Participating Organization(s)	Agency for Healthcare Research and Quality (AHRQ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.
Components of Participating Organizations	Agency for Healthcare Research and Quality (AHRQ) Center for Outcomes and Evidence
Funding Opportunity Title	Deliberative Approaches: Patient and Consumer Input for Implementing Evidence-Based Health Care (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HS-14-007
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.226
Funding Opportunity Purpose	Deliberative methods offer means to gain insight into patient and public views that can inform and improve clinical, program, and policy decisions in health care. The purpose of this FOA is to use deliberative methods to understand and clarify important public or patient values and concerns that affect the implementation of specific interventions, programs or policies to improve health care or research. The input gained through the proposed project must be for the purpose of informing specific activities of the applicant or an organization collaborating with the applicant as part of this project. The applicant or partner organization will have identified and proposed the deliberative question and committed to using the findings from this activity in a way that will contribute to its implementation of patient centered, evidence-based care or development of programs or policies to improve care or research. The deliberative activities proposed under this project must contribute to that effort, in a specific clinical setting or by directly contributing to the development or improvement of a specific policy or program. In addition to obtaining public input, projects should advance the science related to deliberative methods. Projects will include an evaluative component that will define and investigate the success of the deliberative approach employed as compared to an education-only intervention, and that will include pre-deliberation and post-deliberation measures.

Posted Date	November 27, 2013
Open Date (Earliest Submission Date)	January 7, 2014
Letter of Intent Due Date(s)	January 6, 2014
Application Due Date(s)	February 7, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Generally, four months after receipt date
Advisory Council Review	Not Applicable
Earliest Start Date	Generally, four months after peer review date
Expiration Date	February 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

As a recent IOM report notes, "citizens -- each one a past, current, or future patient -- should represent both the healthcare system's unwavering focus, and its fully engaged agents for change."(1) In the paradigm of shared decision making, the patient plays an active role in deciding the best course of care in light of his or her own values and preferences. However, patients and the public have a role beyond the immediate clinical setting as well. Public views can provide important insights to clinicians, researchers, policy makers, and administrators that will assist them in designing and managing research programs, health policies, and health care delivery to best meet public needs.

Interest in eliciting public values and preferences to inform healthcare decisions made by public officials and health care institutions has grown steadily in recent years. Research describing differences in the views of patients and members of the public from those of researchers and professionals has added momentum to efforts to find ways to bring public perspectives into both research and policy decisions. (2) Reasons to involve the public in health care decision making include:

• Increasing the transparency and legitimacy of the decision making processes of health care programs and institutions;
• Allowing decision makers to become better informed about societal values, needs, concerns and preferences;
• Making the health care system more responsive to the needs and desires of the public;
• Fostering discussion about the direction of health care reforms;
• Including users perspectives in designing program changes;
• Educating the public about a particular issue;
• Building support or consensus for a final decision;
• Addressing public or media criticisms of an issue. (3)

Deliberative methods, a form of public consultation, offer means to gain insight into patient and public views that can inform and improve clinical, programmatic, and policy decisions in health care. These insights relate to people's priorities, the values and reasons supporting their views, and the range of views represented in the community. Deliberative methods are particularly suited to obtaining input on the complex, often values-based, perspectives people hold regarding health care decisions, because -- unlike traditional polling or focus group methods -- they involve a strong educational component and offer people the opportunity to explore and debate others' perspectives as they consider and refine their own views.

Deliberative methods are part of a continuum of public consultation methods defined by the intensity of participants' engagement in the process. At one end of the spectrum are survey and polling techniques that ask straightforward questions and elicit direct responses. Focus group methods are intermediate, allowing discussion of views but having the primary objective of eliciting a broad range of reactions or interpretations. Deliberative methods occupy the more "intense" end of the spectrum, identifying the values underlying people's views and requiring participants to focus on the reasons for their perspectives. Deliberative sessions often ask participants to consider a community or societal point of view.

A variety of deliberative approaches are currently in use in health care and in other fields. These include Citizen’s Panels or Councils, Citizens Juries, Deliberative focus groups, Deliberative Polls , Issues Forums (including Community Forums, National Issues Forums, Deliberative Forums ), Study Circles, Town hall meetings (including 21st Century Town Hall Meetings), Choosing Healthplans All Together (CHAT), ChoiceWork DialogueTM, and a number of hybrid methods.

