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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:  Short Courses in Integrative and Organ Systems Pharmacology (R25)

Announcement Type
This is a reissue of RFA-GM-05-006, which was previously released April 26, 2004.

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.

Request For Applications (RFA) Number: RFA-GM-08-010

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release/Posted Date: December 17, 2007
Opening Date: January 26, 2008 (Earliest date an application may be submitted to Grants.gov):
Letters of Intent Receipt Date(s): January 26, 2008
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 26, 2008
Peer Review Date(s): July 2008
Council Review Date(s): October 2008
Earliest Anticipated Start Date(s): December 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 27, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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

The purpose of this FOA is to solicit proposals for a Short Course(s) in Integrative and Organ Systems Pharmacology. The definition of Integrative and Organ Systems Pharmacology for the purpose of this FOA is as follows: "Research using in vivo animal models or substantially intact organ systems that are able to display the integrated responses characteristic of the living organism that result from complex interactions between molecules, cells, and tissues."

The National Institute of General Medical Sciences (NIGMS) recognizes the value of studies using intact organ system and in vivo animal models in the conduct of research. Such studies are important because isolated molecules and cells in vitro do not accurately display all of the properties that they possess in vivo. Isolated molecules and cells do not adequately reflect the function of intact tissues, organs, and organ systems. Normal physiology, pathology, and pharmacology reflect not only interactions between molecules and cells, but interactions of multiple tissues, organs, and organ systems as well. There is a growing need for functional analysis of biological systems to connect results at molecular and cellular levels to the expression of genetic and environmental determinants in the whole organism.

Concerns have been raised by academic and industrial scientists about the training of current students in the area of integrative and organ systems sciences. Most graduate students in the basic biomedical sciences receive limited training in physiology and integrative pharmacology. Even within the discipline of pharmacology, not all students gain sufficient hands-on experience with in vivo animal models and organ systems. Graduates need to have sufficient understanding of how to choose and use models that appropriately reflect the human condition under study. Furthermore, students need the skills to communicate with other scientists across the breadth of science from isolated molecule to whole animal and human clinical research that is required for translation of research results into health benefits.

Several factors suggest an increasing need for students trained in integrative and organ systems sciences. Bioinformatics and genomic approaches are suggesting new targets for study. Hypotheses generated by in vitro studies or by computational biology and systems approaches to the integrative behavior of living systems need to be tested in the actual living organism. Growth in the ability to use of genetically modified organisms requires a parallel growth in the ability to characterize the phenotypic changes in these organisms. Interest is growing in behavioral and neurobiological phenomena that can only be studied in relatively intact systems and living organisms. Discoveries in the areas of chemistry, genomics, and pharmacogenetics have accelerated the rate of research and have increased the demand for integrative and organ systems pharmacologists in the pharmaceutical industry. Pharmacologists, experienced with in vivo models, form an integral part of every drug discovery and development project and are essential to assuring that only safe and efficacious lead compounds go forward to clinical trials. New tools have become available that enhance the collection efficiency and value of pharmacological data obtained in vivo. Appropriate training in the use of these tools is essential.

Academic infrastructure at many institutions may not be able to meet the demand for appropriate training in this area. The success of reductionist approaches based on molecular and cellular methods has resulted in the displacement of many of the researchers formerly engaged in integrative and organ systems studies. The cost of animal subjects research has increased and the use of animal subjects in basic medical and graduate instruction has been significantly curtailed. The training to be provided by the solicited Education Projects will help restore the balance between in vitro and in vivo approaches to science.

