Part I Overview Information
Department of Health and Human Services
Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov)
Components of Participating Organizations
Center for Quality Improvement and Patient Safety
Title: Consumer Assessment of Healthcare Providers and
Systems (CAHPS) III (U18)
Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Request For Applications (RFA) Number: RFA-HS-07-001
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: October 4, 2006
Opening Date: November 20, 2006.
Letters of Intent Receipt Date: November 20, 2006.
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 Submission/Receipt Date: December 18, 2006
Peer Review Date: Within three months of submission.
Earliest Anticipated Start Date(s): June 2007
Expiration Date: December 19, 2006
Due Dates for E.O. 12372
This Funding Opportunity Announcement (FOA) will utilize the cooperative agreement (U18) mechanism in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The purpose of this FOA for CAHPS III is to continue the work of the Consumer Assessment of Healthcare Providers and Systems project (or CAHPS) which AHRQ began in 1995. CAHPS III has four main objectives. The first is to develop and test ways that organizations can use CAHPS data for quality improvement purposes. AHRQ is particularly interested in testing and disseminating ways that data from the CAHPS instrument for clinicians/group practices can be used for this purpose. The second objective concerns conducting research on and strategies for reporting CAHPS results to consumers, patients and other audiences. Though AHRQ continues to be interested in better ways to report survey results to support consumer choice (of health plans, providers, hospitals, etc.), the Agency is also interested in research on reporting CAHPS results to various audiences for quality improvement purposes. In addition, AHRQ is interested in the development and testing of resources to assist report developers in designing useful and usable reports. The third objective concerns instrument development and refinement. Since a large percentage of resources in CAHPS I and II were devoted to instrument development, AHRQ expects to spend a relatively small proportion of CAHPS III resources in this area (See section IV.6, Application Characteristics, for budget assumptions). However, there will be a survey for residents of assisted living facilities developed, and others may be developed as well depending on need, cost and likelihood of use. The fourth and final objective is to continue to disseminate and promote the use of CAHPS products.
Eligible organizations: You may submit (an) application(s) if your domestic organization is a:
Foreign institutions and for-profit organizations may participate in projects as members of consortia or as subcontractors only. Applications submitted by foreign institutions or for-profit organizations will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
While grant awards are made to institutions rather than individuals, the applicants are institutions, although individual researchers assume considerable responsibility for preparation of the applications. This announcement and its instructions are written to inform 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to AHRQ
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
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
A. BackgroundOverview of CAHPS
The purpose of this FOA for CAHPS III is to continue the work of the Consumer Assessment of Healthcare Providers and Systems project (or CAHPS) which AHRQ began in 1995. For the past 11 years, the CAHPS team—CAHPS grantees, the Survey User Network and AHRQ CAHPS staff--has developed and tested surveys through which consumers can assess the quality of care they receive through their health plans, from providers and in hospitals, nursing homes, in-center hemodialysis facilities and other settings. The CAHPS team has also conducted research and developed guidance for reporting these data to consumers, providers and other audiences. (Detailed information about CAHPS products and history can be found at www.cahps.ahrq.gov.) In 2006, 130 million Americans were enrolled in health plans for which CAHPS data were collected.
CAHPS III has four main objectives. The first is to develop and test ways that organizations can use CAHPS data for quality improvement purposes. AHRQ is particularly interested in testing and disseminating ways that data from the CAHPS instrument for clinicians/group practices can be used for this purpose. The second objective concerns conducting research on and strategies for reporting CAHPS results to consumers, patients and other audiences. Though AHRQ continues to be interested in better ways to report survey results to support consumer choice (of health plans, providers, hospitals, etc.), AHRQ is also interested in research on reporting CAHPS results to various audiences for quality improvement purposes. In addition, the Agency is interested in the development and testing of resources to assist report developers in designing useful and usable reports. An example of such a resource can be found at www.talkingquality.gov. The third objective concerns survey instrument development and refinement. Since a large percentage of resources in CAHPS I and II were devoted to instrument development, it is expected that a relatively small proportion of CAHPS III resources will be spent in this area. However, there will be a survey for residents of assisted living facilities developed, and others may be developed depending on need, cost and likelihood of use. The fourth and final objective is to continue to disseminate and promote the use of CAHPS products.Detailed information on CAHPS I and II
Investigators are encouraged to consult the CAHPS section of the AHRQ web site (www.cahps.ahrq.gov). This is a rich source of information about all aspects of CAHPS including products, administration instructions, publications, CAHPS principles for instrument development and much more. This resource will be especially important to applicants who were not funded under CAHPS I or II.
Though the background documents represent the current “best thinking” regarding development and testing of CAHPS products, applicants should not feel constrained by their conclusions or recommendations. Applicants are encouraged to “think beyond” these materials and present different strategies and new approaches to the research challenges stated in this FOA.
Applicants who are unfamiliar with CAHPS products and research may find it helpful to review the definitions listed below before reading the remainder of this section.Definitions of terms
The CAHPS I and II grantees and the Survey User Network (SUN) contractor have conducted their work by dividing team members into groups that perform specific tasks or work towards defined goals. Since this approach has been successful, CAHPS III will begin with these types of work groups. After awards are made and grantees gain experience with the work, they will meet with the Project Officers to determine if there are more efficient ways to subdivide the grantee teams to facilitate the completion of agreed-upon goals.
Provided below are definitions of particular work groups and other terms that will be encountered in documents referenced throughout this FOA.
CAHPS I. “CAHPS I” began in 1995 and concluded in 2002. This was a five year grant program which was extended by two years. During this time span, the CAHPS team developed and tested the health plan (and other) surveys; developed and tested a reporting template for data from this survey; and evaluated the usefulness of survey information to consumers in a number of settings. A supplement to Medical Care (Volume 37, #3, March 1999) provides a detailed description of products developed and research methods used during CAHPS I.
CAHPS II. “CAHPS II” cooperative agreements began in 2002 and will conclude in May 2007. During this time, the team developed and tested CAHPS instruments for clinicians/group practices, hospital patients, residents of nursing homes, family members of residents of nursing homes, in-center hemodialysis facilities and other populations and facilities. They also developed reporting resources and a Report Card Compendium and conducted a quality improvement project with in-center hemodialysis facilities. These products are more fully described on the CAHPS web site (www.cahps.ahrq.gov) and in the “Research Objectives” section of this document.
