Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov/)
Components of
Participating Organizations
This RFA is developed as
a Roadmap initiative. All NIH Institutes and Centers participate in Roadmap
initiatives. This RFA will be administered by the National Center for Research Resources on behalf of the NIH. http://www.ncrr.nih.gov/.
Title: Institutional Clinical and
Translational Science Award (U54)
Announcement Type
This is a reissue of RFA-RM-07-002, which was
previously released August 22, 2006.
Update: The following update relating to this announcement has been issued:
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
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 research are critical for the success of the mission of NIH. 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. Scientific opportunities made possible by recent advances in genomics, proteomics, informatics, imaging and other novel methodologies, and the need to conduct research in human populations, with the attendant regulatory, organizational, cultural, and sociological complexities, dictate that opportunities for transforming our current approaches be provided to the scientific community at large. The importance of overcoming the barriers to, and enhancing the opportunities for, public trust and participation in clinical and translational research cannot be overemphasized. The NIH's Council of Public Representatives recommended ways to foster community involvement in clinical research in 2004 (http://copr.nih.gov/reports/October_2004_COPR_WORKSHOP_Proceedings.pdf). 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 the development of well structured and well recognized career development pathways that are intertwined with original and fundamental research addressing the methods and approaches to clinical research. 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 RFA aims to develop the disciplines of clinical and translational science by providing the resources to create an academic home for translational research. The academic home may be a center/ department/institute, as determined by institutional circumstances that supports the discipline of clinical and translational research. Each individual C/D/I will:
The CTSA program is intended to give new opportunities to institutions and their affiliates to be truly innovative in proposals that transform their programs and resources to foster clinical and translational science. 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.
Key Functions 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 of the C/D/I. Potential topics include:
The C/D/I should provide clinical research resources including infrastructure and training to various disciplines in its institution (e.g., medicine, dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, bioengineering) for the benefit of researchers, trainees, and research projects across multiple aspects of health promotion and disease prevention, pre-emption, 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 limited number of investigators will be returned as unresponsive to this solicitation. Applicants are encouraged to partner with foundations and 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. 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 Steering 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 Steering Committee to ensure interoperability for its clinical and translational investigators.
Research Design, 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 a National CTSA Regulatory Support Steering Committee 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 for 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, facilitating the recruitment of research participants from the community. 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, 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, Training and 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 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.
A Research Education component of this RFA 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., 45CFR46, 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 Predoctoral Research Training (T32 training) component could provide predoctoral 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 the 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 a MD, DDS, DO, DNP, or PharmD. Predoctoral research training must emphasize fundamental research training in clinically related areas of biomedical and behavioral sciences. The training may include, for example, courses 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 grant offsets the cost of stipends and tuition support for the appointed trainees. The T32 training component may also offer health-professional predoctoral level trainees practical experience in clinical research ranging from 2 to 3 months through summer or special rotations each year. The curricula of the rotations should have clearly outlined goals and, ideally, a student should have a research project that will serve as the core of the rotation, and be exposed to many phases of clinical research (design, implementation, data analysis, etc.).
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 NIH Mentored Research Career Development Program Award (K12) mechanism. No U54 award for a CTSA will be made without a complementary K12 award.
Direction of an Institutional CTSA
NCRR will accept applications that name multiple Principal Investigators ((http://grants.nih.gov/grants/multi_pi/).) as key personnel on applications received after October 1, 2007. 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 new 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.
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 http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
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 Directors should be commensurate with the requirements of the positions, 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
5. National CTSA Consortium
Under the Cooperative Agreement, a National CTSA Consortium Steering Committee will be established for the CTSA PIs. Additional CTSA sub-committees will be established for each common theme that NIH identifies (e.g., Research Education, Biomedical Informatics, Pediatrics, Regulatory Affairs etc). These Steering Committees 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 these Committees and will facilitate communication among the CTSAs with support services, which could include teleconferences, a Listserv, and an interactive website. The first meeting of the Committees will be shortly after issuance of awards. 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 Steering 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 these Steering 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 towards adopting and implementing the agreed on policies, procedures, best practices, or other measures established by the National CTSA Consortium Steering Committee.
Further information about expected activities of the each of the Steering Committees will be posted at the CTSA Program web site (http://www.ncrr.nih.gov/clinicaldiscipline.asp)
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
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 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.
Predoctoral Research Training Component-T32
The optional Predoctoral 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.
The T32 component will support research training
experiences for at least 4 predoctoral trainees who are interested in pursuing
research careers in multi-disciplinary clinical and translational science. Only
predoctoral NRSA positions may be requested and supported through the T32 part
of this initiative. 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 predoctoral trainees such as MD, DDS, DO, DNP, PharmDs will
be funded on pro-rated stipends for the 2-3 months they are in the program,
based on the 12-month predoctoral stipend level. 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 must 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.
See Section IV.5. Funding Restrictions, for a description of Allowable Costs.
Mentored Career Development Component-K12
The mentored career development component-K12 will provide for a minimum of two years and a maximum of five years of consecutive funding for each 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 up to $160,000 salary 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).
Effective for all competing research project grant applications submitted for the February 1, 2004, deadlines and beyond, 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 new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.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 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
These costs, which were formerly called indirect costs, will be reimbursed at eight percent of 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.
