GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01)

RELEASE DATE:  January 29, 2002

RFA:  RFA-TW-02-002

PARTICIPATING INSTITUTES AND CENTERS (ICs):

Fogarty International Center (FIC)
 (http://www.nih.gov/fic/)
Office of Dietary Supplements (ODS)
 (http://ods.od.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)

LETTER OF INTENT RECEIPT DATE:  March 22, 2002
APPLICATION RECEIPT DATE:       April 19, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations:

PURPOSE OF THIS RFA

This RFA is intended to promote productive re-entry of NIH-trained foreign 
investigators into their home countries as part of a broader program to 
enhance the scientific research infrastructure in developing countries, to 
stimulate research on a wide variety of high priority health-related issues 
in these countries, and to advance NIH efforts to address health issues of 
global import.  

The specific goal of this initiative is to provide funding opportunities upon 
return home for the increasing pool of foreign biomedical and behavioral 
scientists, clinical investigators, nurses, and other health professionals 
with state-of-the-art knowledge of research methods to advance critical 
issues in global health when they return home.  Upon completion of their 
research experiences using this grant mechanism, developing country 
participants supported by this RFA are expected to continue to pursue 
independent and productive careers, including expert training and 
consultation and/or research of biomedical issues within their 
home institutions.  

RESEARCH OBJECTIVES  

As a part of its global health initiative of the Department of Health and 
Human Services, the National Institutes of Health (NIH), led by the Fogarty 
International Center (FIC), in partnership with Office of Dietary Supplements 
(ODS), the National Eye Institute (NEI), the Office of Research on Women's 
Health (ORWH), the National Institute of Neurological Disorders and Stroke 
(NINDS), the National Institute on Aging (NIA), the Office of Behavioral and 
Social Science Research (OBSSR), the National Institute of Environmental 
Health Sciences (NIEHS), and the National Institute of Mental Health (NIMH), 
invites applications from current foreign investigator trainees, and former 
trainees that have returned to their home country in the last three years, to 
support research projects in their home countries.  Eligible trainees include 
trainees from FIC-supported international training programs (in those using 
the D43 and other training mechanisms) and through the NIH Visiting Program, 
with an emphasis on Visiting Fellows.  Current Visiting Fellows are 
particularly encouraged to apply as they prepare to return home.  Eligibility 
of intramural trainees is restricted to those from Institutes that are 
partners on this RFA, or (with FIC pre-approval) candidates of interest to 
ODS, ORWH or OBSSR.

The NIH has made a significant investment in training biomedical and 
behavioral researchers through various programs.  For example, the NIH 
Visiting Program hosts more than 1,600 junior scientists from almost 100 
countries for periods of one to five years.  Training received at NIH is 
critical as they develop independent research careers.  In addition, through 
the NIH D43 and other (with pre-approval) training and capacity-building 
grant mechanisms, hundreds of researchers receive training in academic 
institutions all across the United States in a range of medical research 
areas critical to advancing global health.
As junior scientists complete their training programs in the U.S., many 
encounter obstacles in identifying continuing support to further their 
research studies in their home countries.  This program provides 
opportunities for junior foreign scientists to compete for funds through a 
peer-reviewed process and as a critical adjunct to further promising 
independent research of benefit to their home countries and the world.  
As women scientists may meet these obstacles even more than men, women 
scientists are especially encouraged to apply for these re-entry grants.
The proposed research topics to be supported through this program are 
targeted to the research interests of the collaborating NIH Institutes and 
Centers, and, additionally, should primarily focus on health and healthcare 
problems of high priority in the investigator's home country and that have 
global import.  It is, however, expected that the research topics will be 
diverse.  Research on issues related to women's health, including studies on 
gender differences in disease onset and progression, identification of 
behavioral strategies that are effective in encouraging healthy lifestyles in 
young girls, and studies that address diseases that are of higher incidence 
or have a particular significance to women than men, including infectious 
diseases, lupus, multiple sclerosis and depression, are particularly 
encouraged.  Also encouraged is research focused on the behavioral and social 
determinants and consequences of health.  All research must be carried out in 
accordance with the relevant NIH and U.S. Government regulations and aspects 
of the ethical, legal and social principles guiding the responsible conduct 
of research in developing countries, particularly related to scientific 
integrity and the protection of the interests of research participants.  
Applicants are encouraged to review the relevant informative areas of the 
OHRP web site (http://www.hhs.gov/ohrp/).
This RFA contributes to the FIC mission and to the broad NIH initiative to 
reduce health disparities among nations by strengthening research in 
developing countries, makes possible the continuation of research activities 
of recently trained international health and health care researchers, and 
maximizes the investment that the NIH has already made in these trainees.  
The FIC recognizes that highly trained individuals from a number of 
disciplines are needed to provide guidance to the research community on 
medical and ethical questions that arise during the conduct of research in 
settings where cultural differences may be relevant.  It is expected that 
such advanced training will enhance the career development of individuals in 
developing countries, will further strengthen collaboration between the 
awardees and their former U.S. scientific mentors, and will help to 
strengthen biomedical and behavioral research expertise at their 
home institutions. 