The following elements characterize deliberative sessions:

• Role of Sponsor: Deliberative sessions are convened by a sponsor having an interest in public input regarding the topic in question. The interests of the sponsor provide the context for the discussion and are important in justifying to participants their contributions of time and energy to the process.
• Type of Question: Deliberative sessions address an ethical- or values-based dilemma. Deliberative questions involve a tension or dilemma -- the process of deliberation is designed to allow the negotiation of competing viewpoints on societal problems.
• Group Composition: Deliberative groups are intentionally diverse, so that participants will have the opportunity to learn about and discuss a variety of viewpoints.
• Educational Component: Deliberative sessions always include an educational component. Balanced, accurate information about the topic and often about opposing views can be provided through educational materials or content expert presentations.
• Deliberative Discussion: In deliberative sessions, participants engage in an active discussion regarding their opinions, preferences, and values. The facilitator encourages participants to provide reasons and justifications for their views, and also to listen to and actively consider the perspectives of others.
• Result Synthesis: The results of deliberative sessions are synthesized and reported to the sponsor. Participants can contribute to the development of a report, or session facilitators can document the main findings.

AHRQ's Community Forum Project. AHRQ initiated the Community Forum Deliberative Demonstration in fall 2009.(4) This project refined and implemented four distinct deliberative approaches, comparing them with an educational-materials-only control. The deliberative approaches varied in the length and number of sessions and in the use of web-based and internet technology to support or facilitate discussion among participants. The approaches evaluated were:

• Brief Citizens Deliberation (BCD): Participants convene in person for one 2-hour session.
• Online Deliberative Polling (ODP): Participants convene online for four 1.25-hour "live" Internet sessions over a four-week period (a total of 5 hours of participation).
• Community Deliberation (CD): Participants attend two in-person 2.5-hour sessions, separated by one week. Between the two sessions, participants review materials on a website and engage in Internet-based asynchronous discussions. (a total of 5-7 hours of participation).
• Citizens Panel (CP): Participants convene in person on three consecutive days, a total of 24 hours of participation.

Nearly 100 groups and approximately 1,200 members of the public participated in these groups, deliberating on questions related to the use of evidence in health care decision making. Participants were selected to reflect the populations of demographically diverse communities in Chicago, Raleigh-Durham, Washington DC, and Sacramento, and randomly assigned to the deliberative methods. Findings from the AHRQ Community Forum Deliberative Demonstration will be available Fall 2013, at http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/ahrq-community-forum/#deliberative

Resources developed during this project, including a comprehensive review of the literature on deliberative methods and tools to support organizations and researchers implementing deliberative sessions, are available at the same location.

The purpose of this FOA is to develop and demonstrate the use of deliberative methods in convening patients or the public to address complex issues related to the implementation of health care policies, programs, or other decisions that are designed to improve research or care (and, ultimately, health outcomes) in a specific setting. The projects will be funded through the Patient Centered Outcomes Research (PCOR) Trust Fund, consistent with the statutory requirement in The Affordable Care Act (P.L. 111-148) that AHRQ broadly disseminate research relevant to comparative clinical effectiveness research. Projects funded under this FOA will promote the active contribution of patients and the public to assuring that comparative effectiveness research is disseminated and implemented to best effect in improving care.

As such, the objectives of this FOA are to:

1. Demonstrate the use of deliberative methods in obtaining information from patients, consumers or the public that is directly relevant to health care or health care research decision makers;

2. Demonstrate the application of that information to inform specific decisions -- the applicant's or those of a partnering organization -- to improve health care or research; and

3. Evaluate the effectiveness of the particular deliberative approach used and the potential factors affecting it, to inform others wishing to use public deliberation to inform decisions in health care or health research.

AHRQ sponsors and conducts research that develops and presents evidence-based information on health care outcomes, quality, patient safety, cost, use and access. Included in AHRQ’s mandate is support of generation, synthesis and dissemination of patient centered outcomes research, and support of research into methods that improve these activities.

AHRQ has consistently involved stakeholders -- patients, clinicians, payers, policy makers, researchers, and others with an interest in patient centered outcomes research -- in its programs. Stakeholder involvement helps ensure that research programs respond to the issues that are most pressing for health care decision makers and in ways that are accessible and useful.

This FOA is designed to support developmental research grants which encourage researchers to work with health care decision makers to explore and demonstrate the use of deliberative methods to involve patients, consumers, and the general public, in health care or care systems decisions that are based on research, or in research decisions. These demonstrations are intended to support AHRQ's efforts to promote the use of patient centered outcomes research in health care interventions, programs, and policy decisions. In addition, they are expected to contribute to the evidence base regarding the use of deliberative methods to inform important patient centered outcomes research and health care decisions.

Applications submitted must include the following research elements:

1. Identify an organization whose decision-making needs underpin the proposed deliberative project. This organization must be an individual or group responsible for health care research, program, intervention, or related decisions. It may be the applicant organization itself, or an organization collaborating with the applicant on this project expressly to obtain input for a decision in its purview. The application should justify the organization's interest in eliciting patient or public input and describe the impact of that information.

