Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This FOA is developed as a Roadmap Initiative.  All NIH Institutes and Centers participate in Roadmap Initiatives. This FOA will be administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (http://www.niams.nih.gov/) on behalf of the NIH.

Title: Patient-Reported Outcomes Measurement Information System™ (PROMIS) Network Center (U54)  

Announcement Type
New

Request For Applications (RFA) Number: RFA-RM-08-022

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release Date: September 26, 2008
Letters of Intent Receipt Date: February 3, 2009
Application Receipt Date: March 3, 2009
Peer Review Date: June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 1, 2009 
Additional Information To Be Available Date (Url Activation Date): http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.aspd
Expiration Date: March 4, 2009

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     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.  Introduction

The Patient-Reported Outcomes Measurement Information System™ (PROMIS) is an NIH Roadmap (RM)-funded initiative.  The original FOA, “Dynamic Assessment of Patient-Reported Chronic Disease Outcomes” (RFA-RM-04-011) was awarded in August 2004 to six primary research sites and a statistical coordinating center to form the PROMIS Network.  The broad objectives of the initial FOA were to: 1) develop and test a large bank of items measuring patient-reported outcomes (PROs), 2) create a computerized adaptive testing (CAT) system that would allow for efficient, psychometrically robust assessment of PROs in clinical research involving a wide range of chronic diseases, and 3) create a publicly available system that could be added to and modified periodically and that would allow clinical researchers to access a common repository of items and CAT system.  For details on the original FOA, see http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-011.html.

The PROMIS Network met or exceeded its goals of developing item banks of disease non-specific PRO domains and making them available as short forms and CAT through the PROMIS Assessment Center.  Documentation of the PROMIS Network and Assessment Center efforts is reported by the grantees at www.nihpromis.org.  A summary of the mid-course evaluation conducted on June 19, 2007 is available at: http://nihroadmap.nih.gov/clinicalresearch/promis/pdf/promismidcoursereview.pdf  Progress and plans from the first two years of the project are also available in a supplement issue of Medical Care (Vol 45, No. 5, May, 2007, Suppl 1).   These achievements have set the stage for the next funding phase of development. 

Due to the success of PROMIS and the growing interest of various research and health care sectors in this methodology, the NIH Roadmap has authorized an additional four years of funding for this initiative.  This second funding phase is structured into four interrelated FOAs that seek to address the scientific needs and priorities identified during the mid-course review, as well as feedback from the original PROMIS investigators, NIH Science Officers, and NIH Scientific Monitoring Board (SMB).

The overall goals of the second funding phase are to validate the PROMIS domains in the context of clinical studies and to develop the PROMIS system to facilitate adoption by clinical researchers, consistent with the overall goals of the program. 

The objectives of the NIH RM PROMIS initiative during the next four years include:

An important priority during the second funding phase of PROMIS will be domain development and validation focused on the following populations:

Effort during the second funding phase of PROMIS will emphasize representation of minorities, women, underserved populations, and especially children in all PROMIS-related research.  

The overall PROMIS Network structure during the second funding phase is designed to: (see PROMIS NETWORK STRUCTURE diagram http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.aspd)

1) encourage active planning and direction of the PROMIS Network’s scientific activities and research priorities;

2) facilitate coordination among PROMIS Network investigators and foster greater opportunities for synergy within NIH and between other Federal agencies, health care organizations and foundations and other interested stakeholders;

3) provide a scientifically sound forum for the development and documentation of PROMIS standards and guidelines and the advancement of PRO science; and

4) expand existing and seek new partnerships and collaborations with private organizations that will facilitate the transition to non-Roadmap funding sources by the end of the project period in FY2012.

This FOA consists of the following four interrelated FOAs that describe the short- and long-term goals for the second funding phase of PROMIS and how this network will be structured and managed. The PROMIS Network is defined as the consortium of investigators that lead the different components of the PROMIS Network funded through these FOAs:

  1. PROMIS Network Center-PNC (RFA-RM-08-022) (this announcement):  The PNC will provide overall coordination, management, infrastructure and leadership for the PROMIS Network, and planning and implementation of the transition from the first to the second funding phase.  The PNC will support and report to the PROMIS Steering Committee (PNSC), which will be responsible for overseeing the scientific and administrative activities of the network, consistent with the terms and conditions of the PROMIS awards and applicable regulations. The PNC will develop, along with the rest of the PROMIS Network, the strategic plan and research agenda to address NIH RM PROMIS goals and priorities, and monitor data accrual to ensure PROMIS is representative of the US general population with a particular emphasis in research involving children, women, minorities, and those with disabilities.  The PNC will continue establishment of PROMIS standards for domain development and clinical validation, planning and development of collaborations, partnerships, and the successful transition to a sustainable PROMIS funding structure by the end of this PROMIS project period in FY2012.
  2. PROMIS Statistical Center- PSC (RFA-RM-08-025):  The PSC will coordinate the data collection from the domain research sites, manage data quality, assist in general population sampling for new item bank testing, and provide psychometric and statistical support for the network as well as development of PROMIS-approved translations of new and extant domains.
  3. PROMIS Technology Center-PTC (RFA-RM-08-024): The PTC will develop and provide computer administration services, including CAT, web access to short forms, and other administration modalities of the PROMIS item banks in clinical research.  The PTC will support the CAT and informatics needs of the network. In addition, the PTC may provide these services to the greater research community at a minimum cost.   
  4. PROMIS Research Sites-PRS (RFA-RM-08-023): The PRS will develop, test and evaluate new domains as per PROMIS item bank development procedures and/or validate new or existing PROMIS item banks in various clinical populations.  

It is expected that PROMIS (www.nihpromis.org) will continue to expand and improve the science of PRO assessment, while at the same time make the products of this work widely available and acceptable to interested stakeholders.  The increased efficiency, flexibility, and sensitivity of the PROMIS tools will allow greater compatibility between studies and greater statistical power with reduced patient reporting burden.  Ultimately, PROMIS will need to become a self-sustaining research resource adaptable to future research needs.  Therefore, establishing a functional public-private partnership (PPP) is intended to be an essential component of this second funding phase of PROMIS.   

