and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
MINORITY HEALTH AND HEALTH DISPARITIES INTERNATIONAL RESEARCH TRAINING
PROGRAM GRANT
RELEASE DATE: October 14, 2004
RFA Number: RFA-MD-04-004 (Reissued as RFA-MD-08-006)
(This RFA has been amended, see NOT-MD-05-003)
EXPIRATION DATE: December 16, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.ncmhd.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Center on Minority Health and Health Disparities (NCMHD)
(http://ncmhd.nih.gov)
Fogarty International Center (FIC)
(http://www.fic.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.307; 93.989
LETTER OF INTENT RECEIPT DATE: November 15, 2004
APPLICATION RECEIPT DATE: December 15, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Center on Minority Health and Health Disparities (NCMHD) and
Fogarty International Center (FIC) of the National Institutes of Health
(NIH), invite applications for the Minority Health and Health Disparities
International Research Training (MHIRT) awards. These awards will support
programs that offer international research training opportunities to
qualified undergraduate, graduate and health professions students who are
from health disparities populations and/or are underrepresented in basic
science, biomedical, clinical or behavioral health research career fields.
Section 485E(a) of the Public Health Service Act (PHS Act) provided that
the general purpose of the NCMHD includes the conduct of training with
respect to minority health conditions and other populations with health
disparities. Further, Section 485E(d) of the PHS Act provides that a
population is a health disparity population if as determined by the
Director of NCMHD, in consultation with the Director of Agency for
Healthcare Research and Quality (AHRQ), there is significant disparity in
the overall rate disease incidence, prevalence, morbidity, mortality, or
survival rates in the populations as compared to health status of the
general population. Based on the 1992 Minority Programs Fact-Finding Teams
Recommendations Report, the recommendations provided guidance to the NIH
for future development of policies on the support of minority training
programs and initiatives. Additionally, Public Law 106-525 recognized a
national need for increasing the number of well trained minority scientists
in the fields of biomedical, clinical, behavioral, and health services
research. The statute recognized that the inclusion of underrepresented
minorities and women in the scientific, technological and engineering
workforce will enable society to better address its diverse needs. Thus,
the MHIRT program is a component of the National Institutes of Health's
(NIH) long-term strategy to help establish a cadre of biomedical, clinical,
behavioral and social science researchers that understands health
disparities populations and will contribute to reducing and ultimately
eliminating health disparities among racial and ethnic minority groups in
the United States.
Recent national and international events have underscored the importance of
addressing the health disparities from a global health perspective.
According to the Institute of Medicine (IOM) (2003, p.36), "for the health
professionals, racial and ethnic disparities in healthcare . . . will be
among the most significant challenges of today's rapidly changing health
system." And, "from a public health standpoint, racial and ethnic
disparities in healthcare threaten to hamper efforts to improve the
nation's health (IOM, p.36)." Yet the health gap between minority and non-
minority Americans has persisted, and in some cases, has increased in
recent years (IOM, 2003, p.35).
Thus, NCMHD, in collaboration with the FIC will support approximately 20
new MHIRT training programs that offer international research training
opportunities for at least eight to ten qualified undergraduate, graduate
and/or health professions students who are from health disparities
populations that are underrepresented in the basic sciences, biomedical,
clinical or behavioral research career fields. At least 75 percent of a
grantee's MHIRT trainees must be undergraduate students. Applications are
requested for innovative programs that provide international research
training for the purpose of:
Encouraging undergraduate, graduate and/or health professions students who
are from health disparities populations to pursue careers in basic science,
biomedical, clinical and behavioral health research fields.
Broadening the research efforts and scientific training of undergraduate,
graduate, and/or health professions students from health disparities
populations to encompass international health issues.
Assisting undergraduate, graduate and/or health professions students who
are from such populations to participate in U.S. and international faculty
collaborative research initiatives.
Seeking innovative approaches to address problems and/or hindrances
associated with closing health disparities gaps.