2. Identify a decision within the sponsor's domain of responsibility, to be informed by deliberative patient or public input. Explain fully the reasons and/or anticipated outcomes that deliberative input -- as opposed to focus groups or surveys -- is required, including a description of possible anticipated outcomes. Identify the values and ethical tensions brought to the fore in the decision. The relevant impact on a decision (i.e., changes in a policy or program) should be anticipated in the near term, within approximately one year following the conclusion of the deliberative study -- that is, the impact should be clearly practical and not simply theoretical.

3. Identify a question or questions that patients or the public can address that will provide useful input regarding the decision. Describe how the informed response to the proposed question in a deliberative process will assist with the decision.

4. Outline the characteristics of the participants to take part in a deliberative process. Because deliberative processes require the exchange of views and the in-depth discussion of the range of perspectives, participants in a deliberative process generally reflect the diversity of an affected community, including diversity of race, ethnicity, age, gender, income and/or education. Justify the choice of participants and the community as defined, explaining how you will capture the relevant diversity in persons affected by the decision.

5. Propose a deliberative approach. Fully describe and justify the proposed deliberative method. Provide a complete description of the proposed deliberative activity including number of deliberative groups, numbers of participants in each group, method of selecting participants, use of technology, and location. In addition to these elements and those referenced above regarding the sponsor, decision, question, and characteristics of participants, the application should address the educational component that will be designed to inform deliberation on the proposed question, including the proposed materials to be developed and use of content experts. Describe how deliberation will be facilitated. Projects may convene standing deliberative bodies or convene groups for purposes of this project only. Finally, the application should address length and structure of deliberative sessions. Proposed method should provide an opportunity for meaningful interaction and discussion -- a minimum of 8 hours of synchronous interaction for participants.

6. Describe the report of the deliberative sessions that will be delivered to the sponsor. Describe who will prepare the report, the role (if any) of participants in the deliberative sessions, and outline the relevant content. Describe how the proposed content will inform the sponsor regarding the decision described above. Describe how the outcomes of the deliberative sessions will be communicated to the participants.

7. Describe an evaluation framework and analytical approach of the project. The project evaluation is distinct from the report provided to sponsors, although there may be some overlap. The application should describe and justify measures of a successful deliberation and explain how these measures will be assessed. At a minimum -- unless justification is provided for a different type of evaluation -- the evaluation should include the following:

• An assessment of knowledge regarding the proposed topic, to be administered to a control group receiving educational materials only, and to participants in deliberative groups pre- and post-deliberation.
• An assessment of attitudes regarding the deliberative topic, to be administered to a control group receiving educational materials only, and to participants in deliberative groups pre- and post-deliberation.
• An assessment of the self-perceived impact of the deliberative process on participants.

The description of the proposed evaluation should explain how the information obtained will inform the field of deliberation in addition to assessing the success of the project.

The deliberative session(s) undertaken in this project should be designed to address a complex issue related to the implementation of health care policies, programs, or other decisions that are designed to improve care or research (and, ultimately, health outcomes) in a specific setting. The decision may relate to implementing a specific intervention that patient centered outcomes research developed by AHRQ or others has shown to be effective in improving patient outcomes. If this is not the case, the applicant should explain the importance and impact on health of the proposed policy, program, or other intervention. Finally, a critical criterion will be the relevance of input regarding the deliberative question to an identifiable decision by an identifiable sponsor/decision maker.

Recent examples of deliberation have addressed, for example:

• Institutional policy on tissue biobanking (5)
• Types of tests to include in expanded newborn genetic screening (6)
• Risks associated with (publicly funded) research on genetic variation (7)
• Setting priorities for clinical and translational research, emphasizing the views of minority and underserved communities (8)
• Surrogate consent for dementia research(9)

These examples are offered as reference for applicants, but are not intended to suggest requirements for proposed topics or AHRQ preferences. Other types of projects that could be of interest include questions related to implementation strategies for specific interventions, questions regarding research priorities, appropriate ways to address disparities in care, institutional policies regarding care and care delivery, handling of personal health information in registries or other contexts, questions regarding participation in research, or other issues of consent.

1. IOM (Institute of Medicine). Patients charting the course: Citizen engagement and the learning ehalth system: Workshop Summary. Washington DC. The National Academies Press. 2011.

2. Gooberman-Hill R, Horwwd J, Calnan M. Citizens juries in planning research priorities: process, engagement and outcome. Health Expectations 11; 2008. pp 272-281.

3. Chafe R, Neville D, Rathwell T, Deber R, Kenny N, Nestman L, Joffres, C, Chappell H, Conrad P, Batema M. A Framework for Involving the public in healthcare coverage and resource allocation decisions, 2007(accessed at www.dal.ca/shsa/Research/)

4. The Community Forum Project was implemented for AHRQ under Contract #290-2010-00005 by the American Institutes for Research (AIR), with organizational partners including the Center for Deliberative Democracy at Stanford University and the Center for Healthcare Decisions.