2. Research Objectives

The PROMIS Network Center (PNC) will require strong leadership to provide support and infrastructure for the overall scientific direction, coordination and management of complex research studies involving a large number of geographically distributed facilities and collaborators including PROMIS Research Sites (PRS), the PROMIS Technology Center (PTC), the PROMIS Statistical Center (PSC), subcontractors, and overall PROMIS Network personnel.  The PNC is expected to establish collaborations with pharmaceutical and biotechnology companies, other NIH-sponsored clinical research programs, and public and private research organizations to identify and evaluate PROMIS item banks and CATs, establish new standards and guidelines for the use of PROs, and initiate new partnerships for support of ongoing projects and for the long-term sustainability of the item banks and the PTC.

Working collaboratively with the other components of the PROMIS Network and through the PROMIS Network Steering Committee (PNSC), the PNC will provide the infrastructure, resources, coordination, oversight, and scientific leadership and expertise for the following activities:

Research Management and Support Activities of the PROMIS Network Center (PNC)

1.     Coordinate the activities of the PROMIS Network: This network will be composed of scientific and clinical investigators awarded by this second phase of this NIH RM PROMIS initiative with expertise in the areas of: (1) psychometrics, clinical trial design, PROs and relevant clinical disease areas as appropriate and (2) methodologies to administer and use PROs applicable in the clinical research, clinical trials and delivery of care areas. Critical functions of the PNC in support of the PROMIS Network include development of a Strategic Plan and Research Agenda (SPRA) as described below, outlining the resources needed to develop the PROMIS Network organizational structure, and coordinating Network activities.

2.     Research and Domain Development:  Working collaboratively with the PROMIS centers and sites, the PNC will design and conduct research and development activities for existing and new candidate PROs needed to accomplish the goals and objectives set forth in the SPRA particularly to address research gaps.  Such activities may include proof-of-principle studies as appropriate. 

3.     Clinical Validation Studies:  Implement the SPRA through the coordination, design and conduct of validation studies to evaluate the applicability of PROMIS item banks and other created resources (e.g. new assessment technologies) to advance, simplify and standardize the use of PROs in clinical trials to evaluate safety and efficacy of promising approaches to improving human diseases.

4.     Establishment of PROMIS standards: The PNC will continue the development, testing, and implementation of PROMIS standards for domain development and clinical validation, planning and development of collaborations, partnerships, and the successful transition to a sustainable PROMIS funding structure by the end of the next PROMIS project period (FY 2012).

5.     Data Collection and Validation:  Provide oversight and coordination for the activities of the PSC, provide scientific input on PSC priority setting, facilitate interactions between the PSC and the PRS, coordinate interactions between large validation studies statistical activities and the PSC.

6.     Development and implementation of collaborations:  Potential collaborators include NIH-sponsored clinical research programs, private organizations, and companies involved in research to advance the understanding and use of PROs in clinical research and care. The scope of collaborative activities range from information and data sharing to participation of the PROMIS Network in studies generated by the collaborators.

7.     Establish partnerships: This will include partnerships with academic, federal and private entities interested in development and application of PROs in clinical research. The partnerships are expected to provide avenues and resources for long-term sustainability of the PROMIS Network.

8.     Develop and implement strategies, in consultation with NIH, to coordinate PROMIS efforts with FDA PRO development.

9.     Design and implement a performance evaluation plan.  This plan will include the criteria and measures to be used to assess Network performance.  Conduct performance evaluations on an annual basis and prepare and submit a report on the results of each performance evaluation for NIH Project Officer review and approval, including recommendations for approaches to improve efficiency, organizational structure, policies and procedures, adherence to established timelines for Network studies, and other factors relevant to the effective performance of PROMIS Network activities.

10.  Develop strategies for distribution, dissemination, and ongoing development and maintenance of item banks and CAT systems to ensure long-term sustainability.

11.  Coordinate state-of-the-art meetings and workshops in conjunction with the PROMIS centers and sites as a forum for providing instructional materials to educate the clinical research community, clinicians, research institutions, and the broader community about PROMIS regarding PRO measurement needs. These meetings will also be used as a vehicle for soliciting feedback regarding PROMIS at its various stages of development. Lead additional activities aimed at maximizing the utility and successful adoption of PROMIS deliverables, such as presentations at professional meetings.

12.  Develop a comprehensive public information strategy for approval by the PNSC that outlines the dissemination of information about the PROMIS project to the Network’s multiple constituencies including potential users, patient advocacy groups, and federal and private organizations.

13.  Integrate intellectual property (IP), data and resource sharing statements (see below), as necessary, to create network-wide policies, consistent with the terms and conditions of the PROMIS awards and applicable regulations.  The PNC will work in consultation with the NIH officers and institutional officials from the participating institutions to ensure the effectiveness of the policies.  All policies will have to be reviewed and approved by the PNSC and by the NIH Project Officer.

14.  Ensure that PROMIS project information, such as PROMIS Network methods and findings, are presented in the context of both PROMIS capabilities and limitations.

15.  Collect information and maintain an inventory of PROMIS presentations and publications.

16.  Establish and implement policies and procedures for publicizing PROMIS Network solicitations, accomplishments, and developments to the scientific and lay communities and other relevant audiences.

Development and Implementation of the PROMIS Network Strategic Plan and Research Agenda (SPRA)

The PNC will develop and implement a Strategic Plan and Research Agenda (SPRA) to advance PROMIS goals including coordination and prioritization of activities in the following areas: a) new psychometric and clinical validation studies, b) new domain and existing domain refinement work, and c) approaches to the use and enhancements of the PTC.  The PNC will prepare a draft SPRA for consideration and approval by the PROMIS Network Steering Committee (PNSC) and the PROMIS Network Executive Committee (PNEC) as described below.  The following items should be considered for the preparation of the SPRA:

1.     State-of-the-art of efforts to develop and use PROs in clinical research. The discussion must include a description of safety concerns, knowledge gaps, and scientific opportunities relevant to the clinical application of PROs, CAT and other related technologies and approaches in human clinical trials.

