CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE INSTITUTIONAL RESEARCH TRAINING GRANT RELEASE DATE: April 23, 2004 RFA Number: RFA-CD-04-003 EXPIRATION DATE: June 22, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: Office of the Director (OD), Office of Science Policy and Technology Transfer (OSPTT), Office of Public Health Research (OPHR) (http://www.cdc.gov/od/ads/) Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.061 LETTER OF INTENT RECEIPT DATE: May 24, 2004 APPLICATION RECEIPT DATE: June 21, 2004 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 Program Directors o Eligible Scholars o Special Requirements o Allowable Costs o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Additional Review Considerations o Receipt Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Centers for Disease Control and Prevention (CDC) Office of Public Health Research (OPHR) announces the availability of FY 2004 public health research funds for institutional training grants to eligible institutions to develop or enhance training programs to provide research training opportunities for individuals, selected by the institution, who are training for careers in specified areas of health protection research. Health protection should be interpreted to include activities that 1) promote health and/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. RESEARCH OBJECTIVES Background The large discrepancies between what Americans spend on health and the outcomes they experience may stem from how the nation’s health knowledge and resources are deployed within the health system and other sectors of society. Most resources are deployed when people seek care for specific diseases and health conditions; health protection, health promotion, and prevention activities account for less than 3% of the nation’s investment for health services. A major obstacle to prioritizing health protection is the lack of evidence supporting specific programs, practices, and policies that affect health decisions made by people and those responsible for health policies and programs in the public health, health care delivery, and educational systems, as well as their counterparts in businesses and other private sector enterprises, governments, and governmental agencies. Development of this evidence is hampered by the lack of appropriately trained, qualified, and supported public health research investigators in relevant disciplines across all academic environments. CDC has initiated this focus on development of institutional training programs that enhance the recruitment and training of public health investigators as one key component of its public health research agenda to address this gap. CDC has aligned its priorities and investments with those of the Department of Health and Human Services to achieve 2 overarching health protection goals: 1) Health protection / Disease, injury and disability prevention: All people will achieve their optimal lifespan with the best possible quality of health in every life stage. The strategies to accomplish this goals include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on health evolving in life stages over a lifetime (infants, children, adolescents, young adults, middle-age adults and older adults), and in all situations (at work, in churches and communities, in school, at home, and at play). Integral to the successful accomplishment of this goal is the elimination of health disparities that afflict many people in our society. 2) Preparedness: People in all communities will be protected from infectious, environmental, and terrorist threats. The strategies to accomplish this goal include developing the knowledge and tools that integrate perspectives from multiple scientific disciplines to focus on exposure prevention, rapid detection and diagnosis, investigation, containment, and recovery from health threats. CDC’s health protection research initiative is designed to support achievement of these goals, and will help develop and disseminate the knowledge and tools that can be used by individuals, public health professionals, health care providers, educators, policy makers, businesses, private sector organizations, and others to measurably improve the health of Americans and reduce health disparities at all life stages and in all settings. Program Objectives CDC is initiating institutional training grants in institutions of higher education to ensure a continuing supply of well-trained scientists prepared to lead efforts in conducting cutting-edge public health research. The institutional research training grants described in this announcement provide support to training programs at institutions of higher education. Institutional training grants are designed to allow the director of the institutional program to select the scholars and to develop a curriculum of study and research experiences necessary to provide high quality public health research training. Training programs that allow support for study opportunities from complementary disciplines and/or stimulate other relevant interdisciplinary training within the institution are encouraged. In order to maximize the unique strengths and capabilities of institutions, consideration will be given to the development of new and innovative academic component programs that are relevant to the field of public health research. In conducting activities to achieve the purpose of this program, the awardee institution will be responsible for the following activities that define the programs to be conducted: o Provide measures of effectiveness that will demonstrate the accomplishment of the various objectives of the grant. Measures must be objective/quantitative and must measure the intended outcomes. These measures shall be submitted with the application and shall be an element of the evaluation. o The applicant shall be an identifiable organizational unit. Relationships and cooperative arrangements should be made with other schools or departments with relevant disciplines and resources (e.g., epidemiology, biostatistics, environmental health, law, business administration, education). o Designate a program director who is full-time faculty and professional staff and who is capable of planning, establishing, implementing, and evaluating the training program. o Designate