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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 an NIH Roadmap initiative (http://nihroadmap.nih.gov) through the Office of
Strategic Coordination (http://dpcpsi.nih.gov/osc/). 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-06-002.
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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution
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)
initiated the Clinical and Translational Science Award (CTSA) program to
transform the local, regional and national environments for clinical and
translational science and to increase the safety, efficiency and speed of
clinical and translational research. The transformation has been approached by
diverse but convergent paths at different awardee institutions, each providing
an academic center, department, or institute (C/D/I), comprising faculty and
programs that integrate clinical and translational science across multiple
departments, schools, clinical and research institutes, and hospitals. C/D/Is
include faculty who conduct original research, develop graduate and
postgraduate training curricula and lead programs that integrate clinical and
translational science across multiple departments, schools, clinical and
research institutes, and hospitals to create an institutional CTSA. The CTSA
program has grown to 46 sites that cooperate to meet consortium-wide CTSA
strategic goals.
Definitions: For the purpose of this initiative, Clinical Research' comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions (see: http://grants.nih.gov/grants/funding/phs398/phs398.html). Translational research includes two areas of translation. One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies also is an important part of translational science.
Background
Clinical and translational science is critical to the success of the NIH mission. The opportunities for translational and clinical research continue to expand as genome-wide association studies become available and individual variation is increasingly taken into account. Safe and cost-effective research draws extensively on collaborative approaches with resources being shared both nationally and internationally. Clinical researchers need specialized training if they are going to thrive in this new environment. Identifying and overcoming barriers to clinical research are high priorities and opportunities to gain and maintain public trust and participation in clinical and translational research must be maximized to translate to better health for the American public.
The Clinical and Translational Science Award (CTSA) initiative was launched to create an integrated academic home for Clinical and Translational Science with the resources to train and advance multi- and inter-disciplinary investigators and research teams. In their first years CTSAs have brought innovative research tools and information technologies to patient care, attracting basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry into new professional interactions, programs, and research projects. CTSA education and career development programs train clinical researchers and offer advanced degrees in clinical and translational research.
To sustain growth, each CTSA will need institutional support and the status of a major administrative entity within the applicant institution, and a Principal Investigator(s) with the authority, perhaps shared with other high-level institutional officials, over requisite space, resources, faculty appointments, protected time, and promotion. Diverse models for CTSAs were funded in the first rounds of awards and NIH welcomes proposals that meet the needs of both the local institution and of the wider research community.
Specific objectives
This CTSA award will sustain the disciplines of clinical and translational science by providing environments and resources for investigators engaged in clinical and translational research. Their academic home may be a center/ department/institute (C/D/I), as determined by institutional circumstances and it will:
The CTSA program will complement the programs of the NIH Institutes and Centers and will work in cooperation with other other relevant trans-NIH activities.
Applicants may re- define the key functions, components, governance and structure of their CTSA. They should describe the existing and planned activities that would be integrated to comprise their CTSA, indicating the roles of the participating schools and departments within the applicant organization, affiliated institutions, community, foundations and industry. Required activities of a CTSA include providing career paths in clinical and translational science through research education, training, and career development leading to advanced degrees (MS or PhD); informatics resources; support for community engagement and for pilot projects. All CTSAs participate in a CTSA Consortium that links to activities within and across NIH Institutes and Centers. Successful applicants will be expected to complement and interact with existing institutional centers that are funded by the categorical institutes of the NIH and to interact with affiliated institutions and industry. In forming an integrated institutional home for clinical research and training, applicants may choose to negotiate partnership(s) with existing CTSA(s) for the provision of selected key functions, components or training programs. Budgetary and administrative arrangements are to be negotiated between the partnering institutions.
2. Key Functions and Components of an Institutional CTSA
The CTSA supports the discipline of clinical and translational science and the needs of its researchers. Applicants are encouraged to draw on their past experience, and that of the consortium, in proposing concepts, methodologies, and approaches that are integrated into a comprehensive, effective, and efficient researcher-, trainee-, and research subject-centered program. Applicants must include education, biomedical informatics, community engagement, pilot projects and an individual or team who works in Regulatory Support (qv) in their list of key functions and components of the CTSA. These activities, and the other potential topics suggested below, may be supported through NIH funds or institutional resources. The selection of optional components for a CTSA should take institutional strengths and available funding levels into account. Collaborations with other CTSA awardees are encouraged and should be described in detail. They must be accompanied by a letter confirming the collaboration.
Required CTSA Key Functions comprise:
Optional CTSA Key Functions include:
The CTSA should provide clinical research resources and training that support multiple disciplines (e.g., medicine, dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, bioengineering) and the research projects of multiple NIH Institutes and Centers. Applications that focus CTSA resources on only a few diseases, specialties, or for limited number of investigators will be considered unresponsive to this solicitation. Applicants are encouraged to partner with foundations, industry and community organizations, as appropriate, with all partners agreeing to follow NIH policies with respect to 1) listing clinical trials at ClinicalTrials.gov; 2) sharing of resources; 3) data sharing and providing public access and 4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights. Acknowledging that existing resources vary among applicant institutions, the support requested for each of these components is expected to vary, reflecting current and projected needs. Where mutually agreed, an applicant institution may propose a partnership with one or more funded CTSAs if this arrangement will extend the resources available to the applicants clinical and translational researchers. Integration of existing resources and grants into the CTSA activities will be viewed as a strength.
Governance and leadership of an Institutional CTSA
CTSA applications should include a plan that defines the overall governance and organizational structure of the C/D/I, including the relationships between the CTSA PI(s) and the Directors of key functions. A plan to manage and, where necessary, reassign, institutional resources and CTSA resources among the schools, departments, specialties, affiliated hospitals, and affiliated independent research institutions that participate in the CTSA; and between the CTSA and outside foundations and/or industry should be described. Administrative policies and procedures should be described, including an evaluation component that will assess the administrative and scientific functioning and accomplishments of the CTSA.
The clinical research experience of the PI(s), who is/are the Program Director(s), should be described, together with his/her/their involvement in the daily activities of the C/D/I. It is expected that PI(s) would include an established clinician scientist and that the PI(s) have the ultimate responsibility for the implementation and function of the CTSA. The PI(s) may be assisted by co-Program Director(s) from the same institution or an affiliated institution. Co-Program Director(s) should also be experienced investigators who have administrative skills and backgrounds that complement those of the PI(s). The amount of effort for the PI and co-Program Director(s) should be commensurate with the requirements of the position(s), and not less than 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see https://commons.era.nih.gov/commons/).
Pediatric PIs appointed under a single Clinical and Translational Science Award may have direct authority over a separate budget and infrastructure for child health clinical research, as may other PIs as described in NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).
Applications designating multiple PDs/PIs should include a section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 12 of the Research Plan in the PHS 398). A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be identified in the Notice of Award.
Biomedical Informatics
Biomedical informatics, a required CTSA activity, is the cornerstone of communications within and between CTSAs and consortium members and collaborators. Applicants should consider both internal, intra-institution communication platform(s) and external interoperability to allow for communication among CTSA consortium members and the research partners of clinical and translational investigators (e.g. government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). Biomedical informatics support is expected to be flexible and innovative. Interoperability, security, workflow, usability, and standards are essential areas of work. To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards (e.g., identifiers, vocabularies, transactions, security measures) that are consistent with those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. All human subjects data must be handled securely to ensure privacy and confidentiality. Biomedical informatics research activity should be innovative in the development of new tools, methods, and algorithms.