2.     Approaches to develop and test item banks, CAT and other related approaches and technologies to evaluate PROs in clinical studies.

3.     State-of-the-art research on the identification, assessment, and validation of PROs. 

4.     Knowledge gaps and opportunities relevant to the further development and improvement of existing PROs including validation against acknowledged disease endpoints; proposed strategies and methods for overcoming and/or reducing variability.

5.     Immediate and long-range goals of the PROMIS Network, potential barriers to success, and potential solutions to overcome those barriers.

6.     Approaches to identify and capitalize on opportunities for industry and other partnerships to accomplish the goals of the PROMIS Network and to accomplish the goals and objectives described in the SPRA.

7.     Timelines and milestones to assess adherence to and success in meeting the major aims of the SPRA.

8.     Posting the SPRA on the PROMIS website (www.nihpromis.org) and outreach efforts to notify the PROMIS Network members and others that the document is available.

9.     Conduct annual reviews of the SPRA to address new scientific, programmatic and fiscal developments and new partnership opportunities; after approval by the PNSC, submit a concise report of recommended revisions to the NIH Project Officer for review and approval by NIH and the PROMIS Scientific Monitoring Board (SMB). 

10.  Following approval, revise the PROMIS SPRA as necessary, post the revised version on the PROMIS website (www.nihpromis.org), and notify the PROMIS Network members that the revised plan is available.

Organizational Structure of the PROMIS Network and Network Center

The goal of the PNC is to coordinate and support the scientific, technical and operational infrastructure of the PROMIS Network, consisting of a multi-institutional consortium of national experts in the areas of PRO development, evaluation and application as well as clinical researchers interested in using PROMIS-generated resources. Specifically, the PNC will be responsible for planning, coordinating, and implementing the organizational entities and activities as delineated below. 

1.     Develop a SPRA for the scientific structure, management and coordination of all PROMIS Network studies to be approved by the PNSC.   The plan will encompass the following:

a.     Establish a process for developing, reviewing and approving concepts for newly proposed studies both in and outside the PROMIS Network;

b.    Establish operating procedures, standards, and criteria for determining PROMIS Network priorities;

c.     Establish a plan and process for monitoring and evaluating progress and performance, including augmenting the PROMIS Network with additional institutions/organizations as may be necessary to capitalize on new scientific opportunities; discontinuing, temporarily or permanently, the services of subcontractors; and terminating or curtailing ongoing and planned PROMIS Network research projects;

d.    Establish a plan to determine the need for redirecting the research focus, including reallocation of funds, as needed to achieve the goals of the SPRA.

2.     Develop a plan for the transition from the first to the second PROMIS funding phase and a plan for the PROMIS final transition:

a.     Initial Transition: Develop and implement an Initial Transition Plan to ensure the efficient and effective transfer of PROMIS activities and resources (including the current PROMIS Assessment Center resources and other databases, if appropriate) into the new PROMIS organizational and scientific structure. The Transition Plan should address the participation of all previously funded PROMIS investigators in the new PNSC; it is expected that the previously funded PROMIS investigators will participate for the first year of the second funding phase. After this first year, PROMIS investigators’ participation will be decided on the recommendation of the PNSC, and if needed, travel support will be provided by the PNC. Additionally, the previously funded PROMIS investigators’ role and duration of participation will be defined based on scientific priorities and activities of the PROMIS Network.

b.    Final Transition Plan: Develop and implement a plan to transition studies, data, equipment and other resources upon termination of this cooperative agreement to any successor organization(s).

3.     The overall PROMIS Network organizational structure must include, at a minimum, the two committees delineated below.  Additional committees and subcommittees may be established to carry out the overall management and coordination functions listed below.  It is important to note that the same person cannot chair both of these committees listed below.

a.     PROMIS Network Steering Committee (PNSC): Serves as the primary governing body for all scientific Network activities related to domain development, validation studies, development of new PRO standards, goals and operations of all PROMIS centers and sites, approval of new collaborations as well as outreach and dissemination efforts.  Makes recommendations to the PNEC regarding implementation of new projects and direction of ongoing studies.

1.     The principal investigators of all PROMIS centers and sites, from which the Chair is elected bi-annually by members of the PNSC;

2.     The NIH Chief Science Officer; and

3.     The NIH Science Officers as appointed by the NIH Project Officer.

1.     Assume responsibility for the oversight of the PROMIS Network SPRA, validation studies, and domain development.

2.     Conduct reviews to assess the scientific progress of all ongoing network projects, new proposed studies; make recommendations; and communicate these results to the PNEC, including recommendations regarding Network support for new domains, validations, PROMIS standards development, and other studies.

3.     Maintain communication with the NIH Project Officer  regarding major Network activities, progress, obstacles and proposed approaches to overcome obstacles; submits requests, documents, manuscripts, reports, and other data and information for NIH Project Officer review and approval.

1.     Review governance and fiscal policies and procedures; monitor progress of and take remedial actions to address delays or other problems with Network-sponsored ongoing clinical and domain studies; review progress of validation studies, other performance assessments, and future plans. Review study proposals submitted by PROMIS Network members and non-Network investigators;

2.     Review new domain and validation studies.   Oversee protocol development for projects approved for implementation by the PNSC.  Identify need for protocol amendments and or remedial actions to ensure adequate patient accrual and retention, adherence to protocol requirements and overall progress of studies in collaboration with the NIH Project Officer; make recommendation to the NIH staff for appropriate actions.

3.     Coordinate data collection and analysis.  Assess requirements for data collection, validation, analysis and security.  Make recommendations to the PNEC about the Network informatics and information management processes. 