faculty and staff with demonstrated training and research expertise, appropriate facilities, and ongoing training and activities in public health research. While the institution is expected to have sufficient ongoing public health research projects, it may lack specific shared public health research support elements. Therefore, programs may ask for funding to develop additional shared public health research support facilities critical to the conduct of team research, including, for example, specialized expertise in research design or biostatistics, or a pool of study coordinators to be used by the scholars. Individuals will be trained in team research settings. Programs will include didactic and practical training in various aspects of the design, conduct, and analysis of public health research with the goal of advancing public health research in complex areas of health protection research and promoting the conduct of research in highly collaborative settings. Programs must develop and propose a core didactic curriculum that will be presented to all first year public health scholars. Examples of a multidisciplinary core curriculum include: o Research methodology (including hypothesis generation, protocol design, pilot studies, outreach efforts to transfer research findings into practice) o Epidemiology o Biostatistics o Informatics o Economics o Ethical issues in research o Compliance with regulatory requirements for research o Team leadership and management o Grant writing The first year of each scholar’s program should be dedicated primarily to core curriculum that must include a multi-disciplinary aspect to foster interaction among scholars and faculty from various disciplines. The curriculum should link to other available research training programs at the institution. The program must demonstrate the flexibility to accommodate multiple disciplines and scholars with different levels of education, training, and didactic and research experience. The second through third year of each scholar’s program should consist of: (1) a hands-on research experience (e.g., protocol development, data analysis, and report writing) in an existing team research setting, and (2) developing a public health research project to provide experience in grant writing and program management. Predoctoral Training. Predoctoral research training must lead to the Ph.D. degree or a comparable research doctoral degree. Students enrolled in health-professional training programs that wish to postpone their professional studies in order to engage in full-time research training may also be appointed to an Institutional Research Training Grant. Predoctoral research training must emphasize fundamental training in areas of public health sciences. Postdoctoral Training. Postdoctoral research training is for individuals who have received a Ph.D., D.V.M, D.D.S., M.D., or a comparable doctoral degree from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize specialized training to meet national public health research priorities. Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have extensive medical/epidemiological training but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, postdoctoral scholars should agree to engage in at least 2 years of research, research training, or comparable activities beginning at the time of appointment. The duration of training has been shown to be strongly correlated with retention in post-training research activity. MECHANISM OF SUPPORT This Institutional research training grant will be awarded for periods up to 3 years. It is the first award of this type offered by CDC and it is not renewable. Successful applicants may use the information and the research results from this first award to show eligibility or responsiveness for future announcements. Awards within an approved project period are made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. The institution is responsible for planning, directing, executing, and evaluating the training program. This RFA uses the non-modular budgeting format, as described in the instructions for non-modular budget research grant applications. http://grants.nih.gov/grants/funding/phs398/phs398.html. This program does not require cost sharing. Scholar appointments are normally made in 12-month increments. No scholar may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of CDC. No individual scholar may receive more than 3 years of aggregate support at the predoctoral or the postdoctoral level. FUNDS AVAILABLE CDC intends to commit approximately $4,000,000 in FY 2004 to fund 2 to 4 new grants. An applicant may request up to three consecutive 12- month budget periods within a project period of up to 3 years. Because the nature and scope of the proposed training program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Matching funds are not required. ELIGIBLE INSTITUTIONS Eligible institutions include: o Non-profit organizations o Public or private institutions, such as schools of public health, schools of medicine, other health professional schools, or other institutions of higher education o Domestic institutions/organizations Foreign institutions and foreign collaborators are not eligible for this award. The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. Collaborating institutions may be included to supplement training activities in needed areas. An applicant organization may submit only one (1) application. Note: Title 2 of the United States Code section 1611 states that an organization described in section 501 (4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. INDIVIDUALS ELIGIBLE TO BECOME PROGRAM DIRECTORS The program director will be responsible for planning, directing, executing, and evaluating the proposed training program for the institution. Program directors should have a strong and active track record in research, research training, and administration that demonstrates the skills, knowledge, and experience necessary to develop and manage the proposed Career Development Program. 