INDEPENDENT SCIENTIST AWARD Release Date: September 8, 1999 PA NUMBER: PAR-99-164 (Reissued as PAR-07-444) Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces its interest in supporting Independent Scientist Awards (ISA) in health services research. The ISA provides support for newly independent scientists who can demonstrate a need for a period of intensive research focus. This award is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. AHCPR supports and conducts research to improve the outcomes, effectiveness, quality, access to, and cost and utilization of health care services. AHCPR achieves this mission through health services research designed to: (1) improve clinical practice, (2) improve the health care systems leader"s ability to provide access to and deliver high quality, high-value health care, and (3) give policy makers the ability to assess the impact of system changes on outcomes, effectiveness, quality, access, cost and use of health care services. AHCPR programs and products are designed to be responsive to the needs of consumers, patients, clinicians, and other providers, institutions, plans, purchasers, and public and private policy makers at all levels for evidence- based information they may need to improve quality and outcomes, control costs, and ensure access to needed services. A copy of AHCPR"s strategic plan is available at http://www.ahcpr.gov AHCPR is committed to achieving the goals of the President"s Race and Health Disparities Initiative: Eliminating by the year 2010 the differences in outcomes and health status for racial and ethnic minority populations in six clinical areas (infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection, and child and adult immunization). Many of these disparities are not due to gaps in knowledge regarding disease processes, but are largely the result of provider factors, patient factors, and organizational factors which impair the implementation of existing knowledge. AHCPR seeks research projects which will advance the implementation of existing research findings to assist in achieving this ambitious goal. In addition, AHCPR recognizes the need for collaborative and integrative work that addresses issues of access to care, outcomes, quality, and the cost and use of services for children. Applications that focus on developing the careers of investigators who will study minority, child, and older adult health services research with the above interests are strongly encouraged. It is anticipated that some awards will be made specifically to highly meritorious applications that foster the research careers of investigators studying these populations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000" a PHS-led national activity for setting health improvement priority for the United States. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000," (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. Nondiscrimination The AHCPR career development program is conducted in compliance with applicable laws that provide that no person shall, on the grounds of race, color, national origin, sex, disability, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination. Applicant organizations are required to have appropriate Assurance of Compliance forms filed with the Office of Civil Rights, Office of the Secretary, DHHS before a grant may be made to that institution. The Division of Research Education, Office of Research Review, Education, and Policy (ORREP) should be contacted with any questions concerning compliance (See INQUIRIES). ELIGIBILITY REQUIREMENTS The candidate must have a clinical (e.g., M.D., D.O., D.D.S.) or research doctoral degree (e.g., Ph.D., Sc.D.), and must be no more than five years out of the latest research training experience. In addition, at the time of award, the candidate will preferably either be playing a key role on a major ongoing peer-reviewed research project or be receiving independent peer- reviewed research support. Alternatively, the candidate can demonstrate potential excellence by having completed a research training experience through a nationally-recognized, peer-reviewed, postdoctoral research program or individual grant. The candidate must also be willing to spend a minimum of 75 percent effort conducting research and research career development during the award, and institutional support for this time allocation must be clear. Lastly, the candidate must demonstrate that the requested period of research focus will foster his/her career as highly productive investigator in the indicated field of research. Applications may be submitted on behalf of candidates by domestic, non-Federal public or private non-profit organizations, including medical, dental, public health, or nursing schools or other institutions of higher education. AHCPR, by statute, can make grants only to non-profit organizations. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Members of minority groups, women, and persons with disabilities are encouraged to apply. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards in response to this program announcement (PA) will use the Research Scientist Development Award (K02) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. However, the institution must demonstrate a commitment to the candidate and the candidate"s goals for career development. The project period for an application submitted in response to this PA is between three and five years and is not renewable. RESEARCH OBJECTIVES Through the career development program ISA award, AHCPR seeks to expand the number of researchers who conduct health care services research in areas identified in the AHCPR Health Services Research Program Announcement (PA) published in the NIH Guide on March 26, 1998. (See Funding Opportunities at http://www.ahcpr.gov) The PA outlines broad research interests that would: o support improvements in health outcomes, at both the clinical and system levels, o strengthen quality measurement and improvement including the use of evidence-based practice information and tools, o identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures including research on the organization, financing, and delivery of health care and the characteristics of primary care practices. A special focus is on health issues related to priority populations including minority populations, older adults, women, and children, o advance methodologies in health services research, especially cost- effectiveness analysis, and o focus on ethical issues across the spectrum of health care delivery. Applications responding to this program announcement should reflect the following: A. Environment: The institution should have a demonstrated commitment to research and a commitment to the continuing development of the candidate as an independent scientist. The institution must provide assurance that the candidate is an integral part of its research and academic program. B. Program: The award provides up to three to five consecutive, 12 month appointments. At least 75 percent of the recipient"s full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. C. Allowable Costs: 1. Salary: The AHCPR will provide salary and fringe benefits for the K02 recipient. Total requested percentage of the candidate"s institutional salary, up to $75,000 annually, plus associated fringe benefits. The institution may supplement the AHCPR contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the ISA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution"s salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: It is expected that candidates for a K02 award will have research support at the time of the award. Candidates may request funds only to offset the cost of tuition, fees, and books related to career development, if needed and justified. Travel support for one scientific meeting per year may be requested. No additional funds for other research support may be requested. Applicants should request additional information from the Division of Research Education listed under INQUIRIES. 3. Ancillary Personnel Support: Salary for secretarial, technical, and/or administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. D. Evaluation: In carrying out its stewardship of human resource related programs, the AHCPR, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. E. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the AHCPR policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and if the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an institute-supported research or training grant for the salaries or fringe benefits of individuals, but freed because of a career award, may not be rebudgeted. An institute will consider approval for use of released funds only under unusual circumstances. Any proposed retention of funds released because of an AHCPR career award must receive prior written approval of the awarding component. F. Special Leave: Leave to another institution, including a foreign health services research program, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior AHCPR written approval is required. To obtain prior approval, the award recipient must submit a letter describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires prior written approval and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the AHCPR and the grantee institution. G. Termination or Change of Institution: When a grantee institution plans to terminate an award, AHCPR must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided that a new career award application is submitted by the new institution, the period of support requested is no more than the time remaining within the existing award period, and the new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. Depending upon the circumstances, AHCPR may require a new review by an initial review group or a review may be carried out by internal AHCPR staff. The AHCPR Administrator may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the AHCPR Administrator shall notify the grantee institution and career award recipient in writing of this determination, the reasons thereof, the effective date, and the right to appeal the decision. Replacement of the Principal Investigator on the grant will not be approved. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. Annual reports describing project progress, and including articles that are published or in-press, are also required. Applicants who have questions regarding the relevance of their research to AHCPR goals should contact, by telephone, E-mail or letter, staff listed under INQUIRIES. The Notice on Request for Planning Ideas published in the Federal Register April 15, 1999 (http://www.access.gpo.gov/su_docs/fedreg/frcont99.html) also lists AHCPR Strategic goals and types of activities in support of those goals. Data Privacy Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a- 1(c)), information obtained in the course of any AHCPR-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the use and purposes of the data collection. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of such identifying information. 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 safeguarded. The grantee 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 Computer Security: The NIST handbook, Generally Accepted Principle 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://www.whitehouse.gov/OMB/circulars/a130/a130.html, http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf, http://csrc.nist.gov/publications/nistbul/csl96-10.txt, http://csrc.nist.gov/publications/nistbul/itl99-04.txt, respectively. Rights in Data AHCPR grantees may copyright 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 AHCPR funds. Such copyrights and patents are subject to a Federal government license to use and permit others to use these products and materials for AHCPR purposes. In accordance with its legislative dissemination mandate, AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHCPR budget constraints, final products maybe made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant- supported products. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHCPR that women, and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification is 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 "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts of March 18, 1994. AHCPR follows the NIH Guidelines, as applicable. Investigators may obtain copies from the above sources or from the AHCPR contractors listed under INQUIRES, or from the NIH Guide website https://grants.nih.gov/grants/guide/index.html. AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHCPR Web site http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). Investigators may obtain copies of these guidelines and policies from the sources listed above or from the AHCPR contractor, Equals Three Communications, Inc., (see INQUIRIES.) AHCPR program staff may also provide information concerning these policies (See INQUIRIES). APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) using the instructions for Research Career Award Applications in Section IV as appropriate. Applications will be accepted on the standard application receipt dates as indicated in the PHS 398 application kit. Application kits are available