NIH attaches importance to assessments of informatics performance and goal setting across the entire CTSA community. Therefore all Biomedical informatics Directors will participate in the national CTSA Informatics Key Function Committee that is the forum for discussion and agreement on standards, best practices, and/or solutions. The CTSA institution must be committed to working toward adoption and implementation of standards and practices endorsed by the CTSA Consortium Steering Committee to ensure interoperability for its clinical and translational investigators.
Research Education, Research Training and Research Career Development
Research education leading to graduate degrees in clinical and translational science is a required component of a CTSA that should be offered for post graduate programs irrespective of the primary interest, degree, or discipline. In response to the emergence of interdisciplinary, team-oriented environments, applicants are strongly encouraged to train investigators from diverse disciplines such as medicine, pediatrics, surgery, dentistry, nursing, and pharmacology, as well as study coordinators, project managers, and other key clinical research personnel in a range of topics relevant to clinical and translational science (e.g., clinical research design, epidemiology, biostatistics, pharmacology, biomedical informatics, ethics, behavioral science, engineering, law, health economics). Education in business practices as related to health research may be included as well.
Research education, 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 integrated and flexible pre-doctoral and postdoctoral research training opportunities. Research education, training, and career development activities should permeate all aspects of the CTSA program and trainees and scholars should be offered opportunities to utilize all resources and research efforts of the CTSA. Applicants are encouraged to consider ways in which training could be shortened without adversely affecting quality.
A research education component of the CTSA could provide didactic courses and/or short term (up to 6 months) research experiences in the fundamental skills of clinical research with the goal of informing clinical research team members about the complex issues of clinical research. Program participants should have innovative clinical research as their long-term clinical research career plan. The core curriculum could include topics of general interest such as biostatistics, bioethics, clinical trials design, informatics, health data standards and observational study design, Federal policies and regulations that address research with human subjects (e.g., 45 CFR 46, FDA, INDs, inclusion of women and minorities as well as children in clinical research projects), scientific writing for publication, team leadership and preparation of competitive grant applications.
Interdisciplinary approaches are strongly encouraged, as are new approaches to education, which should describe and justify the proposed period of training, and plans for enrolling trainees. The scope of the curriculum can be flexible to meet the needs of the institution and participants.
An optional Institutional Research Training (TL1 training) component, if offered, must provide trainees with coursework in clinical and translational research as part of formal advanced degree requirements. Institutional NRSA training grants are designed to allow the director of the program to select both pre-doctoral and postdoctoral trainees and to provide a curriculum of study and research experiences necessary to provide high quality research training. Appropriate advanced degrees include research doctoral degrees (e.g., PhD, DNSc) in a clinical research-related program and a combined clinical research masters degree given in a combined program with a health professional doctoral degree such as MD, DDS, DO, DNP, or PharmD. Pre-doctoral research training must emphasize fundamental research training in clinically related areas of biomedical and behavioral sciences. Postdoctoral research training must emphasize specialized training that corresponds with the interests of NIHs Institutes and Centers. The training may include courses or practicum experience in clinical and translational science, biostatistics, research ethics, epidemiology and regulations governing clinical research. The PhD program could provide each trainee with a minimum of 3 years of full-time research training support. If a combined clinical research master's and health-professional doctoral degree is offered, all institutional requirements for the combined degree must be completed by the trainee by the time the health-professional doctoral degree is completed/conferred. The TL1 training component may also offer health-professional pre-doctoral level trainees practical experience in clinical research ranging from 2 to 3 months through summer or special 12-month research training rotations. No individual trainee may receive more than 5 years of aggregate NSRA support at the pre-doctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.
A required Mentored Career Development Component (KL2) component will support the research career development of clinical researchers who have recently completed professional training and who are commencing basic, translational, and/or clinical research. The goal of this component is to foster the discipline of clinical research and, by increasing clinical research capacity, to expedite clinical and translational research. The programs will accomplish this through a mentored program, bridging clinical training with research independence. This funding opportunity will use the linked NIH Mentored Research Career Development Program Award (KL2) mechanism. No UL1 award for a CTSA will be made without a complementary KL2 award.
Community Engagement and Research
Community engagement is a required CTSA activity that fosters collaborative research partnerships and enhances public trust in clinical and translational research, enhancing community decision making and action for health promotion, health protection and disease prevention. Community engagement activities could include relationships with the public and with community health care providers, community-based organizations or groups such as voluntary and professional organizations, schools, women's health groups, faith-based groups, and housing organizations, in efforts that strengthen coordination, collaboration and partnerships in the dissemination of best research practices. Resources that might be requested for this component include community capacity building and cultural sensitivity training for institutional clinical and translational researchers, community and health care provider education and outreach, establishing a community advisory board, development of software to facilitate the collaboration of community practitioners, and strategies that allow for bidirectional communication with, and participation of, diverse populations and community groups. An environment that introduces scholars and researchers to research in population and community-based research methods would be valuable.
Evaluation
An internal evaluation process is a required CTSA activity. Each CTSA should have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offer recommendations to the CTSA Director. The existing EAC membership should be listed and their role described in terms of how the committee has functioned to inform the CTSA progress and functioning. Potential new members of an EAC should not be named and should not be contacted prior to the review of an application.
Pilot Translational and Clinical Studies
A CTSA applicant must request support for pilot research projects that could 1) allow clinical and translational trainees or researchers to generate preliminary data for submission of a research grant application; 2) seek to improve clinical design, biostatistics, clinical research ethics, informatics, or regulatory pathways; 3) develop new technologies; or 4) others as defined by the applicant. Pilot and collaborative projects should, in general, be of sufficient scope to qualify as a stand-alone research effort and should be well integrated into the activities of the CTSA. Funds for pilot projects must be available promptly and be accompanied by an organizational structure that allows full compliance with regulatory requirements.
Regulatory Knowledge and Support
Each CTSA should name an individual independent of the IRB or compliance officer to act as a sounding board for potential research participants, serve as an advocate for research participants, and work with investigators, trainees, and research teams to ensure that the highest priority is given for human subject protections.
Optional components of an application include support that will promote the protection of human subjects and facilitate regulatory compliance related to clinical and translation research. Applicants are encouraged to be innovative at all levels of clinical research regulation including, for example, the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, safety and regulatory management and compliance, etc. Institutions could develop best practices that reduce or remove institutional impediments to clinical and translational research and, through dissemination and sharing, could enhance inter-institutional collaborations. Regulatory support provided through a CTSA should not take the place of an institutional compliance or enforcement office nor shall it be responsible for Institutional Review Board activities, but should, instead, assist investigators in their documentation requirements. Institutional IRB personnel may interact with the regulatory support personnel at other CTSA institutions through dedicated committees or special interest groups to ensure that collaborative clinical and translational research activities are facilitated, whether by policy, procedures, best practices, or other means. The institution should be innovative in developing the regulatory support interactions with the IRB and compliance office to facilitate clinical and translational science research without loss of participant protections.
