Part I
Overview Information
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National
Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)
Fogarty International Center (FIC) (http://www.fic.nih.gov)
Title: NCMHD Minority
Health and Health Disparities International Research Training (T37)
Announcement Type
This is a reissue of RFA-MD-04-004.
Request For Applications (RFA) Number: RFA-MD-08-006
Catalog of Federal Domestic Assistance Number(s)
93.307
Key Dates
Release Date: June 12, 2008
Letters of
Intent Receipt Date: July 20, 2008
Application Receipt Date: August 19, 2008
Peer Review
Date(s): October-November
2008
Council Review
Date: January 2009
Earliest
Anticipated Start Date: April 2009
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: August 20, 2008
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
- Purpose. 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.
- 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 the reduction
and, ultimately, the elimination of health disparities among racial and ethnic
minority groups in the United States.
- Mechanism of Support. This FOA
will utilize the T37 grant mechanism.
- Funds Available and Anticipated Number of Awards. It is
anticipated that approximately $5 million in total costs will be available in
FY 2009 to support approximately 22-24 awards.
- Budget
and Project Period. Direct
Costs may not exceed $225,000 per year for a period
of up to five years. The total project period for an application
submitted in response to this FOA may not exceed five years.
- Research Plan Component Page Length. The Research Training Plan must
not exceed 25 pages.
- Eligible
Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
- Eligible Project Directors/Principal Investigators
(PDs/PIs). Individuals with the skills, knowledge,
and resources necessary to carry out the proposed research are invited to
work with their institution/organization 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 support.
- Number of PDs/PIs. More than one PD/PI (i.e.,
multiple PDs/PIs), may be designated on the application.
- Number of Applications. Applicant Institutions may only
submit only a single application. Multiple applications from an
institution will be returned.
- Resubmissions: Resubmission
applications are not permitted in response to this FOA. Applicants who have
applied unsuccessfully to previous MHIRT FOAs may apply to the current FOA, but
must present the application as a new application. It must not include an
Introduction section or otherwise explicitly address the review of the previous
application.
- Renewals. Renewal applications are permitted
in response to this FOA.
- Special
Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
- Application Materials. See Section IV.1for application
materials.
- Hearing Impaired. Telecommunications for the hearing
impaired are available at: TTY 301-451-0088.
Table
of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Training Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Training Objectives
The
NCMHD, in collaboration with the FIC, offers international research training
opportunities for support of students in eligible health and research
curriculums who are from health disparities populations that are
underrepresented in the basic sciences, biomedical, clinical or behavioral
research career fields. 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 for addressing issues and/or hindrances associated
with closing health disparities gaps.
- Immersing
the student in a research environment for exposure to the full spectrum of
research activities, including theoretical modeling, development of
hypothesis and design, data collection and analysis, clinical or lab
activities, and practical problem solving exercises.
MHIRT
program awards are designed to enable U.S. institutions to offer short-term
international research training opportunities to qualified students in basic
science, biomedical, clinical or behavioral research programs. The
programs are expected to be structured to accommodate at least eight to ten
students as the annual budget allows. The training will occur in a single
session anticipated to be 10 to 12 weeks in duration during the summer or for
one semester during an academic year. At least 75 percent of a grantee's
MHIRT trainees must be undergraduate students.
Applicants
must provide a description of the proposed program that incorporates the
programmatic aspects listed below. Include projected timelines for the program,
expected outcome(s), and methodology for the assessment of the effectiveness of
the training.
Required
activities:
- 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.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity
will use the T37 award mechanism(s).
The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed training program.
This
FOA uses “Just-in-Time” information concepts. It also uses
non-modular budget formats described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The estimated amount of funds available for support of 22-24 training programs awarded as a result
of this announcement is $5 million for
fiscal year 2009. An applicant may request annual direct costs of up to $225,000 and a
project period of up to five years. Future year
amounts will depend on annual appropriations.
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 IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
2.A. Allowable Costs
Program Administration:
Within the total direct costs of up
to $225,000, the applicant institution may request up to $50,000 to support the
PD/PI 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.
Facilities and Administrative Costs:
Facilities and Administration (F
& A) Costs at a rate of eight percent of allowable direct costs may be
included in the requested total budget (excludes tuition/fees/equipment).
Stipends:
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.
Foreign Faculty Mentors: Foreign
mentors may request 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 foreign 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 foreign country site.
