and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Center for
Research Resources (NCRR), (http://www.ncrr.nih.gov)
Title: Clinical
and Translational Science Coordinating Center (U54)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Key Dates
Release
Date: July
16, 2010
Letters of Intent Receipt Date: December 15, 2010
Application
Receipt Date: January 12, 2011
Peer
Review Date: June 2011
Council Review Date: September 2011
Earliest Anticipated Start Date: December 2011
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: January 13, 2011
Due Dates
for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
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 Process
3.
Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The
purpose of this FOA is to solicit applications for a Clinical and Translational
Science Coordinating Center (CTSCC). The CTSCC will encourage and
facilitate sharing and interactions within the CTSA Consortium and of the
Consortium with non-CTSA institutions, organizations, and programs also focused
on advancing the efficiency and quality of clinical and translational research
and training. The CTSCC will also facilitate communication of CTSA
Consortium activities to others. The CTSCC will provide a web-based site
for collaboration, including wikis, forums, and public and private work spaces,
to facilitate the communal development and adoption of best practices for
conduct of clinical and translational research to enhance quality, efficiency,
and value. This Center will also support conference calls and face to face
meetings of the CTSA Consortium committees and working groups. In
addition, the CTSCC will provide and manage the public non-government website
of the Clinical and Translational Science Consortium to communicate the
activities, resources, and best practices of the CTSA Consortium and individual
CTSAs across the country to the public, industry, and basic, clinical and
translational science investigators and students. The CTSCC will not
provide resources for conduct of research or research projects. This center
will facilitate collaboration and communication within the CTSA Consortium and
with non-CTSA organizations, including industry, to advance clinical and
translational research and training generally and to advance development,
sharing, and adoption of best practices in clinical and translational research,
training, and outreach.
Background: The Clinical and Translational Science Award (CTSA) program provides grants to institutions to create an integrated academic home to train multi- and inter-disciplinary investigators, award advanced degrees in clinical and translational science, and provide investigators and research teams with research cores, tools, and a local environment that encourages and facilitates the conduct of clinical and translational research, including with community and industry partners. As cooperative agreement grants, each awardee is also required to participate in the CTSA Consortium, whose goal is to reduce the barriers and increase efficiency of multi-institutional clinical and translational research both within the Consortium and with other partners, to share knowledge and disseminate best practices for clinical and translational research widely, and to collaborate together and with others to enhance the national environment for clinical and translational research. The NCRR expects the CTSA Consortium to include 60 CTSA awards (excluding the Coordinating Center). The CTSA Consortium Steering Committee, the core governing and decision making body of the CTSA Consortium, is composed of the PI of each CTSA and trans-NIH representatives. In addition, there are over 20 major committees, each of which may include a number of working groups. Committees, focused on key functions of CTSAs such as Community Engagement, Regulatory Knowledge, Translational Research, Biomedical Informatics, allow individuals from CTSAs to share best practices, information, and work on shared projects. Other committees address specific areas of interest, including advancing pediatric clinical and translational research. Each Committee generally includes a representative from each of the CTSAs, while working groups are generally smaller. For further information on the CTSA Consortium, see www.ctsaweb.org.
Specific Objectives: The goal of the CTSCC is to provide staff and resources to support the national CTSA Consortium in its activities. Specific objectives include, but are not limited to:
Special Requirements:
It is anticipated that the CTSCC will establish an independent External Advisory Committee (EAC) that would annually review the activities, progress, and effectiveness of the CTSCC and provide recommendations to the Principal Investigator. It is expected that this EAC would include individuals who have experience in managing large coordinating centers, representatives from the various communities served by the CTSCC, and experts in facilitating national collaboration and communication. The application should include a description of the types of individuals but should not name any potential members and no members should be contacted prior to review of the application.
As noted in the Section VI.2.A Cooperative Agreement Terms and Conditions of Award, the PI of the CTSCC will participate in the CTSA Consortium Steering Committee as a voting member, and provide updates on current activities and discuss proposed modifications to CTSCC activities and support with the CCSC on at least a quarterly basis.
The application should address how the proposed management of each specific objective would facilitate the transition of those activities to a potential successor at the end of the five-year project period. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CTSCC. Inclusion of approaches and activities that would facilitate the transition of the activities and infrastructure of the CTSC, including content of the public website and collaboration site, at the end of the award period is required.
The applicant must include funds for the PI and key personnel to attend the annual two-day CTSA Consortium Steering Committee meeting in the Bethesda area.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the U54 award mechanism(s).
The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains 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". It is unknown at this time if this program will be reissued.
2. Funds Available
Future year amounts will depend on annual appropriations.
Because the nature
and scope of the proposed activities may vary from application to application,
it is anticipated that the size and duration of each award may also vary.
Although the financial plans of the NCRR provides 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.
NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in
response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH program support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number
of Applications. Applicants may submit one
application.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The current 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: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
Additional information is available in the PHS 398 grant
application instructions.
