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Part I Overview Information

Department of Health and Human Services

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

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

Title: Institutional Clinical and Translational Science Award (U54)

Announcement Type
This is a reissue of RFA-RM-08-002.

Update: The following updates relating to this announcement have been issued:

Request For Applications (RFA) Number: RFA-RM-09-004

Catalog of Federal Domestic Assistance Number(s)
93.389, 93.310

Key Dates
Release Date: January 7, 2009
Letters of Intent Receipt Date: September 14, 2009
Application Receipt Date: October 14, 2009
Peer Review Date: February 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (URL Activation Date): March 5, 2009
Expiration Date: October 15, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institutes of Health (NIH) is engaged in a series of initiatives, collectively known as the NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/), that promote clinical and translational investigation and aim to improve health and prevent disease. The goal of the institutional Clinical and Translational Science Award (CTSA) program is to transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research. This transformation will be achieved by creating an academic home, which can be a 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. The C/D/I is expected to include faculty able to 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.

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/HumanSubjects.doc#Question_3). 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 is also an important part of translational science.

Background

Clinical and translational science is critical to the success of the NIH mission. Over the years, the science and disciplines that contribute to translational and clinical research have become increasingly complex. Enhancing the scientific talent pool with the requisite training and intellectual environment needed for further progress may require transformative and innovative approaches. The importance of overcoming the barriers to, and enhancing the opportunities for, public trust and participation in clinical and translational research cannot be overemphasized. NIH has supported the conduct of translational and clinical research through multiple separate programs such as General Clinical Research Centers, specialized laboratories and imaging facilities, funds for new and emerging fields such as research informatics, and the training of generations of translational scientists. These investments, however, fall short of recognizing the important linkages between these resources and the growing need to provide sustained interdisciplinary training in a supportive and dedicated academic and intellectual environment beyond that provided by traditional academic structures. A distinct discipline of translational and clinical science is needed to ensure that the rapid and fundamental advances in biomedical and behavioral sciences will be used in patient-oriented research. The discipline requires recognized career development pathways that are integrated with research addressing the methods and approaches to clinical sciences. This goal may be easiest to reach in an academic home with a dedicated faculty and staff of multiple disciplines who have a transformative vision, mission and strategies.

Specific objectives

This FOA aims to develop the disciplines of clinical and translational science by providing the resources to create an academic home for translational research in the form of a center, department or institute as determined by institutional circumstances. Individual C/D/Is will:

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

Potential Key Functions and Components of an Institutional CTSA

The CTSA should support the discipline of clinical and translational science and the needs of its researchers. Applicants are encouraged to propose novel concepts, methodologies, and approaches that are integrated into a comprehensive, effective, and efficient researcher-, trainee-, and participant-centered program. Applicants should develop their own list of key functions and components of the C/D/I. Potential topics include:

The C/D/I should provide clinical research resources and training to various disciplines (e.g., medicine, dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, bioengineering) for the benefit of researchers, trainees, and research projects involving multiple aspects of health promotion, disease prevention and treatment studied by a wide range of NIH Institutes and Centers. Applications that focus CTSA resources on only a few diseases, specialties, or for a limited number of investigators will not be reviewed. 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 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.

Development of Novel Clinical and Translational Methodologies

Original research on novel methodologies and approaches for translational and clinical sciences will be needed if a C/D/I is to build an environment that sustains intellectual exploration. Areas in which faculty might pursue funded research 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 and methods, predictive toxicology in human populations and ethics research specific to populations rather than specific trials.

Pilot and Collaborative Translational and Clinical Studies

New resources are generally required to determine whether the clinical potential of a promising laboratory finding can be realized. Such funds must be available promptly and be accompanied by an organizational structure that allows full compliance with regulatory requirements. An applicant could request support for Pilot and collaborative clinical research projects that 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.

Biomedical Informatics

Biomedical informatics is the cornerstone of communication within C/D/Is and with all collaborating organizations. Applicants should consider both internal, intra-institution and external interoperability to allow for communication among C/D/Is and the necessary 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) adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. All human subject 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 will be a 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 Key Function Committee to ensure interoperability for its clinical and translational investigators.

Research Design, Epidemiology, Biostatistics and Clinical Research Ethics

Research in trial design, biostatistics and clinical research ethics is quite limited so applicants are encouraged to develop innovative research programs that bridge these functions with other CTSA activities. Topics for research might include, for example, limiting risk to participants, 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.

Regulatory Knowledge and Support

Regulatory support for research teams will promote the protection of human subjects and facilitate regulatory compliance. 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.

Regulatory support should include an individual independent of the IRB or compliance office who acts as a sounding board for potential research participants, serves as an advocate for research participants, and works with investigators, trainees, and research teams to ensure that research involving human subjects accords the highest priority to human subject protections.

Participant and Clinical Interactions Resources

Participant and clinical interactions resources could provide an environment that promotes participation in clinical and translational research in addition to providing clinical resources for cost-effective human subject interactions. Examples of resources that might be requested include the recruitment and retention of research participants, the provision of in-patient, out-patient, or community-based exam rooms, medical vans, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, specialized pediatric services, scheduling services, and services for research specimen collection and shipping. Applicants should describe a plan to recruit investigators, especially those early in their professional careers, and make the availability of participant and clinical Interactions resources known throughout the institution and medical catchments area. Where appropriate, cost recovery could be sought from funded investigators. General Clinical Research Centers at the institutions of successful applicants and their affiliates will be reconfigured into the CTSA.