CAHPS Consortium. “The CAHPS Consortium” refers to the entire line-up of people who work on CAHPS, direct its work or advise the grantees. This includes all grantees, AHRQ CAHPS staff (Project Officers and others), the SUN contractor, and representatives of funding partners such as CMS. Throughout this FOA, the term “CAHPS Consortium” is used interchangeably with “the CAHPS team.”
National CAHPS Benchmarking Database. The primary purpose of the National CAHPS Benchmarking Database (NCBD) is to facilitate comparisons of CAHPS survey results by and among survey sponsors who voluntarily submit their data. This compilation of survey results from a large pool of sponsors into a single national database enables participants to compare their own results to relevant benchmarks (i.e., reference points such as national and regional averages). The NCBD also offers an important source of primary data for research related to consumer assessments of quality as measured by CAHPS surveys. The NCBD currently contains 8 years of data from the CAHPS Health Plan Survey. The 2005 database holds survey results for approximately 327,000 adults and children enrolled in commercial, Medicaid, SCHIP, and Medicare plans. The NCBD will continue to expand as the number and variety of CAHPS survey instruments grows. Over the next year or so, the NCBD expects to develop benchmarking data for the Clinician & Group Survey and possibly other CAHPS surveys. There is additional information about this resource on the CAHPS section of the AHRQ web site (www.cahps.ahrq.gov).
CAHPS Survey and Reporting Kit. The CAHPS Survey and Reporting Kit, or CSRK, is referred to throughout this FOA. The CSRK contains all CAHPS products as well as detailed advice on their use. The entire kit, or portions related to specific instruments, can be downloaded from the CAHPS section of the AHRQ web site (www.cahps.ahrq.gov).
CAHPS Survey User Network. The SUN or Survey User Network contract is a five year contract for the provision of various types of support to the CAHPS Consortium. This support includes preparing CAHPS products for dissemination to potential users; providing technical assistance to users; providing communication support to facilitate the work of the CAHPS Consortium; providing technical and conference support for meetings; and providing support for a National CAHPS Benchmarking Database (NCBD) described below. During CAHPS I and II, the SUN contractor played a critical role in identifying the needs of current users of CAHPS products, responding quickly and efficiently to those needs, and developing effective strategies for communicating with users on a regular basis. The ways in which the grantees will interact with the SUN contractor are described in greater detail in the “Research Objectives” section. Additionally, there is a brief section describing the activities of the SUN contract on the CAHPS section of the AHRQ web site (www.cahps.ahrq.gov).
Grantee Advisory Committee. Including representatives from the target audience in the development and testing of CAHPS products—or any product—is essential to its success and eventual adoption. For some products, the grantees in CAHPS I and II decided that regular, sustained input from users was critical. For example, in CAHPS II, the PI/PDs and instrument team members concluded that the CAHPS survey for clinicians/group practices would best be developed in concert with several stakeholders, such as the Massachusetts Health Quality Partnership, the Pacific Business Group on Health, AARP and others. To facilitate frequent communication and regular contact, the grantees asked representatives from these groups to meet at key intervals by phone or in-person as an advisory committee. Though this instrument is near completion, it is anticipated that the CAHPS team will consult them on issues of interest (e.g., promotion of the instrument; use of the instrument in quality improvement studies) as the work of CAHPS III continues. CAHPS III grantees may choose to develop advisory groups in other areas for similar purposes.
Grantee Team. Each grantee and their contractual partners/collaborators are referred to as a “grantee team.” However, applicants must understand that the primary grantee is ultimately responsible for the project, including the programmatic and fiscal management of third parties.
Steering Committee. The CAHPS Steering Committee meets at the beginning of each project year to determine the direction of the work and outline specific tasks to be completed within that year. In CAHPS II, members of the CAHPS Steering Committee were the AHRQ Project Officers, at least one representative from each of the organizations which partner with AHRQ to fund the CAHPS grants, and the CAHPS PI/PDs and their alternates. The project director of the Survey User Network contract also attended these meetings to provide information about CAHPS user needs but did not have an official voice in determining direction of the work of the cooperative agreements. At this time, CMS is expected to be a CAHPS funding partner. Other funding partners may be identified in the future. Additional members will be added as necessary as decided upon by the existing Committee members.
Project name. Finally, the name of this project has been updated to reflect its expanded focus. At the beginning of CAHPS, going beyond development of instruments for health plans was not anticipated, so the name “Consumer Assessment of Health Plans Study” seemed appropriate. In the years since 1995, instruments have been developed through which consumers can assess the care they receive in many ambulatory and facility-level settings (for the complete list see the CAHPS section at www.cahps.ahrq.gov). In view of this, in 2005, the name of the project was changed to “Consumer Assessment of Healthcare Providers and Systems” which better describes the range of products and allows the CAHPS acronym to be maintained.
B. Research Objectives
This FOA will describe research to be performed within four broad areas: a) quality improvement studies based on CAHPS data; b) reporting CAHPS data, c) developing, maintaining, refining and advancing CAHPS survey products, and d) disseminating and promoting CAHPS products. Each is described in detail below. Performing high quality work in these four areas will require skill and expertise across a wide range of fields and disciplines. It is unlikely that any single organization wishing to respond to this FOA will contain within itself people with a range of skills sufficient to perform all the required tasks. So it is encouraged that applicants team with individuals or organizations who add expertise in important areas.
This FOA lists tasks or approaches to tasks as examples of the kind of work that could be performed in support of a particular effort. These lists are usually based on CAHPS experience and are offered as illustrations or expansions on what is meant by “quality improvement studies” or “reporting research.” Applicants should not feel constrained by these suggestions or regard them as inclusive of all the tasks that may need to be performed in a given area.
Applications that respond only to individual objectives of this FOA rather than the entire range will be returned without review.
