Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement is developed as a Common fund initiative (http://commonfund.nih.gov/) through the Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). This FOA will be administered by the National Center for Research Resources on behalf of the NIH (http://www.ncrr.nih.gov/).

Funding Opportunity Title

Institutional Clinical and Translational Science Award (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Note that awards to successful applicants will be linked and issued as UL1 and KL2, with an optional TL1.

Announcement Type

This is a reissue of RFA-RM-07-002.

Related Notices

  • May 12, 2011 - See Notice NOT-RM-11-017 Modification with regard to the application receipt dates for Clinical and Translational Science Awards (CTSAs) in 2011.
  • May 6, 2011 - See Notice NOT-RM-11-016 This Notice modifies the language of with regard to the section on Special Program Requirements part 20 (Required Institutional Letters) and the section on Format of the Application part I (Human Subjects) to address reporting of serious and unexpected adverse events.
  • March 23, 2011 - See Notice NOT-RM-11-012 This Notice is issued to make 3 amendments to the current funding opportunity announcement for Clinical and Translational Science Awards.
  • December 21, 2010 - See Notice NOT-RM-11-006 The purpose of this Notice is to update statements in the cited FOA.

Funding Opportunity Announcement (FOA) Number

RFA-RM-10-020

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in  Section III. 3. Additional Information on Eligibility.

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

93.389, 93.310  

FOA Purpose

This FOA invites applications for Clinical and Translational Science Award (CTSA) from new applicants and from current awardees. The CTSA program sustains and advances clinical and translational science as a distinct discipline. NIH resources give institutions flexibility to develop their existing configuration, resources and talent to maximize the safety, efficiency, quality and speed of clinical and translational research. The academic home for clinical and translational science can be a center, department, or institute (C/D/I), and is expected to include faculty who conduct original research, develop graduate and postgraduate training curricula and lead programs that integrate clinical and translational science across multiple departments, schools, research institutes and hospitals.

Key Dates
Posted Date
Letter of Intent Due Date

May 11, 2011

Application Due Date(s)

All renewal applications: June 11, 2011

All new applications: October 3, 2011 (Date Withdrawn per NOT-RM-11-017)

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

Renewal applications: September, 2011

New applications: February 2012

Advisory Council Review

Renewal applications: January, 2012

New Applications: May 2012

Earliest Start Date(s)

Renewal applications: (Corrected to (June 2012) per NOT-RM-11-006); July, 2012

New Applications: September 2012

Expiration Date

Renewal applications: June 12, 2011

New applications: October 4, 2011

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.

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

The National Institutes of Health (NIH) initiated the Clinical and Translational Science Award (CTSA) program to transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research. The transformation has been approached by diverse but convergent paths at different awardee institutions, each providing an academic center, department, or institute (C/D/I), comprising faculty and programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes, and hospitals. C/D/Is include faculty who conduct original research, develop graduate and postgraduate training curricula and lead programs that integrate clinical and translational science across multiple departments, schools, clinical and research institutes, and hospitals to create an institutional CTSA. The CTSA program has grown to 55 sites that cooperate to meet consortium-wide CTSA strategic goals.

Definitions: For the purpose of this initiative, "Clinical Research" comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions (see: http://grants.nih.gov/grants/funding/phs398/phs398.html). Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies also is an important part of translational science.

Background

Clinical and translational science is critical to the success of the NIH mission. The opportunities for translational and clinical research continue to expand as genome-wide association studies become available and individual variation is increasingly taken into account. Safe and cost-effective research draws extensively on collaborative approaches with resources being shared both nationally and internationally. Clinical researchers need specialized training to prepare them for this new environment. Identifying and overcoming barriers to clinical research are high priorities and opportunities to gain and maintain public trust and participation in clinical and translational research must be maximized to bring better health to the American public.

The Clinical and Translational Science Award (CTSA) initiative was launched to create an integrated academic home for Clinical and Translational Science with the resources to train and advance future members of multi- and inter-disciplinary research teams. In their first several years CTSAs brought novel research tools and information technologies to patient care.  They attracted basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry into new professional interactions, programs, and research projects. CTSA education and career development programs train clinical and translational researchers and offer advanced degrees in clinical and translational research.

To sustain growth, CTSAs will need institutional support, the status of a major administrative entity within the applicant institution, and a Principal Investigator(s) with the authority, perhaps shared with other high-level institutional officials, over requisite space, resources, faculty appointments, protected time, and promotion. Diverse models for CTSAs were funded in the first rounds of awards and NIH welcomes new and renewal proposals that meet the needs of both the local institution and of the wider research community.

Specific objectives

This CTSA award will sustain the disciplines of clinical and translational science by providing environments and resources for investigators engaged in clinical and translational research. Their academic home may be a center/ department/institute (C/D/I), as determined by institutional circumstances and it will:

The CTSA program will complement the programs of the NIH Institutes and Centers and will work in cooperation with other relevant trans-NIH activities.

Applicants may re-define the key functions, components, governance and structure of their CTSA. They should describe the existing and planned activities that comprise their CTSA, indicating the roles of the participating schools and departments within the applicant organization, affiliated institutions, community, foundations and industry. Required activities of a CTSA include providing career paths in clinical and translational science through research education, training, and career development leading to advanced degrees (MS or PhD); informatics resources; support for community engagement and for pilot projects. All CTSAs participate in a CTSA Consortium that links to activities within and across NIH Institutes and Centers. Successful applicants will be expected to complement and interact with existing institutional centers that are funded by the categorical institutes of the NIH and to interact with affiliated institutions and industry. In forming an integrated institutional home for clinical research and training, applicants may choose to negotiate partnership(s) with existing CTSA(s) for the provision of selected key functions, components or training programs. Budgetary and administrative arrangements are to be negotiated between the partnering institutions.

Key Functions and Components of an Institutional CTSA

The CTSA supports the discipline of clinical and translational science and the needs of its researchers. Applicants are encouraged to draw on their past experience, and that of the consortium, in proposing concepts, methodologies, and approaches that are integrated into a comprehensive, effective, and efficient researcher-, trainee-, and research subject-centered program. Applicants must include education, biomedical informatics, community engagement, pilot projects and an individual or team who works in Regulatory Support in their list of key functions and components of the CTSA. These activities, and the other potential topics suggested below, may be supported through NIH funds or institutional resources. The selection of optional components for a CTSA should take institutional strengths and available funding levels into account. Collaborations with other CTSA awardees are encouraged and should be described in detail. They must be accompanied by a letter confirming the collaboration.

Required CTSA Key Functions comprise:

Optional CTSA Key Functions include:

The CTSA should provide clinical and translational research resources and training that support multiple disciplines (e.g., medicine, dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, bioengineering) and the research projects of multiple NIH Institutes and Centers. Applications that focus CTSA resources on only a few diseases, specialties, or for limited number of investigators will be considered unresponsive to this solicitation. Applicants are encouraged to partner with foundations, industry and community organizations, as appropriate, with all partners agreeing to follow NIH policies with respect to 1) listing clinical trials at ClinicalTrials.gov; 2) sharing of resources; 3) data sharing and providing public access and 4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights. Acknowledging that existing resources vary among applicant institutions, the support requested for each of these components is expected to vary, reflecting current and projected needs. Where mutually agreed, an applicant institution may propose a partnership with one or more funded CTSAs if this arrangement will extend the resources available to the applicant's clinical and translational researchers. Integration of existing resources and grants into the CTSA activities will be viewed as a strength.

Governance and leadership of an Institutional CTSA

CTSA applications should include a plan that defines the overall governance and organizational structure of the C/D/I, including the relationships between the CTSA PI(s) and the Directors of key functions. A plan to manage and, where necessary, reassign, institutional resources and CTSA resources among the schools, departments, specialties, affiliated hospitals, and affiliated independent research institutions that participate in the CTSA; and between the CTSA and outside foundations and/or industry should be described. Administrative policies and procedures should be described, including an evaluation component that will assess the administrative and scientific functioning and accomplishments of the CTSA.