Development of Novel Clinical and Translational Methodologies
An option to conduct original research on novel methodologies and approaches for translational and clinical sciences could build an environment that sustains intellectual exploration. Areas in which faculty might pursue research funded by the CTSA include new translational methodologies, methods for more objective and quantifiable biomarkers or phenotyping, determining cost effectiveness, research into clinical trial designs, clinical informatics for longitudinal studies, home based research devices, predictive toxicology in human populations and ethics research specific to populations rather than specific trials.
Research Design, Epidemiology, Biostatistics and Clinical Research Ethics
Optional activities include developing, validating and integrating research designs and statistical methodologies essential to clinical and translational studies, limiting risks to research subjects, preventing bias, improving recruitment and retention, developing innovative methods of enhancing the power of studies, capturing appropriate data, developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects, informed consent, and issues in diseases with limited treatment options. These topics offer opportunities for research as well as collaborations with CTSA users.
Clinical Research Resources and Facilities
Applicants may opt to request resources such as cores for the recruitment and retention of research participants, in-patient, out-patient, or community-based exam rooms, medical vans, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, specialized child health services, scheduling services, and services for research specimen collection and shipping. Applicants should describe a plan to familiarize investigators in their institution and medical catchments area with the resources available through the CTSA for human subject studies. Where appropriate, cost recovery could be sought from funded investigators and by leveraging with established cores.
Translational Technologies and Resources
Resources that could be requested include advanced technologies such as mass spectrometry, imaging, ultrasound, positron emission tomography, gene expression, proteomics, translational cell and gene therapies and technologies for patient monitoring or examination. Items proposed should be fully justified by local and regional needs. Standard operating procedures are required as is participation in national or international quality control and standardization efforts, where appropriate. The level of support requested must be justified by the projected use by clinical and translational researchers from within and outside the applicant institution(s). If this function is proposed, laboratory equipment, supplies, and personnel are all acceptable costs. Cost recovery for core support should be sought from funded investigators. CTSAs may create opportunities for small business partnerships in clinical and translational research for which NIH funding opportunities exist (see Small Business Innovation Research and Small Business Technology Transfer Research (SBIR/STTR) at http://grants1.nih.gov/grants/funding/sbir.htm). CTSA and SBIR/STTR research collaborations may facilitate development from scientific investigations into final products for commercialization with applications for clinical and translational researchers, health care providers, and patient care.
CTSA Milestones
Specific, well-defined, milestones that will measure progress in each budget period towards the goals of the CTSA should be described. These should have objective criteria and concrete outcome measures that would allow NIH staff to evaluate the progress of a CTSA. Progress to date on the milestones proposed in the prior application should be described and lessons learned on how to improve on the evaluation process.
3. National CTSA Consortium
A national consortium of CTSA institutions has been developed to cooperatively address impediments to clinical and translational science and work towards adopting and implementing agreed-on best practices, policies, procedures, and other measures to advance collaborative clinical and translational research and to reduce burden on individual investigators at all institutions. CTSA institutions are working towards creating a networked environment in which clinical studies can be expedited across multiple institutions. Awardee institutions are encouraged to set funds aside for consortium activities.
Under the Cooperative Agreement, a national CTSA Consortium Steering Committee (CCSC) has been established for the CTSA PIs with NIH representatives. Additional Key Function CTSA committees and groups for common themes identified by the CCSC (e.g., Child Health, Research Education, Informatics etc) exist. The CCSC meets at least once each year in the Washington, D.C. area and each CTSA should be represented. NIH staff are active members of the CCSC and each of the Key Function committees and facilitate communication among the CTSAs with support services, which could include teleconferences, a Listserv and an interactive website. NIH staff conduct periodic visits, review each site's progress in meeting its overall goals, and provide financial oversight of the program.
The CCSC has adopted five Strategic Goals and assigned committees comprised of CCSC members who will be responsible for attaining them. The Strategic Goal committees draw on the expertise of members of Key Function Committees in achieving goals and ensuring their implementation across the consortium. Key Function committees also serve 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. Working together, the Strategic Goal- and Key Function Committees develop, adopt, and implement solutions to impediments to collaborative clinical and translational research. The CTSA institutions must be committed to active collaborative participation in committees at a national level. CTSA committees recommend and work to implement best practices among centers, to include topics such as data formats, common consent forms, patient recruitment strategies, course curricula, implementation of common protocols. A letter from the applicant institution stating that the CTSA will work towards adopting and implementing the agreed on policies, procedures, best practices, or other measures established by the CCSC must be submitted with the application.
Further information about expected activities of the Key Function committees is posted at the CTSA Program web site (http://www.ctsaweb.org)
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding
opportunity will use the UL1 award mechanism with linked K and (optional) T
components. Applicants will submit a single unified U54 grant application
containing separate sets of budget pages for all years for the UL1, KL2 and
TL1 components, as applicable, a summary budget and separate sets as required
for multi-PIs. If a CTSA application is selected for funding, the UL1, KL2 and
TL1 components will be funded as separate, yet administratively linked, grants.
Applicants may request up to 5 years of support.
The NIH UL1 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.
The applicant, 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 UL1 component and is subject to the
consideration in the paragraph above.
Research Training Component (TL1)
The optional Research Training (TL1) 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 TL1 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 TL1 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 (e.g., MD,
DDS, DO, DNP, PharmD) pre-doctoral trainees will be funded on pro-rated
stipends for the 2-3 months they are in the program, based on the 12-month
pre-doctoral stipend level. No trainee may be appointed for less than
nine months without prior approval of the NCRR Program Staff except for
pre-doctoral 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 pre-doctoral 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 NCRR 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 (KL2)
The mentored career development component (KL2) will provide for a minimum of two years and a maximum of five years of consecutive funding for each Scholar, consisting of consecutive 12-month appointments. In general, 75 percent of the Scholars' full-time professional effort must be devoted to the KL2 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-09-069.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 KL2 component.
Under expanded authorities, however, institutions may re-budget 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 KL2 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://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.
Pilot and Feasibility Project Support
KL2 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 meetings, 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 KL2 or TL1 components. Administrative support could be included as part of the UL1 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, consortia 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 renewal of
CTSA awards in 2011 are approximately $116 million. Up to 12 awards are
anticipated from this solicitation with the anticipated start date of July 1,
2011.
Awards will vary in size due to the prior consolidation of multiple programs at the applicant institution(s) into the CTSA program proposal. Potential applicants have been notified of the maximum award amount that may be requested and may contact NCRR Program Staff for verification.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
This FOA is limited to current Clinical and Translational Science Award (CTSA) awardees and current or new collaborators. 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 that will transcend multiple departments, schools, clinical and research institutes and hospitals. Therefore, an institution may submit 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 and long-term 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. 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 UL1 and KL2 components of the CTSA only and may not include the pre-doctoral TL1 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 demonstrate significant institutional commitment when it is offered.
In forming an integrated institutional home for clinical research and training, applicants may choose to negotiate partnership(s) with other 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.
