Part I Overview Information

Department of Health and Human Services

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

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

Title: Patient Safety and Medical Liability Reform Demonstration Projects (R18)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a New Program Announcement.

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

• March 6, 2012 - See Notice NOT-HS-12-008. The purpose of this Notice is to inform the extramural research community that AHRQ will terminate as of March 6, 2012.
• December 13, 2011 - See Notice NOT-HS-12-004. Budget Limitations on AHRQ Large Research, Demonstration, and Conference Grant Applications for Standing AHRQ Funding Opportunity Announcements.

Program Announcement (PA) Number: PAR-11-025

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: November 9, 2010
Opening Date: December 25, 2010 (Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: (Now Expired March 6, 2012 per NOT-HS-12-008) January 8, 2014

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This FOA supports demonstration grants for the development, implementation and evaluation of models that must focus on:
  • putting patient safety first and working to reduce preventable injuries;
  • fostering better communication between doctors and their patients;
  • ensuring that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits; and
  • reducing liability premiums.
• The projects must be designed to optimize promising practices that address both ensuring and improving patient safety, as well as reducing health care costs. The projects must focus on the connections between patient safety and medical liability claims.
• AHRQ is encouraging applications that involve collaborations of States, health systems, and risk management organizations.
• Mechanism of Support. This FOA will use the AHRQ Research Demonstration and Dissemination Grant (R18) award mechanism.
• Funds Available and Anticipated Number of Awards. Awards issued under this FOA depend upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research may vary from application to application, AHRQ anticipates that the size and duration of each award also may vary. The total amount awarded and the number of awards depend on the quality, duration, and costs of the applications.
• Budget and Project Period. The total costs awarded to a grant under this FOA shall not exceed $1 million annually. Projects may be up to three years in duration. AHRQ will not review an application with a project period that exceeds three years or a budget that exceeds $1 million in total costs in any given year. Funding beyond the first year will depend upon AHRQ staff review of an annual progress report and satisfactory performance.
• Application Research Strategy Length: The R18 Research Strategy section may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed [1]research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. A minimum of 20% annual effort is required from the PD/PI or the Project Manager, depending on how the applicant structures the project s organization and work plan.
• Number of PDs/PIs: The application may designate only one PD/PI.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions: Applicants may submit a resubmission application, but such an application must include an Introduction addressing the previous peer review critique (summary statement).
• Renewals: Applicants may not submit a renewal application.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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. Receipt, Review, and Anticipated Start Dates
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
1. Criteria
2. Review and Selection Process
A. Additional Review Process
B. Additional Review Criteria
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
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

AHRQ’s mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. AHRQ achieves this mission by supporting a program of health services research and by working with partners to promote improvements in clinical and health systems practice that benefit patients.

This FOA supports demonstration grants for the development, implementation and evaluation of models that must focus on:

• putting patient safety first and working to reduce preventable injuries;
• fostering better communication between doctors and their patients;
• ensuring that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits;and
• reducing liability premiums.

This FOA presents the opportunity to develop, implement, and evaluate alternatives to our current medical liability system. The projects must be designed to optimize promising practices that address both ensuring and improving patient safety, as well as reducing health care costs. The projects must focus on the connections between patient safety and medical liability claims.

Applicants will have wide discretion and flexibility in designing their patient safety and medical liability innovations that meet the goals identified above. Proposals should seek comprehensive solutions that improve patient safety and address the underlying causes of the malpractice problem.

Applications submitted in response to this FOA may include government action or private action. A credible application assuming governmental action must show appropriate official interest and support. A wider range of applicants could propose a medical liability innovation opportunity that entails only private action (e.g., a health system trying root cause analysis or institutional liability for itself). However, the application should demonstrate how and in what ways the results and findings could be replicated in another setting or locality, relationship to patient safety, and appeal to a wide range of stakeholders. The application should show the sustainability of the innovation if it proves successful during the demonstration period.

AHRQ is encouraging applications that involve collaborations of States, health systems, and risk management organization. Recognizing the impact issues related to patient safety and medical liability have on priority populations, as defined at 42 USC 299(c), projects submitted should specifically address issues related to priority populations. AHRQ priority populations include: low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.

