Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health http://www.nih.gov

Components of Participating Organizations
This RFA is developed as a Roadmap initiative.  All NIH Institutes and Centers participate in Roadmap initiatives.  This RFA will be administered by the National Center for Research Resources on behalf of the NIH.  http://www.ncrr.nih.gov

Title: Interdisciplinary Research Consortium (U54) 

Announcement Type
New

Request For Applications (RFA) Number: RFA-RM-06-008

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates

Release Date: January 20, 2006
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Dates(s): December 19, 2006
Peer Review Date(s): May-June, 2007
Council Review Date(s): September, 2007
Earliest Anticipated Start Date: September 30, 2007
Additional Information To Be Available Date (Url Activation Date): January, 2006
Expiration Date: December 20, 2006

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(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
      B. Sending an Application 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
    A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

In addition to the biological sciences, biomedical research often involves participation by other scientific disciplines, including the behavioral, quantitative, social, computational/information, engineering, and physical sciences.  Distinct disciplinary perspectives represent significant sources of strength to the overall research enterprise because each discipline has its own intellectual history, experimental and analytic approaches, and theoretical context that produce a unique way of thinking about a problem.  Nevertheless, as scientific capabilities move forward, increasingly sophisticated questions arise, and these often require the convergence of perspectives from multiple disciplines.  Over the years, the Institutes and Centers (ICs) of the National Institutes of Health (NIH) have developed many initiatives, mechanisms and programs to support either disciplinary or multidisciplinary research (where multidisciplinary research is defined as bringing together different disciplines to focus on a circumscribed problem, but keeping the disciplines distinct).

It is becoming apparent that, in some cases, multidisciplinary research is not sufficient to address, in a comprehensive and effective way, challenging and complex problems in biomedical and behavioral research.  Rather, interdisciplinary research may be required to tackle these more complex problems.  Like multidisciplinary research, interdisciplinary research brings together different disciplines to address a particular issue.  But unlike multidisciplinary research, interdisciplinary research takes bits and pieces from the contributing disciplines and integrates them in ways that produce a new conceptual framework.  Integrating different disciplines in this way holds the promise of opening up currently unimagined scientific avenues of inquiry, and in the process, may form whole new disciplines.  Historical examples include the development of genomics, which was formed from genetics, molecular biology, analytical chemistry, and informatics.  Another example in which multiple disciplines have, in a less directed way, blended and evolved into a new discipline is neuroscience.  Thirty years ago, students of the brain might have identified themselves as anatomists, physiologists, or psychologists, but today most would consider themselves neuroscientists.  Importantly, interdisciplinary research does not merely result in new technical approaches, but new intellectual approaches; that is, new ways to conceptualize and think about a research problem.

This RFA invites applicants selected under PAR-06-122 to submit an interdisciplinary consortium application.  The purpose of this program is to support interdisciplinary approaches to solving significant and complex biomedical problems, particularly those that have been resistant to traditional approaches.  These applications must hold the promise of leading to new research approaches to improving human health.  Interdisciplinary consortia are expected to identify an important biomedically relevant problem, evaluate why previous approaches have not worked, justify why the proposed interdisciplinary approach will work, identify the methods that will keep the interdisciplinary team focused and coordinated, and propose a timeline.  The review criteria will involve both the significance of the problem as well as the interdisciplinary nature of the approach to solving the problem.  Applications will have to be strong in both of these areas.  A successful interdisciplinary approach is defined as combining aspects of individual disciplines to provide a new conceptual approach to solving a problem that is likely to yield insights that could not have been achieved by an isolated laboratory or using a multi-disciplinary approach. 

Each interdisciplinary research consortium will be submitted as a single unified grant application.  However, applicants will separate this application into component parts described below.  At the time of an award decision, the application will be disaggregated into its components.  Each of these components will receive separate yet administratively linked awards.  Each of these components will have a principal investigator.  Any changes between the components proposed in the X02 application and those in the full consortium application must be discussed with and approved by program staff. 

Because of the diverse needs required for interdisciplinary research, a consortium application will allow:  research grants (R01, R21 mechanisms), research training/mentored career development/research education awards (T90/R90, K01, and R25), and core support for other components (P30).  In addition, each consortium will be required to have a central cooperative agreement that will use the U54 mechanism with elements that are described below.  Applicants are free to choose the best set of mechanisms to fit the needs of the consortium, but they should be parsimonious in the number of mechanisms they choose.  Applicants should not feel compelled to use all of the available mechanisms.  An application may include multiple components that use the same mechanism.  However, in such submissions, each component using the same mechanism must describe in detail the distinctions that require separate funding. 

The sum of all of the direct costs for the entire consortium may not exceed $3M in any year, and is restricted to $2.8M in year 1.  Facilities and Administrative costs (also known as F&A or as indirect costs) for subcontracts in individual applications are not to be counted in this total.  The linkage between the parts of the consortium will be acknowledged in the notice of grant award, and special terms will be included in these awards to provide a means to reallocate resources between awards in future years. 

All of the linked applications that are part of the consortium will be evaluated by the same special emphasis panel.  That panel will score each component of the application as well as the entire application.

 2. Central Cooperative Agreement

The central component of each Consortium will use the NIH U54 cooperative agreement award mechanism, which is intended to support scientific cohesion and operational coordination of the consortium.  The Principal Investigator of the central component will serve as the scientific spokesperson for the consortium, and is the principal contact between the consortium and NIH.  In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the "Cooperative Agreement Terms and Conditions of Award”.  

3. Non-Research Components of an Interdisciplinary Research Consortium Award

It is important to emphasize two points regarding the use of multiple and separate, linked, components in consortia.  First, the various components comprising each consortium must be highly integrated with each other so that synergy is produced by the collection of components that would not be possible through the award of separate, non-linked, grants.  Second, while these consortia allow for activities beyond research, the focus and predominant activity of each consortium must be research; other activities are meant to complement the research efforts and should not overshadow them.

Applicants for these components must identify any potential budgetary or programmatic overlap and/or synergism with existing NIH supported training and education programs so that reviewers and program staff will have a clear understanding of how the programs relate to one another.

Research Career Development Component (K01):

K01 Mentored Research Scientist Development Award – This award is based on the NIH K01 program (see PA-06-001), located at:  http://grants.nih.gov/grants/guide/pa-files/PA-06-001.html) and, for this Interdisciplinary Research Consortium (IRC) program, is specifically interested in eligible individuals who wish to pursue career development activities involving interdisciplinary approaches to solving significant and complex biomedical problems.  Individuals must have a research or a health-professional doctorate or its equivalent at the time of application. Candidates must devote a minimum of 75% of full-time professional effort conducting research and research career development activities associated with interdisciplinary research during the award period of three to five years.

See Section III Eligibility for additional information, Section IV for information to be submitted in the application, Section V for review criteria, and Section VI. 3. Reporting.

Research Training Component (T90/R90)

T90/R90 National Research Service Award (NRSA) Training Grant – This award is based on the NIH NRSA Institutional Research Training Award Program (RFA-RM-06-006) located at:  http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-006.html, and, for this IRC program, is specifically interested in applications to support both predoctoral and postdoctoral research training programs for trainees who wish to pursue interdisciplinary research approaches to resolving significant and complex biomedical problems.  Such programs are for full-time research training, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, and must be unique and distinctly related to interdisciplinary research, in conjunction with the overall goals of the IRC U54 program.  This IRC will support programs that include non-NRSA eligible trainees, however, programs that include only non-NRSA eligible individuals will not be allowed.  This component may not be from for-profit institutions/organizations, and, if awarded, may not be transferred to another institution/organization.  The application must include a Diversity Recruitment and Retention Plan, a plan for Training in the Responsible Conduct of Research, and an Evaluation Plan.

See Section III Eligibility for additional information, Section IV for information to be submitted in the application, Section V for review criteria, and Section VI.3. Reporting.

Research Education Component (R25)

R25 Research Education Program – This award provide support for short courses, seminars, workshops, etc. to allow opportunities for those involved in the consortium to become informed of and present recent findings and new developments for consideration and dissemination to a larger community, as well as the development of web-based or distance learning approaches for information dissemination.  This component can also be used to support innovative educational training programs to support the needs of the consortium members or potential members. The application should focus on how the proposed research education component benefits the interdisciplinary approach proposed by the consortium.  The R25 component, if awarded, may not be transferred to another institution/organization.  The application for the R25 component must include an Evaluation Plan.

4. Technical Assistance Workshop

A technical assistance workshop will be held in conjunction with a meeting on Interdisciplinary Research (http://www.niddk.nih.gov/fund/other/roadmap2006/index.htm) that will occur on February 9 and 10 in the Lister Hill Auditorium on the NIH Campus.  The technical assistance workshop will begin at 1 pm EST on Friday, February 10, 2006.  Potential applicants will be able to participate in the technical assistance workshop either in person on by viewing the workshop online at http://videocast.nih.gov/.  In either case, potential applicants will be able to ask questions of program staff involved in managing this program.