The clinical research experience of the PI(s), who is/are the Program Director(s), should be described, together with his/her/their involvement in the daily activities of the C/D/I. It is expected that PI(s) would include an established clinician scientist and that the PI(s) have the ultimate responsibility for the implementation and function of the CTSA. The PI(s) may be assisted by co-Program Director(s) from the same institution or an affiliated institution. Co-Program Director(s) should also be experienced investigators who have administrative skills and backgrounds that complement those of the PI(s). The amount of effort for the PI and co-Program Director(s) should be commensurate with the requirements of the position(s), and not less than two person-months each and preferably sum to not less than 6 person-months per year. This level of effort is required whether or not salary is requested.

The Directors of the key functions of the CTSA should, in general, be senior faculty members who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct the resource and to speak for the CTSA institution in national forums. Applicants should explain how their clinical and translational science communities would contribute to the selection and allocation of key resources, the implementation and self-evaluation of key functions, and the prioritization of use.

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

Pediatric PIs appointed under a single Clinical and Translational Science Award may have direct authority over a separate budget and infrastructure for child health clinical research, as may other PIs as described in NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).

Applications designating multiple PDs/PIs should include a section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 12 of the Research Plan in the PHS 398). A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be identified in the Notice of Award (NoA).

Biomedical Informatics

Biomedical informatics, a required CTSA activity, is the cornerstone of communications within and between CTSAs and consortium members and collaborators. Applicants should consider both internal, intra-institution communication platform(s) and external interoperability to allow for communication among CTSA consortium members and the research partners of clinical and translational investigators (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). Biomedical informatics support is expected to be flexible and innovative. Interoperability, security, workflow, usability, and standards are essential areas of work. To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards (e.g., identifiers, vocabularies, transactions, security measures) 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. All human subjects data must be handled securely to ensure privacy and confidentiality. Biomedical informatics research activity should be innovative in the development of new tools, methods, and algorithms.

NIH attaches importance to assessments of informatics performance and goal setting across the entire CTSA community. Therefore all Biomedical informatics Directors will participate in the national CTSA Informatics Key Function Committee that is the forum for discussion and agreement on standards, best practices, and/or solutions. The CTSA institution must be committed to working toward adoption and implementation of standards and practices endorsed by the CTSA Consortium Steering Committee to ensure interoperability for its clinical and translational investigators.

Research Education, Research Training and Research Career Development

Mentored Research Career Development leading to graduate degrees in clinical and translational science is a required component of a CTSA that should be offered for post graduate programs irrespective of the primary interest, degree, or discipline. In response to the emergence of interdisciplinary, team-oriented environments, applicants are strongly encouraged to train investigators from diverse disciplines such as medicine, pediatrics, surgery, dentistry, nursing, and pharmacology, as well as study coordinators, project managers, and other key clinical research personnel in a range of topics relevant to clinical and translational science (e.g., clinical research design, epidemiology, biostatistics, pharmacology, biomedical informatics, ethics, behavioral science, engineering, law, health economics). Education in business practices as related to health research may be included as well.

Research education and pre-doctoral training are optional components of a CTSA. Together with the required mentored research career development activities they should be structured to promote the recruitment, training, advancement, and retention of new investigators in clinical and translational science careers. Applicants are encouraged to include novel methods and approaches for providing integrated and flexible pre-doctoral and postdoctoral research training opportunities. Research education, training, and career development activities should permeate all aspects of the CTSA program and trainees and scholars should be offered opportunities to utilize all resources and research efforts of the CTSA. Applicants are encouraged to consider ways in which training could be shortened without adversely affecting quality.

Research Education Component:

An optional research education component of the CTSA could provide didactic courses and/or short term (up to 6 months) research experiences in the fundamental skills of clinical research with the goal of informing clinical research team members about the complex issues of clinical research. Program participants should have innovative clinical research as their long-term clinical research career plan. The core curriculum could include topics of general interest such as biostatistics, bioethics, clinical trials design, informatics, health data standards and observational study design, Federal policies and regulations that address research with human subjects (e.g., 45 CFR 46, FDA, INDs, inclusion of women and minorities as well as children in clinical research projects), scientific writing for publication, team leadership and preparation of competitive grant applications.

Interdisciplinary approaches are strongly encouraged, as are new approaches to education, which should describe and justify the proposed period of training, and plans for enrolling trainees. The scope of the curriculum can be flexible to include curriculum development that meets the needs of the institution and participants.

Institutional Research Training component:

An optional Institutional Research Training (TL1 training) component, if offered, must provide trainees with coursework in clinical and translational research as part of formal advanced degree requirements. Institutional NRSA training grants are designed to allow the director of the program to select both pre-doctoral and postdoctoral trainees and to provide a curriculum of study and research experiences necessary to provide high quality research training. Appropriate advanced degrees include research doctoral degrees (e.g., PhD, DNSc) in a clinical research-related program and a combined clinical research masters degree given in a combined program with a health professional doctoral degree such as MD, DDS, DO, DNP, or PharmD. Pre-doctoral research training must emphasize fundamental research training in clinically related areas of biomedical and behavioral sciences. Postdoctoral research training must emphasize specialized training that corresponds with the interests of NIH's Institutes and Centers. The training may include courses or practicum experience in clinical and translational science, biostatistics, research ethics, epidemiology and regulations governing clinical research. The PhD program could provide each trainee with a minimum of 3 years of full-time research training support.  If a combined clinical research master's and health-professional doctoral degree is offered, all institutional requirements for the combined degree must be completed by the trainee by the time the health-professional doctoral degree is completed/conferred. The TL1 training component may also offer health-professional pre-doctoral level trainees practical experience in clinical research ranging from 2 to 3 months through summer or special 12-month research training rotations for those who wish to interrupt their studies for a year to engage in full-time research training before competing their formal training programs.  No individual trainee may receive more than 5 years of aggregate NSRA support at the pre-doctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.

Mentored Career Development Component:

The required Mentored Career Development Component (KL2) component will support the research career development of clinical researchers who have recently completed professional training and who are commencing basic, translational, and/or clinical research. The goal of this component is to foster the discipline of clinical research and, by increasing clinical research capacity, to expedite clinical and translational research. The programs will accomplish this through a mentored program, bridging clinical training with research independence. This funding opportunity will use the linked NIH Mentored Research Career Development Program Award (KL2) mechanism. No UL1 award for a CTSA will be made without a complementary KL2 award.

Community Engagement and Research

Community engagement is a required CTSA activity that fosters collaborative research partnerships and enhances public trust in clinical and translational research, enhancing community decision making and action for health promotion, health protection and disease prevention. Community engagement activities could include relationships with the public and with community health care providers, community-based organizations or groups such as voluntary and professional organizations, schools, women's health groups, faith-based groups, and housing organizations that promote the dissemination of best research practices. Resources that might be requested for this component include community capacity building and cultural sensitivity training for institutional clinical and translational researchers, community and health care provider education and outreach, establishing a community advisory board, development of software to facilitate the collaboration of community practitioners, and strategies that allow for bidirectional communication with, and participation of, diverse populations and community groups. An environment that introduces scholars and researchers to research in population and community-based research methods would be valuable.

Evaluation

Internal evaluation is a required CTSA activity. Each CTSA should have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offer recommendations to the CTSA Director. Any existing EAC membership should be listed and their role in the committee described. Potential new members of an EAC should not be named and should not be contacted prior to the review of an application.