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
Letter
of Intent Receipt Date: December
15, 2010
Application Receipt Date: January 12, 2011
Peer Review Date: June 2011
Council Review Date: September 2011
Earliest Anticipated Start Date: December 2011
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NCRR staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Office of
Review
National Center for
Research Resources
6701
Democracy Boulevard
Building
Number, Room Number 1084
Bethesda,
MD 20892-4874
Bethesda,
MD 20817 (FedEX or courier)
FAX: (301) 480-3660
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the forms 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)
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
6701
Democracy Boulevard, Room 1001
MSC 4874
Bethesda,
MD 20892-4874 (Regular Mail)
Bethesda,
MD 20817 (FedEX or courier)
Telephone: (301) 435-0811
3.C. Application
Processing
Applications must be received on or before the
application receipt date described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Center. Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
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 award if such costs: 1)
are necessary to conduct the project, and 2) would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.
The incurrence
of pre-award costs in anticipation of a 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.)
6. Other Submission Requirements
Special Requirements that must be addressed in the application.
The applicant must include funds for the PI and key personnel to attend the annual two-day CTSA Consortium Steering Committee meeting in the Bethesda area.
The application should address how the proposed management of each specific objective would facilitate the transition of those activities to a potential successor at the end of the five-year project period. This should include ongoing documentation of required software, hardware, and licenses, as well as ongoing maintenance of standard operating procedures, best practices, and other documentation for management of the CTSCC. Inclusion of approaches and activities that would facilitate the transition of the activities and infrastructure of the CTSCC, including content of the public website and collaboration site, at the end of the award period is required.
It is anticipated that the CTSCC will establish an independent External Advisory Committee (EAC) that would annually review the activities, progress, and effectiveness of the CTSCC and provide recommendations to the Principal Investigator. It is expected that this EAC would include individuals who have experience in managing large coordinating centers, representatives from the various communities served by the CTSCC, and experts in facilitating national collaboration and communication. The application should include a description of the types of individuals but should not name any potential members and no members should be contacted prior to review of the application.
As noted in the Section VI.2.A Cooperative Agreement Terms and Conditions of Award, the PI of the CTSCC will be a voting member of the CTSA Consortium Steering Committee, and provide updates on current activities and discuss proposed modifications to CTSCC activities and support with the CCSC on at least a quarterly basis.
Cooperative agreements: Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Organization of the Application: The Research Strategy section should be organized to address the specific objectives of this funding opportunity: coordination and administrative support; enabling collaboration; and communication, including management of a public website. The Research Strategy section should total 30 pages or less and include separate sections for each of the above objectives.
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Appendix Materials
No Appendix Materials are allowed.
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, applicants are expected to include a brief 1-paragraph description of how final data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced in this project, however reviewers will be asked to comment on the dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:
1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
2. The terms of software availability should include the ability of researchers outside the Center to modify the source code and to share modifications with other colleagues as well as with the Center. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
The application is expected to include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including sub-contractors) to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the program. A separate letter should be included from each institution or organization, including each subcontractor.
The initial review group will comment on the appropriateness of the proposed plan for data sharing and the proposed plan for software sharing. These comments will be factored into the overall score of the application. Program staff and advisors will also consider the adequacy of the dissemination plans as one of the criteria for award. The proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of 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.
The following resource sharing policies do not apply to this FOA:
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCRR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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. Will the proposed Clinical and Translational Science Coordinating Center facilitate the coordination, sharing, collaboration, and communication among the CTSAs in the national CTSA Consortium? Will the proposed Clinical and Translational Science Coordinating Center facilitate the coordination, sharing, collaboration, and communication among the national CTSA Consortium and a broad range of non-CTSA institutions, organizations, and programs? How will the proposed Clinical and Translational Science Coordinating Center advance the field of clinical and translational science?
Investigator(s). Are the PI, collaborators, and other personnel well suited to the project? Have they demonstrated ongoing records of accomplishments in support of coordination, collaboration, and communication of large national-level consortia or networks? Do the personnel have complementary and integrated expertise? Are the proposed staffing approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to impact national interaction, collaboration, and communication paradigms by utilizing novel approaches, methodologies, or tools? Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an on-going basis while meeting the objectives of the solicitation?
Approach. Are the overall strategy, approach, and implementation well-reasoned and appropriate to accomplish the specific objectives of the project? Are potential problems, alternative strategies, and benchmarks for success presented? Will the proposed approach allow rapid deployment and management of a CTSA Consortium public non-government website? Will the proposed approach allow rapid deployment and use of collaborative tools by the consortium members, committees, and partners? Are the proposed activities to enhance coordination, collaboration, and communication flexible enough to meet evolving needs of the CTSA consortium and potential new partnerships with non-CTSA groups? Is the plan for administrative support for the CTSA committee synergistic with proposed coordination and collaboration activities? Is the proposed External Advisory Committee constituted to provide independent, thoughtful, creative, and practical recommendations to address challenges and improve performance? Will the proposed approach and documentation facilitate transition of the content and activities of the coordinating center to a successor at the end of the project period?
Environment. Does the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available and adequate to ensure a rapid start and continuing evolution of the proposed support center? Will the project benefit from unique features of the institutional environment, workforce, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of overall scientific and technical merit, but will not give separate scores for these items.
