Part I Overview Information


Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Outcomes and Evidence (COE), AHRQ
(http://www.ahrq.gov)

Title:  ARRA-AHRQ Recovery Act 2009 Limited Competition: PROSPECT Studies: Building New Clinical Infrastructure for Comparative Effectiveness Research (R01)

Note:  The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This Funding Opportunity Announcement (FOA) is a new RFA.

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

Request for Applications (RFA) Number: RFA-HS-10-005  

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)
93.715

Key Dates - Revised Dates (Per NOT-HS-10-011)
Release/Posted Date: December 8, 2009
Opening Date:  December 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 27, 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):  February 17, 2010
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 18, 2010

Key Dates - Old Dates
Release/Posted Date: December 8, 2009
Opening Date:  December 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 18, 2009
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):  January 20, 2010
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 21, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5, invites Research Project Grant (R01) applications from organizations that propose to develop the infrastructure and improve the methodology for collecting prospective data from electronic clinical databases to generate new evidence on the comparative effectiveness of healthcare interventions

Purpose. The primary purpose of the PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies) Studies will be to advance the quality, depth and scale of the electronic data collection infrastructure as a basis for comparative effectiveness research.  The projects will substantially enhance the nation’s ability and capacity to systematically collect prospective data that will inform comparative effectiveness research on diagnostics, therapeutics, devices, behavioral interventions, and procedures used in clinical care, especially in populations typically under-represented in randomized control clinical trials or that have limited access to healthcare, or both, such as patients with multiple co-morbidities, extremes of age, and minorities.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

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

The purpose of this FOA is to develop the infrastructure and improve the methodology for prospective collection of data from electronic databases containing clinical information.  This methodology will ultimately assist in generating new evidence to examine the comparative effectiveness of healthcare interventions.  Funded projects, henceforth referred to as PROSPECT (Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies) Studies, shall effect a substantial improvement in the nation’s capacity to systematically collect prospective data to perform comparative effectiveness research on diagnostics, therapeutics (drugs and biologics), devices, behavioral interventions, and procedures used in clinical care.  A special focus of this FOA is to understand the comparative effectiveness of clinical interventions in populations that are under-represented in randomized control clinical trials or have limited access to healthcare, or both, such as patients with multiple co-morbidities, extremes of age, and minorities.

Projects selected for funding shall develop new electronic data infrastructure  by building on existing electronic databases, such as electronic medical record (EMR) systems, registries, registry overlays, claims databases, or patient-reported outcomes assessments and periodic surveys, with the ultimate goal of implementing broader, scalable and sustainable systems that enable the collection of longitudinal and comprehensive data across facilities.  Although the primary purpose of the PROSPECT Studies will be to advance the capacity of electronic data collection infrastructure as a basis for comparative effectiveness research, the conduct of specific comparative effectiveness studies using these data will also be an important outcome of funding, both to provide needed comparative effectiveness evidence and to demonstrate the usability of the data networks.  Infrastructure developed in the PROSPECT projects should serve as a long-term source of data supporting future comparative effectiveness and other longitudinal studies. 

Projects shall demonstrate the capability of the proposed data systems to collect and accurately link information, such that data from these systems can readily be used to produce methodologically rigorous and clinically meaningful prospective (observational and experimental) studies.  Useful comparative effectiveness studies that make use of the proposed infrastructure will need to incorporate data from different care delivery sites and cover diverse patient populations to yield valid and generalizable conclusions.  Examples of diverse populations include patients with varying levels of disease severity, multiple co-morbidities, elderly, pediatric, patients of different race/ethnicity and socioeconomic status, patients in different geographic areas, etc. The data gathered may also have relevance for addressing issues of safety and documenting quality improvement, but this should not be the primary purpose.

·        Requirements for PROSPECT Projects

1)  Funded projects must develop an electronic network that collects and links electronic data from multiple and different patient settings, such as clinics, hospitals, and long-term care facilities. 

2)  All funded projects must collect data and study the comparative effectiveness of interventions in an AHRQ priority population: http://www.ahrq.gov/qual/nhdr07/Chap4.htm.  Data collected from priority populations must be adequate to perform rigorous analysis and support conclusions generalizable to the priority population group.  The study population is not limited to a priority population but it must include one in a meaningful way.  In particular, projects that design the electronic data infrastructure such that it can be used to ascertain evidence of comparative effectiveness pertinent or unique to the underserved or underrepresented patient populations are strongly encouraged.