Community Engagement and Research

Community outreach could foster collaborative research partnerships and enhance public trust in clinical and translational research, enhancing the recruitment and retention of research participants that represent the rich diversity of the US population. Engagement of both the public and community providers, and establishing long-term relationships with community-based groups such as voluntary and professional organizations, schools, women's health groups, faith-based groups, and housing organizations, might be required. Resources that might be requested include community outreach and cultural sensitivity training for institutional clinical and translational researchers, community and provider education and outreach, development of software to facilitate the collaboration of community practitioners, and strategies that allow for two-way communication with, and participation by, diverse populations and community groups. Additional resources that expose scholars and researchers to population and community-based research methods as a supplement to ongoing research efforts in order to enhance applications of science to the general community may prove to be valuable.

Translational Technologies and Resources

These resources could 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. The need for core technologies is likely to vary widely amongst institutions. 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). Laboratory equipment, supplies, and personnel are all acceptable costs. Cost recovery for core support should be sought from funded investigators. CTSAs will 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 would facilitate development from scientific investigations into final products for commercialization with applications for clinical and translational researchers, health care providers, and patient care.

Research Education, Research Training and Research Career Development

A key component of a CTSA will be one or more graduate degree-granting and post graduate programs in clinical and translational science that include a knowledge base for clinical and translational researchers, irrespective of their 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). Linked U54, K12 and T32 mechanisms, described below, may be used for this purpose.

Research education, training, and career development activities 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 an integrated and flexible research education, predoctoral and postdoctoral training, and career development environment that is broad enough in scope to train those interested in careers in multi-disciplinary team-based clinical and translational science, and for the development and improvement of new research methodologies that advance the discipline. Research education, training and career development activities should permeate all aspects of the CTSA program, and trainees and career development 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 and could explore possibilities of integrating their activities with other curricula in the same or other relevant schools as feasible.

An optional research education component of this FOA 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 intend 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. Institutions are encouraged to be imaginative in developing new approaches to education, describing and justifying the proposed period of training and their plans for enrolling trainees. The scope of the curriculum can be flexible to meet the needs of the institution and participants. Inclusion of interdisciplinary approaches is strongly encouraged.

An optional Institutional Research Training (T32 training) component could 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 predoctoral 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. Predoctoral 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 three 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 T32 training component may also offer practical experience in clinical research ranging from 2 to 3 months through summer or special 12-month research training rotations to health-professional trainees. No individual trainee may receive more than 5 years of aggregate NSRA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.

A required Mentored Career Development Component (K12) 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 U54 award for a CTSA will be made without a complementary KL2 award.

Direction of an Institutional CTSA

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 pediatric 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 I 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.

CTSA applications should include a governance 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 20% each and preferably sum to not less than 50%. 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.

It is anticipated that each CTSA will have an External Advisory Committee (EAC) that would meet at least annually to review structure and progress and offer recommendations to the CTSA Director. Potential members of an EAC should not be named and should not be contacted prior to the review of an application.

4. Milestones and Implementation

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.

5. National CTSA Consortium

A major goal of this initiative is to develop a national consortium of CTSA institutions that will cooperatively address impediments to clinical and translational science and will work toward 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. NIH anticipates that CTSA institutions will work towards creating a networked environment in which clinical studies can be expedited by their implementation across multiple institutions.

Under the Cooperative Agreement, a national CTSA Consortium Steering Committee (CCSC) will be established for the CTSA PIs with NIH representatives. Additional Key Function CTSA committees and groups will be established for common themes identified by the CCSC (e.g., Child Health, Research Education, Informatics, Regulatory Affairs etc). The CCSC will meet at least once each year in the Washington, D.C. area and each CTSA should be represented. NIH staff will be active members of each of the CCSC and the Key Function committees and will facilitate communication among the CTSAs with support services, which could include teleconferences, a Listserv and an interactive website. NIH Program Staff will conduct periodic site visits, will review each site's progress in meeting its overall goals, and provide financial oversight of the program.

The purpose of each of the Key Function committees is to share and disseminate ideas, experience, and tools for ensuring a supportive institutional environment for high-quality clinical and translational research both at the individual institutions and nationally. In addition, committees will work to develop, adopt, and implement solutions to impediments to collaborative clinical and translational research. The CTSA institutions must be committed to active collaborative participation at the national level and it is through the committees that common governance will be conducted as their charge will be to decide important common issues and practices among centers, to include topics such as data formats, common consent forms, patient recruitment strategies, course curricula, implementation of common protocols. Letters are required stating that the applicant institutions will work toward adopting and implementing the agreed on policies, procedures, best practices, or other measures established by the CCSC.

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

1. Mechanism(s) of Support

This funding opportunity will use the U54 award mechanism that includes linked K and T components. Applicants will submit a single unified U54 grant application containing separate sets of budget pages for all years for the parent U54 activity, K12 and T32 components, as applicable, a summary budget and separate sets as required for multi-PIs. If a CTSA application is selected for funding, the U54, K12 and T32 components will be funded as separate, yet administratively linked, grants. Applicants may request up to 5 years of support.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator(s) retain the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". CTSA awardees will work with NIH staff to ensure that milestones can be achieved within the budget periods of the award. If milestones are not met, funding can be limited until the milestones have been achieved.