The above analysis is based on input NIGMS staff gleaned from multiple sources that were discussed in the previously issued FOA soliciting Short Courses for Integrative and Organ Systems Pharmacology (RFA-GM-05-006). Since then, additional articles have appeared indicating a continued need for training in this area, not only in the U.S., but in the international workforce, e.g., Collis MG (2006) What is the future role of pharmacologists in the pharmaceutical industry? , Trends in Pharmacological Sciences 27, 126-129. British Pharmacological Society and the Physiological Society (2006) Tackling the need to teach integrative pharmacology and physiology: Problems and ways forward. Williams M (2005) Systems and integrative biology as alternative guises for pharmacology: Prime time for an iPharm concept? Biochemical Pharmacology 70, 1707-1706.

Calls for support of research training in the integrative and organ systems science continue to be heard from a broad coalition of scientific societies led by the American Society for Pharmacology and Experimental Therapeutics (ASPET). The International Union of Basic and Clinical Pharmacologists (IUPHAR) has started a new initiative to develop knowledge objectives in this area and increase dissemination of curriculum materials.

Pharmaceutical industry representatives continue to stress the value of a broad training that includes integrative and organ systems research experiences. An ASPET-Industry Integrative and Organ Systems Sciences fund has been established to help provide support for training in this area.

Meetings with the directors of graduate programs in pharmacology that were held at Vanderbilt University (2005) and the University of Utah (2007) indicated a continued need for special initiatives in this area. See: Barnett J (2006) Directors of Pharmacology Graduate Programs: Pharm Phorum. Molecular Interventions 6, 4-7 and website for 2007 meeting: http://www.pharmacy.utah.edu/pharmtox/ndogs07/program.html. Review of recent annual progress reports for the primary NIGMS training grant supported programs of graduate training in the pharmacological sciences indicates that these programs continue to be dominated by work stressing cell cultures and lower eukaryotic models rather than mammalian models.

The Declaration on Animals in Medical Research (2005) by the Research Defense Society reaffirms the importance of research involving animal subjects to advances in medical care, while also reaffirming the importance of ethical use of animals and support for the 3R’s - replacement, reduction, refinement when using animals in research. See: The Veterinary Record 57, 272 (2005). The solicited courses are consistent with these principles by helping to assure that proper training is provided to enable scientists to optimally utilize animals in research.

As the importance of translational research continues to be emphasized, a number of courses have been offered by various for profit and non-profit organizations. However, most of these courses are not suitable for graduate student training, are overly focused on drug discovery and drug development or on single model organisms, and/or do not provide significant hands-on experience.

Thus, the short courses solicited by this and the previous FOA provide unique opportunity for the pharmacological research community to address this training need.

Four courses were funded as a result of the previous FOA (RFA-GM-05-006). Information about these courses is available on the NIGMS website at http://www.nigms.nih.gov/Training/IOSP.htm and on the individual host institution websites that are linked from the NIGMS site. Several articles pertaining to the program and funded short courses have also been published: Preusch, PC (2004), Integrative and Organ Systems Pharmacology: A New Initiative from the National Institute of General Medical Sciences. Molecular Interventions 4, 72-73. Bylund DB, Brunton LL, Cobbett PJR, Persky AM, and Preusch PC (2005), NIGMS Sponsored Integrative and Organ Systems Pharmacology: Synopsis of the 2005 Experience/Anticipation of the 2006 Short Courses. Molecular Interventions 5, 330-333. Shankley N, Cox BF, and Brunton LL (2006), Who’s Afraid of Ligand-Macromolecular Interactions in Complex Physiological Systems?, Molecular Interventions 6, 292-299. Information about the previously funded courses is provided here to assist all potential applicants and does not imply any preferential treatment of the currently funded programs in the present competition.

GOALS FOR THE PROPOSED EDUCATION PROJECT(S):

The project should develop an appropriate and innovative program of instruction in Systems and Integrative Pharmacology to be conducted during an intensive short course (e.g., 2-3 weeks) to be offered in the summer. Other course durations and offering times may be suggested. This program should satisfy the needs of the students for the introduction of basic concepts as well as the acquisition of initial hands-on skills with a number of organ system and intact animal model methods. A combination of lectures, laboratories, demonstrations, and seminars may be employed. The development of novel educational tools and approaches is encouraged. This program embraces physiology and other related areas of integrative and organ systems sciences as they form the underpinnings of in vivo pharmacology.