Data Sharing Plan. A data sharing plan is expected to be included in the application as outlined in the Other Submission Requirements section. The reviewers will comment on the appropriateness and adequacy of the proposed data sharing plan and factor their review into the determination of the overall score.
Plan for Sharing Software. A software dissemination plan, with appropriate timelines, is expected to be included in the application as outlined in the Other Submission Requirements section. Reviewers will comment on and factor into their overall score the appropriateness and adequacy of the proposed plan for software sharing. The review should be guided by the following principles thought likely to promote the largest impact:
1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
2. The terms of software availability should include the ability of researchers outside the Center to modify the source code and to share modifications with other colleagues as well as with the Center. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Not applicable to this FOA.
Resubmission Applications. Resubmissions are not allowed for this FOA.
Renewal Applications. Renewals are not allowed for this FOA.
Revision Applications. Revisions are not allowed for this FOA.
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/priority score.
Applications from Foreign Organizations. Foreign are not allowed for this FOA.
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).
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.
The following resource sharing policies do not apply to this FOA:
Selection Process
The following will be considered in making funding decisions:
NIH considers the following in evaluating Center grant applications:
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 PD/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.
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.
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.
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 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
The Principal Investigator will have the primary responsibility for the overall function of the Clinical and Translational Science Coordinating Center. This includes responsibility for the coordination and administrative support of the CTSA Consortium committees and working groups, enabling collaboration within the CTSA Consortium and with others to facilitate communal development and adoption of best practices, and communication and outreach of the CTSA Consortium, including management of a non-government website for the CTSA Consortium.
The Principal Investigator is expected to participate in all meetings of the CTSA Consortium Steering Committee as a voting member. In addition, the CTSCC PI will present at least quarterly reports to the CTSA Steering Committee of the current and planned activities of the CTSCC. In addition, the PI will serve as an ad hoc member of the CTSA Consortium Executive Committee and is expected to participate in all meetings.
All software developed in this project must be made available as outlined in the Special Requirements.
2. A.2. NIH
Responsibilities
An NIH Project Coordinator
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
The NIH Project Coordinator will serve as a voting member of the CTSA Steering Committee and participate in other committees as appropriate. The NIH Project Coordinator will facilitate interactions with other NCRR and NIH programs; provide relevant expertise and overall knowledge of NIH-sponsored programs and other projects to facilitate collaboration, and provide input and suggestions when challenges or opportunities arise. The NIH Project Coordinator will ensure the CTSCC can connect with a wide range of other projects and programs relevant to clinical and translational science. However, the dominant role and prime responsibility for the project resides with the awardee.
Additionally, an NCRR Program Officer will be
responsible for the normal scientific and programmatic stewardship of the award
and will be named in the award notice. This individual is responsible
for coordinating the assessment of the progress.
2.A.3. Collaborative
Responsibilities
The Principal Investigator and NIH Project Coordinator will serve as voting members of the CTSA Consortium Steering Committee (CCSC); however, neither may serve as a co-Chair of the CCSC. The Principal Investigator will also serve as an ad-hoc member of the CTSA Consortium Executive Committee (CCEC) to ensure open communication between the leadership of the CTSA Consortium and the CTSCC.
The national CTSA Consortium Steering Committee shall
be a forum for sharing policies, practices, and resources and for discussion of
opportunities, impediments, joint agreement on broad issues impeding clinical
research, government policies and practices, and other appropriate topics. The
Committee will identify and approve best practices and policies that will
advance clinical and translational research as a discipline and facilitate
collaboration and sharing among CTSA institutions and with partners in clinical
and translational research, e.g., industry, laboratories, hospitals. Awardee members of the Steering Committee, including
the CTSCC, will be required to accept and implement policies approved by the
Steering Committee.
2.A.4.
Dispute Resolution Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to Dispute Resolution. A Dispute
Resolution Panel composed of three members will be convened. It will have three
members: a designee of the Steering Committee chosen without NIH staff voting,
one NIH designee, and a third designee with expertise in the relevant area who
is chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
The awardee will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement. This
Non-Competing Continuation Grant Progress Report (PHS2590) may be required to
follow Special Instructions from NCRR for Center-like programs.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Renee Joskow, DDS, MPH
Division for Clinical Research Resources
National Center for Research Resources
6701 Democracy Boulevard, Room 923
Bethesda, MD 20892-4874
Telephone: (301) 435-0961
Email: [email protected]
Elaine
Collier, MD
Office of
the Director
National Center for Research Resources
Democracy One, Room 998
6701 Democracy Boulevard Avenue
Bethesda, MD 20892
Telephone: (301) 435-0794
Email: [email protected]
2. Peer Review Contacts:
Dr. Mohan Viswanathan
Office of
Review
National Center for Research Resources
6701
Democracy Blvd
Democracy
1, Room Number 1084
Bethesda, MD 20892
Telephone:
(301) 435-0829
Email: [email protected]
3. Financial or Grants Management Contacts:
Vicki Maurer
Office of Grants Management
National Center for Research
Resources
6701 Democracy Boulevard, Room 1042
Bethesda, MD 20892-4874
Telephone: (301) 435-0837
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human 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. All applications, regardless of
the amount requested, proposing 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. Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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