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

Research Education Component

The Research Education component of the CTSA application will be funded as part of the U54 application and is subject to the consideration in the paragraph above.

Research Training Component (T32)

The optional Research Training (T32) component will be supported under the auspices of the National Research Service Awards (NRSA) program. All regulations and policies governing NRSA awards must be followed. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm. Specifically, please refer to the Ruth L. Kirschstein National Research Service Awards section of the Grants Policy Statement.

The T32 component will support research training experiences for trainees who are interested in pursuing multi-disciplinary research careers in clinical and translational science. Only NRSA positions may be requested and supported through the T32 part of this initiative. Predoctoral and postdoctoral trainees are selected by a Program Director normally for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds. Short-term, health-professional (e.g., MD, DDS, DO, DNP, PharmD) predoctoral and postdoctoral trainees will be funded on pro-rated stipends for the 2-3 months they are in the program, based on the 12-month stipend level (for current NRSA stipend levels, see: http://grants1.nih.gov/training/nrsa.htm). No trainee may be appointed for less than nine months without prior approval of the NCRR Program Staff except for predoctoral health-professional students who are participating in approved, formal short-term research training experiences. All trainees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, and no more than three years of NRSA support in aggregate at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The grant offsets the cost of stipends and tuition support for the appointed trainees.

See Section IV.5. Funding Restrictions, for a description of Allowable Costs.

Mentored Research Career Development Component (K12)

The required mentored career development component (K12) will provide for a minimum of two years and a maximum of five years of consecutive funding for each clinical research (CR) Scholar, consisting of consecutive 12-month appointments. In general, 75 percent of the CR Scholars' full-time professional effort must be devoted to the K12 Program. However, certain clinical specialties can have less than 75 percent, but no less than 50 percent, protected time for this Program if sufficiently justified and programmatically approved (for example, surgical specialties requiring 50 percent direct patient care time to keep up surgical skills). The remaining effort must be devoted to activities related to the development of a successful clinical and translational research career. The salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities. The award will support the salary, fringe benefits, and research costs for scholars planning research careers in multi-disciplinary clinical and translational science. Individual scholars are eligible for salaries up to the current NIH Salary Cap (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html) plus fringe benefits based on the sponsoring institution's rate per year. If full-time, 12-month salaries are not currently paid to comparable staff members, the proposed salary must be appropriately related to the existing salary structure.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from other Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K12 component.

Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislated maximum (http://grants.nih.gov/grants/policy/salcap_summary.htm).

Mentored career award recipients, including K12 scholars, in the last 2 years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This policy can be found at the following website: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html.

Pilot and Feasibility Project Support

K12 Scholars may receive funds to support pilot research projects and career development activities. This support will range from $25,000 up to $50,000 per project per year to cover the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meeting, workshops, or training; (d) statistical services including personnel and computer time.

Ancillary Personnel Support

Salary for mentors, secretarial and administrative assistance, etc., is not an allowed cost as part of the K12 or T32 components. Administrative support could be included as part of the U54 component if sufficiently justified.

Facilities and Administrative Costs for K and T components

Facilities and administrative 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. For the T component, these costs will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, health insurance, consortiums in excess of $25,000 and equipment.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Future Solicitations:

The NIH intends to issue solicitations for additional CTSAs in future years.

2. Funds Available

The total funds available for the new awards are approximately $20 million. Up to 4 awards are anticipated from this solicitation with the anticipated start date of July 1, 2010.

Awards will vary in size due to the consolidation of multiple programs at the applicant institution(s) into the CTSA program proposal. Applicants may request limited total costs annually in addition to the combined current total costs of certain NIH awards (NCRR K12 and M01, NCRR-managed trans-NIH K30 and Roadmap T32 and K12) held by the applicant institution and its affiliates. When summing the awards for NCRR M01 and K12, NCRR-managed trans-NIH K30 and Roadmap K12 and T32 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, 2008 that included FY 2008 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.

Applicants whose NCRR M01 and K12, NCRR-managed trans-NIH K30 and Roadmap K12 or T32 awards end in the interval between a first and subsequent submission should contact NCRR Program Staff to ascertain the budget base for the new application.

If the application is successful, all of the above listed awards at each participating institution will be reconfigured into the CTSA program. Other NIH categorical awards will not be included in the reconfiguration, but it is anticipated that they will continue to benefit from the CTSA infrastructures.

An applicant may request a project period of up to 5 years. Although the financial plans of the NIH Roadmap and NCRR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Direct CTSA costs should not be used for institutional infrastructure that is supported through F & A costs.

3. Special Consideration

NOTE: Notice NIH NOT-RR-06-001 provides information on changes to the NCRR General Clinical Research Centers (M01) program. Additionally, all NCRR K12, the NCRR-managed trans-NIH K30, and Roadmap Multidisciplinary Clinical Research Career Development Programs (K12) and predoctoral and postdoctoral Clinical Research Training Programs (T32) held by successful applicant institutions and their affiliates will transition into a CTSA.