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. NIH recognizes that there are many outstanding and established Individuals from diverse backgrounds (underrepresented racial and ethnic groups, as well as individuals with disabilities and women clinical scientists) who have the institutional authority and expertise to direct a CTSA program and/or components of a proposed institutional home for clinical and translational science. The NIH strongly encourages each institution to consider these individuals when choosing Principal Investigators and leaders of key functions or components for a CTSA application.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 TL1 Program Director must be an established researcher with acknowledged accomplishments in clinical and translational science research, and should be capable of providing both administrative and scientific leadership to the proposed multi-disciplinary training program. The training Program Director will be responsible for planning, directing, and executing the research training program and the selection, appropriate supervision/mentorship, and evaluation of the trainees progress.
The Program Director for the KL2 component must be an established investigator with the scientific and administrative skills, knowledge and leadership to coordinate and supervise the mentored career development program. The individual must be a senior faculty member or director of research with extensive expertise recruiting, advancing, and retaining individuals in clinical and translational science careers.
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 (TL1) Eligibility
At the time of appointment to the training program, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.
Pre-doctoral trainees
Pre-doctoral
trainees must have received a baccalaureate degree by the beginning date of
their NRSA trainee appointment, and must be training at a post-baccalaureate
level and enrolled in a program leading to a PhD in a clinical research-related
doctoral degree program, or a combined doctoral level professional degree plus
a clinical research-related advanced degree, such as a MD, DDS, DO, DNP,
PharmD/MS or MD, DDS, DO, DNP, PharmD/PhD. Students who are officially enrolled
in a qualifying health-professional doctoral program and wish to postpone their
professional studies for one year to gain research experience, may be appointed
to the TL1 research training grant for that period, provided that NRSA
eligibility requirements are met. NRSA traineeships are not provided for study
leading to a MD, DO, DDS, DNP, PharmD or other similar professional clinical
degrees, or a master's degree that is not pursued in a combined program with a
professional level doctorate. Individuals currently supported by other Federal
funds are not eligible for trainee support from the TL1 program at the same
time. Trainees are customarily appointed for full-time, 12-month continuous
periods. An individual trainee may receive no more than five years of NRSA
support in aggregate at the pre-doctoral level, including any combination of
support from institutional training grants and individual fellowship awards.
Postdoctoral
Trainees
Postdoctoral trainees must have received, as of the beginning date of the NRSA
appointment, a PhD, MD, DDS, or comparable doctoral degree from an accredited
domestic or foreign institution. Eligible doctoral degrees include, but are not
limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DPH, DNSc, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well as a doctoral degree in nursing
research or practice. Documentation by an authorized official of the
degree-granting institution certifying all degree requirements have been met
prior to the beginning date of the training appointment is acceptable.
Postdoctoral trainees supported by NRSA awards incur a service payback obligation for the first 12 months of postdoctoral support. The second year of NRSA postdoctoral support will serve to pay back the service obligation. See NIH Grants Policy Statement.
Trainee Appointments: All trainees are
required to pursue their research training full time, normally defined as 40
hours per week, or as specified by the sponsoring institution in accordance
with its own policies. Appointments are normally made in 12-month
increments, and no trainee may be appointed for less than 9 months during the
initial period of appointment, except with prior approval of the NIH awarding
unit, or when trainees are appointed to approved, short-term training
positions.
No individual trainee may receive more than 5 years of aggregate NRSA support
at the pre-doctoral level or 3 years of support at the postdoctoral level,
including any combination of support from institutional training and individual
fellowship awards. Any exception to the maximum period of support
requires a waiver from the NIH awarding office based on a review of the written
justification from the individual trainee, and endorsed by the Program Director
and the sponsoring grantee institution. Trainees seeking additional support are
strongly advised to consult with the NIH awarding office.
Additionally, tuition and fees at the postdoctoral level are limited to that required for specific courses in support of the approved training program which should be identified prior to matriculation.
Mentored Career Development Component (KL2) Scholar Eligibility
Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to appointment, are eligible to become KL2 scholars. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Plans for recruiting scholars should include accessing under-served and under-represented minority and ethnic populations.
KL2 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and research activities associated with the program. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the KL2 program. The eligibility of potential candidates holding VA appointments should be confirmed with NCRR Office of Grants Management and Program staff prior to the individual being appointed to the program. The portion of the memorandum of understanding (MOU) that details the professional responsibilities of the candidate at the VA and the institution may be requested.
KL2 applicants may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g., K07, K08, K22, K23) that duplicates any of the provisions of the KL2 program. Former or current principal investigators on any NIH research project grant (this does not include NIH Small Grants (R03) or Exploratory/ Developmental (R21) grants or their equivalents) or equivalent non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to participate as KL2 scholars. Appointed K12 or KL2 scholars may apply for K23 support; if successful they transfer to the K23 award.
KL2 Mentor Eligibility
The KL2 component of the application must identify a core group of primary sponsor/mentors for the career development program. Each mentor together with the scholar will be responsible for the planning, direction, and execution of each career development plan and research project. Mentors must be recognized as accomplished investigators in clinical and translational research and have a track record of success in training new investigators and fostering their transition to independence. Mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the KL2 and CTSA. The use of co-mentors to achieve the goals of the program is encouraged. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.
2. Cost
Sharing or Matching
There is no requirement for cost sharing or
matching for institutional eligibility under this FOA. However, institutional
commitment by the applicant institution(s) will be recognized. This may take
the form of personnel effort; equipment available for the performance of the
sponsored agreement at no direct costs to the project; other direct costs such
as travel expenses and laboratory supplies; integration of other clinical
grants or centers; or other resources. Any costs volunteered and reflected in
the application by the applicant must be allowable under the applicable OMB
Circulars and by applicant organization policies. Any voluntary institutional
commitment proposed in an application that is subsequently awarded will become
a binding agreement on the part of the grantee.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_2003.pdf.
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) 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 on line 2 of the face page of the application form and the YES box
must be checked.
Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA
Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the contact PD/PI should be entered on the PHS 398 face page. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Key Personnel Table of the PHS 398.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 12 of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If separate budget allocations are requested, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be indicated in the Notice of Award according to NIH policies current at the time of the award (See NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html) for policies currently in use.
Applications requesting a separate budget for a Pediatric Principal Investigator
Funds for Pediatric PIs who request direct authority over a separate budget and infrastructure for child health clinical research should also be submitted separately on PHS 398 budget forms. When the Pediatric PI is at a different institution, this budget should be included as a subcontract to be administered by the prime institution.
Applications involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the PHS 398 forms. All other participating components requiring separate budgets (e.g., pediatric PIs, affiliated institutions) should also submit separate individual budgets on PHS 398 forms.
Special Program Requirements
The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented by this FOA. Applicants are strongly encouraged to contact NIH program staff early in the application process and they should have a thorough understanding of the intent and expectations of this FOA before developing an application. A pre-submission webcast will be conducted on Nov. 5, 2009, between 2:00 and 4:00 pm ET at which NCRR and other NIH staff will explain the goals and objectives of the CTSA program and answer questions. Additional information on the webcast will be available at www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/. The webcast will be archived at www.videocast.nih.gov.
Applicants should address the key functions proposed for their CTSA using the Format of the Application following this section. All information must be contained within the body of the application; appendices are not allowed.