1. Quality Improvement Studies
CAHPS began with a primary goal of providing high-quality information which consumers and purchasers would use to support their health plan selection decisions. As CAHPS has evolved, there has been growing interest in exploring the usefulness of CAHPS data for designing strategies to improve the quality of health care from the consumer or patient perspective. For the purpose of budget preparation for this FOA, applicants should assume that 35% of the budget will go towards designing, conducting and evaluating studies that show how CAHPS data can be used for quality improvement (QI) purposes.
Example: Suppose a health system administers the CAHPS clinician/group practice questionnaire to its providers and discovers that patients give them average-to-low assessments in the “doctors communicate well with patients” composite. Even when providers have these data, they do not always understand how or have the resources to make the leap from ‘data’ to ‘an improved outcome for patients.’ To do this, the health system could collaborate with CAHPS grantees to design and implement a quality improvement study aimed at improving provider communication skills. This could involve these components:
? Identifying which behaviors (or lack of behaviors) prompt patients to give providers average-to-low scores,
? Understanding the best ways to report this information to providers,
? Developing strategies and procedures designed to help change the identified behaviors,
? Planning ways to implement these change strategies and providing mid-course corrections, if necessary,
? Conducting a process evaluation to confirm that change strategies were correctly implemented,
? Developing an outcome evaluation to determine if the changed behaviors had the expected impact,
? Determining how and when to communicate to patients that concerns they conveyed through the survey were recognized and that changes were made, and
? Publishing study results in ways that facilitate adoption by other organizations.
As this sample task list implies, grantees may need to develop different and new CAHPS products to implement a QI study. An example would be qualitative or quantitative data collection tools to pinpoint specific behaviors that need to be changed. Like all CAHPS products, all interview protocols, focus group discussion guides and other such materials developed for QI studies will be published on the web site and available to users free of charge.
In the absence of firm information about the particulars of study design and cost of other CAHPS III tasks, it is difficult to anticipate the number of QI studies that each grantee could perform in a given year. For the purpose of application preparation, each applicant should assume that they will conduct at least two quality improvement studies within the first two years of the project, and three to five in the remaining three years. At least one of the first two studies should be based on the CAHPS clinician/group survey; the other can be based on any of the CAHPS ambulatory surveys. The chosen survey should be used as pre and post measurement of change since there is interest in learning how sensitive these instruments are to the effects of the intervention. The initial two studies should be completed within the first two project years. Studies involving a longer time frame can be performed in years three to five of the project. These initial two studies should also use interventions and measurement strategies that will transplant relatively easily and at low cost to other settings.
AHRQ is interested in seeing studies in years three to five that incorporate multiple interventions in different settings. For example, a QI study on improvement of communication skills could measure the effects of: a) training providers in this area on communication skills, b) enabling a segment of the patient population to be more assertive and ask more questions through skills building; c) working with pharmacists to set aside an for private counseling with patients about medications; or d) staffing a call-line for newly discharged hospital patients to call with their questions about pain, extent of physical activity or other issues that need clarification.
Since AHRQ is more interested in devoting funds to implementation and measurement issues rather than development of complex interventions, the grantees will begin CAHPS III by performing a literature search to identify tested interventions that correspond to elements of CAHPS ambulatory surveys. Though many interventions could be drawn from this source, grantees could also take advantage of naturally occurring interventions. For example, in 2001, Kaiser Permanente settled a disability access lawsuit by agreeing to improve health care delivery and accessibility for members with disabilities. Kaiser agreed to improve accessibility to and within specially designated facilities and to add equipment, such as scales that a person in a wheelchair can use and examination tables that can be raised and lowered. They also appointed an “Access Coordinator” with expertise in ensuring health care access for people with disabilities. If these changes were now being implemented, they would have provided an excellent opportunity for the CAHPS III grantees to collaborate with Kaiser on evaluating the impact of these interventions on quality as perceived by their members with disabilities. Such a study could have also helped refine and improve the CAHPS survey for people with mobility impairments.
Another area for potential QI collaborations is pay-for-performance projects. These projects provide incentives to health plans, provider groups and other health care delivery systems to improve their performance by offering increased financial reimbursement or special bonuses to those who meet certain goals. CAHPS or similar consumer assessment data are often included as one of the performance measures in these types of studies. AHRQ is very interested in seeing applications to this FOA that include QI-focused collaborations involving pay-for-performance as the intervention.
Applicants to this FOA must propose two quality improvement studies which they will conduct, complete and write up for publication within the first two years of CAHPS III. For each of these studies, the applicant should recruit a site or sites at which the studies will be conducted and include letter(s) indicating willingness of the organization(s) to collaborate, should the applicant be successful. Description of these study designs must show that the applicant’s team has all the skills and expertise necessary for designing, conducting, implementing and evaluating a quality improvement study based on CAHPS or CAHPS-like consumer assessment of quality of their health care. For QI studies proposed for years 3 to 5, applicants do not need to recruit sites but should describe these studies in their applications in a way that will allow reviewers to assess that applicant’s ability to perform the work.
2. Reporting CAHPS Data
In CAHPS I, the CAHPS team developed a template for users of CAHPS surveys so they could report results to consumers and other audiences. This was a “turn-key” template—it included information about the CAHPS health plan survey and how it was developed; how the data were collected; how to interpret the data display; why quality information was important in choosing a health plan and how to apply survey findings to choice of a health plan. The sponsor had only to collect and analyze the data as described in the CSRK, complete the data display and disseminate the report to consumers. It was found, however, that most sponsors did not use the template in its entirety. Instead, they used selected sections of the text and developed additional text themselves, or used the format for data display but substituted symbols other than stars, and/or deleted sections of the report that they felt didn’t apply to their circumstances or that unnecessarily lengthened the report. As these reports were collected and reviewed, the following conclusions resulted: 1) the CAHPS team could best serve report developers by developing what is called “reporting resources” rather than a turn-key template and 2) the only report elements regarded as essential and unchangeable were composite presentation and explanation. Based on these insights, the CAHPS II team developed two products, Reporting Resources and the Report Card Compendium, which are briefly described below.
