COORDINATING CENTER FOR THE AHRQ CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS PROGRAM RELEASE DATE: May 8, 2003 RFA Number: HS-03-007 March 14, 2011 - This RFA has been reissued as RFA-HS-11-003. (This RFA has been reissued, see RFA-HS-07-008) Agency for Healthcare Research and Quality (AHRQ)(http://www.ahrq.gov) CFDA: 93.226 LETTER OF INTENT RECEIPT DATE: June 23, 2003 APPLICATION RECEIPT DATE: July 24, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The Agency for Healthcare Research and Quality (AHRQ) invites applications from non-profit and for-profit organizations to act as the coordinating center for the Centers for Education and Research on Therapeutics (CERTs)Program. The program consists of seven geographically dispersed research centers receiving multi-year funding. CERTs is an ongoing multi-year program that supports research demonstration centers. Detailed information on the program can be obtained at http://www.ahrq.gov/clinic/certsovr.htm. Congress expanded the authority of AHCPR under the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), to conduct a demonstration program to conduct research and provide objective information on therapeutics. The centers (CERTs) were created under Sec. 409, which adds a new section (Sec. 905) to the authorizing statute for AHRQ (Public Health Services Act Title IX--42 U.S.C. 299 et seq.). AHRQ administers the demonstration program, in close consultation with the Food and Drug Administration (FDA). The program's legislative mandate is to conduct state-of-the-art research to increase awareness of (1) new uses of drugs, biological products, and devices; (2) ways to improve the effective use of drugs, biological products, and devices; and (3) risks of new uses and risks of combinations of drugs and biological products. Further, the legislation directs CERTs to provide objective clinical information to the following individuals and entities: (1) health care practitioners and other providers of health care goods or services; (2) pharmacists, pharmacy benefit managers and purchasers; (3) health maintenance organizations and other managed health care organizations; (4) health care insurers and governmental agencies; and (5) patients and consumers. Additionally, the centers are to investigate various ways to improve the quality of health care while reducing the cost of health care through an increase in the appropriate use of drugs, biological products, or devices, and the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. Finally, the CERTs will conduct research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices. For the purposes of this document, therapeutics are defined as drugs, biologics, and devices. A CERTs research center is defined as an organization with a core group of investigators with either institutional or similar kinds of professional bonds who have strong experience in the area of research in therapeutics. The research center may be a consortium of organizations, although it is expected that members of a consortium will provide collateral or supplemental support to the applicant organization. The role of coordinating center (CC) is not to lead the program, but to facilitate the leadership of the CERTs Steering Committee (SC), consisting of the research centers , government agencies, and other members, through logistical support and active participation in committee. RESEARCH OBJECTIVES Background The CC works with the AHRQ Program Official, Food and Drug Administration representative(s) and the CERTs SC to enhance synergy across the goals and projects of each of the research centers to fulfill the requirements of the program. The CERTs SC has primary responsibility for leadership of the CERTs program. The CC, through logistical, technical and intellectual support, acts in a consultative role to the research centers and the SC. The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research. The mission of the CERTs program is to provide objective, scientific information on the safe and effective use of therapeutics. The research centers, CC, and SC work together to achieve these goals. The vision of the CERTs program is to become a trusted national resource for people seeking information about medical products. This is being accomplished through research and education by first developing knowledge and then sharing it with people who can use it to manage risk, improve practice, and inform policies. The research centers have participated in 100 projects to date, extending along broad spectra of research and educational efforts. The CC, along with the SC, is at the core of the activities of the program. The CC provides support to the AHRQ Program Official and SC in the achievement of the mission and vision of the program. The principal investigator, in partnership with AHRQ and the SC, provides a global perspective to assure that the program fulfills its goals. The CERTs Principal Investigator acts as a liaison between the CERTs program, the academic researchers and other customers for CERTs-related research. MECHANISM OF SUPPORT The CERTs are funded via the Grants Mechanism as directed under Sec. 409 under the Food and Drug Administration and Modernization Act of 1997 (P.L. 105-115). Section 409 subpart (a) states "The Secretary, acting through the Administrator and in consultation with the Commissioner of Food and Drugs, shall establish a demonstration program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified". The administrative and funding instrument to be used for the CERTs CC will be a cooperative agreement (U18), an "assistance" mechanism in which substantial AHRQ and other government scientific and/or programmatic involvement with the CC is anticipated during performance of the activity. The dominant role and prime responsibility for all CERTs research resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the CC, the SC and the AHRQ Program Officials(s). Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section on Terms and Conditions of Award. The total project period for applications submitted in response to the present request for applications may not exceed four years. The project will undergo program review to determine if it meets the criteria as stated in the RFA. The anticipated award date is September 29, 2003. At this time, AHRQ has not determined whether or how the solicitation will be continued beyond the present RFA. FUNDS AVAILABLE AHRQ expects to award up to $300,000 in total costs in fiscal year 2003 to support one CC. Of this $300,000, $100,000 in total costs should be set aside to fund dissemination and education activities (listed under special requirements) focused on cross-CERTs efforts at training and/or dissemination. The CC will be responsible for coordinating training users to implement findings. Additional projects, (e.g., additional didactic and educational workshops, see Special Requirements) that extend the goals of the CERTs program may be proposed. The total budget request to support these additional projects may not exceed $200,000 in total costs. Thus, no application submitted in response to this RFA may exceed a total budget of $500,000. Applications submitted in response to this RFA with total budget requests that exceed $500,000 will be returned without undergoing peer review and will not be considered for funding. The total project period may not exceed 4 years. Applicants will not be required to match or share in project costs if an award is made. ELIGIBLE INSTITUTIONS Eligible institutions are those that have any of the following characteristics: o For-profit and non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Non-profit firms and foundations o Units of State and local governments o Faith-based or community-based organizations o Domestic (foreign applications will not be accepted) o Tribes and tribal organizations Under recently enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations as well as with public and not-for-profit entities. Thus, for-profit organizations are eligible to respond to this notice with research applications for cooperative agreements. Such applications will be administered in accordance with Subpart E of 45 CFR Part 74 and 42 CFR Part 67 Subpart A. The latter regulation has not yet been amended to reflect these changes in Agency name and authority. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov/hrqa99a.htm). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS o The CERTs SC has primary responsibility for leadership of the CERTs program. The CC and SC act in a consultative role to the research centers. Each individual research center acts independently to accomplish its research goals. The SC consists of members from the research centers, the CC, AHRQ and FDA. It is chaired by a national expert, chosen by AHRQ, with the concurrence of FDA, the research centers and the CC. Other members representing partnership organizations are appointed. o The CC convenes the SC. The CC will organize SC meetings, to be held three to four times per year. Travel will be coordinated through this CC. One meeting per year will be held in the Washington DC area to allow for participation by AHRQ, FDA and other government personnel at a "Government Day" Meeting. The CC will provide facilities to convene SC meetings. The SC will also meet via periodic conference calls to be held at a minimum of every month. o The Principal Investigator (PI) of the CC will work closely with the SC Chair and, with advice from AHRQ and FDA, help the SC develop program goals and to assure that the SC deliberative processes and other activities are adequately tracked and disseminated to appropriate audiences, such as AHRQ, FDA and the research community. o The CC will be responsible for working with the research centers and with AHRQ in training users (e.g. State and Local Health Departments, clinicians, and other healthcare providers) to implement findings. These activities will be focused on cross-CERTs efforts at training and/or dissemination. The CC should develop a plan to work with AHRQ to implement wide-spread dissemination to audiences, such as State policy makers. A separate plan and budget will need to be submitted. The CC will investigate possible approaches to developing this training (e.g., convening experts to develop a research agenda). o The CC will identify opportunities for engaging the research centers in addressing common methodological and technical challenges. o The CC will identify opportunities to disseminate and implement information developed by the research centers on a large scale. It will also identify opportunities to coordinate with and enhance activities of other national efforts to improve the use of therapeutics, e.g., the National Patient Safety Foundation, quality improvement efforts of large health care systems, and the Institute for Healthcare Improvement. o The CC will work with the SC to develop a national plan for dissemination and educational activity for the program. The CC and SC will develop options to transfer knowledge from the research centers to influential leaders in the health care field, and implement specific strategies to assure that the information is disseminated broadly and efficiently. o It will be the responsibility of the CC to determine whether other economies of scale can be identified and developed for the CERTs program. The CC will also coordinate efforts to identify additional funding for the program, e.g., convene an annual meeting of potential partners. o The CC application should have a business plan, which has as its goal development of a program to carry out the various activities identified in the CERTs authorizing legislation on a long-term basis using both public and private sources. o The CC will develop programmatic products for the CERTs (e.g. fact sheets, a web site). The CC should investigate the feasibility of making government data more accessible to the research centers. o The CC will work with the SC to maintain the synergy that has developed across the projects of each of the research centers. o The CC PI will convene and chair the public-private partnership working group (PPPWG) consisting of the principal investigators of the research centers, and others, as needed. This subcommittee of the SC will evaluate potential partnerships using principles developed by the SC to assist