and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
Agency for Healthcare Research
and Quality (AHRQ), (http://www.ahrq.gov)
Components of
Participating Organizations
Center for Primary Care,
Prevention, and Clinical Partnerships (CP3), (http://www.ahrq.gov)
Title: Active Aging: Supporting Individuals and Enhancing Community-based Care through Health Information Technology (HIT) (P50)
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.
Request For Applications (RFA) Number: RFA-HS-10-016
Catalog of Federal Domestic
Assistance Number(s)
93.226
Key Dates
Release Date: December 17, 2009
Letters of Intent Receipt Date(s): February 25, 2010
Application Receipt Dates(s): March 25, 2010
Peer Review Date(s): Generally
three months after receipt date
Earliest Anticipated Start Date: Generally
three months after peer review date
Additional
Information To Be Available Date: Not applicable
Expiration Date: March 26, 2010
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
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
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to AHRQ/NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background and Research Objectives
Between 2005 and 2030, the number of adults aged 65 and older in the United States will almost double from 37 million to over 70 million, an increase from 12 percent to almost 20 percent of the population.1 The old old , those aged 85 and over, remain the fastest growing segment of the population. The sheer number of aging individuals presents both an opportunity and a challenge for society to restructure the way we support adults in their later years.
Aging provides, on one hand, opportunities for continuing and expanding of social interactions with friends, families and communities, especially as work and family responsibilities decrease. On the other hand, aging often results in the decline in many physical and mental capacities and is associated with increased risk of chronic diseases and physical and mental impairments that may result in loss of function, and an increase in dependence on family and friends for informal caregiving and long term care providers for formal caregiving. For many older adults there is often a diminishment of important social networks when extended families no longer live in close proximity, and friends and family members die. For women, who have a longer life expectancy than men, old age often brings years of widowhood. These challenges are not only personal, but have a tremendous impact on society as a whole.
While a large segment of this group will maintain health and independent functioning well past the age of 65, reaching traditional retirement age is generally accompanied by an increasing number of personal health challenges. The elderly, especially the old old, are large users of health care and social services. Although persons 65 and older make up only about 12 percent of the U.S. population, they account for approximately 26 percent of all physician office visits, 47 percent of all hospital outpatient visits with nurse practitioners, 35 percent of all hospital stays, 34 percent of all prescriptions, 38 percent of all emergency medical service responses, and 90 percent of all nursing-home use. In addition, the elderly, being reflective of the larger population, are faced with issues of disparity. In 2006 15.6% of older people lived near, or below the poverty level.2 Numerous older adults also experience one or more geriatric syndromes such as falls and malnutrition as well as more mental health conditions such as depression and anxiety.3 About one in six elderly persons receives long term care services, with one or more activities of daily living (ADLs), such as bathing and dressing, and instrumental activities of daily living (IADLs), such as shopping for groceries and preparing meals, provided by either informal or formal care, including care in the community or in nursing homes.4
The vast majority of these services are provided by informal caregivers, typically a spouse or child, and there is growing awareness that providing these informal caregivers with better information and improving their integration with the formal health care system leads to better overall health for the older adult. These caregivers often lack basic skills and knowledge to assist with home-based technologies, medically oriented treatments, or even simple tasks such as lifting and feeding. This lack of knowledge often leads to unnecessary use of health care and long term care. The management of chronic illness requires daily decision making. Patients and their care networks often lack the knowledge, information, resources, or the skills to be effective members of their health care team. As a result, elderly persons experience preventable events such as injurious falls, pressure ulcers, strokes, heart attacks and premature death. Health information technology exists that can help train informal caregivers and disabled elderly persons to better manage these disabilities and prevent further deterioration. In addition, when professional expertise is needed, communication-focused technologies can be accessed remotely. Health information technology can also be used to provide the essential information to all formal and informal members of the care team to help them prevent many of these negative health events. To the extent that patients and their caregivers are better able to manage their own health, and the care team can function more effectively, they will be less likely to depend upon members of the already limited health care workforce.5
Most people do not identify themselves as sick and old and would choose to remain in their homes and communities and retain their independence as long as possible. But for some, the effect of chronic physical and mental impairments may place inordinate demands on informal caregivers, necessitating formal home care services, assisted living care or nursing home care. The key is to provide support in ways that older persons and families can help balance the desires for independence, the burden of informal care, and the need for more formal services as physical and cognitive deficits increase. Several related informational technologies have the potential to help people remain active and socially engaged as they age. For example, health information technology applications, such as personal health management systems, facilitate the sharing of information among providers and patients and improve the ability to coordinate the complex care of older patients. Remote-monitoring technologies can extend the reach of health care professionals into the home and can provide for real-time communication between providers, the individual’s care network, and the individual. Other assistive technologies can enhance the independent functioning of older adults and reduce the demands placed on direct-care workers and informal caregivers.6
The purposes of this initiative are: 1) to provide a stable strategic mechanism for community-based participatory research that focuses on the use of communication and information focused technologies (IT) to improve the health and functioning of aging individuals and the health and long term services and supports provided to them and that allows for long term goal setting and iterative learning and reformulation and 2) to focus on implementation research7 with the objective of using scientific methods to promote the adoption of evidence-based information focused and communication technologies and practices that improve the health and personal care provided by formal and informal health care providers and the integration care provided by these two types of caregivers.
