and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) |
|
Funding Opportunity Title |
Opportunities for Collaborative Research at the NIH Clinical Center (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-029 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.865; 93.233; 93.839; 93.838; 93.837; 93.286; 93.856; 93.855; 93.273; 93.173; 93.399; 93.396; 93.395; 93.394; 93.393; 93.172; 93.279; 93.879 |
Funding Opportunity Purpose |
The goal of this funding opportunity announcement (FOA) is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators. While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. Teams will have at least one intramural and one extramural investigator. This program will provide access for external researchers to the NIH Clinical Center (CC), and will thus leverage the diverse CC resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention. The special environment of the CC supports studies that may not be readily supported elsewhere. This FOA encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers. |
Posted Date |
November 28, 2012 |
Open Date (Earliest Submission Date) |
February 20, 2013 |
Letter of Intent Due Date(s) |
30 days before application due date |
Application Due Date(s) |
March 20, 2013, March 20, 2014, March 20, 2015 , by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
March 20, 2013, March 20, 2014, March 20, 2015, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
June/July 2013, June/July 2014, June/July 2015 |
Advisory Council Review |
October 2013, October 2014, October 2015 |
Earliest Start Date |
November/December 2013, November/December 2014, November/December 2015 |
Expiration Date |
(Now Expired September 22, 2013 per issuance of PAR-13-358), Originally March 21, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The goal of this funding opportunity announcement (FOA) is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics oustide of the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators. Details about the unique resources available at the NIH Clinical Center may be found at: http://www.cc.nih.gov/translational-research-resources/resources.html.
While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams will have at least one intramural and one extramural investigator.
This grant program will provide access for external researchers to the NIH Clinical Center (CC) and will leverage the diverse CC resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. Examples include:
For entry to the program, projects must have a collaborating Investigatorin the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project.
Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center and intramural investigators included in the Budget Component of the application. Funded projects will include an award to the applicant organization which will exclude funds to support the participation of the Clinical Center. Support for intramural participation will be provided by a budget allocation within the NIH. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what CC unique resources were utilized and any new intramural-extramural partnerships that developed.
Awards for high quality science demonstrating the potential to result in understanding an important disease process or lead to a new therapeutic intervention will be available in topics relevant to the research interests and priorities of the participating NIH Institutes/Centers, to include:
NEI
The National Eye Institute’s mission is to conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual function, preservation of sight, and the special health problems and requirements of the blind. www.nei.nih.gov. Specific areas of interest include:
1. Eye movement recording facility including stimuli presentation, video and eye coil recording equipment, and software to analyze the recordings is available for collaborative research in eye movement research.
2. Collaborative genetic research through eyeGENE: http://www.nei.nih.gov/resources/eyegene/professionals.asp
3. Collaborative research using cohorts of children and adults with inherited eye diseases and ocular malformations including but not limited to: uveal coloboma, Stargardt disease/ABCA4 retinopathy, for spinocerebellar ataxia, type 7 (SCA7), albinism, and modeling disease pathogenesis using induced pluripotent (iPS) cells derived from patients:
http://www.clinicaltrials.gov/ct2/show/NCT01432847?term=brian+p+brooks&rank=2
4. Collaboration in ongoing studies with a focus on retinal vascular diseases and uveitis.
Examples can be found at: http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html
5. Collaborative research using cohorts of children with ocular inflammatory disease, including JIA as well as monogenic disorders
6. Collaboration in evaluating African Americans with ocular inflammatory disease with a particular emphasis on Sarcoidosis. In addition, studying the role of the immune system in African American patients with AMD
7. Collaboration with those interested in investigating autoimmune retinopathy, the underlying pathophysiology and treatment.
8. Evaluating patients with ocular toxoplasmosis
NCI
The National Cancer Institute (NCI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for research, training, health information dissemination, and other programs with respect to the cause, prevention, diagnosis, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. The NCI encourages bedside-to-bench research (www.cc.nih.gov/ccc/btb/) to: increase understanding of the molecular and physiological basis of health and disease; stimulate clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enable the translation of basic discoveries into clinical practice for the benefit of personal and public health; foster training and mentoring of emerging scientists and physicians; and communicate research advances to the public. The NCI Vision and Priorities are found at cancer.gov.