at most institutional offices of sponsored research, from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)-710-0267, email: grantsinfo@nih.gov, on the NIH Website at https://grants.nih.gov/grants/funding/phs398/phs398.html, and from the AHCPR contractor: Equals Three Communications, Inc. 7910 Woodmont Avenue, Suite 200 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. The completed, signed, typewritten, original application and four copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, one additional copy must be sent to AHCPR at: Division of Research Education Office of Research Review, Education, and Policy Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 The application must address the following issues (a concise introductory statement on A and B below should precede the description of the research plan): A. Candidate o Describe the candidate"s commitment to a career in health services research. o Document the candidate"s success as an investigator and his/her potential to make future contributions to the chosen field of research as an independent investigator. o Describe immediate and long-term career objectives. Explain how this award will contribute to these goals. o Describe how the Independent Scientist Award will further the candidate"s research career and ultimate impact on knowledge about health and health care. B. Career Development Plan o Describe the career development plan, incorporating consideration of the candidate"s goals and prior experience. o The candidate must either describe plans to participate in courses related to instruction in the responsible conduct of research or demonstrate competency in this area. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of the candidate"s participation. No award will be made if an application lacks this component. C. Research Plan o Describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. o Describe how the research will advance AHCPR"s mission and goals. D. Environment and Institutional Commitment o The application must contain evidence of the applicant institution"s commitment to the career enhancement of the candidate. Indicate the types of facilities, supplies, equipment, and human resources that will be made available to the applicant. Provide assurance that the candidate will be able to devote 75 percent of his/her full-time professional effort to research related activities. E. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness to the PA by the AHCPR Referral Officer and Scientific Review Administrator. Incomplete and/or non-responsive applications or applications not following form PHS 398 instructions for Research Career Award applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHCPR peer review procedures. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. The following review criteria will be applied: A. Candidate o Capacity to carry out independent research, o Potential to become an outstanding investigator who will make significant contributions to the field, o Past and present research productivity as evidenced by such criteria as: contributions to the scientific literature, and success in obtaining independent funding, o Ability to conceptualize and organize a long-term research approach, and o Level of training, experience, and competence commensurate with the purposes of the award. B. Career Development Plan o Likelihood that the award will contribute substantially to the continued research career development and productivity of the candidate, o The extent to which the award will enable a candidate to devote full time to research and related duties by release from teaching, administration, and other responsibilities, o Consistency of the career development plan with the candidate"s career goals, and o Collaboration with other active investigators and opportunities for professional growth. C. Research Plan o Quality of research plan and significance for contributing to the health services research literature, o Scientific and technical merit of the proposed research plan, o Relevance of the proposed research to AHCPR"s goals and priorities, and o Adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. D. Environment and Institutional Commitment o Institutional commitment to the development of the candidate as an independent scientist and assurances that the institution intends the candidate to be an integral part of its research and academic program, and o Strength of the institution"s commitment to scientific research. E. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA Applications will compete for available funds with all other applications under this Program Announcement. The following will be considered in making the funding decisions: quality of the proposed career development plan and proposed project as determined by peer review, program balance, and availability of funds. It is anticipated that some awards will specifically be made to highly meritorious applicants pursuing research that addresses minority, child, and older adult populations, or to individual investigators from predominantly minority institutions. INQUIRIES Copies of this PA and copies of the grant application form PHS 398 (rev. 4/98) are available from the AHCPR contractor: Equals Three Communications, Inc. 7910 Woodmont Avenue, Suite 200 Bethesda, MD 20814-3015 Telephone: 301-656-3100 or FAX: 301-652-5264 The PA is also available on AHCPR"s Website, http://www.ahcpr.gov and through AHCPR 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 the PA number). The PA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions abut this service, call AHCPR"s Division of Communications at (301) 594-6344. AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants who have read the PA. Written and telephone inquiries concerning this PA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Division of Research Education Office of Research Review, Education and Policy Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-1449 Email: Training@AHCPR.gov Direct inquiries regarding fiscal and administrative matters to: George "Skip" Moyer Grants Management Staff Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 Email: smoyer@AHCPR.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.226. Awards are made under authorization of Sections 901(b), 902(c), and 925(c) of the Public Health Service Act, as amended (42 USC 299(b), 299a(c) and 299c-4(c)) and Section 1142 of the Social Security Act (42 USC 1320b-12) as applicable. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 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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