4.     Review and approve outreach and dissemination efforts as proposed by the PNC. 

5.     Enforce conflict of interest procedures and policies.  The PNSC should develop and implement policies and procedures for identification, disclosure, reporting and management of potential and actual conflicts of interest for members of the PROMIS Network and subcontractors consistent with Federal conflict of interest regulations. The PNSC should engage with the NIH Project Officer to ensure that identified conflicts are appropriately addressed.  Federal regulations and policies related to conflict of interest are further described at http://www.hhs.gov/ohrp/special/conflict.html

6.     Manage publications and communications.  Review and approve policies and procedures for authorship, preparation, review, and final approval of manuscripts resulting from PROMIS Network studies, and for submission of manuscripts for publication in peer reviewed journals.  The PROMIS Network must submit copies of all manuscripts to the NIH Project Officer at the time of submission to journals. The respective role and responsibilities of pharmaceutical companies in the publication review and approval process will be addressed in specific partnerships agreements, as appropriate. 

7.     Review Data and Safety Monitoring Plans.  For each clinical study, the PNSC will review recruitment and the Data and Safety Monitoring Plans to ensure adequate enrollment and monitoring of human subjects research.  The PNC, working with the PROMIS centers and sites, will solicit, prepare and distribute reports and information for review by the PNSC. The PNC will follow up on the recommendations of the PNSC regarding data and safety monitoring to ensure their adequate implementation.

8.     The PNSC will be responsible for reviewing the data and resource sharing statements (see Section IV., 6, Resource Sharing Plan(s) below), consistent with achieving the goals of the program. The PNSC will review and summarize IP management statements provided by awardee institutions, and develop agreements to be approved by the PNSC consistent with the terms and conditions of the PROMIS awards and applicable regulations. The PNC will work in consultation with the NIH officers as well as institutional officials from the participating institutions to ensure the effectiveness of any such agreements.

9.     The PNSC may establish subcommittees or project-specific working groups, or assign responsibility to key staff for other specific PROMIS-related activities.

b.    PROMIS Network Executive Committee (PNEC): The PNEC provides day-to-day operational and management leadership to carry out the work of the PNC and the Network as recommended by the PNSC. The PNEC provides leadership and directions to the operations of the PNC and directs the implementation of the SPRA.  The composition and specific responsibilities of this Committee include:

Governance of the PROMIS Network   

As part of the cooperative PROMIS network, the PNC will participate in the following governance structure.  See: Organizational Structure of the PROMIS Network and Network Center as described above.

1.     The PROMIS Network Executive Committee (PNEC), consisting of the Chair, elected by the PNSC, the NIH Chief Science Officer (CSO), one or more additional NIH Science Officers appointed by the NIH Project Officer, and one or more Principal Investigator(s) selected by the PNSC will provide scientific management, leadership, and overall governance of the operations of the PROMIS Network.

2.     The PNSC will function as the main governing board of all projects awarded under these FOAs, as well as projects that transition from the first to the second PROMIS funding phase. The PNSC will be the primary mechanism for NIH interactions and collaboration with the awardees and with the PROMIS Network.  The voting membership of the PNSC will consist only of the NIH Science Officers and Principal Investigators (PIs) of each cooperative agreement award.  Face-to-face meetings of this committee will occur at least four times per year. Other NIH staff may attend PNSC meetings when their expertise is required for specific discussions.

3.     The PNC (RFA-RM-08-022) will coordinate and direct all activities of the PROMIS Network including those of the PSC (RFA-RM-08-025), the PTC (RFA-RM-08-024) and the PRS (RFA-RM-08-023).  These groups will be interactive and collaborative with each other as well as the NIH, the PNSC, and Scientific Monitoring Board as described below.

4.     The NIH Science Officers (SOs), program officials from NIH institutes involved with specific awards and FOAs, will have substantial scientific and programmatic involvement with the conduct of these awards, through technical assistance, advice, and coordination, above and beyond normal program stewardship for grants.  The SOs will work in partnership with the PIs, and will provide significant input in the planning and conduct of the research, in areas such as item selection for testing, testing methodologies, data analysis planning, data interpretation and, if appropriate, co-authoring manuscripts for publication.  The SOs will also serve as scientific liaisons between the awardees and other NIH program staff; they will have the option to recommend re-allocating NIH support among awardees as scientific goals evolve.

5.     The NIH Project Officer (PO) will have responsibility for normal program oversight and stewardship of the award.  The PO will serve as a non-voting member of the PNSC, conduct continuous review of all activities to ensure objectives are being achieved, and have the option to recommend withholding support to an awardees’ institution if technical performance requirements are not met, as appropriate.

6.     The Scientific Monitoring Board (SMB) will evaluate the awardees’ progress in relation to the goals of this initiative.  The SMB will consist of approximately six scientists who are not affiliated with any of the awardees’ institutions.  The SMB members will be selected for their broad expertise in relevant topics to include methodologists (Information Technology-IT, psychometrics, cognitive testing), clinical metrologists, and members of the Federal government (e.g. FDA, VA, CMS, AHRQ).  The SMB members will evaluate awardee efforts to ensure adequate communication and sharing.  They will make recommendations regarding coordination of these activities and related, future projects.  They may also participate in PNSC conference calls.   Members of the SMB may attend face-to-face PNSC meetings on a rotating basis to provide input and feedback to those not in attendance.

7.     The PNSC, along with the SMB and the PNC, will be involved in discussions and decisions regarding initial transition from the first to the second PROMIS funding phase and final transition plans after Roadmap support.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Specialized Center-Cooperative Agreement (U54) award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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".

At this time, the NIH does not intend to continue this project beyond this four-year funding period (FY2009 – FY2012).  A fundamental objective of the NIH Roadmap (RM) for PROMIS has been to develop new methodologies to evaluate Patient Reported Outcomes (PROs) as part of the RM efforts in re-engineering the clinical research enterprise.  The role of the NIH Roadmap in this effort has been to provide the “incubator space” for this major initiative to develop and mature, and it has been appropriate, therefore, to provide the initial funding for the growth of PROs capability through the Common Fund from which Roadmap projects have been supported. 

