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
Center for Outcomes and Evidence (COE)
(http://www.ahrq.gov)

Title: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a new RFA

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

Request For Applications (RFA) Number: RFA-HS-10-008 

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: July 6, 2009
Letters of Intent Receipt Date(s): September 4, 2009
Application Receipt Dates(s): September 23, 2009

Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date 

Additional Information To Be Available Date:  Not applicable
Expiration Date:  September 24, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose

AHRQ invites applications to develop a prospective clinical registry of orthopedic devices, drugs, and procedures through a practice-based research collaborative and clinical and outcomes data resource (P50 grant mechanism). The goal of this registry initiative is to support the development of a sustainable data infrastructure and to conduct rigorous clinical and scientific research including comparative effectiveness and safety research.  AHRQ envisions utilizing a practice based orthopedic registry across a broad provider network as one of the potentially most effective and productive approaches to develop scientific evidence regarding the short and long term benefits and harms of implantable orthopedic devices and other related services. The registry will be a model and basis for other national device and procedure registries and will actively disseminate study results into clinical practice.

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013 (42 USC 299b-7)(see http://effectivehealthcare.ahrq.gov/) authorized AHRQ to develop a program of comparative effectiveness research, thus, establishing the Effective Health Care (EHC) Program.  To help achieve the objectives of the EHC program, AHRQ will provide support to develop and maintain the infrastructure of a multi-center orthopedic registry and the conduct of multiple collaborative, prospective multi-center studies of orthopedic devices and procedures. The capacity to include community-based smaller practice sites, in addition to high volume institutions, as participants in the registry is strongly encouraged.

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

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing

   D.  Application Assignment
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(s)
3. Anticipated Announcement and Award Dates


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

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The purpose of this FOA is to develop a large multi-center, preferably national orthopedic registry and conduct rigorous clinical and scientific research with a primary focus on comparative effectiveness and safety research and to develop scientific evidence regarding the short and long term benefits and harms of implantable orthopedic devices, drugs, and procedures.

AHRQ will provide support to develop the infrastructure of a multi-center orthopedic registry and the conduct of multiple collaborative, prospective multi-center studies. The development of a large scale practice-based orthopedic registry is intended not only as a resource for affirming the findings of existing population-based studies but also to advance new knowledge and to conduct new innovative comparative effectiveness research. Prospective multi-center clinical studies conducted utilizing the registry will help elucidate the benefits and harms of therapeutics, in particular benefits and harms of implantable orthopedic medical devices and procedures. Further, the registry-based studies will enable and facilitate the inclusion of traditionally understudied subpopulations with inherent vulnerabilities, disparities, or risks of serious outcomes. Improved evidence on comparative clinical effectiveness will inform decisions made by patients, clinicians, payers, and regulators.

In 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was enacted into law. Section 1013 of MMA authorized AHRQ to conduct research, demonstrations, and evaluations designed to improve the quality, effectiveness, and efficiency of Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP), thus, establishing the Effective Healthcare Program (EHC) Program (http://effectivehealthcare.ahrq.gov/ ) at AHRQ.

The EHC program focuses on evidence of the relative benefits and risks of alternative interventions. It does not make treatment or coverage recommendations. Consumers, clinicians, payers, and others can make decisions and select treatments that reflect their own unique needs and values in the context of these effectiveness findings. The program is intended to help build research capacity and provide for support that is specifically intended to fill priority research gaps informed by stakeholders and users.

Americans undergo more than 700,000 hip and knee replacements annually. There are thousands of devices and device combinations in use to perform hip and knee replacement and repair procedures. The comparative effectiveness of these devices is unknown. It is impractical to study comparative effectiveness of these devices and procedures in randomized clinical trials given the enormous number of comparisons and sample sizes necessary to reach valid conclusions. Moreover, randomized clinical trials have a number of limitations that are hard to overcome in the area of comparative effectiveness of devices and less invasive surgery.

Many new devices and procedures are initially advocated by surgeon enthusiasts of the particular device/procedure who are some of the best performing surgeons. Real world performance of these devices is less clear when the technology is rapidly diffused into practice. An Orthopedic registry that captures real world experience with these devices and procedures would be a valuable resource to inform decision makers (patients, physicians, hospitals and policy makers) about comparative effectiveness and will ultimately serve to improve patient outcomes, quality of care, and safety. 

