Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
National Center for Research Resources (NCRR) (No Longer participating per NOT-OD-12-096)

Funding Opportunity Title

Limited Competition: Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research [IDeA-CTR][U54]

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices
  • July 31, 2014 - This PAR has been reissued as PAR-14-303.
  • March 26, 2014 - See Notice NOT-GM-14-111. Notice of Clarification of Information for NIGMS Prior Approval of Pilot Projects Proposed for Support by IDeA Program Grants.
  • April 9, 2012 - See Notice NOT-OD-12-096. Notice of Change in Participation of NIH Institutes and Centers.
  • June 24, 2011 - This Notice modifies the language of PAR-11-229 with regard to Section III. Eligibility Information. See Notice NOT-RR-11-008.
Funding Opportunity Announcement (FOA) Number

PAR-11-229

Companion FOA

None

Number of Applications

Only one application per eligible IDeA state is allowed as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

FOA Purpose

To support the development of infrastructure and other resources required for the conduct of clinical and translational research in IDeA-eligible states.

Key Dates
Posted Date

June 10, 2011

Letter of Intent Due Date
Application Due Date(s)

September 27, 2011; September 27, 2012; September 27, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2012, February 2013, February 2014

Advisory Council Review

May 2012, May 2013, May 2014

Earliest Start Date(s)

July 2012, July 2013, July 2014

Expiration Date

September 28, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1.  Background and Purpose

NIH established the Institutional Development Award (IDeA) program in 1993 to enhance biomedical research activities in states that have had historically low NIH grant funding success rates. The program currently supports competitive research in 23 states and Puerto Rico through two major initiatives: Centers of Biomedical Research Excellence (COBRE) and IDeA Network of Biomedical Research Excellence (INBRE).  Thus far, the COBRE and INBRE initiatives have enabled and continue to foster the development of capacity and infrastructure that allow many investigators in IDeA states to compete successfully for more traditional NIH funding, particularly in areas of basic biomedical research.  While the progress achieved by IDeA investigators in basic research has been significant, tremendous challenges and opportunities remain for pursuing activities aligned with NIH’s growing interest and focus on clinical and translational research.  The proportion of research activity currently supported by the IDeA Program that focuses on developing clinical and translational research capabilities is relatively small (15%).  It is critical that the many advances in basic biomedical science research emerging from IDeA states be translated into better patient care and improved public health by fostering partnerships between basic and clinical scientists in IDeA institutions and among other NIH-funded programs.  This funding opportunity encourages applications from IDeA states to develop Infrastructure for Clinical and Translational Research (IDeA-CTR).

The General objectives of the IDeA-CTR Program are the following:

Goals of the IDeA-CTR Program include but are not limited to:

For the purposes of this initiative, the following definitions will apply:

The IDeA-CTR Program: General Outlines

The applicant institution for an IDeA-CTR Program will be an Academic Health Center in an IDeA-eligible state (the list of states and other eligibility requirements can be found in Section III. Eligibility Information).  For the purposes of this FOA, an Academic Health Center is defined as a post-baccalaureate graduate degree-granting institution, or an affiliated organization, with ongoing research and/or academic programs in the biomedical sciences (e.g., medicine and its related basic and clinical specialties, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering).  In developing the IDeA-CTR, the applicant institution is required to identify one or more partners and collaborators within the state and in one other (or more) IDeA state(s).  The applicant should clearly describe the key component activities, governance, and structure of the IDeA-CTR. In addition to partnerships and collaborations, required activities of an IDeA-CTR include: (1) pilot grants program; (2) education, mentoring, and career development core functions; and (3) Research design, Epidemiology, and Biostatistics core functions.  As necessary, other activities may be proposed to achieve the goals and objectives of the IDeA-CTR.  All planned activities that comprise the IDeA-CTR must be well-integrated into a cohesive and coherent program and clearly indicate the roles of the participating institutions and organizations.  Whenever available, applicants should leverage, complement, and interact with already existing institutional resources funded by the NIH and/or other Federal or non-Federal entities.  The applicant’s programmatic blueprint for the Center should include clear and specific goals and timelines for achieving its stated objectives.

IDeA-CTRs are expected to provide added value to the biomedical research efforts in the participating states through support of activities that cannot easily be provided through standard research grant awards, such as providing the infrastructure and resources that will enhance the competitiveness of the investigators to obtain additional funding for clinical and translational research.  The added value contribution that the proposed Center will make should go beyond what would be expected from the pre-existing funded research at the partnering and collaborating institution(s).  It should promote and encourage activities that enhance collaboration and coordination of clinical research (e.g. multi-site clinical studies on health concerns prevalent in the participating states) and/or translational research activities (i.e., basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations).

The FOA provides funding through the U54 cooperative agreements mechanism. As a cooperative agreement, implementation will involve participation of NCRR program staff in the planning and execution of the proposed activities.  During the execution of the project, NCRR staff will assess progress toward and achievement of milestones prior to releasing funding for each year of the award.  The Progam Director/Principal Investigator (PD/PI) and Program Coordinator(s) (PC) should budget for an annual meeting in Bethesda, Maryland with NCRR staff. These meetings will provide a forum for the exchange of ideas, information and address any concerns, needs, and problems that arise. In addition, NIH staff will provide updates on policies and regulations that relate to the conduct of clinical and translational research.  Applicants are to include in their requested budgets the cost of attending these meetings in the Bethesda area.