The initiative has three broad strategic themes: 1) the use of IT to extend independence and functioning and reduce unnecessary health care utilization by older adults; 2) the use of IT to place the individual and families at the center of expanded and more efficient service delivery networks; and 3) the development of innovative approaches to translate evidence generated in the first two thematic areas into practice.
Community-based participatory research (CBPR) approaches are of particular interest for this initiative. Following the spirit of CBPR, the projects making up this initiative are envisioned to be partnerships between communities and researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be participants in each phase of the work (i.e., conception, design, implementation, analysis, interpretation, conclusions, and communication of results).8
Community-partnered research processes offer the potential to generate more effective interventions, and enhance the translation of research results into practice. Specifically, involving community and academic partners as research collaborators may improve the quality and impact of research by:
For the purpose of this FOA, community refers to populations that may be defined as groups that have a common interest in aging services, such as residential communities for older adults, health or long-term care and supportive service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with aging health concerns. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community. Organizations as varied as Tribal governments and colleges, state or local governments, independent living centers, advocacy organizations, health delivery organizations (e.g., long-term care facilities, hospitals), health professional associations, non-governmental organizations, and federally qualified health centers are possible community partners. Participation of researchers from underrepresented racial and ethnic groups is encouraged as a way to build capacity among a new generation of diverse researchers that reflects the communities involved.
Theme 1: Use of IT to extend independence and functioning of older adults
The goal of this strategic theme is to explore how communication and information focused IT can support aging in place with the optimal level of independence and functioning. Given, however, that people will inevitably need assistance as they age, the secondary goals of this theme are to reduce unnecessary transitions in care and to improve the outcomes of those transitions that do occur. The research focus of this theme is not on particular assistive devices or technologies, but rather on how a variety of IT applications might be integrated to allow for better care management by the individual, his/her informal care network, and professional services providers. While the primary emphasis is on communication and information management technologies, other types of assistive technologies may be included when appropriate in research projects related to this theme.
Theme 2: Use of IT to place the individual at the center of expanded service delivery networks
The second strategic theme explored in this initiative is how IT can support the integration of the individual and his/her informal care network within an expanded health service delivery network. As healthcare becomes increasingly decentralized and distributed, care coordination has emerged as a central challenge. This is particularly true for the aging population. Healthy aging and independent living require more than health services provided in medical offices and other formal healthcare providers. However, the network of care providers and aging services extends far beyond healthcare professionals and paraprofessionals. Social services, as well as services provided in the home, all must be coordinated as well. Community-based continuing care models are becoming central in aging care and significant work has been done addressing the issue of care coordination among service providers.
On the formal organizational side, there is a need to establish better coordination among healthcare providers and organizations that provide other services that impact health, such as long-term care, social services and transportation services.
Beyond the network of formal service-providing organizations, an even more significant network is the individual’s social network of informal care providers. This is often extensive, including not only family and friends, but also individuals hired to provide personal care services.
Currently there is little formal contact between the informal network and the professional care network, yet care received between formal healthcare episodes, e.g., doctor visits, hospitalizations, etc., has a profound influence on the health and functional status, and independence of the individual. This is particularly true for all preventive care, but most importantly for secondary and tertiary prevention interventions, which rely on active participation of the individual and their informal care network.
