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 Diversity (IMSD)(R25)

Announcement Type
This is a reissue of PAR-05-132 which was previously released on June 28, 2005.

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

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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-06-553

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release/Posted Date: September 19, 2006
Opening Date: January 21, 2007 (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(s): February 21, 2007 and 2008, and February 23, 2009
Peer Review Date(s): June-July, 2007, 2008, and 2009
Council Review Date(s): September-October, 2007, 2008, and 2009
Earliest Anticipated Start Date(s): February 1, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 24, 2009

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 to increase the numbers of underrepresented minority faculty, investigators and students engaged in biomedical and behavioral research, and to broaden the opportunities for underrepresented minority faculty and students for participation in biomedical and behavioral research. To accomplish this goal, the Initiative for Maximizing Student Diversity (IMSD) program provides, at research institutions, institutional grants for students from groups underrepresented in biomedical and behavioral research with well integrated developmental activities that will increase their preparation and skills as they advance academically in the pursuit and successful completion of the Ph.D. degree.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Objectives

In the National Institutes of Health (NIH) Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities engaged 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), offers through its Initiative for Maximizing Student Diversity (IMSD) Program, an opportunity to develop new or expand existing effective academic developmental programs, including student research internships, in order to prepare students from groups underrepresented in the biomedical or behavioral sciences for competitive research careers and leadership positions in those fields. MBRS IMSD grants are institutional awards offered to research institutions with significant number of mentors with NIH or other extramural research support and that have significant numbers of full-time matriculated students from groups underrepresented in biomedical or behavioral research fields. These grants may involve one or more biomedical and/or behavioral science-related departments.

The goal of the IMSD Program is to increase the number of students from underrepresented groups in biomedical and behavioral research who enter into and successfully complete the Ph.D. degree programs in these fields. Specifically, the MORE Division of NIGMS expects that the undergraduate students participating in the IMSD program will, upon graduation, directly enter into a Ph.D. program, and that the Ph.D. students participating in the IMSD program will complete their terminal degrees in biomedical and/or behavioral research fields and advance to competitive postdoctoral positions.

Nationally, African-American, Hispanic-American, American-Indian, and Pacific-Islander groups are regarded as underrepresented in these fields. However, it is incumbent on the applicant institution to determine whether a group is underrepresented in biomedical and/or behavioral research fields in establishing its institutional objectives.

The MORE Division recognizes the heterogeneity in institutional settings and institutional missions. Therefore, each applicant institution must establish its own goals and specific measurable objectives for its proposed program within the expectations set by the MORE Division. Various strategies may be utilized to attain the objective of increasing the number of researchers from underrepresented groups 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 successful 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 be prepared for successful research careers, and still others may concentrate on both. The 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.

The specific measurable intermediate stage objectives (milestones), as well as the types of academic developmental activities to achieve the institutional goals and objectives, are entirely determined by the applicant institution. Some examples of measurable objectives are: improvement in the writing and presentation skills of students; improvement of students quantitative skills and academic achievement; and increase in the number of students admitted to research doctoral degree programs. Measurable goals for the doctoral degree students might include improvements in competitiveness for research scholarships, graduation rates, number of research publications, and acceptance to competitive postdoctoral positions.

The IMSD Program can provide support for student academic development activities that are designed to improve reading comprehension and communication skills, time-management, group learning opportunities, independent library or bench research skills, interdisciplinary or advanced courses where students learn quantitative and critical thinking skills to analyze biological and biomedical problems, and opportunities to meet and discuss career choices with appropriate role models.

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 can 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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. 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. Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-03-041, May 7, 2003.

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 amount of funding that NIGMS expects to award through this announcement is approximately $4 Million (total costs) per year for new and renewal applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 4 years. Although the size of award may vary with the scope of the research education program proposed, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $350,000 annually for institutions with programs primarily for baccalaureate degree students, and $550,000 annually for programs that include a significant Ph.D. student component.

The anticipated start dates for new awards are usually February 1 annually.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity announcement.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply in response to this FOA.