Specific Metrics

Specific metrics for patient safety might include the following: incidence of harm/injury for selected patient safety events, reduction in antecedent or precipitating factors and near miss events, system changes and corrective actions taken (if any), effectiveness of risk mitigation approaches implemented, and increased transparency of patient safety events. Applicants should consider using existing safety assessment tools to identify risk and hazards, including various forms of proactive risk assessment such as Failure Mode and Effects Analysis (FMEA) and Probable Risk Assessment (PRA). Measures of patient safety culture such as AHRQ’s Hospital Survey on Patient Safety Culture and, patient experience of care data from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCHAPS or CAHPS Hospital Survey), indicators of harm from administrative data such as AHRQ Patient Safety Indicators (PSI), identification of harm from medical records by the Universal Trigger Tool from the Institute for Healthcare Improvement (IHI), and ratings from Centers for Medicare and Medicaid Services (CMS) Hospital and Nursing Home Compare should also be considered. Examining claims data with other indicators or triggers of harm is strongly encouraged. Too often claims data have not been used as effectively as the data could and should have been used. For example, often researchers exclude Medicare beneficiaries under age 65 (i.e., those qualifying because of disability) without explicit justification. Given that persons with disabilities constitute almost 15% of the Medicare population, excluding them means that research results will not pertain to a substantial fraction of Medicare beneficiaries. Close coordination between risk management data should be considered as a prime source of information. Examples of metrics for medical liability might include effectiveness of strategies to expedite claim resolution, reduction of liability claims being filed, decreased transaction costs, reduction of unintended outcomes, patient and provider satisfaction with interventions; sustainability of new interventions, cost of new systems, and number of physicians choosing to practice in high-risk specialties or specific geographic areas over the long term.

Patient Safety Background

Recent research has shown that there is a highly significant correlation between the frequency of adverse events and malpractice claims.¹ Information from patient satisfaction and patient experiences of care also can predict malpractice risk.²

Improvements in patient safety could decrease the adverse events that lead to medical liability claims. The Institute of Medicine (IOM) report entitled To Err is Human , estimated that between 44,000 and 98,000 people die each year from healthcare-associated harm, the problems associated with healthcare-associated injury and harm continue to persist. Over 15% of patients receiving hospital care are harmed by the process of care they receive.³ System errors cause the majority of these casualties, rather than poor performance by individual practitioners.⁴

Although the United States provides some of the best health care in the world, the health care process harms an unacceptably high number of patients. Stakeholders increasingly recognize that health care needs to prevent injury to patients in lieu of name, blame, and shame after the occurrence. By eliminating or minimizing unintended risks and hazards associated with the structure and process of care, improvements in patient safety could decrease medical liability claims.

The IOM report recommends development of event reporting systems that identify risks and hazards. A focus on patient safety improves health care by learning from adverse events that harm patients, parallel situations in which no harm occurs, and near miss events caught before they harm the patient. The IOM also emphasizes the need to create a culture of safety in which the health care providers and practitioners (institutions and individuals respectively) as defined by the Centers for Medicare and Medicaid Services (CMS) learn from events in order to intervene, improve, and actively search for opportunities to reduce actual or potential harm to patients. Yet in many cases, health care organizations may implicitly discourage adverse event reporting. Health workers may fear employer reprisal or potential litigation from other parties.

The IOM report and its findings spotlight a serious need to capture information that would help to improve quality and reduce harm to patients. A recent AHRQ-supported survey finds that virtually all hospitals reported they have centralized adverse-event-reporting systems, although characteristics varied.⁵ Scores on four performance indices suggest that only 32% of hospitals have established environments that support reporting, only 13% have broad staff involvement in reporting adverse events, and 20 21% fully distribute and consider summary reports on identified events. These results indicate that health care organizations may not be optimizing reporting to improve patient safety. Evidence of lack of organizational support for reporting and learning from events also comes from AHRQ’s Hospital Survey on Patient Safety Culture (HSOPS), a hospital staff survey designed to help hospitals assess the culture of patient safety in their institutions.⁶ Among other areas, hospital staff report difficulties with non-punitive response to error. Hospitals have potential for improvement with 44% of staff believing that their mistakes and event reports are held against them and 35% worrying that the hospital records self-reported mistakes in their personnel files. As James Reason points out there needs to be a Just Culture within an organization.⁷ It must create an atmosphere of trust in which people are encouraged, even rewarded, for providing essential safety-related information; but in which they are also clear about where the line must be drawn between acceptable and unacceptable behavior.