NIH is committed to ensuring that the Federal investment in the development of PROMIS will result in improvements in clinical trial methodologies and ultimately improvements in public health.  NIH would like to be engaged in an ongoing Public-Private Partnership (PPP) in order to ensure that the NIH stewardship of the public health trust related to patient-reported outcome (PRO) measures continues beyond the scope of the current solicitation.  One means to accomplish that end is via the formation of a PPP.  PPPs can be initiated by NIH and/or awardee institutions. Applicants to this PNC FOA should include a statement in their application indicating how they would propose to develop a PPP, or explain why development of a PPP would not be possible. NIH has the following goals with respect to the development of a PPP; the applicant should address each of these goals in his/her statement described above:   

a)     To ensure the exceptional scientific quality of the research and maintain the clinical relevance of the PROMIS work;

b)    To ensure that broad interest continues to drive the PROMIS activity through a representative governance structure including communities such as NIH, other Federal agencies, academia, clinicians, industry, and patient groups;

c)     To leverage the NIH Roadmap investment in PROMIS both during and beyond the second funding phase with additional support and resources from other sectors; and

d)    To ensure that all PROMIS resources remain widely accessible and at minimal cost to advance clinical research and practice.

2. Funds Available

The NIH Roadmap intends to commit approximately $600,000 in FY2009 to fund one new grant application in response to this FOA.  An applicant may request a project period of up to four years and a budget for direct costs up to $400,000 per year.  The earliest anticipated start date for awards under this funding opportunity is September 1, 2009.

The estimated amount of funds available for support of one project awarded as a result of this announcement is $600,000 for fiscal year 20 09. Future year amounts will depend on annual appropriations

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign Institutions are not eligible to apply as the primary applicant but they may enter into collaborations with a domestic institution that is the primary applicant

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA. 

Renewal applications are not permitted in response to this FOA

Institutions are not limited in the number of applications that may be submitted in response to any of the four interrelated FOAs of this FOA: RFA-RM-08-022 (U54), RFA-RM-08-023 (U01), RFA-RM-08-024 (U54), or RFA-RM-08-025 (U54). If an institution applies for more than one U54, the applicant needs to give careful consideration to the different scope of each of the U54s and the value of diversity of scientific leadership and project teams to each application in optimally achieving the overall goals of the program, as well as ensuring that adequate and consistent commitment levels can be met for any of the projects for which an applicant might apply.

Applicants may submit more than one application, provided each application is scientifically distinct.  An individual may serve as PD/PI on only one U54.  The PD/PI of the PNC application may also serve as a co-PI on a U01 application. The same project may not be included by any investigator in more than one application. 

Each PD/PI is expected to commit 3.6 person months or more effort to ensure success of the program.

Applications may be submitted from single institutions.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applications Involving Federal Agencies

The requests from federal agencies, including the NIH intramural program, will not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).

In general, the budget requests will be limited to the incremental costs required for carrying out the proposed work.  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. While support for extramural collaborators may be requested in a separate grant application, funds can be requested for services by an external investigator or contractor as a subcontract/consortium including the applicable indirect (F&A costs) of the contractor/collaborating institution.

Justification must be provided for all requested support and for the Federal employees who will be committed to the project although no funds are requested in the application.

Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

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: February 3, 2009
Application Receipt Date: March 3, 2009
Peer Review Date: June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 1, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Wm. Phil Tonkins Jr., M.S., Dr.PH
Health Scientist Administrator

Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4979
FAX: (301) 480-1284 
Email: tonkinsw2@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

Wm. Phil Tonkins Jr., M.S., Dr.PH
Health Scientist Administrator

Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4979
FAX: (301) 480-1284
Email: tonkinsw2@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

6. Other Submission Requirements and Information

It is recognized that the applications in response to this FOA will be longer and more complex than many other NIH applications.  In order to ensure an effective review, the application should be clearly laid out and well organized into functional cores.

NIH does not specify how these functional cores are to be organized within the center.  The applicant may choose to organize the proposed center in terms of separate functions or in any other manner deemed appropriate for the implementation of an effective research, development, application and dissemination plan.  However, the application must clearly address how the proposed organization of the center will ensure that each of the functions is effectively implemented, consistent with meeting the goals of the program

Organization of the Application:

Applicants must construct the Research Plan component as a single document.  The total page number for the PNC Research Plan is 40 pages.  The application should be organized as follows: 

1.       Form Page 1: Face Page

2.       Form Page 1 – continued:  N/A

3.       Form Page 2: Description, Performance Sites, and Key Personnel.

4.       Form Page 3: Table of contents

5.       Form Page 4: Detailed budget for initial budget period.

6.       Form Page 5: Budget for entire proposed project period.

7.       Biographical Sketch Format Page:  Should be provided for each of the key personnel.

8.       Resources Format Page:

9.       Continuation Form: Use this form for the Research Plan pages, including introductory overview, background and significance, specific aims, preliminary studies/progress report, research designs and methods for each of the proposed functions. 

O In the Research Plan, the applicant should articulate the goals that will be achieved at the end of the funding period in a draft submission of the SPRA as outlined in Part II, Section I, 2. Research Objectives, Background and Purpose.

Overall Center

Overview; Background and Significance:

Background and Significance of the Overall Center: Provide an introductory overview of the proposed center which will include background and significance of the overall center and describe how it can contribute to achieving the overall goals of the PROMIS Network. Describe the center goals.  Explain the proposed contribution of each of the functional cores in achieving the objectives of the center.  The PI of the PNC is expected to devote at least 30 percent (3.6 person-months) of effort to the project.  The application should describe the management plan for the proposed center, and how the plan will support its proposed goals.  It should describe the organization of the proposed center and its management structure, and should address the integration of the functional components to form an efficient structure for research.  The plan should specifically address interactions between key personnel and reporting relationships.   The Overview must contain a Summary Table with all of the functions in the Center.  These functions will have to be organized to improve the efficiency of the center and its activities as they relate to the goals and research objectives of the PROMIS Network and the clinical research community. This section should also address data sharing (see below) and willingness to collaborate with the PROMIS Network, consistent with achieving the goals of this program.