Reporting Resources. Though many organizations develop and distribute reports with health care quality data, very few have the resources to test whether their target audience a) understands these reports, b) uses them to make a selection decision and c) ultimately feels that this information informed their choice and eased their decision-making burden. In other words, though it is commendable that organizations take the time to produce and disseminate these reports, they are working in the dark concerning their extent of use and effectiveness. To respond to this, the CAHPS II team developed a web site, www.TalkingQuality.gov, that organizes existing expertise and research about principles of effective reporting. The TalkingQuality web site describes the entire process of developing a quality report, from “Getting Started” to “Evaluating the Project” and offers, when available, evidence-based advice on strategies that contribute to a successful report. The organization of the web site makes it easy for the user to know where to go for a response to a particular question or for information about a specific issue. TalkingQuality contains a wealth of information both for organizations who have never developed a quality report and for those who have experience in this area. This resource is an improvement over the CAHPS I turn-key template in that it organizes existing knowledge in one location and allows the user to go directly to sources of information that apply to their specific questions.
Report Card Compendium. In addition to advice about effective reporting, sponsors often want to see how other organizations similar to theirs respond to the demand from consumers for easily understandable health quality information. In response, a Report Card Compendium was developed, which is a directory of over 200 sources of comparative information on the quality of health plans and providers. Its purposes are to inform and support the various organizations that develop report cards and to provide easy access to examples of different approaches to content and presentation. To develop the compendium, examples of report cards meeting these criteria were solicited: they must: a) be designed for consumers (defined as enrollees, employees, beneficiaries of Medicare or Medicaid, or the public at large); b) be available to consumers (but not necessarily all consumers or for free) and c) include comparative data on quality for more than one health care organization. The report cards in this database are not offered as stellar examples of quality reporting; rather, they respond to two needs expressed by sponsors—to have convenient access to a range of examples of the types of report cards that are being produced and to allow an easy way to find and network with other sponsors. It is anticipated that the Report Card Compendium will be available via www.cahps.ahrq.gov in early fall, 2006.
There are two reporting elements that the CAHPS team regards as unchangeable: composite presentation and explanation of composites. Each CAHPS survey clusters similar items into a single composite to reduce the amount of information the user needs to process while allowing them to take advantage of the maximum amount of information available. (In addition, many CAHPS sponsors provide access to single item scores for interested consumers.) For example, the 17 core items of the CAHPS health plan survey are distributed into five reporting composites: Getting needed care; getting care quickly; how well doctors communicate; courtesy, respect and helpfulness of office staff; and health plan customer service, information and paperwork. The statistical validity of CAHPS composites—as well as their face validity to consumers—is thoroughly tested by the CAHPS team, as is language that explains composite development and interpretation. Since this type of testing is crucial to user understanding of CAHPS data, it is required that sponsors report composites exactly as specified in the CSRK if they want to use the CAHPS trademark on their documents. Part of the work of the CAHPS III reports team will be to work with analysis team to construct and test labels for composites for new surveys that may be developed during CAHPS III.
CAHPS III grantees will be required to perform the reporting tasks listed below. For the purpose of budget preparation, applicants should assume that 30% of the budget will go towards reporting research and related activities.
? Prepare and test health quality reports for culturally diverse audiences, those with poor reading or cognitive skills, and those with diminished visual capacity.
? Work with the SUN contractor to help promote CAHPS reporting products, as necessary. This includes contributing sections to update the CSRK as needed.
? Update the content of the TalkingQuality web site and the Report Compendium on a regular basis.
? Review and summarize existing research, published and unpublished, on reporting quality information to consumers, patients, providers and other audiences to determine priority topics for reporting research.
? Based on these priority topics, design and conduct a program of research that expands our knowledge of effective strategies for reporting quality information to consumers and other audiences. This research should include lab studies; that is, studies where members of the target audience are presented with health quality information materials where variables are manipulated to examine their effect on consumer understanding, likelihood of using the materials, and other factors. An example of this type of study would be one that presents different types of symbols to convey whether ratings of plans, providers or other entities are average, above average or below average. This research should also include studies in real world settings; that is, studies that examine how consumers, providers and other audiences use actual quality reports for health plan choice, quality improvement and other purposes.
? Develop and test Spanish language reports.
? Work with the instrument and analysis teams to develop and test composite labels and language explaining composites to users of CAHPS reports. Grantees will need to develop and test composites for the CAHPS Surveys for assisted living, people with mobility impairments and possibly others.
? Conduct qualitative research as necessary to determine consumer needs for health quality information on different topics.
? Develop and test new resources to assist sponsors in developing their own reports. An example would be to develop a compendium of report cards for quality improvement purposes. An additional example would be to develop and present a conference on the state of the art of CAHPS-like quality information to consumers and other audiences. This event could be an adjunct to the annual CAHPS User Group Meeting or replace this meeting for one year. These products are offered as examples only; the applicant should describe what types of reporting resources they would propose, why development of those resources is important and how they would develop and test them.
3. Developing, maintaining, refining and advancing CAHPS survey products
This section contains information on three areas: a) completion of survey work begun in CAHPS II, b) development of new CAHPS surveys, c) refining existing surveys, and d) advancing the science and practice of consumer assessment of health care services. For budget preparation, applicants should assume that 20% of the budget will go to these tasks.
The CAHPS III grantees will need to work with the AHRQ Project Officers (POs) to develop an OMB clearance package to cover the collection of data for survey testing and other purposes.
a. Completion of surveys begun in CAHPS II
The CAHPS II team began two survey efforts that will not be completed by the end of their performance period: a survey for people with mobility impairments (PWMI) and an item set on consumer assessment of use of health information technology. These surveys were not funded to the extent that would allow their completion in CAHPS II. CAHPS III grantees will be required to complete these surveys.
The CAHPS II team will provide the CAHPS III team with all papers, reports of testing and other background materials that are required to complete the work. The CAHPS II team will work to the limit of their funding on these products; there will, therefore, be no need for a transfer of funds.
Below the work that was completed for each of these efforts, along with the suggested remaining activities, is described.
People with mobility impairments. During CAHPS II, the grantees developed and tested a screener questionnaire with which to identify people with mobility impairments (PWMIs), conducted a literature search, published a call for measures requesting existing measures for this purpose, assembled an advisory committee, developed an item pool based on the call for measures and literature review, developed and cognitively tested a first-draft questionnaire, and tested a version of the questionnaire in the state of Wisconsin. Suggested follow-up tasks include: performing additional cognitive testing, conducting an actual field test, analyzing the data, and revising the questionnaire according to field test results.