5. Additional Information

A web page with information about the interdisciplinary consortium program will be available at http://www.ncrr.nih.gov soon after this RFA is released.  This Web site will include a frequently asked questions section as well as other material that an applicant might find useful.  Applicants are urged to check this Web site frequently as they develop both their pre-applications and their full applications.

Because several different components are included in this RFA, additional information unique to each component is provided throughout the announcement.  Specific information is located in Sections III, IV, V, and VI.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U54, R01, R21, competitive supplements, T90/R90, K01, R25, and P30 award mechanisms.

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

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting a component (other than a T, K, or R25) with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

Note that the K01, T90/R90, and R25 components are required to use the non-modular concepts submitting budgets, without regard to the amount of total direct costs being requested.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available  

The NIH Roadmap expects to award $40 million to Consortia in the first year of this program to fund eight consortia.  Each Consortium application can request direct costs of up to $2.8M in the first year and up to $3.0M in years 2-5.    Each Consortium will be awarded for five years although the components that make up Consortium need not all be five years in length with the exception of the U54 component.  Depending on the availability of funds and the priorities of the NIH Roadmap funds may be available to extend the program in FY2012. 

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The Interdisciplinary Research Implementation Group (http://nihroadmap.nih.gov/interdisciplinary/) will invite applications for Interdisciplinary Research Consortia from among those that submit a pre-application in response to PAR-06-122.  Only those selected through a peer review of their pre-application are eligible to apply for a full Interdisciplinary Research Consortium.   

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

While foreign institutions are not permitted to submit a U54 application, they are allowed to submit R01, R21, P30, or competitive supplement components of a proposed consortium.  

The applicant institution/organization must be the primary site for the program, and the application must include a Resources Format (PHS 398) page for each participating institution/organization.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

1.B.1 Eligibility for the K01 Component

A candidate for the K01 component must have a research or a health-professional doctorate or its equivalent at the time of application, and must have demonstrated the capacity or potential for highly productive research.  The candidate must identify a mentor with extensive research experience in a new discipline.  A candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development during the entire award period. The candidate must clearly describe the need for intensive research supervision that will lead to mastery in a new discipline.  Candidates for the K01 may have been principal investigators on NIH research or career development awards, provided the research experience proposed in this application is in a fundamentally new field of study.  

Applications may be submitted, on behalf of candidates, by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Individuals from underrepresented racial and ethnic groups, women, and individuals with disabilities are encouraged to apply.  Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award.  Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible for this award.

Candidates for this component must identify a mentor(s) with extensive and appropriate research experience for the proposed research career development plan.  The mentor should be recognized as an accomplished investigator and have a track record of success in training independent investigators.  The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.

The applicant institution must have a well-established record of research career development activities and qualified research faculty to serve as mentors.  The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the candidate.  The candidate, mentor, and sponsoring institution must describe a career development program that maximized the use of relevant research and educational resources.

l.B.2. T90/R90 Eligibility for the T90/R90 research training component

Only domestic, non-profit, public or private institutions/organizations are eligible to submit applications for this component.  The Program Director will be responsible for planning, directing and executing the proposed research training program, as well as for the selection of trainees and the submission of all required forms. The Program Director must be a funded investigator and evidence of ongoing research funding during the requested award period must be provided. 

The proposed component must be distinct from those research training programs currently receiving federal support.  Individuals supported by other federal programs may not receive concurrent support from this program.

Program Director:  The program director will be responsible for the planning, directing, and executing the proposed research training program.  This individual should be an established researcher with acknowledged accomplishments in interdisciplinary research and in training, and should be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.  The program director will be responsible for the selection of trainees and the submission of all required forms.

For the T90 (NRSA) - At the time of appointment, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence.  Individuals on temporary or student visas are not eligible for NRSA support.  In addition, trainees must be able to commit full-time effort to the program at the time of appointment.

For the R90 (non-NRSA) – Individuals select as non-NRSA trainees in the T90/R90 component should satisfy all of the conditions for NRSA trainees, except for those pertaining to citizenship.

Predoctoral  trainees must have received a baccalaureate degree by the beginning date of their research training appointment, and must be training at a post-baccalaureate level and enroll in a program leading to a Ph.D. in a research doctoral degree program, or a combined clinical degree program, such as M.D./Ph.D.  NRSA traineeships are not provided for study leading to a M.D., D.O., D.D.S, or other similar professional clinical degree, or master’s degree.  Individuals currently supported by other Federal funds are not eligible for concurrent trainee support from this program. An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards.

Postdoctoral research training is for individuals who have received, at the time of appointment to the program, a Ph.D., D.N.Sc., D.V.M., M.D., D.M.D., D.C., D.O., O.D., D.P.M., Sc.D., Eng.D., Dr.P.H., D.N.Sc, D.Pharm., N.D., D.S.W., Psy.D., D.D.Ss, allied health doctoral degrees such as the D.P.T., or a comparable doctoral degree with a significant research component from an accredited domestic or foreign institution.  Individuals currently supported by other Federal funds are not eligible for concurrent trainee support from this program.   An individual may receive no more then three years of NRSA support in the aggregate at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship swards.

Additional information may be obtaining in the NRSA Guidelines at:  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187.

1.B.3. Eligibility for the R25 Research Education Component

The Program Director of the research education program should be actively engaged in research and/or teaching in the area of interdisciplinary research, and can organize and administer the research education program. The senior investigator must have greater than 5 years postdoctoral experience.

2. Cost Sharing or Matching

Cost sharing is not required.   

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
 
Not applicable

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the Web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the Face Page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the Face Page of the application form, and the YES box must be checked.

The central U54 component of the application should be the first component presented.  Following that the applicant should present the other components of the application.  Each component should begin with a separate cover page   (see specific instructions below) followed by the description, performance sites and personal page, then a table of contents, then a detailed budget for the initial budget period, then a budget for the entire proposed period of support, then a budget justification, then biographical sketches, then a resources page, and then the research plan.  Specific instructions for the appropriate sections of all of the components can be found in the Other Submission Requirements section.  Individual components, with the exception of the U54, should not have a checklist.  Individual components should not have an appendix.  Only one appendix is allowed for the entire application.

Instructions for Individual Components

Use the PHS 398 continuation page (MS Word PDF) to create a cover page to introduce each project; do not include a PHS 398 Face Page for each project.

Give each research project a unique title. State the name and title of the project leader and participating investigators. For easy cross-referencing, type the research project's number and title on the upper left-hand margin of all relevant pages.

The cover page should contain the following items only:

Note that PHS 398 Section III application instructions must be followed for a K01 component, and PHS 398 Section IV application instructions must be followed for a T90/R90 component.

Note also that K01 applicants must include three sealed letters of reference with the application, in accordance with the “K” instructions.

Foreign Organizations

Several special provisions apply to components submitted by foreign organizations.  Foreign organizations may not submit the T90/R90, K01, or R25 components.

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable
Application Receipt Date(s): December 19, 2006
Peer Review Date: May-June, 2007
Council Review Date: September, 2007
Earliest Anticipated Start Date: September 30, 2007

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Interdisciplinary Consortia
Office of Review
National Center for Research Resources

6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Telephone: (301) 435-0811

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the Face Page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the Face Page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCRR. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable, except for the T90/R90 component. 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 competing continuation 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 competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

T90/R90 research training component:

6. Other Submission Requirements

The interdisciplinary consortium application will be submitted as a single application that is broken up into components.  Each component will start with a cover page.  The entire application must be prepared using the PHS 398 forms.  None of the components of the application may be submitted electronically through Grants.gov.  Follow the instructions in the PHS 398 form for the appendix.  Only one appendix is allowed for the entire application.  Each component must not have a separate appendix. 

1. U54 Component

The U54 component allows the applicant to present a summary of the overall goal of the consortium and the workings of the interdisciplinary team.  The U54 component is a required in all consortium applications and must be the first of the components of the consortium to be presented in the application.  The U54 does not have the same format as the typical application described in the PHS 398, and the headings described in those instructions should not be followed.  Instead, the applicant must have the Overview and Team sections described below.  The applicant can also have an Other Projects section following these two sections.

1.1. U54 Face Page   

On the Face Page of the application, the Title (line 1) must end with “(1 of %) where % indicates the number of components that make up the consortium.  All of the titles of the parts of the consortium must have a similar phrase at the end of their titles.  The PI of the U54 should assign these numbers.

On line 2, the yes box must be checked.  The title of this program should be listed as Interdisciplinary Research Consortia and the number of this RFA (from above) should be included.

In line 7, report the direct and total costs for all of the components of the consortium in the first year.  The direct cost number should match the number in the “Composite Budget” described below.

