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EXPIRED

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: Medical Liability Reform and Patient Safety Planning Grants (R21)

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

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-HS-10-022

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.

A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: October 20, 2009
Opening Date: December 20, 2009 (Earliest date an application may be submitted to Grants.gov)
Technical Assistance Conference Call: November 12, 2009.
Letters of Intent Receipt Date(s): December 23, 2009
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization)
Application Due Date(s): January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: January 21, 2010

Due Dates for E.O. 1237
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
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
1. Letter of Intent
2. Technical Assistance
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 Criteria
B. Additional Review Considerations
C. Resource Sharing Plan
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

Research Objectives

AHRQ has the mission of improving 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 planning grants for States and health care systems to create plans for the development, implementation and evaluation of approaches that put patient safety first and work to reduce preventable injuries; foster better communication between doctors and their patients; ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits; and reduce liability premiums. Parallel AHRQ initiatives will: (1) evaluate current initiatives that improve health care quality and patient safety and decrease medical liability; and (2) support demonstration grants for future initiatives in patient safety and medical liability reform. (RFA-HS-10-021)

Patient Safety Background

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 in hospitals from medical errors. Systems errors cause the majority of these casualties, rather than poor performance by individual practitioners.1 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.

Among other ideas, 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 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.2 Scores on four performance indexes 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.3 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.4 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.

Safe Practices

In addition to the attention devoted to identification of risks and hazards through various forms of detection, patient Safe Practices 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.5 The National Quality Forum used this report to develop a list of Safe Practices which it recently updated.6 Its 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 which guide efforts to reduce harm to patients.7

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 safe practices in a series of ten case studies on reducing harm to patients.8 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.9, 10 AHRQ also supports a program for the National Implementation of TeamSTEPPS. It provides resources for institutions to improve teamwork in their institutions.11

The Keystone Project successfully reduces 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).12, 13 AHRQ has just 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 Infection (CLABSI).14-16 This activity comprises a significant part of the Department of Health and Human Services Healthcare-Associated Infections National Action Plan.17

Patient Safety and Risk Management

Documenting the relationship between implementing Safe Practices and risk management activities (including 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.18 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 the same mistake could be made in another patient’s case.19 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.20 Hickson also discovered that studying patient complaints could predict which physicians would likely put the institution at risk for a malpractice claim.21 Based on feedback from patients, Pichert also identified individual units within an institution that could be considered at high risk.22 Differences in expectations about outcome of a health care process often cause litigation. As Sharpe and Faden point put 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.23 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.24 Health care organizations could also benefit from other mechanisms that encourage hospitals to strengthen their reporting systems (e.g., strong patient-safety programs).

Medical Liability Background

For decades, policymakers and stakeholders have debated the existence, nature, and scope of a malpractice problem. Some perceive fear of lawsuits as a substantial barrier to addressing patient safety, while others emphasize the importance of strong legal remedies because of the persistence of patient injuries caused by health care. In contrast, far more consensus exists regarding the imperative of eliminating preventable patient harms. These differences highlight the opportunity for better understanding of the problem, proposed improvements, and actual outcomes of legislative changes on liability claims, costs, and incidence of preventable patient harm.

Previous literature on medical liability suggests multiple issues relevant to medical liability. Varying evidence exists regarding either different perspectives on the malpractice problem or the effectiveness of proposed solutions to reduce liability and actual malpractice on the occurrence of patient harms, incidence of claims and costs associated with medical liability. Prospective applicants need to have a common understanding of the previous literature in order to identify opportunities for demonstrable or tangible improvements.

Defensive medicine: All stakeholders agree that defensive medicine occurs, but no universally accepted estimates exist.

a. Premiums: Liability premiums constitute less than 2% of gross revenues for the health care sector. Researchers have found a weakly positive relationship between payouts and malpractice premiums.

Relationship between lawsuits and negligence: The Harvard Malpractice Study finds that 45% of claims present no malpractice.25 The older, California Malpractice Study reports 57% false positives.26, 27 The Utah-Colorado Study ascertains similar rates.28,29

Quality improvement: The Institute of Medicine reported that systems failures cause at least half of patient injuries.1 For historical reasons, the legal system can only assign blame to individuals, not to multi-step failures of complex delivery systems.

Professional discipline: State medical boards principally address personal impairment and boundary crossing, rather than poor quality care or professional negligence. Peer discipline for other professions also focuses more on impairment than service quality.

Transaction costs: Studies agree that 54-78% of the payouts go for administrative expenses (lawyers, experts, courts). This proportion parallels the transaction costs for other types of tort litigation (e.g., auto accidents, product liability).

Compensation fairness: No literature appears to quantify patient satisfaction with the malpractice litigation process.