1. Overall Impact: Prior Funding Period
Summarize the impact and achievements of the CTSA in the previous project period. Page limits: up to 20 pages of text and 20 pages of tables (40 pages total). Specifically, this section should address:
2. Approach
Since the scale and range of activities will vary in proportion to prior NIH funding and institutional support, applicants should indicate how funds awarded for a CTSA will sustain clinical and translational research at their institutions. In their plans for next project period, NIH expects that applicants will differ in their approaches to the provision of CTSA resources. Page limits: included in 25 pages of text and 5 pages of tables, 30 pages total. Applicants should describe their plans for the CTSA funding period, focusing on:
3. Governance
Describe in 25 pages (30 pages for multi-PD/PI applications) or less:
4. Biomedical Informatics
Describe in 15 pages or less:
Summarize contributions to the consortium, including how the applicant interacts with the CSTA Informatics Steering Committee to promote interoperability between the CTSA institutions and with their external partners, implement best practices, and conform to standards as decided by the Committee.
5. Overall Plans for Research Education, Training and Career Development
Applicants should describe their existing higher degree-granting programs such as Masters or PhD in Clinical Research. Describe the following sections in 25 pages or less:
Overall Plans for Research Education and Training
Research Education Component
Research Training Component (TL1)
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. 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 TL1 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 that the institution will provide for the proposed training program. This could include, for example, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative and allowable mechanisms to improve the climate for the establishment and growth of the training program (e.g., core facilities).
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 (KL2)
This section should begin with an overview of the proposed program and describe:
Plans for Education Component Evaluation and Tracking Plan, Training in the Responsible Conduct of Research and the Recruitment and Retention to Enhance Diversity
Up to 20 pages is allowed. Describe a strong evaluation and tracking plan for all research education, training and career development activities. The plan should include the review of the effectiveness of all aspects of the program (including curriculum development, training faculty, Program Directors). Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements. The application should describe plans for a research education, training and career development program advisory committee.
The NIH may, in the future, request information about trainees for program evaluation purposes. In addition, institution(s) with other clinical or translational training and career programs must provide strong evidence that the CTSA Program will improve existing clinical and translational research career development and mentoring programs (including but not limited to individuals supported via NIH T32, K12, K23 and K24 grants) and how they will interact with the CTSA program.
Training in the Responsible Conduct of Research
Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all CTSA activities. Applications without plans for instruction in the responsible conduct of research for each component will be returned to the applicant without review.
Every trainee, scholar, or participant supported by this CTSA grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.
Recruitment and Retention Plan to Enhance Diversity
The NIH recognizes the need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce leading to the recruitment of the most talented researchers from all groups; improving the quality of the educational and training environment; broadening research priorities; diversifying the backgrounds of clinical research subjects; and improving the Nations capacity to address and eliminate health disparities.
The NIH encourages institutions to diversify their trainee and faculty populations to include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/) In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.
Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
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.
6. Community Engagement and Research
Applicants are encouraged to collaborate with members of CDCs Prevention Research Centers (PRC) Program, including those within their own institutions (see www.cdc.gov/prc).
Describe in 15 pages or less:
7. Evaluation Plan
Describe in 15 pages or less a detailed self-evaluation plan to assess CTSA activities, including:
The demand for, and effectiveness of, any novel clinical and translational methodologies, pilot translational and clinical studies, community engagement and translational technologies and resources.
Research Education, Research Training and Research Career Development: see Section IV.2.5
Biomedical Informatics
Community Engagement
Research Design, Biostatistics and Clinical Research Ethics
Regulatory Knowledge and Support
Clinical Research Resources and Facilities
Overall Operational Functions
The evaluation plan should also describe how the applicant will participate in the national CTSA program evaluation established to:
8. Pilot Translational and Clinical Studies
In 15 pages or less, applicants should describe a program that will provide pilot project funding for clinical and translational trainees or researchers to generate preliminary data for submission of a research grant application. The size of this key function should be commensurate with that of the CTSA. The proposed organizational structure must allow full compliance with regulatory requirements.
Pilot project support, include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and care of vertebrate animals, as applicable
9. Regulatory Knowledge and Support
Describe potential topics in 15 pages or less:
10. Support for Novel Clinical and Translational Methodologies.
Describe in 15 pages or less:
11. Research Design, Biostatistics and Clinical Research Ethics
Describe potential topics in 15 pages or less:
12. Clinical Research Resources and Facilities (CRRF)
Describe potential topics in 15 pages or less. Examples include:
13. Translational Technologies and Resources
Describe potential topics in 15 pages or less:
14. Milestones and Implementation Plan
Provide, in 5 pages or less, a time-line of milestones
for the goals of the CTSA with alternatives should those milestones not be
reached. In the event that the size of award requested for the next budget
period is significantly different from the last, the applicant should describe
the process by which anticipated budget changes in the CTSA will be implemented
and integrated into the strategic plan of the institution. Include this
section in the Overall Research Strategy.
15. Required Institutional Letters
Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:
Format of the Application
The instructions in the Form PHS 398 do not fully apply to the special needs of a CTSA application so the following instructions are provided that should be read together with the Special Programmatic Requirements and Review Criteria:
A. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Institutional CTSA Program. On Line 2, provide the number of this Funding Opportunity Announcement, RFA-RM-09-019, and the FOA title "Institutional Clinical and Translational Science Awards." The budget figures on this page should be taken from the communication you received from NCRR.
B. Description, Performance Sites, and Key Personnel: Key personnel include the Principal Investigator, co- Program Director(s), Directors(s) and co- Directors(s) of key resources, and other key professional and administrative members of this program. Do not include trainees, mentors, or external advisory committee members. Only include named individuals for whom salary support is requested in the application.
C. Table of Contents: Applicants should provide a customized Table of Contents that properly reflects the organization of their application. Applicants should use inclusive numbering of sections (i.e., provide start and end pages for each section).
D. Detailed Budget Page for Initial Budget Period and Entire Proposed Period of Support: Four sets of budget pages (Form pages 4 & 5) are required that together incorporate all the proposed activities of the CTSA. The first set is for the U54 budget that contains the majority of the items in the program. Justification for equipment, personnel and supplies, including administrative expenses anticipated for a KL2 or TL1 component of the application. The second set for a Career Development (KL2) component should provide information reflecting the costs incurred by the KL2 scholars, such as planned salaries, fringe benefits, and research or pilot project expenses for the number of scholars being proposed in the program as detailed in Section 3.1.2. If a TL1 component is included to pay for trainee stipends, travel, and training-related expenses per NRSA guidelines, this budget should be submitted on Kirschstein-NRSA Substitute Form Pages. The fourth set, showing the composite budget, should include stipends in the personnel category and all other training costs in the other expenses category. Budget items should be requested for 12 months; NCRR will prorate these items accordingly at the time of award. Applicants are requested to copy their budget items into the spreadsheet provided on the CTSA program website (www.ncrr.nih.gov/ctsa.
E. Biographical sketches and research support in standard NIH format for Program Director, co-director(s), other listed key professional and administrative members of this program, and named members of significant internal committees. Do not include biographical sketches for trainees or external advisory committee members, or those who are not directly involved in the CTSA.