Health information technology. AHRQ is funding the development of a set of supplemental items of the patient’s perspective on the use of health information technology. By the end of CAHPS II, the grantees will have: performed a literature review on this topic, conducted focus groups with patients, obtained stakeholder input develop a set of approximately 20- 25 items and performed cognitive testing. Possible completion activities for CAHPS III grantees include: recruiting a sponsor and field testing these items as part of the CAHPS clinician/group survey, analyzing data from the field test, conducting additional cognitive testing, revising the items to produce a final set of about 10 -15 items; translating the items into Spanish and developing a strategy for adoption.
b. Development of new surveys
Though the CAHPS III Consortium may decide to develop additional surveys, the only one that is anticipated to be developed at this time is a survey for residents of assisted living facilities.
Assisted living. AHRQ’s Long Term Care Portfolio is funding the development of a tool box for consumers to assist them in the selection of assisted living facilities. The tool box will contain information which has been deemed useful in helping consumers choose facilities. As part of this toolbox, it is anticipated that the CAHPS III team will work with AHRQ to develop and test a survey through which residents of assisted living facilities can assess the quality of care they receive. Work that will be completed during the CAHPS II period includes an environmental scan of existing measures related to assisted living, a report of information made available by states on assisted living, focus groups with various constituencies regarding the kinds of information that should be in the tool box, summary materials which integrate these and other sources of information, and a Technical Expert Panel Meeting. Documents relating to this work will be posted on the CAHPS section of the AHRQ web site (https://www.cahps.ahrq.gov/default.asp) as they are completed. Funding for instrument development will not be available until CAHPS III. That development will include qualitative research with stakeholders, preparation of a draft survey, cognitive testing with potential respondents, development of a sampling strategy and data collection method, translation into Spanish, field testing, analysis, refinement of the survey and development of an adoption strategy.
c. Maintenance and refinement of existing surveys
To accommodate the needs of CAHPS survey users and stakeholder organizations, the CAHPS team strives to keep CAHPS core survey items stable from year to year. But the world of health care quality measurement is dynamic and from time to time, thus, there may be a need to introduce changes to the survey itself, administration strategies and modes of data collection. This may include developing new surveys based on stakeholder requests or developing sets of supplemental items (such as items related to quality improvement). The CAHPS III team will need to devote a portion of their resources to these types of maintenance functions.
The CAHPS clinician/group survey has recently been completed but will require some refinement in CAHPS III; that is, additional testing of draft items on coordination of care and health promotion and education. Since these two domains are of interest to a number of stakeholders, the CAHPS team is committed to retesting and improving them.
Tasks include reviewing experience with existing surveys, modifying as necessary, testing the modifications in cognitive interviews, conducting field tests and refining the survey.
d. Advancing the science and practice of consumer assessment
Conduct research on cultural comparability. To obtain comparable survey results across a population which contains people of different cultural, ethnic and racial backgrounds, the survey instrument needs to perform consistently across those various groups. Producing such surveys involves testing to see 1) whether the concept to be measured has the same literal meaning and cultural/emotional significance across different ethnic and linguistic groups and 2) whether survey versions developed to respond to these differences are perceived in the way that the developer intends. This testing needs to be conducted for both survey items and response options. Tasks involve performing translation and conducting cognitive and field tests of items to assess comparability. CAHPS III grantees will be required to conduct this work.
Developing new strategies for collecting CAHPS data. For both AHRQ and the CAHPS team, the critical measure of project success is adoption of CAHPS surveys and other products by the intended users. Involving sponsors in the process of survey development from the beginning is one strategy for facilitating future use. An additional way to facilitate use is to investigate the use of nonstandard survey data collection methods, such as in-office distribution, web-based data collection, and interactive voice response. If they yield valid and reliable data, these methods have the potential to reduce the cost of data collection, thus making them more attractive to potential users. As new settings for CAHPS surveys are explored, the team will need to develop reliable methods for obtaining data from (and reporting data to) people with cognitive impairments and people with visual or mobility impairments. Tasks involved in this work include developing testing strategies, conducting field tests, analyzing data and modifying methods.
In addition, the CAHPS II grantees sometimes found it more cost-effective to subcontract field testing of surveys to an organization specializing in survey data collection rather than collecting these data themselves. Applicants are free to propose any strategy for data collection they deem methodologically sound; the option of subcontracting these services as an idea mentioned for consideration.
4. Disseminating and promoting adoption of CAHPS products and providing technical assistance
Though dissemination and promotion is described in this separate category, many of the tasks relating to dissemination and promotion of CAHPS products are intertwined in the development work. For example, as explained above, in CAHPS II, the grantees decided that the CAHPS survey for clinicians and group practices would not be useful to or accepted by the target audience unless representatives of that audience collaborated in its development and testing. They then developed a Grantee Advisory Committee for this purpose and have involved members of this group in development and dissemination activities from the beginning.
CAHPS III grantees must:
? Work with the SUN contractor to plan an annual Survey User Group Meeting and present at that meeting.
? Collaborate with the SUN contractor on various communication and dissemination efforts.
Other dissemination activities that CAHPS III grantees may perform include:
? Presenting information about CAHPS products at professional meetings.
? Meeting with groups critical to the adoption of CAHPS products, such as NCQA, NQF or the Hospital Quality Alliance.
? Publishing articles about CAHPS, including monographs and special journal supplements, if appropriate.See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the U18 award mechanism.
AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.
The AHRQ U18 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PD/PI, as described in Section VI. 2. A., "Cooperative Agreement Terms and Conditions of Award". This FOA is a one-time solicitation. AHRQ has not determined whether or how this solicitation will be continued beyond the present FOA.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, the size of each award may 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.
AHRQ intends to commit approximately $4.5 million dollars in FY 2007 to fund two or three applications. For budgeting purposes, applicants should assume a total annual budget that does not exceed $1.5 million dollars. If additional funds become available in FY2007, AHRQ reserves the option to fund additional applications submitted in response to this FOA. Applications with a total annual budget that exceeds $1.5 million will be returned without review.