2.  Key Component Activities (KCA) of an IDeA-CTR Program

2.1  Required Key Component Activities

The applicant must support clinical and translational activities, particularly research focused on health concerns prevalent in the participating IDeA states.  The IDeA-CTR must include infrastructure and/or activities that will support the following:

2.2  Potential Key Component Activities

In addition to required KCAs, the applicant may also propose other key component activities to achieve the specific objectives of the IDeA-CTR.  Potential KCAs may include but are not limited to the following:

Each proposed KCA/core must be well-justified.  The aims of the KCAs/Cores and the services they provide should address the needs of clinical and translational investigators at the participating institutions and be inclusive of the full range of biomedical and biobehavioral sciences funded at these institutions.  Applicants should describe in detail the operation of each proposed Core, i.e., its quality control, policies and procedures, allocation of core budgets, process for mentoring and training, procedures for reviewing and supporting projects/investigators, prioritization of services.  The application must show that the resources and services offered by each proposed KCA/core are adequate to achieve the stated goals and objectives of the IDeA-CTR program, including capabilities to support intra- and inter-institutional operations and multi-disciplinary activities.

Acknowledging that existing resources vary among applicant institutions, the support requested for each of the proposed components is expected to vary, reflecting current and projected needs.  Where applicable, applicants are encouraged to develop creative collaborations to improve utilization of existing resources.  Applicants must demonstrate synergy between the IDeA-CTR and other IDeA-funded programs in the participating states, and not duplicate or substantially overlap with activities of these programs.  Applicants should describe how cores with partial IDeA-CTR funding will be used to enhance ongoing and planned research.  For example, a proposed IDeA-CTR KCA/core supported by other funding (e.g., COBRE Bioinformatics Core, INBRE Community Outreach Core, or an RCTR Mentoring Core) may become more accessible to prospective clinical and translational investigators through leveraging of these existing resources by the Center. 

All proposed clinical and translational research activities must employ applicable standards that are consistent with those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. 

3.  Descriptions of Required IDeA-CTR Key Component Activities

3.1  Partnerships and Collaborations within and across IDeA-eligible states

The applicant is required to identify one or more collaborating domestic partner(s) within the state and in one other (or more) IDeA state(s); these may include Federal or non-Federal, public or private, and for profit or non-profit organizations, foundations, and/or community organizations as appropriate.  Each IDeA state participating in an IDeA-CTR application must demonstrate significant engagement of one or more partner organizations.  The partners and collaborators (e.g. baccalaureate, post-baccalaureate graduate degree-granting institutions, clinical facilities) will provide the manpower and sites for the conduct of clinical and translational research.  The inclusion of minority-serving institutions is encouraged.  The scientific and administrative management/organizational structure of the program must include individuals from diverse fields and backgrounds.  Of particular importance, plans must be described for facilitating intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations if not currently extant, or enhancing such activities if already in place.  It is the responsibility of IDeA-CTR leadership to define effective partnership and collaboration among the participating states.  The application must provide evidence and/or assurances that adequate cooperative arrangements are in place between participating institutions to ensure that the Center performs effectively as one cohesive and coherent program across institutional boundaries.  Budgetary and administrative arrangements are to be negotiated between the partnering institutions.  Any cross-institutional, geographical, cross-disciplinary, regulatory, and other hurdles in establishing these collaborations must be addressed.

When practical, the IDeA-CTR should seek to utilize existing resources and facilities supported by other programs of the NIH, other Federal, and/or non-Federal organizations.  Examples of resources and facilities that could be leveraged include those supported by NCRR Programs (INBREs, COBREs, Research Centers in Minority Institutions [RCMIs], RCMI Infrastructure for Clinical and Translational Research [RCTRs], and Institutional Clinical and Translational Awards [CTSAs]) in the participating states. 

Collaborations with recipients of other NCRR-funded clinical and translational research center awards (CTSAs, RCTRs), and/or other NIH Clinical/Translational Programs are strongly encouraged.  Funds requested for activities conducted at collaborating institutions in non-IDeA-eligible states are allowed only on a fee-for-service basis.  Sub-awards to organizations in non-IDeA-eligible states are not allowed.

3.2  Clinical and Translational Pilot Grants Program

The IDeA-CTR must have a  mechanism for soliciting and awarding clinical and translational pilot projects.  The description of the pilot grants program must include a plan for the solicitation ofapplications, their review and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards.  One or more pilot projects that are funded per year must be ”clinical” as defined above.  Projects involving collaborative research between basic, clinical, and translational researchers from different disciplines, departments and/or programs within or across institutions are encouraged.  Pilot investigations on diseases that affect the medically underserved and/or diseases that disproportionately affect populations in the participating states are strongly encouraged.  Research plans for individual pilot research projects should not be included in the application.

Principal investigators of pilot projects must hold a faculty appointment or equivalent at the applicant or partnering institutions at the time the pilot award commences.  For the purposes of this FOA, these are individuals who can independently apply for Federal or non-Federal investigator-initiated peer-reviewed Research Project Grants (RPG).  Individuals holding postdoctoral fellowships or other positions that lack independent status are not eligible to lead pilot projects. 

3.3  Clinical Research Education, Mentoring, and Career Development Core

The applicant is required to establish a dedicated/designated core for facilitating mentored clinical and translational research and for overseeing career development activities for investigators from a variety of disciplines and clinical specialties (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering).  Examples of activities that can be proposed include short-term courses, curricula, seminars, workshops, sabbaticals, and visiting scholarships.  If already available, an existing core that provides support for identical or similar activities but supported by other sources should be leveraged by the IDeA-CTR.  Clear plans for the recruitment, mentoring, advancement, and retention of investigators interested in pursuing clinical and translational science careers in IDeA states must be included in the application.

Mentoring can be designed for junior or established senior investigators without previous clinical research experience who wish to pursue such activities.  For the purposes of this FOA, a junior investigator is a post-doctoral level professional (e.g. MD, PhD, DDS, DVM, Pharm D) who qualifies as new investigator by NIH guidelines (http://grants.nih.gov/grants/new_investigators/index.htm).  The application must provide clear and specific outlines/guidelines of what will be expected from mentors and mentees.  Tapping the expertise of both clinical and basic scientist mentors (Dual Mentoring) should be viewed as an important element of robust and effective training of junior investigators embarking on careers in clinical and translational research.