NHGRI
The National Human Genome Research Institute research areas of interest include: biochemical genetics, vesicular trafficking defects, pigment defects, storage diseases, holoprosencephaly, and autoinflammatory diseases. More detail may be found in the NHGRI website, at: www.genome.gov
NHLBI
The National Heart, Lung, and Blood Institute (NHLBI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for a research, training, and education program to prevent and treat heart, lung, blood, and sleep disorders and diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI encourages basic research to increase understanding of the molecular and physiological basis of health and disease; stimulates clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enables the translation of basic discoveries into clinical practice for the benefit of personal and public health; fosters training and mentoring of emerging scientists and physicians; and communicates research advances to the public. Specific research interests of the Institute are identified in the NHLBI Strategic Plan (http://www.nhlbi.nih.gov/about/strategicplan/index.htm).
NIAAA
NIAAA invites translational, collaborative research projects aimed at reducing alcohol related problems in a wide range of scientific areas including genetics; neuroscience; epidemiology; health risks and benefits from alcohol consumption on prevention and treatment. Of particular interest are studies which increase the understanding of normal and abnormal biological functions and behavior relating to alcohol use as well as improving the diagnosis, prevention and pharmacological treatment of alcohol use disorders across the lifespan.
NIAID
The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. To accomplish its mission, NIAID conducts and supports a comprehensive portfolio of research on the biology, pathogenesis, and host response to microbes; the mechanisms of normal immune function and immune dysfunction resulting in autoimmunity, immunodeficiency, allergy, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat the many infectious, immune-mediated, and allergic diseases that afflict people throughout the world. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.)
NIAMS
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Areas of particular interest to the NIAMS intramural clinical program which would enhance the use of Clinical Center resources include studies on the genetics, genomics, prevention, and treatment of immune deficiencies associated with inflammation, systemic lupus erythematosus, inflammatory muscle disease, genetic autoinflammatory diseases, osteoporosis, ankylosing spondylitis and spondyloarthropathies, and the development and use of stem cells in therapy.
NIBIB
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health through the development and acceleration of applications of biomedical technologies. The Institute is committed to integrating engineering and physical sciences with the life sciences to advance basic research and medical care. The NIBIB Intramural Research Program plays a key role in fulfilling the Institute’s mission, particularly to advance knowledge in imaging and bioengineering research using a combination of basic, translational, and clinical science and to develop effective training programs in related fields. Advanced imaging resources at the NIH Clinical Center available for investigators include high field MR imaging, MRI/PET, advanced cardiovascular CT/ MRI/ PET capability, and interventional oncology capabilities. Multiple cyclotrons are on-site, and advanced radiotracer synthesis is available for application in oncology, neurological, cardiovascular, and infectious disease research. Image processing services are available for 3D analysis and processing, as well as transfer/ storage of large scale image data. More information about research conducted by NIBIB intramural investigators can be found at http://www.nibib.nih.gov/Research/Intramural
NICHD
The Eunice Kennedy Shriver National Institute of Child Health and Human Development invites research project grant applications in research areas relevant to the institute’s scientific objectives. The general mission of NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives. In pursuit of these goals, NICHD supports a broad spectrum of research on normal and abnormal human development, including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, and childhood development through adolescence. The mission areas also include research on intellectual and developmental disabilities and rehabilitation medicine. More detailed information can be found at: http://www.nichd.nih.gov/research/org/supported_by.cfm
NIDCD
NIDCD seeks to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The faculty and research interests of the NIDCD intramural research program can be found at http://www.nidcd.nih.gov/research/faculty/pages/alpha.aspx. The intramural program uses a variety of tools of molecular and cellular biology, genetics, development, physiology, neuroimaging and systems biology to understand normal and disordered processes. The research areas of focus for intramural/extramural collaborations under this FOA include hearing, balance, taste, voice, speech and language.
NIDA
The National Institute on Drug Abuse is interested in collaborative translational projects addressing programmatic priorities of the Institute. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. To achieve this mission, NIDA encourages researchers to build strategic alliances, including those with the NIH Clinical Center that will increase the pace at which translational research findings can become clinical applications that improve community and population health. The research areas of focus for this FOA include neuroscience, human genetics, imaging, medication development, the comorbidity of HIV and substance use, and the intersection of pain, analgesia and addiction.
NLM
For this initiative, the National Library of Medicine is interested in projects relating to enhancement or use of electronic health records.
