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 Research Curriculum Award (K30)
Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-HL-04-004
Request For Applications (RFA) Number: RFA-RR-09-006
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release/Posted Date: March 9, 2009
Opening Date: June 1, 2009 (Earliest date an application may be submitted to
Grants.gov)
Letters of
Intent Receipt Date(s): June 1, 2009
Application Due Date(s): June 30, 2009
AIDS Application
Due Date(s): Not Applicable
Peer Review
Date(s): September October 2009
Council Review Date(s): January
2010
Earliest Anticipated Start Date(s): March
1, 2010
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: July 1, 2009
Due Dates
for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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 and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
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
Background
and Description
The National Institutes of Health (NIH) is engaged in a series of activities that accelerate both the pace of discovery in the life sciences and the translation of those discoveries into potential therapies. Scientific advances are increasingly being made at the interfaces of traditional disciplines, and approaches to science are becoming more integrative. This requires a cooperative effort, typically involving investigators from diverse research backgrounds working collectively across traditional disciplinary boundaries to answer scientific questions and achieve specific endpoints. This effort requires a workforce capable of crossing disciplinary boundaries and leading and participating in integrative and team approaches to research on complex biomedical problems.
The CRCA is intended to support the development of new didactic programs in clinical research at institutions that do not currently offer such training and, in institutions with existing didactic programs in clinical research, to support and improve the quality of instruction. Graduates of CRCA programs should be better qualified to participate in interdisciplinary research efforts and should compete more effectively for research funding. Earning a higher degree (e.g., MS or PhD) is a desirable, but not mandatory, component of CRCA training. If a new degree program is planned by the institution, justification should be provided for its value to scholars appointed to this K30 program, curriculum components that distinguish it from existing degree programs, duration of study to acquire a degree, the presence of a faculty core at the institution to teach and/or mentor the appointed scholars in new topic areas, and the expected time for either governmental or educational certification agencies to approve the course curriculum.
NIH defines human clinical research as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. For additional information see the recommendations of the NIH Director's Panel on Clinical Research (see: http://www.oenb.at/de/img/executive_summary--nih_directors_panel_on_clinical_research_report_12_97_tcm14-48582.pdf), and those from the Institute of Medicine Committee on Addressing Career Paths for Clinical Research.
Inclusion of interdisciplinary approaches is strongly encouraged and the curriculum options offered should educate scholars in the translation of basic science advances into clinical hypothesis testing, and the dissemination of clinical trial outcomes to health-related fields that serve the general community.
Scholars participating in this K30 program should have a career plan that includes innovative clinical research as a major focus. Institutions or consortia applying for an award must be able to demonstrate a historical record of attracting and producing such individuals. If not already ongoing, new programs should have the faculty and specific plans for recruiting participants to enter the didactic program.
The curriculum must span a variety of fields of clinical research and be inclusive of a broad range of clinical scientists who are interested in the mechanisms of human disease, the genetics of complex disorders, and therapeutic interventions. The core curriculum should include, but is not limited to, broadly applicable clinical research-related topics such as biostatistics, bioethics, clinical trials design, observational study design, Federal policies and regulations that address research with human subjects (e.g., 45CFR46, FDA, INDs, the inclusion of women and minorities as well as children in clinical research projects), community health research, preparation of competitive grant applications and scientific writing. The program may include bioinformatics, human genetics, pharmacokinetics, medical applications of new technologies, specialized courses in epidemiology, the study of health disparities and other relevant fields. The scope of the curriculum should match the educational background of the appointed scholars and be sufficiently flexible to address the needs of predoctoral, doctoral, and postdoctoral individuals.
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 K30 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).
2. Funds Available
The total funding that NCRR expects to award through this
announcement is $4.8 million for sixteen awards. Direct costs will be
approximately $275,000 per award.
Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
The following organizations/institutions are eligible to apply:
Applicant institutions that are primary or partnering institutions in a CTSA award are not eligible to apply.
Environment: The institution must have the requisite expertise in the individual disciplines that are being integrated through the interdisciplinary course(s) or curricula that are being developed. The institution must demonstrate a commitment to the further development and implementation of these courses and curricula following the award.