In line 8, report the direct and total costs for all of the components of the consortium over the full five year period.  The direct cost number should match the number in the “Composite Budget” described below.

If the Other Projects section proposes experiments that involve human subjects or vertebrate animals, lines 4 or 5 should be completed.  If human subjects or vertebrate animals may be part of pilot projects in future years that are not described in this application, lines 4 and 5 should be checked yes, following instructions in the PHS 398.  If human subjects or animal studies are parts of the component projects but are not part of any of the work proposed in the U54 component, lines 4 and 5 should be checked no. 

1.2. U54 Table of Contents

On Form Page 3, the Research Plan should include the divisions specified below rather than the normal A-D sections discussed in the PHS 398 instructions. 

1.3. U54 Budget

On the budget pages, the PI for the consortium must devote at least 35% effort to the U54.  An appropriate salary should be requested.  The salary for the project manager and any administrative personnel for effort distinctly associated with the U54 also may be requested.  Salaries requested for this U54 must be consistent both with the established salary structure at the sponsoring institution/organization and salaries provided from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The direct costs for the Other Projects cannot exceed $150,000 in the first year and cannot exceed $300,000 in years 2-5.  The budget for the Other Projects should use a separate Form Page 4 and Form Page 5.  The modular budget format must not be used.

In addition to the budget for the U54, the applicant should prepare a composite budget for all of the components that are part of the consortium.  This budget should be labeled “Composite Budget” and should be placed after Form Page 5.  The format for this budget is different from the usual budget format for either Form Pages 4 or 5. In the composite budget, the applicant should list the direct costs (not including F&A costs for subcontracts) for each component for each year of support.  The applicant should also list the total costs (which would include the F&A costs for both subcontracts and for the parent institution) for each year of support.  This page should be useful to the applicant to ensure that the direct costs for the consortium as a whole do not exceed the overall annual limits.

1.4. U54 Biographical Sketches and Resource Section

The instructions in the PHS 398 should be followed for the biographical sketches and the resources section.  The biographical sketch for the PI of the U54 component should be first.  The biographical sketches for all of the other members of the consortium should follow this in alphabetical order. 

The resources section of the U54 application should only include information about the U54 component and should not include information about all of the other components.

1.5. U54 Research Plan

The research plan should follow the resources section and should have the format described below.  The overview section is limited to 20 pages, the team section is limited to 20 pages, and other projects section, if present, is limited to 15 pages.

1.5.1 U54 Overview Section

The U54 component must begin with an Overview section.  The Overview section is limited to 20 pages. This section should be subdivided into:

A) an Introduction describing the problem that the consortium is going to address,

B) a Background section describing the previous disciplinary and multidisciplinary approaches to the problem, and explaining why these approaches have not solved the problem,

C) an Interdisciplinarity section describing the proposed interdisciplinary approach.  This section must contain a table with a listing of disciplines involved and the members of the research team that represent each discipline.

1.5.2 U54 Team Section

Following the Overview, the U54 must have a section entitled Team that will describe the membership and workings of the proposed interdisciplinary research team.  The Team section is limited to 20 pages.  The Team section should be broken down into two parts:  Membership and Management. 

A) The Membership part of this Team section must describe the role to be played by each of the key personnel involved in the consortium application (which includes all of the components of the consortium).  At a minimum, all of the principal investigators of all of the components of the consortium must be included in this section.  Applicants are reminded that key personnel are defined as individuals who contribute to the scientific development or execution of the project in a substantive, measurable way.  The inclusion of a professional project manager is expected in these consortia, and should be supported in the U54 component; the project manager is considered one of the key personnel.  Biographical sketches must be included for all key personnel.  This portion of the application should be used to justify the choice of particular representatives of disciplines as members of the team.

B) The Management part of the Team section must discuss the management of the consortium.  In this section, a very brief summary of each of the components should be made.  The relationship and interactions among these components, as well as the synergies and the value added by these interactions should be summarized.  Applicants will have the ability to describe the interactions between components of the application in more detail in a later section entitled “Interactions” in each of the components.  In addition to describing the research interactions among the various components, this section should address the management of the team.  How often will team members get together?  What steps will be taken to continue to build a common language among the existing members of the team and any new team members?  How will disagreements be managed?  Since independent awards will be made, how will the team ensure that all members will continue to work together toward the objectives of the consortium?  The Cooperative Agreement Terms and Conditions of Award require that an Interdisciplinary Research Consortium (IRC) Steering Committee be established.  The composition of this IRC Steering Committee must be described in this section.  The IRC Steering Committee will monitor progress of the Consortium, will encourage improvements, and will coordinate the interdisciplinary research of the Consortium.  In addition, the applicant should describe whether there will also be an External Advisory Board and how will that board interact with the team.  If an External Advisory Board is going to be proposed, applicants must not include the names of people who would serve on that board in the application although they may indicate the sorts of expertise that they will recruit for the advisory board.  Applicants should not contact potential board members until after awards have been made.

The management section should also describe the process for identifying and reviewing the projects that will be supported under the “Other Projects” section. The quality of the “Other Projects” included for first year funding will be evaluated during NIH peer review as an indication of the quality of the U54 process for choosing these “Other Projects.”

1.5.3 U54 Other Projects

Finally, the U54 component may have an Other Projects section.  The Other Projects section is limited to 15 pages.  This part of the application will describe other activities that are necessary for successful operation of the interdisciplinary team that do not have a logical home elsewhere in the set of consortium applications.  Examples could include pilot projects; travel for members of the external advisory committee; travel and support for seminar speakers; evaluation efforts; support required to obtain access to information in national, state, or local government offices; or efforts to continue to develop a common language among both existing and new team members from different disciplines.  This list is not exhaustive, but applicants should contact program staff if they are considering projects not on this list.  The applicant should explain why these other projects are necessary for a successful interdisciplinary consortium.  If more than one type of project is proposed, the budget allocations among these various projects could change from year to year.  For that reason, a timeline may be useful in the Other Projects section.  The budget for the Other Projects is restricted to $150,000 direct costs in year 1 and $300,000 in years 2-5.  Applicants should take care not to request funds for similar items in the Other Projects section and in any of the other components of the consortium. 

In summary, the body of the U54 application must have the following parts:

Overview Section (required section limited to 20 pages)

A) Introduction
B) Background
C) Interdisciplinarity
        Table of disciplines

Team Section (required section limited to 20 pages)
A) Team Members
B) Team Management
        Composition of the IRC Steering Committee

Other Projects (optional section limited to 15 pages)
        Timeline (if appropriate)

If appropriate, sections E trough J (human subjects, vertebrate animals, literature cited, consortium arrangements, resource sharing, and letters) should follow the body of the U54 application.  The PHS 398 instructions must be followed for each of these sections. 

The Checklist should be the final page of this part of the application.

1.6 Other Components

The next component of the consortium should follow the checklist for the U54.  With the exception of the P30 component, there is no limit to the number or type of components that are chosen.  An applicant can choose to use several different components that have the same mechanism. However, when several different components with the same mechanism are included in the application, the application must describe in detail the distinctions identifying unique characteristics that differ to the degree that separate funding is being requested.  Any real or apparent overlap with existing sources of support or with the components for which funds are being requested for research training or research education must be thoroughly explained. The only limit is imposed by the overall budget limits for the consortium.

2. R01 Component

It is anticipated that the R01 component will be used in a variety of ways depending on the needs of the consortium.  Traditional, hypothesis based science that has commonly been supported using this mechanism will be welcome.  However, discovery based or non-hypothesis based science is also welcome.  Such applications might involve tool and technique development, could focus on public policy issues, or could focus on social, legal, and ethical issues.  In cases where the R01 is being used to support “non-traditional” approaches, reviewers must not penalize the application for the lack of a hypothesis.

The R01 component can also be used to build bridges to existing awards from non-NIH agencies as part of the interdisciplinary research consortium.  Examples of non-NIH parent awards could be those from another federal agency such as NSF or DOE, or those from private foundations like the Howard Hughes Medical Institute.  The direct costs for the parent award must be at least $250,000 per year.  If the ending date of the non-NIH parent award does not correspond to the end date of the interdisciplinary consortium, the applicant should follow one of three options:

1) The R01 could terminate when the parent award terminates.

2) The R01 could have a significant reduction in effort that would allow for a phase out of the proposed project.

3) If the parent award has provided all of the items needed to continue the proposed activities, the award could continue with no reduction in effort.  An example of this situation would be the case where the parent award was used to build instrumentation that could be used by this R01.  The applicant would be expected to provide strong justification for this option.  

2.1 R01 Cover Page

See instructions for individual components: #IndividComponentsInstructions.

2.2 R01 Budget

Applicants do not need special permission to have a budget larger than $500,000 direct costs.  If the direct costs for the budget are $250,000 or less, the modular budget format should be used.