The applicant institution must be a research institution that has a significant number of mentors with NIH or other extramural research support, and that awards the baccalaureate and/or doctoral degree in biomedical or behavioral science fields with a significant number of students from groups underrepresented in these fields.

Institutions supported by the MBRS Support of Competitive Research (SCORE) or Research Initiative for Scientific Enhancement (RISE) programs are not eligible to apply for or hold an IMSD grant.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., Reporting. )

The Principal Investigator, referred to as Program Director (PD), should possess the research and teaching experience and leadership and administrative capabilities required to develop and implement the proposed research education. The PD must have a regular full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) preferably at the rank of associate or full professor.

PDs are responsible for the administration and management of the overall institutional program and serve as liaison between the grantee institution and NIH. Typically, a PD possesses a Ph.D. or equivalent degree.

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.

Student Participants: The participants are selected by the applicant institution. There is no specific eligibility requirement for participation in IMSD-supported activities. The program should not deny participation to anyone based solely on his/her race, religion, gender or ethnicity. However, 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 full-time 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 underrepresented groups. Therefore, selection of students in the IMSD program should take into consideration whether the student’s participation would help achieve the overall goals/objectives of the proposed institutional program. Unless strongly justified on the basis of exceptional relevance to the NIGMS/MORE mission, this research education program should be used primarily for the education of students from underrepresented groups. Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans, Alaska Natives, Native Hawaiians, and Pacific Islanders.

It is the responsibility of the applicant institution to establish the qualifications of students prior to their IMSD participation.

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

Applications must contain an evaluation plan.

Applications submitted without these sections may be delayed in the review process or not reviewed.

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

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PD/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 Started

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.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 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 301-710-0267, 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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

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 should also identify the selected evaluator and present his/her credentials.

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 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.

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 and listed as person months.

IMSD student travel is limited to domestic scientific conferences if presenting his/her research.

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, provided there is an employee-employer relationship between the student and the institution, that the total compensation is reasonable and commensurate with the institution s support scale for the work performed, that it is the institution’s practice to provide compensation for all students in similar circumstances regardless of the source of support for the activity, that 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 that participation in the specific developmental activity is not a curriculum requirement for graduation. (Note: 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.). If the requested support for undergraduates is more than $10 per hour, a justification must be provided.

Graduate (Ph.D.) students are allowed a salary compensation package for up to two years 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 a Ph.D. program as part of the IMSD program will have been 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 mentor’s 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.

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.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 21, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: Not required
Application Submission/Receipt Date(s): February 21, 2007 and 2008, and February 23, 2009.
Peer Review Date(s): June-July, 2007, 2008, and 2009.
Council Review Date(s): September-October, 2007, 2008, and 2009.
Earliest Anticipated Start Date: February 1, 2008.

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.

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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction (3 pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

Please note that 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:

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: are necessary to conduct the project, and 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.

6. Other Submission Requirements

The NIH requires the PD/PI 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. 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

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:

Videos, CDs, and/or DVDs specifically related to the research education program. Applicants should contact the SRA for submission instructions after application assignment.

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.

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

2. SF 424 Research & Related Other Project Information, Item 9 (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 as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. The biographical sketch for each key personnel, including the consultant(s) and potential research mentors, should include information on his/her teaching and/or research achievements, current grant support, and the past student training record.

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 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.2 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:

There are five parts to the Research Plan. Part 1 refers to PHS 398 section on Introduction, and is required only for resubmissions (previously known as revisions). Parts 2-5 correspond to PHS 398 sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods.

IMSD applications typically include academic programs that extend across several departments, e.g., Biological Sciences, Behavioral Sciences, Mathematics, Chemistry, Physics, Computer Sciences, etc. Hence, 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, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods) is 25 pages, including tables, figures, diagrams, and charts.

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.