U.S. Faculty
Mentors: Applicants may request salary support for one U.S. faculty mentor at a foreign country training site where adequate foreign faculty
mentorship is not available to the 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, and such practice is consistent with institutional policy.
Applicants can request support for a maximum of two U.S. faculty mentors in two
foreign countries annually.
Tuition and Fees:
Funds for tuition and fees
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 visas required for trainee
participation in the program. All expenses in this category of tuition
and fees should be itemized and justified for each foreign site.
Trainee Travel Expenses:
Airfare and local ground
transportation to each foreign site may be requested for trainees and U.S. faculty mentors. Foreign site housing living expenses of up to $1600 per month
may be requested for trainees and U.S. faculty mentors (when appropriate and
supported by applicant's program plan). 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 PD/PI’s institution or at a
collaborating site designated by the PD/PI. 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).
Training-Related Expenses (including
Health Insurance):
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 to cover other expenses directly
related to the MHIRT program activities including program and cultural related
orientation, responsible conduct of research training instruction and health
insurance, but must be itemized in the budget justification section. 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 only if such practice is
consistent with institutional policy.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH grants
policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in
response to this FOA.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- Hispanic-serving Institutions
- Historically Black Colleges and
Universities (HBCUs)
- Tribally Controlled Colleges
and Universities (TCCUs)
- Alaska Native
and Native Hawaiian Serving Institutions
Foreign institutions are not eligible to apply for this
program.
1.B.
Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to
carry out the proposed research as the PD/PI is invited to work with his/her
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 support.
More than one PD/PI, or
multiple PDs/PIs, may be designated on the application for projects that
require a “team science” approach and therefore clearly do not fit
the single-PD/PI model. Additional
information on the implementation plans, policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to
apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility
of the investigators and applicant organizations, and should be determined by
the scientific goals of the project. Applications for grants with multiple
PDs/PIs will require additional information, as outlined in the instructions
below. The NIH review criteria for approach, investigators, and environment
have been modified to accommodate applications involving either a single PD/PI
or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that
the structure and governance of the PD/PI leadership team as well as the
knowledge, skills and experience of the individual PDs/PIs will be factored
into the assessment of the overall scientific merit of the application.
Multiple PDs/PIs on a project share the authority and responsibility for leading
and directing the project, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization, or, as appropriate, to
a collaborating organization, for the proper conduct of the project or program,
including the submission of required reports. For further information on
multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
An applicant institution may form a
consortium with other postsecondary entities for the purpose of maximizing
resources to support a MHIRT program. Applications that include
consortiums should describe the specific plans for the management and
participation of students and mentoring faculty for all components of the
applicant's proposed program plan as they relate to the various participating
institutions.
Renewal applications will be permitted for this FOA.
Trainee Eligibility Requirements:
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.
- Health Disparity Populations
Trainees must be from a health
disparity population as determined by the Director, NCMHD, in consultation with
the Director, AHRQ. For the purposes of this FOA, health disparity
populations are defined as African Americans, Asian Americans, Hispanic
Americans, Native Americans, Alaskan Natives, Native Hawaiians and Pacific
Islanders, and the medically underserved (i.e., socio-economically
disadvantaged individuals in rural and urban areas).
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.
Section
IV. Application and Submission Information
1. Address
to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. 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 D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
Applications
with Multiple PDs/PIs
When multiple PD/PIs are
proposed, use the Face Page-Continued page to provide items 3a – 3h for
all PD/PIs. NIH requires one PD/PI be designated as the “contact
PD/PI” for all communications between the PD/PIs and the agency. The
contact PD/PI must meet all eligibility requirements for PD/PI status in the
same way as other PD/PIs, but has no special roles or responsibilities within
the project team beyond those mentioned above. The contact PD/PI may be changed
during the project period. The contact PD/PI should be listed in block 3 of
Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the “Contact PD/PI, et. al.” The
contact PD/PI must be from the applicant organization if PD/PIs are from more
than one institution.
All individuals designated
as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI
role in that system (other roles such as SO or IAR will not give the PD/PI the
appropriate access to the application records). Each PD/PI must include their
respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.
Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled “Multiple PD/PI Leadership
Plan” must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.
If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.
Additional information
is available in the PHS 398 grant
application instructions.
3.
Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date: July 20, 2008
Application Receipt Date: August 19, 2008
Peer Review Date(s): October-November 2008
Council Review Date: January 2009
Earliest
Anticipated Start Date(s): April 2009
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
- Descriptive title of proposed research training program
- Name, address, and telephone number of the PD/PIs
- Names of other key personnel
- Participating institutions
- Number and title of this funding opportunity
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
in Section IV.3.A.
The letter of intent
should be sent to:
Robert
Nettey, MD
Division of Extramural
Activities and Scientific Programs
National Center on
Minority Health and Health Disparities
6707 Democracy Boulevard
Suite 800, MSC 5465mber
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email:
netteyr@mail.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Lorrita
Watson, PhD
Division of Extramural
Activities and Scientific Programs
National Center on
Minority Health and Health Disparities
6707 Democracy Boulevard
Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email:
watsonl@ncmhd.nih.gov
Appendix
material must be provided on CDs only. Five identical CDs must be
included with the two applications being sent to the NCMHD. Do not send
any appendix material to CSR with the original application material.
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity 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 a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity 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.
Information on the
status of an application should be checked by the PD/PIs in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
Pre-award costs
are not allowable for either stipends or tuition on institutional
training grants since stipends and tuition costs may not be charged to the
grant before the trainee appointment is actually made. However, the policies
governing the pre-award cost authority for the expenditure of the other funds
provided in a training grant are those permitted in the NIH Grants Policy
Statement as follows: a grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the
project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Use PHS 398 Institutional Training
Substitute Form Page 3 for the Table of Contents.
Summary Progress Report (required
for renewals only)
Previously funded NCMHD MHIRT
grantees must include a summary progress report generally describing the
outcome of the program and the methodology for program assessment. Also
included should be descriptions of the program’s most important successes
and accomplishments and how these accomplishments have contributed to the
realization of the stated goals and objectives of the training program.
In addition, applicants must provide a tracking history by funding year of all
trainees to include at least name, race/ethnicity, training site, graduation
date, degree, major, and most recent information on employment/educational
status.
The Research Training Plan:
In place of the research plan
requested in the PHS 398 application instructions, applicants should follow the
instructions regarding institutional research training grants.
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:
- Broad
description of the goals and objectives of the research plan
- General
depiction of proposed/established foreign research sites including the
procedures to insure the appropriate human subjects or vertebrate animal
approvals for research projects that may be assigned a trainee
- Procedure
for trainee recruitment and application solicitation
- Criteria
for evaluation of trainee application and of the trainee selection process
- Cultural orientation and scientific preparation of trainees
for an international research training experience
- Criteria and process for matching trainees with U.S. and foreign faculty mentors and mentorship activities
- Procedure for selection of a trainee research training
assignment/project under each foreign faculty mentor
- Trainee evaluation format for assessing their international
research training experience
- U.S. and foreign faculty mentors
evaluation of MHIRT trainee performance during the research training experience
- Criteria
and requirements for written and oral presentation(s) to be by trainees
about the international research training experience and their
research results
- Follow up
program for the long-term tracking of each trainee's health research
careers, including the impact of the MHIRT program experience on the
trainee's career path.
In addition, the following
information should be included:
Types of Trainees
Proposed programs should give
undergraduate students priority when providing international research training
opportunities by selecting at least 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 period. During the trainee
selection process, priority should be given to those 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 FOA, 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. Experience in international research efforts will be
invaluable in the coordination and management of the MHIRT program.
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 document prior and/or ongoing
collaborations between the U.S. and foreign institution’s mentors,
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 foreign 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 foreign
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.
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.
Applicant institutions must provide
evidence of their ability and expertise to manage an international training
program, including logistical and scheduling demands, scientific coordination,
and managerial oversight of the foreign activity to ensure compliance with U.S. government requirements for training and training-related research.
A foreign institution for MHIRT
trainees will have existing and ongoing research relationships with U. S. institutions that can demonstrate established lines of international communication
and an ability to coordinate research efforts across cultural and geographic
barriers. Describe this relationship as well as the research
training procedures that ensure the protection and well being of the trainees.
Training Advisory Committee
Each program must establish a
Training Advisory Committee that will 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 the evaluation of the overall training program progress.