2.3. R01 Biographical Sketches and Resource Section

The biographical sketches for key personnel involved in the R01 should be included in the U54 component of the application and should be duplicated in this component.  The resources section should be completed for this component.

2.4 R01 Interactions Section

Following the Research Designs and Methods section (part D of the Research Plan), the applicant must prepare a section with the title “Interactions.”  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the results of the various specific aims will be used by other applications that are part of the consortium.  They should also discuss what other components of the consortium will provide to this application.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the 25 page limit of the Research Plan.

3. R21 Component

The goal of the R21 component is to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects.

3.1 R21 Cover Page    

See instructions for individual components: #IndividComponentsInstructions.

3.2 R21 Budget

Applicants can request a budget of up to $275,000 for two years.  No more than $200,000 can be requested in any one year.  The modular budget format should be used.

3.3. R21 Biographical Sketches and Resource Section

The biographical sketches for key personnel involved in the R21 should be included in the U54 component of the application and should be duplicated in this component.  The resources section should be completed for this component.

3.4 R21 Research Plan

The Research Designs and Methods section is limited to 15 pages.  No preliminary data is required, but it may be included if it is available.

3.5 R21 Interactions Section

Following the Research Designs and Methods section (part D of the Research Plan), the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the results of the various specific aims will be used by other applications that are part of the consortium.  They should also discuss what other components of the consortium will provide to this application.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the 15 page limit of the Research Plan.

4. Competitive Supplements to Existing NIH Awards

A competitive supplement allows the interdisciplinary consortium to form links to existing research programs and research training and to bring a new interdisciplinary approach to those programs.  Competitive supplements to existing R01, R24, R37, T32, T90/R90, all P awards and all U awards will be accepted. 

4.1 Competitive Supplement Cover Page

See instructions for individual components: #IndividComponentsInstructions.

The competitive supplement must have the same Principal Investigator as the currently funded award. 

4.2 Competitive Supplement Budget

The budget period can only last as long as the funding period of the parent award.  The budget format (modular or non-modular) used in the parent grant should also be used for this component. 

4.3. Competitive Supplement Biographical Sketches and Resource Section

The biographical sketches for key personnel involved in the competitive supplement should be included in the U54 component of the application and should be duplicated in this component.  The resources section should be completed for this component.

4.4. Competitive Supplement Research or Research Training Plan

The research plan can be no longer than 15 pages and must include the specific aims of the currently funded award and a description of how the competitive supplement will be used to bring an interdisciplinary approach to the funded award.  The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application. 

4.5 Competitive Supplement Interactions Section

Following the Research Designs and Methods section (part D of the Research Plan), the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the results of the various specific aims will be used by other applications that are part of the consortium.  They should also discuss what other components of the consortium will provide to this application.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the 15 page limit of the Research Plan.

5. T90/R90 Components

The goal of the T90/R90 component is to develop and implement novel training programs focused on interdisciplinary science.  This component will use the T90/R90 award mechanisms.  This component of the consortium is based on RFA-RM-06-006 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-006.html) with some small modifications.  Awardees will be expected to participate in the annual meetings referred to in RFA-RM-06-006.

5.1 T90/R90 Cover Page    

See instructions for individual components: #IndividComponentsInstructions.

5.2 T90/R90 Budget Guidelines

Applicants can request funds for up to five years rather than the four-year limit specified in RFA-RM-06-006.  There is no limit on the direct costs for the T90/R90 component of the consortium although these direct costs do count toward the overall direct costs for the consortium.  There is no limit on the number of non-NRSA eligible individuals that can be supported in any year, but programs to train only non-NRSA eligible individuals are not allowed.  Detailed information must be provided that document the distinction from current research training programs currently receiving federal support at the sponsoring institution/organization.  Individuals currently being supported by other federal funds may not receive concurrent trainee support from this U54 program.

Funds may be requested in accordance with FY 2006 NRSA budgetary allowances.  See the NIH Notice dated August 2, 2005 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html  which states the tuition policy, and the NIH Notice dated January 9, 2006 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html for stipend and training related expense amounts that may be requested.

A facilities and administrative allowance based on 8% of total modified direct costs (excludes tuition, fees, health insurance, and equipment) may be requested. 

5.3 T90/R90 External Advisory Committee

This component should not have a separate external advisory committee.

5.4. T90/R90 Biographical Sketches and Resource Section

The biographical sketches for key personnel involved in the T90/R90 should be included in the U54 component of the application and should be duplicated in this component.  The resources section should be completed for this component.

5.5 T90/R90 Research Training Program Plan

5.5.1 All Program Components (T90 and R90)

Scientific Environment:  The scientific environment is expected to be strongly collaborative and with many opportunities to engage in interdisciplinary research, such as journal clubs, seminar series and other activities.  There should also be adequate infrastructure which may be evidenced by co-authored publications, collaborative research projects, joint service on dissertation committees, team teaching of courses, etc.

Institutional Environment and Commitment to the Program:  It is expected that a rich institutional environment will be present, and evidence of interdepartmental interaction/collaboration, adequate coursework, research support, equipment, facilities, etc. should be provided.  The program should take advantage of all opportunities present in the overall institutional environment, and should be an integral component of the institution’s overall research program/mission.  The institutional environment should make itself available and accessible to the faculty, staff, and students participating in the program.  Institutional commitment may be indicated by providing funds, space, materials, and protected time to the Program Director, etc. Documentation of commitment may include letters from the institution, such as Department Chairs, Deans, or other appropriate institutional administrators. 

Evaluation and Tracking Plan:  The program evaluation and tracking plan should include measures to evaluate the effectiveness of each training and education component, and should build on strengths and correct weaker areas.  Should specific weaker areas be identified, the program should be able to specifically address them.  The evaluation and tracking report should be included annually as part of the Progress Report and as part of the Final Report.

Applicant Recruitment, Selection and Retention Plans: Applicants must describe how they will recruit appropriate trainees/participants from both inside and outside their sponsoring institution to the program.  A selection plan outlining how they will select from the pool of potential trainees/participants must be presented.

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. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

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

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

C. Individuals from disadvantaged backgrounds which 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 have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

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

This RFA requires all applicants to submit a diversity recruitment and retention plan. 

Training in the Responsible Conduct of Research:  Formal or informal instruction in scientific integrity and ethical principles in research is a required component of the training program and must be present in every year of trainee participation.  Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.  The plan should provide specific information with respect to seminars, courses and other training opportunities, the degree of faculty participation, trainee attendance and the frequency of instruction. 

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.  Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the trainees appointed to the program.

The rationale for the proposed plan of instruction must be provided.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications.  The NIH encourages institutions to provide instruction in the responsible conduct of research to all undergraduate students, graduate students, postdoctorates, and research staff regardless of their source of support.

Budget pages: Each application may submit two budget pages.  If the training program consists of only NRSA-qualified individuals (i.e., predoctoral candidates or postdoctoral trainees, who are U.S. citizens or U.S. permanent residents), then only one budget page (NRSA SUBSTITUTE FORM PAGE 4) is required.  If awarded, funds will be issued under a T90 grant mechanism.  Programs may not be designed to only support non-NRSA predoctoral or postdoctoral trainees.

If trainees who are not U.S. citizens or U.S. permanent residents are included in the overall training program, then PHS 398, FORM PAGE 4 must be submitted.  In addition, if the Program Director requests any salary support, include PHS 398 FORM PAGE 4.  Awarded grant funds will be issued under an R90 grant mechanism for these requested training costs.

If the T90 application requests support for both NRSA-qualified and non-NRSA qualified trainees or salary support for the Program Director, then both budget pages must be submitted.

Statement of Appointment forms:

Statement of Appointment forms: PHS 2271 (Statement of Appointment) must be submitted to initiate each trainee enrolled in either the predoctoral or postdoctoral T90/R90 programs.  A Payback Obligation must be signed by postdoctoral NRSA/T90 trainees. The Termination Notice, PHS416-7, must used for all trainees supported by the T90/R90 grants.

5.5.2 Full-time NRSA Institutional Predoctoral Training Component (T90)

The NRSA component will support research training experiences for up to four years for U.S. citizens or permanent residents who are interested in pursuing research careers in interdisciplinary research.  Trainees are selected by a Program Director normally for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds.  Appointments for less than 9 months are not allowed.  

An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

All regulations and policies governing NRSA awards must be followed.  Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at:  http://grants.nih.gov/grants/policy/policy.htm. 

5.5.3. Full-time non-NRSA Institutional Predoctoral Education Component (R90)

The non-NRSA component will support research training experiences for up to four years for students who are neither U.S. citizens nor U.S. permanent residents.  The funding authority directs that the funding be considered as part of the Research Education Program (R90).  See Section III for eligibility.  Appointments for less than 9 months are not allowed.