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

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization conducts translational and clinical research and has any of the following characteristics:

Because the Institutional CTSA program is focused on the development of a rigorous and robust academic discipline of clinical and translational science, the applicant institution(s) must include a graduate school accredited to award higher degrees in clinical research. Examples of acceptable higher degrees include MS and PhD in topics such as Clinical Research, Public Health, Pharmacology, Nursing and Epidemiology. Partnerships among schools of medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and other clinically-related institutions are strongly encouraged, as is the inclusion of other relevant clinical research entities and organizations. The CTSA is expected to form an integrated institutional home that includes faculty committed to developing the discipline of clinical and translational science and will transcend multiple departments, schools, clinical and research institutes and hospitals. Therefore, an institution may submit, or be part of, only a single application in response to this FOA. Multiple applications from different divisions, faculties, centers, schools, etc. of the same university or medical school will be returned without further consideration by the NIH. Potential applicants whose existing affiliations will be disrupted by this rule must contact NIH Program Staff to determine whether they may be eligible for a waiver of the restriction on grounds such as the affiliation is supported through active NIH Roadmap Training (T32), Career Development (K12) awards, or long-term affiliations. Foreign institutions are not allowed to apply for this program. Domestic institutions may use CTSA resources to support the foreign activities of projects that receive primary funding from DHHS. These activities are permitted under the U54 and K12 components of the CTSA only and may not include the T32 component. Appropriate clearances, a mentoring plan for any foreign training and approval by NIH Program Staff are required before the use of CTSA resources begins. Applications from ineligible institutions will not be reviewed. Applicants are encouraged to include clear detailed evidence of significant institutional commitment.

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 and clearly laid out in the relevant parts of the application.

An organization is eligible to hold a CTSA or an M01 award, but not both. At the time of the CTSA award, current NCRR K12 and M01 awards, NCRR-managed trans-NIH K30 and NIH Clinical Roadmap K12 and T32 (Predoctoral and Postdoctoral Clinical Research Training Program) awards to the institution(s) or affiliated institutions will be relinquished and any remaining funds, including unobligated balances, will be transferred into the new CTSA award. The remaining funds will be restricted and unavailable for use without prior approval of NCRR Program Staff. If the applicant is unsuccessful, the institution(s) retains the current awards for the awarded project period.

1.B. Eligible Individuals

1.B.1. Eligible Principal Investigators

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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. NIH recognizes that there are many outstanding and established 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.

More than one PI, or multiple PIs, may be designated on the application. Additional information on the implementation plans and policies and procedures to allow more than one PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/Commons).
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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PI or multiple PIs. When considering multiple PIs, please be aware that the structure and governance of the PI leadership team as well as the knowledge, skills and experience of the individual PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each 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. Pediatric PIs appointed under a single Clinical and Translational Science Award may have direct authority over a separate budget and infrastructure for pediatric 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 proposed 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 C/D/I and at least one is expected to be an established clinician-scientist.

1.B.2. 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 T32 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 K12 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.

1.B.3. 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 (T32) 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.

Predoctoral trainees

Predoctoral 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. 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 T32 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 predoctoral 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 Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., D.P.H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research or practice. Documentation by an authorized official of the degree-granting institution, certifying that 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 predoctoral 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 (K12) 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 K12 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.

K12 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 K12 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.

K12 scholars 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 K12 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 K12 scholars. Appointed K12 or KL2 scholars may apply for K23 support; if successful they transfer to the K23 award.

K12 Mentor Eligibility

The K12 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 should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the K12 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 or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. Significant institutional commitment by the applicant institution(s) is encouraged. This may take the form of office, laboratory, or clinical space; personnel; equipment; integration of other clinical grants or centers; other resources; or dollars.

3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed 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 I 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 budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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 pediatric clinical research should also be submitted separately on PHS398 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 PHS398 forms. All other participating components requiring separate budgets (e.g., pediatric PIs, affiliated institutions) should also submit separate individual budgets on PHS398 forms.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: September 14 2009
Application Receipt Date: October 14, 2009
Peer Review Date: February 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (URL Activation Date): March 5, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:
(e-mail acceptable)

Dr. Anthony Hayward
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard
Room 906, MSC 4874
Bethesda, MD 20892
Telephone: (301) 435 0791
Email: haywarda@mail.nih.gov

3.B. Sending an Application to the NIH

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: (301) 435-0715

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

At the time of submission, two additional copies of the application 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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.
.
With the exception of the T32 component, pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

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 K12 and T32 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 Committee meetings in Bethesda, MD, for their representatives. Costs may include Patient care costs, Alterations, Other expenses and Consortium/contractual costs.

Applicants may 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 K12 scholars should be included in the K12 budget.

Funds requested for payment to a hospital for Participant and Clinical Interaction resources 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 U54 (approved Institutional indirect costs) and K12 (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 T32 or K12, education costs should be placed on the U54 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 (such as Masters in Clinical Research obtained after a MD or DDS degree, etc.); 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 post-doctoral scholars to help defray laboratory or other research related expenses associated with hosting a trainee or scholar. Trainee stipends and K12 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 (K12)

The NIH will also help defray the costs for the following expenses: (1) tuition and fees related to career development; (2) Up to $2500 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 (T32)

Allowable costs for each predoctoral 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 predoctoral and postdoctoral trainee position selected for the research training component according to the appropriate fiscal year predoctoral and postdoctoral 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 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 $1000 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, consortiums 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 support beyond the initial five-year project period but this is not guaranteed and will be 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

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 videoconference will be conducted on March 5, 2009, between 2:00 and 4:00pm at which NCRR and other NIH staff will explain the goals and objectives of the CTSA program and answer questions. All prospective applicants are invited to view the meeting through videocast (webcast). Additional information on webcasting will be available at (http://www.ncrr.nih.gov/clinicaldiscipline.asp) and the meeting videocast will be archived at videocast.nih.gov. A Frequently Asked Questions website is available (http://www.ncrr.nih.gov/clinicaldiscipline.asp). A listserv (CTSA-L; http://list.nih.gov/cgi-bin/show_list_archives) will be used to notify applicants of the web cast and any changes to the FAQ list.