RESEARCH OBJECTIVES
MHIRT program awards are designed to enable U.S. institutions to offer
short-term international research training opportunities for qualified
eligible students in basic science, biomedical, clinical or behavioral
research programs for at least 10-12 weeks during the summer or one
semester during an academic year. More specifically, an applicant's
research objectives should address the following programmatic aspects and
be measurable with a defined timeline and expected outcome(s):
Training MHIRT recipients in experimental research design, procedures for
analyzing and interpreting data and the use of current scientific
literature and analytical methods;
Familiarizing MHIRT student researchers with the scientific literature
associated with their individual research project;
Addressing cultural, linguistic and ethical appropriateness and related
issues affecting professionals who are engaged in scientific and public
health research at the foreign site;
Ensuring academic and/or professional forums for written and oral
presentations by MHIRT recipients of their scientific research experience
and results; and
Mentoring MHIRT recipients through encouragement to complete current
academic degree programs and pursue additional training leading to an
advanced biomedical or behavioral health research career.
MECHANISM OF SUPPORT
This RFA will use NIH institutional training grant (T37) award mechanism.
As an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and will
be reviewed according to the customary NIH peer review procedures. The
anticipated award date is July 1, 2005.
This RFA will not use the just-in-time concepts. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement
at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
FUNDS AVAILABLE
The participating ICs intend to commit approximately $5 million in FY 2005
to fund approximately 20 new grants in response to this RFA. An applicant
may request a project period of up to four years and a budget for total
direct costs of up to $225,000 per year (http://grants2.nih.gov/grants/guide/
notice-files/NOT-OD-04-040.html). Because the nature and scope of
the proposed research training 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 NCMHD and FIC 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.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has the following
characteristic:
o Domestic public or private university or college that offers at
least the baccalaureate degree in fields relevant to basic science,
clinical, biomedical, and/or behavioral health science.
Only one application per institution will be accepted for review.
An applicant institution may form a consortium with other postsecondary
entities for the purpose of maximizing resources to support a MHIRT
program. The application from a consortium of institutions should describe
the specific plans for the management and participation of students and
mentoring faculty at consortia institutions for all components of the
applicant's proposed program plan.
In keeping with the Presidential Executive Orders 12876, 12900 and 13270,
Historically Black Colleges and Universities (HBCUs), Hispanic-Serving
Institutions (HSIs) and Tribal Colleges and Universities (TCUs) are
eligible to participate as a member of an applicant's consortium or apply
directly for a MHIRT program grant under this RFA.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to serve as principal investigator by
working with their institution to develop an application for support under
this RFA. Individuals from health disparities populations, as well as
individuals with disabilities are always encouraged to apply for NIH
programs.
More specifically, the person selected to head the MHIRT program should
show evidence of experience at administering multifaceted international
research programs involving significant student research training
activities. The program director should be a full-time faculty member at
the applicant institution and the principal investigator for the
application. The program director will be responsible for coordinating all
aspects of the proposed training activities, and submitting annual progress
reports and trainee tracking data to the National Center on Minority Health
and Health Disparities.
SPECIAL REQUIREMENTS
Trainee Eligibility Requirements:
Citizenship
Trainees must be citizens or non-citizen nationals of the United States, or
have been lawfully admitted to the United States for permanent residence
(i.e., possess a currently valid Alien Registration Receipt Card I-551, or
other legal verification of such status). Non-citizen nationals are
generally persons born in outlying possessions of the United States (e.g.,
American Samoa). Individuals on temporary or student visas are not
eligible to participate in the MHIRT Program.