5.5.4 Postdoctoral Research Training and Education Program (T90 and R90)

Postdoctoral research training and education components are for individuals who have received a Ph.D., D.N.Sc., D.V.M, D.D.S., M.D., D.M.D., D.C., D.O., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., N.D., D.S.W., Psy.D., D.D.Ss, allied health doctoral degrees such as the D.P.T., or a comparable doctoral degree with a significant research component from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize interdisciplinary research training to meet national research priorities in the biomedical, behavioral, or clinical sciences.

Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have extensive clinical training but limited research experience.  For such individuals, the training may be a part of a research doctoral level degree program.  In all cases, since the duration of training has been shown to be strongly correlated with post-training research activity, postdoctoral trainees should agree to engage in at least 2 years of research, research training, or comparable activities beginning at the time of appointment.  NRSA (T90) and non-NRSA (R90) components may be proposed. 

A major goal of this funding opportunity is to foster the development and implementation of an interdisciplinary research training program that trains students from multiple disciplines in an integrated program.  Trainees are expected to participate in a formal, integrated, multi-year curriculum that provides integrated, cohesive and novel approaches to interdisciplinary research, including theories, techniques, and applications of that research.  The product of the postdoctoral research training program should be independent interdisciplinary scientists who are adept in not just combining, but integrating multiple approaches, theories and principles as part of their research interests, goals, and career paths. 

Program components should include:

Training program: The training program should provide broad-based, integrated training in interdisciplinary science.

Program Director: The Program Director should have the scientific background and experience to run the training program, and should be committed to its coordination and supervision.  The Program Director must be a funded investigator and include evidence of ongoing research funding during the requested award period must be provided.

Mentors: Trainees’ research projects must be supervised by appropriate faculty mentors.  Each trainee is expected to have a mentoring team that includes at least two co-mentors, from different disciplines, that combine to form the backbone of the interdisciplinary research training team.  Mentors should be funded investigators in an appropriate research area and evidence of ongoing research funding during the requested ward period must be provided.  Trainees’ input into decisions regarding the direction of the science, research protocol, interpretation, etc. is expected. 

Research Training and Education Record:  It is expected that the Program Director and mentors will demonstrate a history of successfully mentoring graduate students.   

The number of trainee slots requested must be justified in terms of the available pool of NRSA-eligible and non-NRSA eligible trainees, the training track record of the mentors, and the design of the training program.  The number of trainees recommended by the RFA review panel is considered the ceiling and may be decreased by NIH program staff based on availability of funds and the track record for filling positions as assessed by annual progress reports and statements of appointments.

5.5.5 Full-time NRSA Institutional Postdoctoral Training Component (T90)

The NRSA component will support research training experiences for up to three years for U.S. citizens or permanent residents who are interested in pursuing research careers in interdisciplinary research.  Trainees are normally selected by a Program Director for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds.  Appointments for less than 9 months are not allowed.  An individual trainee may receive no more than three years of NRSA support in the aggregate at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

All regulations and policies governing NRSA awards must be followed.  This includes a payback obligation for every month of training up to the first 12 months.  Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at:  http://grants.nih.gov/grants/policy/policy.htm.

5.5.6 Full-time non-NRSA Institutional Postdoctoral Training Component (R90)

The non-NRSA component will support research education experiences for up to three years for trainees who are neither U.S. citizens nor U.S. permanent residents.  The funding authority directs that the funding be considered as part of the Research Education Program (R90).  Appointments for less than 9 months are not allowed.

5.6 T90/R90 Interactions Section of the Research Training Program Plan

Following the Research Training Program Plan, the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this component relates to the others that are part of the consortium.  Applicants should discuss how the trainees participating in this T90/R90 will be made part of the rest of the consortium.  They should also discuss what other components of the consortium will provide to this component.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the page limit of the Research Training Program Plan.

6. K01 Component

The goal of a K01 component is to support interdisciplinary career development.  Candidates for this award must have a research or health-professional doctorate and postdoctoral research experience at the time of application.  The candidate must be able to demonstrate the need for a period of additional supervised research as well as the capacity and/or the potential for highly productive research.  The length of the research experience can vary.  For many candidates, a 3-5 year application is likely to be appropriate.  The proposed career development experience must be in a research area new to the applicant and/or one in which an additional supervised research experience will substantially add to the research capabilities of the applicant, which should be well supported in the application.

The award provides up to five consecutive 12-month awards.  At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award.  The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award.  Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in a new scientific area that will enhance the ability of the researcher to conduct interdisciplinary research.

Candidates for the K01 should propose a period of study and career development consistent with her or his previous research experience.  For example, a candidate with limited experience in the proposed field of research may find a two phase approach that begins with a period of didactic training followed by a period of closely supervised research experience the most efficient means of becoming part of the interdisciplinary team.  A candidate with previous research experience in a related field may not require extensive additional didactic preparation and may propose a program that focuses on an intensive, supervised research experience.  All programs must be tailored to meet the individual needs of the candidate ensuring that he/she will gain the skills and knowledge necessary to carry out high quality health-related research.  The candidate and the mentor are jointly responsible for the preparation of the plan for this program.  The sponsor may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program.

Candidates must name a primary sponsor (or mentor), who together with the applicant is responsible for the planning, direction, and execution of the program.  The mentor should be recognized as an accomplished investigator in the proposed research area and have a record of success in training independent investigators.  The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.  The mentor should be involved in one of the other Interdisciplinary Consortium components and may request the laboratory and non-salary costs associated with the candidate as part of that component.  Candidates also may nominate co-mentors as appropriate to the goals of the program.  Where feasible, women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

6.1 K01 Salary

The NIH will provide salary and fringe benefits for the career award recipient. The total salary requested is normally based on a full-time, 12-month staff appointment.  It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.  In no case will the award provide salary in excess of the current legislated maximum salary (in fiscal year 2006 the maximum salary provided by a federal grant is $183,500).

The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.   Because the salary amount provided by this award is based on the full-time institutional salary, no other NIH funds may be used for salary supplementation.   Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01.  Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale up to the current legislated maximum salary.

6.2. K01 Research Development Support 

Research development support may be used for the following expenses:  (a) tuition, and fees, related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; (d) statistical and computational services including personnel and computer time.   All expenses must be directly related to the proposed research career development program. 

6.3. K01 Ancillary Personnel Support

Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

6.4. K01 Facilities and Administrative Costs

These costs will be reimbursed at 8 percent of modified total direct costs for this component.

6.5. K01 Other Income

Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

6.6 K01 Evaluation

In carrying out its stewardship of human resource related programs, the NIH is likely to request information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

6.7 K01 Forms and General Instructions

K01 applications must use Section III of the PHS 398 form and should follow the instructions for preparing an Individual career development award application. 

6.8 K01 Cover Page  

See instructions for individual components: #IndividComponentsInstructions.

6.9 K01 Candidate

Describe the candidate's commitment to a career in biomedical or behavioral research.  Establish the candidate's potential to develop into an investigator who is able to obtain independent research funding and work in an interdisciplinary team.  Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment.

6.10 K01 Career Development Plan

Describe the career development plan incorporating consideration of the candidate's goals and prior experience.  A systematic plan should be presented for obtaining the necessary basic biomedical or behavioral science background and research experience to launch an interdisciplinary research career.  The career development plan must be specifically tailored to the needs of the candidate and the ultimate goal of achieving independence as a researcher.

Candidates must justify the need for the requested period of mentored research experience and must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem.

6.11 K01 Training in the Responsible Conduct of Research

Candidates must describe plans to receive instruction in the responsible conduct of research.  These plans must detail the proposed subject matter, format, frequency, and duration of instruction.  No award will be made if an application lacks this component.

6.12 K01 Research Plan

Describe the research plan and the use of an interdisciplinary approach to a biomedical or behavioral problem.  The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods.  The candidate should consult with the mentor regarding the development of this section.

6.13 K01 Mentor's Statement

The application must include a statement from the mentor including information on the mentor’s research qualifications and previous experience as a research supervisor.  The applications also must include information to describe the mentor's research support related to the candidate's research plan and nature of the supervision that will occur during the proposed award period.  Similar information must be provided by any co-mentor.  If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

6.14 K01 Environment and Institutional Commitment

The sponsoring institution must document a strong, well- established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate.  The sponsoring institution also must provide a statement to document the level of commitment to the candidate's development into a productive, investigator capable of interdisciplinary research.  This must include an indication of support for candidate's proposed level of effort, commitment to the necessary release time, as well as the availability of support and supervision during the award period. 

Interactions

6.15 K01 Interactions

In addition to the usual sections in a CDA application, the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages.

6.16 K01 Letters of Reference

Follow the instructions in Section III, “Preparing an Individual CDA Application” in the PHS 398 concerning letters of reference.  Three letters are required for this program.  Since this K01 program announcement is a little different from other K01 announcements, it would be a good idea for the candidate to provide those writing a letter with a copy of this program announcement.

