PEDIATRIC CRITICAL CARE SCIENTIST DEVELOPMENT PROGRAM RELEASE DATE: May 28, 2003 RFA: HD-03-015 - (Reissued as RFA-HD-08-022) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.929 LETTER OF INTENT RECEIPT DATE: September 17, 2003 APPLICATION RECEIPT DATE: October 16, 2003 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 National Institute of Child Health and Human Development (NICHD) issues this initiative in order to support a program of career development awards in pediatric critical care through the Pediatric Critical Care Scientist Development Program (PCCSDP) intended to develop resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that improve the acute care and long-term outcomes for children with serious illness and injury. The PCCSDP will support research career development of pediatric intensivists who have recently completed subspecialty training, and who are commencing basic and/or clinical research relevant to improving outcomes, decreasing morbidity, and minimizing disability in children who are survivors of pediatric critical care. The goals of this initiative are to expand the cadre of investigators trained to advance research in pediatric critical care and to support educational institutions in their ability to stimulate novel research. The intent of the initiative is to stimulate pediatric critical care research in the basic and clinical sciences that will improve long-term outcomes in children who sustain critical illness and/or injury. RESEARCH OBJECTIVES Background Several convergent developments in critical care medicine, as well as in the larger medical, scientific, and national communities, underlie the decision to develop and maintain special support of pediatric critical care career development and research at the junior faculty level. One of the most pressing is that clinical expertise in this rapidly evolving specialty is in such short supply, while the demand for intensivists to supervise the care of hospitalized patients, both in and out of the pediatric intensive care unit, is presently burgeoning. Recently publicized studies, as well as the interest of the business community, have heightened the benefits for patients of the intensivist-led model. As the clinical, educational, and administrative agenda increases in critical care, time for fully trained intensivists to devote to research is in ever-shorter supply. Modern pediatric critical care medicine has introduced a number of principles of management and innovative methodologies without rigorous use of the controlled observation necessary for their objective evaluation. A major problem has been the balance between assuring prompt implementation of new technologies, procedures, treatments, and drugs, and evaluation of their safety, efficacy, and cost/risk/benefit ratios. Indeed, because of the urgent demands of critically ill children, care is based on limited knowledge of new modalities not subjected to critical studies prior to introduction and use. In a critically ill child, for example, an innovative idea may be tried, which, if the patient's condition improves, may rapidly start a new trend and become the standard of care, expected and demanded by families of critically ill children and the professionals caring for them. As a result, incorporation into the arsenal of critical care therapies may be based on limited experience, with efficacy and/or safety partially evaluated scientifically due to the pressured operational clinical milieu that surrounds pediatric critical care practice. In addition, careful descriptive studies of the pathophysiology of critical illness in special needs children as related to long-term outcome remain minimal, but urgently needed. Earlier attempts to address this need by the community of critical care investigators, while productive of smaller studies, have not resulted in the level of scientific knowledge that should underlie the emergence of a dynamic new specialty and optimize outcomes for children who are critically ill. Research that will improve long-term outcomes is the focus of this initiative. It is expected that Principal Investigators and Mentors supported by this initiative will emphasize long-term outcomes, and reductions in morbidity and disability, during research training. As well, support that directs the attention of pediatric intensivists at the junior faculty level toward rigorous research is vital to progress in pediatric critical care medicine as an emerging specialty. Recent discoveries across a broad range of basic science research areas have greatly expanded the options for the critically ill child. Crucial advances in understanding of the molecular biology underlying organ system failure offer the possibility of manipulating otherwise poorly controlled processes, including inflammation, cell and organ death, and regeneration of tissues and functional organ system capacity. Modalities of mechanical ventilation, non- invasive ventilation, circulatory support, and extracorporeal life support have extended therapeutic options to patients previously thought to be beyond the reach of state-of-the-art therapy. The use of less invasive techniques in neurosurgery, general, and vascular surgery, as well as implementation of newer techniques of respiratory and circulatory support, have been central to the radical changes in morbidity and the declines in mortality achievable with state-of-the-art pediatric critical care medicine. As a result, children in higher risk groups who are victims of critical illness or injury, and those who might benefit from surgical interventions once not feasible, are benefiting from critical care in increasing number. More often, in the present context of pediatric critical care, children with complex illnesses, combinations of medical, surgical, and traumatic processes, are surviving to discharge from multidisciplinary critical care units. As mortality from critical illness and injury declines, survival of patients with disabling residuals of the critical pathology increases, and chronic medical conditions become more common. In children, it is well known that such conditions make the risk of subsequent critical illness greater. Relatively few studies are available that might quantitate this risk and the impact of the increasing