Pilot Translational and Clinical Studies

A CTSA applicant must request support for pilot research projects that could 1) allow clinical and translational trainees or researchers to generate preliminary data for submission of a research grant application; 2) seek to improve clinical design, biostatistics, clinical research ethics, informatics, or regulatory pathways; 3) develop new technologies; or 4) others as defined by the applicant. Pilot and collaborative projects should, in general, be of sufficient scope to qualify as a stand-alone research effort and should be well integrated into the activities of the CTSA. Funds for pilot projects must be available promptly and be accompanied by an organizational structure that allows full compliance with regulatory requirements.

Regulatory Knowledge and Support

Each CTSA should provide research participant protections through research subject advocacy functions that should: (1) be independent from the IRB function (2) complement and integrate with existing entities at the institution and (3) work with investigators, trainees, and research teams to promote and facilitate the safe and ethical conduct of human research.

Optional components of an application include support that will promote the protection of human subjects and facilitate regulatory compliance related to clinical and translation research. Applicants are encouraged to be innovative at all levels of clinical research regulation including, for example, the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, safety and regulatory management and compliance, etc. Institutions could develop best practices that reduce or remove institutional impediments to clinical and translational research and, through dissemination and sharing, could enhance inter-institutional collaborations. Regulatory support provided through a CTSA should not take the place of an institutional compliance or enforcement office nor shall it be responsible for Institutional Review Board activities, but should, instead, assist investigators in their documentation requirements. Institutional IRB personnel may interact with the regulatory support personnel at other CTSA institutions through dedicated committees or special interest groups to ensure that collaborative clinical and translational research activities are facilitated, whether by policy, procedures, best practices, or other means. The institution should be innovative in developing the regulatory support interactions with the IRB and compliance office to facilitate clinical and translational science research without loss of participant protections.

Development of Novel Clinical and Translational Methodologies

An option to conduct original research on novel methodologies and approaches for translational and clinical sciences could build an environment that sustains intellectual exploration. Areas in which faculty might pursue research funded by the CTSA include new translational methodologies, methods for more objective and quantifiable biomarkers or phenotyping, determining cost effectiveness, research into clinical trial designs, clinical informatics for longitudinal studies, home based research devices, predictive toxicology in human populations and ethics research specific to populations rather than specific trials.

Research Design, Epidemiology, Biostatistics and Clinical Research Ethics

Biostatistics and sound research design are of critical value to clinical research, and strengths in this area are essential to a CTSA, whether funded through the award or through institutional funds. Relevant activities include developing, validating and integrating research designs and biostatical methodologies essential to clinical and translational studies, limiting risks to research subjects, preventing bias, improving recruitment and retention, 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, informed consent, and issues in diseases with limited treatment options. These topics offer opportunities for methodologic research as well as collaborations and consultations with CTSA users.

Clinical Research Resources and Facilities

Applicants may opt to request resources such as cores for the recruitment and retention of research participants, in-patient, out-patient, or community-based exam rooms, medical vans, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, specialized child health services, scheduling services, and services for research specimen collection and shipping. Applicants should describe a plan to familiarize investigators in their institution and medical catchments area with the resources available through the CTSA for human subject studies. Where appropriate, cost recovery could be sought from funded investigators and by leveraging with established cores.

Translational Technologies and Resources

Resources that could be requested include advanced technologies such as mass spectrometry, imaging, ultrasound, positron emission tomography, gene expression, proteomics, translational cell and gene therapies and technologies for patient monitoring or examination. Items proposed should be fully justified by local and regional needs. Standard operating procedures are required as is participation in national or international quality control and standardization efforts, where appropriate. The level of support requested must be justified by the projected use by clinical and translational researchers from within and outside the applicant institution(s). If this function is proposed, laboratory equipment, supplies, and personnel are all acceptable costs. Cost recovery for core support may be sought from funded investigators. CTSAs may create opportunities for small business partnerships in clinical and translational research for which NIH funding opportunities exist (see Small Business Innovation Research and Small Business Technology Transfer Research (SBIR/STTR) at http://grants1.nih.gov/grants/funding/sbir.htm). CTSA and SBIR/STTR research collaborations may facilitate development from scientific investigations into final products for commercialization with applications for clinical and translational researchers, health care providers, and patient care.

CTSA Milestones

Specific, well-defined, milestones that will measure progress in each budget period towards the goals of the CTSA should be described. These should have objective criteria and concrete outcome measures that would allow NIH staff to evaluate the progress of a CTSA.

National CTSA Consortium

Under the Cooperative Agreement, a national CTSA Consortium Steering Committee (CCSC) has been established for the CTSA PIs with NIH representatives. Additional Key Function committees and groups for common themes identified by the CCSC (e.g., Child Health, Research Education, Informatics etc) exist.  The consortium of CTSA institutions cooperatively addresses impediments to clinical and translational science and works towards adopting and implementing agreed-on best practices, policies, procedures, and other measures to advance collaborative clinical and translational research and to reduce burden on individual investigators at all institutions. CTSA institutions are working towards creating a networked environment in which clinical studies can be expedited across multiple institutions. Awardee institutions are encouraged to set funds aside for consortium activities.

The CCSC meets at least once each year in the Washington, D.C. area and each CTSA should be represented. NIH staff are active members of the CCSC and each of the Key Function committees and facilitate communication among the CTSAs with support services, which could include teleconferences, a Listserv and an interactive website. NIH staff conduct periodic visits, review each site's progress in meeting its overall goals, and provide financial oversight of the program.

The CCSC has adopted five Strategic Goals and assigned committees of CCSC members and administrators to be responsible for them. The Strategic Goal committees draw on the expertise of Key Function Committee members in achieving goals and promoting their implementation across the consortium. Key Function committees also share and disseminate ideas, experience, and tools that support an environment for high-quality clinical and translational research both at the individual institutions and nationally. Working together, the Strategic Goal- and Key Function Committees develop, adopt, and implement solutions to impediments to collaborative clinical and translational research. The CTSA institutions must be committed to active collaborative participation in committees at a national level. CTSA committees recommend and work to implement best practices among centers, to include topics such as data formats, common consent forms, patient recruitment strategies, course curricula, implementation of common protocols. A letter from the applicant institution stating that the CTSA will work towards adopting and implementing the agreed on policies, procedures, best practices, or other measures established by the CCSC must be submitted with the application.

Further information about expected activities of the Key Function committees is posted at the CTSA Program web site (http://www.ctsaweb.org)

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

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.

This funding opportunity will use the UL1 award mechanism with linked Mentored Career Development (KL2) and optional Training (TL1) components.

Application Types Allowed

New applications are permitted
Renewal applications are permitted

Opportunities for revision applications will be separately announced.

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

Funds Available and Anticipated Number of Awards

The total funds available for renewal of CTSA awards in 2012 are approximately $100 million. Up to 12 awards are anticipated from this solicitation with the anticipated start date of June 1, 2012.

Awards will vary in size due to the prior consolidation of multiple programs at the applicant institution(s) into the CTSA program proposal. Competing renewal applicants have been notified of the maximum award amount that may be requested and may contact NCRR Program Staff for verification

New applicants may request limited total costs annually in addition to the combined current total costs of certain NIH awards (NCRR M01 and K30 ) held by the applicant institution and its affiliates. When summing the awards to calculate the Base Budget above which CTSA funding may be requested, the amounts that should be used are the “Approved Budgets” from the latest Notice of Grant Award prior to October 1, 2010 that  included FY 2010 funds. Applicants may request annual total costs up to the larger number of three options: 1) the Base Budget increased by up to 45%, 2) the Base Budget increased by $1.5 million or 3) up to $4 million annually in total costs. Applicants who would like verification of their calculations should contact NCRR Program Staff..

Award Budget

Applicants will submit a single unified U54 grant application containing separate sets of budget pages for all years for the UL1, KL2 and TL1 components, a summary budget and separate sets as required for multi-PIs, as applicable. If a CTSA application is selected for funding, the UL1, KL2 and TL1 components will be funded as separate, yet administratively linked, grants..