IT now offers the capability to create a much tighter integration between the formal and informal care networks, putting the individual more squarely at the center of their care in a more decisive role. Integrating the informal care network with the formal care network would also provide opportunity to enhance the knowledge and skills of informal caregivers. This initiative seeks to assess the potential of this tighter social network integration to achieve the goals of the first strategic theme. It is anticipated that this research would rely heavily on social science methodologies such as network analysis. For example, researchers might first assess whether IT increases the centrality and prominence of the older adult within their formal and informal care networks, then evaluate whether the increased centrality and prominence result in higher independence, functioning, and improved health status.
Theme 3: Translation of best practices
The third strategic theme is focused on how IT can support innovative approaches to translate findings from the research supported by the first two themes into practice at the level of service delivery.
Gathering evidence and identifying best practices provides the framework for positive change, but does not motivate change directly. Traditional avenues of dissemination of research findings such as peer-reviewed publications and presentations at conferences are passive in nature and have very limited diffusion capabilities. Other push publication methods, such as web sites, while perhaps reaching larger audiences, also have limited behavioral change impact. Participatory learning and continuing re-enforcement based on meaningful feedback provides more individualized interaction and produces greater and more permanent behavioral change. IT is increasingly providing tools that support this level of rich interaction down to the individual level and the interaction of individuals in teams. This expansion of the capacity to communicate effectively with anyone, anywhere, offers a rich field of inquiry on effective approaches for translating research into action.
Studies of the multidimensional challenges of translating research into everyday practice are hampered by the current concentration of clinical research in academic settings. In addition, the majority of strategies that have been studied focus on changing clinician behavior. To pursue translational studies outside the academic setting and to include informal care networks, researchers must be able to work closely over time with community-based providers and with communities themselves. They need to study the patient populations cared for in the aging services community and better understand the realities of community practice (e.g., providing care to a heterogeneous population of patients in a variety of home and community-based settings or busy office settings). At the same time, community providers appear to be more willing to participate in research if they are involved in its design, conduct and analysis.9 Through their active participation in the research effort, providers not only develop greater ownership of the entire process but also come to understand the tangible applications of the research to their practice. This sense of research ownership has been shown in community-based participatory research to extend beyond professionals to individual members of the community as well. Since community-based research networks allow academic researchers access to the aging services community, while also actively engaging the community in the research effort, they offer a unique opportunity to address important issues related to the translational block. 10
The Center projects funded under this initiative are expected to identify, refine, and evaluate successful strategies for translation of research findings into practice such that the efforts are sustainable, can be rapidly transferred to or replicated in other settings, and can lead to demonstrable improvements in care quality, outcomes, efficiency, or cost-effectiveness. Sustainable efforts are those that continue beyond the period of funding support and will persist despite the rapid changes in staff and conditions that health care organizations are facing today.
Research Topics and Approaches
The grantee will develop an overarching, comprehensive strategic plan that prioritizes a broad base of research needs across the three strategic areas outlined above. Specific projects conducted by the grantee should focus on strategies to achieve goals that fit within the framework of the overall initiative. While each proposed project should be distinct in its goals and implementation, it should also be explicitly part of a larger strategic plan that reflects the related nature of this initiative’s three strategic themes. Projects that build on each other and ultimately result in changes in day to day practice of formal and informal caregivers and self-care with a community based strategy for dissemination are preferred.
AHRQ funding will provide infrastructure support (a research team with adequate facilities, institutional support, and access to appropriate expertise needed to perform research, dissemination and translation of research into practice), as well as resources for several interrelated projects over the five year period of performance that address the three strategic themes as a whole. A minimum of 3 core research projects (one supporting each strategic theme) are to be included in this application.