ORWH
Office of Research on Women’s Health (ORWH) is responsible for fostering and facilitating research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) through the Trans-NIH ME/CFS Working Group (WG). One of the goals of the WG is to increase focus on collaborative ME/CFS research by identifying NIH resources that may be useful to advance the translational research within this field. ORWH encourages applications from investigators to address research questions focused on the etiology, diagnosis, underlying mechanism, or treatment of ME/CFS.
For more complete listing of resources in these areas at the NIH Clinical Center and for assistance in identifying intramural scientists for possible collaboration, please refer to the web-based listing of resources at, http://clinicalcenter.nih.gov/translational-research-resources/index.html
IMPORTANT: Applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science for which they are planning to develop an application. Early contact provides an opportunity for Institute or Center staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets need to reflect the actual needs of the proposed project. The maximum amount available per application is $500K direct costs (exclusive of any contract/consortium F&A) per year for a period of up to 3 years; this amount includes Clinical Center costs and intramural investigator's costs attributed to the proposed research project. The NIH Clinical Center costs and intramural investigator's costs will not be included in the award paid to the grantee. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 3 years. |
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This program requires the full collaboration of the (extramural) PD/PI of the applicant institution and the intramural investigator. Accordingly, the Multiple PD/PI model is strongly encouraged but not required. For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the PD/PI role.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Other Attachments
Collaboration Plan. Applications must include a proposed Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award. The following areas should be addressed:
The Collaboration Plan should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments." The filename "Collaboration Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. The Collaboration Plan is NOT included in the page limit of the Research Strategy.
Clinical Protocol Synopsis. The clinical protocol synopsis should be included as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments". If the research includes a clinical protocol, applications that lack the Clinical Protocol Synopsis will not be peer reviewed. The clinical protocol synopsis must include the following information:
Statistical Analysis Plan. A statistical analysis plan should also be provided in the application as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments." This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study. The ability to make conclusions of primary outcomes other than safety will be particularly important in small studies.
Data and Safety Monitoring (DSM) Plan. If the research includes a clinical protocol, a Data and Safety Monitoring (DSM) Plan should be inlcuded as an attachment to the SF424 (R&R) Research and Related Other Project Information component under "Other Attachments." The DSM plan should be commensurate with the risk level of the proposed clinical research must be included for all clinical trials (see http://grants.nih.gov/grants/guide/notice-files/not98-084.html). All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used).
The DSM Plan must address the following areas:
Milestone Plan and Complete Clinical Protocol for Projects Involving Clinical Trials
If the research includes a clinical protocol, a Milestone Plan and Complete Clinical Protocol must be included as a single .pdf attachment in the Other Attachments field of the SF424 (R&R) Other Project Information component and will not count toward the page limit for the Research Strategy. Applications that lack the Milestone Plan and/or the Complete Clinical Protocol will not be reviewed.
Applicants are required to provide detailed project performance and timeline objectives in a section entitled Milestone Plan . This section must include:
If a protocol is part of the grant, the complete Clinical Protocol must be included immediately after the Milestone Plan. Investigators are referred to the Trans-NIAID Clinical Research Toolkit website for clinical protocol guidance and templates (http://www3.niaid.nih.gov/LabsAndResources/resources/toolkit/protocol). Investigators are urged to be succinct.
Because of the anticipated complexity of the budget information and the need to clearly delineate costs for the extramural awardee, the intramural investigator, and the NIH Clinical Center, applicants will need to submit a detailed budget in the "R&R Budget Component" following all instructions in the SF 424 (R&R) Application Guide. Submission of a Modular Budget is NOT allowed for this FOA.
The budget request for this FOA must distinguish between extramural costs, the NIH intramural investigator costs, and NIH Clinical Center costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project. NIH Clinical Center costs are additional costs to the Clinical Center that directly result from the proposed research project. The total of all three types of cost shall not exceed $500,000 (direct costs) per year.
EXTRAMURAL GRANTEE COSTS. Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s). Extramural costs would also include travel costs for any patients not already at the NIH Clinical Center.
INTRAMURAL INVESTIGATOR COSTS. Intramural investigator costs may include salary for contract staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and other items typically listed under Other Expenses. Budget requests from the NIH intramural program may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs). Although the budget request may not include salary support for such individuals, it should indicate person months for any key personnel. Resources required need to be determined before the research protocol can be approved by the respective NIH Institute/Center. Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate.