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 programs.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
INDIVIDUALS ELIGIBLE TO BECOME PROJECT DIRECTORS/PRINCIPAL INVESTIGATORS
The PD/PI should be an active participant in the research and/or academic programs of the institution and willing to spend at least 20% of his/her full-time professional effort on course(s) and curriculum development for the period of the award. PDs/PIs should have the stature to be able to recruit other individuals at the institution to develop a comprehensive curriculum that recognizes recent advances in both basic and translational clinical research. These individuals are invited to work with their institution/ 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.
INDIVIDUALS ELIGIBLE TO BECOME PROGRAM FACULTY
Faculty involved in the CRCA should have a record of developing and teaching the type of curriculum required under this award. Generally, faculty will also be accomplished investigators. The faculty records of teaching and mentoring, as well as the percent of faculty effort planned for the courses should be described. Inclusion of program faculty members from under-represented minority groups or with disabilities is encouraged.
INDIVIDUALS ELIGIBLE TO BECOME PROGRAM SCHOLARS
All CRCA appointed scholars must be U.S. citizens, non-citizen nationals or lawfully admitted permanent residents of the U.S. Participants may include those with the following degrees: M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D. (Doctor of Naturopathy), doctorally prepared nurses, Ph.D. with clinical responsibilities, and others who could benefit from a core curriculum for clinical research. Because clinical research is multidisciplinary, scholars in this program should represent diverse academic backgrounds.
Scholars may include those individuals with NIH support (F32, T32, Ks, etc.) as well as those who have non-NIH support for training and career development.
In all respects, the NIH remains strongly committed to increasing the participation of individuals from underrepresented minority groups and individuals with disabilities in biomedical and behavioral research. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaska Natives, and Pacific Islanders. Applicants must describe their program plans and efforts to recruit such individuals, as well as their success in the recruitment, retention, and graduation of these individuals. All applications must contain plans to demonstrate commitment and proactive recruitment efforts.
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 more than one application, provided they are
scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications may be permitted in response to this FOA
Section IV. Application and Submission Information
1. Address
to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of
this funding opportunity must be typed in item (box) 2 only of the face page of
the application form and the YES box must be checked.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3.
Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A).
3.A. Receipt, Review and Anticipated Start Dates
Opening Date: June
1, 2009 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt
Date(s): June 1, 2009
Application Due Date(s): June 30, 2009
Peer Review
Date(s): September - October, 2009
Council Review
Date(s): January, 2010
Earliest
Anticipated Start Date(s): March 1, 2010
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The
letter of intent should be sent to:
David
Wilde, M.D., Ph.D.
Division of
Clinical Research Resources
National
Center for Research Resources
6701
Democracy Blvd.
Democracy
One, Room 912
Bethesda,
MD 20892-4874
Telephone:
(301) 435-0790
Fax: (301)
480-3661
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 and all
copies of the appendix material must be sent to:
Mohan Viswanathan, Ph.D.
Deputy Director, Office of Review
National Center for Research Resources
National Institutes of Health, DHHS
1 Democracy Plaza, 6701 Democracy Blvd.
Room 1084, MSC 4874
Bethesda, MD 20892-4874 (Fedex or Other
Courier Service Zip: 20817)
Phone: (301) 435-0829
Fax: (301) 480-3660
E-mail: [email protected]
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 Institute Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. 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 or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
Allowable costs:
Salary: Allowable costs may include personnel (support for the PD/PI, faculty, and administrative support), supplies, travel, honoraria and per diem for outside speakers, seminars, development of course materials, consultants, and other costs, such as printing, telephone, audio-visual, postage, recruitment materials, and computer software. The compensation for the PD/PI must not exceed the actual institutional salary rates for the effort being devoted to the CRCA. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. In addition, salary rates are subject to the DHHS salary cap. The PD/PI must devote at least 20% effort and no greater than 50% effort to this award, and may also be a principal investigator on other research awards. Funds may not be requested to directly support the individual scholars appointed to this K30 program. Their activities are expected to be supported by other Federal or non-Federal sources. However, in some circumstances, and for scholars supported by non-governmental funds, tuition is an allowable expense if approved by NCRR program and grants management staff. Annual meetings of PD/PIs and other staff members to exchange information about effective approaches in the training of new clinical investigators, including the sharing of course materials, have been initiated in the Washington DC area and are expected to be continued. Funds to support travel of the PD/PI and another staff person to these meetings should be included. This award will provide salary and fringe benefits for at least 20% of PD/PI effort, subject to the DHHS salary cap. The total salary requested must be based on the PD s/PI s full-time, 12-month staff appointment.