This award may support investigators from a variety of disciplines and clinical specialties, including research training for postdoctoral fellows and graduate students. 

3.4  Clinical Research Design, Epidemiology, and Biostatistics Core

A core must be proposed that will provide IDeA-CTR investigators with expertise and assistance on, but not limited to, the following: developing, validating and integrating research designs and biostatistical methodologies essential to clinical and translational studies; preventing bias in research methodology; developing innovative methods of enhancing the power of studies; capturing appropriate data; developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects.  Funds may be requested for the recruitment of appropriate personnel.

4.  Description of Potential Key Component Activities

4.1  Recruitment of Clinical/Translational Faculty

Funds can be requested for the recruitment of established clinical and translational investigators with proven track records of independent support as evidenced by current or recent (within the last 2 years) external peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) support from either Federal or non-Federal sources.  These individuals will act as ‘Magnet Faculty’, experienced investigators who will serve as role models and mentors to junior investigators.   Support can be provided to new faculty to establish research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants.

4.2  Community Engagement and Outreach

If proposed, clear and detailed plans must be presented for identifying priority health issues and concerns of communities/populations within the participating states.  Equally important to outline are plans for developing the capacity to respond to these issues/concerns.  The core will provide support for investigators in conducting community engagement and outreach activities; this may include planning, implementing, evaluating, and disseminating effective preventions and interventions.  Other appropriate activities could include cultural sensitivity training for institutional clinical and translational researchers, community and health care provider education and outreach, establishing community advisory boards, software development for facilitating collaboration with community practitioners, and developing/evaluating strategies for communicating with and promoting participation of diverse populations and community groups.

4.3  Clinical Research Resources and Facilities

Applicants may propose a core that will oversee the recruitment and retention of research participants and the provision of necessary resources for cost-effective research participant interactions.  Some examples of resources that may be requested include out-patient or community-based examination rooms, satellite research participant recruitment/enrollment sites at smaller institutions, research nurses, research coordinators and other support personnel, scheduling services, and services for research specimen collection and shipping.

It is important that applicants describe a plan to familiarize investigators at all partner institutions/organizations and medical catchment areas of the available IDeA-CTR resources to support clinical translational research studies.

4.4  Biomedical Informatics Resources

Applicants may propose a core for the organization and analysis of biological and related information, involving the use of computers to develop databases, retrieval mechanisms, and data analysis tools.  Comprehensive supporting infrastructure (often termed cyberinfrastructure) may be proposed that integrates data-gathering facilities, computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity, and technical support.  Resources that provide cyber access to rural areas and other hard to reach populations are strongly encouraged.  Equally important are resources to enhance communications within the participating states and with the rest of the world, including but not limited to library access to research journals and video-teleconferencing services.

Applicants should consider both inter- and intra-institution communication platform(s) and external interoperability to allow for communication among the IDeA-CTR partners of clinical and translational investigators and other entities (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers).  Whenever available, bioinformatics resources already provided through other NIH-funded programs should be leveraged by the IDeA-CTR as it develops its own biomedical informatics infrastructure for clinical and translational activities.  Biomedical informatics research activities should show innovation in the development of new tools, methods, and algorithms.

4.5  Ethics, Regulatory Knowledge, and Other Support Activities

Regulatory knowledge and support activities of the IDeA-CTR should promote the protection of human subjects and facilitate regulatory compliance.  Best practices can be formulated that will reduce or remove institutional impediments to clinical and translational research.  This KCA will develop the regulatory support interactions with the IRB and compliance office to facilitate research without loss of participant protections.  A group that is independent of the institutional IRB or compliance office should be identified and will act as a sounding board for potential research participants, serve as their research subject advocate (RSA), and work with investigators to ensure that research involving human subjects places the highest priority for human subjects protections.

Regulatory support provided through an IDeA-CTR may not take the place of an institutional compliance or enforcement office nor shall it be responsible for Institutional Review Board (IRB) activities.  Instead, it should assist investigators in their documentation requirements for these offices.  Other regulatory support activities can include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, and safety and regulatory management and compliance.

4.6  Technologies and Resources for Core Laboratories

If research resources core(s) are requested, they must be for multiple users and include infrastructure applicable to various disciplines in the partner institutions/organizations (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) for the benefit of researchers and research projects across disease areas.  The level of support requested must be justified by the projected use by clinical and translational researchers from among the partner institutions/organizations. 

The applicant should describe the standard operating procedures of each core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required.  Where applicable, participation in national or international quality control and standardization efforts should be outlined.  Examples of core resources that can be developed include those for biorepositories, -omics technologies (e.g., genomics, proteomics, metabolomics), and technologies for patient monitoring or examination.  NCRR encourages reducing redundancy and using, enhancing, or improving existing core facilities rather than creating new cores.

If applicants propose to acquire new technologies, the plans must be fully justified within the context of the overall proposed program goals.  Core facilities supported through this FOA must not duplicate existing facilities within the participating states made available through other NIH funding mechanisms (e.g. INBREs, COBREs, RCMIs, RCTRs, CTSAs). 

Laboratory equipment, service contracts, supplies, and personnel are all acceptable costs.  Cost recovery for core support should be sought from funded investigators. 

4.7  Other Potential Key Component Activities 

Applicants may describe up to three additional optional component activities that are expected to foster, facilitate, and enhance clinical and translational efforts in the participating institutions. 

5.  Administration of IDeA-CTR Awards (Administrative Core)

5.1  Leadership and governance plan of an IDeA-CTR

A detailed plan defining the overall governance and organizational structure of the IDeA-CTR must be provided in the application, including the functional relationships between the Program Director/Principal Investigator and the Directors of Key Component Activities, and between the IDeA-CTR leadership and steering and advisory committees.  The management and, when needed, the realignment of institutional resources among the different partnering and collaborating institutions and organizations should be clearly described.  Applicants are expected to provide a description of the policies and procedures that will govern the administrative and scientific operations of the IDeA-CTR.