AHRQ grants policies as described in the PHS Grants Policy Statement (see http://grants.nih.gov/grants/policy/gps/index.html) will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your domestic organization is a:
Foreign institutions and for-profit organizations may participate in projects as members of consortia or as subcontractors only. Applications submitted by foreign institutions or for-profit organizations 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 with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his or 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 programs.
Status as a previous CAHPS grantee is not a prerequisite for this FOA. Though each applicant organization or team must have experience in all areas described in the “Research Objectives” section, this experience need not be based on CAHPS products. Previous CAHPS grantees may apply to this FOA by submitting a new grant application.
2. Cost Sharing or Matching
AHRQ does not require cost sharing for applications in response to this FOA.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
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.
Note that if a PD/PI is also an AHRQ peer reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
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 in both Grants.gov and the Commons. AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
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. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the AHRQ R&R uses ONLY the detailed Research & Related Budget. Do not use the PHS 398 Modular Budget. Applications submitted in modular budget format will be returned without review.
3. Submission Dates and Times
See (Section IV.3.A) for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 20, 2006
Letter of Intent Receipt Date(s): November 20, 2006
Application Submission Date(s): December 18, 2006 http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Within three months of receipt date http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): June 2007 http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
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 are asked to 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 PI/PD.
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 to this document.
The letter of intent should be sent to:
Center for Quality Improvement and Patient Safety
540 Gaither Road, Room 3343
Rockville, MD 20850
Telephone: (301) 427 1402
FAX: (301) 427 1341
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/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be evaluated for
completeness and responsiveness by the Center for Scientific Review and AHRQ.
Incomplete or non-responsive applications will be returned without review.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
AHRQ will not accept any application in response to this FOA 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.
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 AHRQ's confidentiality 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 included in the DUA is the requirement that the 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 6 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 Section VII (Agency Contacts).
To avoid double counting, applicants should not include the cost of the CMS data in the budget. Small research grant applicants should be aware that the costs of the grant, including the cost of CMS data, cannot exceed $100,000 total costs. In the event the total costs of the project plus the cost of CMS data is greater than $100,000, 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 $100,000.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
For efficient grant administration, Awards under this FOA are subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable to you based on your recipient type and the purpose of this award. This includes any requirements in Parts I and II (available at http://www.hhs.gov/grantsnet/gps/index.htm) of the HHS GPS that apply to an award as well as any requirements in Part IV (available at http://www.hhs.gov/grantsnet/gps/index.htm) that apply based AHRQ as the awarding Agency.
6. Other Submission
PD/PI Credential (e.g., Agency Login)
AHRQ requires the PD/PI 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. 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 “Registration FAQs-
Important Tips” - “Electronic Submission of Grant Applications.”
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.”
Research Plan Component Sections
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 and with the following requirements for applications:
The following materials may be included in the Appendix:
Up to 20 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication.
Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.
Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe the relevant policies and procedures may be delayed in the review process.
Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
To simplify budget preparation, applicants should follow the assumptions listed below for budgeting purposes. These are assumptions for application purposes and may or may not represent the manner in which AHRQ and the CAHPS III Consortium will choose to conduct the work.
Number of awards. AHRQ intends to commit approximately $4.5 million dollars in FY 2007 to fund two or three applications. For budgeting purposes, applicants should assume a total annual budget that does not exceed $1.5 million dollars. If additional funds become available in FY2007, AHRQ reserves the option to fund additional applications submitted in response to this FOA.
Resource allocation by project area. Applicants should use the following percentages as guides for allocation of resources by project area:
Quality improvement projects 35%
Reporting research 30%
Survey completion, development and refinement 20%
Dissemination, adoption and technical assistance 15%
Meetings. For each year of the cooperative agreement, the appropriate grantee representative(s) will be required to attend the following meetings:
- Weekly conference calls with PI/PDs, their back-ups and Project Officers
- Cross-grantee team meetings as necessary (in-person as necessary; assume ten person trips)
- Two Steering Committee meetings (in-person)
- Two Grantee Advisory Committee meetings (in-person)
- One CAHPS User Group annual meeting (in-person)
- One NCBD Advisory Committee meeting (in-person)
- One NCBD Technical Advisory Panel (TAP) meeting
- One NCBD Executive Research Committee meeting
- Five online workshops for CAHPS users
–Grantees will need to cover all meeting costs (tape-recording, etc.) for in-person meetings with the exception of the CAHPS User Meeting. These costs include facility costs if AHRQ conference facilities are not used.
–The grantee teams will share the cost of transportation, lodging and per diem for Advisory Committee member attendance at each meeting. All other costs for these meetings (obtaining space, materials preparation, etc.) will be borne through the SUN contract.
–The CAHPS Consortium usually holds one meeting of CAHPS users per year. Though the SUN contractor takes the lead responsibility for this meeting, each of the grantees will contribute to planning the content of and making presentations at the meeting.
-The grantees will participate in an annual site visit conducted by the AHRQ project officer (PO); the purpose of the site visit is to review project progress and to assess the level of institutional support and commitment.
Project organization and management. Each grantee must propose a PI/PD as well as a back-up. The PI/PD has ultimate fiscal and intellectual responsibility for the project but the back-up, a senior investigator on the team, will be responsible for all aspects of project management when the lead person is unavailable. These individuals should coordinate their schedules so that one or the other is always available.
The PI/PD serves as the official voice of that grantee team. Communication from the grantee team to the AHRQ Project Officer should come from the PI/PD rather than from multiple members of that team.
Applicants should propose staff with a range of experience and skill levels. Our goal is to avoid the situation where extremely qualified or senior level staff are performing tasks that a person with less experience could perform just as well.
Grantees must propose a lead staff person (and alternate) for three of the four “cross-grantee teams” (quality improvement studies, reports and instrumentation). During the course of the project, other cross-grantee teams may be created. Cross-grantee teams are composed of members of each grantee team organized to perform defined tasks. The length of time cross-grantee teams are needed is dependent upon the work being performed by the team. For example, the instrumentation and reports teams in CAHPS I and II were formed early in the project and continued to meet (by conference call and in-person) throughout its life. Other groups are formed for shorter term goals (e.g., development of an agenda for a user group meeting) and disband when those goals have been met. Sometimes certain tasks can be performed most efficiently through the development of sub-groups. For example, a sub-group of the survey and report kit team was developed to proof-read and edit the final version.
