and Human Services (HHS)
EXPIRED
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Biomedical Imaging and
Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov)
Title: ARRA OS Recovery Act Limited Competition: Impact of
Decision-Support Systems on the Dissemination and Adoption of Imaging-Related
Comparative Effectiveness Findings (UC4)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-OD-10-012
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.701
Key Dates
Release/Posted Date:
March 10, 2010
Opening
Date: April 5, 2010 (Earliest date an application may
be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 5, 2010
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): May 5, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information to Be
Available Date (Activation Date): Not Applicable
Expiration Date: May 6, 2010
Due Dates for
E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Part I Overview
Information
Part II Full Text of 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 - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Nature
of the Research Opportunity:
The increasingly broad adoption of advanced imaging techniques in screening, diagnosis and treatment is having a high-impact on medicine. However, imaging is not without risks. In particular, X-ray computed tomography (CT), positron emission tomography (PET), single-photon emission computed tomography (SPECT) and fluoroscopy all involve significant radiation exposure. Both under-diagnosis and over-diagnosis can also lead to inappropriate screening and treatment strategies that do not improve patient outcome, repetitive diagnostic procedures and the non-optimal use of resources.
Comparative effectiveness research (CER) is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. CER can provide information that helps clinicians and patients choose which option best fits an individual patient's needs and preferences. Clinicians and patients need to know not only that a treatment works on average but also which interventions work best for specific types of patients (e.g. children, elderly, racial and ethnic minorities). The dissemination and adoption into practice of CER findings are essential to translating new discoveries into better health outcomes for Americans, accelerating the application of beneficial innovations, and delivering the right treatment to the right patient at the right time.
This initiative will support projects that implement and study real-time clinical decision support systems as a vehicle for effectively disseminating and increasing the adoption of imaging-related CER findings. To be responsive to this initiative, applications must meet the threshold criteria for these ARRA funds.
Background:
Approximately 500 million diagnostic X-ray examinations, 19 million nuclear medicine procedures and 1 million radiation therapies are done every year in the United States. Recent studies have suggested that 10-30% of CT scans are not justified by medical need, and up to 20 million adults and 1 million children may be irradiated unnecessarily every year.
Government agencies, the scientific community and professional societies recognize the need for the adoption of evidence-informed radiological imaging procedures and consideration of vulnerable populations. They have begun to fund more comparative effectiveness studies, create data registries to capture knowledge and issue guidance to clinicians. For example, the American College of Radiology has created the National Radiological Data Registry and developed the ACR Appropriateness Criteria, while NIH is currently funding two large randomized trials, the National Lung Screening Trial and the Prospective Multicenter Imaging Study for Evaluation of Chest Pain, which are investigating the impact of screening and diagnostic imaging on patient health.
Decision support systems are knowledge-based systems which integrate information assets to inform decision-making and are commonly used in many business areas. The translation and incorporation of these systems to support clinical practice are one of the goals identified for the meaningful use of electronic health record (EHR) technology by the Centers for Medicare and Medicaid Services (CMS). These tools assist clinicians at the point of care, indicating the appropriate range of diagnoses, treatment options and the utility of procedures. Recent studies support the hypothesis that these systems can modify clinical behavior, but that they must be integrated into the clinical workflow and existing health IT systems to overcome barriers to acceptance and adoption.
For the purposes of this funding opportunity, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council, which can be found at http://www.hhs.gov/recovery/programs/cer/execsummary.html:
Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.
Active engagement and support of the medical community and representative professional societies are critical to increasing adoption, and CER findings to be incorporated into clinical decision support systems should be widely supported.
Successful applications will be supported by funds provided through the American Recovery and Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. There were four main inputs for establishing the priorities for ARRA comparative effectiveness research funds: public input, an internal Departmental workgroup, the Federal Coordinating Council (FCC) report, and the Institute of Medicine (IOM) report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:
The Comparative Effectiveness Research-Coordination and Implementation Team (CER-CIT) requires the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded under this announcement. These criteria are:
Finally, investments funded from this appropriation must address at least one of the following topic areas:
Objectives:
The objective of this program is to support two pilot studies that will implement and assess real-time clinical decision support systems as vehicles for increasing the dissemination and adoption of CER findings. To meet this objective, applicants are asked to outline strategies and identify key milestones for:
Goals:
The goal for this program is to accelerate dissemination and adoption of current imaging-related comparative effectiveness research findings by studying whether real-time decision support systems integrated into clinical health IT systems are an effective means of disseminating evidence-based findings. Successful adoption is considered to be an integrated system which is routinely used by clinicians as part of their workflow and efficiently and effectively assists them in making well-informed decisions. The long-term goal, beyond the scope of this program, is to provide models for how these systems can be incorporated into healthcare providers nationwide if they are shown to be an effective method for disseminating CER-findings.
With a project duration of only two years, applicants must have sufficient health IT infrastructure without existing clinical decision support systems incorporating CER findings to be in a position to meet the objectives of this announcement. Applicants are encouraged to work with institutions with clinical decision support systems incorporating CER findings and/or vendors to meet milestones. Healthcare systems in IDeA states and those serving vulnerable and underserved populations are strongly encouraged to apply.
