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 Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)

Title:Initiative for Maximizing Student Development (IMSD) (R25)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-553.

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

Program Announcement (PA) Number: PAR-09-104

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release/Posted Date: February 18, 2009
Opening Date: December 25, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not required
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date: January 25, 2010, 2011, 2012
Peer Review Date: June-July

Council Review Date: October, 2010, 2011, 2012
Earliest Anticipated Start Date(s): December 2010, 2011, 2012
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration/Closing Date: January 26, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Minority Biomedical Research Support (MBRS) Program was created in response to a legislative mandate of increasing the numbers of underrepresented (UR) faculty, investigators and students engaged in biomedical and behavioral research, and to broaden the opportunities for their participation in biomedical and behavioral research. To accomplish this goal, the Initiative for Maximizing Student Development (IMSD) program provides institutional grants to establish research training programs at institutions with research intensive environments that will increase the preparation and skills of UR students in the biomedical and behavioral sciences as they academically advance in the pursuit of the Ph.D. degree in these fields.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Education Objectives

Section II. Award Information
1. Mechanism 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
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 Education Objectives

Several reports from the National Science Foundation (NSF) as well as from the National Academies reveal the national need for a well-trained workforce in biomedical and behavioral sciences and the continuing importance of developing and maintaining a strong, vital scientific workforce whose diversity reflects that of our nation. It was also reported that as a nation, African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands have been found to be underrepresented (UR) in the biomedical and behavioral sciences (National Research Council, 2000. Addressing the Nations Changing Needs for Biomedical and Behavioral Scientists. Washington, D.C.: National Academy Press; and National Science Foundation, Division of Science Resources Statistics. 2002. Doctoral Scientists and Engineers: 1999 Profile. Arlington, VA: National Science Foundation). The National Institutes of Health (NIH) was specifically encouraged, in the NIH Revitalization Act of 1993, to increase the participation of members from nationally underrepresented groups in biomedical and behavioral research. In response to this Congressional Act, the Minority Biomedical Research Support (MBRS) Branch of the Division of Minority Opportunities in Research (MORE) of the National Institute of General Medical Sciences (NIGMS) announces the Initiative for Maximizing Student Development (IMSD) Program. This program is an opportunity to develop new or expand existing effective institutional developmental programs designed to academically and scientifically prepare UR students in the biomedical or behavioral sciences for competitive research careers and leadership positions in these fields. These grants are institutional awards to institutions that confer the baccalaureate and/or doctoral degree in biomedical and/or behavioral science fields, have a demonstrated commitment to encourage and assist UR faculty, students and investigators in biomedical and behavioral sciences, and have a research-intensive environment with a significant number of potential mentors with NIH R01 or equivalent extramural research support.

The goals of the IMSD program are to (a) increase the number of UR students that graduate from Ph.D. programs in the biomedical and behavioral sciences at institutions with research intensive environments; and (b) reduce the gap in the completion of Ph.D. degrees between UR and non-UR students in the biomedical and behavioral science departments of those institutions. The MORE Division of NIGMS also expects that the proposed IMSD programs will increase the total number of UR students at the institution that, upon graduating from Ph.D. programs advance to competitive postdoctoral positions.

The MORE Division recognizes the heterogeneity in institutional settings and institutional missions. Based on this, the expectations of the MBRS IMSD program at the national level are that: (a) the IMSD program will increase the overall number of UR students that complete a Ph.D. and continue biomedical research careers; (b) at least 60% of the undergraduate students participating in the IMSD program will, upon graduation, directly enter into a Ph.D. program; (c) at least 90% of the Ph.D. students participating in the IMSD program will complete the degree; and (d) the program will contribute to ongoing student and faculty efforts to reduce the gap in the completion of Ph.D. degrees between UR and non-UR students in the biomedical and behavioral science departments of those institutions. To accomplish these objectives, the design of the proposed institutional programs should be derived from an institutional self assessment of the (a) research environment; (b) student and faculty demographics; (c) number of UR and non-UR students that complete the Ph.D. degree, continue competitive postdoctoral training, and engage in productive research careers; and (d) challenges/impediments that the students encounter in completing the Ph.D. degree. As a result of the self-assessment each applicant institution must establish the programs goals and specific measurable objectives, which should be consonant with the MBRS IMSD program expectations. These goals and specific measurable objectives should help design an institutional program that will have a significant institutional impact and a greater contribution to the overall IMSD goals.

Various strategies may be utilized to attain the objective of increasing the number of UR researchers via the IMSD program. These may include, but are not limited to, the initiation of new academic developmental activities as well as the expansion, enhancement, and/or improvement of existing activities. Some institutions may opt to offer programs to improve preparation of undergraduate students for admission to research doctoral degree programs, others may concentrate on training graduate students to obtain their doctoral degrees and prepare for successful research careers, and still others may concentrate on both. Each IMSD program is strongly encouraged to develop a partnership with NIH-funded T32 training program(s) (http://grants1.nih.gov/grants/guide/pa-files/PA-06-468.html) at the applicant institution or another institution in order to facilitate the networking and transition of IMSD students to T32 training programs, as well as to magnify the institutional impact of the program.