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 CDC programs. The research training program director at the institution will be responsible for the selection and appointment of scholars to the research training grant and for the overall direction, management, evaluation and administration of the program. ELIGIBLE SCHOLARS Research scholars are appointed to the training program with the primary objective of developing or extending their research skills and knowledge in preparation for a public health research career. The scholar must be a citizen or non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Scholars must devote 100 percent (at least 40 hours per week) of their full-time professional efforts to the training program and have a mentor with extensive research experience. Predoctoral Scholars. Predoctoral scholars must have received a baccalaureate degree by the beginning date of their appointment, and must be training at the post baccalaureate level and enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health-professional students, graduate students in the quantitative sciences, or individuals in postgraduate epidemiologic training who wish to interrupt their studies for a year or more to engage in full-time research training before completing their normal training programs are also eligible. Postdoctoral Scholars. Postdoctoral scholars must have received, as of the beginning date of the appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.P.H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable. SPECIAL PROGRAM CONSIDERATIONS The primary objective of the program is to develop and establish programs to ensure a continuing supply of well-trained scientists to lead efforts in conducting cutting edge public health research. Within the expanded framework of public health research, recruiting individuals from racial or ethnic underrepresented groups is a high priority. The following groups have been identified as underrepresented in translating knowledge about disease and injury into scientifically grounded public health programs, policies, and interventions with significant impact on people in all life stages: African Americans, Hispanic Americans, Native Americans, Alaska Natives, Asians, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. ALLOWABLE COSTS Funds may be requested for: A. Stipends: Funds, in the form of stipends, are provided to graduate students and postdoctoral scholars. A stipend is provided as a subsistence allowance to help scholars defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all scholars at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted nearly every year and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. The training institution may not alter established stipend levels. Further, stipend amounts are not to be changed in the middle of an appointment period. Stipends may be adjusted only at the time of appointment or reappointment. Finally, stipends must be based on the levels established for the current fiscal year of the grant. For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration. 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 scholars the appropriate stipend level is based on 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, public health duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. B. Tuition, Fees, and Health Insurance: 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 applied consistently to all persons 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/nihgps_2001/part_iib_4.htm#_Toc504812072. C. Other Scholar Costs: Scholar travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable scholar 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, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the scholar's career stage and goals. This type of research training requires prior approval from the CDC. Letters requesting such training may be submitted to the OPHR at any time during the award period. Under exceptional circumstances, which can include providing accommodations for a scholar with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional scholar costs must be explained in detail and carefully justified in the application. Consultation with OPHR program staff in advance of such requests is strongly advised. D. Training Related Expenses: Institutional costs of $2,200 a year per predoctoral scholar and $3,850 a year per postdoctoral scholar may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years. E. Facilities and Administrative Costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. Information on Facilities and Administrative Costs is available in the Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812080. STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the CDC. Such additional amounts either may be 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 conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the scholar's approved research training grant program. Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require additional effort from the scholar. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the CDC and the other Federal Agency. Compensation: An institution may provide additional funds to a scholar in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A scholar may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS 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 the research training experience. 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 research training grant may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this grant. Tax Liability: Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or any 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 scholar and institutions. The stipends are not considered salaries. In addition, scholars supported under the grant are not considered to be in an employee-employer relationship with the CDC or the awardee institution. It is therefore, inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the training grant. 