The institution may supplement this award contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may DHHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Curriculum Development Award.
Research Support: A maximum of $50,000 per year may be requested for ancillary needs, such as collaborators, consultants, equipment, computer time, etc. All requests for ancillary support must be justified. In no case will the allowance provided exceed $50,000. Salaries for mentors are not allowed.
Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less.
6. Other Submission Requirements and Information
The application should address the following issues:
Program Director/Principal Investigator (PD/PI):
Describe the PD/PI s qualifications to develop and implement an interdisciplinary course(s) or curriculum, which meet the scientific and educational requirements of the interdisciplinary fields and the institution.
Course or Curriculum Development Plan:
Describe the plan and how it fits into institutional curricula, both existing and future. Explain how the CRCA curriculum is distinguished from other curricula within the existing educational infrastructure and framework of the applicant/participating institution(s). Describe the immediate and long-term objectives of the award and how implementation of the CRCA curriculum will expand or enhance the academic or research capacity of the institution in interdisciplinary research.
Environment and Institutional Commitment:
The institution must provide evidence of commitment to, and support for, the proposed program. There must be evidence of support for the PD/PI and his/her course and/or curricula development and implementation plans and for the further enhancement of the interdisciplinary scientific area. Plans should be presented for continuation of the CRCA curriculum upon termination of the three-year budget period of the award.
Collaborator's Statement:
Principal Investigators must include information about any collaborator(s) including her/his research and training qualifications. A collaborator may assist in the development of the didactic curriculum or may act as a guest speaker, for instance, on a topic in which he/she is expertly qualified. The application also must include information describing the nature and extent of collaboration that will occur during the proposed award period.
Advisory Committee:
The application should describe plans for a research education program Advisory Committee that will provide guidance on the establishment and implementation of an interdisciplinary curriculum and seek innovative means to integrate various disciplines within the didactic framework. To avoid compromise of the pool of reviewers for CRCA applications, proposed members of the Advisory Committee should not be named in the application or contacted in advance by the PI regarding their possible role as Advisory Committee members, as this will lead to a conflict of interest and may disqualify those members as reviewers of CRCA applications. It is sufficient to describe the charter, general composition, expertise, duties and meeting schedule of the Advisory Committee in the application. Advisory Committee members may be drawn both from institutions that are named as participating institutions in the CRCA program and from institutions that are nonparticipants in the CRCA application.
Education Component Evaluation and Tracking Plan:
The application should describe a strong evaluation and tracking plan that should include both formative and summative evaluation to review the effectiveness of all aspects of the program (e.g., curriculum development, training faculty, recruitment and retention rates of scholars, diversity of scholars/faculty, concurrent activities and accomplishments in clinical research by CRCA appointed scholars). Evaluation of CRCA outcome measures may be performed by an internal or external Advisory Committee that reports back to the PD/PI. Committee members should be independent of CRCA grant support and vetted for possible conflicts of interest with the institution or PD/PI. The PD/PI is encouraged to develop plans to obtain feedback from current and former scholars to help identify weaknesses in the training program and to provide suggestions for program improvements. Potential Advisory Committee members should not be named in the CRCA application, as this will create a conflict of interest for potential review of applications received in response to this FOA.
The NIH may, in the future, request information about appointed scholars for program evaluation purposes. In addition, institution(s) with other clinical or translational training and career programs must provide strong evidence that this CRCA Program will improve existing clinical and translational research career development and mentoring programs (including but not limited to individuals supported via NIH T32, K12, K23, K24 and K30 grants).
Budget:
Budget requests must be provided according to the instructions in form PHS 398. The request for ancillary support, i.e., essential books, travel, consultants, equipment, computer time, etc., must be justified and specified by category.
6. Other Submission Requirements and Information
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NCRR 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 following will be considered in making funding decisions:
The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Ability to Enhance Clinical Research Capacity: Will the immediate and long-term objectives of the award expand or enhance the academic or research capacity of the institution in the interdisciplinary research area? Is the proposed plan likely to increase the number of clinical researchers and develop their individual competitiveness to obtain support for clinical, interdisciplinary research? Does the proposed program have the potential to increase networking among clinical researchers?