3) All funded projects must collect data and study the comparative effectiveness of interventions targeting one of the AHRQ priority conditions or one of the first quartile of IOM priority topics for comparative effectiveness research. The lists are available at: http://effectivehealthcare.ahrq.gov/FAQs.cfm and http://www.iom.edu/Object.File/Master/71/032/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.pdf.

A specific area of interest for AHRQ is electronic networks with the capability of collecting quality of life and other patient reported outcomes to compare effectiveness of interventions, such as for mental health disorders.  Proposed studies should highlight important real-world questions of comparative effectiveness.  For example, data could be collected on a patient population consisting of different age groups, different races/ethnicities, varying level of disease severity, and a range of co-morbidities commonly observed in clinical practice.   

4) Funded projects may collect data that compare the effectiveness of various diagnostic tests in predicting outcomes and improving selection of appropriate interventions.  A specific area of interest for AHRQ is the creation of an electronic network that will substantially enhance our understanding of the use of laboratory tests, imaging tests, or both; their impact on treatment decisions; and the health outcomes of those treatment decisions.  A project limited to diagnostic accuracy or impact of test information on treatment decisions without also considering impact on health outcomes will not be considered responsive and will not undergo peer-review.  

5)  Proposed comparative effectiveness studies using the data collected may be observational, such as prospective cohort studies, or the data collection may support a randomized controlled trial.  Regardless of type, all studies must be rigorous, internally valid and generalizable to the population of interest. 

6) Clinical informatics:  The design of the clinical informatics infrastructure must ensure that the infrastructure is readily scalable and inter-operable across a variety of software platforms and IT architectures.  The use of open-source software and data platforms and linkages is strongly encouraged.  The data collection needs to be efficient and designed to minimally impact clinical workflow. The applications must provide details on their approach to linking data and ensure this is consistent with ongoing national efforts to harmonize health IT standards. The timeline and resources for these projects do not allow for developing and testing new network system architectures or building a de-novo informatics infrastructure. Applications that have already developed and tested a clinical informatics infrastructure, even on a small scale, will have the highest priority.

7) Governance: The applications need to provide adequate details of a governance plan for project oversight, especially on issues related to data linkage, access, and privacy and confidentiality of patient information.  In addition, the governance plan should describe provisions for oversight and responsibility concerning operational issues and scientific and technical concerns related to study design, implementation and data analysis.  Provisions to review conflict of interest of investigators and other personnel on an ongoing and regular basis should be included.  The governance plan should also describe provisions for obtaining input and feedback concerning important aspects of the design of data collection infrastructure as well as on the comparative research undertaken.  End-user feedback will be important in designing the infrastructure so that clinical workflow is minimally impacted and the data is efficiently collected. 

8) Scientific Collaboration:  Applications must budget to travel up to three persons, at a minimum the project PD/PI and program manager/coordinator must travel annually to AHRQ for a PROSPECT program meeting.  The PROSPECT program will have one meeting for two days annually. In addition, at least one project personnel will be required to attend at least three in-person meetings convened at AHRQ by the Electronic Data Methods (EDM) forum (see related FOA: RFA-HS-10-006).

9)  Minimum effort of personnel: The PD/PI must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.  A program manager/coordinator must devote a minimum level of effort of 30% annually (3.6 calendar months) to manage the project.  There must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study as well as training of new investigators.  Budgeted effort of other personnel must be appropriate to the needs of the project. 

10) Reporting:

Section 1512 of The American Reinvestment and Recovery Act of 2009 (ARRA) requires prime recipients of the ARRA funds to submit quarterly reports, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10).  Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the ARHQ Website at http://www.ahrq.gov/about/arrawebinars.htm.

In addition, AHRQ is currently developing AHRQ-specific reporting requirements.  Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Grant Award and incorporated into AHRQ Terms and Conditions of Award. 

It is anticipated that the details of the approach used to build the clinical informatics infrastructure as well as the results of the comparative effectiveness studies will be published in peer-reviewed literature as well as reported to AHRQ.  Quarterly conference calls with the AHRQ program officer, and other individuals deemed necessary by the program officer, are required. These calls will review the progress on all aspects of the project.  Annual progress reports will detail the progress on all scientific, technical and programmatic aspects of the project. 

12) EDM Forum Activities: The PI and other key personnel of the PROSPECT study are expected to contribute to the activities of the EDM forum (see related FOA RFA-HS-10-006) on a regular basis.  Participation may involve meetings, teleconferences, participation in working groups, or other responsibilities, depending upon the nature of the workgroup activities and the match with the expertise on PROSPECT project teams.