The target audience for the Education Project(s) includes scientists at all advanced levels of training and career development, although a concentration on students at the graduate level may be appropriate. These projects will not support K-12 or undergraduate education. Graduating seniors who expect to enter graduate school in the near future may be included. Participation of students supported by NIH predoctoral training grants in the Pharmacological Sciences is highly encouraged, but the training should be available to other students as well. Inclusion of students pursuing MD, PharmD, DVM, and other advanced degrees, as well as PhD degree students, is encouraged. Inclusion of postdoctoral fellows and established researchers who are seeking new directions is also appropriate. The course should be open to students from industry and government as well as academia.

NIGMS intends that these courses should serve a national student pool. The awards are intended to benefit the entire research community, not primarily the host institution. Students from the host institution should not make up more than 20-25% of the total student enrollment and in no case should students be enrolled in these courses in lieu of other courses already offered by the host institution. 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.

The project should develop plans for recruiting and selecting students to participate in the project. These plans should be structured in a way that encourages integration of the proposed short course experience into the program of training of students at their home institutions. Agreements with a number of institutions might be developed to encourage participation of their students, but the course should not be limited to institutions with whom such agreements exist. Projects may (but are not required to) include components that provide matching of students to follow-up academic or industrial experiences that will provide additional training in integrative and organ systems pharmacology. It would be useful to establish collaborations with a number of industrial organizations expressing willingness to accept the number of students to be placed. It would be useful to obtain commitments from academic mentors indicating how the student will be able to utilize their training after the course.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

Projects must include plans to evaluate the effectiveness of short course and other activities and to further refine the program in subsequent years of the project period. Plans should also be considered for long-term evaluation of effects on career outcomes of students who participate in the course.

Projects must describe plans to disseminate the educational tools and approaches developed by this project to additional institutions. Provision of handout materials via websites and access to lectures via streaming video or other technologies is highly encouraged. Access to archival video material is desirable.

SUGGESTED SHORT COURSE TOPICS:

The following list of topics for inclusion in a short course is suggestive only, not inclusive or prescriptive:

The short course should not merely cover the necessary techniques to execute a particular protocol. Rather, it should provide an understanding of the strengths and weaknesses of particular models and the important concepts needed to design meaningful experiments. The course should provide not only familiarity with systems that are inherently integrative in their function but should also enhance the ability of the scientist to integrate information about systems. Although much attention may be focused on mouse and rat models, inclusion of other species in some capacity is required.

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.

Institutions which received an award during the previous competition for Short Courses in Integrative and Organ Systems Pharmacology (RFA-GM-05-006) are welcome to apply for a competing renewal in response to this announcement; however, they should include plans to transition to other sources of support for any further activity beyond the end of the renewal project period. Institutions that have not previously hosted a short course in response to RFA-GM-05-006) should submit a new competing application and may be able to apply for a competing renewal, if this FOA is reissued again in the future. At this time, however, NIGMS has made no commitment to continue this program beyond the current FOA.  

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 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 $200,000 d.c. 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.  

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is $1.0 million total costs for fiscal year 2009. Future year amounts will depend on annual appropriations.

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. Foreign institutions that can provide a unique experience to enhance the education program may be included as subcontractors. Foreign scientists with appropriate skills may be included as consultants.

In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified, but is not discouraged in responses to this FOA.

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 PD/PI should be an established investigator in the scientific area in which the application is targeted who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program. The Principal Investigator is expected to commit a sufficient effort to the organization, oversight, development of materials, and instruction of the short course to assure it will be successful.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedure to formally allow more than one PD/PI on individual research projects is available at http://grants.nih/gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a 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 multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/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.nihi.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.