The IMSD program can provide support for student academic development activities that are designed to improve scientific critical thinking and quantitative skills, communication skills, time-management, group learning opportunities, independent library or bench research skills, interdisciplinary or advanced research-based courses, and opportunities to meet and discuss career choices with appropriate role models. Program activities are also expected to expand the scope of ongoing institutional inclusiveness efforts, e.g., training for faculty and administration officials that will assist the institution in contributing to the MBRS goals of increasing the numbers of UR faculty, investigators and students engaged in biomedical and behavioral research and broaden the opportunities for their participation in biomedical and behavioral research. The proposed program must include a plan to assess and evaluate both institutional and program outcomes. The plan should be based on cited literature and methodology designed to clearly demonstrate the value of the proposed program to the institution, as well as to document the institutional contribution in achieving the MBRS IMSD goals, i.e., the impact of the program on decreasing the existing gap between UR and non-UR students pursuing and completing Ph.D. degrees in biomedical and behavioral sciences.

The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and may not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is renewable. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a competing renewal (formerly competing continuation) application. Only one resubmission (formerly revisions/amendments) of a previously reviewed research education grant application may be submitted. This resubmission application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

2. Funds Available

Because the nature and scope of the proposed research education program 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 NIGMS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the research education program proposed and there are no specific budget limitations, the requested direct costs must be reasonable, well documented, fully justified and commensurate with the scope of the proposed program. All awards are subject to the availability of funds.

Facilities and Administrative (F&A) 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 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 grant 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. When considering the multiple PD/PI option, 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

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education project. Appropriate institutional commitment to the project includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education project. The application should include a letter explaining the institutional commitment to the proposed research education program.

Participants: The IMSD program is an institutional program and it is expected that program-supported activities will be open to all students at the institution. There is no specific eligibility requirement for participation in IMSD-supported activities. The program should not deny participation in program-supported activities to anyone based solely on his/her race, religion, gender or ethnicity. The program-supported participants are selected by the applicant institution. To receive salary support from the IMSD program, students must be U.S. citizens or non-citizen nationals or permanent residents and must be matriculated fulltime in baccalaureate or doctoral degree programs in biomedical or behavioral science fields at the applicant institution. (A non-citizen national is a person who, although not a citizen of the United States, owes permanent allegiance to the U.S. This is generally a person born in a land that is not a state, but that is under U.S. sovereignty, jurisdiction, or administration -- for example, American Samoa.) An individual lawfully admitted for permanent residence must possess an alien registration receipt card (I-551) prior to appointment on the grant. Individuals on temporary visas, those seeking asylum, or refugees are not eligible for support from the IMSD Program.

The purpose of the IMSD program is to achieve greater participation in the biomedical and behavioral research enterprise of this country of students from UR groups. For the purpose of the IMSD program UR groups include those reported by the National Science Foundation (NSF) as well as the National Academies to be nationally underrepresented in biomedical and behavioral sciences (i.e., African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands, and people with disabilities). Applicants may include and identify any other categories that institutional policies have determined to be underrepresented in biomedical and behavioral research fields with a strong rationale, appropriate references, and official validated documentation. Selection of program supported participants should take into consideration whether the students participation would help achieve the overall goals/objectives of the proposed institutional program and the MBRS goals. It is the responsibility of the applicant institution to establish the qualifications of students prior to their selection for the IMSD program.

Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Evaluation and Dissemination Plan: Applications must contain an evaluation plan and a dissemination plan. Applications submitted without Evaluation and Dissemination section may be delayed in the review process or not reviewed.

Number of Applications. Applicants may not submit, or have pending, more than one IMSD grant application. Eligible institutions may only hold one IMSD award.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Renewal applications are allowed for this research education program.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs.

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 14 of the SF424(R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the 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.

Research Education Program

While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The evaluation plan must be based on appropriate literature and cited methodology. The plan should also identify the selected evaluator and present his/her credentials.

A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g. Web postings, presentations at scientific meetings, workshops, etc.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Salary support for the PD/PI (or combination of multiple PDs/PIs) is limited to up to 2.25 person months during the academic year and 0.75 person months in the summer, depending on person months devoted to the administration of the program. Program coordinators are allowed as long as their role in the program implementation is clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the program coordinators with a strong justification must be included in the budget justification.

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.

Cost of consultants for evaluation of the program is allowed; however, if the evaluator is an employee of the applicant institution, the cost must be included in the category of key personnel salary (listed as person months).