The IDeA-CTR is expected to have scientific and fiscal flexibility.  The leadership is responsible for the use of IDeA-CTR resources to meet the needs of partners and collaborators, including the authority to change allocation of resources according to the guidelines of the program’s operating policies and procedures.  Applicants should state what policies and procedures will be used as the basis for reallocation of initial core funds to permit the establishment of new cores, as needed, without additional funding.  Applicants should describe how proposed policies and procedures provide structure for decision-making on several levels (e.g., IDeA-CTR PD/PI and PC(s), Core Director(s), internal advisory committee, external advisory committee, and IDeA-CTR investigators), and how each of the individuals or groups would participate in the decision process. Applicants should also state the process for informing the NIH of major changes in the IDeA-CTR.

5.2  Program Director/Principal Investigator (PD/PI) and Program Coordinator(s) (PC) of the IDeA-CTR

The implementation of the activities detailed in the application is the ultimate responsibility of the IDeA-CTR Program Director/Principal Investigator (PD/PI).  Multiple PD/PIs are not allowed.  The PD/PI is expected to be an established clinician scientist with clinical research experience and active peer-reviewed funding from NIH, NSF, or other Federal or non-Federal funding entities.  Additionally, the PD/PI must have sufficient authority and credibility to work across institutional boundaries and the requisite administrative experience and leadership skills to direct and integrate all components of this multi-faceted program.  As the director of the IDeA-CTR, the PD/PI will establish the appropriate administrative structure that will ensure efficient management of the facilities and resources across the institutions and organizations that participate in the IDeA-CTR program. The PD/PI is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies.  The PD/PI will, in consultation with the Steering Committee, be responsible for selecting the core directors, resolving disputes arising in the priority of usage of the core facilities, and for final budget decisions.  This person must devote a minimum time commitment for administrative oversight of the IDeA-CTR of 3.6 person months per year; however, up to 6.0 person months may be committed.

The PD/PI may be assisted by co-Program Director(s) from the same institution or at a partner institution. Co-Program Director(s) should also be experienced investigators who have administrative skills and experience that complement those of the PD/PI.  The PC(s) will provide day-to-day operational and administrative oversight of assigned area(s) of responsibilities, and as appropriate, help core directors set work priorities, and coordinate recommendations for major purchases of supplies, equipment upgrades, technical support staff, and assist in the resolution of other budget issues with the core directors and the PD/PI.  Each individual named as a PC must devote 3.6 - 6.0 person months annually.  The levels of effort specified for the PD/PI and the PC(s) are required whether or not salary support is requested.

5.3  Directors of Key Component Activities

Directors of KCAs must be experienced personnel with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource.  Each KCA director and any proposed Research Core Director will direct a team of specialists in the specific area of service to: (1) develop plans for standard operating procedures governing the utilization and management of KCA/Core expertise and resources, (2) develop plans for disseminating information, training, and serving as subject matter experts to investigators, (3) maintain state-of-the-art technologies and knowledge capabilities, and (4) recommend to IDeA-CTR PD/PI and PC any updates and/or replacement of equipment or personnel.  Each Director must devote a minimum of 2.4 person months annually to direct the KCA. 

5.4  Internal and External Advisory Committees

Prior to submitting an application, an Internal Advisory Committee (IAC) that is advisory to the IDeA-CTR PD/PI must have been constituted and named accordingly in the submission.  The IAC may consist of six to eight members depending on the scope and complexity of the proposed IDeA-CTR.  The application must provide functional and operational details of the duties and responsibilities of the group. 

Each IDeA-CTR is also required to establish an External Advisory Committee (EAC) that will meet at least annually to review structure and progress of the IDeA-CTR and offer recommendations to the PD/PI. In order to maintain the largest possible reviewer pool for this FOA, the applicant should not contact potential EAC members or provide the names of potential EAC members during the preparation or review of the application.  However, the areas of expertise and requisite qualifications of members who will be recruited for the EAC and their terms of service must be clearly defined and appropriately aligned with the objectives of the Center.

Plans must be included in the application for ensuring that the efforts and recommendations of the IAC and EAC are secured, considered and, as appropriate, implemented by the IDeA-CTR leadership.  Official minutes of committee meetings must be kept on file with particular attention to documenting problems and special concerns, along with any recommendations for their mitigation or resolution.  A summary of the issues discussed at each IAC and EAC meetings, recommendations made, and actions taken will have to be provided in yearly progress reports submitted to NIH.

6.  Institutional Commitment

While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment.  It is recognized that the availability of resources is variable among institutions.  Consequently, the level of institutional commitment will differ among applicant institutions.  At a minimum, the application should include communication from a senior institutional official (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the IDeA-CTR throughout the period of funding and the commitment to maintain these resources that will be made beyond the period of grant support.  Some examples of institutional commitments that may be documented include financial support, adequate space, release time agreements, tenured or tenure-track positions for clinical/translational faculty, FTEs for clinical support or ancillary personnel, core consolidation and maintenance.

7.  IDeA-CTR Evaluation Milestones

The applicant must provide a well-defined internal evaluation plan for monitoring and documenting progress towards achieving the target goals and timelines.  Objective criteria and concrete outcome measures must be included that will allow the applicant and NIH staff to evaluate the progress and trajectory of the IDeA-CTR.  Summative evaluations should be made at least annually; more frequent formative evaluations are expected.  Annual evaluation reports that include plans for any corrective actions must be provided to the advisory committees, KCA directors, other key personnel, institutional stakeholders, and NIH Program Staff.

8.  Alteration and Renovation

Alteration and Renovation (A&R) costs to improve existing physical infrastructure are allowed.  This FOA will provide up to $300,000 in direct costs in Year One of the award as one-time cost expenditure.  Direct costs requested for A&R will not be subject to facilities and administrative costs (F&A) and will be in addition to the total costs requested for the applicant IDeA-CTR program.  PD/PIs are strongly encouraged to complete all A&R work in an expeditious manner.

