Part I Overview Information


Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)

Title:  ARRAOS: Recovery Act Limited Competition: Behavioral Economics for Nudging the Implementation of Comparative Effectiveness Research: Pilot Research (RC4)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-OD-10-002

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: December 28, 2009
Opening Date:   February 19, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
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): March 19, 2010
Peer Review Date(s): May/June 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: March 20, 2010

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

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

This FOA invites applications to understand better how the principles of behavioral economics could be used to enhance the uptake of the results of comparative effectiveness research (CER) among health care providers in their practice. In addition, the projects could also be designed to understand the maintenance of CER-supported treatments and procedures once prescribed in patient populations. Research to foster the uptake of CER is seen to be necessary given the surprisingly modest level of uptake and compliance of health care providers and health care systems to information concerning comparatively effective treatments and procedures. Given impressive previous success in radically changing behavior in financial contexts, (e.g., Choi, Laibson, & Madrian, 2004) behavioral economics is thought to provide potentially effective tools to enhance the uptake of CER by health care providers. These techniques, however, have not been adequately studied in the area of health services, leaving a substantial opportunity for improvement that could be met in part by successful applications to this FOA.

2. Background

Comparative effectiveness research (CER) holds significant promise to improve health care quality and potentially lower costs. Remarkably, however, knowledge of which procedures and treatments are comparatively effective may not be sufficient to change critical provider practices and crucial patient behaviors. For example, although the prescription of aspirin, beta blockers, and ACE inhibitors/ARBs after acute myocardial infarction (AMI) has been shown to be extremely effective in clinical trials, strongly endorsed by professional societies such as the American College of Cardiology, and used as a quality indicator by government organizations including the Centers for Medicare and Medicaid Services (CMS), rates of prescription for these drugs in hospitals following AMI show substantial regional and institutional variation and are still below 100% according to the 2008 AHRQ National Healthcare Quality Report (NHRQ). Even when comparatively effective treatments are prescribed, adherence to treatment can be disappointingly low. As late as the beginning of this decade, for example, approximately 50 percent of all AMI patients stop taking prescribed statins within two years of their event (Jackevicius et al., 2002). Among asthmatics only 32% took their preventive asthma medicine daily. Similar adherence problems exist among diabetics, resulting in poor health outcomes. Fewer than 60% of all adults age 40 and over with diagnosed diabetes have their blood sugar, cholesterol, or blood pressure under optimal control. Moreover, only 40.1% received all three recommended services for diabetes, including an HbA1c measurement, a dilated eye examination, and a foot examination. (2008 AHRQ National Healthcare Quality Report)  

It is generally presumed that both providers and patients respond to incentives to change their behaviors, but to date, efforts to incentivize the uptake of CER have had only modest success. This funding opportunity seeks applications that will investigate whether the principles of behavioral economics could be used to enhance the uptake of the results CER among health care providers and also enhance the maintenance of such treatments in patient populations. Moreover, this FOA also encourages applications to use behavioral economics to examine the sustained uptake of CER—to investigate the dynamics of why a provider may delay uptake, later adopt a CER result, and then later stop using it.

For the purposes of this FOA, the definition of comparative effectiveness research will adhere to that adopted by the Federal Coordinating Council given at
http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf: “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.

It should, however, be noted that applicants are not restricted to focusing on CER from any one source. Valid CER findings can be taken from a variety of sources including the findings of AHRQ (http://effectivehealthcare.ahrq.gov/), the conclusions of NIH Consensus Conferences (http://consensus.nih.gov/), the recent Institute of Medicine (IOM) report on Initial National Priorities for Comparative Effectiveness Research (http://www.iom.edu/CMS/3809/63608/71025.aspx), or sufficiently convincing CER results from literature. Note also that this FOA is dedicated to enhancing the uptake of existing CER research rather than to find new comparatively effective treatments.