This advisory committee will contain at least six members and should be
composed of U.S. and foreign faculty who will be directly involved in the MHIRT
program. The committee should also include at least two faculty members
(from biomedical, behavioral, or health disparity career fields), who are not
involved in the MHIRT program, and that have experience and expertise in
addressing the training needs associated with preparing students from health
disparities populations for international research opportunities. The
applicant should describe the composition and qualifications of the proposed
committee members, their proposed responsibilities, and the processes and
annual timetable by which the group will be expected to accomplish its
responsibilities. Biosketches and letters of commitment from the training
advisory committee should be included in the application.
Budget
Applicants should develop a budget
(not to exceed $225,000 direct costs annually) that reflects the resources
necessary to implement the components of the comprehensive research training
plan described 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.
Using the Standard PHS 398
Detailed Budget Form Page 4 and 5, reflect Institution based expenses,
including personnel, supplies, travel, consortium and other expenses, as they
relate to the planning, and oversight of the MHIRT T37 training program.
Using the PHS 398 Institutional
Training Detailed Budget Substitute Form Page 4 and 5, list trainee
specific expenses as described in this FOA.
Record the total trainee expense on
the standard PHS 398 budget form page 4 and 5 under the “Other
Expenses” category and provide the Institutional Training Substitute Forms
as detailed information.
Contingency Plan:
Applicants should have contingency
plans prepared in case a research training 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, see the attached link (http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
Applications must describe a program to provide formal and informal instruction
on scientific integrity and ethical principles in research.
- Although the NIH does not
establish specific curricula or formal requirements, all programs are
encouraged to consider instruction in the following areas: conflict of
interest, responsible authorship, policies for handling misconduct, data
management, data sharing, and policies regarding the use of human and
animal subjects. Within the context of training in scientific integrity,
it is also beneficial to discuss the relationship and the specific
responsibilities of the institution and the predoctoral trainees appointed
to the program.
- Plans must address the subject
matter of the instruction, the format of the instruction, the degree of
training faculty participation, trainee attendance, and the frequency of
instruction.
- The rationale for the proposed
plan of instruction must be provided.
Research
Plan Page Limitations
The Research Training Plan is limited to
25 pages.
Appendix
Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five
identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.
Resource Sharing
Plan(s)
NIH considers the sharing of unique research resources
developed through NIH-sponsored research an important means to enhance the
value of, and advance research. When resources have been developed with NIH
funds and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the
amount requested, investigators are expected to include a brief 1-paragraph
description of how final research data will be shared, or explain why
data-sharing is not possible. Applicants are
encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing
Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of
the amount requested, all applications where the development of model organisms
is anticipated are expected to include a description of a
specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate reasons why such sharing is restricted or not
possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested,
applicants seeking funding for a genome-wide association study are
expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why
submission to the repository is not possible. A genome-wide association
study is defined as any study of genetic variation across the entire genome
that is designed to identify genetic associations with observable traits (such
as blood pressure or weight) or the presence or absence of a disease or
condition. For further information see Policy for Sharing of Data
Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section
V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to
the FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the NCMHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer
review, all applications will:
- Undergo a
selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score.
- Receive a
written critique.
- Receive a
second level of review by the NCMHD National Advisory Council
The
following will be considered in making funding decisions:
- Scientific
and technical merit of the proposed project as determined by peer review
- Availability
of funds
- Relevance
of the proposed project to program priorities
- Geographic
and program balance
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research 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 an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious 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: Does this study
address an important problem? If the aims of the application are achieved, how
will scientific knowledge or clinical practice be advanced? What will be the
effect of these studies on the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? 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? 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: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs? Is the trainee
selection process adequate? Are there recruitment plan and application processes
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? If applicable, is there a
participation plan for involvement of students and faculty in the recruitment
and application process? 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? Are methods and criteria will be used in
selecting students and U.S. and foreign faculty participants well thought out?
Does the applicant's plan provide adequate trainee instruction in: 1) 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 2) the preparation of written and oral scientific presentation of
research results by trainees? Does the applicant's description of the
proposed research training at the foreign site(s) include: A broad description
of the students' research training projects, training schedules and research
skills to be taught U.S. and/or foreign faculty mentorship Research experiences
related to health disparities in U.S. and/or developing countries populations. 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? If applicable, are the plans adequate for the
management and participation of the students and mentoring faculty of the
consortium institutions?
Innovation: Is the project original and innovative? For
example: Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area? Does the program design allow
for and offer enriching international research training experiences to the
program's trainees? 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.?