7. R25 Component

This component can be used to support:

(1) innovative educational or training programs to support the needs of the consortium members or potential members. This would include up to one year specialized educational experience for senior investigators (with greater than 5 years postdoctoral experience) to learn a new discipline.  No more than 3 individuals will be supported per year and such individuals could be supported up to a maximum of 45% effort for a 12-month period.  If needed, research support costs should be derived from research projects supported by the consortium.

(2) short courses or seminars to update members of the consortium about recent developments or to present new findings by members of the consortium to the larger community

(3) web based or distance learning approaches to disseminate information to members of the consortium and others. The proposed program must be distinct from those research education programs at the sponsoring institution/organization currently receiving other federal support. The R25 component is required to include evaluation plans.

The audience for these proposals may focus on members of the consortium or on members of a broader community.  If aimed at a broader community, the members of that community can be principally an academic audience or at can be a lay audience.  No matter which audience is targeted, the application should focus on how the proposed educational components benefit the interdisciplinary approach proposed by the consortium. 

7.1 R25 Cover Page

See instructions for individual components: #IndividComponentsInstructions.

7.2 R25 Budget

The non- modular budget format should be used. Note that funds requested for the R25 component may not duplicate items for which funds are being requested for “Other Projects” such as funds for travel and support for seminar speakers and evaluation efforts (see Section IV. 6. 1.1.3. U54 Other Projects).

Facilities and administrative costs are limited to 8% of total modified direct costs for the R25 research education component.

7.3. R25 Biographical Sketches and Resource Section

The biographical sketches for key personnel involved in the R25 should be included in the U54 component of the application and should be duplicated in this component.  The resources section should be completed for this component.

7.4 R25 Research Plan

The research plan for most R25 applications should use the normal subheadings (specific aims, background and significance, preliminary studies, and research design and methods).  An evaluation plan is required for each application.  This plan should follow the research design section.  The evaluation plan should clearly describe how the proposed activity will be evaluated for success or failure based on its purposes and objectives.  The evaluation plan must be contained within the 25 page limit of the overall research plan.

For applications involving a one year specialized educational experience for senior investigators, the normal headings (specific aims, background and significance, preliminary studies, and research design and methods) should also be used. 

7.5 R25 Interactions Section

Following the evaluation plan, the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the results of the various specific aims will be used by other parts of the consortium.  They also should discuss what other parts of the consortium will provide to this application.  This section provides a way for the applicant to explain how the consortium is going to work and how this activity fits into the consortium.  The Interactions section is limited to three pages, and does not count toward the 25 page limit of the Research Plan. The Interactions Section is not necessary if the R25 is being used for only a one year specialized research experience since this information will already be contained in the Research Plan.

8. P30 Component

The P30 component can be used to support core facilities that will be used by multiple components of the consortium.  Two different types of P30 components are permitted:  A) a research and facilities core and B) a human subjects core.  Applicants can submit one of each of these P30 components as part of their consortium application.  If an applicant does propose both cores, two separate P30 applications should be prepared. 

The principal aim of these cores is to enhance the performance of interdisciplinary research in the consortium.  A proposed core must serve more than one part of the consortium, but it is not essential for a core to serve all parts of the proposed consortium.  Facilities that are needed for only one R01, for example, should be contained in the R01 application.  The cores provide a mechanism for integrating, coordinating, and fostering interdisciplinary research among the components of the consortium.

8.1 Instructions for a Research and Facilities Core

It is anticipated that these consortium applications will use a research and facilities core in a variety of ways.  The following areas may be appropriate for a research and facilities core.  This list is not exhaustive.  Applicants may propose other similar facilities as part of a Research and Facilities core.

Animal models (general, phenotyping, transgenic)
Antibody development
Assay development
Cell culture
Cell repository
Computational/Information Technology
Instrumentation (such as DNA sequencing, flow cytometry, imaging, mass spectrometry, microarrays, microscopy, NMR, proteomics, protein crystallography)
Machine shop
Tissue resource

8.1.1 Instructions for a Research and Facilities Core Cover Page

See instructions for individual components: #IndividComponentsInstructions.

The members of the consortium should think carefully about naming an appropriate Principal Investigator for the P30.  In some cases, the Principal Investigator for the central U54 may be the best Principal Investigator for the P30.  However, this consortium format has been designed to give appropriate credit to all members of the interdisciplinary research team.  One way to demonstrate that the consortium is sensitive to this review criterion could be to name someone other than the U54 Principal Investigator to lead the P30.

8.1.2 Instructions for a Research and Facilities Core Budget

Applicants do not need special permission to have a budget larger than $500,000 in direct costs in any single year. The modular budget format must not be used.  The budget can include funds for instrumentation, supplies, and for technical support necessary to operate the core.  Alteration and renovation costs are not allowed.

8.1.3 Instructions for a Research and Facilities Core Research Plan

The Research Designs and Methods section is limited to 25 pages for this core.  In most cases, the full 25 pages will not be needed.  This expansive page limit is meant to cover the situation where two or more of the areas listed above are part of the research and facilities core.  Do not include what would normally be in Items a-d of the PHS 398 Research Plan but divide the Research Designs and Methods section into the following headings:

A) Justification of Need:  Describe the facility.  Make a table of similar instruments/facilities existing at the applicant institution, neighboring research institutions, or otherwise accessible to members of the consortium.  Describe why the facilities on this list are unavailable or inappropriate for the consortium.  Include specific documentation on the current usage and downtime of existing facilities and a realistic estimate of the projected usage for the requested facility.  Such documentation should be expressed as hours of use, setup time, etc., per day or week, not simply as percentage of available time.  Be specific and quantitative.

B) Research Projects:  Give a brief description of the major users of the facility.  Since these projects will be presented as other components of the application, the project descriptions should be concise and focus on the benefit of the facility to the research objectives of each user.  Sufficient technical detail (preliminary data and/or supplemental information) should be included within the research plan to evaluate whether the facility is appropriate, would be effectively employed, and would provide advantages over other methods.  If possible, each user should highlight those publications that demonstrate the user's expertise in using the requested facility.  Use a table to list the names of the users, the part of the consortium that will support those users, and the estimated percentage of use.

C) Technical Expertise:  Describe the technical expertise present at the institution to set up, run and maintain the facility.  Specify who will operate the instrument or be in charge of the facility, train new users and ensure that this core is operated safely.

D) Organizational/Management Plan:  Describe the organizational plan to administer the instrument/facility.  Include how the instrument/facility will be utilized, how requests for time/resources will be made, how limited resources will be allocated among users.  Describe a plan for managing access to the facility if users projects involve human subjects, animals or human of infectious materials.

8.1.4 Research and Facilities Core Interactions
Following the Research Plan, the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the facilities in the core will be used by other applications that are part of the consortium. They should also discuss what other components of the consortium will provide to this application. This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the 25 page limit of the Research Plan.

8.2 Instructions for a Human Subjects Core

It is anticipated that a human subjects core may be used in a variety of ways.  The following areas may be appropriate for a human subjects core.  This list is not exhaustive.  Applicants may propose other areas involving human subjects under this core.

Data management
Human assessment (interviewing, testing)
Image analysis and interpretation
IRB issues
Patient recruiting/Patient advocacy
Phlebotomy
Psychometrics
Statistics

8.2.1 Human Subjects Core Cover Page

See instructions for individual components: #IndividComponentsInstructions.

The members of the consortium should think carefully about naming an appropriate Principal Investigator for the P30.  In some cases, the Principal Investigator for the central U54 may be the best Principal Investigator for the P30.  However, this consortium format has been designed to give appropriate credit to all members of the interdisciplinary research team.  One way to demonstrate that the consortium is sensitive to this review criterion could be to name someone other than the U54 Principal Investigator to lead the P30.

8.2.2 Human Subjects Core Budget

Applicants do not need special permission to have a budget larger than $500,000.  The modular budget format should NOT be used.

8.2.3 Human Subjects Core Research Plan

The Research Designs and Methods section is limited to 25 pages for this core.  In most cases, the full 25 pages will not be needed.  This expansive page limit is meant to cover the situation where two or more of the areas listed above are part of the human subjects core.  Do not include what would normally be in Items a-d of the PHS 398 Research Plan but divide the Research Designs and Methods section into the following headings:

A) Justification of Need:  Describe the need for the human subjects core. 

B) Research Projects:  Give a brief description of the major users of the human subjects core.  Since these projects will be presented as other components of the application, the project descriptions should be concise and focus on the benefit of the core to the research objectives of each user.  Sufficient detail should be included to evaluate whether the core is appropriate, and would be effectively employed.  Use a table to list the names of the users, the part of the consortium that will support those users, and the estimated percentage of use.

C) Technical Expertise:  Describe the technical expertise present at the institution to set up, run and maintain the proposed core.