In the context of this FOA, behavioral economics refers to the interdisciplinary efforts involving cognitive and social psychologists, decision scientists, and other social scientists together with economists to model economic decision-making and consequent actions. The approach is inclusive, since at its heart it tries to take into account what is known about how people actually make decisions rather than relying on the assumption that economic agents are fundamentally rational in the sense of expected utility. As a field, behavioral economics seeks to understand how human social, cognitive, and emotional factors affect economic decisions. It considers the values assigned to all aspects of a choice, including, but not limited to monetary factors. In addition, behavioral economics acknowledges the important role that a specific context (or frame) may have on decisions, and takes into account people’s apparently irrational preferences (e.g., losses count more than gains, an object that is owned is more valuable than the same object that is not owned). For a recent review of behavioral economics from an economic perspective, Dellavigna (2009) is useful; from a psychological standpoint, Kahneman and Tversky (2000) provides useful data and historical context. There is growing evidence that such approaches may hold more promise than approaches based on either conventional theories of behavior change or neoclassical economics. The application of approaches from behavioral economics to the health care field could be valuable in the development of incentives or disincentives to motivate sustainable changes in provider and patient behavior.

It should be noted that the use of conventional economic incentives to affect provider behavior, including the uptake of CER, has been the subject of considerable research. Perhaps most germane to the topic of this FOA is the literature on “pay for performance”, also known as P4P. The logic of P4P is clear: rather than paying physicians or other health care providers (just) for the specific, billable, services they provide (which naturally incentivizes the ordering of more tests and procedures), we should pay them based on patient outcomes or on their achievement of other objective milestones that should be directly related to patient outcomes. In a classical economic context, it would be a puzzle if physicians and other treatment providers did not align their practice with the procedures or guidelines for practice that are incentivized. Strikingly, however, the evidence for the effectiveness of P4P schemes are often quite modest (reviewed by, e.g., Petersen et al., 2006). Although there are explanations in part for some of these incentive failures (e.g., the principal-agent problem), it seems clear that the incentive system could be improved, and behavioral economists would argue that key improvements could be made in the design and delivery of incentives and the construction of the decision environment for the health care provider.

To date, implementation of behavioral economic approaches to change decision-making and behavior has focused primarily on economic topics such as behavioral finance (but see, e.g., Volpp et al., 2009 for a recent trial involving smoking cessation), but the underlying ideas would seem to have much broader applicability. Behavioral economic interventions are generally of two basic types:  one can restructure the choice environment, or manipulate the individual’s perceived incentives. One notable example of the former was Choi, Laibson, and Madrian’s (2004) intervention to increase retirement savings participation. By changing the default action to “contribute” they relied on behavioral inertia to maintain that level of participation. This is an example of altering behavior by manipulating the "choice architecture" that confronts individuals in daily life (see also Thaler and Sunstein, 2008). By structuring choice architectures to subvert individuals’ entrenched biases to stick with the status quo and discount future benefits, a well-developed system of so-called asymmetric paternalism (Loewenstein, Brennan, and Volpp, 2007) could provide interesting opportunities to induce change in provider behavior with respect to selecting a comparatively effective treatment while preserving a clinician's freedom to choose an alternative treatment when the CER-recommended treatment is counter-indicated. One relevant example of the use of a default option approach that is widespread in the current health system in a non-CER context are some state laws or policies that generic equivalents may be substituted for brand name drugs by pharmacists unless a physician specifically notes (or checks off a box denoting that) the prescription is to be “dispensed as written” (DAW). Here, the “transaction cost” of over-riding the default is almost zero, but the effect on generic dispensing rates can be quite large. In particular, generic drug utilization rates varied from 37 percent to 83 percent among Medicare Part D plans (Levinson, 2007), and it would appear that some of this variation is attributable to systemic factors that could be manipulated.

In addition to these more passive, environmental manipulations, behavioral economists have explored the manipulation of incentives to alter behavior. There has been particular interest in the use of deposit contracts, lotteries, and other monetary contingencies to effect health-related behavior change (e.g., Volpp et al. 2008). (Also note that some self-imposed commitment devices can be at least modestly effective at nearly zero external cost, e.g., Ariely and Wertenbroch, 2002). The effect of these devices is generally to allow individuals to overcome their own behavioral inertia, or to make continued compliance with recommended courses of action more attractive. Some of these techniques are similar in spirit to P4P, but the design of the incentives can be very different, and reflects what is known by psychologists about people’s preferences, and how those preferences can be manipulated. Like P4P, however, there can be concerns about the efficiency of providing incentives to reward behavior that would occur in any event, and questions concerning the overall cost effectiveness of monetary incentives, and it is hoped that the projects supported by this funding opportunity will allow these issues to be examined.