For competing continuation applications only:
Course/Curricula Development Plan: Is the proposed curriculum adequate to develop a sound knowledge base in clinical research methodologies and analysis? Is the curriculum capable of addressing the needs of appointed scholars who may have different levels of training and different roles in an interdisciplinary team of investigators? Is the justification for the proposed curriculum adequate relative to other on-going education and/or training activities at the institution(s)? Is there evidence for the capacity to develop and implement course(s) or curricula that are based on sound research concepts and educational principles? Will the proposed training provide new perspectives for investigators to solve complex biological problems? Will the curriculum provide examples or methodologies to enable investigators to make discoveries at the interface of their respective disciplines? Will investigators understand the roles within a team project, where experts from diverse fields of study must coordinate their efforts in a team environment? Is training in the Responsible Conduct of Research required for all candidates?
Principal Investigator(s)/Program Director(s): Do(es) the Principal Investigator(s)/Program Director(s) have a record demonstrating excellence in clinical, research, and administrative activities? Do(es) s/he (they) have the quality and breadth of prior training experience relevant to clinical research? Do(es) the PI(s)/PD(s) demonstrate evidence for the potential to become a leader(s) in developing educational interdisciplinary scientific programs at the institution(s)?
Faculty/Mentors/Advisory Committee/Collaborators: Do the faculty/mentors have a portfolio of funded, clinical projects? Do they have publications and training experience in clinical research? Do they meet regularly? Are their functions adequately described? Are the roles of any Collaborator(s) adequately described in terms of contributing to the goals of the program?
For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
Candidate Pool/Selection Process: Are there adequate criteria for publicizing the availability of the program to potential participants and for selecting participants? Is there demonstration of a sufficient number of high quality participants?
For competing continuation applications only include your assessment of:
Is there diversity of appointed scholars in prior years and enrollment by scholars from multiple schools at the institution?
Program Evaluation: Are the plans for program oversight and ongoing assessment adequate? Are there plans for including, and processes for acting on, input from the CRCA Advisory committee? Is the institutional collection of data relevant to the evaluation plan?
Innovation: Is the proposal original and innovative? For example: Are existing paradigms for clinical educational practices challenged? Are critical barriers identified and addressed? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for training?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Does the proposed training benefit from unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of strong institutional commitment? If the institution plans to support a degree-granting program, is there evidence that this program will serve to strengthen interdisciplinary clinical research and educational activities in areas relevant to biomedical research? If proposed, are the scope and nature of collaborations among participating schools and departments adequate? Are the adequacy and availability of institutional facilities and resources demonstrated in the application?
2.A. Additional Review Criteria
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the rating:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.)
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.
2.B. Additional
Review Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The overall impact/priority score
should not be affected by the evaluation of the budget.
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the 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 Notice of Award will be generated via email
notification from the awarding component to the grantee business official
(designated in item 14 on the Application Face Page). If a grantee is not email
enabled, a hard copy of the Notice of Award will be mailed to the 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 Notice of Award. 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).
3.
Reporting
Awardees 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.
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 Contact(s):
David Wilde, M.D., Ph.D.
Division of
Clinical Research Resources
National
Center for Research Resources
Democracy
One, Rm. 912
6701 Democracy Blvd.
Bethesda, MD 20892-4874 (20817 for courier service)
Telephone:
(301) 435-0790
Fax: (301)
480-3661
Email:
[email protected]
2. Peer Review Contact(s):
Mohan Viswanathan, Ph.D.
Deputy Director, Office of Review
National Center for Research Resources
National Institutes of Health, DHHS
1 Democracy Plaza, 6701 Democracy Blvd.
Room 1084, MSC 4874
Bethesda, MD 20892-4874 (Fedex or Other
Courier Service Zip: 20817)
Phone: (301) 435-0829
Fax: (301) 480-3660
E-mail:[email protected]
3. Financial/Grants Management Contact(s):
Jenelle
D. Wiggins
Grants
Management Officer
Office
of Grants Management
NCRR/NIH/HHS
6701
Democracy Blvd.,
Rm. 1050
Bethesda, MD 20892-4874 (20817 for
courier service)
Phone:
(301) 435-0843
Fax:
(301) 480-3777
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. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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 public
access to research data through the Freedom of Information Act (FOIA) under
some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH funding
or state why such sharing is restricted or not possible. This will permit other
researchers to benefit from the resources developed with public funding. The
inclusion of a model organism sharing plan is not subject to a cost threshold
in any year and is expected to be included in all applications where the
development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and individuals
designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research.
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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