F. Institutional Clinical and Translational Science Award Program: The application must present all the proposed activities of the CTSA within the page limits shown below. Note that these are upper limits: applicants are urged to be concise and to present information in tables where possible. According to NIH policy, applicants should not provide programmatic URL's in their applications. No appendices are allowed. Note that the additional 50 permitted pages of Tables or Figures may be sited in the text so as best to facilitate review. 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 Impact: Prior Funding Period: Performance that includes an assessment of the local and consortium-wide impact of the CTSA in the prior project period. This section may include 20 pages of text and 20 pages of tables, 40 pages total.
(2) Approach (25 pages plus 5 pages of Tables).
(3) Governance (25 pages) to include the following sub-headings. Multi-PI applications must preface these with a leadership plan and have a page limit of 30 pages.
(4) Up to 15 pages for each selected key functions, except as shown
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.
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: May 3, 2010
Application Receipt Date: June 1, 2010
Peer Review Date: September 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (URL Activation Date): November, 2009
Expiration date: July 1, 2012
3.A.1. Letter of
Intent
Prospective applicants are asked to e-mail their
intent to apply with 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 at the beginning
of this document.
The letter of intent should be sent by e-mail to:
Dr. Anthony Hayward
Division for Clinical Research Resources
National Center for Research Resources
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, it will be
returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness by the CSR and responsiveness by the NCRR. Incomplete or
unresponsive applications will not be reviewed. Although there is no immediate
acknowledgment of the receipt of an application, applicants are generally
notified of the review and funding assignment within eight (8) weeks.
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.
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 http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs: With the exception of a TL1
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: are necessary to conduct the project, and 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 KL2 and TL1 components; other expenses category of PHS 398 pages 4 & 5).
Consultant costs, Equipment and Supplies. Applicants may include travel costs and are advised to include travel to CTSA Steering and Key Function Committee meetings in Bethesda, MD, for their representatives. Costs may include patient care costs, alterations, other expenses and Consortium/contractual costs.
Applicants should request funds to support pilot research projects. These funds can be used for research expenses, such as supplies, equipment, and technical personnel. Pilot projects undertaken by KL2 scholars should be included in the KL2 budget.
Funds requested for payment to a hospital for clinical research resources and facilities shall be requested on PHS 398-Form Page 4, as Patient Care Costs. If there is a negotiated Research Patient Care Rate Agreement established between the hospital and DHHS that will be applied to the provision of CTSA services, include a copy of that agreement with the application. Categories for which F&A costs are included in the negotiated research patient care agreement should be excluded from F&A costs in the U54 budget (i.e., F&A costs may not be charged twice.)
Awards will be made on the basis of Total Cost Commitment. Awardees can request the transfer of awarded funds between the UL1 (approved Institutional indirect costs) and KL2 (8% indirect costs) components. No component of a CTSA award will have automatic carryover authority. Approved fund transfers and carryovers will be provided in award notices. Requests for cost-of-living increments with non-competing continuations will be handled according to prevailing NIH policy.
5.1 Specific Instructions and Limitations Related to the Research Education, Research Training and Research Career Development Components
5.1.1 Research Education Component
Research Education, but not TL1 or KL2, education costs should be placed on the UL1 budget pages. These might include, but are not limited to: 1) curriculum and degree granting elements including costs to develop and provide lectures, courses, seminar series, etc.; 2) programs to provide research educational experiences to undergraduate students, allied health professionals such as study coordinators and project managers, and non-doctoral master's students (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 postdoctoral scholars to help defray laboratory or other research related expenses associated with hosting a trainee or scholar. Trainee stipends and KL2 scholar salaries are not allowable costs for the Research Education Component. However, under certain circumstances subsistence allowances may be permitted for other program participants.
5.1.2 Mentored Career Development Component (KL2)
The NIH will also help defray the costs for the following expenses: (1) tuition and fees related to career development; (2) up to $2,500 for scholar travel to attend two training and/or scientific meetings per year; (3) recruitment costs (up to $3,000 per year for costs such as brochures, recruitment-related travel, etc.) to attract participants who can excel in, and potentially become leaders in, clinical research.
Facilities and Administrative Costs for K components
These costs, which were formerly called indirect costs, will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, and equipment for the K component.
5.1.3. Research Training Component (TL1)
Allowable costs for each pre-doctoral and postdoctoral trainee for a 12-month appointment period include:
Stipend
A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. The NIH will provide stipends for each pre-doctoral trainee position selected for the pre-doctoral research training component according to the appropriate fiscal year pre-doctoral NRSA stipend schedule. Stipend levels are adjusted periodically. The current NRSA stipend schedule can be found on the NIH Web site at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid. Such funds may be provided either in the form of stipend supplementation from non-federal funds, or in the form of compensation such as salary or tuition remission for services provided by the trainee such as teaching or serving as a laboratory assistant. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.
Postdoctoral trainees supported by NRSA awards incur a service payback obligation for the first 12 months of postdoctoral support. The second year of NRSA postdoctoral support will serve to pay back the service obligation. See NIH Grants Policy Statement.
Tuition and Fees
The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at NOT-OD-06-093 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html). For tuition, an amount per pre-doctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., MD-PhD, DDS-PhD), the amount provided per trainee will be up to $21,000 per year. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. A full description of the NIH tuition policy is in the NIH Grants Policy Statement and on the NIH website at: http://grants.nih.gov/training/nrsaguidlines/nrsa_toc.htm.Training related expenses: For institutional training grants, the training related expenses category has been be modified to include health insurance as an allowable expense. This category will continue to be referred to as training related expenses but will now include health insurance as an allowable cost (see: NOT-OD-06-093).
Trainee Travel
Up to $1,000 for trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is allowable.
Facilities and Administrative Costs
These costs, formerly known as indirect costs, will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, health insurance, consortia in excess of $25,000, and equipment. See NRSA Policy Guidelines on the NIH Web site at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm and NOT-OD-06-090 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-090.html).
Concurrent Awards: An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.
Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligation.
5.2. Plans for support beyond 5 years:
NIH is planning for additional 5 year competitive renewal of these
awards. NIH support beyond the five-year project period is not guaranteed and
is dependent upon the availability of appropriated funds, and success in any
competition for renewed support. In the event that there is no further support,
no phase-out funds will be provided. Thus, the applicant institution(s) must
have plans in place to provide continued support to remaining trainees in the
event that funding from the NIH is not available.
6. Other Submission
Requirements
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.
Plan for Sharing
Research Data
Data sharing at local and national levels
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.
All applicants must include a plan for
sharing research data in their application. The data sharing policy is
available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers and
will be factored into the determination of scientific merit or the
impact/priority score.
Resource Sharing Plans
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131.
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff when making recommendations about funding applications will
consider the adequacy of the resources-sharing plan and the related
data-sharing plan. The effectiveness of the resource sharing will be evaluated
as part of the administrative review of each non-competing Grant Progress
Report. (PHS 2590). See Section VI.3. Reporting. Plans for the development of
research resources for use by the biomedical community should have appropriate
timelines and milestones.
The application must include clear
written commitments from the officials responsible for intellectual property
issues at all of the applicant institutions and their sub-contractors, to the
effect that the institution(s) supports and agrees to abide by the research
resource dissemination plans put forth in the application. A separate letter
should be sent by each participating organization including each subcontractor.