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 approach

Applicants should describe the components and functions selected for their CTSA with special reference to:

Because the scale and range of activities will vary in proportion to prior NIH funding and institutional support, applicants should indicate how any new funds awarded for a CTSA will transform clinical and translational research at their institutions. Progress toward projects' goals will be considered when renewal applications are re-competed. Applicants are requested to relate the goals described above to the key functions in their application and, where appropriate, to the examples of CTSA activities listed below. NIH expects that applicants will differ in their approaches to the provision of CTSA resources.

2. Governance

Applicants should describe:

The rationale for these approaches should be described. Applicants describing an External Advisory Committee should not contact potential members until after an award has been made. Names of potential members must not be listed in the application.

Applicants should indicate the level of authority that the institution(s) will delegate to CTSA personnel when they participate on the institution(s)'s behalf in developing trans-CTSA policies, procedures, or best practices. They should also indicate the institution's willingness to adopt and implement these practices.

3. Support for Novel Clinical and Translational Methodologies and for Pilot and Collaborative Translational and Clinical Studies

Applicants should describe the means for selecting novel clinical and translational methodologies that will receive core support, together with a plan for their governance, operation and evaluation. Pilot and collaborative project support may be described in the same or a separate section and should 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.

4. Biomedical Informatics

Applicants should describe:

The CSTA Informatics Steering Committee promotes interoperability between the CTSA institutions and with their external partners. This committee also works with national leaders in healthcare informatics technology, national standards organizations and the government to address national issues impacting clinical and translational science research.

5. Research Design, Biostatistics and Clinical Research Ethics

Potential topics include:

6. Regulatory Knowledge and Support

Potential topics include:

7. Participant and Clinical Interactions Resources (PCIR)

Potential topics include:

8. Community Engagement and Research

Descriptions of community engagement could include plans for involving the community in setting research priorities that directly affect patients, innovative ways to engage community members in mentoring processes, partnerships in clinical and translational research, and collaborations to enhance research perspectives (e.g., health disparity research), public trust, and recruitment for clinical and translational research. Additional topics could include plans for: two-way communication with relevant community groups; outreach through community practitioners, including means to secure their participation, and plans for training CTSA researchers, trainees and scholars in community outreach, cultural sensitivity, and population and community-based research methods. Applicants are encouraged, where appropriate, to collaborate with members of CDC’s Prevention Research Centers (PRC) Program, including those within their own institutions (see www.cdc.gov/prc).

9. Translational Technologies and Resources

Potential topics include:

10. Research Education, Research Training and Research Career Development

Applicants should describe their existing higher degree-granting programs such as Masters or PhD in Clinical Research on which they base their eligibility to apply. The description should include the quality, innovation and content of courses and adequacy of the syllabus; the scientific qualifications and experience of the faculty; the criteria for selecting participants; efforts to publicize the availability of the program to potential participants. Additional potential topics include

Research Education Component

Applicants should describe the content of the proposed courses, their potential benefits to the participants and how continuation and/or expansion of an existing program or development of a new program will benefit clinical and translational science training at the institution. The commitment of the applicant institution and the faculty to providing didactic and mentoring experiences should be described, together with the pool of potential participants and information about the types of prior clinical and research training.

Research Training Component (T32)

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 number of trainees and how they will engage on research projects and the relationship of such activities to the overall goals of the education and career development program of the cooperative agreement and the career goals of the trainees. Trainees supported through the T32 mechanism are expected to be working in a clinical research-related area.

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 (financial or otherwise) that the institution will provide for the proposed training program. This could include, for example, space, 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 mechanisms to improve the climate for the establishment and growth of the training program (e.g., core facilities).

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.

Mentored Career Development Component (K12)

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

Education Component Evaluation and Tracking Plan

The application should 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 this 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, K24 and K30 grants) and ways in which 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.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the trainees appointed to the program. Plans must address the subject matter of the instruction, the format of the instruction, the degree of training faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

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

Please see http://www.nih.gov/sigs/bioethics/researchethics.html for additional guidance.

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 Nation’s 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 classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/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.

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:

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

11. Tracking and Evaluation Plan

The proposal should first include a detailed self-evaluation plan to assess implementation of the short-term and long-term CTSA goals, including implementing program activities and tracking trainees and scholars and their mentors, their pilot projects, and their involvement with multidisciplinary team research. For each proposed key function, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources. Applicants should describe procedures to obtain IRB approval and informed consent from trainees, scholars, and mentors in evaluation data collection efforts, if necessary. Listed below are examples of evaluation objectives for illustrative key functions:

CTSA Key Functions

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

Biomedical Informatics

Design, Biostatistics and Clinical Research Ethics

Regulatory Knowledge and Support

Participant and Clinical Interactions Resources

Research Education, Research Training and Research Career Development

Overall Operational Functions

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

To support this effort, the NIH will request that grantees participate in the planning, design, and conduct of the national evaluation and that grantees plan local evaluation activities that will provide data necessary for both their own evaluation and the national evaluation.