Overall, the possible contributions that behavioral economics could make to changing health care provider behavior have not improving health have not been systematically investigated at either a small or large scale, which is the opportunity presented by this Recovery Act FOA.

Priority-Setting Process and Inputs for use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS CER funds: public input, an internal Departmental workgroup, the FCC report, and the IOM report.  The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1)         Included within statutory limits of ARRA and the Council’s definition of CER;
2)         Potential to inform decision-making by patients, clinicians or other stakeholders;
3)         Responsiveness to expressed needs of patients, clinicians or other stakeholders;
4)         Feasibility of research topic (including time necessary for research).

The CER-CIT will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds.  These criteria are:

1)         Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),
2)         Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,
3)         Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,
4)         Addresses a need or is unlikely to be addressed through other organizations,
5)         Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1)         One of the 100 IOM topic recommendations or the 10 general recommendations and/or
2)         An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed;

3)         Fall into one of the AHRQ identified evidence gaps or be identified in the FCC report to the Congress.

The current list of priority conditions includes:

3. Scope and Specific Requirements

This FOA solicits applications for small, 3-year projects proposing pilot clinical trials, observational studies, or demonstration projects from multidisciplinary teams with relevant expertise in behavioral economics, psychology, and health services targeting the uptake of specific, previously identified CER. (Note: this FOA does not target establishment of new CER findings, but the uptake of previously validated CER.) As noted above, there are a wide range of valid sources for CER and substantial evidence that in many areas of CER, uptake has been slow and uneven at best. Broad areas of problematic uptake include (but are not limited to) the prescription of comparatively more effective medications or procedures where not directly counter-indicated, failures to schedule or execute indicated screening tests (which also clearly have a patient component), inadequate post-procedure follow-up assessment, failure to adopt education programs to educate patients about effective options (such as smoking cessation after AMI, weight loss programs for the obese, etc.), failure to use new management technologies (such as electronic medical records), and failure to adopt new training methods (such as surgery simulators, residents working past the recommended 16-hour limit for shifts without naps, etc.).  Some of the potentially more applicable behavioral economic approaches to the general problem are mentioned above. Applicants must provide a rationale for the specific behavioral economic methods they propose to evaluate, and demonstrate how they differ from currently implemented P4P methods.
 
The scope of possible approaches to the behavioral economics/CER problem is left open. The general guideline is that the results of grants following from this FOA could set the stage for other, future studies establishing the effectiveness of the intervention proposed. But the intervention itself could have been identified as promising as the result of a small-scale randomized clinical trial (RCT) or clustered randomized trial (CRT), or identified as a result of secondary analysis of provider performance or claims data, or identified as a possible intervention in an observational study of health care delivery programs that systematically differ in their uptake of CER (possibly due to differences in standard operating procedure or payment systems), or identified using any other valid method. Applicants should be aware of the fact that any proposed project should be feasible within a three year period and a total costs budget of $1.25 million.

Applicants should plan to attend an AHRQ CER conference of awardees supported under this FOA for dissemination purposes.  For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.

In addition, applicants should plan to attend an annual investigator’s meeting including grantees from this FOA and, the companion Clinical Trials FOA, and other currently funded investigators working in the areas of behavioral economics and increasing the uptake of CER.

References.

Ariely, D., & Wertenbroch, K. (2002). Procrastination, deadlines, and performance: self-control by precommitment. Psychological Science, 13(3), 219-224.

Choi, J., Laibson, D., & Madrian, B. C. (2004). Plan design and 401(k) savings outcomes. National Tax Journal, 57(2), 275-98.

DellaVigna, S. (2009). Psychology and economics: evidence from the field. Journal of Economic Literature, 47(2), 315-372.

Jackevicius, C. A., Mamdani, M., & Tu., J. V. (2002). Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 288(4), 462-467.

Kahneman, D., & Tversky, A. (1979). Prospect theory: an analysis of decision under risk. Econometrika, 47(2), 263-291.

Kahneman, D., & Tversky, A. (Eds.) (2000). Choices, Values and Frames. New York: Cambridge University Press and the Russell Sage Foundation.

