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 301/435-0714, Email:  GrantsInfo@nih.gov.

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:  barbara_sina@nih.gov

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:  dayc@csr.nih.gov

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:  butrumb@mail.nih.gov

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:  smoldin@mail.nih.gov

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:  harrisje@mail.nih.gov

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:  velazqu1@niehs.nih.gov

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:  szakhari@niaaa.nih.gov

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:  finkelsr@ninds.nih.gov

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:  jm522n@nih.gov

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:  jp183r@nih.gov

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.


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