Alteration and Renovation projects must be relevant to the scope of the proposed IDeA-CTR.  Sufficient detail must be provided to estimate the cost and the suitability of the project.  Failure to adequately justify an A&R request may result in its deletion from the requested budget. 

Funds designated for A&R under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research or clinical equipment/instrumentation or equipment intended for teaching or other non-research related purposes.  A list of fixed and movable equipment is available at http://ncrr.nih.gov/research_funding/instruments/.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Total Costs of $4,000,000 per year.  This FOA will provide an additional one time cost of up to $300 thousand in direct costs in year one for A&R.

Award Project Period

Applicants may request up to 5 years of support.  Scope of the proposed project should determine the project period.

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
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Foreign (non-U.S.) components of U.S. Organizations are notallowed.

Criteria for Eligibility of an IDeA State to participate in this IDeA-CTR competition: In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards of less than 20 percent over the period of 2001-2005 or received less than an average of $120 million per year during that time period. Under these criteria, the following states/commonwealths are the IDeA-eligible states:

Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.

Additional Restrictions and Considerations for Submitting an Application:

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

The PD/PI must be an established biomedical or behavioral research scientist with demonstrated administrative leadership skills. The PD/PI is responsible for overall direction and development of the Center to support collaborative research efforts within and across institutions.  The Program Director/Principal Investigator of the IDeA-CTR award will coordinate the activities of all the Directors of Key Component Activities.  Multiple PDs/PIs are not allowed.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

 Only one application per institution (normally identified by having a unique NIH IPF number) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Mohan Viswanathan Ph.D.
NIH - National Center for Research Resources
6701 Democracy Blvd
Room 1084 - MSC 4874
Bethesda MD 20892-4874
Telephone: 301-435-0829
Email: mv10f@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application must be sent to:

Mohan Viswanathan Ph.D.
Deputy Director
Office of Review
National Center for Research Resources/NIH
6701 Democracy Blvd
Room 1084 - MSC 4874
Bethesda MD 20892-4874
Telephone: 301-435-0829
Email: mv10f@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, unless defined and specified elsewhere in this funding announcement.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

SPECIAL PROGRAM REQUIREMENTS

All the following information must be contained within the body of the application; appendices are not allowed.  Applicants should address the key component activities proposed for their IDeA-CTR as detailed in Section 1. Funding Opportunity Description and in the following section.  The page limitation designated in the following section includes tables, graphs, figures, diagrams, and charts that are built-in the narrative.

I.  Background, Collaborations, and Institutional Commitments (up to 12 pages)

Background and Setting.  The application must provide a narrative sketch of the current environment in which the proposed IDeA-CTR will operate.  This section should summarize the major health concerns in the participating states, the efforts that have been made to address these concerns, the biomedical research resources available in these states, and the areas in which a greater focus on clinical and translational activities would have a significant impact.  As appropriate, summarize the impact of previous support from IDeA and other Federal and/or non-Federal sources for developing the infrastructure required to conduct multidisciplinary clinical and translational research.  These could include:

Partnerships and Collaborations

Applicants are required to provide details of the following:

Institutional Commitment.  Commitment of the IDeA-CTR institution and its partners and collaborators is particularly important for the coordination of resources across the broad areas and potential boundaries of clinical and translational research which the Center proposes.  Examples of the types of institutional commitment (from the applicant and each participating institution/organization) that must be demonstrated at these Centers are:

These are examples and are not inclusive of other possible ways in which the lead and the participating institution(s) demonstrate support for the proposed Center and all its component partners and collaborators, resources, and activities. 

II.  Overall Center Organization and Management Plan (Administrative Core)(up to 12 pages)

The Administrative Core is responsible for the overall administration, coordination and management of the Center.  The PD/PI of the application should be the Core Leader (CL) of the Administrative Core. The IDeA-CTR Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that the Center milestones are being met and are being implemented effectively within the proposed timelines. A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed and a discussion on how the Center will ensure effective and timely communications between the Center and partners, core leaders, investigators, and NCRR Program staff. The Core Leader (CL) will be assisted by the Program Coordinator(s) who will be responsible for the daily administration of Center activities. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the participating institutions/organizations, KCA/Cores and Center investigators. 

This Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the KCAs/Cores and other related activities. If warranted, applicants should describe plans for recruiting and hiring additional research personnel that may be required to accomplish the goals of IDeA-CTR.  This may include hiring of senior “magnet” clinical and translational investigators who must have independent research support and will serve as mentors to junior investigators.  These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants.  As appropriate, applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member. 

The core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed (see Policies and Procedures below).  A description of how KCAs/Cores and Center activities will be managed, how communications such as periodic meetings and conference calls with minutes will be organized and managed should be provided.  The applicant must describe the major locations of Center activities, including those in collaborating institutions and discuss distances between locations; a chart or map illustrating the location and setting of the IDeA-CTR parent institution in relation to collaborating institutions, especially if there are Cores that are located outside of the parent institutions, and describe the functional relationships.  Each IDeA-CTR must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of clinical and translational research, and ensure a productive research effort.

Policies and Procedures.  Policies should be considered to be "a set of guiding principles of operation."  There are no "correct" policies, and different IDeA-CTRs may adopt different policies.  Below are several examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of an area that an IDeA-CTR considers in the development of policies and procedures. 

Procedures should be considered to be a set of specific actions used to conduct the affairs of the IDeA-CTR.  Procedures should specify how various tasks will be accomplished within the policy guidelines of the IDeA-CTR.  Policies and procedures should describe:

III.  Required Key Component Activities

(Note: applies for both required and potential KCAs)  Although a PHS 398 face page should not be used for each individual key component activity, a Cover page should be included that indicates the KCA title and the name of the KCA director and co-director(s).  The Cover page will not counted against the 12-page limit. 