5. O'Doherty, K.C., Hawkins, A. Structuring public engagement for effective input in policy development on human tissue biobanking. Public Health Genomics. 2010;13,197 206

6. Hayeems RZ, Miller FA, Bombard Y, Bombard Y, et al. Expectations and values about expanded newborn screening: a public engagement study. Health Expect. 2013 Feb 1. doi: 10.1111/hex.12047.

7. Terry SF, Christensen KD, Metosky S, Rudofsky G, Deignan KP, Martinez H, et al. Community engagement about genetic variation research. Popul Health Manag. 2012; 15(2):78-89.

8. Susan Door Goold, MD PI. NIH Project No. 5R01AG040138-02 (2012). Deliberative engagement of communities in decisions about research spending.

9. De Vries R, Ryan KA, Stanczyk A, Appelbaum PS, Damschroder L, Knopman DS, Kim SY.

Public's Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism. Am J Geriatr Psychiatry. 2013 Apr; 21(4):364-72. doi: 10.1016/j.jagp.2012.11.010. Epub 2013 Jan 12

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	AHRQ intends to fund up to 5 awards, for a total of $1.0 million for fiscal year 2014. Future year amounts will depend on availability of funds. The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications
Award Budget	The total costs (direct and indirect) for a project awarded under this FOA will not exceed $200,000 in any given year or $400,000 for the entire project period.
Award Project Period	The project period may not exceed 2 years.

Title 42 USC, section 299b 37(a)-(c) authorizes AHRQ to make these awards to support the agency’s dissemination of comparative clinical effectiveness research findings. AHRQ is authorized to conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to quality, effectiveness, efficiency, appropriateness and value of health care services, including ways in which we acquire new information about best practices and health benefits and the effect of our use of this information. 42 USC 299(b)(1) and (2), and 42 USC 299a(1) (4).

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

You may submit an application(s) if your institution/organization is a (an):

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Eligible agency 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 Organization.

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

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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account and should work with his/her organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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.

Only one PD/PI may be designated on the application.

This FOA does not require cost sharing.

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 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 information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD/PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent electronically to the following email address: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Budget Component: Special Instructions for AHRQ 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

Specific Aims:

The specific aims should address the specific Purpose/Research Objectives of this FOA (See Section I above).

Research Strategy:

Research strategy should address the following (See Section I for additional detail):

1. Identify a sponsor.

2. Identify a decision within the sponsor's domain of responsibility, to be informed by deliberative patient or public input.

3. Identify a question or questions that patients or the public can address that will provide useful input regarding the decision.

4. Outline the characteristics of the participants to take part in a deliberative process.

5. Propose a deliberative approach with a minimum of 8 hours of synchronous interaction for participants.

6. Describe the report of the deliberative sessions that will be delivered to the sponsor.

7. Describe the evaluation of the deliberative process.

Letters of Support:

Letters of Support must include one or more letters from an individual or organization (the sponsor) responsible for health care or research decisions, indicating the organization's interest and commitment to using the findings of the proposed deliberative sessions.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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/funding/grants/policies/hhspolicy.html.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
The PD/PI must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ. Applications that are incomplete and/or non-responsive will not be reviewed.

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.

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.

AHRQ supports research, evaluations, and demonstration projects concerning 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). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at 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.

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.

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. 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.

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, 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 applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

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 support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. 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) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html).

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. 

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

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

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

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific 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 project address an important problem in patient centered research or care? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

Investigator(s)

Are the PD/PI, collaborators, and other researchers appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project?

Innovation

Is the project original and innovative in bringing public or patient views to a decision that has not previously been informed by a deliberative process? Does the project develop deliberative concepts, approaches or methodologies?

Approach

Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are benchmarks for success presented? Does the applicant address all of the elements described in Section I (under Specific Areas of Research Interest) to develop a proposal consistent with the goals of this funding opportunity in Section I (under Purpose/Research Objectives)?

Environment

Do(es) the environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from useful collaborative arrangements? Is evidence of institutional support provided?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this FOA.  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA? [NOTE: Information may be added here]

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements ).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research. [NOTE: Information may be added here].

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention. (Note: use this as appropriate)

Not Applicable

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ portfolio priorities, as well as overall programmatic balance.

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

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

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 and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

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, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the Notice of Award.

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

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

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Direct your questions about general FOA issues, including information on the inclusion of priority populations to [email protected].  For reasons of equity and consistency, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email. A compilation of frequently asked questions and answers will be posted at: http://www.ahrq.gov/fund/grantix.htm

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

Ileana Ponce-Gonzalez, MD, MPH
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1769
Fax: (301) 427-1562
E-mail address: [email protected]

Direct your questions regarding fiscal matters to:

Kathryn Carr
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1025
Fax: (301) 427-1462
E-mail address: [email protected]

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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.