Lack of such letters will result in withdrawing the application as non-responsive.
Additionally, peer reviewers, program staff, and advisors will evaluate the
adequacy of dissemination plans prior to award (see below). Please note that
institutional sign-off on the grant application signifies that all relevant
components of the institution(s), including their technology transfer
office(s), have reviewed and approved the document.
The initial review group will comment on
the appropriateness of the proposed plan for data and resources dissemination.
Program staff and advisors will also consider the adequacy of the dissemination
plan as one of the criteria for award. The proposed sharing plan, after
negotiation with the applicant when necessary, will be made a condition of the
award. Evaluation of competing renewal application and annual non-competing
progress reports will include assessment of the responsiveness to NIH
guidelines of data, materials, methods, and software dissemination practice by
the grantee.
(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 may 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.
Plans for Training in the Responsible Conduct of Research and for Recruitment
and Retention to Enhance Diversity
Applications with plans determined to be unacceptable by reviewers will not be funded until a revised plan is received that is acceptable to Program staff with guidance from the appropriate national advisory committee or council.
Section V. Application Review Information
1. Criteria
The following
will be considered in making funding decisions:
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 criteria stated below.
As part of the initial merit review, all applications
will:
CTSA Overall Evaluation:
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 impact/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. 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 impact/priority score determined after evaluation of all components.
CTSA Review Criteria: This is a complex review that includes the following major parts:
1. Renewal criteria: Performance in the prior project period will be evaluated by the reviewers using Significance, Investigators, Innovation, Approach, Environment and Evaluation.
2. Plans for the next project period: Has the applicant demonstrated continuity in the program, such that strengths in the previous project period are identified and facilitated while challenges are recognized and addressed? Headings under which this question should be addressed include:
Performance in prior project period
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Did the CTSA attract new clinical and translational researchers, assist their transition to independent funding and ensure that their contributions were recognized within the institutions promotions and tenure program?
Innovation: Did the CTSA create new and innovative opportunities for users? Were any novel concepts, approaches, methodologies, tools, or technologies employed?
Approach: Were the resources of the CTSA distributed equitably across specialties and NIH-funded researchers at the applicant institution in the previous project period? Was Pilot Project funding, if offered, accessible and effective?
Environment: Was the institutional commitment appropriate to create an integrated home for clinical and translational research? Was the CTSA able to assist researchers in bringing projects from the bench to the bedside, and from proof of principle to clinical application? Was the community engagement program effective in reaching a target population? To what degree has the translated research been accepted and disseminated by the community? Does the research being translated address the needs of the community?
Evaluation: Did progress toward measurable goals and milestones, outlined in the previously funded grant application, meet prior expectations? Did the applicant identify potential problem areas and mitigate or avoid them when necessary or apply timely corrective measures where avoidance was not possible?
Plans for next project period
Overall Impact: Will the CTSA significantly impact the overall quality of clinical and translational science at the applicant institution? Will the overall program vision and strategy sustain a home for clinical and translational science that incorporates a wide range of clinical disciplines, specialties, and sub-specialties? Will the CTSA have potential to contribute significantly 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? Will the CTSA 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 opportunities for careers in clinical research be sustained across the spectrum of clinical and translational science? If significant changes have been proposed from the focus of the previously funded period, are the changes justified and has a plan for transition been included with this application? Are plans for participation in the national consortium clearly addressed and appropriate to the CTSA program? Are there adequate resources identified for participation in the national consortium? Have the selection of key functions and their scope for the next project period been well justified? Were significant changes proposed to key functions developed during the previously funded period?
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 PD/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? Are there plans to resolve conflicts and implement recommendations? Is the institutional support clearly demonstrated in the governance structure? Has the administration and governance structure been significantly restructured from the previously funded program? If so, has this restructuring been justified and are adequate transition plans included with this application? If the applicant has an External Advisory Committee, is its organization within the structure of the CTSA conducive to providing critical, stimulating, and thoughtful advice for the overall CTSA performance and CTSA key functions?
Implementation Plans: Does the implementation plan adequately address any transitioning that may be needed from the previously funded grant period? 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?
Integration: How well have the components of the CTSA been integrated with each other? Will existing NIH-supported cores be appropriately integrated with the CTSA program? Are approaches proposed that would develop the integration of clinical, basic and other relevant (e.g. public health, bioinformatics) disciplines? Are there plans to further 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?
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 to meet program goals? Are plans included to address regulatory hurdles locally? Is there a commitment to and plans for adopting and implementing national standards?
Innovation: Will the CTSA program create new and innovative opportunities for clinical researchers, research scholars and trainees? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies that will improve the discipline? Is the program likely to develop or sustain 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? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements?
Investigator(s): Have there been changes in the PD/PI(s) or key personnel during the first project period? Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s)? Do the PD/PI(s) have the experience and authority and committed time to administer the institutional home for clinical and translational research? Do the PD/PI(s) have sufficient authority and credibility in the institution to work across institutional boundaries? Do the PD/PI(s) have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the CTSA? Does the program leadership and management team bring complementary and integrated expertise to the project? Does the CTSA have the professional staffing to impact significantly the overall quality of clinical and translational science at the institution? For key functions that are included in the proposal, do the Directors of key functions have the appropriate training, experience and resources for their leadership roles? Have the Directors of the key functions committed sufficient time to this program? Will the Directors have the authority at their institution to implement best practices identified by the Consortium key function Committees? Are the administrative and professional staff appropriately trained and well suited to carry out this work?
Environment: Does the applicant have a track record of awarding higher degrees in clinical research? Will the academic and scientific environments sustain a home for clinical and translational science? Is there a strong training record at both institutional and faculty levels? Does the proposal provide strong evidence that the CTSA will provide resources to the institution that would not otherwise be possible? Has there been an effort made to include accessible health related schools and scientific areas? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the CTSA program performs effectively as one activity across institutional boundaries?
Institutional Commitment: What was the institutional commitment to the CTSA program during the first project period? Will the institution align or adjust incentives and rewards to promote the academic mission and team-based research? Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, dedicated space, or tuition rebates, as a few examples? Is the institutional leadership committed to protect the time of the investigators to pursue clinical and translational research and mitigate the demands of providing patient care? Will the contributions of clinical researchers be recognized by the institutions promotions and tenure program?
Key Function Areas:
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 Key Function Committee? As applicable, will this resource be sufficient for intra- and inter-institutional operations? Will the institution be willing to work toward interoperability of the informatics systems and adopting national data standards?
Research Education, Research Training, and Research Career Development: Do the research education, training and career development components strengthen the training and career pathways for all clinical and translational research professionals and team members? Can increased efficiency shorten the period of training? Does the institution have a sufficient pool of academically strong trainees and 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?
Preceptors/Mentors: Does the applicant demonstrate high caliber of mentors as researchers, including successful competition for research support in areas directly related to the proposed research training or career development program? 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 and career development programs? How strong is their record as mentors?