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Salary support is allowed for undergraduate students participating in a research internship, as long as there is an employee-employer relationship between the student and the institution. The total compensation must be reasonable and commensurate with the institutions support scale for the work performed provided the following criteria are met: (a) it is the institutions practice to provide compensation for all students in similar circumstances regardless of the source of support for the activity, (b) the undergraduate student is not supported for more than 15 hours per week during the academic year and not more than 40 hours/week during the summer, and (c) student participation in the specific developmental activity is not a curriculum requirement for graduation. A justification must be provided if the requested support for undergraduates is more than $12 per hour. Support for students is not provided for time spent by the students participating in IMSD-sponsored, non-research activities, e.g., group-learning activities, attendance at conferences, etc.

Graduate (Ph.D.) students are allowed a salary compensation package that includes salary, fringe benefits, tuition and fees up to the maximum NIH-permitted annual graduate student support, which is NRSA level #0 for postdoctoral trainees, as indicated in the Graduate Student Compensation policy, located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html. (See NIH webpage for current figure http://grants.nih.gov/training/nrsa.htm.).

It is an expectation of NIGMS that those students who are enrolled in Ph.D. programs as part of the IMSD program will be trained in two years to compete successfully for support from other departmental, federal or non-federal graduate-training sources for which they are eligible, in order to complete their programs. Students may not concurrently hold another federally sponsored stipend or fellowship, other federal award that duplicates IMSD support, or supplemental salary support, e.g., from a mentors federal research grant. However, concurrent with IMSD support, students may make use of federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill), or may receive funds from a Pell Grant, based on financial need. Such funds are not considered supplementation or compensation.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged. The applicant institution must provide information that documents a commitment to the MBRS goal of increasing the number of UR students, faculty and investigators engaged in biomedical and behavioral research. In addition, the applicant institution must demonstrate that the goals of the proposed IMSD research education program will be an integral part of its research and research training endeavor. The application must include a description of support (financial or otherwise) to be provided to the program, which could include support for curriculum implementation, support for additional participants in the program, space, shared laboratory facilities and equipment, release time for the Program Director and participating faculty, or any other creative ways to improve and enhance the growth of the research education program. While cost sharing is not required, the applicant institution should show that funds for program activities, especially student support, are not merely being substituted for institutional resources.

A letter of institutional commitment may be attached at line Item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date: December 25, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not required
Application Submission/Receipt Date: January 25, 2010, 2011, 2012
Peer Review Date: June-July

Council Review Date: October, 2010, 2011, 2012
Earliest Anticipated Start Date(s): December 2010, 2011, 2012

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays to view the application image.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critiques from the previous review.

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.

Pre-award costs are allowable. 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 the NIH Grants Policy Statement.

IMSD applications must present an integrated set of student development activities and therefore a single consolidated budget is required. Each item in the budget must be clearly justified. IMSD grant awards include some restrictions as to how the funds may be used. The following account summarizes the non-allowable costs under the IMSD Program.

Unallowable Costs include:

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS 398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

2. SF 424 Research & Related Other Project Information, Item 7 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI (or multiple PDs/PIs, if applicable) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. Provide the biographical sketch for each key personnel, including the consultant(s) and potential research mentors. The biographical sketches of the faculty members must include the past record in training and mentoring UR students, their teaching and/or research achievements, and extramural research support. Additional biographical sketches of faculty members that can serve as mentors can be included as a document in the appendix.

4. Research & Related Budget: Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI (or multiple PDs/PIs, if applicable) must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program.

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. The allowable categories of participant support costs are summarized in Section IV.5 for this FOA.

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.

5. PHS 398 Research Plan Attachments:

The Research Plan component of the IMSD application should be organized to reflect the institutional scope of the proposed program, and it should be presented as an integrated set of student developmental activities that enhance academic excellence and promote timely progression of students to the next academic/career step. The page limit for the Research Plan (corresponding to PHS 398 sections on Specific Aims, Significance, Preliminary Studies for New Applications and Progress Reports for Renewal and Revision Applications, and Approach) is 25 pages. Use the appendix to include tables (samples provided below), figures, diagrams, charts, and evaluation instruments. Make clear and precise statements to refer to their location in the body of the research plan.

Details of the information required to be included in an IMSD grant application in each of these sections in the Research Plan are presented below.

Part 1 of this section (Introduction): is required and permitted only for resubmissions (previously known as revisions). The introduction must provide detailed information regarding the changes to the proposed project in response to the comments provided by reviewers in the summary statement of the previous application. The introduction should not exceed three pages (these are not counted as part of the 25-page limit of the Research Plan).

Part 2 of this section (Specific Aims): The application must address (a) the overall goals and specific measurable objectives (including anticipated milestones defined as anticipated intermediate steps toward the objectives) that the institution expects to accomplish in preparing UR students to pursue/complete Ph.D. degrees in biomedical and/or behavioral science research and in striving to achieve the IMSD goals and expectations; (b) the future impact of the proposed IMSD program on the institutional demographics of both the student and faculty pools; (c) the overall number of UR students at the institution that complete Ph.D. degrees in biomedical and/or behavioral sciences at institutions with research-intensive environments (including the applicant institution) and that continue competitive post doctoral training and engage in productive research careers; and (d) how the proposed IMSD program will contribute to the NIH-MBRS goals as described in the research education objectives, see Section I.