An example of such a set of independent but related projects that address the three strategic themes in an integrated way could be the implementation of an integrated care portal built on an expanded consumer health IT application (such as a health self management system). Such a portal might receive health event information from the individual through remote physiologic sensors, or through information provided by the individual (or his/her care network) such as activity or nutrition logs. These devices could be located in the individual’s home, or could be mobile devices that can be carried with the individual as they go about their daily activities. The implementation, integration, and use of the various technologies could be a specific project under this initiative. Data and information captured by the information technology (such as the devices described above) could be sent to a central repository, such as an online health record. This health record would be controlled by the individual, but it would function as an integrated care management record in that it would provide information and decision support not only to the individual, but to all of the various caregivers (both formal and informal) that need to interact in order to provide optimum support. The system could be capable of using decision support tools to create an alert that is sent to both professional caregivers and informal caregivers should the data and information received from the individual indicate a possible change in health and/or functional status. Development of such an enhanced consumer health IT application is an example of a specific project that could be proposed under this initiative, that would require use of participatory design approaches which engage the patient and both informal and formal care providers, as well as a rigorous understanding of the context in which the application would be used and the type of health management work in which both patients and informal caregivers are engaged.
Once alerted to the possible need for supportive intervention, the integrated care network of formal and informal care providers might then use social networking or collaborative tools and electronic reports to discuss the issue and develop an intervention. The results of the intervention could then be monitored through the system and modified if necessary to achieve the outcomes desired. Part of the products for such a project would include the programming specifications for commercial health IT vendors and would likely include vendors as part of the community of participants. Other uses for such a collaborative work space might be to provide remote consultation with specialists, skills training for informal caregivers relevant to the individual’s needs, and a space for the individual to develop and maintain a broader social network. Research projects related to social networking/collaborative technologies as active research translation tools would serve to round out this integrated set of projects described in this example.
Research Settings for this FOA
Applications responsive to this FOA must focus on implementation of health IT in one or more of the following care settings: ambulatory setting(s); transitions in care between ambulatory settings; or transitions in care between an ambulatory setting and non-ambulatory setting. For the purposes of this FOA, ambulatory care settings include: health care clinician offices; clinician practices; outpatient clinics; outpatient mental health centers; outpatient substance abuse centers; urgent care centers; ambulatory surgery centers; community-based, school, or occupational health centers; safety-net practices; pharmacies; patients homes; independent living centers; and residential care.
Applications that feature health IT implementation in a non-ambulatory setting, such as a hospital or a skilled nursing facility or an inpatient mental health facility for purposes other than facilitating transitions in care to and from an ambulatory setting will be considered non-responsive to this FOA and will not be reviewed.
Features of the Application
See Section IV.6, Other Submission Requirements, for instructions on the required and requested fundamental features of a research proposal.
See Section VIII, Other Information Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the P50 Specialized Center mechanism. The PD/PI sponsored by the organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.
The total project period for applications submitted in response to this FOA may not exceed five years.
Non-competing continuation awards will be contingent upon satisfactory progress. The AHRQ program officer is responsible for the annual progress review. However, AHRQ, at its discretion, may convene external reviewers to supplement the program officer review.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.
2. Funds Available
AHRQ intends to commit up to $2,000,000 total costs in FY 2010 to fund one application to build an infrastructure that supports the initiative and to begin the research agenda. AHRQ plans to award a total amount of up to $10,000,000 (total costs) over five years. The total amount awarded will depend upon the quality, duration, and proposed research projects of the applications received.
Applications may be up to five years in duration not to exceed $2,000,000 per year in total costs to the government in any given year. Applications with project periods that exceed five years or budgets that exceed $2,000,000 total costs in any given year will not be reviewed.
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. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.
Section
III. Eligibility Information
1. Eligible Applicants
You may submit an application(s) if your institution/organization has any of the following characteristics:
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. 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 not be reviewed. 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.
2. Cost Sharing or Matching
This program does not require cost sharing for applications in response to this FOA.
While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This can be included at the end of the budget justification section of the application, but institutional support dollars are not to be included in the detailed budget request.
3. Other-Special Eligibility Criteria
The PD/PI for applications responding to this FOA will need to act as the Lead for the Active Aging Research Center (AARC) and build the Center, as well as establish governance through a National Steering Committee. To inform the AARC development activities, the PD/PI must hold preliminary discussions with relevant aging services and other important stakeholders regarding current and expected trends in aging services research, particularly as related to communication and information technologies.