Kahneman, D. (2003). Maps of bounded rationality: psychology for behavioral economics. Americal Economic Review, 93, 1449-1475.

Loewenstein, G., Brennan, T., & Volpp, K. G. (2007). Asymmetric paternalism to improve health behavior. JAMA, 298(20), 2415-2417.

National Healthcare Quality Report, 2008. AHRQ Publication No. 09-0001: Rockville, MD. March 2009. www.ahrq.gov/qual/qrdr08.htm 

Petersen L. A., Woodward, L. D., Urech, T., Daw, C., & Sookanan, S. (2006). Does pay for performance improve the quality of health care? Annals of internal medicine, 145(4), 265-272.

Thaler, R. H., & Sunstein, C. R. (2008). Nudge: improving decisions about health, wealth, and happiness. New Haven: Yale University Press.

Volpp, K. G., Loewenstein, G., Troxel, A. B., Doshi, J., Price, M., and others. (2008). A test of financian incentives to improve warfarin adherence. BMC Health Services Research, 23(8), 272-277.

Volpp, K. G., Troxel, A. B., Pauly, M. V., Glick, H. A. and others. (2009). A randomized, controlled trial of financial incentives for smoking cessation. New England Journal of Medicine, 360(7), 699-709.

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 ARRA-specific RC4 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 (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

This initiative is supported by funds provided to the NIH and AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. The NIH has designated $5,000,000 in FY(s) 2010, 2011, and FY2012 to fund 4-5 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for this FOA; total costs are limited to $1,250,000 over an RC4 three-year period, with no more than $500,000 in total costs allowed in any single year. Grants that are awarded will have to use a non-modular budget. NIH grants policies as described in the 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 see http://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 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 GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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 Strategy
PHS398 Checklist
Research & Related Budget

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 Research Plan section and 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: February 19, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Due Date(s): March 19, 2010
Peer Review Date(s): May/June 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): August 31, 2010

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.

Applicants are requested to notify the National Institute on Aging Referral Office by email (vemuriR@nia.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

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 non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the 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).

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 Strategy 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 Strategy 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:

Appendix Materials

Appendices are not permitted.

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 National Institute on Aging 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 NIH RC4 grant is a mechanism for supporting research under ARRA. 

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

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? Would this project help establish the likelihood that behavioral economic approaches can enhance the rate of uptake of CER by providers or the maintenance of such treatment in patients?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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? Does the research team include sufficient expertise in the areas of behavioral economics and the uptake of CER to allow adequate progress in the accelerated time line required by this FOA?

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? Does the application specifically propose the use of an intervention strategy based on behavioral economic principles rather than the use of more conventional incentives?

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?

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? Will the applicants be able to obtain access to either provider populations or the appropriate data sources to complete the proposed work in the time allowed for by this FOA?

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.

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.

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.

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:

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.

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.”  

Applicants should plan to attend an AHRQ CER conference of awardees supported under this FOA for dissemination purposes. For budgetary purposes, applicants should plan for two representatives to travel to the Washington, DC, area for conference presentations as arranged by AHRQ and NIA. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such a conference.

In addition, applicants should plan to attend an annual investigator’s meeting including grantees from this FOA, the companion Clinical Trials FOA, and other currently funded investigators working in the areas of behavioral economics and increasing the uptake of CER.

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.

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.

Section VII. Agency Contacts


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 lobbyist1. 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.

[1] Formal application includes the preliminary application and letter of intent phases of the program.

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):

Jonathan W. King, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave. #533
Bethesda, MD 20892-9205

Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: kingjo@nia.nih.gov

Bill Encinosa, Ph.D.
Center for  Delivery, Organization and Markets 
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: 301-427-1437
Fax: 301-427-1430
Email: William.encinosa@ahrq.hhs.gov 

2. Peer Review Contact(s):

Ramesh Vemuri, Ph.D.
Scientific Review Branch
National Institute on Aging
7201 Wisconsin Ave. #2C212
Bethesda, MD 20892-9205
Telephone: (301) 402-7700
Email: VemuriR@mail.nih.gov  

3. Financial/Grants Management Contact(s):

Lesa McQueen, M.Sc.
Grants & Contracts Management Branch
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301 402-3672
Email: McQueenL@nia.nih.gov  

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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