Underrepresentation and Health Disparity Populations
Trainees must be from health disparities groups that have been determined
by the applicant institution to be underrepresented in basic science,
clinical, biomedical or behavioral health research. The NIH particularly
encourages applicants to recruit individuals from health disparities groups
that are underrepresented in health-related research. Nationally, these
groups include but are not limited to, African Americans, Hispanic
Americans, Native Americans, Alaskan Natives, Native Hawaiians and Pacific
Islanders, and rural Appalachians. Programs should recruit trainees who
could most benefit from a financially supported opportunity for an
international scientific research experience. Programs should support
students that are most likely to pursue basic science, clinical, biomedical
or behavioral health research careers that will contribute ultimately to
the elimination of health disparities in the U.S and between populations
living in developing countries and the U.S. Applicants must describe, as
well as provide demographic data on all categories of the eligible student
populations that are available for recruitment to the program at their
institution and consortium institutions.
Program Evaluation
The Program Director will be required to interact regularly with NCMHD
staff in order to monitor the progress of the training program through
review of annual progress reports and participation in network meetings.
Grantees must submit data annually on each current and past trainee via a
web-based tracking system that will be used to monitor the impact of the
program on the careers of MHIRT trainees. Details of the required format
for the narrative progress report and instructions for submission of data
to the web-based tracking system will be provided by the NCMHD after grants
are awarded.
Contingency Plan
Applicants should have contingency plans prepared in case a research
country is placed on restricted travel by the U.S. State Department.
Responsible Conduct of Research
Applicants are required to provide all trainees with training in the
responsible conduct of research. For more information on this provision,
see the NIH Guide for Grant and Contracts (volume 21, number 43
http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does
not require a specific curriculum or format for instruction. However, the
following areas should be included as a separate component of the research
training plan: conflict of interest, responsible authorship and
institutional policies for handling scientific misconduct, human subjects,
animal studies, data management and data sharing. The inclusion of
training in the international perspectives on these topics is strongly
encouraged. The following information must be provided in the description
of your plan: topics to be covered, format, faculty participation,
instructional materials, frequency and duration of training and how trainee
attendance will be monitored. Applications without plans for instruction
in the responsible conduct of research will be considered incomplete and
will be returned to the applicant without review.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
DeLoris L. Hunter, Ph.D.
Director, Division of Research and Training Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: Hunterd2@mail.nih.gov
Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31 Room B2C39
31 Center Drive MSC2220
Bethesda, MD 20892
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: sinab@mail.nih.gov
o Direct your questions about peer review issues to:
Lorrita Watson, Ph.D.
Review Branch, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: WatsonL@ncmhd.nih.gov
o Direct your questions about financial or grants management matters to:
Bryan S. Clark, MBA
Chief, Office of Grants Management
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: ClarkB@ncmhd.nih.gov
LETTER OF INTENT
Each prospective applicant is asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that the
letter provides will allow staff to estimate the potential review workload
and plan the review.
The letter of intent is to be received by the date listed at the beginning
of this document. The letter of intent should be sent to:
Lorrita Watson, Ph.D.
Review Branch, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: WatsonL@ncmhd.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001) with appropriate substitute pages as
noted below. Applications must have a D&B Data
Universal Numbering System (DUNS) number as the Universal Identifier when
applying for Federal grants or cooperative agreements. The DUNS number can
be obtained by calling (866) 705-5711 or through the web site at
http://www.dnb.com/. The DUNS number should be
entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. You must use the National Research Service Award
Substitute Form Pages 3, 4, and 5 in your application. Links to these
pages are available at http://grants.nih.gov/grants/funding/phs398/instructions2/
p1_preparing_NRSA_app.htm. Click on Form Page 3; Form Page 4: NRSA Instructions; and
Form Page 5: NRSA Instructions. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS:
The Training Plan
Each MHIRT program grant application must include a comprehensive plan to
support an international research training experience, under the
collaborative mentorship of outstanding U.S. and foreign scientists, for at
least eight to ten qualified eligible undergraduate, graduate and health
professions students. While the NCMHD and its collaborator, FIC recognize
that there are likely to be significant differences in applicant
institutions, research environments, MHIRT trainees, and an applicant's
approaches to international research training, all applicants must describe
in detail the following components of their proposed research training
programs:
o Broad description of trainees' research plan
o Procedures for trainee recruitment and application solicitation
o Criteria for evaluation of trainee application and the trainee
selection process
o Cultural orientation and scientific preparation of trainees for an
international research training experience
o Criteria and process for matching trainees with U.S. and foreign
faculty mentors and mentorship activities
o Procedures for selection of a trainee research training assignment/
project under each foreign faculty mentor
o Trainee evaluation of international research training experience
o U.S. and foreign faculty mentors evaluation of MHIRT trainee
performance during the research training experience
o Criteria and requirements for written and oral presentation(s) by
trainees about the international research training experience and
their research results
o Long-term tracking of each trainee's health research careers,
including the impact of the MHIRT program experience on the trainee's
career path.