Upon award, the PD/PI will appoint the AARC Steering Committee Chair and members of the AARC Steering Committee, which will include not only initiative project investigators but other relevant stakeholders. An AHRQ Program Official will also serve as ex-officio member of the Steering Committee. Since the preferred methodological approach is community-based participatory research, the AARC Steering Committee should also include representatives from involved communities, including a consumer representative. All ex-officio members are non-voting, and the PD/PI will have the final approval for all committee appointments. The AARC Steering Committee chair shall be a well regarded researcher and shall not have any financial conflict of interest.
The Center Steering Committee (CSC)
The AARC will have a CSC as the governing body of the Center development. Voting members of the CSC include, at a minimum, the Chair and lead co-investigators for the core projects. The chair will advise the PD/PI (AARC) on research activities and functions, and conduct SC meetings. The AARC will support the CSC to ensure compliance with Center policies/procedures.
The AARC will also support the CSC in identifying and prioritizing topics for investigation and evaluate secondary proposals developed by participating researchers. The CSC will ensure that project results are reported in the scientific literature in a timely manner and promptly disseminated to those directly involved in the care of patients.
Funds must be budgeted to hold CSC meetings as often as three times in the first 12 months of the AARC development, two to four times per year thereafter, and by teleconference on a monthly basis throughout the initiative period.
It is anticipated that the AARC will be a great resource for conducting numerous non-AHRQ supported secondary research projects in addition to three core large scope project proposals outlined in the application. The CSC will be responsible for approving these leveraged secondary proposals submitted by participating researchers. Prior to being forwarded to the steering committee, secondary proposals will be evaluated by the Publication and Proposal Review Subcommittee (see section IV, 6).
Applicant institutions may submit more than one application in response to this RFA, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.
Applications must include a data safety and monitoring plan. There must be a system for the appropriate oversight and monitoring of the conduct of research to ensure the safety of participants and the validity and integrity of the data for all AHRQ-conducted or supported research. 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 plans are required in all research grant applications when support is sought to study the effect of a health-related intervention on outcomes in human subjects, including biomedical, behavioral, public health, health care system, and/or diagnostic interventions that potentially affect the outcome of the study participants. 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 potential risk to research participants, multiple sites, blinded (masked) designs, or vulnerable populations (e.g., children, pregnant women, frail elderly).
Resubmissions: Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Number of Applications. Applicants may submit more than one application in response to this solicitation and may simultaneously respond to other AHRQ funding announcements, provided each application is scientifically distinct.
Section
IV. Application and Submission Information
1. Address to Request
Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently
approved version of the PHS 398. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the
face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A below
for details.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): February 25, 2010
Application
Receipt Date: March
25, 2010
Peer
Review Date(s): Generally three months
after receipt date
Earliest
Anticipated Start Date(s): Generally three 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 can be sent
electronically, and should be sent to:
Angela Lavanderos
Center for Primary Care, Prevention, and Clinical
Partnerships
Agency for Healthcare Research and
Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1505
FAX: (301) 427-1597
Email: [email protected]
The letter of intent is to be sent by the date listed in Section IV.3.A
3.A.2. Technical Assistance
AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on Wednesday January 13, 2010 at 1:00 pm EST. To register to participate in the conference call, please send an e-mail request to Angela Lavanderos ([email protected]) by Friday January 8, 2010. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB Monday January 11, 2010. Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).
The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to [email protected] by Friday January 8, 2010. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ web site.
3.B.
Sending an Application to AHRQ/NIH
Applications must be prepared using the forms found in
the PHS 398 instructions for preparing a research grant application. Submit a
signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications
are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the
application and all copies of the appendix material must be sent to:
Angela Lavanderos
Center for Primary Care, Prevention, and Clinical
Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1505
FAX: (301) 427-1597
Email: [email protected]
3.C.
Application Processing
Applications must be received
on or before the application receipt date described
above (Section IV.3.A.). If an application is received after that date, the
application may be delayed in the review process or not reviewed. Upon
receipt, applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
Use of CMS Data
Purchase of Centers for Medicare and 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 Privacy rules 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 ultimate goal of this grant is the implementation of evidence-based use of health IT to improve health outcomes for older adults. Each applicant must demonstrate evidence of its ability to develop research, education, dissemination and implementation plans to match the needs and priorities that they have identified within the initiative’s strategic themes.