Part 3 of this section (Significance): include the following specific items:

1) Institutional Setting and Current Status of the Undergraduate and/or Graduate Biomedical Science-Related Academic Programs: Provide a brief description of the mission of the institution and its academic components. Provide evidence of the institutions commitment to diversify the student and faculty demographics in the biomedical and/or behavioral sciences and describe ongoing institutional efforts in this area. Briefly describe the current diversity programs and counseling/mentoring services (funded by the institution and by sponsoring entities) and their success in preparing and graduating UR students as well as all other students in the sciences. Applicants are strongly encouraged to use the following format to provide the required information.

Table 1 Summary of Student Development and Research Training Programs

 

Title Program 1

Title Program 2

Title Program 3

Project Duration (Years)            Start and Ending Dates

 

 

 

Funding Entity

 

 

 

Program Goals

 

 

 

Participant Number

 

 

 

Target Audience

 

 

 

Eligibility Criteria (if applicable)

 

 

 

2) Institutional Student and Faculty Profile: For the last five (5) years, provide the numbers and trends of (a) the total number and percent of students that completed B.S./B.A. degrees in biomedical/behavioral-related disciplines at the institution and completed Ph.D. degrees in biomedical and/or behavioral sciences at institutions with research-intensive environments; and (b) the total number and percent of students that have completed Ph.D. degrees in biomedical and/or behavioral sciences at the institution, continued competitive postdoctoral training, and engaged in productive research careers. Applications must include data for UR* groups (defined as members of any of the following groups: African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands), as well as data for non-UR* groups. Applicants may also include data for other-UR1 groups defined as members of the groups not included in the provided UR definition and that fit the description provided in the diversity recruitment and retention plan section below (i.e., individuals from other underrepresented groups that the applicant institutions policies can convincingly demonstrate to be underrepresented, individuals with disabilities, individuals from disadvantage backgrounds). For the current year only, provide the number of faculty (overall, UR, Non-UR and/or Other-UR) and their research funding history (NIH R01 or equivalent) in the biomedical/behavioral-related departments at the institution. Applicants are strongly encouraged to use the following formats to provide the required information.

Table 2 Cumulative Summary of Institutional Baseline Data

Reporting Period: __________________

INSTITUTIONAL BASELINE DATA

UR*

Number (%)

Non-UR*

Number (%)

Other-UR1

Number (%)

Total number and percent of student enrollment at the institution

 

 

 

Total number and percent of undergraduate students enrolled in biomedical/behavioral-related departments

 

 

 

Total number and percent of graduate students enrolled in biomedical/behavioral-related departments

 

 

 

Total number of students who completed B.S./B.A. degrees in biomedical/behavioral-related departments

 

 

 

Total number of students who completed M.S. degrees in biomedical/behavioral-related departments

 

 

 

Total number of students who completed Ph.D. degrees in biomedical/behavioral-related departments

 

 

 

Number of alumni from biomedical/behavioral-related departments who went on to obtain Ph.D. degrees in sciences in the past 10 years. (This information can be obtained from WebCaspar, an NSF database.)

 

 

 

List of departments included in this table:

Instructions: For the last five (5) years, provide the institutional cumulative number and percent for the indicators above to create an institutional baseline profile. Note: UR* is defined as members of any of the following groups: African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands. Other-UR1 is defined as members of the groups not included in the provided UR* definition and that fit the description provided in the diversity recruitment and retention plan section below (i.e., individuals from other underrepresented groups that the applicant institutions policies can convincingly demonstrate to be underrepresented, individuals with disabilities, individuals from disadvantage backgrounds).

Table 3 Institutional Faculty Data

Reporting Period: __________________

Biomedical/Behavioral Related Departments

Total Tenure-Track Faculty

Faculty participating in externally funded research

Number (%)

UR*

Number (%)

Non-UR*

Number (%)

Other-UR1

Number (%)

Total

Biology

 

 

 

 

 

Chemistry

 

 

 

 

 

Physics

 

 

 

 

 

Psychology

 

 

 

 

 

Mathematics

 

 

 

 

 

Other:_______

 

 

 

 

 

Institution-wide

 

 

 

 

 

Instructions: For the current year only, provide the number and percent of tenure-track faculty (total, UR*, Non-UR* and/or Other-UR1) in biomedical/behavioral related departments. Of these totals provide the number and percent of faculty who are engaged in externally funded research defined as NIH R01 or equivalent. Examples of participating departments are shown; modify and/or include others as appropriate and that match the departments whose data was provided in Table 2. Note: UR* is defined as members of any of the following groups: African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands. Other-UR1 is defined as members of the groups not included in the provided UR* definition and that fit the description provided in the diversity recruitment and retention plan section below (i.e., individuals from other underrepresented groups that the applicant institutions policies can convincingly demonstrate to be underrepresented, individuals with disabilities, individuals from disadvantage backgrounds).

Table 4 Institutional Graduation Data: Undergraduate / M.S. / Ph.D.