Functional Cores

Specific Aims:

List specific aims and milestones for the first year and projected milestones for subsequent years of the program.  In subsequent years, milestones will be reconsidered each year in negotiation with NIH program staff.

Preliminary Studies/Progress Report:  

The Preliminary Studies/Progress Report section of the Research Plan should provide information on the investigator’s accomplishments and scientific contributions to the field of PRO research and development, consistent with achieving the goals of this program.  The application should address/include the following: a description of the experience of the investigators or their collaborators with PRO or other outcomes instruments uses and administration modalities;  a description of and/or preliminary data demonstrating experience in new instrument outreach, demonstration and training efforts targeting research and clinical health professionals involved in clinical research;  data demonstrating experience serving as a resource center in a multi-site clinical study;  a description of experience in meeting milestones;  a description of experience with the sharing of data and providing appropriate access to Intellectual Property (IP) in similar settings, as applicable, such as in the context of other NIH-funded, complex/large research projects, i.e. clinical trials, programs, etc.  

Research Design and Methods:

The research plan should address comprehensively all of the items listed under Research Objectives (Section I.2). Specifically, the application should include detailed descriptions of:

Administrative Unit 

An Administrative Unit should be proposed to coordinate the Center and administer the program activities. The application should describe a well-conceived management plan and a significant commitment of effort by the PI and leaders of the project.  Applicants must discuss the ways in which close working interactions will be promoted and maintained in cases where the key personnel on a given project will be at geographically distinct performance sites (as will be the case for some PROMIS Research Sites, the PSC, the PTC and the PNC).  The plan should specifically address how any collaborations or subcontracts will be managed.  The PI is encouraged to propose a project manager for the center to manage the day-to-day operations.  All center applicants are expected to apply process management methods for planning, monitoring and managing the workload over the lifetime of the grant period and are expected to communicate this to NIH program staff upon request.

The management plan should also address the interactions of the proposed center with the other components of the PROMIS Network (e.g., PRS, PSC, PTC, the PNSC, the NIH program staff; these components are described in more detail below) and how the center would structure new collaboration with investigators working on PROs outside the PROMIS network.    

Letters of Support

Include a letter documenting institutional commitment to the PROMIS Network, including provision of funding, space, faculty positions, and/or commitments for construction or renovation.  A letter from an appropriate institutional official, generally a dean or provost, should follow the Research Plan. If multiple institutions are involved in the center application, a letter should come from each institution.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

All applications and proposals for NIH funding must be self-contained within specified page limitations. The page limit for the PROMIS Network Center research plan (including overview, and specific aims, background, and significance, preliminary studies, and research design and methods) is limited to 40 pages.  Please refer the format described above in Section IV, 1 and 6.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.  (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. The adequacy of the applicant’s data/resource sharing statements will be considered by the NIH officials when making funding decisions.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

 (b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

(d) Software Development: Applications are expected to include a statement regarding how or whether software developed through PROMIS funding will be deposited in the PROMIS website (www.nihpromis.org) or another NIH-approved common public database for public distribution, and how the applicant’s disposition of software that it develops will advance the Research Objectives. The applicant is also expected to include a statement regarding its planned response if the PNSC recommends that a particular software application should be made available for public use and maintained in a user-friendly format.  

NIH has the following goals with respect to software developed under these awards; the applicant should address each of these goals in the statement described above. 

1. The software should be freely available to biomedical researchers, educators, and institutions in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3.  The terms of software availability should include the ability of research institutions outside the Center to modify the source code and to share modifications with other colleagues as well as with the Center.

Management of Intellectual Property

Certain research plans will require collaboration and coordination between investigators at different institutions, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is understood that some information developed under the grants will be proprietary and might not be shared immediately without damaging the commercialization potential of the technology. In addition, it is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution. Therefore, grant applicants are expected to address, for example, how the applicant will coordinate patent prosecution and licensing activities, if necessary to enable a licensee to access the bundle of intellectual property needed to take a product to market on commercially viable terms consistent with achieving the goals of the program. Suggested strategies include: (1) assigning intellectual property rights to related inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions; and (3) agreeing in advance that if multiple parties are to independently license-related inventions, the total of stacked royalties will not exceed a predetermined percentage rate. Alternatives to the suggested strategies, which accomplish the same goals, will be considered. The applicant's institution should avoid exclusively licensing those inventions that are research tools unless either: (1) the field of use of the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the research tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological research resources (“research tools”) at http://grants.nih.gov/grants/intell-property_64FR72090.pdf.

Applicants should note that the IP statements submitted with the applications will be used following awards by the PNC to develop Network-wide IP guidelines for collaborative activities. Applicants are expected to include a statement in the applications indicating their willingness to abide by the PNC IP guidelines approved by the PNSC and NIH to the extent they are consistent with the goals of the program, the applicant’s IP management statement, and applicable grant regulations.

During the first funding phase, the PROMIS Network Steering Committee developed guidelines and agreements on data sharing applicable to achieving the goals of the PROMIS Roadmap (RM) Initiative (http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.aspd). During the second funding phase, the NIH expects that the existing guidelines will be reviewed, updated, and adopted by all collaborating institutions. Consistent with such guidelines, NIH believes that the PROMIS goals will be achieved only if all data generated by the PROMIS Network is deposited into the www.nihpromis.org website or another NIH-approved common public database upon data verification. For this, the term “data” is intended to include, but should not be limited to, procedures, protocols and/or links to published procedures implemented in the first funding phase of PROMIS; performance data for procedures and items and item banks; primary data generated by domain and validation sites, and links to published or unpublished manuscripts.

Section V. Application Review Information


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

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

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

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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? What is the importance of the PROMIS Network Center research objectives to the PROMIS Network goals? Is it likely that these research objectives will be completed within the project period?  Are the experimental design and methods adequate to achieve the research objectives, including the involvement of basic and clinical scientists, psychometricians, statisticians, and study design experts and project managers in the conception, design, and proposed implementation of the project? Are the proposed project milestones, and the feasibility of achieving the research objectives, adequate?