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. The CDC takes no position on the status of 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. LEAVE In general, scholars may receive stipends during the normal 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 an active time of research and research training and is not considered to be a vacation or holiday. Scholars 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. Scholars 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 here must seek approval from the CDC for an unpaid leave of absence. At the beginning of a leave of absence, the scholars must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the scholars must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). PART-TIME TRAINING Under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a scholar appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the CDC 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, public health practice, public health training, or for other responsibilities associated with the scholars' position at the institution. In each case, the Program Director must submit a written request countersigned by the scholars and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the scholars intends to return to full-time training when that becomes possible, and an assurance that the scholar intends to complete the research training program. In no case will it be permissible for the scholar to be engaged in supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from training grant support. The stipend will be pro-rated in the grant award during the period of any approved part-time training. WHERE TO SEND INQUIRIES CDC encourages inquiries concerning this RFA and welcomes the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Tanja Popovic, M.D., Ph.D., F.A.A.M. Acting Associate Director for Science Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road, N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: TPopovic@cdc.gov o Direct your questions about peer review issues to: Catherine Spruill Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (404) 639-7240 Email: CSpruill@cdc.gov o Direct your questions about financial or grants management matters to: Sylvia Dawson Procurements and Grants Office Centers for Disease Control and Prevention Koger Office Park, Colgate Building, Mail-Stop E-14 2920 Brandywine Road, Atlanta, Georgia, 30341-5539 Telephone: (770) 488-2771 Email: SDawson@cdc.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, telephone number, and e-mail address of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC 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: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Instructions provided with this RFA supercede instructions provided in PHS 398. 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/labels.pdf. SENDING AN APPLICATION Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application and the appendix material must be sent to: Heidi Steele Office of Public Health Research Office of Science Policy and Technology Transfer Centers for Disease Control and Prevention 1600 Clifton Road N.E., Mail Stop D-50 Atlanta, Georgia, 30333 Telephone: (770) 488-8612 Email: HSteele@cdc.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Upon receipt, applications will be reviewed for completeness by Center for Scientific Review, NIH, and for responsiveness by the Office of Public Health Research, CDC. Incomplete applications and applications that are not responsive to the eligibility criteria will not be reviewed. Applicants will be notified that their applications did not meet submission requirements. PEER REVIEW PROCESS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CDC in accordance with the review criteria stated below. CDC uses a peer review process modeled after that of the NIH, including a streamline review process, essentially as spelled out in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique Applications in the upper half will receive a secondary review by the secondary review committee. REVIEW CRITERIA The goal of this Institutional Research Training Grant is to ensure that highly trained public health researchers will be available in adequate numbers and in appropriate research areas to enhance the public health research enterprise for the conduct of public health investigation. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of these goals. o Approach/Meeting the Intent of this Initiative o Institutional Commitment o Public health Research Capability and Infrastructure o Program Leadership/Management o Program Mentors/Team Leaders o Didactic Core Requirements o Interactions o Scholar Pool and Recruitment Plans o Evaluation/Tracking o Planning Phase The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific and technical merit and thus deserve a high priority score. (1) APPROACH/MEETING THE INTENT OF THIS INITIATIVE: The adequacy of the overall program strategy from the planning to the full implementation and evaluation phase in satisfying the intent of this initiative to develop and sustain a high quality institutional research training program that addresses a wide range of public health disciplines, specialties, and sub-specialties. Does the program provide excellence in the design and conduct of public health research and training? Is the plan for evaluation including process, output, and outcome measures adequate? Will the program prepare scholars to become potential leaders in public health research? Does the program take maximum advantage of existing didactic capabilities, public health infrastructure, and faculty strengths? (2) INSTITUTIONAL COMMITMENT: Is the institutional leadership committed to this program and its goals? Does the institution provide assurances that the institution intends the program to be an integral part of its research endeavor, and that public health research facilities and training opportunities will be a critical part of the environment? Have institutional barriers for public health research and public health researchers been adequately addressed? Adequacy of cooperative arrangements between consortium institutions, if applicable, that will ensure that the program performs effectively as one activity across institutional boundaries. Does this Program cross all departments and integrate all public health research training programs and public health research infrastructure elements within the institution, to benefit the entire institution? Is there adequate commitment of the institution(s) from the institutional leadership to Department Chairs to protect the time of scholars, guarantee 100 percent professional effort (at least 40 hours per week) of each scholar, actively engage in the promotion of each scholar’s public health research career, and support the career and tenure process