To date, the States have often favored focused responses to the malpractice problem. Incremental developments generally pertain to court procedure, rather than overall compensation systems or other changes to the health care system’s response to adverse events. Some health care systems have experimented with more innovative responses including disclosure of all patient safety events; and apology to patients and families, combined with prompt compensation.

Because of the long period between enacting legislation, filing claims in the new environment, and final payout; little scientific literature quantifies the effect of recent changes in medical liability law. Nevertheless, the States different approaches to the malpractice problem constitute a natural experiment with other States acting as the control group. As evidence accrues, stakeholders will learn if the change fulfills its intended purpose and whether it imposes undue side effects.

Innovation Opportunity

This FOA presents States and health systems with the opportunity to plan for the development, implementation, and evaluation of alternatives to our current medical liability system. Applicants will have wide discretion and flexibility in designing their patient safety and medical liability innovations that meet the goals of putting patient safety first and work 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. Proposals should seek comprehensive solutions that improve patient safety and address the underlying causes of the malpractice problem. AHRQ will convene a subcommittee to its National Advisory Council on October 26, 2009 to discuss selected examples of innovations that address medical liability and patient safety. Subcommittee members will advise the National Advisory Council about specific promising approaches that applicants might consider, as well as additional evaluation criteria. Minutes from the NAC subcommittee meeting will be made available to the public on the AHRQ website immediately following the meeting and prior to the Technical Assistance call scheduled for November 12, 2009, 1:00 2:00 p.m. Eastern time. [see Section IV.3.A.3, below]

Proposals may entail government action or private action. A credible application assuming governmental action should show appropriate official interest. Any application should demonstrate generalizability, relationship to patient safety, appeal to a wide range of stakeholders, and proposed outcome measures. The application should show the sustainability of the innovation if adopted.

Specific metrics for patient safety might include the following: Incidence of selected patient safety events, reduction in antecedent or precipitating factors, system changes and corrective actions taken (if any), effectiveness of risk mitigation approaches implemented, and increased transparency of patient safety events on a State or system-wide basis. Applicants should consider using existing safety assessment tools to identify risk and hazards; including culture assessment, patient experience of care such as AHRQ’s Hospital Survey on Patient Safety Culture, 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 IHI, and ratings from Centers for Medicare and Medicaid Services (CMS) Nursing Home Compare. 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 processing times, control of overall health care costs, reduction of randomness of 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.

This R21 presents States and health systems, and other eligible applicants with the opportunity to create detailed plans for patient safety and medical liability reform. The parallel R18 initiative supports demonstration projects in patient safety and medical liability reform. Innovations deemed too investigational to address via the R18 mechanism might better fit the R21 mechanism.

Section II. Award Information

1. Mechanism of Support

This FOA uses the AHRQ Exploratory and Developmental Grants (R21) award mechanism The individual researcher sponsored by each organizational awardee will have responsibility for planning, directing, and executing the projects.

AHRQ will not use the Modular Grant Application and Award Process. It will not review applications submitted in modular format.

2. Funds Available

AHRQ intends initially to commit approximately $4 million total costs in FY 2010 funds to cover a period of up to one year. If AHRQ fails to receive a sufficient number of meritorious applications for the parallel FOA solicitation for R18 demonstration projects; then it reserves the option of transferring unused funds from the R18 program to this FOA. In such an eventuality, the total funds available could increase without further notice to applicants or prospective applicants.

Each single award may total up to $300,000 over one year. The FY 2010 award will fully fund all one year in advance. However, AHRQ staff may terminate an on-going grant for failure to make satisfactory progress. The total amount awarded depends upon the quality, duration, and proposed research projects of the applications received. The award issued under this FOA is contingent upon the availability of funds and the submission of meritorious applications. The total cost limitation includes facilities and administrative (F&A) rates.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your domestic institution or organization has any of the following characteristics.

Established health care systems. Roemer defines a health system as having capacities (e.g., hospitals, physicians), activities (e.g., health services), interconnections (e.g., financing, oversight, management), and purpose.30, 31 Its components might include multiple States, localities, Tribal governments, universities, colleges, hospitals, nonprofit organizations, faith-based organization, community-based organizations, and Federal agencies. Applicants to this FOA must share a long-established, legal entity as sponsor and sufficient service volume to statistically power any proposed intervention. Organizations must also fit under AHRQ’s grant authorization under 42 USC 299c-5(c), which allows AHRQ to make grants to public and nonprofit entities.

Other organizations may participate in projects only as third parties. Because the purpose of this program seeks to improve health care in the United States, foreign institutions may participate in projects only as subcontractors. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying may not participate.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI may work with their sponsoring organization to develop an application. AHRQ encourages individuals from underrepresented racial and ethnic groups as well as individuals with disabilities to apply.

AHRQ expects a minimum time commitment of 20% annual effort from either the 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 responding to this FOA.