13) Sharing access to research databases:  It is anticipated that the databases generated from the clinical research infrastructure will be a national resource.  The application must describe a data sharing and access plan that offers a viable and reasonable mechanism to allow other qualified researchers access to these databases (after it has been validated for comparative effectiveness research) to test a valid hypothesis such as a project testing a hypothesis that has been vetted by an AHRQ or NIH study section.  Apart from database access for testing a hypothesis, the application must also offer a mechanism for qualified researchers to have reasonable access to the database to generate a new hypothesis.  However, the PROSPECT study is not expected to bear the expenses for this access and must not budget for these in response to this FOA. 

Below are examples of projects that would be considered responsive to the requirements. These examples are provided as illustrations of topics responsive to the FOA. Applicants may choose topics other than those provided here.

·        Linking multiple EHRs of different care delivery sites. An important goal of the PROSPECT funding will be to demonstrate the ability to establish connectivity between multiple hospital electronic medical records and data collected from other healthcare settings, such as skilled nursing facilities, long-term care facilities, ambulatory surgical centers, rehabilitation facilities, ancillary services, home health agencies, durable medical equipment suppliers, hospices, and physician offices.  For example, a study might look at long-term outcomes of chronic hip disease.  A patient might be admitted to a community hospital with a hip fracture and transferred to a higher level facility for a joint replacement.  Following surgery, the patient is transferred to a rehabilitation facility for therapy prior to discharge home, where home health agencies are involved initially and then additional therapy is provided at a local physical therapy clinic.  Routine follow-up is initially done by the operating physician and subsequently by a primary care physician. Thus the study will need to collect patient-level information from a community and a higher-level hospital, rehabilitation facility, home health agency and physical therapy clinic. The information will have adequate clinical detail to maximize internal validity while the study design will account for internal and external validity.  Finally, the information will be collected as part of routine clinical care to the extent possible. Another example is a study that would link de-identified patient data from EMRs in clinics, hospitals, and other care delivery organizations and supplement it with data collected at point of care in order to determine episodes of care and the comparative effectiveness of clinical interventions in a manner similar to the work done by AHRQ-funded distributed research network projects (http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=53; http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=94; http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=54; ).  The ideal PROSPECT study would establish electronic interfaces, using a method that is readily scalable, with each of these clinical entities and any others that might be needed (e.g. claims databases to ascertain sources of healthcare utilization) to collect relevant data while also maintaining the capability to add new, non-electronic data.

·        Adding longitudinal data to a current database.  Numerous registries currently collect point of care data.  However, many have little or no long-term follow-up of the patients and most do not have the capability to collect data across different care delivery sites such as ambulatory, in-patient or long-term care facilities. Adding longitudinal, clinically-rich data from different care delivery sites will significantly enhance the quality and usefulness of the data from a registry.

·        Merging databases.  Diagnostic data are often collected and maintained separately from patients’ inpatient and outpatient records.  For example, even when the data from imaging studies are sent electronically, they are stored as a PDF within an EMR, which makes it challenging for extraction via automated query approaches in the EMR.  In the mental health arena, the diagnostic instruments used for screening or monitoring effectiveness of therapies for depression in the specialty care setting differ from those used in the primary care setting. Also, primary care providers commonly refer mental heath patients for additional therapy from a psychiatrist if first-line therapies are not successful.  The details of psychotherapy delivered by a psychiatrist are typically not present in EMRs.  Merging the complementary databases to enable linkage of diagnostics, primary and specialty care would improve our ability to study the outcomes of mental health therapies.

·        Augment current databases.  The data collected in EMRs are limited by the data fields designed by the EMR vendor.  Free text can be entered in EMRs and the information can be extracted by natural language processing methods.  These data can be quite useful for clinical studies, but there are challenges in standardizing the technology to extract the data across different EMRs and in accounting for the variability in the information that is stored in free text.  Long-term registries generally limit the number of data elements they collect to decrease the burden of reporting.  Commonly, the addition of a small number of data elements would significantly improve the ability to answer specific clinical questions.   For example, a joint registry spanning several care delivery sites would be significantly augmented by adding device-specific and operator-specific information to allow comparison of outcomes from differing devices that have differing properties.

HHS Definition of CER

HHS will use the definition of CER used in the Federal Coordinating Council’s Report to Congress to guide the HHS operational plan with regard to OS ARRA funds. The definition is as follows:

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.

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;

2)  An issue within one the MMA 14 priority conditions identified by AHRQ which are not currently addressed; and/or   

3)  Fall into one of the AHRQ identified evidence gaps.

The current list of priority conditions includes:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Research Project Grant (R01) award mechanism.  The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will mot be reviewed.