D) Organizational/Management Plan:  Describe the organizational plan to administer the core.  Include how the facilities that are part of the core will be utilized, how requests for resources will be made, and how time will be allocated among users.

E) Human Subjects.  Describe the standard operating procedures and approaches that will be used for ensuring that all activities performed by this core  involving human subjects meet all human subject protection and inclusion requirements, consistent with the PHS 398 instructions.

8.2.4 Human Subjects Core Interactions
Following the Research Plan, the applicant must prepare a section with the title Interactions.  In this section, the applicant should discuss how this application relates to the others that are part of the consortium.  Applicants should discuss how the facilities in the core will be used by other applications that are part of the consortium.  They should also discuss what other components of the consortium will provide to this application.  This section provides a way for the applicant to explain how the consortium is going to work and how this component fits into the rest of the consortium.  The Interactions section is limited to three pages, and does not count toward the 25 page limit of the Research Plan.

9. Appendix

Follow the instructions in the PHS 398 form for the appendix.  Only one appendix is allowed for the entire application.  Each component must not have a separate appendix.  
 
Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants are expected to include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

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

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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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 to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCRR in accordance with the review criteria stated below.

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

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

The goals of the research training and career development programs are to help insure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs.

Most of the components of the Interdisciplinary Research Consortium will be evaluated on the following general criteria.  Additional or different criteria listed below will be used for some of the components.

Interdisciplinarity: Does the application represent a new conceptual approach?  Is there either a plan for or evidence of the ability of the team of investigators to work together in an interdisciplinary fashion over the multi-year period of the award?  Is the proposed interdisciplinary approach likely to yield new insights into the problem being addressed?  Are institutional barriers that would hinder an interdisciplinary approach identified and addressed?

Significance: Does this study address an important problem?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? In cases where the R01 is being used to support “non-traditional” approaches, reviewers must not penalize the application for the lack of a hypothesis.

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is it clear how the various components of the consortium will interact with each other?  Is the management structure proposed for the interdisciplinary research team likely to be successful?

Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Does the investigative team bring complementary and integrated expertise to the project?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support for interdisciplinary research?

R01/R21 components will use these review criteria plus the additional review criteria in section 2.A. below as appropriate.

2.1 Review Criteria for the T90/R90 Component

The review criteria listed in RFA-RM-06-006 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-006.html#SectionV) will be used to evaluate this component instead of the criteria listed above.

All Program Components (R90 and T90)

Scientific Environment: 

Institutional Environment and Commitment to the Program: 

Evaluation and Tracking:

Applicant Recruitment, Selection and Retention: 

Reviewers will be asked to address and discuss the following criteria in assigning the overall score of the application for the predoctoral and/or postdoctoral research training programs, weighting each as appropriate.  Reviewers will first determine the quality of the proposed training program and then consider whether the requested number of trainee positions is appropriate for the number of high-quality trainees likely to be accepted in the planned research training program in interdisciplinary science.

Training Program: 

Program Director:

Mentors: 

Trainee Recruitment and Selection:

2.2 Review Criteria for the K01 Component

The following review criteria will be used to evaluate this component instead of the criteria listed above.  Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. 

2.2.1 Candidate

2.2.2 Career Development Plan

2.2.3 Training in the Responsible Conduct of Research

2.2.4 Research Plan

Reviewers recognize that applicants will have variable amounts of previous research experience.  Those with limited research experience are less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator.  Nevertheless, all applications must include a fundamentally sound research plan.  Reviewers, however, will consider the applicant's prior research experience in judging the level of detail provided.

2.2.5 Mentor/Co-Mentor

2.2.6 Environment and Institutional Commitment

2.2.7 Interdisciplinarity 

2.2.8. Letters of Reference

2.3 Review Criteria for the R25 Component

The following review criteria will be used to evaluate this component when the R25 proposes short courses or distance learning approaches. These criteria are in addition to the general criteria listed above.  If the R25 is being used to for a specialized educational experience for a senior investigator, only the general review criteria will be used.

2.3.1 Education Program Director:

2.3.2 Dissemination Plan: 

2.3.3 Evaluation Plan

2.4 Review Criteria for the P30 Core Components

The following review criteria will be used to evaluate this component instead of the general criteria listed above.  Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate.  Note that the component 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.

2.4.1 Justification of Need:  Is the need for the core clearly and adequately justified?  Is the requested facility essential and appropriate?

2.4.2 Technical Expertise:  Does the institution have the technical expertise to make effective use of the core?  How well qualified are the participating investigators to operate and maintain the core, conduct the projects, and evaluate the research results?  How will new users be trained?  How will biosafety procedures be implemented? Do the procedures for human subjects research address the human subjects protections and inclusion requirements?

2.4.3 Research Projects:  How would the research projects of the parts of the consortium that will use the core be enhanced?  Will the core be used by multiple components?

2.4.4 Organization/Management Plan:  Is the plan for the management and maintenance of the core appropriate?  How will research time be allocated among the projects?  Are the sharing arrangements equitable?

2.4.5 Interactions:  Will the instruments or services provided by the core requested benefit the consortium?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

Training in the Responsible Conduct of Research (K01 and T90/R90 Component only): 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 plans 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 plans will be described in an administrative note in the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component, will determine whether amended plans are acceptable.

Diversity Recruitment and Retention Plan (T90/R90 Component only): 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 diversity 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 NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data  

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.  Any approved data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant awardee recipients 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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
N/A.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

At the time of an award decision, the U54 application will be disaggregated into the appropriate components presented in the application and separate yet administratively linked awards will be made.  The K01, T90/R90, and R25 awards will be subject to the 8 percent F&A rate reimbursement standard for these mechanisms.   The other awards will reflect full F&A rate reimbursement based upon the negotiated rate in effect at the time of award.   

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Note: The following guidelines are recommended for use in developing and implementing health and safety operating procedures and practices for both personnel and facilities:

Grantee organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines. However, if requested by the awarding office, grantees should be able to provide evidence that applicable Federal, State, and local health and safety standards have been considered and have been put into practice.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), the NIH Grants Policy Statement (rev. 12/2003) and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U54, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

The decision to modify the terms of an award – by imposing special conditions, by withdrawing approval of the PI or other key personnel, or otherwise – is discretionary on the part of the NIH awarding office (NIHGPS, rev 12/2003).

1. Principal Investigator Rights and Responsibilities
The U54 Principal Investigator will have the primary responsibility to:  define the research objectives of the consortium, conduct specific studies, analyze and interpret research data, manage the team of other investigators, and provide information to the assigned NIH program officer concerning progress.  The NIH program officer for this U54 award will be known as the IRC Coordinator.  Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.  The PI must keep the IRC Coordinator informed about the use of the Other Projects portion of the U54 budget.  Approval must be sought before paying salaries from this portion of the budget or for any expense in excess of $10,000.  The U54 Principal Investigator will be the chair of the IRC Steering Committee.

2. NIH Responsibilities
Each of the linked awards for a Consortium will have a program officer assigned by the primary Institute or Center.  This group of program officers will form the IRC Program Team for that Consortium.  The IRC Coordinator will be the chair of the IRC Program Team.  The IRC Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  The IRC Coordinator will convene meetings of the IRC Program Team to discuss the performance of the overall Consortium.  As needed, the IRC Coordinator will arrange for site visits to the consortium.  Non-NIH staff may be asked to take part in those site visits to help the IRC Program Team evaluate either an individual Consortium or the Interdisciplinary Research Consortia program as a whole.  The IRC Coordinator may provide information concerning the operation of the Consortium to outside evaluators, and may facilitate the interaction of outside evaluators with awardees.  Such information will not infringe on the awardees’ custody of primary data or software. 

The IRC Coordinator will assist in the interactions between the awardees and between program officers and awardees.  The IRC Coordinator will be able to provide the Principal Investigator and the IRC Steering Committee with budget information from the linked awards that are part of the consortium.  The IRC Coordinator will be able to provide the Principal Investigator and the IRC Steering Committee with copies of progress reports from any of the linked awards that are part of the consortium.  The IRC Coordinator, with advice from the IRC Program Team and after consultation with either the principal investigators or the IRC Steering Committee or both, will have the ability to recommend moving money from one award in the Consortium to another.  The IRC Coordinator, with advice from the IRC Program Team, will retain the option of recommending termination of any of the awards if the technical performance falls below acceptable levels or if an awardee is no longer functioning as a member of the consortium.  The IRC Coordinator will also be responsible for normal programmatic stewardship of the U54 award.