12. Milestones and Implementation Plan

The applicant should describe the process by which the CTSA will be implemented and integrated into the strategic plan of the institution. A time-line of milestones for the goals of the CTSA should be provided, with alternatives should those milestones not be reached.

13. Required Institutional Letters

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

Separate letter(s) co-signed by the CTSA Principal Investigator and the Principal Investigator of each of the NIH-funded NCRR, Roadmap, and Trans-NIH awards listed above to acknowledge that each of these grants will be relinquished in the event this application is funded. These letters must be also co-signed by the appropriate business officials of each specific award and of this CTSA application. Applications with unacceptable letters will not be reviewed.

Separate letter(s) co-signed by the PI and all the appropriate technology transfer offices that they will abide by the data and resource sharing plans specified in the application. Applications with unacceptable letters will not be reviewed.

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 Request for Applications, RFA-RM-09-004, and the FOA title "Institutional Clinical and Translational Science Awards." The budget figures on this page should be taken from the consolidated program budget (see below).

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.

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 K12 or T32 component of the application. The second set for a Career Development (K12) component should provide information reflecting the costs incurred by the K12 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 5.1.2. If a T32 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 (http://www.ncrr.nih.gov/clinicaldiscipline.asp).

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 below. Note that these are upper limits: applicants are urged to be concise and to present information as tables where possible. Applicants are strongly discouraged from giving programmatic URL's in their applications, and reviewers are not obligated to view applicant's web sites to review existing public information. No appendices are allowed. References are not included in the page limits and may be cited in the appropriate sections of the application or in Section G. The information should be arranged as follows:

(1) Overall integrated approach and governance (25 pages) to include, for multi-PI applications, a leadership plan, in which case the page limit is 30 pages.

Note: this section should include a description of resources and environment, replacing the corresponding page in PHS 398.

(2) Up to 15 pages for each selected Key function as, for example:

(3) Tracking and evaluation (20 pages)

(4) Implementation phase and milestones (10 pages)

(5) Tables (50 pages maximum). The organization and content of the tables is left up to the applicant; however, summary and graphical displays are encouraged. Organization tables can be distributed throughout the application in proximity to their respective sections. Programs may wish to comment on the past and current funding for, and productivity of:

G. Literature cited

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.

This program is not subject to the streamlined non-competing application process (SNAP). In general, this means that all reporting of budgetary information and program progress is provided in greater detail in an annual progress report.

Research Plan Page Limitations

The overall page limitation is 290 pages and the specific page limitations are described in the previous section, Format of the Application.

Appendix Materials

N/A

Resource Sharing Plan(s)

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

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

Additional Requirements for CTSA Applicants

Data sharing is a requirement of this FOA and the data sharing plan should be included in the description of the CTSA governance. The precise content of the data-sharing plan will vary, depending on the data being collected. The applicant may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing. References to data sharing may also be appropriate in other sections of the application.

(a) Plan for Sharing Software : An additional software dissemination plan, with appropriate timelines, must be included in the description of the CTSA Governance. There is no prescribed single license for software produced in this project. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

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

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

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

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

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

Management of Intellectual Property

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

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

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

CTSA Overall Evaluation:

All components of the unified CTSA application, i.e., all related sections of the single overall application that are received as a unit, will be awarded a single overall priority score determined after evaluation of all components. 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?

Significance: Will the proposed CTSA significantly impact the overall quality of clinical and translational science at the applicant institution? Is 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?

Approach: Will the CTSA program enhance, 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?

Innovation: Is the CTSA program original and innovative? Are new approaches proposed that would 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 increasing the ease and efficiency of clinical and translational research, allowing research results to move from patient observations and laboratory discoveries to the bedside and to clinical practice?

Environment: Does the applicant adequately demonstrate that a program for awarding higher degrees in clinical research is in place? Do the academic and scientific environments contribute to the probability of success in establishing 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 addition of 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?

Implementation Plans: Is an implementation phase well described? 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?

Investigators: 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 PIs have the experience and authority and committed time to administer the proposed institutional home for clinical and translational research? Will the PI have sufficient authority and credibility in the institution to work across institutional boundaries? Will the PI have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the C/D/I? Do the program leadership and management team bring complementary and integrated expertise to the project? Will the proposed C/D/I have the professional staffing to impact significantly the overall quality of clinical and translational science at the institution? If part of the proposal, do the key function Directors have the appropriate training, experience and resources to assume leadership roles? Have the Directors of the key functions committed sufficient time to this program? Will the Directors have the authority to implement best practices identified at Steering Committees at their Institution? Are the administrative and professional staff appropriately trained and well suited to carry out this work?

CTSA Governance: Have the applicants described an effective administration and governance structure that will promote the discipline of clinical and translational science? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the CTSA and the expertise of each of the PD/PIs? Is the governance structure designed to ensure both accountability of multiple PIs, and integration of the components of the C/D/I into a coherent program? Will the leadership and governance plans accommodate changes in the direction of research and allow for the efficient use of funds? Will an Advisory Committee be constituted to provide critical, stimulating, and thoughtful advice for the overall CTSA performance and CTSA key functions? Are there plans to resolve conflicts and implement recommendations?

In addition to the above criteria, the following components of the CTSA application will be considered in the determination of the overall priority score for the entire U54 application.