Research studies proposed as part of developing the registry must be designed as multi-center initiatives and serve to guide infrastructure development. The studies must have a high impact, be implemented in practice, and have a substantial capacity to inform decision-making that improves patient outcomes and public health. The studies must be set up to address questions that are of great public health and patient outcomes concerns that are viable only with the support of public funding.  Studies must be powered to address clinically important endpoints and must also be able to study comparative effectiveness and safety across demographic and clinical subpopulations.  A minimum of 3 core research studies are to be included in this registry application.

Below are examples of core research studies that are responsive to research plan requirements of this FOA. These include, but are not limited to, those described below:

The proposed research projects must start with a critique and synthesis of available data and the medical literature and critically evaluate the evidence and the outstanding research, and identify public health questions that are uncertain or unanswered.  Based on the critique, the application must describe an approach to address identified questions. The proposed approach must specify the analytic design, statistical power, and feasibility of addressing the unanswered questions. 

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the P50 (specialized center) award mechanism.  The individual researcher sponsored by the organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

2. Funds Available

AHRQ intends to commit up to $3,000,000 total costs in FY 2010 to fund one application that will include a RDCC to build an infrastructure that involves at least five separate clinical centers (systems).  AHRQ plans to award a total amount of up to $12,000,000 (total costs) over four years. The total amount awarded will depend 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.  Applications may be up to four years in duration not to exceed $3,000,000 per year in total costs to the government.  Applications with project periods that exceed four years or budgets that exceed $3,000,000 total costs in any given year will not be reviewed.

Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

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

A minimum time commitment of 40% annual effort is expected from the Principal Investigator and a minimum of 25% annual effort is expected from the Lead Co-Investigator at each CC.

2. Cost Sharing or Matching

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

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

3. Other-Special Eligibility Criteria

The PD/PI for applications responding to this FOA will need to act as the Lead for the Research and Data Coordinating Center (RDCC) and build the registry including at least five Clinical Centers/Systems (CC) as well as establish governance through a National Steering Committee. To inform the registry development activities, the PD/PI must hold preliminary discussions with relevant orthopedic specialty societies and other important stakeholders regarding any on-going data standardization and transmission effort and coordinate with all participating clinical centers on the harmonization of such protocols.

The application must describe the plan of collaborative work between the RDCC and the participating CCs, as well as include a description of how the projects fits with the AHRQ Effective Health Care program. The grantee must report semi-annually on patient recruitment and study progress. The PD/PI will ensure disclosure of conflicts of interest. Upon award, the PD/PI, in consultation with AHRQ, will appoint the Registry Steering Committee Chair and members of the Registry Steering Committee and Subcommittees, which will include not only registry studies investigators but other relevant stakeholders.  An AHRQ Program Official will also serve as ex-officio member of the Steering Committee.  The Registry Steering Committee should also include representatives from the Center for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) as ex-officio members, as well as a patient representative.  All ex-officio members are non-voting, and the PD/PI will have the final approval for all committee appointments.  The Registry Steering Committee chair shall be a well regarded researcher and shall not have substantial financial conflict of interest.

The PD/PI must propose three core studies addressing topics related to comparative effectiveness that will be conducted in the multicenter environment within a 4 year time frame. The three core research studies must be agreed by all clinical centers that will be participating in the registry. The proposed studies must demonstrate detailed knowledge of the conduct of multi-center clinical studies, involve large number and broad spectrum of patient populations (including racial and ethnic minority populations) and require multicenter participation. The PD/PI, in collaboration with CCs, will ensure proposals adherence, accurate and timely transmission of collected data and dissemination of research findings.  A minimum time commitment of 40% annual effort is expected from the PD/PI, and 25% annual effort is expected from the lead Co-Investigator at each CC.

The Registry Steering Committee (RSC)

The registry will have a RSC as the governing body of the registry development. Voting members of the RSC include, at a minimum, the Chair and lead co-investigators for CCs. The chair will advise the PD/PI (RDCC) on research activities and functions, and conduct SC meetings. The RDCC will support the RSC to ensure compliance with registry policies/procedures and will have a data safety and monitoring plan.