Requirement for Involvement of Multiple Participating Organizations: These Education Project awards will not support curriculum development projects focused on a single institution. For administrative purposes, only one organization may serve as the applicant organization and should coordinate all activities of the project. However, multiple organizations must be committed to the Education Project. It is recommended that the course be run by an organizing committee and that multiple organizations be represented on the organizing committee. The short course may make use of the facilities at multiple organization sites, but this is not essential--appropriate academic, government, independent laboratory, or industrial research facilities should be proposed. Faculty should be drawn from multiple organizations. Inclusion of faculty members representing academia, industry, and government is encouraged. The participation of individual industrial sponsors or industrial organization sponsors is encouraged. The inclusion of letters indicating commitment of non-host institution faculty and of commitment to participation by the target community of the project is recommended.

Participants: Participating faculty and supporting staff may include any scientists with the appropriate skills to provide the intended training. Participating students may include any scientists who would benefit from the proposed training, although it is expected that they will predominantly be predoctoral graduate students. Advertising, application procedures, and selection of students will be a grantee responsibility. The students should be drawn from multiple institutions, not just the grantee institution. No more than 20-25% of the students in any year should be from the host site. Efforts must be made to insure recruitment of a diverse student pool. Both faculty and students may include non-U.S. citizens; however, participating students should primarily be U.S. citizens and permanent residents.

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

Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.

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.

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

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: [email protected].

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

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 15 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 (Section 14 of the Research Plan Component in the SF424 (R&R)), 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, including 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. (See also: NOT-OD-07-017).

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.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

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.

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. Support will be provided only for a combination of curriculum development and short course implementation. Funds may not be requested for curriculum development projects alone.

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.

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. Costs for animals, supplies, and other educational materials; production and dissemination of course content; and program evaluation may be requested. Faculty from participating institutions that are not also providing facilities should be treated as consultants and may be paid a consulting fee as well as reimbursed for travel costs and per diem expenses.

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. Funds may be requested to cover participating student travel costs and per diem expenses. Fees for course credit registration or certification with the grantee institution or the student’s home institution may be charged and these may also be treated as an allowable grant expense. Other tuition and fees that are not associated directly with participation in the short courses may not be charged to the grant. It is recommended that part of the cost be borne by the student, the student’s home institution, mentor, and/or employer as a way to assure commitment to the student’s training. The participating students may be asked to pay tuition or registration fees and differential fee structures may be proposed based on the student’s home institution, financial need, or other factors to be defined by the grantee institution.

Funds for travel expenses to other sites that may participate in follow-on industrial internships and other follow-on activities should not be requested but may be mentioned as industrial or other types of contributions to the overall education program.

Funds will not be provided for fringe benefits or health insurance for participants in any research education program. Individuals supported by National Research Service Awards (T or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism as participants, but may not receive salary or stipend supplementation from a research education program.

Non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens. Fees for foreign travel are not an allowable expense.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged. Such commitment may take the form of contributions of faculty time and effort, laboratory and other educational resources, and follow-on activities that derive from the Education Project grant award. Co-sponsorship of the course by other organizations, such as non-profit and industrial sponsors, is encouraged and should be mentioned in the application. A letter of institutional commitment may be attached at line item 16 (Letters of Support).

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. Submission, Review, and Anticipated Start Dates
Opening Date: January 26, 2008 (Earliest date an application may be submitted to Grants.gov):
Letters of Intent Receipt Date: January 26, 2008
Application Submission/Receipt Date(s): February 26, 2008
Peer Review Date(s): July 2008
Council Review Date(s): October 2008
Earliest Anticipated Start Date: December 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Richard Okita, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
Building Number 45, Room Number 2AS.49
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: 301-480-2802
Email: [email protected]

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. 

In order to expedite the review, applicants are requested to notify the NIGMS Referral Office by email ([email protected]) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.
 
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. Applications will be reviewed for responsiveness by NIGMS staff; those not responsive 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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 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:

APPENDIX MATERIALS

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

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.