MECHANISM OF SUPPORT

This RFA will use the NIH Research Project Grant (R01) mechanism using the 
modular grant format.  If an application has a significant collaboration with 
a NIH intramural laboratory, the application will be converted to the 
cooperative agreement (U01) mechanism and awarded as a cooperative agreement.

This RFA is issued for fiscal year 2002.  FIC and our NIH partners expect 
that a similar RFA will be issued for the next several years, depending on 
the availability of funds.  Applications submitted in response to this RFA 
may have a project period from three to five years.  A project period of 
three years is the minimum amount of time that is acceptable.

An applicant can request up to two modules of $25,000 each, or total direct 
costs of $50,000 per year, plus Facilities and Administrative (F&A) costs up 
to a maximum of eight percent for a foreign institution.  The PI is expected 
to devote at least 50 percent of his/her total effort to this project.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.

Any future unsolicited competing continuation applications based on this 
project will compete with all investigator-initiated applications. 

FUNDS AVAILABLE

The participating ICs intend to commit approximately $1 million in FY 2002 to 
fund up to 18 new grants in response to this RFA.  An applicant may request a 
project period from three to five years and a budget of direct costs of up to 
$50,000 per year.  The PI is expected to devote at least 50 percent of 
his/her total effort to this project. Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of the ICs provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.  Grants, once 
awarded, are not transferable to another Principal Investigator and may not 
be transferred to another foreign institution.  The earliest anticipated 
award date is September 30, 2002.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your foreign institution has any of the 
following characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of state and local government of developing countries
o  Faith-based organizations

Only foreign institutions from developing countries are eligible to apply.  
For the purpose of this RFA, the following geographic regions or countries 
could be represented in the final award pool:  North Africa, West Africa, 
East Africa, Central Africa, Southern Africa, Russia, the Newly Independent 
States (NIS), Eastern Europe, the Middle East (except Israel), India, Asia 
(except Japan, Singapore, South Korea, and Taiwan), the Pacific Islands 
region (except Australia and New Zealand), Latin America, and the Caribbean.

INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups, as well as individuals with disabilities, are always 
encouraged to apply for NIH programs.

Only applicants from developing countries are eligible to apply.  For the 
purpose of this RFA, the following geographic regions or countries could be 
represented in the final award pool:  North Africa, West Africa, East Africa, 
Central Africa, Southern Africa, Russia, the Newly Independent States (NIS), 
Eastern Europe, the Middle East (except Israel), India, Asia (except Japan, 
Singapore, South Korea, and Taiwan), the Pacific Islands region (except 
Australia and New Zealand), Latin America, and the Caribbean.

Applications may be submitted by investigators who have recently completed 
(within three years of the receipt date in this RFA), or who are in the 
process of completing, a training program under the NIH D43 or other 
international training and capacity-building grant mechanism (with pre-
approval from FIC staff), or who have completed or are presently completing 
an appointment in the NIH intramural research program as a Visiting Fellow in 
an NIH intramural laboratory of a partner Institute or Center for this RFA.  
Under extraordinary circumstances, on a case-by-case basis with FIC staff 
pre-approval, consideration may be made for previous trainees who have 
completed such training within three to five years of the receipt date of 
this RFA.  Applicants should expect to return to their home country as a 
condition of this award since the research to be supported must be carried 
out in their home country and the award will be made to their home 
institution on their behalf.  Therefore, the application must be submitted by 
the institution to which the applicant has returned or will be returning.