numbers of medically fragile children on families, schools, pediatric practice, and health care costs. Measuring the efficacy of critical care practice by morbidity, while essential in the early years of the specialty, is no longer practical. Support of pediatric critical care research must depend on basic and clinical science derived by intensivists in order to form the foundation of pediatric critical care practice. The subspecialty has evolved rapidly in the clinical arena as described above, and the clinical services and leadership provided are in great demand. The current pediatric literature provides documentation that one half (45-55 percent) of emergency admissions to pediatric intensive care units (PICUs) occur in children with known special needs. When one considers the admission of children for postoperative critical care following elective surgical procedures, the percentage of children in the pediatric intensive care units with special needs is much higher. Program Scope Only applications that address the following will be considered responsive to this solicitation: o Developing guidelines for training, didactic interactions, career development, and the responsible conduct of research. o Developing and promoting a network of established faculty with a record of research support and productivity, who could serve as potential mentors and secondary resources for trainees. o Assuring that first consideration be given to candidates whose research interests will lead to expanded knowledge that ultimately will improve outcomes and quality of life for children with potential and present disability. o Negotiating and coordinating with participating institutions and departments to ensure that trainees get appropriate research support, non- clinical time commitments, and opportunities for advancement. o Recruiting, selecting, and placing those individuals who would most benefit from participation in this program and are most likely to develop independent careers in research. o Providing special opportunities for research presentations and professional advancement, and career counseling and networking. o Enhancing the involvement of individuals from underrepresented minority groups or those returning to research careers after family obligations and, whenever possible, enabling persons with disabilities as trainees, mentors, and other resource positions. o Providing a periodic evaluation of the PCCRSD program as a whole. MECHANISM OF SUPPORT This RFA will use the NIH Mentored Research Scientist Development Program (K12) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is July 01, 2004. FUNDS AVAILABLE The NICHD intends to commit approximately $400,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2004 and approximately $800,000 in FY 2005 – 2008 to support up to one new grant in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs of up to $400,000 in Year 01 and $800,000 per year in Years 02 - 05. Facilities and Administrative costs on K12 awards are limited to eight percent of modified total direct costs. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The National Institute of Neurological Disorders and Stroke (NINDS) recognizes the importance of supporting the career development of pediatric intensivists. While not a participant in this RFA, the NINDS will consider supporting individuals appointed to an NICHD-funded PCCSDP Program. Individuals considered for such career development support by NINDS include, but are not limited to, pediatric neurology or neurosurgery junior faculty who are conducting basic and/or clinical research in pediatric neurotrauma. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Faith-based or community-based organizations o Domestic Institutions outside the United States are not eligible for this award. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research career development program is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Candidates must be citizens of the United States or permanent, legal residents of the United States. SPECIAL REQUIREMENTS COMPONENTS OF A K12 PEDIATRIC CRITICAL CARE SCIENTIST DEVELOPMENT AWARD: The K12 award provides five years of funding to the applicant organization to support a national training program. The Program Director, in consultation with the Advisory Committee, shall define the application process, review candidates, make appointments to qualified individuals, and monitor progress. For each candidate, the four- to five-year career development program consists of two phases. In Phase I, the candidate receives two to three years of intense training in a basic or clinical science discipline with an established mentor scientist at the mentor's institution. In conjunction with the mentor, the candidate develops a research and career development plan, which will be reviewed annually by the PCCSD program. Phase II begins with the transition to independent investigator status. The PCCSD program will assist with placement in a sponsoring PCCM (or related) department, and continue to monitor progress and provide support as necessary. During Phase II (generally two to three years), individuals should be supported by independent research grants, departmental funds, and possibly even clinical duties - but not directly from the K12 grant. It is expected that the PCCM departments associated with this PCCSD program will make a strong commitment to supporting individuals as they reach Phase II, including faculty positions and the provision of protected research time. A. Principal Investigator The Principal Investigator of the PCCSD should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a national, multidisciplinary research-training program. The Principal Investigator is responsible for appointing the Program Director and members of the Advisory Committee (see below) and uses their recommendations to determine the appropriate allotment of funds for research and career development. The Principal Investigator may not receive salary or fringe benefit support from the grant for this role per se, but may receive financial support for additional roles in the PCCSD program (e.g., Program Director). B. Program Director and Administrative Staff The Program Director has responsibility for the day-to-day administration of