Award Project Period

 Applicants may request up to 5 years of support

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

For profit Organizations

Governments

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

 CTSA resources are intended to serve institutions with a substantial number of NIH-funded investigators. Eligibility to apply is therefore restricted to institutions whose NIH funding, together with NIH funding to any partners or affiliates, exceeded $50M in FY2008

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 (Project Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

 NIH recognizes that there are many outstanding and established Individuals from diverse backgrounds (underrepresented racial and ethnic groups, as well as individuals with disabilities and women clinical scientists) who have the institutional authority and expertise to direct a CTSA program and/or components of a proposed institutional home for clinical and translational science. The NIH strongly encourages each institution to consider these individuals when choosing Principal Investigators and leaders of key functions or components for a CTSA application.

The decision of whether to apply for a single PI or multiple PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi. Pediatric PIs appointed under a single Clinical and Translational Science Award may have direct authority over a separate budget and infrastructure for child health clinical research. The Principal Investigator(s) are expected to have the institutional authority to direct the C/D/I or other entity that comprises the institutional home for clinical and translational science. Where multiple PIs are proposed, a governance plan should define their responsibilities and describe a reporting structure to an official with broad trans-institutional authority. The governance plan should describe processes that will be used to resolve conflicts and to ensure implementation of CTSA Consortium-wide recommendations. Each PI should have direct knowledge and hands-on involvement in the daily activities of the CTSA and at least one is expected to be an established clinician-scientist.

Eligible Key Function Directors

All Directors of key functions and any co-Program Directors should have the necessary recent clinical and translational research background and administrative qualifications and experience to provide scientific leadership, management, and coordination of their respective programs or components. The Principal Investigator of the CTSA will coordinate the activities of all the Directors of key functions.

A TL1 Program Director must be an established researcher with acknowledged accomplishments in clinical and translational science research, and should be capable of providing both administrative and scientific leadership to the proposed multi-disciplinary training program. The training Program Director will be responsible for planning, directing, and executing the research training program and the selection, appropriate supervision/mentorship, and evaluation of the trainees' progress.

The Program Director for the KL2 component must be an established investigator with the scientific and administrative skills, knowledge and leadership to coordinate and supervise the mentored career development program. The individual must be a senior faculty member or director of research with extensive expertise recruiting, advancing, and retaining individuals in clinical and translational science careers.

Eligible Research Education, Research Training and Research Career Development Trainees, Scholars and Mentors

Research Education Component:

Clinical research is multidisciplinary, so participants in this program should represent diverse academic backgrounds with the potential for benefit from a core curriculum for clinical research. Interactions during the early years of career development may serve to enhance the team approach necessary to meet the multidisciplinary challenges of clinical research. Individuals supported by other NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the research education component, as participants, but may not receive salary or stipend supplementation from the CTSA research education component.

Research Training Component (TL1) Eligibility:

At the time of appointment to the training program, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Pre-doctoral trainees:

Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA trainee appointment and must be training at a post-baccalaureate level and enrolled in a program leading to a PhD in a clinical research-related doctoral degree program, or a combined doctoral level professional degree plus a clinical research-related advanced degree, such as a MD, DDS, DO, DNP, PharmD/MS or MD, DDS, DO, DNP, PharmD/PhD. Students who are officially enrolled in a qualifying health-professional doctoral program and wish to postpone their professional studies for one year to gain research experience, may be appointed to the TL1 research training grant for that period, provided that NRSA eligibility requirements are met. NRSA traineeships are not provided for study leading to a MD, DO, DDS, DNP, PharmD or other similar professional clinical degrees, or a master's degree that is not pursued in a combined program with a professional level doctorate. Individuals currently supported by other Federal funds are not eligible for trainee support from the TL1 program at the same time. Trainees are customarily appointed for full-time, 12-month continuous periods. An individual trainee may receive no more than five years of NRSA support in aggregate at the pre-doctoral level, including any combination of support from institutional training grants and individual fellowship awards.

Postdoctoral Trainees:

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DPH, DNSc, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well as a doctoral degree in nursing research or practice.  Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Postdoctoral trainees supported by NRSA awards incur a service payback obligation for the first 12 months of postdoctoral support. The second year of NRSA postdoctoral support will serve to pay back the service obligation. See NIH Grants Policy Statement.

Trainee Appointments:   All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.  Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the pre-doctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.  Any exception to the maximum period of support requires a waiver from the NIH awarding office based on a review of the written justification from the individual trainee, and endorsed by the Program Director and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Additionally, tuition and fees at the postdoctoral level are limited to that required for specific courses in support of the approved training program which should be identified prior to matriculation.

Mentored Career Development Component (KL2) Scholar Eligibility:

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to appointment, are eligible to become KL2 scholars. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Plans for recruiting scholars should include accessing under-served and under-represented minority and ethnic populations.

KL2 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and research activities associated with the program. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the KL2 program. The eligibility of potential candidates holding VA appointments should be confirmed with NCRR Office of Grants Management and Program staff prior to the individual being appointed to the program. The portion of the memorandum of understanding (MOU) that details the professional responsibilities of the candidate at the VA and the institution may be requested.

KL2 applicants may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g., K07, K08, K22, K23) that duplicates any of the provisions of the KL2 program. Former or current principal investigators on any NIH research project grant (this does not include NIH Small Grants (R03) or Exploratory/ Developmental (R21) grants or their equivalents) or equivalent non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to participate as KL2 scholars. Appointed K12 or KL2 scholars may apply for K23 support; if successful they transfer to the K23 award.

KL2 Mentor Eligibility:

The KL2 component of the application must identify a core group of primary sponsor/mentors for the career development program. Each mentor together with the scholar will be responsible for the planning, direction, and execution of each career development plan and research project. Mentors must be recognized as accomplished investigators in clinical and translational research and have a track record of success in training new investigators and fostering their transition to independence. Mentors without a track record in mentoring should have documentation of sufficient expertise, national recognition, and adequate training to serve in this role. Mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the KL2 and CTSA. The use of co-mentors to achieve the goals of the program is encouraged. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.  Voluntary Institutional Support Guidelines for Clinical and Translational Science Award KL2 scholars are described in NOT-RM-09-017.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or 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.

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 by e-mail to:

Dr. Anthony Hayward
Division for Clinical Research Resources
National Center for Research Resources
Telephone: 301-435-0791
Email: haywarda@mail.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 and all copies of the appendix files must be sent to:

Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1001
Bethesda, MD 20892-4874 (Regular mail)
Bethesda, MD 20817 (FedEx or courier)
Phone: (301) 435-0811

Page Limitations

All page limitations are defined below in special Instructions.

Research Plan

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.

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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or Cooperative Agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs:

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI," who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the contact PD/PI should be entered on the PHS 398 face page. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Key Personnel Table of the PHS 398.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan:

For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 12 of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If separate budget allocations are requested, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be indicated in the Notice of Award according to NIH policies current at the time of the award (See NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html) for policies currently in use.

Applications requesting a separate budget for a Pediatric Principal Investigator:

Funds for Pediatric PIs who request direct authority over a separate budget and infrastructure for child health clinical research should also be submitted separately on PHS 398 budget forms. When the Pediatric PI is at a different institution, this budget should be included as a subcontract to be administered by the prime institution.

Applications involving Multiple Institutions:

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the PHS 398 forms. All other participating components requiring separate budgets (e.g., pediatric PIs, affiliated institutions) should also submit separate individual budgets on PHS 398 forms.

Special Program Requirements

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 on January 13, 2012, between 2:00 and 4:00 pm ET at which NCRR and other NIH staff will explain the goals and objectives of the CTSA program and answer questions. Additional information on the webcast will be available at www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/. The webcast will be archived at www.videocast.nih.gov.