See Section VIII, Other Information -
Required Federal Citations, for laws and
policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will
use the UC4 award mechanism. 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 (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (seehttp://grants.nih.gov/grants/funding/modular/modular.htm).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. NIBIB intends to designate up to $3,000,000 in FY(s) 2010 to fund two grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.
Budget proposals are limited to $500,000 total direct costs per year for a total of $1,000,000 total direct costs over two years.
Because the nature and scope of the proposed research will vary
from application to application, it is anticipated that the size 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.
The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., 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 and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH electronic Research Administration (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. When considering the multiple PD/PI option, 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 seehttp://grants.nih.gov/grants/multi_pi.
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 each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
To
download a current SF424 (R&R) Application Package and SF424 (R&R)
Application Guide for completing the SF424 (R&R) forms for this FOA, use
the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact Grants Info --
Telephone 301-710-0267; Email: [email protected].
Telecommunications for the hearing impaired: TTY:
(301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or
Research & Related Budget, as appropriate
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
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, the 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 5,
2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 5, 2010
Application Due Date(s): May 5, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): August 31, 2010
3.A.1. Letter of Intent
Although the Letter of Intent (LOI) is not required, not binding and does not enter into the review of the subsequent application, an applicant may choose to submit one.
The information that the LOI contains allows IC staff to estimate and plan for the potential review workload.
Prospective applicants are asked to submit a LOI that includes the following information:
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:
Alan McLaughlin, Ph.D.
Director, Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard
Suite 200
Bethesda, MD 20892-5477
Telephone: (301) 496-9321
Email: [email protected]
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to
this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be
provided to NIH in PDF format, filenames must be included with no spaces or
special characters, and a .pdf extension must be used.
3.C.
Application Processing
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.
All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov,
NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons https://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
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.
4.
Intergovernmental Review
This initiative
is not subject to intergovernmental
review, as
indicated in the NIH Grants Policy Statement.
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.
Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new award.
The incurrence of pre-award costs in anticipation of a
competing 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 the NIH
Grants Policy Statement).
None of the funds appropriated or otherwise made available in ARRA may be used by any state or local government, or any private entity, for any casino or other gambling establishment, aquarium, zoo, golf course, or swimming pool. (ARRA Sec. 1604)
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)
Research Strategy Page Limitation: The Research Strategy is limited to a total of 12 pages.
PHS398 Research Plan Component Sections
Item Number and Title |
Instructions |
1. Introduction to Application |
Omit (N/A: Resubmissions and Revisions not allowable) |
2. Specific Aims |
One page maximum. Separate PDF attachment |
3. Research Strategy |
Limited to 12 pages. Attach the 12- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations. |
Excluded from the 12-page Research Strategy limitation are the following items:
Note the 12-page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).
All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations will not undergo peer review.
No supplemental/update information will be accepted.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Regardless of the amount requested, applicants under this FOA 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 (e.g., 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 (go to 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
Review Process
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Biomedical Imaging and Bioengineering 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:
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. 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, technological advances, technical capability, clinical practice, and/or health be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Will the clinical decision support system have a tangible effect on clinical outcomes? Can the proposed implementation strategies be readily adopted within and across other healthcare organizations and delivery systems?
Investigator(s). Are the PD/PIs, 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?
Do the PD/PIs have a strong record of successful leadership and management? Does the team have a track record of working together? Does the team have experience implementing change across a healthcare system?
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, technological developments, 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?
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?
Do the findings to be incorporated into the decision support systems meet the definition of comparative effectiveness research as used by the Federal Coordinating Council for the Comparative Effectiveness Research? Will the comparative effective research findings be conveyed to clinicians in a real-time meaningful way? Have the investigators identified appropriate and meaningful milestones? Are important technical and non-technical barriers to implementation identified and addressed? Are the outcome metrics for evaluation appropriate?
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?
Are the health IT infrastructure and institutional support adequate to permit implementation of a clinical decision support system within the timeframe? Are the milestones well matched to the time and resources available?
2.A.
Additional Review Criteria
As
applicable for the project proposed, reviewers will consider the
following additional items in the determination of scientific and technical
merit, but will not give separate scores for these items.
ARRA
Criteria. Does the application meet the FCC minimum threshold criteria for
funding? Is the project a high priority under the FCC prioritization criteria?
Which of the IOM CER priorities and/or MMA Priority Conditions will be
addressed?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. 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.
Resubmission Applications. Not applicable for this FOA.
Renewal Applications. Not applicable for this FOA.
Revision Applications. Not applicable for this FOA.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
Selection Process
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.
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 NIH 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 . In addition, as part of just-in-time information
for those Recovery Act awards, for any modular budget application, a detailed
budget will be required prior to award.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
The terms of the NoA will reference the requirements of the Recovery Act.
In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
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 Section IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant
and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart
B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in
addition to, and not in lieu of, otherwise applicable OMB administrative
guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92
(Part 92 is applicable when State and local Governments are eligible to apply),
and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities
may be shared among the awardees and the NIH as defined below.