The RDCC will also support the RSC in identifying and prioritizing topics for investigation and evaluate secondary proposals developed by participating physician-researchers. The RSC will ensure that study results are reported in the scientific literature in a timely manner and promptly disseminated to those directly involved in the care of patients.

Funds must be budgeted to hold RSC meetings as often as three times in the first 12 months of the registry development, two to four times per year thereafter, and by teleconference on a monthly basis throughout the project period.

It is anticipated that the registry will be a great resource for conducting numerous non-AHRQ supported secondary research studies in addition to three core large scope study proposals outlined in the application. The RSC will be responsible for approving these leveraged secondary proposals submitted by participating researchers.  Prior to being forwarded to the steering committee, secondary proposals will be evaluated by the Publication and Proposal Review Subcommittee (see section IV, 6).

Applicant institutions may submit more than one application in response to this FOA, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Applications must include a data safety and monitoring plan. There must be a system for the appropriate oversight and monitoring of the conduct of research to ensure the safety of participants and the validity and integrity of the data for all AHRQ-conducted or supported research.  The method and degree of monitoring must be commensurate with the degree of risk involved for participating subjects and the size and complexity of the research.   Applications that do not include a data and safety monitoring plan will not undergo peer review or consideration for funding.

Data and safety monitoring plans are required in all research grant applications when support is sought to study the effect of a health-related intervention on outcomes in human subjects, including biomedical, behavioral, public health, health care system, and/or diagnostic interventions that potentially affect the outcome of the study participants.  Data and safety monitoring involving some level of independent monitoring, generally in the form of a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), is required for research studies involving:  interventions that entail potential risk to research participants, multiple sites, blinded (masked) designs, or vulnerable populations (e.g., children, pregnant women, frail elderly).

Applicants are not permitted to submit a resubmission application in response to this FOA. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number must be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A below for details. 

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 4, 2009
Application Receipt Date:  September 23, 2009
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.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent can be sent electronically, and should be sent to:

Karen Siegel, PT, MA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road

Rockville, MD 20850
Telephone: (301) 427-1321
FAX: (301) 427-1640

Email:  OrthopedicRegistry@ahrq.hhs.gov

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 August 17, 2009 from 1:00 – 2:00 pm Eastern daylight time.  To register to participate in the conference call, please send an e-mail request to OrthopedicRegistry@ahrq.hhs.gov by August 10, 2009.  Once a registration email has been submitted, an email reply will be sent within 2 business days containing information on the call, including call-in information.  Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply.  Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to OrthopedicRegistry@ahrq.hhs.gov by August 10, 2009.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be posted on the AHRQ web site. 

3.B. Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Karen Siegel, PT, MA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road

Rockville, MD 20850
Telephone: (301) 427-1321
FAX: (301) 427-1640

3.C. Application Processing

Applications must be received on or before the application receipt date stated above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR, NIH, and AHRQ.  Incomplete and/or non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application.

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

Information on the status of an application must be checked by the PD/PI in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements  

PD/PI Responsibilities

A minimum time commitment of 40% annually is required from the PD/PI. The PD/PI is expected to be readily available to respond directly to questions about registry matters. The PD/PI must have a demonstrated track record of successful leadership of a multi-disciplinary team, including multi-center clinical collaboration.  The PD/PI must be the lead for RDCC and the application must provide strong evidence of commitment of CCs to support the development of the registry and conduct collaborative research with the applicant organization and other participating centers.  Letters of institutional and departmental support for participation in the registry are required, which must include assurances that in the case of studies competing for the same patient population, the AHRQ registry initiative will take priority.

The PD/PI must coordinate all phases of multi-center clinical studies, proposal and manual of operations development, data collection and management, data safety and monitoring, confidentiality, adverse events, quality assurance, data analysis, distributed data entry, electronic communications, and administrative management and coordination.

The PD/PI of the application must discuss various aspects of study design that would be important in developing clinical proposals including eligibility, sample size and power calculations; methods and frequency of data collection, monitoring accuracy of data collection, quality control including training and certification for multiple proposals. Further, the PD/PI must describe RDCC plans for administrative management of the data collection and quality control, support of the Registry Steering Committee (RSC), and associated subcommittees. A plan must also be included for the development and maintenance of a web site with both public and secure components that would include information for investigators.