Both providers and practitioners have concerns regarding openness and transparency in health care delivery. To implement the Patient Safety and Quality Improvement Act of 2005 (PSQIA), 42 USC 299b-21 to 299b-26, the Department of Health and Human Services issued the Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3, which became effective in January 2009 (PSQIR). The PSQIA and PSQIR authorize the creation of Patient Safety Organizations (PSOs) to improve quality and safety through the collection and analysis of data on patient events. By providing both privilege and confidentiality, PSOs create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data to improve quality by identifying and reducing the risks and hazards associated with patient care. PSQIA confidentiality and privilege protections for hospitals reporting data to PSOs should also help stimulate improvements in hospitals internal reporting processes.

In addition to the attention devoted to reporting and the identification of risks and hazards through various forms of detection, Safe Practices for patient safety have received equal attention. Their adoption is intended to eliminate or mitigate harm to patients. AHRQ supported and published an evidence-based review on patient Safe Practices. ⁸ The National Quality Forum (NQF) used this report to develop a list of Safe Practices that it recently updated.⁹ The NQF 2009 Safe Practices for Better Healthcare lists 34 evidence-based practices built on six years of development, and represents practices that should be implemented in every hospital. The Joint Commission issues patient safety goals on an annual basis that guide efforts to reduce harm to patients.¹⁰

AHRQ has undertaken a robust effort to encourage safe practices implementation in health care facilities and organizations, and to produce and disseminate tools and resources to support safe practices. McCarthy and Blumenthal have completed a report on the implementation of safe practices in a series of ten case studies on reducing harm to patients.¹¹ Sachs and colleagues report that improved team work decreases the incidence of injury and reduces medical liability claims in labor and delivery units. AHRQ and the Department of Defense (DoD) have developed an evidence-based curriculum and training support resources for team work improvement called TeamSTEPPS.^12,13 AHRQ also supports a program for the National Implementation of TeamSTEPPS. It provides resources for institutions to improve teamwork in their institutions.¹⁴

The Keystone Project successfully reduced harm from central line-associated infections in intensive care units in Michigan. Pronovost and colleagues have published about the dramatic improvements from this effort using a Comprehensive Unit-based Safety Program (CUSP).^15,16 AHRQ launched an initiative to spread the lessons learned from the Keystone Project to all states and all hospital-based ICUs who wish to participate in achieving the vision of eliminating Central Line-Associated Bloodstream Infections (CLABSI).^17-19

Documenting the relationship between implementing Safe Practices and risk management activities such as medical liability litigation has proven to be a major challenge. Too often providers have not integrated or coordinated risk management and patient safety activities well. Traditional risk management focuses on limiting financial liability using a deny and defend approach instead of focusing on identifying risks and hazards that lead to litigation in the first place.²⁰ Vincent and colleagues found that patients feel the need to hire an advocate when they have not received adequate answers to questions about their outcomes, when they sense the absence of accountability for what happened to them, and when they worry that the same mistake could be made in another patient’s case.²¹ The study also found that 37% of respondents to the survey said an explanation and an apology would have made a difference.

More complete integration of risk management activities and patient safety efforts would benefit health care. Hickson determined that 24% of the patients he surveyed filed a suit when they found that the physician had failed to be completely honest with them about what happened, allowed them to believe things that were not true, or intentionally misled them.²² Hickson also discovered that studying patient complaints could predict which physicians would likely put the institution at risk for a malpractice claim.²³ Based on feedback from patients, Pichert also identified individual units within an institution that could be considered at high risk.²⁴ Differences in expectations about outcome of a health care process often cause litigation. As Sharpe and Faden point out, poor or inadequate risk communication in the informed consent process is often an underlying factor and may account for the difference in perception by both parties and sometime the courts in whether the litigation amounts to malpractice.²⁵ Sensory and communication disabilities might also affect patients perception. Effective informed consent is the first step in risk management. Boothman and others stress the need to perform root cause analysis on what leads individuals to seek a legal advocate and initiate malpractice litigation.²⁶ Health care organizations also could benefit from other mechanisms that encourage hospitals to strengthen their reporting systems (e.g., strong patient safety programs).