NIH CLINICAL CENTER COSTS. Clinical Center costs include inpatient services, outpatient and day hospital services, pharmaceuticals, specialized research services, and other additional costs incurred by the Clinical Center as a result of the proposed research project. Resources required need to be determined before the research protocol can be approved by the Clinical Center. The collaborating intramural PD/PI is responsible for coordination with the Clinical Center, Office of the Chief Financial Officer to assure that all NIH Clinical Center related costs are clearly identified and documented. NIH Clinical Center related costs should be identified in the Extramural Collaborations budget template provided by the Clinical Center Office of the Chief Financial Officer. Once the Clinical Center costs are known, the (extramural) applicant will enter this amount as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor, and attach appropriate justification and documentation, including any spreadsheets as appropriate. Applicants should allow sufficient time to identify and calculate these costs. More detailed information about Clinical Center costs may be found at: http://www.cc.nih.gov/translational-research-resources/funding.html.
F&A (INDIRECT) COSTS. Applicant organizations are reminded that Facilities and Administrative (F&A) or indirect costs are allowable for only the allowable extramural costs of the project. F&A will not be paid for any NIH Clinical Center services or intramural investigator costs.
Budget Justification
Detailed information about intramural investigator costs and NIH Clinical Center costs should be included in the narrative "Budget Justification" section.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Consortium Contractual Arrangements
The Clinical Center cost spreadsheets may be appended in the Research Plan Attachments (section 13 "Consortium/Contractual Arrangements").
Letters of Support
Applications submitted in response to this FOA must include a letter from the Director of the NIH Clinical Center and a letter from the respective NIH Institute/Center to confirm that the Clinical Center facilities will be able to accommodate the proposed research and that the intramural scientist from the respective NIH Institute/Center will be able to collaborate on the project. Both letters must be included in the "Letters of Support" attachment for the PHS 398 Research Plan. APPLICATIONS SUBMITTED WITHOUT BOTH LETTERS WILL BE CONSIDERED INCOMPLETE AND WILL NOT BE REVIEWED.
Applicants may send requests for Collaboration Letters to:
Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
Please note: The Letter of Intent may serve as the request for Clinical Center and NIH Institute/Center Collaboration Letters.
In addition, letter(s) from the collaborating intramural investigator(s) along with any other collaborators/consultants should also be included in the "Letters of Support" section.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following additional modification:
If the research plan includes a clinical protocol, the following additional documents should be included in the Appendix material:
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
If an award is made, the grantee will receive only the extramural costs and associated F&A. The NIH Clinical Center and the intramural investigator’s costs associated with the research project will not be paid to the grantee, but instead will be supported directly by the awarding NIH Institute/Center. The Clinical Center and intramural investigator costs will not appear in the Notice of Award.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, please note the additional considerations listed under "Approach", below.
Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. 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 of the project 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)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
In addition:
Is it clear which unique research opportunities in
the NIH Clinical Center will be utilized?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group(s), convened by the Center for Scientific Review or an appropriate IC Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
Additional information that may be required as part of just-in-time procedures includes:
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
If an award is made, the grantee will receive only the
extramural costs and associated F&A. The NIH Clinical Center and the
intramural investigator's costs associated with the research project will not
be part of the extramural NoA or paid to the grantee, but instead will be
supported directly by the awarding NIH Institute/Center.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
Extramural Awardee Responsibilities
NIH Intramural Investigator Responsibilities
NIH Extramural Staff
Areas of Joint Responsibility
Since the purpose of this FOA is to establish and/or further develop collaborative arrangements between extramural and intramural investigators, many responsibilities are shared between awardees and NIH staff and will require close coordination. Responsibilities will be divided between awardees and NIH staff, as described above.
Annual progress reports will prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what CC unique resources were utilized and the new intramural-extramural partnerships that developed. This will be evaluated by the program official/IC program director.
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Membership will include: a designee of the institution 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. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
T&C Inclusions and Modifications
The Terms and Conditions of Award will include references to the currently approved versions of the Collaboration Plan and the Multi-PD(s)/PI(s) Leadership Plan, if applicable, and the Sharing Plans for Resources and Data. Before the initial award is made, NIH and the awardees may negotiate changes or additions to the versions of these plans in the application. Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s). Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.
Program Evaluation
In addition to ongoing monitoring by program staff, the NIH plans to conduct a prospective and comprehensive evaluation of the Opportunities for Collaborative Research at the NIH Clinical Center (U01) program, including (but not necessarily limited to) the processes supporting the collaboration and the various types of projects and their outcomes relative to meeting the strategic goals of this announcement. Accordingly, potential areas of interest to this evaluation may include understanding how and which research review, funding, or administrative processes and procedures influenced the outcomes of the collaborations; and identifying the scope and impact of the research projects that were implemented their publications; the range and types of resources utilized, including patient; and the formation of new research partnerships. To support this effort, the NIH will request that grantees participate in various aspects of the evaluation. In addition, awardees are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the program’s overall impact.