During CAHPS III, it will be required that one staff person from the SUN contract participate in each cross-grantee team to prepare and publish call notes and sometimes to participate in the content of the work.
For critical periods during CAHPS I and II, the PI/PDs met weekly by phone and sometimes in person with the AHRQ project officers, representatives from the SUN contractor, team conveners and other people as required. Towards the latter part of CAHPS II, these meetings occurred monthly. CAHPS III may begin with weekly phone calls to set the initial agenda and determine how to best organize the work, and then move to monthly calls once major decisions have been made. AHRQ toll-free lines may be used for conference calls.
There will be two major components to the organizational structure of the CAHPS III project–the CAHPS Steering Committee and Grantee Advisory Committee(s) both of which are defined above. The Steering Committee will set the overall direction of the CAHPS project and decide on project priorities from year to year. The Committee will establish a five year plan with broad goals at the beginning of the project. Each year it will review progress towards these goals, review emerging needs for new or different CAHPS products and adjust project direction if necessary.
The grantees will determine whether and what types of Grantee Advisory Committee(s) are necessary. These committees are usually comprised of representatives of key stakeholder groups affected by the implementation of CAHPS products. They might include organizations representing consumers/patients; health care providers, purchasers; health plans; accrediting organizations and others. These committees advise the CAHPS grantees about the needs and concerns of the organizations that use CAHPS products. The grantees will select the members of these groups, set meeting agendas, make all meeting arrangements, and convene the group as often as necessary. One representative from each organization on the Steering Committee is an ex officio member of the Grantee Advisory Committee.
AHRQ encourages potential 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, October 18, 2006 from 1:30 - 3:00 p.m. EDT. To register to participate in the conference call, please send an e-mail request to CAHPSIII@ahrq.hhs.gov by Oct 11, 2006. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB Oct 16, 2006. Potential applicants are encouraged to contact Dr. Crofton with any questions (see Where to Send Inquiries, 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 CAHPSIII@ahrq.hhs.gov by Oct 11, 2006. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be available. Please send requests for a copy of the notes to CAHPSIII@ahrq.hhs.gov.
Specific 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 be returned without review.
The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also found at 42 USC 299. 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.
To facilitate generalizability of CAHPS products to a variety of populations and settings, applicants to this FOA should indicate their strategies for inclusion of representatives of these populations in their testing studies: people with poor cognitive skills and/or reading ability; people for whom English is not the primary language; people with visual impairments; people with mobility impairments.
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, the 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 are to 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.
HCUPS & 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 inpatient 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 databases include: the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states. 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, noninstitutionalized population. MEPS comprises 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.
This does not preclude the use of secondary data sources or primary data collection.
Sharing Research Data
Sharing Research Resources
Section V. Application Review Information
Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness. Merit Review Criteria are described in Section V.2 below.
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 be returned to the applicant without further consideration. AHRQ uses these procedures in evaluating the cooperative agreement under this FOA.
As part of the initial merit review, all applications will:
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:
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.
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 high 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?
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, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment 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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Budget: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research.
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
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?
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 item 7 of the Research Plan component of the SF 424 (R&R)).
Inclusion: The adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see discussion on Priority Populations in the section on Other Submission Requirements IV.6 above, and Inclusion Criteria included in the section on Required Federal Citations in Section VIII.)
Applications (formerly “revised/amended” applications): In addition to the above
criteria, the following criteria will be applied to resubmission applications:
Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
The review criteria listed below include experience and skills necessary to perform the work of the FOA. It is not necessary that this experience be based on previous CAHPS experience.
1. Quality Improvement Studies. Experience and skills in these areas:
--Designing and implementing four to five methodologically sound quality improvement programs in health care settings.
--Designing and implementing process and outcome evaluations, including: specification of evaluation questions and outcome measures; data analysis; development of data-based recommendations and use of the recommendations to improve products and procedures.
--Developing measurement tools for use in QI and evaluation studies.
--Identifying and working productively with stakeholders from different organizations (e.g.,accreditation organizations, health plans, consumer advocacy organizations, purchasers of health care services, etc.) and different health care service delivery settings (e.g., hospitals, community-based clinics, nursing homes, assisted living facilities, etc.)
2. Reporting CAHPS Data. Experience and skills in these areas.
--Developing and testing understandable and useful print and electronic reports which contain health quality data for use by a wide range of audiences (patients, consumers, providers, health plans, national, state and local policy makers, government agencies, etc.).
--Designing and implementing methodologically sound studies for laboratory and real world testing of health quality materials for consumers and other audiences.
3. Developing, refining and advancing CAHPS survey products. Experience and skills in these areas:
--All aspects of fielding a large-scale, multi-site survey, including but not limited to: formulation of a methodologically sound design; performance of validity and reliability studies on large-scale survey instruments; identification and resolution of methodological issues associated with sample selection and sample size, and with administration of surveys to the subpopulations of interest and within a variety of health care delivery settings; identification and resolution of methodological issues associated with mode of administration.
--Producing detailed survey operations manuals suitable for use by groups with minimal as well as extensive experience in fielding large-scale, multi-site surveys.
--Conducting cultural comparability studies on questionnaires and other materials.
4. Disseminating and promoting adoption of CAHPS products and providing technical assistance. Experience and skills in these areas:
--Collaborating with, provide technical assistance or training to, and/or monitor the progress of test sites, community-based organizations, data supplying organizations and site representatives.
5. Cross-cutting experience and skills found in each of the areas above:
--Conducting qualitative research and analyzing the resulting data, including cognitive testing, focus groups and usability testing
--Understanding the needs of various audiences who use health care information (e.g., consumers, patients, purchasers, plans, providers, payers, State and local-level health care organizations, etc.) and the ways in which they may use this information (selection of plans and providers; comparison of plan/provider performance; identification of local or multi-site quality problems; etc.).
--Identifying and recruiting appropriate sites audiences for survey instrument testing, report template testing, QI studies, and evaluation studies. It is particularly important to include representatives of these groups in product development testing: people with poor cognitive skills; people with poor reading skills; people from diverse ethnic and cultural backgrounds; people with diminished visual capacity.