Specific Aims (Part 2): In this section, the application must address the overall goals and specific measurable objectives (including anticipated milestones) that the institution expects to accomplish in preparing underrepresented group students to pursue/complete a Ph.D. degree in biomedical and/or behavioral science research, and how these objectives contribute to the NIH-MBRS goals. The objectives must be presented in context of MORE Division’s expectations that a) at least 60% of the undergraduate students participating in the IMSD program will, upon graduation, directly enter into a Ph.D. program, and b) at least 90% of the Ph.D. students participating in the IMSD program will complete their terminal degree in biomedical and/or behavioral research fields.

Background and Significance (Part 3): Include the following specific items in this section:

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 institution's commitment to diversity, particularly in the hiring of faculty from groups underrepresented in biomedical and/or behavioral fields, especially in the participating science departments. Describe the current academic programs and counseling/mentoring services, and their success in preparing and graduating students from underrepresented groups and all other students in the sciences. Discuss any perceived impediments at your institution to the success of students in biomedical sciences in general, and of underrepresented group students in particular, with reference to graduation and preparation for careers in research in biomedical sciences. Cite literature on which you base your rationale for incorporating particular features into your program.

2) Student Enrollment, Graduation and Career Paths: Provide baseline data, e.g., average data over the previous four years on the overall and underrepresented student enrollment, number of students (overall and underrepresented) majoring in the participating departments, their relative graduation rates and the subsequent career paths and/or education plans of students.

3) Vision and Anticipated Value of the Proposed IMSD Program to the Institution: Discuss the potential impact of the proposed IMSD program on the institution’s academic programs for preparation and graduation toward careers in biomedical and behavioral research, with regard to underrepresented and other students. Describe the institution’s vision of the IMSD program and how it will be integrated into any of the existing academic programs. Describe how the IMSD program will partner with and complement other externally funded initiatives, including NIH-funded T32 training programs, for undergraduate/graduate student training. Describe options available to the institution for embracing and incorporating, beyond the scope of the grant, any particularly effective curricular, training, programmatic, etc., elements that may be developed within the institution’s IMSD Program.

Preliminary Studies/Progress Report (Part 4): This section should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal applications.

For new applications, briefly describe and summarize any significant achievements within the last four years of any programs at the institution that have encouraged and helped retain underrepresented students, postdocs and faculty in the IMSD program-participating departments.

For renewal applications, an explicitly identified, detailed progress report (in place of Preliminary Studies) must be included. State the original and specific measurable objectives, anticipated milestones and outcomes. Provide, in narrative and/or tabular form, a summary of the accomplishments of the IMSD program during the previous four-year project period, including the number and percent of underrepresented minority undergraduate, and Ph.D. students (as applicable) who participated in and graduated from, and who entered into or completed (as applicable) the Ph.D. degree in biomedical and/or behavioral research fields. Describe the effect of IMSD program activities on the enrollments, academic environment, and graduation rates of underrepresented students and other related aspects of the institution. Provide a list of those students who participated, during the previous four-year project period, in research and/or other IMSD Program-supported developmental activities, e.g., workshops, scientific meetings, etc. Describe any significant honors, and awards to these students (give specific dates) that were related to, or resulted from, involvement in activities supported by the IMSD program. Describe what has been learned through the program evaluation and any changes made in the program as a result of the evaluation.

Provide a list, for the previous eight-year project period (if applicable), of those students who were supported by the IMSD program. This list should give each student’s name, department, the underrepresented group he/she belongs to, type and year of degree earned, current plans or status, and contact information.

Research Design and Methods (Part 5): This section should be retitled "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(s): Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NIGMS, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.

The responsibilities of the PD typically include selection and 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 is a required component of the application. It can provide counsel to the PD and to the chief executive of the institution in meeting the goals of the IMSD program and those of the institution. The IMSD advisory committee may include the PD (ex officio), one or more key personnel from the IMSD program and NIH-funded T32 training programs, IMSD student representative(s), a representative of the institution's business office (preferably the fiscal administrator assigned to handle the grant), and a representative of the institution’s central administration (e.g., dean or provost). Other representatives may be selected based on their ability to further the goals and specific measurable objectives of the program.