the research centers in determining whether a partnership is appropriate for the CERTs program. These principles can be viewed at the following web address http://www.certs.hhs.gov/partners/principles.html. o The applicant should describe experience with partnerships, both governmental and private. Products of these partnerships (e.g.: program descriptions and publications) may be included as an appendix to the application. o Appropriate accomplishments should be placed in the section of the proposal, as instructed on the application forms. Past accomplishments should focus on experience related to leadership and logistical support for multi-disciplinary and multi-center research (e.g., multi-center clinical trials or large-scale multi-center educational or dissemination programs). Publications, to date, should be placed in an appendix with a complete bibliography. Qualifications o The CC director must be an experienced senior investigator, with extensive research experience and experience managing multi- disciplinary research. He/she should be a manager who can provide strong administrative and academic leadership. The CC director will be responsible for the organization and operation of the Center. The CC director should have experience as a leader within the research community and outside entities such as professional societies, subcontractors, and consumer groups. o The director should have extensive experience working with Federal agencies such that he/she is able to coordinate and communicate with AHRQ and other Federal Agencies on scientific and operational matters. o Applicants should provide evidence of personnel and institutional resources capable of maintaining a substantial commitment to patient outcomes research, patient safety, dissemination and education and program management. The CC should consist of core staff with significant time commitment to the Center, and experience working as a team. Evidence of past collaboration among personnel working within the Center should be presented (e.g., publications or past research collaboration). o The CC should present evidence of appropriate staff persons with experience working with data and information on therapeutics, as evidenced by appropriate publications. o The CC should be able to provide writing and editorial assistance on an ongoing basis for meeting minutes, written manuscripts and research summaries. The CC may be expected to develop original manuscripts covering topics related to therapeutics research and education. o The CC must demonstrate expertise in dissemination and translation of research on therapeutics into practice, through publications and participation in program planning activities. o The CC should have demonstrable evidence of a sophisticated understanding of health care systems and current quality improvement strategies. o The CC should have experience in working with health system leaders to translate research into practice, with potential for developing partnerships between the research centers and health care systems to enhance opportunities for broad scale implementation. o Since the CERTs program functions as a multi-center research program, with ongoing interactions and partnerships between the research centers, the CC should have experience in leading such multi-center collaborative research. Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS and PHS grants administration policy statements. Applicants should be familiar with the Agency's grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. The administrative and funding instrument to be used for this program will be a cooperative agreement (U18), an "assistance" mechanism, in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, The AHRQ purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the CC awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the AHRQ Project Scientist, and the FDA. Cooperative activities are intended to strengthen the individual CERTs activities through the facilitation of data sharing, data access and communications. Through the CC and the SC joint decisions regarding the program can be made. All cooperative activities that include significant government involvement will require prior approval by the AHRQ program officer who is expected to consult with the SC. Awardee Responsibilities The Coordinating Center will do the following: o The CC will organize, and work with the SC to develop themes, and provide funding for logistical support of SC meetings to be held 4 times per year. Travel will be coordinated through this Center. o The CC will be responsible for conference calls to be held on a monthly basis (or more frequently as needed). o The CC will support and maintain the CERTs website. The CC will comply with Federal requirements for websites and coordinate with AHRQ on website issues. o The CC convenes, monthly, as needed, a working group, which consists of all research center principal investigators, to review public-private partnerships. o The CC employs appropriate staff to facilitate the activities of the SC and monthly working group, and to provide support for dissemination and education. o The CC will work with the AHRQ Program Official, FDA representative(s) and the SC Chair to enhance synergy in order to achieve the goals set forth in the CERTs authorizing legislation. o The CC will identify opportunities for engaging the research centers in addressing common methodological and technical challenges. o The CC will identify opportunities to disseminate and implement information developed by the research centers on a large scale. It will also identify opportunities to coordinate with and enhance activities of other national efforts to improve the use of therapeutics through educational strategies. o The CC will work with the SC to develop national dissemination and educational activities for the program. The CC and SC will develop options to transfer knowledge from the research centers to "opinion leaders" and "change agents" in the health care system, and implement specific strategies to assure that the information is disseminated broadly and efficiently. o The CC will work with the SC to develop criteria for