--Knowledge of quality issues (especially those important to consumers and other purchasers) as they pertain to long-term care, hospital care, care to those with poor cognitive or visual skills, and care received in ambulatory settings.
--Writing clear, concise reports, summaries and other documents.
--Translating materials into Spanish.
--Collaborating with government agencies in the performance of research studies and demonstrations.
--Managing and collaborating productively with geographically distant team members who represent different disciplines, fields of study and points of view.
2.B. Additional Review Considerations
2.C. Sharing Research Data
Pursuant to 934 (c) of the PHS Act 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 now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, there must be a description of 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 42 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 of 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/
The PI 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 websites 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.
2.D. Sharing Research Resources
Rights in Data
AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. 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; and 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 the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's web site http://www.gpoaccess.gov/cfr/index.html).
3. Anticipated Announcement and Award Dates
Generally, applicants should anticipate 7 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 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 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).
A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the successful applicant organization(s). The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.
2. Administrative and National
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 (HHS GPS) that are applicable to you based on your recipient type and the purpose of this award. This includes any requirements in Parts I and II (available at http://www.hhs.gov/grantsnet/gps/index.htm) of the HHS GPS that apply to an award as well as any requirements in Part IV (available at http://www.hhs.gov/grantsnet/gps/index.htm that apply based AHRQ as the awarding Agency.
necessary, Terms and Conditions will be incorporated into the award statement
and will be provided to the appropriate institutional official at the time of
Activities conducted under this award that involve the collection of information e.g. conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA). Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted awardees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least 6 months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until awardees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found here http://www.hhs.gov/ocio/infocollect/.
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines. DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), 45 CFR 67, and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.
The administrative and funding instrument used for this program will be the cooperative agreement U 18, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, although specific tasks and activities may be shared between an awardee and AHRQ as described in this subsection of the FOA.
Project Director/Principal Investigator (PD/PI) Rights and Responsibilities
The PD/PI will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access and use consistent with current Department of Health and Human Services regulations and other policies referenced in this FOA.
The PD/PI will have primary and lead responsibilities for the project as a whole including:
–Survey instrument development and appropriate testing;
–Feasibility studies as necessary to support the development of new CAHPS products;
- Formation of the Grantee Advisory Committee, including selection of members, convening meetings, planning meeting agendas and documenting activities;
-Writing up meeting notes and associated follow-up actions;
–Report development and testing;
–Translation of instruments and report templates into other languages;
–Evaluation of the cultural comparability of questionnaires;
–Design, implementation, and analysis of quality improvements studies, including evaluation of the impact of intervention(s);
–Design, implementation, and analysis of evaluation studies;
–Development of relationships with testing sites, QI study sites, and evaluation sites;
–Provision of AHRQ access to all data generated under this award as it is collected; and
–Cooperation with other key parties in these cooperative agreements, including but not limited to the SUN contractor; other CAHPS grantees; and AHRQ Project Officers and other AHRQ staff.
2.A.2. AHRQ Responsibilities
The AHRQ Program Officials associated with CAHPS will have substantial programmatic involvement in guiding grant activities to address priority issues of the DHHS, or the Federal Government regarding consumer assessment of quality of care.
For these cooperative agreements, AHRQ program officials are responsible for convening and participating in regular conference calls, reviewing quarterly progress reports and providing input as needed, and conducting annual site visits. Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantees in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across projects. Specific cooperative tasks and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials.
AHRQ program officials may also provide expertise/technical assistance to the awardees and assist them with their project activities or in coordinating the activities of other grantees (e.g. author or co-author articles on issues related to consumer assessment and reporting or quality improvement studies).2.A.3. Collaborative Responsibilities
When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their projects. These collaborative relationships may be facilitated by AHRQ POs, program officials, and contractors; instigated by the awardees through self-identified opportunities, or developed via other mechanisms during the life of the project. It is expected that the cooperative agreements will be conducted in a dynamic environment with AHRQ reviewing the results on an ongoing basis.
Each grantee will be working closely with the other CAHPS grantees as specified in the Research Objectives section (Part II Section 1). Grantees will also be required to work with the SUN contractor for the following:
- developing, testing, and revising the CSRK
- updating other CAHPS products as necessary
- answering technical questions that arise from the technical assistance to CAHPS users, if necessary
- providing all meeting materials, reports, and other items to the SUN contractor in a timely manner
- serving on the NCBD Advisory Committee
- participating in five online user workshops2.A.4. Arbitration Process
The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions.
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. 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 and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.
The following reports will be required during CAHPS III:
- Annual work plan in a mutually agreed-upon format within each of the four major project areas: QI, reporting research, survey development and dissemination and adoption. These should include timeline, deliverables, major mile posts and person(s) responsible for work performance.
- Internal memos in a mutually agreed-upon format for summarizing quality improvement studies, psychometric testing, cognitive testing, reports testing and other areas.
- Non-competitive renewal progress reports no later than 60 days prior to the budget period start date.
Section VII. Agency Contacts
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential PIs or applicant organization.
Inquiries may fall into three areas: scientific/research, 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 Women, Minorities and Children, and other priority populations to:
Christine Crofton, PhD
Center for Quality Improvement and Patient Safety
540 Gaither Road, Room 3345
Rockville, MD 20850
Telephone: (301) 427-1323
2. Peer Review Contacts:
Direct your questions about peer review issues of grant applications made in response to this FOA to:
Office of Extramural Research Education and Priority Populations
540 Gaither Road, Room 2113
Rockville, MD 20850
Telephone: (301) 427-1549
FAX: (301) 427-1562
3. Financial or Grants Management Contacts:
Direct your questions about financial or grant management matters to:
Office of Performance Assessment, Resources and Technology
Division of Grants Management
540 Gaither Road, Room 4337
Rockville, MD 20850
Telephone: (301) 427-1454
FAX: (301) 427-1462
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 conducted and 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 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:
regulations 45 CFR 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 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, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA. 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", for example, if they constitute 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 the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 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 authorization of 42 USC 299 et seq, and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement. The PHS Grants Policy Statement and the above authorizing statutes and applicable regulations. The PHS Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/gps/index.html.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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