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 the NIGMS.

IMSD mentors are expected to have significant NIH or other extramural research support; provide relevant information on a sample of these faculty members who would be research mentors and, in addition, those faculty and/or staff who would conduct the student development activities. Provide their biographical sketches (see Section IV.6, SF424 Research & Related Senior/Key Person Profile, above), emphasizing their teaching and/or research achievements, extramural research support, and their record in training and mentoring students.

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 underrepresented students at the undergraduate and/or graduate levels and to increase their entry into, and 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 reading comprehension and 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 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 programs may be offered to students during the academic year and/or in special summer sessions.

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 training 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 and follow-up activities that would ensure a highly qualified participant pool.

Student participants must be U.S. citizens or non-citizen nationals or permanent residents and must be matriculated full-time in baccalaureate or doctoral degree programs in biomedical or behavioral science fields at the applicant institution. The data on student pool in the participating departments must be consistent with the enrollment numbers provided under the Background and Significance section of the PHS 398 Research Plan Attachments (Section IV.6).

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 be returned without review.

The main purpose of the evaluation is to provide information useful to the PD and the institution for improving the IMSD program. Thus, the emphasis of the evaluation activities should be on overall program improvement and on informing the senior leadership in deciding which elements of the IMSD program should be institutionalized. The plan should also identify the selected evaluator and present his/her credentials.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIGMS in accordance with 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 Nation’s biomedical, behavioral, and clinical research needs. 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 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 NIGMS in meeting its objectives. Applicants are strongly encouraged to contact NIGMS program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NIGMS? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NIGMS? In which ways will the proposed program produce a significant improvement in the academic preparation and competitiveness of students from underrepresented groups for entry into/successful completion of the 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 underrepresented 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 underrepresented students advancing to the next academic/career step?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 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 participant pool?

For renewal applications only: Has the research education program successfully achieved its stated objectives, especially in the context of NIGMS-MORE Division’s expectations (see Section IV.6 Specific Aims ), during the prior project period? 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? What is the track record of this program in preparing students from underrepresented groups who enter into and successfully complete the Ph.D. degree programs in biomedical and/or behavioral research fields?

Innovation: Is the research education program original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area, and specifically for competitively preparing students from underrepresented groups to enter into/successfully complete the Ph.D. degree programs in biomedical or behavioral research fields? Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution? 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.

For renewal applications only: Has the program been innovative in the past and does it continue to demonstrate innovation?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Is the make-up of the advisory committee appropriate and consistent with the scope of the proposed research education program? Is there an adequate pool of research mentors who are extramurally funded and experienced in training students in research?

Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? How does this program interact with NIH-supported T32 training programs? Is the institutional commitment to the proposed program and to diversity, particularly in hiring of faculty from groups underrepresented in biomedical and/or behavioral fields, appropriate? Is there an adequate pool of underrepresented students in the participating science department(s) who are interested in research careers in biomedical and behavioral fields?

Evaluation Plan: Is the evaluation plan, including the benchmarks, and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Are the planned activities consonant with the proposed objectives and are they appropriate to the background and ability of the undergraduate and/or graduate IMSD participants? Does the application provide adequate details of the planned student developmental activities? Will the planned IMSD activities enhance the academic preparation and competitiveness of the targeted population(s) of students and thereby promote their entry into/successful completion of the Ph.D. degree programs in biomedical and/or behavioral research fields?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF 424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

Resubmission Applications (formerly revised/amended applications): In addition to the above criteria, the following criteria will be applied to resubmission applications:

Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

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 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 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.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

Not applicable

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

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.

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.

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.

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 during and 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:

Hinda Zlotnik, Ph.D.
Chief, 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: zlotnikh@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
E-mail: sunshinh@nigms.nih.gov

3. Financial or Grants Management Contacts:

Ms. Antoinette Holland
Grants Management Officer
PPBC/MORE Team
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
E-mail: hollanda@nigms.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (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).

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 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.

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