Applicants should address the key functions proposed for their CTSA using the Format of the Application following this section. All information must be contained within the body of the application; appendices are not allowed.

1. Overall Impact: Prior Funding Period


Where relevant, applicants should summarize the impact and achievements of the CTSA in the previous project period. Page limits: up to 30 pages of text and 12 pages of tables (42 pages total). Specifically, this section should address:

2. Approach

Since the scale and range of activities will vary in proportion to prior NIH funding and institutional support, applicants should indicate how funds awarded for a CTSA will sustain clinical and translational research at their institutions. In their plans for next project period, NIH expects that applicants will differ in their approaches to the provision of CTSA resources. Page limit: 30 pages total. Applicants should describe their plans for the CTSA funding period, focusing on:

3. Governance

Describe in 30 pages or less:

4. Biomedical Informatics

Describe in 12 pages or less:

5. Overall Plans for Research Education, Training and Career Development

Applicants should describe their existing higher degree-granting programs such as Masters or PhD in Clinical Research. Describe the following sections in 30 pages or less:

5.2. Research Training Component (TL1)

5.2.1. Proposed Training Program

If this option is selected, the training program must be described in detail, including the objectives, design and courses planned for the trainees. Within the 40 hours per week training period, provide the plan for the proposed research training and the role of the Program Director and faculty serving as mentors to the trainees. Justify the proposed number of trainees and explain how they will be engaged on research projects and the relationship of such activities to the overall goals of the education and career development program. Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing trainees’ career development and progression including degree completion (if applicable), publications, and subsequent positions. Trainees supported through the TL1 mechanism are expected to be working in a clinical research-related area.

5.2.2. Institutional Commitment

The administration of the applicant institution as well as all participating units and departments should indicate, in the application, their support for the goals of the training program. Describe support that the institution will provide for the proposed training program. This could include, for example, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative and allowable mechanisms to improve the climate for the establishment and growth of the training program (e.g., core facilities).

5.2.3. Faculty and Mentors

Describe the plans for mentoring of the trainees selected for the program. Include information about past mentoring experiences and active research programs being conducted by the proposed mentors and faculty involved in the proposed training program. Describe collaborative arrangements with mentors and trainees which will enhance the training program and broaden the training experiences involved in the clinical and translations science program.

Additional NRSA information and instructions are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.

5.3. Mentored Career Development Component (KL2)

This section should begin with an overview of the proposed program and describe:

6. Plans for Education Component Evaluation and Tracking, Training in the Responsible Conduct of Research and the Recruitment and Retention to Enhance Diversity

Up to 12 pages is allowed. Describe a strong evaluation and tracking plan for all research education, training and career development activities. The plan should include the review of the effectiveness of all aspects of the program (including curriculum development, training faculty, Program Directors). Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements. The application should describe plans for a research education, training and career development program advisory committee.

The NIH may, in the future, request information about trainees for program evaluation purposes. In addition, institution(s) with other clinical or translational training and career programs must provide strong evidence that the CTSA Program will improve existing clinical and translational research career development and mentoring programs (including but not limited to individuals supported via NIH T32, K12, K23 and K24 grants) and how they will interact with the CTSA program.

Training in the Responsible Conduct of Research

Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all CTSA activities. Applications without plans for instruction in the responsible conduct of research for each component will be returned to the applicant without review.

Every trainee, scholar, or participant supported by this CTSA grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019.  Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.  All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.   See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.

Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes the need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce leading to the recruitment of the most talented researchers from all groups; improving the quality of the educational and training environment; broadening research priorities; diversifying the backgrounds of clinical research subjects; and improving the Nations capacity to address and eliminate health disparities.

The NIH encourages institutions to diversify their trainee and faculty populations to include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following:

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

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

C.    Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.


Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.


Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

Applicants are encouraged to collaborate with members of CDCs Prevention Research Centers (PRC) Program, including those within their own institutions (see www.cdc.gov/prc).

Describe in 12 pages or less:

8. Evaluation Plan

Describe in 12 pages or less a detailed self-evaluation plan to assess CTSA activities, including:

The demand for, and effectiveness of, any novel clinical and translational methodologies, pilot translational and clinical studies, community engagement and translational technologies and resources.

Biomedical Informatics

Community Engagement

Research Design, Biostatistics and Clinical Research Ethics

Regulatory Knowledge and Support

Clinical Research Resources and Facilities

Overall Operational Functions

The evaluation plan should also describe how the applicant will participate in the national CTSA program evaluation established to:

9. Pilot Translational and Clinical Studies

In 12 pages or less, applicants should describe a program that will provide pilot project funding for clinical and translational trainees or researchers to generate preliminary data for submission of a research grant application. The size of this key function should be commensurate with that of the CTSA. The proposed organizational structure must allow full compliance with regulatory requirements.

Pilot project support, include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and care of vertebrate animals, as applicable.

10. Regulatory Knowledge and Support

Describe potential topics in 12 pages or less:

11. Support for Novel Clinical and Translational Methodologies.

Describe in 12 pages or less:

Describe potential topics in 12 pages or less:

Describe potential topics in 12 pages or less. Examples include:

14. Translational Technologies and Resources

Describe potential topics in 12 pages or less:

15. Milestones and Implementation Plan

Provide, in 6 pages or less, a time-line of milestones for the goals of the CTSA with alternatives should those milestones not be reached. In the event that the size of award requested for the next budget period is significantly different from the last, the applicant should describe the process by which anticipated budget changes in the CTSA will be implemented and integrated into the strategic plan of the institution. Include this section in the Overall Research Strategy.

16. Other Program Functions

Applicants may describe up to three additional optional program functions, up to 12 pages per function; 36 pages total

17. Preliminary Studies for New Applications.

For new applications, include information on Preliminary Studies. Discuss the PD/PI’s preliminary studies, data, and/or experience pertinent to this application. Preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed CTSA. Page limit 30 pages.

18. Progress Report for Renewal Applications.

For renewal applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the key aims of the previous project period and describe the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions.  Limit 30 pages.  A list of publications, manuscripts accepted for publication, patents, and other printed materials should be included in G, Literature Cited.

19. Other Tables, graphs, figures, Drawings and Charts

Other Tables, Graphs, Figures, Drawings and Charts (12 each, 60 pages total). The organization and content of these tables are left to the applicant; however summary and graphical displays are encouraged. They may be sited in the text so as best to facilitate review.

20. Required Institutional Letters

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

Format of the Application

The instructions in the Form PHS 398 do not fully apply to the special needs of a CTSA application so the following instructions are provided that should be read together with the Special Programmatic Requirements and Review Criteria:

A. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Institutional CTSA Program. On Line 2, provide the number of this Funding Opportunity Announcement, RFA-RM-10-020, and the FOA title "Institutional Clinical and Translational Science Awards." The budget figures on this page should be taken from the communication you received from NCRR.

B. Description, Performance Sites, and Key Personnel: Key personnel include the Principal Investigator, co- Program Director(s), Directors(s) and co- Directors(s) of key resources, and other key professional and administrative members of this program. Do not include trainees, mentors, or external advisory committee members. Only include named individuals for whom salary support is requested in the application.

C. Table of Contents: Applicants should provide a customized Table of Contents that properly reflects the organization of their application. Applicants should use inclusive numbering of sections (i.e., provide start and end pages for each section).