In those circumstances where a consortium arrangement is part of an approved K or T research training program and consortium costs are separately awarded, F&A costs for consortium arrangements are limited to 8 percent of total direct costs subject to the above exclusions. The first $25,000 is included in the F&A base while costs greater than $25,000 are excluded from the base.
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 $38 million. Up to 8 awards are anticipated from this solicitation with an anticipated start date of June 1, 2008
Awards will vary in size due to the consolidation of multiple programs within the CTSA program. Applicants may request total costs up to $6 million annually in addition to the combined current total costs of certain NIH awards (NCRR K12, K30, M01 and Roadmap T32 and K12) held by the applicant institution and its affiliates. When summing the awards for NCRR M01, K12, K30 and Roadmap K12 and T32 to calculate the base 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, 2006. Applicants whose NCRR M01, K12, K30 and Roadmap K12 or T32 awards end in the interval between a first and revised submission should contact NCRR Program Staff to ascertain the budget base for the revised application. If the application is successful, all of the above listed awards at each participating institution will be reconfigured into the CTSA program. The CTSA policy and guidelines for patient care restricted funds will replace those of other mechanisms and these new guidelines will be defined in the Notice of Grant Award for the CTSA. Institutions without the above awards may request up to $6 million annually in total costs.
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. Annual increments and cost-of-living adjustments will follow NIH guidelines.
Applicants for CTSA awards in excess of $4M total costs above the combined current total costs of certain NIH awards should meet the following additional requirements:
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 Clinical Research Training Programs (T32) held by successful
applicant institutions and their affiliates will transition into a CTSA.
Section III. Eligibility
Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit (an) application(s) if your
organization has any of the following characteristics:
Domestic institutions including universities, academic health centers, or other research organizations conducting translational and clinical research are eligible, with the following requirements. 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 M.S. and Ph. D. 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 institution(s) is expected to form an integrated institutional home that includes faculty committed to developing the discipline of clinical and translational science that 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 RFA. 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 foreign components activities of projects that receive primary funding from DHHS. Appropriate clearances and approval by NIH program staff are required before the use of CTSA resources begins. These activities are permitted under the U54 component of the CTSA only and may not include K12 or T32 components. Applications from ineligible institutions will not be reviewed. The application must include clear detailed evidence of significant institutional commitment.
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, K30, M01 awards, and NIH Clinical Roadmap K12 and T32 (Predoctoral 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 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/ElectronicReceipt/preparing.htm for instructions). 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. For further information on multiple PIs, please see http://grants.nih.gov/grants/multi_pi. 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, Training and 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 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.
Predoctoral 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 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 Ph.D. 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. No trainee may be appointed for less than nine months without prior approval of the NIH program staff except for predoctoral health-professional students that 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, 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.
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.
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 NIH staff responsible for the fiscal management of the award prior to the individual being appointed to the program.
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.
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
Significant
institutional commitment is required by the applicant institution(s). This may
take the form of office, laboratory, or clinical space; personnel; equipment;
integration of other clinical grants or centers; other resources; or dollars.
There is no requirement for cost sharing or matching for institutional
eligibility.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3.
Other-Special Eligibility Criteria
Not
applicable
Section IV. Application and
Submission Information
1. Address to Request
Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
2. Content and Form
of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA
Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
SPECIAL PROGRAM INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered on the PHS398 face page. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Key Personnel Table” of the PHS398.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 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 separate budget allocations are requested, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be indicated in the Notice of Award according to NIH policies current at the time of the award (See NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html) for policies currently in use.
Applications requesting a separate budget for a Pediatric Principal Investigator.
Funds for Pediatric PIs who request direct authority over a separate budget and infrastructure for 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.
Special Program Requirements
The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented by this RFA. 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 RFA before developing an application. A pre-submission videoconference will be conducted on 5/14/2007, between 2:00 and 4:00 pm 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 videoconference or videocast (webcast). Additional information on videocasting 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 how the CTSA will transform clinical and translational research at their institutions. They should describe the components and functions of a C/D/I with reference to:
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.
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. Development of Novel Clinical and Translational Methodologies and 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. The description of Pilot and Collaborative Project support 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:
Biomedical Informatics is expected to be the subject of an overall NIH CSTA Informatics Steering Committee that ensures interoperability between the CTSA institutions and with their external partners. National issues impacting clinical and translational science research will be addressed jointly by the NIH CTSA Informatics Steering Committee, working with national leaders in healthcare informatics technology, national standards organizations, and the government.
5. Design, Biostatistics and Clinical Research Ethics.
Applicants should describe:
6. Regulatory Knowledge and Support.
Applicants should describe:
7. Participant and Clinical Interactions Resources (PCIR).
Applicants should describe and justify:
8. Community Engagement and Research
Descriptions of Community Engagement could include how the institution will involve 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.
9. Translational Technologies and Resources.
Applicants should describe:
10. Research Education, Training and Career Development.
Applicants should describe:
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.
Predoctoral Research Training Component-T32
1. Proposed Training Program
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. Explain how the trainees will be engaged 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 predoctoral 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 how they will interact with the CTSA program.
Training in the Responsible Conduct of Research
Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all CTSA activities. Applications without plans for instruction in the responsible conduct of research for each component will be considered incomplete and may 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 predoctoral 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 a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify their trainee and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/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/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health 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 RFA 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, Training and Career Development
Overall Operational Functions