Institutional Environment and Commitment to the Program: Is there a high quality institutional training environment for trainees? Is the TL1 program integrated to the broader training program (if appropriate)? 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?Does the applicant indicate appropriate commitment to the program, such as may be reflected in recruitment efforts, necessary educational resources and equipment, and available established investigators who will serve as mentors? Is there a convincing planthat scholars will have sufficient protected time to devote to the program?Trainee Recruitment, Selection and Retention: Is there a high quality applicant pool? Is there a functional plan for selection of individuals for appointment to the training or career development program? Specifically, what are the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined?
Evaluation and Tracking of Research Education, Research Training and Research Career Development: 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 that includes 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?
Community Engagement and Research: Will the CTSA effectively involve the community in which the CTSA institution 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?
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?
Pilot Projects in Translational and Clinical Studies: Is there an adequate plan to solicit proposals, prioritize the projects and review their methodology and research performance? Are there plans to disseminate the benefits to the CTSA to the wider research community? Will benefits be measured and tracked?
Regulatory Knowledge and Support: Will this resource provide researcher-focused support for regulatory compliance and management? Is the resource well integrated with biomedical informatics and participant and clinical interactions? Is there duplication of IRB responsibilities? Does the institution have experience in working with multi-site trials and with the FDA with respect to studies involving investigational new drug application procedures? Will CTSA staff members be available with the necessary experience in working with the FDA and in ensuring that standards for reporting adverse events are met? Are criteria for the research subject advocate functions sound?
Development of Novel Clinical and Translational Methodologies: Is there an active program of research in novel methodologies? Is the outcome likely to benefit the CTSA? Is there a plan to involve new investigators? How well are these activities integrated with the CTSA as a whole?
Research Design, Biostatistics, and Clinical Research Ethics: 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, and 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?
Clinical Research Resources and Facilities: Will human subject participation in clinical research protocols be encouraged? Will the institution work with underserved populations in clinical research? Has the applicant adequately described and justified the resources to be provided? Will resources meet the highest standards for subject safety, quality of science and statistical and ethical design? Is the application of Good Clinical Practice guidelines appropriate? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Will the resources provided serve small as well as large studies or trials?
Translational Technologies and Resources: Is the plan to identify technologies to be offered appropriate? Will resource utilization and evaluation be adequate? Is there flexibility in types of resources to be offered? Will faculty members be encouraged to pursue research in areas that develop translational methodologies?
Additional Review Criteria:
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Training in the
Responsible Conduct of Research: For the research education, training
and career development components , the reviewers will evaluate plans for
instruction in responsible conduct of research as well as the past record of
instruction in responsible conduct of research, where applicable. Reviewers
will specifically address five Instructional Components (Format, Subject
Matter, Faculty Participation, Duration and Frequency), taking into account
the characteristics of institutional programs or the unique circumstances
for short-term training programs, detailed in NOT-OD-10-019. The review of
this consideration will be guided by the principles set forth in
NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or
UNACCEPTABLE. Applications with unacceptable plans will not be funded until
the applicant provides an acceptable, revised plan.
Recruitment and Retention Plan to Enhance Diversity: Is there a plan to
promote diversity in the biomedical, behavioral, clinical and social sciences
workforce? Will this plan improve the quality of the educational and training
environment; to balance and broaden the perspective in setting research
priorities? Will it improve the ability to recruit subjects from diverse
backgrounds into clinical research protocols? Will the plan reach 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? The recruitment and retention plan to enhance
diversity will be evaluated after the overall score has been determined. The
review panels evaluation will be included in an administrative note in the
summary statement.
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.
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 UL1 and the KL2 and TL1 (as applicable) awards. Each component will
have a separate NoA. The UL1 award will reflect full F&A rate reimbursement
based upon the negotiated rate in effect at the time of award. The KL2 and TL1
awards will be subject to the 8 percent F&A rate reimbursement standard for
these mechanisms.
The budgetary recommendations of the peer review committee and programmatic considerations will be taken into account in developing a funding plan for successful applicants.
Research Education, Research Training and Research Career Development
Evaluation
In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of CTSA components. Accordingly, recipients of Research Education, Training and Career Development support through a CTSA are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Predoctoral Research Training Component-TL1
Leave: Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-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 TL1 component of the Cooperative Agreement award will be terminated.
Transfer of Program: The research training component may not be transferred to another institution. If there are plans to alter or terminate the approved program, the NIH must be notified immediately to take appropriate actions.
Mentored Career Development Component-KL2
Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.
Funds budgeted in a KL2 component of a CTSA that are freed as a result of a career award change may be rebudgeted to support a new Scholar who meets the eligibility criteria specified in the FOA and the selection criteria specified in the application. The Grants Management Specialist and the Program Officer of the award must be notified within thirty days of the change of supported scholars and an updated institution scholar roster form listing all scholars receiving NIH support must be provided.
The mentored career development component (K12/KL2) provides support for a minimum of two years and a maximum of five years of consecutive funding for each Clinical Research Scholar, consisting of consecutive 12-month appointments.
Special Leave: Under unusual and pressing circumstances, a scholar may submit a written request to the awarding component requesting a reduction in professional effort below 75 %. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the scholar. In addition, the scholar must submit assurance of his/her intention to return to at least 75% effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.
Termination: When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Grant Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.
Transfer of Program: The KL2 component may not be transferred to another institution, and scholars who wish to move to another institution must terminate their support under the KL2 program.
Changes in Research Education, training, and Career
Development: Program Consultation with NIH staff should occur if a significant
change in the approved career development program and/or research plan is being
considered.
2. Administrative and National Policy Requirements
All NIH grant
and Cooperative Agreement awards include the NIH Grants Policy Statement as
part of the NoA. For these terms of award, see the NIH Grants Policy Statement
Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 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. approaches of the
Principal investigators and key personnel as
appropriate are expected to participate in Steering and Key Function 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 Committee, including
those constituted to address key functions. A given individual may serve on
more than one CTSA 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. For purposes of voting, CTSA
recipients with multiple PIs will be expected to select a single PI to vote. A
Chair or Co-Chairs will be elected by the Steering Committee at an annual
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 (CCSC) 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 CCSC 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.
The national CTSA Consortium Executive Committee is elected annually from the CCSC membership and serves to enhance the efficiency of interactions between the CTSA PIs, the NIH/NCRR and other committees. The CCEC takes the lead on timely action of emergent CCSC issues and reports to the CCSC. Additional details of governance for the CTSA program are available at www.ctsaweb.org.
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, Clinical Innovation) 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.
The CCSC has established a series of Strategic Goals
and identified Committees to be responsible for achieving these goals.
Membership of these Strategic Goal Committees is drawn from the CCSC, the CTSA
Administrators Key Function committee and the NIH.
2.A.4. Dispute Resolution
Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. A Dispute Resolution Panel composed of three members will be convened.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special dispute resolution procedure does not alter the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
The NIH has an
independent CTSA Evaluation contract to perform an evaluation of the overall
program. The awardees are expected to provide information that is requested by
the NIH for the evaluation process. The submission of this material is expected
to be electronic but may require submission of some paper.
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.
TL1 Appointment Forms and Termination Notices: xTrain provides Training grant program directors, university administrators and Trainees the ability to electronically process the required paperwork associated with awarded TL1 research training grants.
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
Vertebrate Animals:
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 impact/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, Minorities, and Children:
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-09-116.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.
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 (TL1) 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, child health, 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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