Types of Trainees
Proposed programs should give undergraduate students priority when
providing international research training opportunities by selecting
approximately 75% undergraduate students as participants per year. It is
strongly suggested that all undergraduate participants being considered for
the program have completed at least two years of coursework in a major
related to biomedical or behavioral health science, a minimum GPA of 3.0
and have demonstrated evidence of exceptional scientific research interest
and talent, such as previous undergraduate research experience.
Approximately 25% of the student participants may be graduate or health
professions students in each budget. During the trainee selection process
priority should be given to students who are interested in research
pertinent to reducing and/or eliminating health disparities. All trainees
must be involved in original data collection. Routine clinical or lab
work, coursework or training in scientific techniques alone can not be
supported by this RFA, except in those instances where such activities are
allowing the trainees to pursue original data collection.
Training Faculty
U.S. faculty participants who will serve as mentors for student
participants must have full-time academic appointments at the applicant
institution or at an institution in an associated consortium. Applications
should describe the specifics of the mentoring-experience, including
documentation of the U.S. faculty's prior mentoring training of
undergraduate, graduate, students and/or health professionals in
international research. The international research training experience
should be planned at foreign universities or research institutions where
the mentoring U.S. faculty participants have ongoing collaborative research
relationships. Applicants should also document prior and/or the ongoing
collaborations between U.S. faculty mentors and faculty mentors from the
proposed foreign training institution(s), including citing sources of joint
funding for research and joint publications. Furthermore, the grant
application must include a detailed description of the research resources
and scientific educational environment available to the trainees during
their foreign research training experience. With sufficient justification,
U.S. faculty may serve as the international mentor for trainees at
developing country training sites where adequate foreign mentorship is not
available. In instances when it is proposed that a U.S. faculty will serve
as the trainee's mentor at a developing country training site, the
applicant must include curriculum vitae, biosketches and a letter from the
participating U.S. faculty mentor defining the mentor's specific role,
responsibility to the student and time commitment to the training program.
Foreign research collaborators of U.S. faculty mentors with doctoral
degrees and full-time positions should serve as mentors for students
training at the proposed foreign training institution(s). Curricula vitae,
biosketches, and letters from the participating foreign faculty mentors
defining their specific roles, responsibility to the student and time
commitment to the training program should be included in the application.
Training Advisory Committee
A training advisory committee of at least six members must be established
to assist the program director with recruitment and trainee selection,
scientific review of trainee research projects, evaluation of trainees and
their international research training experiences and overall training
program progress. This advisory group should be composed of both U.S. and
foreign faculty who are directly involved in the MHIRT program. The
committee should also include at least two faculty members (from
biomedical, behavioral, or health disparity career fields), not involved in
the MHIRT program, that have experience and understanding in addressing the
training needs associated with preparing students from health disparities
populations for international research opportunities. The applicant should
describe the composition and expertise of the proposed training advisory
group, the responsibilities of the group, and the processes and annual
timetable by which the group will be expected to accomplish its
responsibilities. Biosketches and letters from proposed members describing
their commitment to serve in the training advisory committee should be
included in the application.