Eligibility of intramural trainees is restricted to those from Institutes 
that are partners on this RFA, or (with FIC pre-approval) candidates of 
interest to ODS, ORWH or OBSSR.

It is expected that the Principal Investigator will have an appointment at an 
academic or other institution in his/her home country and that the 
institution has the capacity to support the research proposed.  One indicator 
of an institution's support is the institution's commitment to pay part of 
the potential awardee's salary.

Applicants are encouraged to develop collaboration with the U.S. institution 
from which they have received or are receiving research training through the 
D43 or other mechanisms, or a comparable U.S. institution/laboratory, in 
order to build on experience, partnership, mentorship and prior investments.  
Intramural laboratories at the NIH are considered appropriate U.S. mentors 
and collaborators in this RFA.  U.S. collaborators should demonstrate how 
this program will support ongoing research collaborations. 

The NIH intramural researcher must have pre-approval of the Associate 
Director for Intramural Research and the Scientific Director from their NIH 
Institute prior to the submission of the grant application.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into four 
areas:  scientific/research, eligibility, peer review, and financial or 
grants management issues.

o  Direct your questions about scientific/research and eligibility issues to:
 
Aron Primack, MD, MA
Fogarty International Center
National Institutes of Health
Bldg. 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
email:  primacka@mail.nih.gov

Direct your questions about review issues to:  

Sandy Warren, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, Room 5134
Bethesda, MD  20852
Tel:  (301) 435-1019
Email:  warrens@csr.nih.gov

Direct your questions about financial or grants management matters to: 

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, Maryland  20892-2220
Telephone:  (301) 496-1670
Fax:  (301) 594-1211
Email:  butrumb@mail.nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit a letter of intent by March 22, 
2002, which includes the following information:  

o  Descriptive title of the proposed research
o  Name, address, and telephone and fax numbers of the Principal Investigator
o  Name of the foreign institution to which the trainee has returned or 
intends to return
o  Names of other key personnel
o  Name and address of the leader of the training program in which the 
trainee has participated or is participating
o  Participating institutions
o  Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.

The Letter of Intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Aron Primack, MD, MA
Fogarty International Center
National Institutes of Health
Bldg. 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
email:  primacka@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

SUPPLEMENTAL INSTRUCTIONS:  Applicants may request up to two modules, or 
$50,000, of direct costs per year and the application must be in modular 
format.  The PI is expected to devote at least 50 percent of his/her total 
effort to this project. The modular grant concept establishes specific 
modules in which direct costs may be requested, as well as a maximum level 
for requested budgets.  Only limited budgetary information is required under 
this approach. 

It is understood that writing an application for such a R01 grant may be 
difficult and time-consuming.  Therefore, it is encouraged that potential 
applicants seek assistance in such grant writing.  Those being trained via 
the D43 grant mechanism should seek such assistance at or from their training 
institutions.  Those within the NIH intramural program should seek such 
training within the NIH framework.  

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES with any questions regarding the adherence to the guidelines of 
their proposed project to the goals of this RFA.

Budget Instructions

Applicants will request direct costs in $25,000 modules, up to a total direct 
cost request of $50,000 per year.  The total direct costs must be requested 
in accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project.  The PI is expected to devote at 
least 50 percent of his/her total effort to this project.  The Principal 
Investigator may only request support of up to 50 percent of his/her effort 
on this project.  The Principal Investigator's salary and any other salaries 
should be commensurate with the salary structure at the applicant institution. 