If multiple sites are involved in the research education program, the applicant institution must be one of these sites for the program. A justification must be included for sites other than the applicant institution in the program narrative.

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. For example, list here financial contributions to the program expected from private foundations, industry sponsors, or other sources.

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 developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. Key personnel are defined as individuals who contribute in a substantive, measurable way, whether or not salaries are requested. Consultants should be included if they meet this definition.

Also use this section to list any Other Significant Contributors (OSCs). This should include any faculty members participating in the course that are not covered under Senior/Key Personnel. OSCs should be listed after all Key Persons. OSCs are individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (in person months) to the project. These individuals are typically presented at effort of zero person months or as needed (individuals with measurable effort cannot be listed as Other Significant Contributors). Consultants should be included if they meet this definition.

A biosketch, including Research Support information, should be included for all faculty members, regardless of whether they are considered Senior/Key Personnel or Other Significant Contributors (OSCs)..

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. Refer to Section IV.2 for allowable categories of participant support costs.

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:

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

Part 5 of this section (Research Design and Methods) 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)/Principal Investigator(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 practice of research in Integrative and Organ Systems Pharmacology., 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.

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 practice of research in Integrative and Organ Systems Pharmacology.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops). Describe here the specific steps that will be taken to achieve the short course goals stated under Section I.1, Research Objectives, and the specifics of the short course topics, including specific techniques and animal species that will be involved in each course session. Provide details on the instructional format (lecture, demonstration, or laboratory) for each course session.

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. It is recommended that applicants identify in advance a reasonable number of institutions that are committed to sending students to the short courses and obtain appropriate documentation of their commitment to this initiative.

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.

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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p.262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.

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 candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or 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 undergraduate candidates, but would be more difficult to justify for individuals beyond that level of 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 panel’s 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 National Advisory General Medical Sciences Council, will determine whether amended plans and reports submitted after the initial review are acceptable.

For renewal applications, the success of past efforts to recruit and retain a diverse student group will be considered by the peer review group in assigning the priority score.

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. Plans should include follow-up monitoring of student activities after they have completed the course. In addition to undertaking individual evaluation activities of their own courses, directors of funded short courses will be expected to participate in activities related to evaluation of the program as a whole.

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, etc. Directors of funded short courses are expected to share their course experience and instructional materials with the directors of other courses funded in response to this FOA and to otherwise participate in joint activities, such as workshops organized at national meetings, intended to provide benefits to all of the funded courses and to the community at large.

Animal Welfare Assurances: The applicant organization must provide assurance that all students receive appropriate training in the Responsible Conduct of Research involving Animal Subjects prior to beginning any work with animal subjects. If students have received such training at their home institutions, the organization must obtain appropriate documentation of this fact. If students have not received such training at their home institutions, the organization must provide this training. In either case, the organization should provide any additional training necessary for students to meet assurance requirements for use of animals at the host site. Plans to meet assurance requirements should be described in the application. Documentation of assurance will be requested as part of the Just-in-Time information requested at the time of award.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy expects that grant recipients will make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Research education programs are not generally expected to generate research resources. The Dissemination Plan mentioned above should include plans for sharing educational research resources generated by the program such as videos, simulations, web-based instructional materials. Applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Section V. Application Review Information

1. Criteria 

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

2. Review and Selection Process

Applications that are complete and responsive will be evaluatedfor scientific and technical merit by an appropriate review group convened by the 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:

Program priorities may include geographical distribution, balance of scientific topic coverage, institutional commitment and other sponsorship, and diversity of the faculty and student pools with respect to all dimensions of diversity.

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. 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 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 research community for training in Integrative and Organ Systems Pharmacology. 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 area of Integrative and Organ Systems Pharmacology? How will implementation of the proposed program advance the objectives of this funding opportunity announcement?

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 and diverse participant pool?