Budget
Applicants should develop a budget that reflects the resources necessary to
implement the components of the comprehensive research training plan
included in their application. The budgets may include costs to support
the proposed training activities, trainees and faculty mentors during the
training period at the foreign site, and costs for the administration of
the program. Costs will be considered at levels higher than those included
in this Request for Application but the applicant must include convincing,
detailed budget justification(s). These requested cost(s) should not be
significantly in excess of any existing cost levels for comparable items at
the applicant institution. Adequate resources to meet U.S. government
requirements for training and training-related research should be included
in the budget.
Trainees Stipends
Trainees may be paid a stipend to help defray living expenses during the
foreign research training experience according to their academic
professional level experience. The approved stipend levels are $1,000 per
month for undergraduates (Junior/Senior), $1,400 per month for Post-
baccalaureate/Master level degree students, and $1,900 per month for Pre-
doctoral degree level students. Trainees are not viewed as employees of
either the Federal government or the awardee institution.
U.S. Faculty Mentors
Applicants may request stipend support for one U.S. faculty mentor at a
developing country training site where lack of adequate foreign faculty
mentorship is available for trainees. U.S. faculty stipend support
equivalent to U.S. institutional salary may be requested only if no
institutional or federal salary support is available during the research
training period as documented by the applicant institution administrative
official. Applicants can request support for a maximum of two U.S. faculty
mentors in two developing countries annually.
Foreign Faculty Mentors
Foreign mentors may be provided funds up to $500 for use in research
support activities related to hosting the trainee. This amount may be
offered to only the foreign mentors from developing country institutions
that do not charge student bench fees or tuition. Foreign faculty
honorarium may not be requested if support is requested for a U.S. faculty
mentor for the research training period at that developing country site.
Program Administration
The applicant institution may request up to $50,000 to support the
principal investigator and/or other personnel for administrative efforts
related to the MHIRT program. The administrative duties and
responsibilities and time commitments for personnel receiving salary
support should be thoroughly described and justified in the application.
Trainee-Related Expenses
Funds to support trainee research costs (such as lab supplies, computer
access, interpreters) at the foreign site may be requested for up to a
maximum level of $850 per month per trainee. Additional funds may be
requested for expenses such as photocopying, training materials and long
distance phone/fax costs directly related to the MHIRT program activities.
Funds may be requested to cover expenses related to specific MHIRT program
activities, including program and cultural related orientation, responsible
conduct of research training instruction and evaluation activities.
Tuition, Fees and Insurance
Funds for tuition, fees and self-only medical insurance expenses associated
with the international research experience may be requested up to a maximum
level of $1800 per trainee. Tuition at the U.S. institution or bench fees
at the foreign institution during the 10-12 week foreign research training
period will be allowed only if such charges are required of all persons in
similar training status at the applicant or host foreign institution.
Tuition for specific coursework related to the project, such as language
courses at the U.S. or foreign institution can be supported. The program
may provide funds to cover fees for passports, visas, Centers for Disease
Control and Prevention recommended vaccinations and prophylactic drugs.
The applicant must ensure that all trainees have comprehensive medical and
international travel insurance for the duration of the trainees
international research experiences. If institutional or personal medical
insurance does not adequately cover trainees during foreign travel, self-
only medical insurance may be charged to the grant. All expenses in the
category of tuition, fees and insurance should be itemized and justified
for each foreign site.
Foreign Living Expenses
Foreign site housing expenses of up to $1200 per month may be requested for
trainees and U.S. faculty mentors (when appropriate and supported by
applicant's program plan).
Travel Expenses
Airfare and local ground transportation to each foreign site may be
requested for trainees and U.S. faculty mentors. Trainees from consortium
institutions may be supported for travel and per diem expenses to attend
orientation and responsible conduct of research training as well as post-
travel activities associated with the MHIRT program at the program
director's institution. U.S. faculty mentors from consortium institutions
may be supported for travel and per diem expenses to attend training
advisory committee meetings. Travel and per diem expenses may be requested
for short-term visits (less than 1 month stay) of foreign faculty mentors
to the U.S. applicant institution to participate in MHIRT program
associated student training activities and/or training advisory committee
meetings. Funds should be requested for the MHIRT program director to
attend a two-day annual MHIRT network meeting in the Washington, D.C. area.