D. Detailed Budget Page for Initial Budget Period and Entire Proposed Period of Support: Four sets of budget pages (Form pages 4 & 5) are required that together incorporate all the proposed activities of the CTSA. The first set is for the U54 budget that contains the majority of the items in the program. Justification for equipment, personnel and supplies, including administrative expenses anticipated for a KL2 or TL1 component of the application. The second set for a Career Development (KL2) component should provide information reflecting the costs incurred by the KL2 scholars, such as planned salaries, fringe benefits, and research or pilot project expenses for the number of scholars being proposed in the program as detailed in Section 3.1.2. If a TL1 component is included to pay for trainee stipends, travel, and training-related expenses per NRSA guidelines, this budget should be submitted on Kirschstein-NRSA Substitute Form Pages. The fourth set, showing the composite budget, should include stipends in the personnel category and all other training costs in the other expenses category. Budget items should be requested for 12 months; NCRR will prorate these items accordingly at the time of award. Applicants are requested to copy their budget items into the spreadsheet provided on the CTSA program website (www.ncrr.nih.gov/ctsa.

E. Biographical sketches and research support in standard NIH format for Program Director, co-director(s), other listed key professional and administrative members of this program, and named members of significant internal committees. Do not include biographical sketches for trainees or external advisory committee members, or those who are not directly involved in the CTSA.

F. Institutional Clinical and Translational Science Award Program: The application must present all the proposed activities of the CTSA within the page limits shown above. Note that these are upper limits: applicants are urged to be concise and to present information in tables where possible. According to NIH policy, applicants should not provide programmatic URL's in their applications. No appendices are allowed. References are not included in the page limits and may be cited in the appropriate sections of the application. The information should be arranged as described above. Note that the additional 60 permitted pages of Tables or Figures may be sited in the text so as best to facilitate review.

G. Literature cited

(a) Bibliography and References Cited – Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.

The references should be limited the relevant and current literature. While there is not a page limitation, it is important to be concise and select only those literature references pertinent to the proposed research.

(b) Progress Report Publication List – For Renewal applications list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.

H. Required institutional letters (see Special program requirements above) and other relevant letters

I. Human subjects

J. Patient care rate agreement (if applicable)

K. Vertebrate animals

L. Checklist

Note: Appendices are not allowed.

Appendix

Not Applicable

Foreign Organizations

Not Applicable.

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.

Program budget--Most items in the program will be listed on pages 4 & 5 of the PHS 398 for the U54 budget including:

Salary and fringe benefits for the CTSA PI(s), component directors(s) or co-director(s), professional and administrative staff, etc. (personnel category of PHS 398 pages 4 & 5).

Research education component (excluding KL2 and TL1 components; other expenses category of PHS 398 pages 4 & 5).

Consultant costs, Equipment and Supplies. Applicants may include travel costs and are advised to include travel to CTSA Steering and Key Function Committee meetings in Bethesda, MD, for their representatives. Costs may include patient care costs, alterations, other expenses and Consortium/contractual costs.

Applicants should request funds to support pilot research projects. These funds can be used for research expenses, such as supplies, equipment, and technical personnel. Pilot projects undertaken by KL2 scholars should be included in the KL2 budget.

Funds requested for payment to a hospital for clinical research resources and facilities 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 CTSA 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.)

Awards will be made on the basis of Total Cost Commitment. Awardees can request the transfer of awarded funds between the UL1 (approved Institutional indirect costs) and KL2 (8% indirect costs) components. No component of a CTSA award will have automatic carryover authority. Approved fund transfers and carryovers will be provided in award notices. Requests for cost-of-living increments with non-competing continuations will be handled according to prevailing NIH policy.

5.1. Specific Instructions and Limitations Related to the Research Education, Research Training and Research Career Development Components

5.1.1. Research Education Component

Research Education, but not TL1 or KL2, education costs should be placed on the UL1 budget pages. These might include, but are not limited to: 1) curriculum and degree granting elements including costs to develop and provide lectures, courses, seminar series, etc.; 2) programs to provide research educational experiences to undergraduate students, allied health professionals such as study coordinators and project managers, and non-doctoral master's students (.); 3) a faculty core to provide mentor support and training in mentoring, leadership, research and laboratory management, and research team building skills. Mentors may receive non-salary costs up to $3,000 for pre-doctoral trainees and up to $10,000 for postdoctoral scholars to help defray laboratory or other research related expenses associated with hosting a trainee or scholar. Trainee stipends and KL2 scholar salaries are not allowable costs for the Research Education Component. However, under certain circumstances subsistence allowances may be permitted for other program participants.

5.1.2. Mentored Career Development Component (KL2)

The NIH will also help defray the costs for the following expenses: (1) tuition and fees related to career development; (2) up to $2,500 for scholar travel to attend two training and/or scientific meetings per year; (3) recruitment costs (up to $3,000 per year for costs such as brochures, recruitment-related travel, etc.) to attract participants who can excel in, and potentially become leaders in, clinical research.

Facilities and Administrative Costs for K components

These costs, which were formerly called indirect costs, will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, and equipment for the K component.

5.1.3. Research Training Component (TL1)

Allowable costs for each pre-doctoral and postdoctoral trainee for a 12-month appointment period include:

Stipend:

A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. The NIH will provide stipends for each pre-doctoral trainee position selected for the pre-doctoral research training component according to the appropriate fiscal year pre-doctoral NRSA stipend schedule. Stipend levels are adjusted periodically. The current NRSA stipend schedule can be found on the NIH Web site at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid. Such funds may be provided either in the form of stipend supplementation from non-federal funds, or in the form of compensation such as salary or tuition remission for services provided by the trainee such as teaching or serving as a laboratory assistant. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

Postdoctoral trainees supported by NRSA awards incur a service payback obligation for the first 12 months of postdoctoral support.  The second year of NRSA postdoctoral support will serve to pay back the service obligation. See NIH Grants Policy Statement.

Tuition and Fees:

The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at NOT-OD-06-093 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html). For tuition, an amount per pre-doctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., MD-PhD, DDS-PhD), the amount provided per trainee will be up to $21,000 per year. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. A full description of the NIH tuition policy is in the NIH Grants Policy Statement and on the NIH website at: http://grants.nih.gov/training/nrsaguidlines/nrsa_toc.htm.Training related expenses: For institutional training grants, the training related expenses category has been be modified to include health insurance as an allowable expense. This category will continue to be referred to as training related expenses but will now include health insurance as an allowable cost (see: NOT-OD-06-093).

Trainee Travel:

Up to $1,000 for trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is allowable.

Facilities and Administrative Costs:

These costs, formerly known as indirect costs, will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, health insurance, consortia in excess of $25,000, and equipment. See NRSA Policy Guidelines on the NIH Web site at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm and NOT-OD-06-090 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-090.html).

Concurrent Awards: An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligation.

5.2. Plans for support beyond 5 years:

NIH is planning for additional 5 year competitive renewal of these awards. NIH support beyond the five-year project period is not guaranteed and is dependent upon the availability of appropriated funds, and success in any competition for renewed support. In the event that there is no further support, no phase-out funds will be provided. Thus, the applicant institution(s) must have plans in place to provide continued support to remaining trainees in the event that funding from the NIH is not available.

6. Other Submission Requirements and Information

Renewal applications must be received by June 11, 2011. New applications must be received by October 3, 2011.. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive 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.

For this particular announcement, note that a document summarizing the approach to peer review is posted at: http://NewPostingw

2. Review and Selection Process

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

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

Applications compete for available funds with all other recommended applications submitted in response to this FOA . The following will be considered in making funding decisions:

CTSA Overall Evaluation

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed CTSA program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria, and additional review criteria (as applicable for the project proposed).  Reviewers will be asked to summarize the overall strengths and weaknesses of the application, focusing particularly on the anticipated impact of the proposed CTSA on the quality of clinical and translational science at the applicant institutions. Does the program make only modest incremental improvements to previously-supported programs, or will significant value be added?  Will the resources be equitably distributed among different disciplines (e.g., pediatrics, medicine, pre-clinical research, etc.)? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the institutional commitment appropriate? Reviewers will be asked to take past clinical and translational science activity at the applicant institution (whether supported by the institution or through a CTSA) into account in assessing potential future performance.