Patient Safety and Medical Liability Initiative Background

Review of Reforms

On, December 31, 2009, AHRQ published an article Review of Reforms to Our Medical Liability System, that examined a number of medical liability reforms that have been proposed and some that have been implemented. The article examined different approaches to reforming our current malpractice liability system and reviewed what is known about the impact of these approaches on health care costs and patient safety. The reforms to the medical liability system discussed in the article include full disclosure and early offer programs, certificate of merit programs, caps on damage awards, screening panel, and health courts.

These reforms are intended to address some of the limitations of the current medical liability system, such as costs, patient safety, and administrative burden. Applications submitted in response to this FOA must address medical liability reform models and/or some of the limitations of the current medical liability system cost, patient safety and administrative burden.

Previous AHRQ funding

On June 11, 2010, AHRQ announced the funding of 20 patient safety projects to allow states and health care systems to develop, implement, and evaluate evidence-based patient safety and medical liability models. The demonstration and planning grants are part of the patient safety and medical liability initiative that President Obama announced during the September 9, 2009, address to a joint session of Congress. The projects are intended to: (1) put patient safety first and work to reduce preventable injuries; (2) foster better communication between doctors and their patients; (3) ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits; and (4) reduce liability premiums. Some of the patient safety projects that are being planned and tested under this initiative address limitations of the current medical liability system such as costs, patient safety, and administrative burden for doctors. Additional information on these projects can be obtained at http://www.ahrq.gov/qual/liability/#moreinfo. This FOA is part of the Patient Safety and Medical Liability Initiative.

Cross-Grant Evaluation

Applicants must include an evaluation plan for their proposed innovation. In addition, applicants must agree to participate in cross-grant, multi-year evaluation activities. AHRQ has contracted with an external entity to serve as the Longitudinal Program Evaluator for this initiative as an outside evaluator to analyze all the demonstration projects. Grantees must agree to participate with the AHRQ’s evaluator in establishing common outcome measures and making summary results available. The PD/PI and at least one key program staff member of the project must attend and budget for travel to AHRQ s annual conference during which all grantees will meet to discuss establishing common measures, methodology, and study results. This 3 day meeting will be held annually in the Washington, D.C. area.

To allow evaluation of this initiative, grantees will be required to submit patient safety data to AHRQ s network of patient safety databases (NPSD) and use the common formats for patient safety events released 9/2/2009 by HHS (http://edocket.access.gpo.gov/2009/E9-21080.htm). Specific information regarding submission of all data, including required data elements and process for submission, will be included in the Notice of Award.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Research Demonstration and Dissemination Grants (R18) award mechanism. The individual researcher sponsored by each organizational awardee will have responsibility for planning, directing, and executing the project.

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

2. Funds Available

The total amount awarded depends upon the quality, duration, and proposed research projects of the applications received. Awards issued under this FOA are contingent upon the availability of funds and the submission of meritorious applications. Facilities and administrative (F&A) costs requested by the applicant are included in the total cost limitation.

The total costs awarded to a grant under this FOA will not exceed $1 million annually. Projects may be up to three years in duration. AHRQ will not review an application with a project period that exceeds three years or a budget that exceeds $1 million in total costs in any given year. Funding beyond the first year will depend upon AHRQ staff review of an annual progress report and satisfactory performance.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Units of local or State government;
• Eligible agencies of the Federal government;
• Indian/Native American Tribal Government (Federally Recognized);
• Indian/Native American Tribal Government (Other than Federally Recognized);
• Indian/Native American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or by foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

AHRQ is encouraging applications that involve collaborations of States, health systems, and risk management organizations.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

AHRQ requires a minimum time commitment of 20% annual effort from the PD/PI or the Project Manager, depending upon how the applicant structures the project’s organization and work plan.

2. Cost Sharing or Matching

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

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This can be included at the end of the budget justification section, but the detailed budget request should not include institutional support dollars

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).

Renewals. Applicants may not submit a renewal application.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons.
• The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• The PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget
(See Section IV.6., Special Instructions, regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates [TBD]
Opening Date: December 25, 2010 (Earliest date an application may be submitted to Grants.gov).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date.

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically.

PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH and AHRQ for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete or non-responsiveapplications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

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

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. The applicant should obtain and estimate for the costs of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements

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

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.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 25 pages.