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

3. Other-Special Eligibility Criteria

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

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.

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

Note 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 Information

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

The SF424 (R&R) application has several components. 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

Opening Date: December 20, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 23, 2009
Application Due Date(s): January 20, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

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

AHRQ does not require a letter of intent. The letter does not bind the author to apply. AHRQ does not consider the letter in the review of a subsequent application. However, these letters greatly help grant administration. To be most useful, the letter of intent should arrive by the date listed.

The letter of intent can be sent electronically or in hard copy. Please send it to: David Hsia, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850-6649; [email protected].

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

3.A.2. Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on November 12, 2009 from 1:00 pm to 2:00 pm EDT. To register to participate in the conference call, please send an e-mail request to [email protected]) by November 6, 2009. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB November 10, 2009. Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

3.A.3. AHRQ National Advisory Committee Subcommittee Meeting on Patient Safety and Medical Liability

AHRQ will convene a meeting of its National Advisory Committee (NAC) Subcommittee on Patient Safety and Medical Liability on October 26, 2009. This meeting is open to the public, including potential applicants. Meeting logistic details can be found on the AHRQ website www.ahrq.gov

Input from the NAC subcommittee meeting may inform review criteria included in this FOA or clarify additional issues for applicants to consider. Minutes from the NAC subcommittee meeting will be made available to the public on the AHRQ website immediately following the meeting and prior to the Technical Assistance call scheduled for November 12, 2009, 1:00 2:00 p.m. Eastern time.

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

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.

Once an application package has been successfully submitted through Grants.gov, any 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 application image to determine if any further action is necessary.

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, NIH, 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, 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/AHRQ 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 NIH 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 responsiveness by AHRQ. Incomplete or non-responsive applications will not be reviewed.

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

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

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

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

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

o Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award. Please note that prior approval is not given prior to issuance of an 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 requested 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

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

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. The Research Plan component of the PHS398 may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided 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 additional requirements:

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

Special Instructions for Modular Grant applications

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

Appendix Materials

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

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. 42 USC 299(c). To implement this 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), 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.

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

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

Section V. Application Review Information

1. Criteria

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

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will be returned to the applicant without further consideration.

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

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:

Significance
Approach
Innovation
Investigators
Environment
Collaborative Research Experience
Patient Resources
Stakeholder Involvement

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score.

Significance: Does the proposed study address an important problem? If application achieves its aims, how would it advance scientific knowledge? How would the study affect the variables and trends that drive this field?

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?

Innovation: Does the proposed study show originality and innovation? 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?

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? Does the investigative team bring complementary and integrated expertise to the project?

Environment: Does the scientific 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?

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?

2.A. Additional Review Criteria

In addition to the above criteria, peer review will consider the following items in the determination of scientific merit and the priority score.

Innovation: Does the application propose planning for an original innovation in patient safety and/or medical liability reform? Would the plan produce evidence about the innovation’s effectiveness? Does the plan go beyond merely duplicating incremental changes already introduced in other jurisdictions? Does the plan propose directly addressing the malpractice problem (however defined) or just shift the problem elsewhere? Can the innovation link patient safety to medical liability?

Feasibility: Can the applicant create a plan for innovation in patient safety and medical liability reform? Could the applicant secure implementation of the plan? Would the plan result in the predicted outcomes? Can the applicant measure the outcomes in a way that permits comparison to other States innovations? Could the plan garner wide public and stakeholder support? Will it produce generalizable conclusions?

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

Budget: Does the application propose a reasonable budget? Does it allocate costs appropriately across the project period?

2.B. Additional Review Considerations

Not Applicable.

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed (e.g., to researchers). Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/. Confidentiality provisions of PSQIA and the Patient Safety Rule, 42 CFR Part 3, may also be applicable if patient safety work product, as that term is defined in the rule, is used.

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).

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

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

2. Administrative and National Policy Requirements

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

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

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

A Financial Status Report (FSRs; SF 269) is 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, Financial Status Report, and Final Invention Statement are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

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):

James Battles (patient safety) or David Hsia (medical liability)
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
Telephone: (301) 427-1332 (Battles) or 1499 (Hsia)
Fax: (301) 427-1341 (Battles) or 1520 (Hsia)
E-mail: [email protected] or [email protected]

2. Peer Review Contact(s):

Ying Tian, M.D., Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
Telephone: (301) 427-1530
Fax: (301) 427-1562
E-mail: [email protected]

3. Financial/Grants Management Contact(s):

Michelle Burr or George Gardner
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850-6649
Telephone: (301) 427-1451 (Burr) or 1450 (Gardner)
Fax: (301) 427-1462
E-mail: [email protected] or [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 CRF 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:
The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authority of 42 USC 299 et seq. (see, e.g., 42 USC 299a(a)(1), (2) and (9)) 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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