Institutional Commitment: Is there institutional commitment to establishing the CTSA program as an integral part of its overall clinical research environment? Will the institution align or adjust incentives and rewards to promote the academic mission and new modes of team-based research? Is there substantial commitment from the institutional leadership to protect the time of the investigators to pursue clinical and translational research and mitigate the demands of providing patient care? Will clinical researchers/trainees career development be supported in terms of a specific tenure process for clinical researchers at the institution? 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? Will existing NIH-supported cores be appropriately shared with the CTSA program?

Evaluation Plan: Is the plan adequate to evaluate the short and long-term goals for each of the key proposed 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?

Development of Novel Clinical and Translational Methodologies: Is there an active program of research in novel methodologies? Is the outcome likely to benefit the C/D/I? Is there a plan to involve new investigators? Will these activities be integrated with the CTSA as a whole?

Pilot and Collaborative Translational and Clinical Studies: Is there an adequate plan to solicit proposals, to prioritize the projects and to review their methodology and research performance? Will the expected benefits to the CTSA and to the wider research community be measured and tracked? Will lessons learned be shared?

Biomedical Informatics: Will the biomedical informatics resources offered be 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 Steering 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?

Design, Biostatistics, and Clinical Research Ethics: What types of support and resources will be in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will this training include conflict of interest, federal codes requirements, guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? Are there plans for creation and innovation in developing the application of these topics to clinical research? As applicable, will this resource be sufficient for intra- and inter-institutional operations?

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 identifying a research participant advocate sound?

Participant and Clinical Interactions: 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 PCI 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?

Community Engagement and Research: Will this CTSA effectively involve the community in which it resides, both the public and practitioners, in clinical and translational research priority setting, participation, and follow-up? 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 bidirectional relationships between the CTSA institution and the community for their mutual benefit? Will the research interests of CDI faculty contribute to an intellectually stimulating environment?

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

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 commensurate 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: Is the experience and qualifications of the faculty well suited to training in areas of clinical, translational research? Are there appropriate criteria for selecting participants? Are the efforts to publicize the availability of the program to potential applicants adequate?

Research Training Component (T32): Does the proposed training program provide appropriate courses for clinical and translational science research as evidenced by the quality, innovation and content of courses and adequacy of the syllabus? Are appropriate programmatic activities incorporated into the training program? Is the number of slots commensurate with the scope of the proposed training program?

Research Training Record: This criterion evaluates the past research training record of both the program and the designated mentors. How successful are former trainees in seeking further career development as assessed, in part, by completion of an advanced degree (e.g., Ph.D., M.P.H, or other advanced degrees); receipt of fellowships and/or career development awards; additional training appointments; or similar accomplishments? Do former trainees demonstrate records of establishing productive scientific careers as evidenced by a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, or any other measure of success consistent with the nature and duration of the training received? What is the experience of the mentors in directing training or the potential of those mentors who have not yet developed a record of past training experience?

Mentored Career Development (K12) and Research Program Design: Will the proposed career development and research plans contribute significantly to the scientific development of the candidate scholars to successfully pursue clinical and translational research careers? Will the proposed plans include appropriate course work and/or activities to achieve program goals? Are the proposed research projects the scholars will be pursuing of sufficient scientific quality and do they have the technical merit relevance to support development of a career in clinical translational research?

Training (T32) and Career Development (K12): In addition to the above criteria, reviewers will be asked to comment on the following criteria for both the T32 and the career development (K12) programs:

Preceptors/Mentors: What is the overall quality of mentors' research, their publication record, and their successful competition for research support in areas directly related to the proposed training program? How strong is their record as mentors? Do the mentors have research records of successful competition for research support in areas directly related to the proposed research training or career development programs?

Institutional Training Environment and Commitment to the Program: For the NRSA-supported trainees, is the quality of the institutional training environment and the relationship of the NRSA program to other institutional training programs (if any) appropriate and non-redundant? What is the level of institutional commitment, quality of the facilities, availability of appropriate courses, and the availability of research and research training support? Does the environment in which the training program will be conducted, i.e. the quality of the participating departments and the extent of their participation, contribute to the probability of success? Is there evidence of adequate institutional commitment?

For the career development program, is the institutional commitment to the program, such as recruitment efforts, necessary educational resources and equipment, and available established investigators who will serve as mentors, in evidence? Will the scholars have sufficient protected time to devote to the program?

Recruitment, Selection and Retention of Trainees and Career Development Participants: What is 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: Is the plan adequate to determine progress and outcome measures for each of the research education, training and career development components? Does it include a system for tracking participants following program completion to determine success or failure of the program? Do the plans for tracking include information on program publications; grant proposals and awards; and career trajectory of the trainees that were supported in the program? 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?

Training in the Responsible Conduct of Research: Is there a plan for training in the responsible conduct of research? Is it adequate?

Recruitment and Retention Plan to Enhance Diversity: Is there a plan to recruit and retain under-represented trainee and faculty populations? Will the plan increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research?

Integration: How well will the components of the CTSA be integrated with each other? Are there plans to integrate CTSA activities into all the relevant schools and clinical research sites that participate in clinical and translational science in the applicant institution? Is there a commitment to integrate the CTSA into the institution and into a national network of CTSAs and also to reach out to the local community? Will this integration be reflected in the senior leadership and decision-making processes of the CTSA? Is the CTSA program integrated, cohesive, synergistic, adaptable, and potentially more effective than what currently exists?