The applicant should describe in detail an approach to the initiative’s strategic themes, including the priorities and criteria for the choice of projects within each theme and how each project contributes to the overall initiative. In addition, the applicant should articulate specific outcomes it expects to achieve as a result of the program of work being undertaken.
The applicant should identify and describe relationships with several intermediary (e.g., appropriate professional organizations) and end-user groups (e.g., consumers and patients, service providers) who the applicant will consult with as research, products, and implementation strategies are designed. These partners must be willing to help foster dissemination and translation of findings and products into practice. Letters of support from these organizations should be included in the application.
The application must address 1) core functions related to management and coordination of an interrelated set of specific projects addressing the three strategic themes of the initiative and how findings of these projects will be synthesized and translated into practice, and 2) the specifics of each project proposed for each theme, including any outcomes to be measured.
Additional Guidance for Core Functions:
PD/PI Responsibilities:
1. Within three months after the award, the PD/PI as lead for AARC, will be required to organize the first meeting of the Center Steering Committee (CSC) where Chair, voting, non-voting members of steering committee and stakeholder representatives will be elected/ approved. ARCC will also perform all necessary work to establish a central IRB (whenever possible) to facilitate conduct of projects.
2. The PD/PI must establish a Publications and Proposal Review Subcommittee (PPRS) of the steering committee. The subcommittee will consist of a chair and clinicians and scientists with broad range of expertise relevant to the proposed projects. The PPRS will evaluate leveraged secondary study proposals (beyond the three core proposals) under review by the CSC based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, and appropriateness for the Center. The PPRS will provide a written critique of each proposal and a final recommendation to the Center Steering Committee. All project proposals performed by the ARCC investigators must be recommended by the PPRS and approved by the Center Steering Committee before initiation. It is anticipated that more than one proposal will be active at any given time. The Publications and Presentations Review Subcommittee will facilitate and work with AARC in preparation of manuscripts prior to submission for publication.
3. The PD/PI and co-investigators involved in the AARC may find it advantageous to seek additional support from or other involvement by industry or other third parties (e.g., the VA, CMS, nonprofit foundations) for the studies themselves or for leveraged studies. Accordingly, the PD/PI must establish Public Private Partnership subcommittee of the Steering Committee that will be responsible for approval of all partner involvements. The applicant should structure the application, such that it is evident that the applicant will have the flexibility to develop new projects on an annual basis and develop collaborative relationships with other organizations engaged in similar activities.
4. The PD/PI must be an experienced senior investigator and manager who can provide strong administrative and academic leadership. The PD/PI will be responsible for the organization and operation of the ARCC; liaison with the research community and outside entities such as professional societies, subcontractors, and consumer groups; and communication with AHRQ on scientific and operational matters.
5. The PD/PI must contribute a minimum of 25 percent (three person/months/year) effort throughout the course of the grant.
1. AHRQ does not expect the findings from these demonstration projects to be generalizable in a national sense. However, applications should demonstrate that findings will be transferable to other settings and/or populations and to acknowledge limitations, if any, in interpretation of those findings. Applications should articulate how information generated from a proposal could be transferable to other ambulatory settings or transitions in care given the extent to which a similar health IT application is or could be deployed.
Additional Guidance for Thematic Projects:
Overall Budget:
AHRQ intends to commit up to $2,000,000 total costs in FY 2010 to fund one application that will include an AARC to build an infrastructure that supports at least three core research projects related to the initiative strategic themes. AHRQ plans to award a total amount of up to $10,000,000 (total costs) over five years. The applicant must submit a composite budget for the overall AARC and individual budgets and budget justifications for the AARC and each of the three research projects. The individual budgets, totaled together, must equal the composite budget. The budget must include, at a minimum:
Applications must use the detailed budget format.
Applications in response to this FOA, must be structured as to allow for the review of a discrete budget for each proposed major project.
Privacy and Security Protections in the Development and Implementation of Health IT Systems:
From its earliest investments in health IT research activities, AHRQ has emphasized the importance of the privacy and security of personal health information to engender individual trust in the use and exchange of health information. Without this trust and faith in an information system, patients and other users (e.g. clinicians, caregivers, etc.) will not use it fully, and system data will be inaccurate or incomplete. As a result, the potential for quality and safety improvement from investments in health IT will be lost. More importantly, assuring privacy and security are values patients should expect and receive from the health care system.
Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information. New concerns arise, such as who has access to and use of electronic data, how electronic data are stored and kept secure, disclosure to patients regarding the collection and use of the data, patient consent requirements, the ability of patients to decline participation in electronic data collection, patient access to audit records, what happens to data after research is completed, and informing patients of any security breaches.
Developers of electronic health information systems have promulgated policies in order to assure patient awareness of, comfort with, and participation in electronic data collection and use. While privacy and security solutions are not intended to be the focus of projects under this announcement, interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://healthit.ahrq.gov/hiepolicyissues).
Distinct from a Plan for Protection of Human Subjects, applications must contain a Plan for Privacy and Security Protections in the Development and Implementation of Health IT System. Near the end of the Research Methods, applicants must insert the header, Plan for Privacy and Security Protections in the Development and Implementation of Health IT System. This section must contain a concise summary of the planned resources and processes to be used to address privacy and security issues in the development and implementation, and/or use of the health IT intervention.
A full description of the plan for Privacy and Security Protections must be included in Appendix A. The appendix must describe how, in the development and implementation, and/or use of the health IT intervention; privacy and security issues related to the exchange of sensitive health information will be identified and addressed. The appendix should describe the resources and processes they will use to assure that these privacy and security concerns are being met throughout the project period. These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.
The adequacy of the Plan for Privacy and Security Protections in the Development and Implementation of Health IT System will be assessed by the peer review panel and will be reflected in the priority score. AHRQ reserves the right to request clarification on the Plan for Privacy and Security Protections prior to funding.
Research Plan Page Limitations
The research plan section of the application must be no more than 25 pages in length.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CD only. Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
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 include two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), 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.
Considerations for Informed Consent
AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.
IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in (45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.
Section
V. Application Review Information
1. Criteria
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.
Merit Review Criteria are
described below. The review criteria described below will be considered
in the review process.
2. Review 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:
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.
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).
Core 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 this application address the three strategic themes identified in the announcement? Does this application demonstrate that an important challenge or gap in the literature regarding health IT implementation and use in addressing health needs of older adults and formal and informal caregivers will likely be addressed? Does the application adequately recognize and describe the limitations in the generalizability of the results and demonstrate the applicability of the research findings to other settings and circumstances? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Does the PD/PI and investigative team bring complementary and integrated expertise to the initiative? Is there adequate PD/PI support allocated throughout the research period or a well-justified reallocation of leadership during the course of initiative when PD/PI’s support is less than suggested fifteen-percent level? Does the application demonstrate the investigators aptitude to identify and address weaknesses found either in the proposal or encountered during the conduct of the initiative? Does the application demonstrate that the project team will have adequate administrative structure and processes in place to oversee the successful conduction of the proposed study?
Does the applicant demonstrate a history of involvement in multi-center research or similar programs, as the grantee will work cooperatively with a variety of partners from government and the private sector?
Does the applicant provide evidence of past success in developing partnerships, including reports on funds obtained through leverage of public-private partnerships for a program should be included with this application?
Does the PD/PI and investigative team have experience with implementation research and with dissemination and translation of research?
Innovation: Is the approach to the initiative and the specific projects proposed original and innovative? For example, do the projects challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Do the projects develop or employ novel concepts, approaches, methodologies, tools, or technologies; or combine common research elements in an innovative fashion? Do the projects extend existing health IT to new settings or with new providers and patient populations? If the research elements are not novel, would the projects generate much-needed insight to inform the field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the initiative? Does the applicant address the role of community-based participatory research in the development of specific projects? To what extent are patients and/or families and other informal caregivers directly involved in the design, development and/or selection of the health IT application or is adequate justification of why their involvement is not feasible or appropriate provided? To the extent that staff, patients and families are directly involved in the health IT implementation, is their perspective on the use and/or utility of the health IT sought or an adequate justification of why such information is not feasible or appropriate provided? Does the application reflect an appropriate level of understanding of workflow and factors impacting successful health IT implementation, use, and sustainability? How appropriate are the proposed process and clinical outcome measures? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Environment: Do the environments in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the environments, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support.