Budget Component

Special Instructions for Modular Grant applications

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

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality Web site (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

Plan for Sharing Research Data

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

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

Section V. Application Review Information

1. Criteria

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

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

2. Review and Selection Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the proposed study address an important problem within both patient safety and medical liability? If application achieves its aims, how will it advance scientific knowledge within both the fields of patient safety and medical liability? How would the study affect the variables and trends that drive both patient safety and medical liability?

Investigators. Does the proposed study have key personnel appropriately trained and well suited to carry out this work? Do the PD/PI and other researchers have appropriate experience levels for work within both patient safety and medical liability? Does the investigative team bring complementary and integrated expertise to the project?

Innovation. Does the proposed study show originality and innovation within the fields of both patient safety and medical liability? For example, does the project challenge existing paradigms or practices? Does it 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?

Approach. Does the proposed study have a conceptual framework, design, methods, and analyses appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Environment. Does the scientific, clinical and administrative environment contribute to the probability of success? Do the proposed studies benefit from unique features of the environment, subject populations, or collaborative arrangements? Does the proposed study have institutional support? Does the institutional have adequate resources?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and rating.

Collaborative Research Experience. Does the proposed study team show willingness and ability to participate fully in all studies and to adopt standard operating procedures? Has the applicant shown a willingness and ability to establish collaborations?

Stakeholder Involvement. Has the application demonstrated that the project is applicable to problems important to stakeholders? Does the application describe a plan to involve key stakeholders in the research?

Patient Safety Opportunity. Does the application propose an intervention that will reduce the incidence of adverse events, or merely buffer the liability effect of the usual rate of bad outcomes? Does the proposal address systems failures or only personal errors? Does the innovation attempt to control antecedent causes of the adverse outcome and/or mitigate damage afterwards, or does it only address variables under immediate institutional control? Does the implementation increase system transparency? What are the planned Safe Practices that will be part of the project? What experience does the applicant have with patient safety activities? Do the plans involve any of the large scale implementations programs currently being supported by AHRQ or other organizations within and without the government? Does the applicant plan to use current assessment tools such as AHRQ’s Survey on Patient Safety Culture, PSIs, or HCHAPS? Does the applicant participate in a Patient Safety Organization (PSO)? How does the applicant plan to use the patient safety data on risks and hazards? How will it relate risk management information to claims or litigation and patient safety activities?

Medical Liability Opportunity. Does the application propose a paradigm shift for the medical liability problem (or merely duplicate incremental change already introduced in other jurisdictions)? Will the proposal address the causes of the medical liability problem? Can the innovation link patient safety to both the medical liability problem and the proposed solution?

Feasibility. Can the applicant accomplish the proposed intervention? Will implementation of the proposed innovation likely result in the predicted outcomes? Can the applicant measure the outcomes in a way that permits comparison to other innovations? Could the proposed innovation garner wide public and stakeholder support? Can the organization and team carryout their work plan? Will the proposal produce valid results? Will it produce results that can be replicated elsewhere? Is there evidence of plans for sustainability once grant funds have expired?

Degree of Responsiveness. How well does the application address the purpose and objectives of the FOA? Specifically does the study adequately address the issues of medical liability risk management, and patient safety in a manner that will provide a meaningful approach to this problem? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support. Does the application propose a reasonable budget? Does it allocate costs appropriately across the project period?

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

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

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

Resubmission Applications (formerly revised/amended applications). Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Selection Process

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

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities
• Programmatic balance
• Portfolio balance within AHRQ and DHHS

2.B. Additional Review Considerations

Not applicable.

2.C. Resource Sharing Plan(s)

Data Confidentiality

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

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

Sharing Research Resources: Rights in Data

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

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

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

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

3. Reporting

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

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

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

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the AHRQ Grants Process web site at http://www.ahrq.gov/fund/postawrd.htm#terms for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Jennifer Devine
Center for Quality Improvement and Patient Safety
Telephone: (301) 427-1141
E-mail: [email protected]

2. Peer Review Contact(s):

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

Andrew Louden
Office of Extramural Research, Education, and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1183
E-mail: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

AHRQ Grants Management
Office of Performance Accountability Resources and Technology
Telephone: (301)-427-1447
[email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

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

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The HIPAA Privacy Rule, 45 CFR Parts 160 and 164 governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data may also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

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

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

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