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 (if applicable)? Are the qualifications of the basic and clinical investigators, psychometricians, statisticians, and other design experts to conduct the proposed research, adequate to the conduct 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? Is the scientific environment in which the research work will be done, and the unique features, if any, of the environment adequate to support the proposed work?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the overall priority score.

The center will receive an overall priority score that reflects the synergy and strength of the center as a whole; the scientific merit of the cores; and the scientific merit of the proposed interactions with other components of the PROMIS Network.

The overall center will be assessed according to the following criteria:

1.  Significance:  What will be the effect of these studies on the concepts, methods, and technologies that drive this field? Are the research sites and protocol development support plans appropriate and likely to contribute to the success of the PROMIS Network?

2.  Center as a whole: What is the potential for impact? What is the degree of synergy, i.e., does the center as a whole serve a purpose greater than the sum of the individual components? Is the proposed center likely to meet the goals of the NIH RM PROMIS? Are there high quality facilities and services provided by center (including procedures, techniques, and quality control)? Are the qualifications, experience, and commitment of the personnel involved adequate? 

3.  Data Management: Are data management and support procedures developed sufficiently? Are procedures in place for quality control and quality assessment for data?

4.   Program Administration and Management: Does the PD/PI have the scientific and organizational vision and experience to serve effectively as the center Director? Is there evidence of sufficient management capabilities for the center that include fiscal administration, procurement, property and personnel management, planning, and budgeting?

5.  Facilities: Are facilities adequate for the overall functions of the center and to implement the goals of PROMIS?

6.  Institutional Commitment: Is there evidence for institutional commitment to the program, including provision of funding, space, faculty positions, and/or commitments for construction or renovation?  Are the research environment and resources, including equipment and facilities, adequate? Is there potential for interaction with scientists from other departments and components?

7.  Interaction:  Are there adequate plans for ensuring effective communication, interaction, and coordination among the PI, Core PIs, PROMIS Network, PROMIS Statistical Center, Research Sites and NIH staff?  Do the applicants state their willingness to collaborate extensively and share information, data, software and other resources fully, consistent with meeting the goals of the program and with the applicant’s submitted statements and applicable grant regulations? 

Review Criteria for Center Functional Cores

Each functional core will be assessed according to the following criteria and will receive a priority score:

Approach: Are the concepts or 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? How effective is the overall organization of the cores in relation to the center's goals?  Will each component enhance collaborative and/or interdisciplinary research within the center and the wider research community?  Are data management and support procedures developed sufficiently?  

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 PD/PI(s), project manager, and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? What are the qualifications, experience, and commitment of the personnel involved in the cores? Does the PI have the scientific and organizational vision and experience to serve effectively as the center Director? Is there evidence of sufficient management capabilities for the center that include fiscal administration, procurement, property and personnel management, planning, and budgeting?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? What are the qualities of the facilities or services provided by this functional unit (including procedures, techniques, and quality control)? Are facilities adequate for the overall functions of the center and to implement the goals of the NIH RM PROMIS initiative? Is there evidence for institutional commitment to the program, including provision of funding, space, faculty positions, and/or commitments for construction or renovation? Are the research environment and resources, including equipment and facilities, adequate?  Is there potential for interaction with scientists from other departments and components?

2.A. Additional Review Criteria:

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

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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

2. Administrative and National Policy Requirements

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

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), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement 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 below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: the scientific and administrative leadership and coordination of the project at the awardee institution.  The PI will have primary responsibility for defining the details for the projects within the guidelines of this FOA, and for performing all scientific activities.  The awardee institution will agree to accept the close coordination, cooperation, and participation of the NIH staff (NIH Roadmap Officials, PROMIS Scientists, NIH Science Officers, NIH Chief Science Officer, and the NIH Project Officer, in those aspects of scientific and technical management of the project as described below. 

Specifically, the PI of the PNC will:

1.      Determine experimental approaches, design protocols, set project milestones, conduct experiments, and analyze and interpret research data.

2.       Provide goals for procedures and protocols, quality, and cost to the NIH Project Officer and Chief Science Officer as requested (usually at the outset of the award and in six-month progress reports, but also at other times as requested by the Project Officer and Chief Science Officer).

3.       Serve on the PNSC, and participate, along with critical staff, in the PNSC meetings held four times annually, three times/year in the metropolitan Washington, DC area.

4.       Adhere to PROMIS guidelines and other policies that might be established, as agreed upon by the PNSC, PNEC, and   Science Officers e.g., regarding data release, IP, and/or publications and the sharing of research resources, tools, and data of interest with other PROMIS sites and centers, to the extent consistent with the applicant’s submitted statements and applicable grant regulations.

5.       Ensure, if consistent with the applicant’s submitted statements and applicable grant regulations, that primary and secondary data, protocols and procedures are made available to meet the goals of the program, (e.g., deposited in a centralized public database, as specified by the NIH Project Officer and NIH Science Officers) according to a timeline agreed upon by the PNSC, and the PNEC, and to the extent consistent with the applicant’s submitted statements and applicable grant regulations, assure that resources developed as a part of this project (e.g., procedures and protocols) are made available according to guidelines determined by the PNSC and PNEC consistent with achieving the goals of the program.

6.       Accept and implement all scientific, practical, and policy decisions approved by the PNSC to the extent consistent with the applicant’s submitted statements and applicable grant regulations.

7.       Submit data for quality assessment in any reasonable manner specified by the PNSC.

8.       Submit periodic (e.g., six-month and annual) progress reports to the PNC in a standard format, as reasonably agreed upon by the PNSC and PNEC.

9.    Agree not to disclose confidential information obtained from other members of the PROMIS Network.

10.    Be prepared for annual administrative site visits by NIH staff.

11.        Be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project.

12.        Be required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sec. 200-212 (Bayh-Dole Act).

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the PROMIS staff, or other mechanisms.

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.

2. A.2. NIH Responsibilities

The NIH PROMIS Chief Science Officer, Science Officers, and Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. 