Create a separate table for each academic level offered at the applicant institution and label them: Table 4A (Undergraduate Graduation Data), Table 4B (M.S. Graduation Data) and Table 4C (Ph.D. Graduation Data), as applicable.

Reporting Period: __________________

Biomedical/Behavioral Related Departments

Total Graduated Students

Number (%)

Total Non- UR*

Number (%)

Total UR*

Number (%)

Detailed UR* Totals

Other-UR1

Number (%)

African American

Number (%)

Hispanic American

Number (%)

American Indian

Number (%)

Natives of the U.S. Pacific Islands

Number (%)

Biology

 

 

 

 

 

 

 

 

Chemistry

 

 

 

 

 

 

 

 

Physics

 

 

 

 

 

 

 

 

Instructions: For the last five (5) years, provide the cumulative number and percent of undergraduate / M.S. / Ph.D. students that graduated from the applicant institution. Examples of participating departments are shown, modify and/or include others as appropriate. Notes: UR* is defined as members of any of the following groups: African Americans, Hispanic Americans, American Indians, and Natives of US Pacific Islands. Other-UR1 is defined as members of the groups not included in the provided UR* definition and that fit the description provided in the diversity recruitment and retention plan section below (i.e., individuals from other underrepresented groups that the applicant institutions policies can convincingly demonstrate to be underrepresented, individuals with disabilities, individuals from disadvantage backgrounds).

3) Vision and Anticipated Value of the Proposed IMSD Program to the Institution: Discuss the potential impact of the proposed IMSD program on: (a) the institutions academic programs for preparation and graduation of UR students for biomedical and behavioral research careers, and (b) the demographics of both the student and faculty pools. Provide the rationale for incorporating particular features into the proposed IMSD program based on appropriate referenced literature and the institutional self-assessment. Describe the institutions vision of the IMSD program and how it will be integrated into any of the existing academic programs, and how it will partner with or complement other externally funded and institutionally funded educational research training programs, including NIH T32 training programs and other undergraduate/graduate student training programs. Describe options available to the institution for embracing and incorporating, beyond the scope of the grant, any particularly effective curricular, training, programmatic elements, etc., that may be developed within the institutions IMSD program.

Preliminary Studies for New Applications and Progress Reports for Renewal and Revision Applications should be contained in the Research Education Program Plan.  Applications should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal (noncompeting continuation) applications.

For new applications, briefly describe and summarize any significant achievements within the last five years of institutional and externally sponsored initiatives that have encouraged and helped retain UR students, postdocs and faculty in the IMSD-program-participating departments.

For renewal applications, a detailed progress report must be included. Applications with only one previous funding cycle must provide information on the past funding cycle. Applications with more than one previous funding cycle must provide information on the past two consecutive funding cycles. In the report, state the original and specific measurable objectives, anticipated milestones and outcomes, as well as a summary of the accomplishments of the IMSD program.

Programs with an undergraduate component must report (a) the number of the IMSD-supported undergraduate students; (b) the number who graduated with B.S./B.A. degrees in biomedical/behavioral-related disciplines; (c) the number who matriculated into graduate-degree programs in biomedical and/or behavioral sciences at institutions with research-intensive environments (including the applicant institution if applicable); and (d) the status of those who entered graduate programs (number who remain in training, completed graduate training, or withdrew from graduate training).

Programs with a graduate component must report (a) the number of the IMSD-supported graduate students; (b) the number who remain in training or other support); (c) the number who graduated; and (d) the number who pursue(d) postdoctoral positions and the number who pursue(d) academic, research-related or non-research-related career paths.

Describe the impact and/or value of IMSD program activities on the enrollment numbers, profile, academic environment, and graduation rates of UR students and other related aspects of the institution. Describe what has been learned through the program evaluation and any changes made in the program as a result of the evaluation.

Applicants submitting renewal applications are strongly encouraged to use the following formats to provide the required information.

Table 5 Cumulative Summary of IMSD Program Participants

Create a separate table for each academic level supported by the IMSD program and label them: Table 5A (Undergraduate IMSD Students Data), and/or Table 5B (Graduate IMSD Students Data), as applicable. For example,

Reporting Period: __________________

Table 5A Undergraduate IMSD Student Data

Indicators

Undergraduate (B.S/B.A.) Participants

Number of IMSD-supported participants (IMSD students)

 

Number of IMSD students who participated in summer extramural research internships

 

Number of IMSD students who withdrew from the IMSD program

 

Number of IMSD students who graduated

 

Number of IMSD students still in the program

 

Number of IMSD students who entered M.S. programs*

 

Number of IMSD students who entered Ph.D programs*

 

Number of IMSD students who entered M.D. programs*

 

Number of IMSD students who entered M.D./Ph.D. programs*

 

Number of former IMSD undergraduate students who entered Ph.D. programs that are still in graduate training

 

Number of former IMSD undergraduate students who entered Ph.D. programs that completed graduate training

 