Funds may be requested to support MHIRT trainees to present their research
findings at one national or regional scientific conference. All travel
expenses requested should be based on economy class round trip airfare on
U.S. carriers (to the maximum extent possible) plus per diem at the
standard U.S. government rates
(http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm).
Facilities and Administrative Costs
Costs should be included in the budget request at a rate of eight percent
of allowable costs (Checklist form page II).
USING THE RFA LABEL
The RFA label available in the PHS 398 (rev. 5/2001) application form must
be affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review. In addition, the RFA title and number must
be typed on line 2 of the face page of the application form and the YES box
must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH
Submit a signed, typewritten original of the application, including the
appendix (if any), the Checklist, and three signed, photocopies without
appendices, 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)
At the time of submission, two additional copies of the application and all
five copies of the appendix material must be sent to:
Lorrita Watson, Ph.D.
Review Branch, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: WatsonL@ncmhd.nih.gov
Appendices should be comprised of unbound materials, with separators
between documents.
Applications hand-delivered by individuals to the CSR will no longer be
accepted. This policy does not apply to courier deliveries (i.e., FedEx,
UPS, DHL, etc…) (See http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-012.html).
APPLICATION PROCESSING
Applications must be received on or before the application receipt date
listed in the heading of this RFA. If an application is received after
that date, it will be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review assignment
within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an
RFA, it is to be prepared as a NEW application. That is, the application
for the RFA must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes
from the previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the National Center on Minority Health and Health
Disparities and/or Fogarty International Center. 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 NCMHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate National Advisory
Council or Board.
REVIEW CRITERIA
The goals of NCMHD-supported research training are to advance the trainees'
understanding of behavioral and biological systems and encourage
participants to pursue biomedical or behavioral health research careers
focused on enhancing the overall health and well-being of health
disparities populations. In the written comments, reviewers will be asked
to evaluate the application in order to judge the likelihood that the
proposed international research training will have a substantial impact on
the pursuit of these goals. The scientific review group will address and
consider each of the following criteria in assigning the application's
overall score, weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important
work that by its nature is not innovative, but is essential to move a field
forward.
SIGNIFICANCE
1. What is the likelihood that the proposed program will provide
international research training experiences that will encourage
participants to pursue biomedical or behavioral health research
careers?
2. What will be the effect of these student-focused research training
opportunities on furthering the advancement of individuals from health
disparities populations in career fields that address problems related
to the elimination of health disparities?
APPROACH
1. Are the design, methods, and analyses adequately developed, well-
integrated, and appropriate to achieve the aims of the training plan?
Does the applicant acknowledge potential problem areas and consider
alternative approaches?
2. Is the trainee selection process adequate?
o Are there a recruitment plan and application process that capture a
pool of the best qualified eligible candidates who could benefit most
from an international research experience that encourages their
pursuit of a biomedical or behavioral health research career?
o If applicable, is there a participation plan for involvement of
students and faculty in the recruitment and application process?
o Does the applicant present a process to achieve the best match of
trainees to U.S. and foreign faculty mentors and research projects at
a foreign institution?
o What methods and criteria will be used in selecting students and U.S.
and foreign faculty participants?
3. Does the applicant's plan provide adequate trainee instruction in:
A) the responsible conduct of research, particularly addressing ethical
and cultural issues, associated with research at the foreign sites, lab
safety, statistical methods and data analyses, and scientific
literature reviews related to their research; and B) the preparation of
written and oral scientific presentation of research results by
trainees.
4. Does the applicant's description of the proposed research training at
the foreign site(s) include:
o A broad description of the students' research training projects,
training schedules and research skills to be taught
o U.S. and/or foreign faculty mentorship
o Research experiences related to health disparities in U.S. and/or
developing countries populations
5. Are the processes used by the program adequate to monitor and evaluate
the short- and long-term impact of the international research training
experience on trainees and their career path?