3. Collaborative Responsibilities

The Interdisciplinary Research Consortium will be governed by an IRC Steering Committee.  The IRC Steering Committee will monitor progress of the Consortium, will encourage improvements, and will coordinate the interdisciplinary research of the Consortium.  The composition of the IRC Steering Committee will be defined in the Team section of the U54 application.  Each member of the IRC Steering Committee will have a single vote.  The IRC Coordinator will also be a voting member of the IRC Steering Committee.  The non-federal Chair of the IRC Steering Committee will be the Principal Investigator of the U54 award.  Any of the awardees within an individual consortium will have to accept and implement policies approved by the IRC Steering Committee.  The IRC Steering Committee will meet at least once a year although more frequent meetings may be necessary.  The Chair will determine the meeting schedule and will prepare an agenda for the meeting.  The Chair is also responsible for preparing a concise summary of the meeting (2-5 pages) and distributing that summary to the members of the IRC Steering Committee and to all of the awardees participating in the Consortium within 30 days of the end of the meeting.  The IRC Steering Committee can request information such as budget information or progress reports from the IRC Coordinator about any of the components of Consortium.
 
4. Arbitration Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration.  An Arbitration Panel composed of three members will be convened.  The three members will include: a designee of the Principal Investigator, a designee of the IRC Coordinator, and a third designee with expertise in the relevant area who is chosen by the other two.  This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

2.B. Administrative Policies that Apply to NIH Research Career Award (“K”) Programs

A. Evaluation:

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of the NIH awarding institute or center is required.  Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.) 

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50% effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff is strongly encouraged when either termination or a change of institution is being considered. See (http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm).

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. 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 research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period. 

2.C. Administrative Policies that Apply to Institutional Training Award (“T”) Programs

Changes of Program

Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIH Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

Change of Program Director

If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided:

Transfer of Program

Neither the program as a whole nor any component of the program may be transferred to another institution.

Termination

The Program Director must consult with NIH staff when termination of the program is being considered. When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. 

Service Payback (NRSA postdoctoral trainees only)

As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Kirschstein-NRSA postdoctoral support. The 13th and subsequent months of Kirschstein-NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the second year.

Applicants accepting an award for the first 12 months of Kirschstein-NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.

Those who do not pay back their obligation through continued Kirschstein-NRSA supported training may satisfy their obligation by serving in a position in which health- related research, research training, or teaching are the primary activities.   Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country.  Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by the NIH. The NIH will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of Kirschstein-NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury.  Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience. Policies regarding the Kirschstein-NRSA payback obligation are explained in the Kirschstein-NRSA Section of the NIH Grants Policy Statement available at http://grants.nih.gov/grants/policy/policy.htm.  Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at http://grants.nih.gov/training/faq_fellowships.htm.  Other questions on payback should be directed to the appropriate NIH institute contact.

Leave

Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding leave.  Undergraduate and non-NRSA predoctoral trainees should also follow these guidelines and institutional policies.

Carryover of Unobligated Balances

The carryover of funds from one budget period to the next requires prior written approval of NIH.

2D. Administrative Policies that Apply to the R25 Research Education Program Component

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

Change of Program: Awards are made to a specific institution for a specific program under the guidance and leadership of a particular PI.  A change in any of these parameters requires prior approval by the responsible NIH program officer.  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 Principal Investigator: If change of PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH, provided that the following conditions are met.  The current PI or the grantee institution must submit a written request for the change, countersigned by the appropriate institutional business official, to the responsible NIH program officer describing the reasons for the change.  The Biographical Sketch of the proposed 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 PI and that the new PI has the appropriate research and administrative expertise to lead the research education program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

3. Reporting

3.1 All Awards

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

3.2 U54 Award

A second annual progress report, in addition to the 2590, will be required for the U54 award.  An electronic version of this second report will be sent to the IRC Coordinator who will distribute it to the other members of the IRC Program Team.  The due date for this second report will be the same as the due date for the 2590.  The report will contain a narrative section describing the progress made in the consortium over the past year.  The report also will contain at least two “highlights”.  Each highlight will be based on a publication, less than a year old, which acknowledges support from one of the consortium awards.  The highlights will be written at a level that is understandable by a technically literate, but non-expert individual.  The final component of the progress report will be a list of papers that acknowledge support from any of the consortium applications.

3.3 K01 Award

K01 awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:  Note that the instructions for Research Career Development applications must be followed for this program http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

The Progress Report for the K01 must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the2590 instructions. Evaluation of the awardee's progress will encompass the following:

For the K01, a final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

3.4 T90/R90 Awards

This program is not subject to Streamlined Non-competing Application Process (SNAP).

The annual progress report should provide information about changes in the integrated program, and a description of the training and education, research and career progress of each trainee and participant.  They must include a detailed account of experiences in recruiting individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies.  The report should provide aggregated information on the racial/ethnic distribution of all applicants and those accepted and appointed.  The aggregated report should also include information on individuals with disabilities and those from disadvantaged backgrounds. 

For all trainees who were enrolled in the academic program, the report should include information about the duration of research training and education, and whether those trainees finished their training in good standing. Similar information should be provided separately for the research education component of the program.

The NRSA instructions for the non-competing grant progress report (starting on page 19, Form 2590) should be followed, with any necessary modifications for other program components.

Note that for programs that include NRSA predoctoral and postdoctoral research training programs, a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.

Predoctoral and Postdoctoral Research Training Program (T90 and R90)

NRSA Institutional Predoctoral and/or Postdoctoral Training Components (T90) and
Non-NRSA Institutional Predoctoral and/or Postdoctoral Training Components (R90)

The NRSA instructions for the Non-Competing Grant Progress Report (Form 2590, starting on page 19) should be followed. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions. An evaluation and tracking report as described in Section VI.3. of this announcement should be included annually as part of the Progress Report.  Additional information should be reported in concert with the PHS 2590 Progress Report instructions. This information is applicable to all trainees (NRSA and non-NRSA), except where noted below:

Trainee Reporting Requirements:  The institution must submit a completed Statement of Appointment (PHS 2271) for each NRSA trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter.  Additionally, a completed Payback Agreement Form (PHS 6031) must be submitted for each NRSA postdoctoral trainee in his or her first 12 months of NRSA support.  No funds may be provided until this document is submitted and accepted by the funding Institute. Within 30 days of the end of the total support period for each trainee

(NRSA and non-NRSA), the institution must submit a Termination Notice (PHS 416-7) to the NIH. Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Trainee Reporting Requirements (non-NRSA):  The institution should provide information about each trainee appointed to the non-NRSA predoctoral and postdoctoral training component of the program in the form of an NIH Biosketch (PHS 398).    

Evaluation and Tracking Report: Provide information annually collected under the evaluation and tracking plan proposed in the initial application. Information to be provided includes the number of students in each component of the overall program, tracking information for students who have completed the program, and evaluation and tracking information for the short-term faculty education component, if applicable.

Additional Reporting Requirements:

Financial Status Report (FSR):  An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and reviewed.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH Roadmap may request information essential to an assessment of the effectiveness of this Program.  Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contacts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program. 

Publication and Sharing of Research Results:  Trainees are encouraged to submit reports of their findings for publication in the journals of their choice. For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ______ which is part of the NIH Roadmap. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Inventions:  Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants. 

Copyrights:  Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Final Reports:  A final Progress Report, Invention Statement (for applicable mechanisms) and Financial Status Report are required at the end of the grant project period of upon relinquishment of an award for any individual component of the U54 funded as a separate award, 

3.5 R25 Awards

Provide information annually collected under the evaluation plan proposed in the initial application.

R25 component annual progress reports:  The progress report should include information on the development and implementation of the research education program, those who benefited from the program, dissemination of information, etc. Also, the evaluation and tracking report must be included annually.

Final Reports:  A final Progress Report, Invention Statement (for applicable mechanisms) and Financial Status Report are required at the end of the grant project period of upon relinquishment of an award. 

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:

Greg Farber, Ph.D.
National Center for Research Resources
6701 Democracy Boulevard
Room 960, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone:  (301) 435-0778
FAX: (301) 480-3659
Email: farberg@mail.nih.gov

Michael F. Huerta, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard
Room 7202, MSC 9645
Rockville, MD 20892-9645 (U.S. Postal Service Express or regular mail)
Rockville, MD 20817 (for express/courier service; non-USPS service)
Telephone:  (301) 443-3563
FAX: (301) 443-1731
Email: mhuert1@mail.nih.gov

2. Peer Review Contacts:

Carol Lambert, Ph.D.
National Center for Research Resources
6701 Democracy Boulevard
Room 1076, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone:  (301) 435-0811
FAX: (301) 480-3660
Email: lambert@mail.nih.gov

3. Financial or Grants Management Contacts:

Judith Musgrave
National Center for Research Resources
|6701 Democracy Boulevard
Room 1048, MSC 4874
Bethesda, MD 20892-4874 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone:  (301) 435-0841
FAX: (301) 480-3777
Email:  musgravj@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

NIH Public Access Policy:
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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  The National Research Service Award (T90) component is made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288), and Title 42 CRF, Part 66.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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