Number of former IMSD undergraduate students who entered Ph.D. programs that withdrew from graduate training

 

Table 5B Graduate IMSD Student Data

Indicators

Graduate (Ph.D.) Participants

Number of IMSD-supported participants (IMSD students)

 

Number of IMSD students who withdrew from the IMSD program

 

Number of IMSD students who graduated

 

Number of IMSD students still in the program

 

Number of IMSD students who transitioned to other training mechanisms (i.e., T32 programs, fellowships, research grants)*

 

Number of former IMSD students in postdoctoral positions*

 

Number of former IMSD students in non-tenure-track faculty positions for the reporting period*

 

Number of former IMSD students in tenure-track faculty positions for the reporting period*

 

Number of former IMSD students in other research-related positions (industry, government, etc.)*

 

Number of former IMSD students in non-research-related positions

 

Instructions: Provide the information for total number of IMSD-supported participants only (students that received salary wages). Applications with only one previous funding cycle must include information from the last funding cycle. Applications with more than one previous funding cycle must include information from the last two consecutive funding cycles. Note for tables 5A and 5B: *Include only the number of IMSD participants who actually entered a post-graduate program, training mechanism or career path. Do not include graduates who applied for or were accepted into a program, training mechanism or career path but did not enter it.

Table 6 Summary of Research Publications Co-authored by IMSD Students as

Reporting Period: __________________

Student Name (Year of Entry)

Student Academic Level (Undergraduate/ Graduate)

Mentor (s)

Publications/Electronic Link (if available)

Student name 1 (XXXX)

 

 

 

Instructions: Applications with only one previous funding cycle must include information from the last funding cycle. Applications with more than one previous funding cycle must include information from the last two consecutive funding cycles. List IMSD supported students sequentially by the year of entry and provide the academic level while supported by the program. Provide the citation of publications resulting for the students work and highlight the name of the program-supported student. Provide the electronic link to the publication, if available. Do not include conference presentations or abstracts.

The Research Strategy should be re-titled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director/Principal Investigator (or multiple PDs/PIs, if applicable): Describe arrangements for administration of the program, provide evidence that the Program Director(s) is actively engaged in research and/or teaching in an area related to the mission of the NIGMS and the NIH, and can organize, administer, monitor, and evaluate the research education program; and provide evidence of institutional and community commitment and support for the proposed program. The responsibilities of the PD typically include placement of students in research laboratories and coordination and implementation of developmental and mentoring activities. In addition, the PD is the principal contact with MBRS/MORE/NIGMS at the institution and prepares and submits in a timely manner the required reports, e.g., annual progress reports, changes in program activities if any, etc. The PD works with the program evaluator (see below) to monitor and evaluate the progress of individual program elements and the overall functioning of the program.

An institutional IMSD Advisory Committee may be included as a component of the application. Describe its role and how it will provide counsel to the PD and to the chief executive of the institution in meeting the goals of the IMSD program and the institution. The composition of the committee must reflect the institutional approach and support for the proposed program and may include representatives of the administration, faculty, investigators, mentors, collaborators, PD/PIs of other student development programs at the institution, current and former student participants.

Describe the composition and functions of the advisory committee and list the names and titles of the members including their institutional affiliations. The following are some typical functions of an advisory committee: advise and assist the PD in the development and implementation of program procedures and practices, assist the PD in establishing criteria and procedures for the admittance/retention of students and faculty mentors, monitor progress of program activities and student participants, advise on rebudgeting of funds, help to expand the present effort by identifying internal and external funding sources, monitor compliance with NIH policies and regulations, and, if necessary, assist in selecting a new PD and addressing faculty and student grievances related to the IMSD program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of NIH. IMSD mentors are expected to have NIH R01 or equivalent extramural research support as well as high-impact publications in their fields. Provide a summary of relevant information on the faculty members who would be research mentors and, in addition, those faculty and/or staff who would conduct the student development activities. Provide the biographical sketches of the faculty members with past records in training and mentoring UR students, include their teaching and/or research achievements, and extramural research support in the Research & Related Senior/Key Person Profile Section (see Section IV.6, SF424, above). Additional biographical sketches of faculty members that can serve as mentors can be included as a document in the appendix. Applicants are strongly encouraged to use the following format to summarize the required information in the application.

Table 7 Summary of Research Mentors and Student Development Facilitators

Faculty Name

Biomedical/Behavioral Related Department

Program Role (Mentor/Facilitator)

Research Topic

Current Research Funding

 

 

 

 

 

Instructions: For the current year only, provide the name of faculty that will serve as research mentors and the faculty that will conduct the student development activities. For each faculty member provide his/her biomedical/behavioral-related department, research topic, and current external research funding defined as NIH R01 or equivalent.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops). Provide detailed information on plans to improve the academic and research competitiveness of UR students at the undergraduate and/or graduate levels and to increase their graduation from Ph.D. programs. A coordinated development plan is required, designed to achieve the overall goals and specific measurable objectives of the proposed program.