for public health researchers at the institution? (3) PUBLIC HEALTH RESEARCH CAPABILITY AND INFRASTRUCTURE: The adequacy of the overall public health research and training environment and track record of the institution(s) in conducting interactive, multidisciplinary, collaborative, peer-reviewed public health research (e.g., translational research, epidemiological studies, etc.) involving a broad range of public health disciplines and diseases. The adequacy of the existing infrastructure of the institution(s) (e.g., cores for biostatistics, informatics, data management, research nurses, data managers) supported by CDC and other sources. Are there sufficient plans to improve and complement the existing infrastructure, and to integrate infrastructure and eliminate overlap in order to support a high quality Career Development Program in public health research? Are the plans for the shared public health research Support Facility adequately justified? (4) PROGRAM LEADERSHIP/MANAGEMENT: Does the Program Director have the necessary recent public health research background and administrative qualifications and experience to provide scientific leadership, management, and coordination of a public health research training program of this size and complexity? Have the Program Director and co- director(s) committed sufficient time to devote to this program? Will the program director have sufficient authority and credibility in the Institution to work across institutional boundaries? (5) PROGRAM MENTORS/TEAM LEADERS: Are the mentors and team leaders who will participate in this program clearly delineated, do they have the experience, skills, and track record at mentoring necessary to provide scholars with high quality multidisciplinary, team-oriented research training, and do they broadly represent the disciplines, specialties, and sub-specialties necessary to make this program work effectively? Will the mentors commit sufficient time to ensure the success of the program? (6) DIDACTIC CORE REQUIREMENTS: Are the didactic requirements sufficient to train scholars to lead, design, and conduct public health research, and work effectively in collaborative teams? Have the various didactic resources within the institution (been integrated and extended, as necessary (e.g., specialized courses and shared facilities), to effectively meet the needs of the program? Does the program have adequate flexibility to accommodate scholars with different levels of experience? (7) INTERACTIONS: Commitment of the applicant to work with other programs and the CDC as reflected by their proposed ideas to improve performance and outcomes. Commitment to share best practices and to participate in improving the national public health research enterprise. (8) SCHOLAR POOL AND RECRUITMENT PLANS: Does the application demonstrate well-defined recruitment procedures, potential sources, and number of high-quality scholars, scholar selection criteria, and retention strategies? Are these processes adequate to achieve a high- quality pool of scholars representative of a broad range of public health disciplines, specialties, and sub-specialties? Does the program seek to recruit scholars from outside the institution? Adequacy of plans to recruit women and members of underrepresented racial/ethnic minorities. (9) EVALUATION/TRACKING: Adequacy of the plans for evaluate the performance of the program as a whole (e.g., quality of the didactic cores, adequacy of the performance of mentors, adequacy of faculty participation), and to make changes that improve performance and outcomes. Adequacy of the plans to track career outcomes of scholars, including positions held, papers published, grants and awards submitted/obtained, and other relevant information. Annual and close out reports will be required to include evaluation measures as specified in the evaluation plan. (10) PLANNING PHASE: If all milestones are met during the planning phase, will this be sufficient to implement the program after six months? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. RECEIPT SCHEDULE Letter of Intent Receipt Date: May 24, 2004 Application Receipt Date: June 21, 2004 Earliest Anticipated Start Date: October 1, 2004 AWARD CRITERIA Applications are selected for funding primarily based on scientific and educational merit. Other factors considered by the secondary review committee are: availability of funds, research program priorities, the balance among types of research training supported by CDC, the acceptability of the plan for minority recruitment, and the acceptability of the proposal for instruction in the responsible conduct of research. The CDC will notify the applicant of the final action shortly after secondary peer review. For additional information, see the current Grants Policy Statement at: http://www.cdc.gov/od/pgo/forminfo.htm . REQUIRED FEDERAL CITATIONS For full explanation of additional federal citations required for applications to this RFA see: http://www.cdc.gov/od/pgo/funding/ARs.htm HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN PUBLIC HEALTH RESEARCH: It is the policy of CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in all CDC-supported studies involving human subjects, whenever feasible and appropriate. Furthermore, it is CDC policy to identify significant gaps in knowledge about health problems that affect women and racial and ethnic minority populations and to encourage studies which address these problems. Policy available in the Federal Register volume 60 number 179, September 15, 1995, page 47948-51. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. Guidance is available at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN CDC GRANT APPLICATIONS OR APPENDICES: All applications and proposals for CDC funding must be self-contained within specified page limitations. Unless otherwise specified in a CDC solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: Awards are made under authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92. This RFA is not subject to the intergovernmental review requirements of Executive Order 12372. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


NIH Office of Extramural Research Logo
   Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) 		  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.