A.  Clinical and Translational Pilot Grants Program (up to 12 pages)

Applicants should describe a program that will provide funding for clinical and translational pilot projects.  The program should be structured to allow the development of novel concepts, approaches, and methodologies. It is required that one or more projects funded through this initiative per year is/are ”clinical” studies as previously defined.  Projects that focus on the medically underserved and/or on health concerns prevalent among the population(s) in the participating states are strongly encouraged.  Research plans for individual pilot projects should not be included in the application.  The description of the Pilot Grants Program should include the following:

B.  Clinical Research Education, Mentoring, and Career Development Core (up to 12 pages)

The presence or absence of a Medical School in the applicant’s IDeA state or region may impact the types of educational, mentoring, and career development activities that can be proposed.  At a minimum, this designated core will facilitate mentoring in clinical and translational research and for overseeing career development activities.  Applicants that propose collaborations with existing CTSAs or RCTRs are encouraged to leverage the educational and training opportunities already in place at these sites. 

If such opportunities are unavailable, applicants may propose to develop entirely new activities or programs to support research training and career development that specifically targets postdoctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PhD, Pharm D, RN); these can include short-term courses, curricula, seminars, workshops, sabbaticals, and visiting scholarships.  The activities or programs proposed must address scientific/education areas and/or topics important to clinical and translational science in a variety of research areas.

Important information to include in this section are the following:

If no currently funded training program exists at any of the institutions in the participating states, applicants should describe how the proposed IDeA-CTR activities will enhance their ability to apply for training awards, or partner with other institutions to leverage existing or proposed training activities.

C.  Clinical Research Design, Epidemiology, and Biostatistics Core (up to 12 pages)

Applicants should describe:

IV.  Potential Key Component Activities

Each proposed KCA/core must be well-justified as to how the proposed KCA/Core provides added value to clinical and translational research efforts at the institution(s). Applicants should describe in detail the operation of each proposed Core, i.e., its quality control, policies and procedures, allocation of core budgets, process for mentoring and training, procedures for reviewing and supporting projects/investigators, prioritization of services.  The application must show that the resources and services offered by each proposed KCA/core are (1) adequate and appropriate to achieve the stated goals and objectives of the IDeA-CTR program and its component activities, (2) capable of supporting intra- and inter-institutional operations and multi-disciplinary clinical and translational efforts, and (3) structured to allow the development of novel concepts, approaches, and methodologies.  The application must describe the mechanisms that will be employed for tracking utilization of core resources and for adapting to the needs of investigators.  When practical, the IDeA-CTR should seek to utilize existing resources and facilities supported by other programs of the NIH, other Federal, and/or non-Federal organizations and amply justify requests that duplicate or substantially overlap with these resources.

A.  Clinical Research Resources and Facilities (up to 12 pages)

If proposed, the IDeA-CTR application must provide details for the oversight of recruitment and retention of research participants, and the provision of necessary resources for cost-effective research participant interactions.  Examples of resources to facilitate participation in clinical and translational research may include (but are not limited to) the recruitment of research participants, the provision of out-patient or community-based examination rooms, satellite research participant recruitment/enrollment sites at smaller institutions, research nurses, research coordinators and other support clinical personnel (e.g. phlebotomists, scheduling services), and services for research specimen collection and shipping.

Applicants should describe:

B.  Community Engagement and Outreach (up to 12 pages)

If proposed, the IDeA-CTR application must provide clear and detailed plans for identifying health issues/concerns of communities or populations in the participating states, and for developing capacity to respond to these issues/concerns. 

If proposed, applicants should describe:

Other appropriate activities may include establishing community advisory boards and the development of software or other materials to facilitate collaboration with community practitioners.

C.  Biomedical Informatics Resources (up to 12 pages)

If proposed, the applicants must describe:

D.  Ethics, Regulatory Knowledge and Other Support Activities (up to 12 pages)

If proposed, applicants should describe:

E.  Technologies and Resources for Core Laboratories (up to 12 pages)

If proposed, applicants should describe:

F.  Other Program Component Activities

If proposed, applicants may describe up to three additional optional component activities, up to 12 pages per KCA.

V.  Evaluation Milestones (up to 12 pages)

The application must include a detailed internal evaluation plan to assess implementation of the short-term and long-term goals of the IDeA-CTR, including implementation of specific program activities.  The applicants must present plans on documenting the accomplishments anticipated for each budget period and within the total award period.  The applicant must provide plans for evaluating overall operational functions of the IDeA-CTR including, but not limited to, the following:

For each proposed key component activity, applicants must provide detailed performance milestones and a timeline that will be used to measure progress in each budget period towards the goals of each KCA.  This section must include:

VI.  Alterations and Renovations (up to 12 pages)

For any proposed A&R, narrative summary, line drawings, and cost estimates must be provided as follows:

Narrative Summary

Line Drawings

Cost Estimates

VII.  Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution and partnering institutions that:

Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty research, communications, and implementation at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated.

As appropriate, letters from the /Program Directors/Principal Investigators of other NCRR-funded centers (e.g. INBREs, COBREs, CTSAs, RCMIs, RCTRs) must be included indicating their program’s role in supporting the IDeA-CTR’s goals for clinical and translational activities.

FORMAT AND ORGANIZATION OF THE APPLICATION

Applicants must consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc. Adhere to NIH format described in the PHS 398 instructions for font, line spacing and margins. The application should be organized as follows:

Face Page: Use Form 1 of the PHS 398.  On Line 1, include the title that best represents the nature of the IDeA-CTR Program.  On Line 2, provide the number of this FOA, PAR-11-XXX and the PAR title “Limited Competition: The Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research”.    Information for the PD/PI should be entered on the PHS398 face page.  Please remember that the PD/PI must be registered in the eRA Commons prior to application submission. The budget figures should be taken from the consolidated program budget (see below).