Provide a brief rationale for each activity proposed and concise information on the selection process for the participants in the IMSD program, including the criteria related to the students academic status, monitoring of student progress, and role of the faculty/personnel involved. Describe how each proposed specific academic development activity will contribute toward realization of the measurable objectives. Describe the milestones (i.e., anticipated intermediate steps toward the objectives). Give a brief account of the proposed schedule of the activities and whether these activities will be available to all students. Discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives.

Proposed student development activities may include, but are not limited to, the following: activities to improve scientific critical thinking, written/oral communication, and problem-solving skills; time-management and group learning opportunities; supplemental instruction [see for example, Treisman, U. (1992), College Mathematics Journal 23(5), 362-372]; independent library and/or bench research; interdisciplinary or advanced courses with focus on critical thinking and use of quantitative skills to address biomedical/behavioral problems; opportunities to meet and discuss career choices with appropriate role models; research-oriented technical training courses or workshops for graduate students; research proposal development and grants writing workshops for graduate students; research and other training experiences; and any other training that could facilitate entry into careers in biomedical or behavioral research for persons trained in mathematics, computer sciences, and other quantitative sciences. These activities may be offered to full-time matriculated students during the academic year and/or in special summer sessions. Activities may also expand the scope of ongoing institutional efforts to diversify the pool of students and faculty members, i.e., offer training for faculty and administration officials that will support achieving the MBRS goals of increasing the numbers of UR faculty, investigators and students engaged in biomedical and behavioral research, and broadening the opportunities for their participation in biomedical and behavioral research.

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. 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. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc. Describe the retention strategies and follow-up activities that would ensure a highly qualified participant pool. Describe the potential participant pool. Applicants must include a description (including numbers and percent) of the potential applicant pool based on the selection criteria established for the proposed IMSD program. The data on student pool in the participating departments must be consistent with the enrollment numbers provided under the Significance section of the PHS 398 Research Plan Attachments (Section IV.6). Applicants requesting support for a graduate component must also include an applicant outreach and recruitment plan listing the institutions that will be providing the potential IMSD participants.

Describe the process for the selection of the program-supported participants. Include the program selection criteria, candidate qualification process, and final selection process. Also include the name, background, and academic position of the members of the participant selection committee (if applicable). Program-supported participants must be U.S. citizens or non-citizen nationals or permanent residents, must be matriculated fulltime in baccalaureate or doctoral degree programs in biomedical or behavioral science fields at the applicant institution, and their selection must be consistent with the goals of the IMSD program.

Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panels evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIGMS, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will not be reviewed. The purpose of the evaluation is to provide information on the effectiveness of the proposed program on the students and the institution. The plan should be designed to assess and evaluate how the proposed program progresses toward meeting its specific aims, measurable objectives, goals and outcomes. The plan must provide useful information to the PD and the institution for improving the IMSD program. Thus, the emphasis of the evaluation activities in the plan should be on (a) assessment of the overall impact of the program on the institutions baseline numbers and efforts to accomplish its proposed goals of diversifying the institutional pool of students that complete Ph.D. degrees in biomedical and/or behavioral sciences, (b) improvement of the overall program outcome, and (c) informing the senior leadership in deciding which elements of the IMSD program should be institutionalized. The evaluation plan must be based on appropriate literature and cited methodology. The plan should also identify the selected evaluator and present his/her credentials. In general, the evaluator must have formal training and experience in evaluation methodology and statistics demonstrated by publications and/or reports in the field. His/her responsibilities usually include preparation of reports and recommendations for the PD and institutional administrators; interaction with IMSD staff and staff from other campus-wide student academic preparation and educational partnership and research training programs; making recommendations of new administrative structures, policies and procedures; establishing and maintaining contact with institutional officials for the collection and exchange of information; gathering data and information; finding and evaluating alternative solutions; and making recommendations for program direction. The evaluator also provides the conceptual framework for institutional change and suggests ways of reducing the resistance to change. He/she will provide training and technical assistance, as necessary, to staff and to partners to insure integrity and adequacy of data capture and reporting.

Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, program website, etc. The plan must describe how the resources (including but not limited to websites) will be maintained and/or institutionalized beyond the funding cycle. Applications that lack a dissemination plan will not be reviewed.

Resource Sharing Plan(s)

Not Applicable

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 will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nations biomedical, behavioral, and clinical research needs. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. 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 education program 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 high impact/priority score. These criteria are not listed in any order of priority.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the Institute in meeting its objectives. Applicants are strongly encouraged to contact the Institute program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance:

Does the proposed research education program address an important problem or critical question in scientific/education areas and/or topics outlined in this funding opportunity announcement (FOA)?  How will implementation of the proposed program advance the objectives of this FOA?  If the aims of the education program are achieved, will they (1) lead to the development of highly trained scientists in adequate numbers and in appropriate scientific areas as outlined in the FOA, and (2) will they provide public education and outreach on NIH-funded research to a variety of audiences?