Within three months after the award, the PD/PI as lead for RDCC, will be required to organize the first meeting of Registry Steering Committee where Chair, voting, non-voting members of steering committee and stakeholder representatives will be elected/ approved. RDCC will also perform all necessary work to establish central IRB (whenever possible) to facilitate conduct of studies.

The PD/PI must establish a Publications and Proposal Review Subcommittee (PPRS): of the steering committee. The subcommittee will consist of a chair and clinicians and scientists with broad range of expertise relevant to the proposed studies. The PPRS will evaluate leveraged secondary study proposals (beyond the three core proposals) under review by the RSC based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the registry and consistency with comparative effectiveness. The PPRS will provide a written critique of each proposal and a final recommendation to the Registry Steering Committee.  All study proposals performed by the registry investigators must be recommended by the PPRS and approved by the Registry Steering Committee before initiation. It is anticipated that more than one proposal will be active at any given time.  The Publications and Presentations Subcommittee will facilitate and work with RDCC in preparation of manuscripts prior to submission for publication.

The PD/PI and co-investigators involved in the registry may find it advantageous to seek additional support from or other involvement by industry or other third parties (e.g., the VA, CMS, charitable foundations) for the studies themselves or for leveraged studies.  Accordingly, the PD/PI must establish Public Private Partnership subcommittee of the Steering Committee that will be responsible for approval of all partner involvements.

The application must describe how the 3 core proposed research projects will provide new information and important information that is distinct from existing studies and how the study extends what is already known. 

The application must explain how the proposed research projects will provide actionable information that meets the Effective Health Care program goals in comparative effectiveness.  Specifically, what are the potential impacts of the findings from the proposed research and how will these findings relate to specific knowledge gaps relevant to improving the health care delivered through the Medicare, Medicaid, or the State Children's Health Insurance (SCHIP) programs.

The application must highlight specifics of the unique data that can be included in the registry through primary data collection and describe how the collection of certain patient reported outcomes not otherwise available will be done. Special attention must be given to the rigor and efficiency of the data collection and management systems, protocols for data confidentiality and the governance for data use and sharing.

Clinical Centers (CC) Participating in the Registry

The application must describe the critical responsibilities of CCs in recruitment of patients and data collection. It is expected that individual CCs will vary in nature and experience, and thus may represent both different patient populations and unique expertise. For example, the CCs could be geographically diverse major medical centers with existing relationships with private or community hospitals and physician practices. The lead co-investigator at each CC must demonstrate clinical research excellence and a proven ability to recruit patients from various racial/ethnic groups. As a whole, the registry will enroll eligible patients and assess clinical interventions on a broad range of diagnostics and therapeutics. 

The application must include detailed sections on the applicant’s clinical and data resources and capabilities. The application must include at least five (5) CCs each with sufficient patients to support recruitment in a variety of studies in the registry. For each CC the application must provide a detailed description of the clinical and data collection/management capabilities. Below are some of the specific and desired critical data that can help to address important comparative effectiveness questions:

  1. Patient characteristics (demographic variables such as age, race, ethnicity, sex, medical history and co-morbid conditions such as diabetes, renal insufficiency)
  2. Procedural characteristics (i.e. type and number of devices used, side, surgical approach, surgery time etc)
  3. In-hospital and procedural complications (such as mortality, myocardial infarction (MI), bleeding, other)
  4. Follow up data beyond 2-3 years
  5. Substantial number of people in important subgroups (elderly, women, diabetes, multiple comorbidities, etc)
  6. Information and plan to identify all implants (not just names but strategies like barcode scanning and others)
  7. Medication and rehabilitation therapy (aggressive pain management, medication use and how drug use or drug exposure is measured in the long term
  8. Genetic markers
  9. Long term activity, functioning and quality of life measures to address specific study questions (not necessary for every person)

The application must discuss the agreements and operational arrangements between CCs to define all data elements, definitions, collection, transmission protocols, etc., across all registry participants.  It must also describe the timeliness, ownership, signed usage agreements, and governance on use of data contained in the registry. Specifically, across all CCs where local data collection and databases will be used to develop the registry, concrete plans for the following issues must be included in the application: 