Investigators: Are the
PD/PI(s) and other key personnel appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other
researchers? Does the PD/PI(s) and investigative team bring complementary and
integrated expertise to the project (if applicable)? Is/are the PD/PI(s) appropriately trained and well suited to carry out
this international research training program? Is the work proposed appropriate
to the experience level of the PD/PI(s) and other proposed researchers/mentors? Are the qualifications of the
proposed PD/PI(s), 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: Do(es) the scientific environment(s) in which
the work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support? Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed research
training efforts take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there evidence of
institutional support? Is there a contingency plan for the safety of the
trainee while in a foreign environment?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
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 the Research Plan section on Human
Subjects in the PHS 398 instructions).
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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan section on Human Subjects in the
PHS 398 instructions).
Care
and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the budget.
Training
in Responsible Conduct of Research: Peer reviewers will assess the applicant’s
plan for training in the responsible conduct of research on the basis of the
appropriateness of topics, format, amount and nature of faculty participation,
and the frequency and duration of instruction.
2.C.
Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3.
Reporting
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
As part of the Continuation Progress Report
include the following:
Overall Summary: Summarize the
progress made by the program over the past year (limited to six pages).
State the originally funded specific aims or objectives for the program and
indicate the aims for which progress will be presented in this report.
The PHS 2590 subsections may not be relevant for preparing the overall summary
of progress. Do not feel compelled to use them if other headings are more
suitable
- Highlight only the most
significant progress based on outcomes, accomplishments, and recognition
resulting from programmatic activities. This summary should be
prepared for a general audience. National honors and/or significant
promotions or recognition of key personnel or trainees should be mentioned
if related to NCMHD funding. Focus on what is significant rather than the
routine.
- State in lay terms the
scientific, medical or public health significance of the actual
progress. Also, state the significance of the progress relative to
achieving the goals of the grant. Do not simply include a generic
statement pulled from the original application or a previous progress
report.
- Be sure to state the plans for
the upcoming year.
Assurances: Verify that all trainee
eligibility requirements were satisfied at the time of their participation in
international training, at least 75% of the trainees in the program were
undergraduate students, and that all trainees received appropriate training in
the responsible conduct of research.
Trainee Recruitment: Discuss the
challenges and successes of student recruitment, application process, and
selection. Include the aspects of scientific preparation and cultural
orientation for the research experience.
Trainee Accomplishments: Discuss the
specific accomplishments of each trainee during and after the international
research training experience. Include publications or presentations as a
result of the trainee’s foreign experience. If there are U.S. faculty members serving at the foreign site as research mentors or in another
capacity, provide specific details regarding their background, role, and
responsibilities in the research training experience.
Program Effectiveness: Discuss the
challenges or obstacles encountered in reaching its training goals and
objectives. Include the best products generated by the program (e.g., new
collaborations, enhanced training environment, etc.) and any significant
unexpected outcomes (positive or negative) achieved by the project. Also,
the progress made in tracking the long-term career path of trainees should be
discussed.
Program Evaluation: Include a
description of the efforts to measure the program’s progress and changes
potential changes to the project as a result of the internal evaluation.
The assessment tools (e.g., questionnaires, etc.) can be appended to the
progress report.
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 and instructions for submission of data to the web-based tracking system
will be provided by the NCMHD after grants are awarded.
A final
progress report, invention statement, and Financial Status Report are required
when an award is relinquished when a recipient changes institutions or when an
award is terminated.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Robert
Nettey, MD
Division of Extramural
Activities and Scientific Programs
National Center on
Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: netteyr@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
2. Peer Review Contacts:
Lorrita
Watson, PhD
Division of Extramural
Activities and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email:
watsonl@ncmhd.nih.gov
3. Financial or Grants Management Contacts:
Priscilla
Grant, JD, CRA
Division of Extramural Activities
and Scientific Programs
National Center on Minority Health and Health Disparities
Suite 800, MSC 5465
6707 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: grantp@mail.nih.gov
Section
VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
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)
as mandated by the Health Research Extension Act of 1985 (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). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and 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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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 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 funding opportunity 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.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 (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 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 Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical 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 (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 applications for research involving human subjects
and individuals designated as key personnel. The policy is available 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 (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.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance 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 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 2 CFR Parts 215. 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.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.