AHRQ NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL RESEARCH TRAINING GRANTS RELEASE DATE: May 2, 2002 RFA: HS-03-001 PARTICIPATING INSTITUTES AND CENTERS (ICs): Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) LETTER OF INTENT RECEIPT DATE: July 26, 2002 APPLICATION RECEIPT DATE: August 26, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators 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 OF THIS RFA The Agency for Healthcare Research and Quality (AHRQ) will award National Research Service Award (NRSA) institutional training grants (T32) to eligible institutions who have demonstrated an interest in health services research to develop research training opportunities for qualified individuals. The mission of AHRQ is to support, conduct, and disseminate research that improves the outcomes, quality, access to, and cost and utilization of health care services. AHRQ achieves this mission through health services research designed to (1) improve clinical practice, (2) improve the health care system"s ability to provide access to and deliver high quality, high-value health care, and (3) provide policymakers with the ability to assess the impact of payment and organizational changes on outcomes, quality, access, cost, and use of health care services. The purpose of the NRSA program is to help ensure that adequate numbers of highly trained individuals are available to carry out the Nation"s health services research agenda, in order to improve quality, assure value for health dollars spent, and enhance access to services. A goal of the NRSA program is to equip students with the necessary knowledge, skills, and experiences to conduct future research which will meet the needs of patients, providers, plans, purchasers, and/or policy makers. Accomplishing the above effectively will require fostering a mixture of academic and applied training opportunities to meet the needs of students who wish to pursue traditional academic careers, as well as those who opt for careers in applied research settings. NRSA institutional training grants assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain one or more years of experience in developing the necessary methodological and substantive expertise to address critical issues facing the Nation"s health care delivery system. Predoctoral Training: Predoctoral research training must lead to the Ph.D. degree or a comparable research doctoral degree. Students enrolled in health professional programs that are not part of a formal, combined program (e.g., M.D./Ph.D.) and who wish to postpone their professional studies in order to gain research experience may also be appointed to a T32 grant. Predoctoral research training must emphasize fundamental training in areas relevant to health services research. Postdoctoral Training: Postdoctoral research training is for individuals who have a Ph.D., M.D., Sc.D., Dr.P.H., doctor of nursing, D.D.S., Pharm.D., or comparable doctoral degree from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize specialized training to meet national priorities in health services research. A research training grant is a desirable mechanism for the postdoctoral training of physicians and other health professionals who have extensive clinical training, but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, health- professional postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable activities beginning at the time of appointment, since the duration of training has been shown to be strongly correlated with post-training research activity. RESEARCH OBJECTIVES Areas of Training AHRQ-sponsored NRSA awards emphasize inter- and multidisciplinary health services research training. Training should provide individuals with rigorous academic and health services research experiences that will allow them to address emerging issues in our changing health care system. It is expected that AHRQ-supported health services research training programs be responsive to research needs associated with the ongoing shifts in the source and demand for services, and provide training in identified areas of need, such as outcomes/health status and quality measurement, biostatistics, epidemiology, health economics, decision analysis, cost effectiveness analysis, and health policy. At the conclusion of the training program, trainees should have the conceptual, methodological, and practical foundation to conduct research. Information and announcements describing AHRQ"s research areas of interest can be found at http://www.ahrq.gov (see Funding Opportunities). Applicants are encouraged to review this information and contact the Agency staff (listed under WHERE TO SEND INQUIRIES) who match their research interests to seek additional guidance. For a description of recent research topics of interest to the Agency, applicants are encouraged to review the following research solicitations: o Impact of Payment And Organization on Cost, Quality And Equity – http://grants.nih.gov/grants/guide/pa-files/PA-01-125.html o Patient-centered Care: Customizing Care to Meet Patients" Needs – http://grants.nih.gov/grants/guide/pa-files/PA-01-124.html o Translating Research into Practice – Joint Program Announcement – http://grants.nih.gov/grants/guide/pa-files/PA-02-066.html Applicants are encouraged to propose training programs which address research issues critical to priority populations, including: individuals living in inner city and rural (including frontier) areas, low-income and minority groups, women, children, and the elderly, and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care. MECHANISM OF SUPPORT This RFA will use the Institutional NRSA (T32) award mechanism. Applicants are solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. AHRQ has not determined whether this solicitation will be continued beyond the current request. The anticipated award date is July 1, 2003. Duration of Support Institutional NRSA research training grants (T32) may be made for periods of up to 5 years, but can be renewed on a competitive basis with the submission of a competitive continuation grant application submitted and peer-reviewed in response to a subsequent RFA. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of AHRQ. No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards, except by an extension approved by the director of AHRQ. Waivers for extensions must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to AHRQ Grants Management Office. The request must show good cause and a compelling justification for an extension of the statutory limits on the period of support. FUNDS AVAILABLE AHRQ expects to award up to $7.0 million in total costs (direct costs plus facilities and administrative costs) in fiscal year 2003 to support the first year of up to 30 projects under this RFA. The total project period for applications submitted in response to the present RFA may not exceed five years. The actual number of awards is dependent on the AHRQ NRSA budget and the number of high quality applications and their individual budget requirements, it is not the intent of AHRQ that the awards be equal in size. Although this program is provided for in the financial plans of AHRQ, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Funding beyond the initial budget period will depend upon annual progress reviews by AHRQ and the availability of funds. ELIGIBILITY REQUIREMENTS Applicant Institutions Only domestic non-profit private, public institutions, and faith-based organizations may apply for grants to support doctoral and postdoctoral health services research training programs. Foreign institutions may not apply, nor may they be involved as a collaborating institution. The applicant institution must have the staff and facilities required for the proposed program. Eligible Trainees Trainees appointed to the proposed training program must have the opportunity to carry out supervised health services research with the primary objective of extending their research skills and knowledge in preparation for a health services research career. Prospective trainees must be U.S. citizens or non- citizen nationals or permanent residents of the United States in possession of an Alien Registration Receipt Card I-551, or other legal verification of such status at the time of appointment. Individuals on temporary or student visas are not eligible. Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health professional degrees except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical specialty or subspecialty, except when the residency program credits a period of full- time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. In such instances, coverage can only be requested for the portion of the residency training in which the trainee engages in full-time research training. Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and enrolled in a program leading to a Ph.D. or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their professional degrees are also eligible. At the beginning of a the NRSA appointment, a postdoctoral student must have a Ph.D., M.D., O.D., D.D.S., Dr.P.H., Sc.D., D.N.Sc., or other doctoral degree, or an equivalent degree from any accredited domestic or foreign institution. (Persons holding the J.D., as the sole advanced degree, are not considered postdoctoral for purposes of NRSA appointments.) Certification by an authorized official of the degree-granting institution that all requirements for the doctoral degree have been met is acceptable. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Part-Time Training: Under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to select a trainee or change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by AHRQ for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee"s position at the institution. In each case, the Program Director must submit a written request countersigned by the trainee and the institutional business official that includes documentation supporting the need for the part-time training. The written request also must include an assurance by the trainee that he/she intends to return to full- time training when that becomes possible and that he/she intends to complete the research training program. Also, the grantee must have a trainee slot available to allow reappointment if and when the part-time trainee returns to full-time training. In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 20 hours per week. Individuals who must reduce their commitment to less than 20 hours per week must take a leave-of-absence from the training program. The stipend will be pro-rated in the grant award during the period of any approved part-time training, and the slot occupied by the part-time trainee will count as one of the slots approved for support by AHRQ. Part-time training may also affect the rate of accrual or repayment of the service obligation for postdoctoral trainees. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Training Program Directors or Principal Investigators (PIs) Any individual with the skills, knowledge, and resources necessary to organize and implement a high quality research training program is invited to work with their institution as the director of the research training program in order 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. The research training program director at the institution will be responsible for the selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program. SPECIAL PROGRAM CONSIDERATIONS Recruitment of Underrepresented Minorities The primary objective of the NRSA program is to prepare qualified individuals for careers that significantly impact the Nation"s research agenda. Within the framework of the program"s longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from racial or ethnic groups underrepresented in research. The following groups have been identified as underrepresented in research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. Duration of Training and Transition of Trainees Other considerations relate to the duration of training and the transition of trainees to individual support mechanisms. Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health-professional degrees strongly correlates with subsequent application for and receipt of independent research support. Training grant program directors, therefore, should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant or in post-training grant research experience for a cumulative minimum of 2 years. It has also been shown that transition to independent support is related to career success. Therefore, program directors should encourage postdoctoral trainees to apply for the individual postdoctoral fellowships (F32) or mentored career development awards (K awards). During the review of training grants applications, peer reviewers will examine the training record to determine the average duration of training appointments for health- professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that health professional trainees, who train in combined programs with postdoctoral researchers with an intensive research background, are more likely to apply for and receive research grant support. Programs located in clinical departments that focus on research training for individuals with an M.D. or other health-professional degrees should consider developing ties to basic science departments or modifying their program to include individuals with research doctorates when this approach is consistent with the goals of the program. Applications should describe the basic science department"s contribution to the research training experience and also indicate if both health professional trainees and trainees with research doctorates are included in the training program. Ongoing Program Evaluation Finally, Program Directors are encouraged to develop methods for ongoing evaluation of the quality of the training program. Although the T32 application process requires extensive career tracking of former trainees, it is often useful to obtain more proximal feedback. For example, Training Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify any weaknesses in the training program and to provide suggestions for program improvements. Applicants are encouraged to include such plans in their competing applications, and as noted below, competing continuation applicant need to include these results in their applications. Payback Provisions As specified in the NIH Revitalization Act of 1993, which AHRQ currently follows, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993, specifies that the second and subsequent years of postdoctoral NRSA training will serve to payback a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the payback agreement and do not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) before initializing an appointment and will incur 1 month of service payback obligation for each month of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals who continue under an award for 2 years, have fulfilled their obligation by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching an average of more than 20 hours per week of a full work year after the award. o Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the AHRQ Division of Grant and Contract Management specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the AHRQ Division of Grant and Contract Management of changes in status or address. o For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options available to individuals who complete the program and whether the types of positions available are consistent with the nature of the training provided and where applicable whether those positions are likely to satisfy any outstanding service payback obligation. Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in his/her first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. The forms are available on the AHRQ website at http://www.ahrq.gov/fund/training/tools.htm#forms. Leave In general, trainees may receive stipends during periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training, and is not considered to be a vacation or a holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth pursuant to the Pregnancy Discrimination Act (42 USC 2000 e(l)). Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified must seek approval from AHRQ"s Grants Management Office for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first twelve months of postdoctorate support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. Allowable Costs Stipends National Research Service Awards provide funds in the form of stipends to predoctoral and postdoctoral trainees. A stipend is provided as an allowance for trainees to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Trainees may not receive stipends for periods during which they are not enrolled in the training program. Stipend levels are adjusted nearly every year and current stipend levels are available on the NIH website at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html. In FY 2002 predoctoral students will receive a stipend of $18,156. For appointments of less than a full year, the stipend will be based on a monthly or daily proration. The monthly stipend amount is calculated by dividing the current annual stipend by 12. The daily stipend is calculated by dividing the current annual stipend by 365. For postdoctoral trainees, the current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. Current postdoctoral stipend levels, effective October 1, 2001, are as follows: Full years of Stipend relevant experience Less than 1 $ 31,092 1 32,820 2 38,712 3 40,692 4 42,648 5 44,616 6 46,584 7 or more 48,852 A trainee with a health-professional doctoral degree who is enrolled in a graduate degree program is considered to be in postdoctoral training and will receive the appropriate postdoctoral stipend listed above. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The stipend for each additional full year of stipend support is the next level in the stipend structure and does not change in the middle of an appointment. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by AHRQ. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions are met: o Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the grantee institution, but must not require any additional obligation from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may PHS funds be used for supplementation. o Compensation. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a laboratory assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a PHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. Without the prior approval of AHRQ, the level of effort devoted to compensated services must not exceed 10 hours per week. Requests for compensated services in excess of 10 hours per week must be requested by the training program director in a letter countersigned by the trainee and an appropriate institutional business official. The letter must describe the nature of the requested additional effort and how it relates to the current training experience. The letter should also provide assurances that the additional effort will not interfere or prolong the NRSA supported training experience. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee"s approved NRSA training program. Educational Loans or G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. A NRSA traineeship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. Tuition Fees and Health Insurance The AHRQ will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition, fees, and health insurance are allowable only if they are required for all individuals in a similar research training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the Grants Policy Statement at http://grants.nih.gov/grants/policy/gps Other Training Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual"s research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, how these opportunities differ from those offered at the parent institution, and the relationship of the proposed experience to the trainee"s career stage and goals. Justification for research training experience away from the institution must be described in detail in the budget justification section of the application. Institutional costs of up to $2,200 a year per predoctoral trainee and up to $3,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request institutional costs above the standard rate. Requests for additional costs must be explained in detail and carefully justified in the application. Consultation with program staff in advance of such requests is strongly advised. A facilities and administration cost allowance (indirect cost allowance) of 8 percent of total allowable direct costs (this excludes tuition, fees, health insurance and equipment) may be requested. Applications from State and local government agencies may request full indirect cost reimbursement (see PHS Grants Policy Statement). Information on Facilities and Administrative Costs is available in the Grants Policy Statement at http://grants.nih.gov/grants/policy/gps Tax Liability Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA trainees and institutions. NRSA stipends are not considered to be salaries. In addition, trainees supported under the NRSA are not considered to be in an employee/employer relationship with the AHRQ or within the awardee institution. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. AHRQ takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. SPECIAL REQUIREMENTS Publication Transmittal: General AHRQ Requirements To allow the Agency to evaluate its fulfillment of a statutory mandate to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are expected 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"s or contractor"s 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 AHRQ information dissemination activities with the grantee"s or contractor"s plan, especially issues related to printing and electronic dissemination, and outreach to the media. Position (slot) Request, Approvals, and Funding Institutions may apply for support for predoctoral students, postdoctoral students, or a combination. Applicants should include a rationale for their proposed choice of supporting the type and number of positions requested, including the requested level(s) of postdoctoral students. An applicant may request as many postdoctoral or predoctoral positions as the proposed program can adequately accommodate, but the number of positions awarded will be determined by the review process, program needs, and availability of funds. WHERE TO SEND INQUIRIES AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Karen Rudzinski, Ph.D. Office of Research Review, Education and Policy Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400W Rockville, MD 20852 Telephone: (301) 594-1449 FAX: (301)594-0154 Email: training@AHRQ.gov Direct your questions about peer review issues to: Scott Andres, Ph.D. Health Scientist Administrator Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 400W Rockville, MD 20852 Telephone: (301) 594-6408 FAX: (301) 594-0154 Email: sandres@AHRQ.gov Direct your questions about financial or grant management matters to: George B. Gardner Grants Management Specialist Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-6826 FAX: (301) 594-3210 Email: ggardner@AHRQ.gov 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 consideration 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 Karen Rudzinski, Ph.D. (see address under WHERE TO SEND INQUIRIES). SUBMITTING AN APPLICATION Applications must be prepared using Section V, "Institutional National Research Service Award" of the PHS 398 research grant application instructions and form (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 301-435-0714, Email: GrantsInfo@nih.gov. AHRQ recommends applicants use Arial 12. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. In instances in which instructions provided in this announcement differ from those listed in the PHS 398, the former will take precedence. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO AHRQ: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) All grant applications submitted to CSR must come via United States Postal Service or a recognized delivery/courier service. Individuals may not personally deliver packages to CSR. For further information please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. At the time of submission, two additional copies of the application, labeled "Advanced Copy" must also be sent to: Karen Rudzinski, Ph.D. NRSA Project Officer Agency for Healthcare Research and Quality 2101 East Jefferson St., Suite 400 Rockville, MD 20852-4908 E-mail: training@AHRQ.gov APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The 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. The CSR and AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Applicants are encourage to read all PHS Forms 398 instructions prior to preparing an application in response to this RFA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. The RFA is available on AHRQ"s Web site, http://www.AHRQ.gov, (see "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 the RFA number). The RFA 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness to the RFA by AHRQ. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific, technical, and educational merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. 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. All applications will be judged on the basis of the scientific merit of the proposed training plan and the documented ability of the applicant to meet the research objectives of the RFA. Although the technical merit of the proposed project is important, it will not be the sole criterion for evaluation of a program, as noted below. REVIEW CRITERIA The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research training grant will have a substantial impact on the pursuit of the above goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. 1. Program Characteristics o Objectives, design, and direction of the research training program -- including the probability of achieving stated goals. o Substantive and methodological content of the proposed program and its relevance to the Program Objectives noted above, including relevant descriptions of courses and experiential opportunities offered and/or required. o The extent to which proposed approaches address areas in need of research given changes in the health care delivery system. o Innovativeness of program design. o The inclusion of a firmly grounded plan for mentoring students, available to students, including options for students to be involved in selection of mentors. o Caliber of preceptors as researchers, including successful competition for research support in areas directly related to the proposed research training program. o The formation of partnerships with: - other universities traditionally not involved in extensive health services research and newly emerging centers of excellence such as recipients of AHRQ Building Research Infrastructure and Community Grants (BRIC) and Minority Research Infrastructure Support Program (M-RISP) grants. More information on these programs can be obtained at http://www.ahrq.gov/news/press/pr2001/infrapr.htm, and/or – state governments to provide trainees first hand experience in conducting rigorous health services research to address state government information needs for improving health programs and developing health policy, and (to the extent feasible and applicable) – components of the health care delivery system. 2. Program Support and Organizational Structure and Plans o Quality of the institutional training environment for NRSA supported trainees and the relationship of the NRSA program to the broader training program (if appropriate). The level of institutional commitment, quality of facilities, availability of appropriate courses, and the availability of research and research training support, including offices and computers. o Organizational structure of the proposed training program, including delineation of administrative responsibilities for planning, oversight, and evaluation. o Demonstration of cooperation by any proposed collaborating facilities, institutions, or departments in providing research experiences and/or sites for trainees, including (where applicable) documentation of mechanisms by which trainees will be integrated into the ongoing health services research activities of other entities. o Demonstration of extent to which and ways in which AHRQ support will be (has been in the past) leveraged to maximize health services research training within the institution. o Availability of other relevant support. 3. Trainee Recruitment & Retention Plans o Quality of the applicant pool and the selection of individuals for appointment to the training grant. This assessment will include consideration of the diversity of the trainee pool, taking into account various recruitment and retention efforts as well as the availability of individuals from underrepresented minority groups within the relevant pool of applicants (see below for details). o The targeting of AHRQ priority populations -- in addition to underrepresented minority groups -- (e.g., low income populations, elderly, children, chronically ill, persons with special health needs, women, and inner city, rural and frontier populations) in both the research portfolio and trainee applicant pool. o For applicants submitting competing continuations, their record in recruiting and retaining trainees, noting past annual success rates in filling committed slots. o When appropriate, record (including appropriate statistical rates) of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training or other research activities. 4. Program Record and Evaluation Plans o Proposed methods for monitoring and evaluating performance of trainees and the overall program, including tracking of graduates after completion of training, record of trainees in obtaining individual research awards or fellowships following training and in establishing careers in health services research. o For applicants submitting competing continuation applications, their past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers, as well as satisfaction of former students with their training, and indication that the program has incorporated student, faculty, and labor market input into continuous quality improvement. Evidence of further career development can include receipt of fellowships, career awards, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for individual research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotions in academe or industry, and any other appropriate measure of success consistent with the nature and duration of the training received. o For applicants submitting competing continuation applications, the outcomes and impact on improvements in the delivery of health care or health care policy stemming from their investment in training. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: Minority Recruitment Plan: The AHRQ remains committed to increasing the participation of individuals from underrepresented minority groups in health services research. All applications for institutional NRSA research training grants must include a specific plan to recruit minorities. If an application is received without a plan, it will be considered incomplete and will be returned to the applicant without review. The plan should include information on the racial/ethnic distribution of: o Students or postdoctorates who applied for admission or positions within the department(s) relative to the training grant, o Students or postdoctorates who were offered admission to or a position within the department(s), o Students actually enrolled in the academic program relevant to the training grant, and o Students or postdoctorates who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of research training and whether those trainees finished their training in good standing. AHRQ will now be strengthening these efforts in line with recent procedures implemented and announced by the National Institute for Child Health and Human Development (see http://grants.nih.gov/grants/guide/notice-files/NOT- HD-02-004.html. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. Following standard initial review of T32 applications, AHRQ staff will review the comments of the review panel with respect to the peer reviewers" judgment of inclusion plans and, when appropriate, the record of inclusion. The AHRQ will then categorize further this component of the application. Each "acceptable" application will now be categorized as either "acceptable" or "exemplary. To be defined as "exemplary," applications must describe comprehensive and creative strategies for recruiting individuals from underrepresented minority groups. Exemplary competing continuation applications also must have demonstrated significant success in recruiting and retaining underrepresented minority trainees during the previous award period, given the program"s institutional and geographical environment. Exemplary new and competing continuation applications will be eligible for additional training positions when they are awarded and to receive additional training positions at the end of each Federal fiscal year subsequent to the initial award, in each case up to the review panel"s recommended level, depending on availability of funds. Training in the Responsible Conduct of Research: Every Predoctoral and Postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. o Although the AHRQ does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding research on human subjects, and data management (including confidentiality). Within the context of training in scientific integrity it is also useful to discuss the mutual responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The AHRQ encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a training program or department, regardless of the source of support. AHRQ initial review groups will assess the applicant"s plans on the basis of: o ACCEPTABILITY: Including the the appropriateness of syllabus of study, topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by AHRQ staff (See 42 CFR 66.206). o PROTECTIONS: Including the adequacy of the proposed protection of human research subjects or the environment, to the extent they may be adversely affected by the research proposed to be conducted by trainees. o INCLUSION: Including the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) DATA SHARING Data Privacy Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made or implied regarding the possible uses and disclosures of such data. 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. 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 application of these confidentiality and security standards to subcontractors and vendors, if any, should be addressed. Rights in Data AHRQ 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 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 research 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. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ"s grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO"s website http://www.access.gpo.gov/nara/cfr/index.html). 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 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). o BUDGET: The reasonableness of the proposed project budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 26, 2002 Application Receipt Date: August 26, 2002 Peer Review Date: November 2002 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA Funding decisions will be based on peer review, research program and population priorities, the need for research personnel in specified program areas, creating a sustained partnership with newly emerging institutions involved in health services research, balance among types of research training supported by AHRQ, and the availability of funds. 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. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. It is not likely that data gathered under projects supported through this initiative will be used as a basis for federal regulation or action having the force and effect of law. However, should applicants wish to place data collected under this PA 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 think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 93.225. Awards are made under Sections 304 (a) and 487 (d)(3) and Title IX of the Public Health Service Act as amended (42 U.S.C. 242 b and 42 U.S.C, 288 (d) (3) and 299-299c-7 as amended by P.L. 106-129, 1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations, see in particular, 42 CFR 66, Subpart B, Part 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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