Scored Review Criteria

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.

Significance:

Will the proposed CTSA significantly improve the overall quality of clinical and translational science at the applicant institution? Are the overall program vision and strategy adequate to satisfy the intent of this initiative to facilitate and sustain a home for clinical and translational science that incorporates a wide range of clinical disciplines, specialties, and sub-specialties? Will the proposed CTSA have potential to make significant contributions to a national consortium of CTSAs?

Investigator(s):

Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s)? Do the PD/PI(s) have the authority and committed time to administer the proposed CTSA? Will the PD/PI(s) have sufficient authority to work across institutional boundaries? Do the PD/PI(s) have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the CTSA? Does the program leadership and management team bring complementary and integrated expertise to the project? Does the CTSA have the professional staffing to impact significantly the overall quality of clinical and translational science at the institution? For Key Function Areas that are included in the proposal, do the Directors of Key Function Areas have the appropriate training, experience and resources for their leadership roles? Have the Directors of the Key Function Areas committed sufficient time to this program? Will the Directors have the authority at their institution to implement best practices identified by the Consortium Key Function Committees? Are the administrative and professional staff appropriately trained and well suited to carry out this work?

Innovation:

Does the CTSA program propose innovative approaches to integrate clinical, basic and other relevant (e.g. public health, bioinformatics) disciplines? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies that will improve the discipline? Is the program likely to develop novel approaches to promote the efficiency of clinical and translational research?

Approach:

Will the proposed CTSA program sustain, complement, or extend the applicant's current resources for clinical and translational science research? Does the application identify key obstacles to the performance of translational and clinical research and then propose plans or means to overcome these? Will the proposed C/D/I include relevant scientific disciplines to maximize productivity? Does the application make efficient use of potentially unique resources, such as access to certain human subject populations or the provision of pre-clinical resources? Does the applicant indicate how the organization will be adapted to respond to changes in translational focus? Will new opportunities for careers in clinical research arise across the spectrum of clinical and translational science?

Environment:

Is a program for awarding higher degrees in clinical research in place? Will the academic and scientific environments contribute to the probability of success in establishing or maintaining a home for clinical and translational science? Is there a strong training record at both institutional and faculty levels? Does the proposal provide strong evidence that the CTSA will provide resources that would not otherwise be possible? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the CTSA program performs effectively as one activity across institutional boundaries? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements? Is infrastructure in place indicating a likelihood of success of the proposed C/D/I?

Implementation Plans:

Is the timeline for implementation feasible and are specific goals and milestones set? Are alternatives proposed should the goals and milestones not be reached in a timely manner? Is there a feasible time line for integrating CTSA resources with other complementary resources available to the institution? Has the PD/PI and/or institution already made progress in establishing a center for clinical and translational science?

Integration:

Will existing NIH-supported cores be appropriately integrated with the CTSA program? Are approaches proposed that would develop the integration of clinical, basic and other relevant (e.g. public health, bioinformatics) disciplines? Will CTSA activities be integrated into all the relevant schools and clinical research sites that participate in clinical and translational science in the applicant institution? Will this integration extend to the local community and to the national network of CTSAs? Is integration reflected in the senior leadership and decision-making processes of the CTSA?

Local and National Collaboration, Data Sharing, and Dissemination:

Will the institution and its researchers collaborate, share and disseminate resource tools and resources at institutional, community, and national levels to meet program goals? Are plans included to address regulatory hurdles locally? Is there a commitment to adopt and implement national standards?

Institutional Commitment:

Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, dedicated space, or tuition rebates, as a few examples? Is the institutional leadership committed to protect the time of the investigators to pursue clinical and translational research and mitigate the demands of providing patient care? Are the contributions of clinical researchers to be recognized by the institution’s promotions and tenure program?

Key Function Areas:

Biomedical Informatics:

Are the biomedical informatics resources offered commensurate with the breadth of the CTSA program? Will data security and privacy be safeguarded? Are assessments of performance of this resource included? Will the Biomedical Informatics Director have the necessary authority to ensure implementation of best practices as adopted by the Biomedical Informatics Key Function Committee? As applicable, will this resource be sufficient for intra- and inter-institutional operations? Will the institution be willing to work toward interoperability of the informatics systems and adopting national data standards?

Research Education, Research Training, and Research Career Development:

Do the research education, training and career development components strengthen the training and career pathways for all clinical and translational research professionals and team members? Can increased efficiency shorten the period of training? Does the institution have a sufficient pool of academically strong trainees and experienced and well-qualified mentors to justify the career development pathways that are proposed? Will the curricula and courses proposed provide appropriate training in clinical and translational research relevant to a broad range of specialties? How will trainee registration for higher degrees in clinical research be encouraged? Has the Program Director committed adequate time to program administration?

Research Education Component: Are the quality, innovation and content of courses and the curriculum adequate? Are the scientific qualifications and experience of the faculty, the criteria for selecting participants and the trainee recruitment strategies appropriate?

Research Training Component (TL1): Does the applicant have experience in running pre-doctoral training programs? Have former trainees established productive scientific careers? Are the quality of the proposed training program and the requested number of trainee positions appropriate to the planned research training program? Does the proposed training program provide appropriate courses for clinical and translational science research? Are appropriate programmatic activities incorporated into the training program?

Mentored Career Development (KL2) and Research Program Design: Does the applicant demonstrate the likelihood that the career development and research programs will contribute significantly to the scientific development of the candidate scholars to successfully pursue clinical and translational research careers? Do the plans include appropriate course work and/or activities to achieve program goals? Does the applicant demonstrate the scientific quality, technical merit, and degree of relevance in the research projects the scholars will be pursuing?

Training (TL1) and Career Development (KL2):

In addition to the above criteria, reviewers will be asked to comment on the following criteria for both the TL1 and the career development (KL2) programs.

Preceptors/Mentors: Does the applicant name high caliber, productive, researchers as mentors? Do the proposed mentors have a strong training record?

Institutional Environment and Commitment to the Program: Is there a high quality institutional training environment for trainees? Are the KL2 (and TL1, if appropriate) programs integrated with other institutional K and T program at the institution? Will the level of institutional and departmental commitment contribute to the probability of success? Does the applicant indicate appropriate commitment to the program, such as may be reflected in recruitment efforts, necessary educational resources and equipment, and available established investigators who will serve as mentors? Is there a convincing plan that scholars will have sufficient protected time to devote to the program?

Trainee Recruitment, Selection and Retention: Is there a functional plan for selection of individuals for appointment to the training or career development program? What are the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined?

Evaluation and Tracking of Research Education, Research Training and Research Career Development: Does the program have a rigorous evaluation plan to review the quality and effectiveness of the training, education, and/or career development? Are effective mechanisms in place for obtaining feedback from current and former participants and monitoring participants’ subsequent career development?  If an external advisory committee is proposed, are plans adequate and appropriate to ensure proper monitoring of the research education, training and career development components? Are there means to modify the research education, training and career development components based on appropriate recommendations from the External Advisory Committee?

Community Engagement and Research:

Will the CTSA effectively bring local public and community health care providers, community-based organizations and other groups into healh care research partnerships? Are there adequate plans to train researchers, trainees, and scholars in the methodology of community/population-based research and outreach? Will the resource foster long-term relationships between the CTSA institution and the community for their mutual benefit?

Evaluation Plan:

Is the plan adequate to evaluate the short and long-term goals for each of the proposed key functions? Are the measures valid for the programs' goals to be assessed and how accessible and practical are the available data sources? Does the plan make sufficient resources available for participation in the national CTSA programs? If necessary, is the plan to obtain IRB approval and informed consent from program participants adequate for self-evaluation activities and the national program evaluation?