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. AHRQ has designated $44 million to fund approximately five research project grant applications under this FOA, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget applications are limited to $3 million in total costs per year for a total of $9 million over 3 years.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years or budgets that exceed $9 million total costs will not be reviewed.

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 AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act).  The purposes of the Recovery Act are 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.  Consistent with these goals, eligible domestic (United States) institutions/organizations who are 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 total costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to three years.

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 of one of the types listed below. The United States institution/organization must be located in the 50 states or in the territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia.  Foreign organizations/institutions are not permitted as the applicant organization.

You may submit an application(s) if your institution/organization has any of the following characteristics:

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

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 AHRQ support. The PD/PI must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.


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.

Research on Humans:

All Federal regulations on research on human subjects will apply.  Successful applicants will be required to have IRB approval prior to commencing research. 

Applications must specify a data safety and monitoring plan that provides for the appropriate level of oversight and monitoring of the conduct of research to ensure the safety of participants, and the validity and integrity of the data.  The method and degree of monitoring must be commensurate with the degree of risk involved for participating subjects and the size and complexity of the research.   Applications that do not include a data and safety monitoring plan will not undergo peer review or consideration for funding.

Data and safety monitoring involving some level of independent monitoring, generally in the form of a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), is required for research studies involving interventions that entail significant potential health risk to research participants due to the nature of the intervention, even when the potential harm may occur to certain patient populations.  A committee will also be needed to coordinate collection of valid data across multiple sites.

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:

A PD/PI should work with his/her institution/organization to make sure he/she is 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 PD/PI 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 AHRQ.  Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (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 Research & Related Budget

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

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. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: December 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 18, 2009
Application Due Date(s): January 20, 2010
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent must be sent electronically to:

PROSPECTgrants@ahrq.hhs.gov, with a subject line of “Letter of Intent: PROSPECT Grants”.

The full address included in the Letter of Intent should read:

Letter of Intent PROSPECT Grants
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: PROSPECTgrants@ahrq.hhs.gov

The letter of intent is to be sent by the date listed in Section IV.3.A

3.A.2. Technical Assistance

Applicants may submit questions to AHRQ via email at PROSPECTgrants@ahrq.hhs.gov.  AHRQ will respond to questions via email only.  In addition, based on inquiries received, AHRQ will post a list of Frequently Asked Questions (FAQs) and responses to these questions approximately 4 weeks after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm 

3.B. Submitting an Application Electronically to AHRQ

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. 

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.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 Center for Scientific Review, NIH, and AHRQ.  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. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/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.

AHRQ 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.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

o Use of CMS Data

Purchase of Centers for Medicare & Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, the DUA will include the requirement that the data user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ 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 are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ 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 AHRQ 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. AHRQ 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.

6. Other Submission Requirements

The PD/PI must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.  A program manager/coordinator must devote a minimum level of effort of 30% annually (3.6 calendar months) to manage the project. Applications should budget to travel three persons, (at a minimum the project PD/PI and program manager must travel), to AHRQ for an annual PROSPECT program meeting.  In addition, at least one project personnel will be required to attend three in-person meetings convened by the Electronic Data methods (EDM) Forum annually (see RFA-HS-10-006).

The PD/PI and other key personnel of the PROSPECT study are expected to contribute to the activities of the EDM Forum (see RFA-HS-10-006) on a regular basis.  Participation may involve activities such as meetings, teleconferences, participation in working groups, or other similar activities.

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.”

PHS398 Research Plan Component Sections

The research plan component of the PHS398 (Items 3-5) may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.  While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements. 

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

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 of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.  

No supplemental/update information will be accepted.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations.  Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  This authority is found at 42 USC 299(c).  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’ Inpatient Database (KID), the Nationwide Emergency Department Sample, and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD).  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population.  MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).  The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information


1. Criteria 

Administrative Criteria:  Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria:  The review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. 

As part of the initial merit review, all applications will:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Apart from the five criteria listed below, the reviewers will also be asked to comment on additional review criteria, as outlined later, including the focus of the project on a priority population and priority condition.  

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  How will the infrastructure developed through this project advance our ability to collect meaningful data for studies on the comparative effectiveness of healthcare interventions?  How will the specific comparative effectiveness study (ies) proposed in this project inform important healthcare decisions?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?   

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  

Investigators: Is the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?  

Environment: Does the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?   