1.    Willingness of data owners to collect the core set of data elements

2.    How data can be shared (centralized collection and study by study basis)

3.    Data access and ownership

4.    Data Use Agreements or Memos of Understanding

5.    Restrictions on using the data

6.    Medical device and procedure coding and diagnostic information

7.    Short and long term health outcomes collection plans

Budget Information

AHRQ intends to commit up to $3,000,000 total costs in FY 2010 to fund one application that will include a RDCC to build an infrastructure that involves at least five separate clinical centers (systems). AHRQ plans to award a total amount of up to $12,000,000 (total costs) over four years. The applicant must submit a composite budget for the overall registry and individual budgets and budget justifications for the RDCC and each of the three research projects.  The individual budgets, totaled together, must equal the composite budget.  The budget must include, at a minimum:

1.    A minimum of 40% effort annually for the PD/PI.

2.    Steering Committee expenses. The Steering Committee meets an average of three times a year and conducts biweekly conference calls and monthly subcommittee calls for each active proposal based study subcommittee.

3.    Visits to each CC for training and data audit during the four-year grant period.  Audits could occur as frequently as once per year for each CC during the life of the grant.

4.    Monthly Conference call expenses.

5.    Expenses associated with data collection form development. Instituting quality control measures will be included in the Research and Data Coordinating Center budget.

6.    Expenses associated with training the Nurse Coordinators at the beginning of each study if necessary.

7.    Expenses associated with travel for the PD/PI and at least one other project member to participate in one annual meeting sponsored or supported by AHRQ.

8.    Other research expenses as appropriate.

Applications must identify the potential source(s) for any drugs, substances, or devices that are being considered for the proposed clinical studies that are currently unavailable commercially.

The funds allocated to CC must include only core costs and must not include research participation costs. Core budget costs allocated to CC may include but are not limited to the following:

Research Plan Page Limitations

The research plan must be limited to 25 double spaced pages with font size 11 or greater.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CD only, and include five identical CDs in the same package with the application.

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

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

Within the network research data must be shared. The precise content of the data-sharing plan will vary, depending on the data being collected. For external data sharing applicants 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 are described below.  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 not be reviewed.  

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

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. 

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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Do the registry and studies address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach: Are the clinical registry framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the registry? Does the applicant acknowledge potential problem areas and consider alternative tactics?   

Innovation: Is the registry project original and innovative? For example: Do studies challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Do studies develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?  

Investigators: Are key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the registry project?  

Environment: Do(es) the scientific and administrative environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Are institutional resources adequate for patient care and follow-up: including personnel, space, and special facilities?

Collaborative Research Experience:  Is there evidence of a willingness and ability to participate fully in all studies and to adopt and follow standard operating procedures? Is there evidence from past experience of an ability to conduct rigorously designed trials including a clinically relevant and testable hypothesis, well described patient population, explicit selection criteria, and effective control of bias?  Has the applicant shown a willingness and ability to establish collaborations with appropriate clinical specialists for conducting trials that bridge both the surgical and medical therapies in relation to the proposed studies? 

Patient Resources:  Are the plans to recruit, enroll, and retain study populations adequate for the proposed studies?  Does the application demonstrate that there are sufficient patient resources to participate in the registry?

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?  Stakeholders may include, for example, decision makers such as the relevant policy makers of the subject matters (e.g., CMS, FDA) and patients.  This evidence may include specific and detailed plans to solicit stakeholder input during the registry development and research process.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

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

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See Part II, Section 5.1 “Protection of Human Subjects” of the PHS398 application instructions. 

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

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

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)   

Data Confidentiality

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

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

Sharing Research Resources: 

Rights in Data

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

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information


1. Award Notices

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

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

Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NoA) will be provided to the applicant organization.  The NoA 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, special Terms and Conditions will be incorporated into the award statement.

3. Reporting

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

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

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

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

A final Progress Report, Final 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 Contacts:

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

Karen Siegel, PT, MA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road

Rockville, MD 20850
Telephone: (301) 427-1321
FAX: (301) 427-1640
Email: OrthopedicRegistry@ahrq.hhs.gov

2. Peer Review Contacts:

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

Ying Tian, M.D., Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1530
Fax: (301) 427-1562
E-mail address:  ying.tian@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct inquiries regarding fiscal matters to: 

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address:  george.gardner@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

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

Human Subjects Protection:

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

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

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

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

Healthy People 2010:

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

Authority and Regulations:

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

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


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