2. A.1. Principal Investigator Rights and
Responsibilities
The PD(s)/PI(s) will have the primary responsibility for: defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. Awardees are responsible for identifying specific milestones and quantitative success criteria that will be achieved during the project period.
Awardees agree to participate in the overall
coordination of NIH research efforts in accelerating the consideration of
comparative effectiveness research. This participation may include
collaboration and consultation with other agencies and awardees, participation
in meetings to disseminate results and the sharing of information, data, and
research materials. In addition, awardees are expected to participate in any
research community based efforts to implement and assess decision support
tools.
Awardees will retain custody of and have primary rights to the data and
software developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies (http://www.hhs.gov/grantsnet/adminis/gpd/, http://grants.nih.gov/grants/policy/gps/, http://grants.nih.gov/grants/policy/nihgps_2003/).
2. A.2. NIH Responsibilities
An NIBIB Project Scientist will have
substantial scientific-programmatic involvement during conduct of this
activity, through technical assistance, advice and coordination above and
beyond the normal program stewardship role in awards as described below and
participate as one voting member of the Steering Committee and applicable
subcommittees. The NIBIB Project Scientist will be responsible for technical
monitoring of the project, which includes approval of changes in approach,
objectives, milestones and timelines; assessing the progress against specified
milestones and stated project timelines, as well as for recommending if further
funds should be released to the project. However, the role of the Project
Scientist is to facilitate and not to direct the activities. It is
anticipated that decisions in all activities will be reached by consensus
between the PD(s)/PI(s) and the NIBIB Project Scientist, and that NIBIB staff
will be given the opportunity to offer substantial input into this process. The
Project Scientist may provide assistance by accessing NIBIB-supported
resources and services or recommend collaborations between awardees and other
persons or organizations whose participation will assist with the accomplishment
of project goals. These persons or organizations may include other federal
agencies, professional organizations, or software development companies
Additionally, an NIBIB Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The duties of the Program Official include:
2.A.3. Collaborative Responsibilities
A Steering Committee comprised of representatives from the institution(s) and departments involved, representatives from Health and Human Services including the NIBIB Project Scientist and, where appropriate, outside expert(s) will serve to facilitate adoption and assessment by monitoring progress and outcomes, identify problems and suggest possible solutions, and promote strategies to enhance the rate of adoption of CER findings. Responsibilities of the Steering Committee include approving changes in the implementation plan, evaluating performance and final approval of budgets and allocation of discretionary funds. Meetings of the Steering Committee will ordinarily be held by telephone conference calls or face to face meeting. The frequency of meetings, not fewer than six per year, will be determined by the PD/PI who will be responsible for scheduling and for preparing concise minutes which will be delivered to the committee members within 30 days of the meeting.
The Steering Committee members will be
selected by the PD/PI in consultation with the Project Scientist after the time
of the award and must be approved by NIBIB. Regardless of the number of NIH
staff participating in technical advisory roles, the NIBIB will be limited to
one vote on the Steering Committee. Each full member of the Steering Committee
will have one vote and all major scientific decisions will be determined by a
majority vote. The Chairperson of the Steering Committee will be the PD/PI or a
Co-PI. Awardee members of the Steering Committee will be required to accept and
implement policies approved by the Steering Committee.
2.A.4. Dispute Resolution Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16..
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.
In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
Recovery Act-related reporting requirements will be incorporated as a special term of award.
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. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.
This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application[1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist[1]. This restriction applies unless:
(i) the communication is purely logistical;
(ii) the communication is made at a widely attended gathering;
(iii) the communication is to or from a Federal agency official and another Federal Government employee;
(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency
official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or
(v) the communication is initiated by the Federal agency official.
For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Alan
McLaughlin, Ph.D.
Director, Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 200
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Telephone: (301) 496-9321
Email: [email protected]
2. Peer Review Contact(s):
David T. George, Ph.D.
Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
Democracy 2, Suite 920
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Telephone: (301) 496-8633
Fax: 301 480-0675
Email: [email protected]
3. Financial/Grants Management Contact(s):
Angelos
Bacas
Office of Financial Management
National Institute of Biomedical Imaging and Bioengineering
Democracy 2, Suite 900
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Telephone: (301) 451-4785
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5):http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf
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 (45 CFR 46) 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 institutional
review board (IRB) rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For
additional information, see http://grants.nih.gov/grants/gwas/
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. Beginning October 1, 2004, all investigators submitting an
NIH application or contract proposal 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.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this
funding opportunity in a public archive, which can provide protections for the
data and manage the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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 SF424 (R&R) application; and
updated roles and responsibilities of NIH staff and the extramural community.
The policy continues to require for all NIH-defined Phase III clinical trials
that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including subgroups if
applicable; and b) investigators must report annual accrual and progress in
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the
NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in
the project description and elsewhere in the application as appropriate, the
official NIH identifier(s) for the hESC line(s) to be used in the proposed
research.
NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).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 (HHS)
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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 Sections 301 and 405 of the PHS Act, as amended (42 USC
241 and 284) and are subject to 42 CFR Part 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 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/.
[1] Formal application includes the preliminary application and letter of intent phases of the program.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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