Description, Performance Sites, and Key Personnel:  Key Personnel include the program/Director/Principal Investigator, Program Coordinator(s), Director(s), and co-Director(s) of key resources, and other key professional and administrative members of this Program.  Do not include names of external advisory committee members.  Only include named individuals for whom salary support is requested.

Table of Contents

Detailed Budget Pages for Initial Budget Period and Entire Proposed Period of Support: Several sets of budget pages (Form pages 4 & 5) are required.  The first set is for the entire U54 budget that summarizes the total budget for the all of the Key Component Activities in the program and must include justification for equipment, personnel and supplies.  The subsequent sets of budget pages (Form pages 4 & 5) will contain the budgets required for each of the IDeA-CTR Key Component Activities included in the application and must include justification for equipment, personnel and supplies required for the Key Component Activity.  Total costs per year should not exceed $4.0 million including F&A costs but excluding the additional $300 thousand for A&R in the first year.  

Funds provided via the IDeA-CTR award are intended to develop infrastructure in participating institutions.  Budget items should be requested for 12 months.  Most items in the program will be listed on pages 4 & 5 of the PHS 398 for the IDeA-CTR U54 budget including: Salary and fringe benefits for the IDeA-CTR PD/PI, component directors(s) or co-director(s), professional and administrative staff, (personnel category of PHS 398 pages 4 & 5), consultant costs, equipment, travel, and supplies. Other Costs may include patient care costs, other expenses and contractual costs.

Funds requested for payment to a hospital included in the Clinical Research Resources and Facilities KCA shall be requested on PHS 398-Form Page 4, as “Patient Care Costs.” If there is a negotiated Research Patient Care Rate Agreement established between the hospital and DHHS that will be applied to the provision of IDeA-CTR services, include a copy of that agreement with the application. Categories for which F&A costs are included in the negotiated research patient care agreement should be excluded from F&A costs in the U54 budget (i.e., F&A costs may not be charged twice). 

Biographical Sketches and Research Support: are required in standard NIH format for Program Director/Principal Investigator, Program Coordinator(s), KCA Directors and co-director(s), key professional and administrative members of this program, and named members of significant internal committees.  Do not include Biographical Sketches for external advisory committee members or any individuals who do not have direct roles in the IDeA-CTR program.

Resources Section: must be included using the PHS398 Resources form page and instructions.  A separate resources section must be submitted for the lead organization and, as applicable, each key component activity following the same order that they are described elsewhere in the application.   Although there is no page limit for each KCA resource section, it should be concise and contain only information that is not included in the Research Strategy section for that corresponding KCA.  Do not include information required by the FOA that belongs in the page-limited Research Strategy sections for the corresponding KCA.

IDeA Infrastructure for Clinical and Translational Research (IDeA-CTR) Program: The application must present all proposed activities of the IDeA-CTR within the page limits listed below.  Note that these are upper page limits: applicants are urged to be concise and to present information in tables where possible.  The information must be arranged as follows:

1.  Background, Collaborations, and Institutional Commitment (up to 12 pages)

2.  Overall Center Organization and Management Plan (Administrative Core)(up to 12 pages)

3.  Required Key Component Activities (up to 12 pages each)

4.  Other Proposed IDeA-CTR Key Component Activities (up to 12 pages per KCA)

5.  Evaluation Milestones (up to 12 pages)

Alterations and Renovations (up to 12 pages)

Literature Cited

Required Institutional Letters (see Special Programmatic Requirements above)

Human Subjects

Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects in studies supported by this IDeA-CTR initiative.  If clinical studies or trials (biomedical and biobehavioralintervention studies) are to be supported by the IDeA-CTR, include a general description of the plan for data and safety monitoring of such studies and adverse event reporting to the IRB, NCRR, NIH, and others (as appropriate) to ensure the safety of research participants.

Patient Care Rate Agreement (if applicable)

Vertebrate Animals

Checklist

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Appendices are not allowed.  Applications that include an appendix will not be accepted for review.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.     

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed IDeA-CTR benefit clinical and translational research activities in the participating IDeA states? Are the overall program vision and strategy adequate to facilitate and sustain clinical and translational research on health concerns prevalent in the participating states? Will the proposed IDeA-CTR have potential to enhance the competitiveness of the investigators to obtain additional funding for clinical and translational research?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the PD/PI and PC have the experience, authority, and committed time to administer the proposed IDeA-CTR? Will the PD/PI have sufficient authority and credibility in the institution to work across institutional boundaries? Do the program leadership and management team bring complementary and integrated expertise to the project?  Will the proposed IDeA-CTR have the organizational structure to benefit significantly clinical and translational research activities at the participating institutions?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Is the program likely to develop novel approaches to increasing the ease and efficiency of clinical and translational research activities at the institution(s) in the participating states?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application identify key impediments to the performance of translational and clinical research and then propose plans or means to overcome these? Does the applicant indicate how the organization will be adapted to respond flexibly to changes in plans and priorities?  Has the applicant included collaborations with at least one other IDeA state?  Does the IDeA-CTR facilitate intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations?  Are plans included to address cross-institutional, geographical, cross-disciplinary, regulatory, and other hurdles?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Will the PD/PI and PC(s) have adequate support for managing the resources committed by the institution(s) for the IDeA-CTR? Does the application provide strong evidence that the addition of the IDeA-CTR will provide resources that would not otherwise be possible? If applicable, are there adequate cooperative arrangements between participating institutions to ensure that the IDeA-CTR performs effectively as one activity across institutional boundaries? Will the resources be available to researchers in different disciplines (e.g., medicine, pre-clinical research)? Do major resources facilitate the objectives of the IDeA-CTR?  Are the operation and maintenance of resources and facilities appropriate and necessary for the functioning of the IDeA-CTR?

Other Scored Components

In addition to the above criteria, the following components of the IDeA-CTR application will be scored independently AND will be considered in the determination of the overall impact/priority score for the application.