successful achievement of goals. These goals will be accomplished with the assistance of AHRQ and FDA. o The CC will develop an annual report and quarterly program briefs. These briefs will be developed in conjunction with the SC and the research centers. Federal Agency Responsibilities o AHRQ and FDA representatives will be permanent members of the SC. Other government agencies may also be invited by the SC Chair to become members of that committee. o AHRQ with assistance from FDA, the CC, and the research centers will identify a chair for the SC, should the current chair resign. o The AHRQ Program Official(s) will work in conjunction with FDA, the centers' principal investigators, the CC and the SC to assure that issues for further study receive adequate review. o The Federal agencies may have substantive involvement in the development of the education and dissemination programs (e.g., program briefs) for which the CC has the lead. o The Federal agencies involved will facilitate access to appropriate government resources, such as additional funding and data sources. o The Federal agencies involved will work with the CC staff to facilitate dissemination of results. o As additional data and sources of funding are identified, the Federal agencies will work with the research centers, through the PPPWG, to establish appropriate agreements to optimize use and sharing of these resources. o AHRQ reserves the right to terminate or curtail any study or an entire award in the event of substantial lack of progress or lack of participation in CERT-related activities. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the AHRQ members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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 and/or contractors are to inform the Office of Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OHCI 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. Contact with the media will take place in close coordination with OHCI and the press offices of the grantee or contractor institutions. In cases when products are created (such as annual or final reports, web- based tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a brief plan describing how the product will be publicized. An OHCI 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. WHERE TO SEND INQUIRIES AHRQ encourages inquiries about this announcement and welcomes the opportunity to answer questions from applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your inquiries about scientific/research issues, including information on the inclusion of women, minorities, and children in study populations to: Lynn Bosco, MD, MPH 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Phone: 301-594-2416 Email: email@example.com o Direct your questions about peer review issues to: Veronica M. Friel, Ph.D. 2101 East Jefferson Street, Suite 400W Rockville, MD 20852 Phone: 301 594 6225 E-mail: firstname.lastname@example.org o Direct your question about financial or grants management matters to: Michelle Burr 2101 East Jefferson Street, Suite 600 Rockville, MD 20852 Phone: 301-594-1840 Email: email@example.com LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Veronica M. Friel, Ph.D. 2101 East Jefferson Street, Suite 400W Rockville, MD 20852 Phone: 301 594 6225 E-mail: firstname.lastname@example.org SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Because of the complexity of the required application, applicants are allowed an additional five pages beyond the usual twenty five pages allowed for a research plan. If the applicant is currently receiving funding to function as the CERTs coordinating center, the following additional information should be provided in the application. o Evidence should be presented of a continuing infrastructure capable of maintaining the CC. Past or planned changes in the CC and its team should be described in detail and a discussion of the impact of these changes should be included. o An appendix describing partnerships (both governmental and private) with products should be attached. Activities and accomplishments of the public- private partnerships working group should be described, with detailed examples of these activities (e.g., descriptions of programs funded through private funds). o Evidence should be presented that the CC serves the needs of the CERTs program through support of the SC and the program as a whole. Provide evidence, such as completed reports and presentations, which support the goals as described in the mission, vision, and authorizing legislation. (e.g.,letters of support). o Accomplishments should be described. Accomplishments may include publications, meeting abstracts, and documents which exemplify the leadership activities of the SC and CC (e.g., program briefs and white papers). o Evidence should be presented of logistical support provided by the SC and CC (e.g., publication tracking, web site information, proceedings of conferences ) o This application may summarize past activities, such as progress and challenges that can be identified in the area of public-private partnerships. The CC will also summarize efforts to date, to identify additional external resources for the program. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications according to instructions provided in form PHS 398. Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and five 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 (20817 for express/courier service) APPLICATION PROCESSING: Applications must be received by the receipt date listed in the heading of this Request for Application. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) and AHRQ will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this announcement. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The "AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications" was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). This announcement is available on AHRQ's Website, http://www.AHRQ.gov, (see under Funding Opportunities) and through AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as this announcement number). This announcement will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594- 6344. APPLICATION PREPARATION In carrying out its stewardship of research programs, the AHRQ, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of the Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ- sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency-sponsored research. Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WP5.1 or WP6.0 is preferable). PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. An appropriate peer review group convened by AHRQ in accordance with standard AHRQ peer review procedures will evaluate applications that are complete and responsive to the RFA for scientific and technical merit. As part of the merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA General review criteria for AHRQ grant applications relevant to this application include: adequacy of the plan for organizing and carrying out the project; qualification and experience of the Principal Investigator and proposed staff; reasonableness of the proposed budget; adequacy of the proposed facilities and resources available to the applicant. For a coordinating center, the latter is of particular importance. o Of all the criteria set forth, the infrastructure and capacity of the applicant are the most important criteria. Capacity should include evidence of the ability to provide rapid production of information, the ability to link geographically and academically diverse research centers, and the capability for accessing and interfacing with the health care delivery systems. o The applicant institution should have a broad base of skills with demonstrated experience in multi disciplinary research in therapeutics, including clinical epidemiology, health services research, analyses of large databases and clinical pharmacology. The CC will need to be able to work closely with the research centers in the translational and evaluation activities, thus a strong background in therapeutics research should be demonstrated o Applicants will have an appropriate administrative structure in place that will enable it to complete projects in a timely fashion, with full accountability for funds. o The CC director must be an experienced senior investigator and manager who can provide strong administrative and academic leadership. The director should be appropriately trained and well suited to carry out this work. The investigator should demonstrate appropriate experience level, through publications and leadership activities. The director will need to have training such that he/she is able to interact with senior members of the academic and health care communities. o Evidence of past successes in developing partnerships, including reports on funds obtained through leverage of public-private partnerships for a program should be included with this application. o The applicant for the CC will need to have a history of involvement in multi-center research or similar programs, as the CERTs research centers work cooperatively with a variety of partners from government and the private sector. o The CC should demonstrate experience in working with health system leaders to translate research into practice, with potential for developing partnerships between the research centers and health care systems to enhance opportunities for broad scale implementation. o The CC applicant will need to demonstrate experience with dissemination and translational research. o The CC personnel should have experience working together as a team, as evidenced by previously funded grants or publications. ADDITIONAL REVIEW CRITERIA: Reviewers will also consider the responsiveness of the proposal to the goal of the Centers for Education and Research on Therapeutics legislative mandate. The purpose of the center is to facilitate leadership of the SC through logistical and programmatic support. DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute. (42 U.S.C.299c-3(d)) In the Human Subjects section of the application, 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 the 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 RFA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp/. The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those 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. Rights in Data AHRQ grantees may copyright unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government 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, data bases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 23, 2003 Application Receipt Date: July 24, 2003 Peer Review Date: August 2003 Earliest Anticipated Award Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o quality of the proposed project as determined by peer review o program balance o availability of funds o potential impact of proposed research AHRQ reserves the right to fund all or part of any application. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. 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 AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some 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 act is taken, having the force and effect of law, in reliance upon an AHRQ-supported research project, the underlying data is not subject to this disclosure requirement. Also, disclosure of identifiable data from any AHRQ-supported-study is exempted from FOIA disclosures under "the (b)(3) exemption.", unless the identifiable subjects or provider(s) of data consent to such disclosures. It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information. However, courts have generally not regarded a researcher's interest in "his" data as proprietary. NIH has provided guidance for researchers on the requirements of A-110.36 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Should applicants wish to place data collected under this RFA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subjects protection procedures to permit or restrict disclosures of identifiable data, as warranted. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. 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 on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106- 129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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