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

2.A. Additional Review Criteria

1. Additional criteria for proposed infrastructure:   

a. Applicant must arrange for partnership with multiple clinical organizations having different IT environments and must document commitments from those sites.

b. Proposed project must involve data collection from more than one type of care delivery site (e.g. hospital, long-term care facility, ambulatory clinic etc.).

c. Applicant must provide explanation and detail on how proposed infrastructure will support the collection of improved data, i.e. data that will allow for better, timely and more valid (both internally and externally valid) comparative effectiveness research than would be feasible with existing data related to studies proposed in the application.

d. Applicant must describe how the proposed infrastructure will be leveraged or modified to address the evidentiary needs for underserved or underrepresented patient population groups.

e. Application must include technical detail on the clinical informatics approach adequate to assess its feasibility, including consideration of issues related to interoperability and scalability.

f. Applicant must demonstrate a track record of successfully collecting and managing electronic health care data, preferably from disparate sources.  To address this criterion, applicant should submit letters from previous partner organizations, attesting to the usability and positive contribution of data collected and to the applicant’s ability to work cooperatively with partner facilities.  

2. Additional review criteria for comparative effectiveness research to be undertaken using data collected through proposed infrastructure. 

 a. Application must include scientific team with expertise in comparative effectiveness research.

 b. Application must demonstrate that the applicant’s comparative effectiveness research team is involved with the infrastructure development aspects of the project as well as the specification and design of comparative effectiveness studies included in the application.

c. Application must focus on a priority condition, particularly one that would benefit from this infrastructure

 d. Application must address a  priority patient population that is under-represented in randomized control clinical trials or with limited access to healthcare, or both, such as elderly, pediatric, patients of different race/ethnicity and socioeconomic status, multiple co-morbidities, etc.

e. Application must reflect a real-world population,

f. Application must compare effectiveness of clinical interventions (diagnostics, devices, drugs, biologics, procedures, counseling and behavioral intervention or a combination of these),

g. Application must focus on health outcomes,

h. Application must describe how the proposed research will yield internally valid as well as generalizable conclusions.

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Degree of responsiveness:  How well does the application address the purpose and objectives of this FOA?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements,” and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Privacy and Security Protections for Patients:  The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Appeals will not be permitted.  See http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html, Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

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, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once any/all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization.   The NOA will be generated via email notification from the awarding component to the grantee business official.  The NOA signed by the grants management officer is the authorizing document.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the HHS standard Terms and Conditions for American Recovery and reinvestment Act of 2009 (ARRA).  The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions: American Recovery and Reinvestment Act of 2009 (see, http://www.ahrq.gov/fund/arraterms.htm).   

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NOA are at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5., “Funding Restrictions.”

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, additional Terms and Conditions will be incorporated into the award statement.

3. Reporting

The awardees are required to have a quarterly teleconference call with the AHRQ program officer to update progress on the project and to collaboratively discuss any challenges or problems affecting the project and the potential solutions to these challenges or problems.

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress report summary must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions.  For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

Section 1512 of The American Reinvestment and Recovery Act of 2009 (ARRA) requires prime recipients of the ARRA funds submit quarterly report, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10).  Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the ARHQ Website at http://www.ahrq.gov/fund/arraterms.htm.

A final Progress Report and Financial Status Report are required when an award ends.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

In addition, AHRQ is currently developing AHRQ-specific reporting requirements.  Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Award and incorporated into AHRQ Terms and Conditions of Award.

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 (includes the preliminary application and letter of intent phases of the program), 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.  This restriction applies unless:

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):

Direct your questions about general FOA issues, including information on the inclusion of priority populations to: PROSPECTgrants@ahrq.hhs.gov.  All scientific/research (program-related) inquiries pertaining to general FOA issues must be submitted by e-mail and will only be replied by e-mail.

Amy Lindinha
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
E-mail address:  PROSPECTgrants@ahrq.hhs.gov

2. Peer Review Contact(s):

Direct your questions about peer review issues of grant applications made in response to this FOA to:

Kishena Wadhwani, Ph.D., M.P.H.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov.

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address: George.Gardner@ahrq.hhs.gov

Michelle Burr
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address:  Michelle.Burr@ahrq.hhs.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 AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm   

Funding under this program is subject to the “Updated Guidance Regarding Communications with Registered Lobbyists About Recovery Act Funds” that was issued by the Office of Management and Budget on July 24, 2009 to implement section 3 of the President’s March 20, 2009 Memorandum entitled “Ensuring Responsible Spending of Recovery Act Funds.”  Many of the restrictions described in the guidance also apply to non-lobbyists after the submission of competitive applications for Recovery Act funds and before awards are made.  The guidance is available at http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.

Inclusion of Women and Minorities in Research Study Populations:
Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html).  A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:
Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, 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).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:
The OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain 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 or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption” in FOIA, 5 USC 552(b)(3).  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information.  NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

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 health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.


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