The infrastructure and capacity of the applicant are among the most important criteria. Capacity should include evidence of the ability to provide rapid production of information, the ability to link geographically and academically diverse research groups, and the capability for accessing and interfacing with the health care delivery systems supporting older adults and with older populations directly. Applicants must have an appropriate administrative structure in place and demonstrated management capability that will enable it to complete projects in a timely fashion, with full accountability for funds.
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.
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?
Privacy and Security Protections in the Development and Implementation of Health IT System: Has the applicant adequately described the privacy and security policies and features of the health IT systems being developed, implemented, or used in the proposed studies? Has the application adequately described the process for identifying and addressing privacy and security issues related to the exchange of sensitive health information and encouraging the involvement of patients to the extent appropriate? Has the application adequately considered patients access to audit records, disclosure to patients regarding collection and use of electronic data, patient notification of security breaches, patient consent process, and ability for patients to decline participation in electronic data collection?
Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? To what extent is the support of key personnel appropriate across the duration of the study? Is the budget allocation for purchase of health IT hardware, software, and support appropriate and well justified?
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).
Translation: Programs developed for this application should show plans for how the research will be translated into specific, measurable outcomes. It should include a plan that describes the steps required to progress from developmental pilot programs to national programs that measurably affect outcomes
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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 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
AHRQ grantees may copyright, unless otherwise provided in grant awards, 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).
Selection Process
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:
3. Anticipated Announcement and Award Dates
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under
consideration for funding, 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 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. Once all administrative and programmatic issues
have been resolved, the Notice of Award will be generated via email
notification from the awarding component to the grantee business official. The NOA signed by the grants management officer is the
authorizing document.
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, Terms and Conditions will be incorporated into the award statement.
When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.
The annual progress reports must include Section 2.2.6 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.
A final Progress Report, Final Invention Statement, and final 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.
We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may be written or by telephone,
and fall into three areas: scientific/research (program), peer review, and
financial or grants management issues.
1. Scientific/Research Contacts:
Direct your questions about general FOA issues, including information on the inclusion of priority populations to:
Robert Mayes
Center for Primary Care, Prevention, and Clinical
Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1492
Fax: (301) 427-1597
E-mail address: [email protected]
2. Peer Review Contacts:
Direct your questions about peer review issues of grant applications made in response to this FOA to:
Boris Aponte
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) 427-1396
Fax: (301) 427-1562
E-mail address: [email protected]
3. Financial or Grants Management Contacts:
Direct inquiries regarding fiscal matters to:
Al Deal
Office of Performance Accountability, Resources and
Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1792
E-mail address: [email protected]
Section
VIII. Other Information
Required Federal Citations
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 (HIPAA) of 1996 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 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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, 5 USC 552(b), 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 or Health
Systems Agency review. 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.
References
1. Retooling for an Aging America: Building the Health Care Workforce. (2008). National Academies Press, Institute of Medicine.
2. Administration on Aging (2008). A Profile of Older Americans: 2008. http://www.aoa.gov/AoAroot/Aging_Statistics/Profile/index.aspx
3. Retooling for an Aging America: Building the Health Care Workforce. (2008). National Academies Press, Institute of Medicine.
4. Spector WD, F. J., Pezzin LE, Spillman BC. (September 2000). The characteristics of long-term care users, AHRQ Research Report.
5. Retooling for an Aging America: Building the Health Care Workforce. (2008). National Academies Press, Institute of Medicine.
6. Retooling for an Aging America: Building the Health Care Workforce. (2008). National Academies Press, Institute of Medicine.
7. Eccles MP, A. D., Baker R, Cleary K, Davies, H, Davies S, Glasziou P, Ilott I, Kinmouth A, Leng G, Logan S, Mareau T, Michie S, Rogers H, Rycroft-Malone J, and Sibbald B. and (2009). "An implementation research agenda." Implementation Science 4:18.
8. Vishwanathan M, e. a., (ed.) (2004). Community Based Participatory Research: Assessing the Evidence Rockville, MD, Agency for Healthcare Research and Quality.
9. Nutting PA, B. J., Werner JJ. (1999). "Practice-based research networks answer primary care questions. ." Journal of the American Medical Association 37: 1092-1104.
10. Genel M, D. S. "Translating clinical research into practice: practice-based research networks a promising solution." J Invest Med 51(2): 64-71.
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