Pilot Projects in Translational and Clinical Studies:

Is there an adequate plan to solicit proposals, prioritize the projects and review their methodology and research performance? Are there plans to disseminate the benefits to the CTSA to the wider research community? Will benefits be measured and tracked?

Regulatory Knowledge and Support:

Will this resource provide researcher-focused support for regulatory compliance and management? Is the resource well integrated with biomedical informatics and participant and clinical interactions? Is there duplication of IRB responsibilities? Does the institution have experience in working with multi-site trials and with the FDA with respect to studies involving investigational new drug application procedures? Will CTSA staff members be available with the necessary experience in working with the FDA and in ensuring that standards for reporting adverse events are met? Are criteria for the research subject advocate functions sound?

Development of Novel Clinical and Translational Methodologies:

Is there an active program of research in novel methodologies? Is the outcome likely to benefit the CTSA? Is there a plan to involve new investigators? How well are these activities integrated with the CTSA as a whole?

Research Design, Biostatistics, and Clinical Research Ethics:

Are adequate types of support and resources in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will consultative support and collaborative activities in biostatistics and research design for investigators be adequate for the scale of CTSA that is proposed? Will training opportunities be adequate and will they include conflict of interest issues, federal codes requirements, and guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? Are there plans for creativity and innovation in developing the application of these topics to clinical and translational research? As applicable, will this resource be sufficient for intra- and inter-institutional operations?

Clinical Research Resources and Facilities:

Will human subject participation in clinical research protocols be encouraged? Will the institution work with underserved populations in clinical research? Has the applicant adequately described and justified the resources to be provided? Will resources meet the highest standards for subject safety, quality of science and statistical and ethical design? Is the application of Good Clinical Practice guidelines appropriate? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Will the resources provided serve small as well as large studies or trials?

Translational Technologies and Resources:

Is the plan to identify technologies to be offered appropriate? Will resource utilization and evaluation be adequate? Is there flexibility in types of resources to be offered? Will faculty members be encouraged to pursue research in areas that develop translational methodologies? 

Additional Review Criteria

As applicable, 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.

Resubmission Applications:

When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications:

Whe reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Overall Impact: Has the applicant demonstrated impact on the quality and extent of clinical and translational science at the applicant institution? Has the CTSA demonstrated impact on the health research communities outside the awardee institution? Has impact included research priorities identified by the CTSA Consortium Steering Committee and other CTSA consortium-wide Committees? Have health or healthcare delivery been impacted?
 
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims 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?
 
Investigators: Did the CTSA attract new clinical and translational researchers, assist their transition to independent funding and ensure that their contributions were recognized within the institution’s promotions and tenure program?
 
Innovation: Did the CTSA create new and innovative opportunities for users? Were any novel concepts, approaches, methodologies, tools, or technologies employed?
 
Approach: Were the resources of the CTSA distributed equitably across specialties and NIH-funded researchers at the applicant institution in the previous project period? Was Pilot Project funding, if offered, accessible and effective?
 
Environment: Was the institutional commitment appropriate to create an integrated home for clinical and translational research? Was the CTSA able to assist researchers in bringing projects from the bench to the bedside, and from proof of principle to clinical application? Was the community engagement program effective in reaching a target population? To what degree has the translated research been accepted and disseminated by the community? Does the research being translated address the needs of the community?
 

Evaluation: Did progress toward measurable goals and milestones, outlined in the previously funded grant application, meet prior expectations? Did the applicant identify potential problem areas and mitigate or avoid them when necessary or apply timely corrective measures where avoidance was not possible?

Revision Applications:

Not applicable.

Additional Review Considerations

As applicable, 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(s) convened by the National Center for Research Resources (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

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 submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Council . 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.

Awards Involving Separate Budgets for Multi-PIs

Funds for PIs (including Pediatric PIs) at the applicant institution who request direct authority over a separate budget will be indicated in the NoA and may be restricted to the use of the designated PI until options involving linked awards have been developed. Where multi-PIs are at different institutions, their budgets should be included as subcontracts to be administered by the applicant institution. These funds may be restricted for the use of the designated PI until options involving linked awards have been developed (see NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects.

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

At the time of an award decision, the U54 application will be disaggregated into up to three separate yet administratively linked awards: the UL1 and the KL2 and TL1 (as applicable) awards. Each component will have a separate NoA. The UL1 award will reflect full F&A rate reimbursement based upon the negotiated rate in effect at the time of award. The KL2 and TL1 awards will be subject to the 8 percent F&A rate reimbursement standard for these mechanisms.

The budgetary recommendations of the peer review committee and programmatic considerations will be taken into account in developing a funding plan for successful applicants.

Research Education, Research Training and Research Career Development

Evaluation

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

Predoctoral Research Training Component-TL1

Leave: Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-10-036.html for guidance regarding vacations and requested leave.

Carryover of un-obligated balances: The carryover of funds from one budget period to the next requires prior written approval of the NIH awarding component.

Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided: The current Program Director of the TL1 component of the U54 has submitted a written request for a change of Program Director, countersigned by the Cooperative Agreement Principal Investigator and the appropriate institutional business official, to the NIH Program Staff describing the reasons for the change. The Biographical Sketch of the proposed new Program Director, including a complete listing of active research grant support, is provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new Program Director will remain unchanged, and that the new Program Director has the appropriate research and administrative expertise to lead the program. The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIH Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the TL1 component of the Cooperative Agreement award will be terminated.

Transfer of Program: The research training component may not be transferred to another institution. If there are plans to alter or terminate the approved program, the NIH must be notified immediately to take appropriate actions.

Mentored Career Development Component-KL2

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

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

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

Funds budgeted in a KL2 component of a CTSA that are freed as a result of a career award change may be rebudgeted to support a new Scholar who meets the eligibility criteria specified in the FOA and the selection criteria specified in the application. The Grants Management Specialist and the Program Officer of the award must be notified within thirty days of the change of supported scholars and an updated institution scholar roster form listing all scholars receiving NIH support must be provided.

The mentored career development component (K12/KL2) provides support for a minimum of two years and a maximum of five years of consecutive funding for each Clinical Research Scholar, consisting of consecutive 12-month appointments.

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

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

Transfer of Program: The KL2 component may not be transferred to another institution, and scholars who wish to move to another institution must terminate their support under the KL2 program.

Changes in Research Education, training, and Career Development: Program Consultation with NIH staff should occur if a significant change in the approved career development program and/or research plan is being considered. 

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.

The PD(s)/PI(s) will have the primary responsibility for:

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, a Project Scientist and a Grants Management Specialist to each CTSA. NCRR Program Officials will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The Program Official will:

NIH Project Scientists may:

NIH staff Advisors:

Areas of Joint Responsibility include:

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.

The NIH has an independent CTSA Evaluation contract to perform an evaluation of the overall program. The awardees are expected to provide information that is requested by the NIH for the evaluation process. The submission of this material is expected to be electronic but may require submission of some paper.

Other Reporting Requirements

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

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.  

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)

Dr. Anthony Hayward
Division for Clinical Research Resources, NCRR
6701 Democracy Blvd
Room 906, MCS 4874
Bethesda, MD 20892
Telephone: 301-435 0791
Email: haywarda@mail.nih.gov

Peer Review Contact(s)

Dr. Mohan Viswanathan
Office of Review, NCRR
6701 Democracy Blvd
Democracy 1, Room Number 1084
Bethesda, MD 20892
Telephone: (301) 435-0829
FAX: (301) 480-3660
Email: mv10f@nih.gov

Financial/Grants Management Contact(s)

Ms. Vicki Maurer
Office for Grants Management, NCRR
6701 Democracy Blvd
Democracy 1, Room Number 1046
Bethesda, MD 20892|
Telephone: (301) 435-0837
FAX: (301) 480-3777
Email: maurerv@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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