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what CC unique resources were utilized and any new intramural-extramural partnerships that developed.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Consultation with NIH staff prior to submitting an application is strongly encouraged for this collaborative program.
NIH CLINICAL CENTER
Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
NICHD
Catherine Y. Spong, MD
Associate Director for Extramural Research
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-435-6894
Email: spongc@mail.nih.gov
Eugene G. Hayunga, PhD
Director, Office of Extramural Policy
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-435-6856
Email: ehayunga@mail.nih.gov
NCI
Lee Helman, MD
National Cancer Institute (NCI)
Center for Cancer Research
Telephone: 301-496-4257
Email: helmanl@mail.nih.gov
Minkyung (Min) H. Song, PhD
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)
Telephone: 301-435-4321
E-mail: songm@mail.nih.gov
NEI
Donald F. Everett, MA
Director, Collaborative Clinical Research Program
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: dfe@nei.nih.gov.
NHLBI
Michelle Olive, PhD
Program Director
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: olivem@mail.nih.gov
NHGRI
Dan Kastner, MD, PhD
Division of Intramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2023
Email: kastnerd@mail.nih.gov
Bettie J. Graham, PhD
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: bettie_graham@nih.gov
NIAAA
Raye Z. Litten, PhD
Associate Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0636
BlackBerry: 240-393-7018
Fax: 301-480-5790
NIAID
H. Clifford Lane, MD
Deputy Director for Clinical Research
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-496-7196
Email: clane@niaid.nih.gov
NIAMS
Susana Serrate-Sztein, MD
Director, Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS)
Telephone: 301-594-5032
Email: szteins@mail.nih.gov
Richard Siegel, MD, PhD
Chief, Immunoregulation Section
Clinical Director, NIAMS
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS)
Telephone: 301 496-3761
Fax 301-451-5394
Email: rsiegel@nih.gov
NIBIB
Steven Krosnick, MD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Extramural Science Programs
Telephone: 301-594-3009
Email: krosnics@mail.nih.gov
NIDCD
Judith A Cooper, PhD
Director, Division of Scientific Programs
National Institute on Deafness and Other Communication
Disorders
Telephone: 301-496-5061
Email: cooperj@nidcd.nih.gov
NIDA
Petra Jacobs, MD
National Institute on Drug Abuse
Center for Clinical Trials Network
Telephone: 301-451-6338
Email: pjacobs@mail.nih.gov
NLM
Dr. Hua-Chuan Sim
NLM Extramural Programs
Telephone: 301-594-4882
Fax: 301-402-2952
Email: simh@mail.nih.gov
ORWH
Susan E. Maier, PhD
Associate Director for Special Projects
Office of Research on Women’s Health (ORWH)
Telephone: 301-435-1573
Fax: 301-402-1798
Email: Susan.Maier@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
NICHD
Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301/435-6975
Email: clarkb1@mail.nih.gov
NHLBI
Ms. Suzanne White
National Heart, Lung, and Blood Institute
Division of Extramural Research Activities (DERA)
Office of Grants Management
Telephone: 301-435-0166
Email: whitesa@mail.nih.gov
NHGRI
Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
Telephone: 301-435-7858
Email: cc149o@nih.gov
NIAAA
Judy Fox
Chief, Grant Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
NEI
Mr. William Darby
Grants Management Officer
National Eye Institute
Telephone: 301-451-2020
Email: darbyw@nei.nih.gov
NIAID
Ms. Tina M. Carlisle
Lead, Grants Management Specialist
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-402-6579
Fax: 301-493-0597
Email: tc48k@nih.gov
NIAMS
Mark Langer
National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS)
Telephone: 301-451-8216
Email: langerM@mail.nih.gov
NIBIB
Angela M. Eldridge
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
Telephone: 301- 451-4793
Email: Angela.Eldridge@nih.gov
NIDCD
Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities, NIDCD
Telephone: 301-435-0713
Fax: 301-402-1758
Email: myersc@nidcd.nih.gov
NLM
Mr. Dwight Mowery
NLM Extramural Programs
Telephone: (301) 496-4221
Fax: (301) 402-0421
Email: moweryd@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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