PROMIS Chief Science Officer (CSO) ResponsibilitiesThe PROMIS CSO is an NIH extramural program scientist who will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. This includes facilitating the partnership relationship between NIH and the PROMIS PRS, PTC, and PSC, helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities, and ensuring that the activities of the PROMIS sites are consistent with the mission of the NIH. However, the role of the PROMIS CSO will be to facilitate and not to direct. Each PROMIS site will have one designated NIH Science Officer and a given Science Officer may be assigned to multiple centers.

The PROMIS Chief Science Officer (CSO) will have the following substantial involvement:

1)       Provide relevant scientific expertise and overall knowledge.

2)       Assist in the integration of the individual PROMIS sites and centers into a research network, including coordinating regular conference calls for sharing of approaches and fostering inter-center collaborations.

3)       Participate, as a voting member, with the other PROMIS Steering Committee members in the group process of setting research priorities and milestones, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as necessary. The PROMIS CSO will assist and facilitate the group process and not direct it.

4)       Serve as scientific liaison between the awardees, other NIH program staff, and the PROMIS Science Officers. 

5)   Assist in avoiding unnecessary duplication of effort across the PROMIS, and help coordinate collaborative research efforts that involve multiple sites.

6)   Review and comment on critical stages of PROMIS development for presentation to the PROMIS Science Officers and Project Team.

7)   Retain the option to recommend, with the advice of the Science Officers re-allocation of NIH support among awardees, as scientific goals evolve.

8)   Consult with non-NIH experts in the field, as necessary and appropriate.

9)   Share opportunities and discuss strategies and potential avenues of collaborations (such as with industry, private foundations and/or NIH intramural scientists);

10)   Be a voting member of the PNSC.

PROMIS Science Officers ResponsibilitiesThe PROMIS Science Officers are NIH extramural program staff who work as a team with the PROMIS CSO and the NIH Project Officer to:

1) provide a broad base of scientific expertise to assist in oversight of the PROMIS research network in areas such as scientific information;

2) assess scientific progress;

3) identify new research needs;

4) identify core items to be used in developing item banks;

The PROMIS Science Officers will have the following involvement:

1)       Assist the awardees, in conjunction with the Chief Science Officer as needed.

2)       Provide relevant scientific expertise and overall knowledge about specific aspects of PROMIS operations to the Chief Science Officer.

3)       Serve as subject matter experts to assist other NIH program staff in providing advice to investigators about the PROMIS program.

4)       Assist the Chief Science Officer in reviewing critical stages of development in the research program for presentation to the NIH Project Team and to make determinations regarding the implementation of subsequent stages.

5)       Facilitate interactions between the awardee institution and investigators at other institutions.

6)       Provide information about ongoing NIH-supported research and resources, and recommend the development of PROMIS related initiatives to the Project Team (see below).

7)       Participate with the other PROMIS Steering Committee members in the group process of setting research priorities and milestones, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as necessary and appropriate in a voting liaison member role.

8)  Be a voting member of the PROMIS Steering Committee

Project Officer ResponsibilitiesThe Project Officer is an NIH program staff member who will have responsibility for normal program oversight and stewardship of the PROMIS Network on behalf of the PROMIS Project team.

The Project Officer will have the following involvement:

1)       Approval of progress reports and support for out-years, on behalf of the NIH for the U01 and U54 cooperative agreements that comprise the PROMIS network.

2)       Have the option to recommend, following consultation with the Chief Science Officer, PROMIS Science Officers and NIH officials, the possible withholding, reduction, or reallocation, as appropriate, of support from any center that substantially fails to achieve its goals according to the milestones agreed to by the center at the time of the award or fails to comply with the Terms and Conditions of the award, at the appropriate times.

3)       Have the option to recommend, following consultation with the Chief Science Officer and NIH Science Officers and the NIH officials, an increase in support to engage in further research efforts under the program, as appropriate, for any center showing that additional research would be substantially exceeding its goals according to the milestones agreed to by the center and substantially improving state-of-the-art capabilities, at the appropriate times.

4)       Participate in the PROMIS Steering Committee meetings as an ex officio (non-voting) member.

5)       Carry out continuous review of all activities to ensure objectives are being met.

PROMIS Project Team Responsibilities: The PROMIS Project Team will serve as the trans-NIH body consulting and advising PROMIS activities. PROMIS Project Team membership will include one or more representative(s) from each of the NIH Institutes and Centers (IC) participating in the PROMIS network.

The PROMIS Project Team may be involved in following activities:

1)       Review and provide advice about current and future direction based on recommendations from the Project Officer and the PROMIS CSO.

2)       Evaluate progress of the PROMIS projects in consultation with the Project Officer, PROMIS CSO, and the PROMIS Science Officers.

3)       Attend the PROMIS Science Officer meetings and the PROMIS Steering Committee meetings.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities (optional)

Refer to the Organizational Structure of the PROMIS Network and Network Center and Governance of the PROMIS Network in Section I, 2. Research Objectives.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.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. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The PD/PI of the PNC will be responsible for organizing an annual report on all of the activities of their center to be reported to the NIH. The PD/PI of the PNC will be providing semi-annual status reports to NIH and reports to the Steering Committee as agreed upon by the Network.    

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

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Wm. Phil Tonkins Jr., M.S., Dr.PH
Health Scientist Administrator

Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4979
FAX: (301) 480-1284 
Email: tonkinsw2@mail.nih.gov

OR

Barbara E. Footer, M.S.
Program Analyst
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 435-1141
Fax: (301) 480-1284
Email: footerb@mail.nih.gov

2. Peer Review Contacts:

Michael Micklin, Ph.D.
Chief
Risk, Prevention, & Health Behavior Integrated Review Group
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3100 MSC 7808
Bethesda, MD 20892 (20817 for overnight delivery)
Tel: (301) 435-1258
FAX: (301) 594-6363
Email: micklinm@csr.nih.gov

3. Financial or Grants Management Contacts:

Andrew Jones
Deputy Grants Management Officer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Telephone: (301) 435-0610
FAX: (301) 480-5450
Email: aj30i@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

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

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

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

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

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

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. 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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