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.

Update: The following update relating to this announcement has been issued:

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

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:

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:

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:

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.

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) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

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:

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:

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.

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:

The following will be considered in making funding decisions:

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

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.


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