6. If applicable, are the plans adequate for the management and
participation of the students and mentoring faculty of the consortium
institutions?
INNOVATION
1. Does the program design allow for and offer enriching international
research training experiences to the program's trainees?
2. Does the project use approaches to encourage the pursuit of biomedical
and behavioral research careers that address health problems
disproportionately affecting the different populations in the U.S.?
INVESTIGATOR
1. Is the principal investigator appropriately trained and well suited to
carry out this international research training program?
2. Is the work proposed appropriate to the experience level of the
principal investigator and other proposed researchers/mentors?
3. Are the qualifications of the proposed program director, and U.S.
and foreign faculty participants adequate to direct the international
research training activities of the student projects and act as
effective mentors for the trainees?
ENVIRONMENT
1. Does the scientific environment in which the work will be done
contribute to the probability of success?
2. Do the proposed research training efforts take advantage of unique
features of the scientific environment or employ useful collaborative
arrangements?
3. Is there evidence of institutional support?
4. Is there a contingency plan for safety of the trainee while in a
foreign environment?
ADDITIONAL REVIEW CRITERIA
In addition to the above criteria, the following items will be
considered in the determination of scientific merit and the priority score:
PREVIOUSLY FUNDED APPLICATIONS: The career progress and accomplishments of
previous undergraduate and graduate student trainees supported by the MIRT
program award will apply for applications for competitive renewal. These
applications should provide tables listing all former MIRT trainees and
current data on their post-training completion of academic degrees, entry
into graduate and health professional programs or pursuit of other
biomedical and behavioral health or international careers, presentation of
MIRT research results at scientific meetings, peer reviewed publication of
MIRT research results and related honors or awards.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of
the research. Plans for the recruitment and retention of subjects will
also be evaluated. (See Inclusion Criteria in the sections on Federal
Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are
to be used in the project, the five items described under Section f of the
PHS 398 research grant application instructions (rev. 5/2001) will be
assessed.
ADDITIONAL REVIEW CONSIDERATION
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research training will be addressed.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 15, 2004
Application Receipt Date: December 15, 2004
Peer Review Date: March/April 2005
Council Review: June 2005
Earliest Anticipated Start Date: July 1, 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION
Recipients of PHS support for activities involving live, vertebrate animals
must comply with PHS Policy on Humane Care and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf),
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA
Animal Welfare Regulations (http://www.nal.usda.gov/awic/
legislat/usdaleg1.htm), as applicable.
HUMAN SUBJECTS PROTECTION
Federal regulations (45CFR46) require that applications and proposals
involving human subjects must be evaluated with reference to the risks to
the subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of
the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible
(http://grants.nih.gov/grants/policy/data_sharing). Investigators should
seek guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research. This policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants
and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines
are available at http://grants.nih.gov/grants/funding/women_min/guidelines_
amended_10_2001.htm. The amended policy incorporates: the use
of an NIH definition of clinical research; updated racial and ethnic
categories in compliance with the new OMB standards; clarification of
language governing NIH-defined Phase III clinical trials consistent with
the new PHS Form 398; and updated roles and responsibilities of NIH staff
and the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or proposals
and/or protocols must provide a description of plans to conduct analyses,
as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by
sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons not
to include them.
All investigators proposing research involving human subjects should read
the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for
Grants and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as
appropriate, 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 data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is
a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of
individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am I a
covered entity?" Information on the impact of the HIPAA Privacy Rule on
NIH processes involving the review, funding, and progress monitoring of
grants, cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas. Potential
applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under the authorization of
Sections 307 and 485E of the Public Health Service Act as amended (42 USC
2421 and 287c-31) and under Federal Regulations 42 CFR 52 and 45 CFR Parts
63a and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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