Other Requirements

o  The applicant should list the date that he/she has or expects to return to 
their home country.

o  For investigators associated with D43 grants and other NIH capacity-
building programs:  include a letter from the U.S. host institution, 
outlining the nature of the future collaborative relationship, and how the 
NIH laboratory or other program supported, and/or will support, a continued 
collaboration with the investigator, using all appropriate resources.

o  For NIH Visiting Fellows:  include a letter from the NIH laboratory chief 
outlining the nature of the collaborative relationship and how the NIH 
laboratory will support a continued collaboration with the investigator, 
using all appropriate resources.  Participation by NIH intramural programs 
requires concurrence by both the scientific directors of the participating 
Institutes and the Deputy Director for Intramural Research of the NIH.  
Eligibility of Visiting Fellows to apply is limited to those from Institutes 
that have agreed to participate in this program.

o  The investigator must describe current or previous training under the D43 
(or other) mechanism or the NIH intramural program.  The applicant must 
provide a brief paragraph providing the grant number, the name and address of 
the NIH mentor or Principal Investigator of the D43 or other eligible grant, 
and a description of the training received.

o  Include two letters of reference relating to the abilities of the 
applicant investigator, specifically indicating the ability to become a 
leader in scientific pursuits.

o  Checklist:  This page should be completed and submitted with the 
application.  Applications submitted by foreign or international institutions 
or applications can request F&A costs up to a maximum of eight percent.  
Please see the web site 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html 
for more information on the allowability of F&A costs for 
foreign and international organizations.  

Applications not conforming to these guidelines will be considered 
unresponsive to this RFA and will be returned without further review.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line two of the face page of the application form 
and the YES box must be marked.  The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH (Do not hand-carry applications):  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  208892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the FIC.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the CSR in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit , generally the top half of the applications under 
review, will be discussed and assigned a priority score
o  Receive a second level review by the FIC Advisory Board.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals 
including the career development of the Principal Investigator.  

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative, but is essential to move 
a field forward.

(1)  SIGNIFICANCE:  Does your study address an important problem and is it 
specifically a priority issue in your home country?  If the aims of your 
application are achieved, how will scientific knowledge be advanced and your 
research career be enhanced?  What will be the effect of these studies on the 
concepts or methods that drive this field?  

(2)  APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider 
alternative tactics?  

(3)  INNOVATION:  Does your project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?  

(4)  INVESTIGATOR:  Are you appropriately trained and well-suited to carry 
out this work?  Is the work proposed appropriate to your experience level as 
the Principal Investigator and other researchers (if any)?  How will this 
award enhance your career development and help you achieve a position of 
scientific leadership in your home country?  Do the letters of support 
document a strong commitment to help develop your career? 

(5)  ENVIRONMENT:  Does the scientific environment, in which your work will 
be done, contribute to the probability of success?  Has your home institution 
made a convincing commitment to you (e.g. to provide a research/academic 
appointment and partial salary support)?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?  
What is the continuing commitment of the U.S. collaborating institution 
(e.g., the institution associated with the NIH D43 award or the NIH 
intramural program laboratory) to further develop your career and 
research interests?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o  INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o  DATA SHARING:  The adequacy of the proposed plan to share data.

o  BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    March 22, 2002
Application Receipt Date:         April 19, 2002
Peer Review Date:                 July 2002
Council Review:                   September 10, 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

Applications will compete with all other recommended applications for 
available funds.  Award criteria that will be used to make award decisions 
include:  

o  Quality of the proposed project, as determined by peer review
o  Availability of funds
o  Geographic balance
o  Programmatic priority 

Awards will not be made until applicants have actually returned to their home 
countries (or other developing countries).  Awards, once made, are not 
transferable to another PI.

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998:  http://grants.nih.gov/grants/guide/notice-files/not98-084.html.

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 clinical research 
projects, unless a clear and compelling justification is provided indicating 
that inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research.  This policy results from the NIH Revitalization 
Act of 1993 (Section 492B of Public Law 103-43). 

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research – Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates:  the use of a NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups, if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.  

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at:  
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy in the NIH Guide for Grants and 
Contracts, June 5, 2000 at:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for Federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned 
without review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e. a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place date collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in a NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  
Because the applications are expected to cover many and varied areas, this 
RFA will probably be related to many priority areas of this activity 
including general public health, cardiovascular disease, diabetes, and 
infectious diseases.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.989, and is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and 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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