 In which ways will the proposed program produce a significant improvement in the academic preparation and competitiveness of UR students for successful completion of Ph.D. degree programs? If the aims/objectives of the program are achieved, what impact will they have on the education, research training and career preparation of UR students, and on their graduation rate in the participating department(s), college(s), and institution? If the aims of the application are achieved, will there be a significant impact on the number of UR students advancing to the next academic/career step? Will the proposed IMSD program significantly improve the institutional baseline number of undergraduate UR students that enter high-quality, competitive graduate programs and complete Ph.D. degrees in biomedical and/or behavioral sciences at institutions with research-intensive environments? Will the proposed IMSD program significantly improve the institutional baseline number of graduate UR students that complete the Ph.D. degree in biomedical and/or behavioral sciences at the applicant institution, continue competitive postdoctoral training, and engage in productive research careers?

Investigator(s): Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, does the PD/PI have appropriate experience to lead the program?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?

Innovation: Is the proposed research education program characterized by innovation, scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?  If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Is there an adequate pool of UR students in the participating science department(s) who are interested in research careers in biomedical and behavioral fields?

Environment: Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Evaluation Plan.

Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?  If applicable, are the plans for obtaining feedback from participants adequate to measure the quality and effectiveness of the research education program?   

 Is the evaluation plan based on appropriate literature and cited methodology? Does the plan adequately describe how the program outcomes will be determined and evaluated? Do the evaluation plan and timeline adequately assess the effectiveness (process and outcome) of the program in achieving its goals and objectives? Is the planned evaluation consonant with the specific aims, measurable objectives, and goals of the proposed IMSD program and the institutional setting? Will the planned evaluation appropriately assess how the proposed IMSD activities will enhance the academic preparation and competitiveness of the targeted population(s) of students and thereby promote their entry into/successful completion of Ph.D. degree programs in biomedical and/or behavioral research fields? Does the plan adequately address evaluation of the programs impact on institutional baseline numbers and efforts to reduce the gap between UR and non-UR students completion of Ph.D. degrees in the biomedical and behavioral science departments? Does the proposed evaluator have the appropriate background and credentials to complete the proposed evaluation plan?

For Renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory?  Do the results of the evaluation document a continued need for support for this program?  Is the approach for the next project period responsive to the results of the program?s evaluation?

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Dissemination Plan: Is the dissemination plan strong and of high quality? Does the plan include a clear statement of how resources (including but not limited to websites) will be maintained and/or institutionalized beyond the funding period?

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans 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.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the impact/priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the impact/priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panels evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the Institute, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

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 NIH 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.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

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 NIGMS to the grantee business official.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research education program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

3. Reporting

Awards made in response to this FOA are subject to SNAP.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. Each year, the progress report must include the number of appointed (program-supported) undergraduate and graduate participants (including name, contact information phone, email, UR group, gender, current academic status, degree pursued and institution), the total number of peer-reviewed publications including program-supported participants as co-authors, the number of former program-supported participants initiating and/or continuing postdoctoral training (including name, contact information phone, email, UR group, gender, current academic status, degree pursued and institution), and the number of former program-supported participants engaged in research careers (including name, contact information phone, email, UR group, gender, current academic status, degree pursued and institution). Since the IMSD is an institutional program, the report must also provide for both program and the institution (students not directly supported using program funds) the following information: the total (cumulative) number of undergraduates completing B.S./B.A. degrees at the applicant institution, the total (cumulative) number of B.S./B.A. graduates that enrolled in M.S., Ph.D. and professional degree programs (D.D.S., M.D., etc) at the applicant institution or elsewhere, the total (cumulative) number of B.S./B.A. graduates that enrolled in Ph.D. programs in biomedical and/or behavioral sciences at institutions with research-intensive environments (including applicant institution), the total (cumulative) number of B.S./B.A. graduates that completed Ph.D. degrees in biomedical or behavioral sciences (including at the applicant institution), and the total (cumulative) number of graduate students that completed Ph.D. degrees in biomedical and/or behavioral sciences at the applicant institution or elsewhere.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Final Reports: A final Progress Report and Financial Status Report are required 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:

Alberto L. Rivera-Rentas, Ph.D.
Program Director, MBRS Branch
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.37, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3900
Fax: (301) 480-2753
Email: riverara@nigms.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3AN.12, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Fax: (301) 480-8506
Email: sunshinh@nigms.nih.gov

3. Financial or Grants Management Contacts:

Ms. Lori Burge
Grants Management Specialist
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
Fax: (301) 480-2554
Email: burgel@nigms.nih.gov


Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
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 (45 CFR 46) 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 institutional review board (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 impact/priority score.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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.

Inclusion of Women, Minorities, and Children:
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 SF424 (R&R) application; 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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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. 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 Part 52 and 45 CFR Parts 74 and 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900, Educational Excellence for Hispanic Americans February 22, 1994, Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993, and Executive Order 13021, October 21, 1996 and Outline of Work Plan, August 18, 1998, White House Initiative on Tribal Colleges and Universities. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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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