Center Organization and Management Plan (Administrative Core): 

Has the applicant described an effective administrative and governance structure that will promote the discipline of clinical and translational research?  How well will the components of the Center be integrated with each other?  Is the governance structure designed to ensure both accountability and integration of the components of the IDeA-CTR into a coherent program?  Has the applicant demonstrated the need for all proposed optional key component activities and the effectiveness of these activities to enhance clinical and translational efforts in the participating states?  Are the lines of administrative responsibilities within the IDeA-CTR and the relationships between the PD/PI, PC, and the KCA Directors clearly delineated?  Is the IDeA-CTR guided by an appropriately constituted Internal Advisory Committee?   

Clinical and Translational Pilot Grants Program:

Is the Pilot Program well integrated into the overall IDeA-CTR goals and objectives?  Is the program designed to serve the needs of investigators from a variety of research areas?  Will the expected benefits to the IDeA-CTR and to the wider research community be measured and tracked? Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate pilot project applications?  Is the program structured to allow the development of novel concepts, approaches, and methodologies?  Is there an adequate plan to solicitapplications, to prioritize the projects and to review research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections, and to review their methodology?  Does the IDeA-CTR have a sufficient pool of qualified investigators from multiple fields from whom to solicit applications?  

Clinical Research Education, Mentoring, and Career Development Core: 

If a research education program is proposed, does the program address scientific/education areas and/or topics important to clinical and translational science as applicable to a variety of research areas?  Are the Core Director and other Mentors qualified to carry out their responsibilities?  Do these individuals dedicate sufficient time? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate?

Clinical Research Design, Epidemiology, and Biostatistics Core:

Will this resource be sufficient for intra- and inter-institutional operations?  Are the core Director and core personnel suitably trained and qualified to carry out their functions?  Do these individuals dedicate sufficient time?  Are staff members of sufficient numbers and adequate training to support the needs of the IDeA-CTR?  Are the operational plans for marketing resources, assisting users, and prioritizing projects well-delineated and appropriate? Will extant Research Design, Epidemiology, and Biostatistics resources supported by other programs be leveraged and utilized?  Are the resources and expertise provided by the core adequate and appropriate for accomplishing the overall objectives of the IDeA-CTR and its other component activities?

Other Potential Key Component Activities:

Is each proposed KCA/core well-justified?  Are the resources and services offered by each proposed KCA/core adequate and appropriate to achieve the stated goals and objectives of the IDeA-CTR program and its component activities?  Are the core Director and core personnel suitably trained and qualified to carry out their functions?  Do these individuals dedicate sufficient time?  Are staff members of sufficient numbers and adequate training to support the needs of the IDeA-CTR?  Is the core/KCA structured to allow the development of novel concepts, approaches, and methodologies?  Does the core propose novel approaches to providing training and services to projected users?  Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators?  Will resources, expertise, and support services already provided by existing programs by other Federal or non-Federal support be leveraged and utilized in standing up the core/KCA?   

Evaluation Milestones:

Do the milestones and timelines provide feasible objectives, detailed quantitative and/or concrete criteria by which milestone achievements will be assessed?  Is the plan adequate to evaluate the short-term and long-term goals for each of the key component activities?

Alteration and Renovation: 

Are requested alteration and renovation projects relevant to the scope of the proposed activities of the IDeA-CTR? Are the costs and suitability of the project justified?  Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project?  Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)?  Is justification provided for all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor plans with the scale clearly indicated?  Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project?  Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room?  Are the total net and gross square feet of space to be renovated provided?  Does the plan indicate the location of the proposed renovation area in the building?  Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished?  Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

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

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(Special Emphasis Panel convened by NCRR)  , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Council (NARRC). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

Program Director/Principal Investigator (PD/PI) and Program Coordinator (PC) will have the primary responsibility for:

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 DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NCRR will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to each IDeA-CTR. 

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination.  NIH Project Scientists(s) will:

An NIH Program Official will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The program official(s) will:

Additionally, the NIH Program Official(s) may recommend the termination or curtailment of an investigator or KCA/core in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

Awardees agree to governance, through voting and decision making, of the IDeA-CTR through a Steering Committee.  Steering Committee voting membership shall consist of the Principal Investigator, Program Coordinator(s), and NCRR Program staff [Program Official and Project Scientist(s)].  The IDeA-CTR PD/PI will serve as chairperson of the steering committee.  Quarterly meetings of the Steering Committee will ordinarily be held by telephone conference call in the first year of the award.  Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period.  In person meetings will be held once yearly in Bethesda, MD.  Each member of the Steering Committee will have one vote.  The IDeA-CTR leadership will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, 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.

 A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented by this FOA. Applicants are strongly encouraged to contact NIH program staff early in the application process and they should have a thorough understanding of the intent and expectations of this FOA before developing an application.  A pre-submission webcast will be conducted at a time and date that will be posted at the NCRR website, http://ncrr.nih.gov.  At the webcast, NCRR and other NIH staff will explain the goals and objectives of the IDeA-CTR program and answer questions from potential applicants.  The webcast will be archived at www.videocast.nih.gov.      

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

J. Rafael Gorospe M.D. Ph.D.
Medical Officer
Division of Research Infrastructure
National Center for Research Resources/NIH
6701 Democracy Blvd Room 928
Bethesda MD 20892
Telephone: 301-435-0832
Email: gorospejr@mail.nih.gov

Peer Review Contact(s)

Mohan Viswanathan Ph.D.
Deputy Director
Office of Review
National Center for Research Resources/NIH
6701 Democracy Blvd Room 1084
Bethesda MD 20892-4874
Telephone: 301-435-0829
Email: mv10f@nih.gov

Financial/Grants Management Contact(s)

Stacia H. Fleisher, M.P.P.
Grants Management Specialist
Office of Grants Management
National Center for Research Resources/NIH
6701 Democracy Blvd Room 1045
Bethesda MD 20892 (20187 for express delivery)
Telephone: 301-435-0851
Email: stacia.fleisher@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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