
Ehtical, Legal and Social Implications Program
National Human Genome Research Institute
31 Center Drive, Room B2B07
Bethesda, MD 20892-2033
Telephone: (301) 402-4997
Fax: (301) 402-1950
Email: [email protected]
Jonathan Pollack, Ph.D.
Genetics and Molecular Neurobiology Research Branch
National Institute on Drug Abuse
6001 Executive Blvd., Room 4274
Bethesda, MD 20892
Telephone: (301) 435-1309
Fax: (301) 594-6043
Email: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.989, (use appropriate program number). Awards are made under
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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