Local and National Collaboration, Data Sharing, and Dissemination: How adequately will the institution and its researchers collaborate, share and disseminate resource tools and resources at institutional, community, and national levels? Are plans included to address regulatory hurdles locally? Is there a commitment to and plans for adopting and implementing national standards?

2.A. Additional Review Criteria:

Resubmission Applications (formerly revised/amended applications): Are the responses in the Introduction to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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

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

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

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
Is the range of support to be provided appropriate to the institution's environment, track record, and current and projected needs? Is the proposed budget and requested period of support reasonable in relation to the proposed research and size of the clinical research base, trainee pool, and faculty expertise?

2.C. Resource Sharing Plan(s)

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

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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

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 (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)). 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 (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).

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 U54 and the K12 and T32 (as applicable) awards. Each component will have a separate NoA. The U54 award will reflect full F&A rate reimbursement based upon the negotiated rate in effect at the time of award. The K12 and T32 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 and Postdoctoral Research Training Component-T32

Leave: Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding 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:

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 T32 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-K12

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.

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 K12 component may not be transferred to another institution, and scholars who wish to move to another institution must terminate their support under the K12 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 NOGA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2.A.1. Principal Investigator Rights and Responsibilities

Principal Investigator(s) will have the primary responsibility to define objectives and approaches of the CTSA. The primary responsibilities of the awardees are to:

Awardees will retain custody of and primary rights to their data and intellectual property developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies and subject to the terms and conditions of this FOA.

Principal investigators and key personnel as appropriate are expected to participate in annual Steering Committee meetings.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

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:

Additionally, the NCRR CTSA Program Official will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

NIH Project Scientists will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. One or more Project Scientists may be assigned by the NIH CTSA Program Director to each CTSA and to each CTSA Steering Committee, including those constituted to address key functions. A given individual may serve on more than one CTSA Steering Committee. To help carry out these duties, Project Scientists may consult with non-NIH experts in the field.

NIH Project Scientists may:

NIH Staff Advisors are trans-NIH representatives to the CTSA program who provide technical assistance, advice and coordination through Key Function Committees and special interest groups, beyond normal grant stewardship. One or more NIH Staff Advisors are assigned by the NCRR to each CTSA Committee, including those constituted to address specific topics. A given individual may serve on more than one CTSA Committee. To help carry out these duties, NIH Staff Advisors may consult with non-NIH experts in the field. NIH Staff Advisors:

2.A.3. Collaborative Responsibilities

A national CTSA Consortium Steering Committee comprising a single PI from each CTSA and appropriate NIH Staff has been established. CTSA recipients with multiple PIs will be expected to select a single PI to serve on this committee for a 2-year term, with potential for renewal. A Chair or Co-Chairs will be selected by the Steering Committee at an early meeting of the group from among the non-Federal members. The national CTSA Consortium Steering Committee will enlarge to accommodate new PIs of CTSAs that are funded in future years and to accommodate the NIH Staff Advisors and Project Scientists of Key-Function Committees. Each PI will have one vote while the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Committee voting members.

The national CTSA Consortium Steering Committee shall be a forum for sharing policies, practices, and resources and for discussion of opportunities, impediments, joint agreement on broad issues impeding clinical research, government policies and practices, and other appropriate topics. The Committee will identify and approve best practices and policies that will advance clinical and translational research as a discipline and facilitate collaboration and sharing among CTSA institutions and with partners in clinical and translational research, e.g., industry, laboratories, hospitals.

Each CTSA institution must agree to work toward adopting and implementing the policies and best practices that are approved by the national CTSA Consortium Steering Committee.

Key Function CTSA Committees and groups have been established for common themes identified by NIH (e.g., Research Education and Career Development, Ethics, Child Health, Informatics, Research Design, Communications, Participant Interactions, Regulatory Knowledge) and additional committees or groups for key functions or emergent issues will be established as required. Membership of these Committees comprises the Directors (who may be PIs) of the corresponding key functions at each CTSA or their designee and one or more NIH Staff Advisors and Project Scientists appointed by the NCRR CTSA Program Director. A Chair will be selected by the committee at an early meeting of the group from among the non-Federal members. Each full member will have one vote with the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Committee voting members. The Chair will report recommendations regarding policies and best practices to the national CTSA Consortium Steering Committee for approval. New topic-specific Committees will be added, and existing committees merged, as needed as the CTSA Consortium expands.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

The NIH will convene an independent CTSA Evaluation Committee 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.

Progress Reports: Awardees will be required to submit the PHS Non-Competing Grant Progress Report, annually and financial statements as required in the NIH Grants Policy Statement. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available at most institutional offices of sponsored research. The report should provide information about changes in the program and a summary report of any evaluations by external advisory committees. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program. Since the Form PHS 2590 does not apply easily to this grant, information about PHS 2590 requirements for CTSAs will be posted on the NCRR web site after 1/1/2009.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Dr. Anthony Hayward
Division for Clinical Research Resources, NCRR
6701 Democracy Blvd
Room 906, MCS 4874
Bethesda , MD 20892
Telephone: (301) 435 0790
FAX: (301) 480-3661
Email: haywarda@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Ms. Mary Niemiec
Office for Grants Management, NCRR
6701 Democracy Blvd
Democracy 1, Room Number 1046
Bethesda , MD 20892|
Telephone: (301) 435-0842
FAX: (301) 480-3777
Email: niemiecm@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov// and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The National Research Service Award (T32) component is supported under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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