Does the proposed curriculum of the short course meet the needs of the targeted students?

Does the proposal include follow-on experiences, and if proposed, are the plans for student placements appropriate and the commitment of follow-on experience sponsors adequate?

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 research education program original and innovative? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does this 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.

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? Do the investigators have the necessary administrative experience and leadership skills to assure success of the short course? Do they have sufficient stature in the targeted research community to attract participation of students from the most highly competitive research laboratories and institutions?

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? Is the institutional commitment to the proposed program appropriate? 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)? Are the laboratory and other resources necessary for this project available? Is there evidence of institutional commitment to the courses?

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:

Special Review Criteria: A goal of this FOA is to broadly stimulate research and training in Integrative and Organ Systems Pharmacology by engaging the scientific community broadly in the courses through participation of both faculty and students from multiple institutions. Does the application demonstrate that the course will broadly engage the scientific community?

For renewal applications only:

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? 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?

Dissemination Plan: Is the dissemination plan strong and of high quality? 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.

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.

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 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.

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 panel’s 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 NIGMS national advisory council, will determine whether amended plans and reports submitted after the initial review are acceptable.

For renewal applications, the success of past efforts to recruit and retain a diverse student group will be considered by the peer review group in assigning the priority score.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

NIH policy expects that grant recipients will make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Reviewers will be asked to assess the adequacy of the plan for Sharing Research Resources.

Program staff will also be responsible for the administrative review of the plan for sharing research resources. The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

3. Anticipated Announcement and Award Dates

Applicants may anticipate the announcement of projects to be funded in response to this FOA in December or January, 2009. Non-funded applicants will be notified that their applications have been administratively withdrawn.

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, unless strongly justified.

Consultation with the NIGMS program staff is strongly encouraged when a change of institution is being considered. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the NIGMS may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the NIGMS for review:

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.

Joint Activities of Funded Projects: Dissemination activities involving joint meetings of the faculty and program directors of the funded programs with or without participation from additional members of the educational community may be developed after the initial awards are made. The costs for such activities may be paid from the grant awards. Funds for such activities may be approved as administrative supplements to one or more of the funded grants.

3. Reporting

Awards made in response to this FOA are not 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.

The Progress Report should include a schedule of the course lecture, demonstration, and laboratory sessions as they were actually conducted during the reporting period. It must include a list of the faculty that participated in the course and their home institutions and departments. It must also include a list of students who participated in the course, along with their home institutions, departments or degree program, research mentors or sponsors, and research project title at the home institution. The report should indicate any known follow-on activities in which the students are participating. If the coordination of such activities is a formal part of the Education Project, then a detailed summary, including information about follow-on host site, mentor, and specific project, should be provided. Information about efforts to recruit students and implementation of plans to recruit a diverse student pool should be discussed. Samples of advertising and curricular materials developed as part of the project that cannot be submitted electronically should be mailed directly to the responsible program official named in the Notice of Award. The report should describe any resource sharing activities that have taken place.

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.

The final Progress Report should summarize all activities conducted during the entire funded project period, not just the last year of support. It must include the names of all faculty members who participated in the course and their home institutions and departments. It must also include a list of all students who participated in the course, along with their home institutions, departments, and research mentors, if known. It should include a statement of any plans regarding continuation of course offerings with other sources of support and final reports on evaluation and dissemination activities.

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:

Richard Okita, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
Building Number 45, Room Number 2AS.49
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: 301-480-2802
Email: [email protected]

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
Building Number 45, Room Number 3AN.12F
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Fax: 301-480-8506
Email: [email protected]

3. Financial or Grants Management Contacts:

Lisa Moeller
Grants Administration Branch
Division of Extramural Activities
National Institute of General Medical Sciences
Building Number 45, Room Number 2AN.50C
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3914
Fax: 301-451-5601
Email: [email protected]

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).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
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.

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance 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 Part 52 and 45 CFR Parts 74 and 92. 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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