the PCCSD, and may receive up to 10 percent support from the K12 grant. The Principal Investigator also may serve in the role of Program Director, and can receive appropriate remuneration for this role. The Program Director must be a physician and senior faculty member who is knowledgeable about pediatric critical care research, has a record of success in laboratory and/or clinical investigation, and demonstrated skill in career development. The Program Director may be assisted by a grant-supported part-time secretary. In addition, limited funds may be provided for a well-qualified recruitment officer to enhance participation in the program by women, members of minority groups that are underrepresented in biomedical research, and individuals with disabilities. C. Advisory Committee The Advisory Committee, chaired by the Principal Investigator, is a select group of scientists and clinicians who have interests and expertise in pediatric critical care research. They also may be potential PCCSD mentors. The Committee may involve advocates of the rehabilitation community, as appropriate. The Advisory Committee evaluates all applicants to the program, monitors progress of current trainees, and provides direct feedback to individuals as appropriate. D. Mentors Mentors shall be tenured faculty (or their equivalent) who have an established record of research productivity and grant support (preferably from the NIH) in areas of basic and translational research relevant to pediatric critical care medicine. Generally, they will be researchers and clinicians from allied fields, whose particular expertise is needed to support certain career research goals. Linkages to other departments should be encouraged, as they enhance the power of this career development program and pediatric critical care rehabilitation research, in general. Although mentors must demonstrate a commitment to the PCCSD program and potential trainees, they cannot receive salary, fringe benefits, or research support for this role from the K12 grant. However, provisions are made to support the research activities of particular PCCSD trainees within their laboratories, as described below. Mentors may be added to the roster of the program as appropriate, with NCMRR staff approval. It is expected that institutions that support PCCSD trainees in Phase I make a strong commitment to supporting these candidates in Phase II when they seek positions as independent investigators. E. PCCSD Candidates As part of its recruitment efforts, the PCCSD program should make every effort to broadly advertise training opportunities and provide information on prospective mentors. The program is required to seek out qualified women, individuals from underrepresented minorities, and persons with physical disabilities. PCCSD candidates should be physicians who have completed clinical training and are no more than five years beyond fellowship training when they enter the program. An individual who has previously served as Principal Investigator of an NIH research grant (R01, R03, R21, P01), mentored career development award (K series), subproject of program project (P01) or contract (N01) may not be considered for training in this program. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Prospective trainees should be encouraged to contact potential mentors prior to formally applying to the PCCSD program. Although remaining at the institution of their fellowship is a possibility for trainees under this award, academic diversity through research training and clinical practice at a different institution should be strongly encouraged. When possible, the program should support career development in those areas of research that would have the most impact on the emerging field of pediatric critical care medicine. Candidates must make a commitment to the PCCSD program for four to five years, spanning both Phase I and Phase II training. Upon entering the program, trainees should develop, in conjunction with their primary mentor, a long-range research and career development plan. During Phase I, at least 75 percent of the trainee's time must be devoted to basic research activities supported by the PCCSD program. Provided they are making appropriate progress as judged by the Advisory Committee, trainees may be renewed annually for up to three years of total Phase I support. Toward the end of the second year, trainees should be strongly encouraged to seek outside grant support as they transition to independent researcher positions in sponsoring PCCM institutions. Phase II trainees will remain associated with the PCCSD program for another two to three years, submit yearly progress reports, and attend PCCSD meetings. However, they should develop independent and stable means of research support outside the K12 grant. It is expected that their departments provide at least 50 percent - and preferably 75 percent - protected time for research activities during this period. Total training under the PCCSD program may not exceed five years. During Phase I or II, trainees may engage in brief research activities at another institution if it is directly related to the purpose of the award. Periods of leave from the program for greater than two months, whether for professional or personal reasons, require prior written approval from NICHD. In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, awardee institutions are hereby notified that PCCSD trainees may be contacted after the completion of their career development experiences for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. SPECIAL BUDGETARY REQUIREMENTS: A composite budget and individual budgets for the Administrative Core and the total trainee costs should be provided. o Administrative Core: The Administrative Core may include salaries and support for a Program Director (up to 10 percent time and effort), a part- time secretary, and a recruiting officer (up to 10 percent time and effort). It may also include funds for services specific to the administration of this program and not typically covered by institutional overhead charges (e.g., supplies, duplicating equipment, telephone, or maintenance contracts for equipment). Travel of Principal Investigator and Program Director to annual PCCSD meetings may also be included. The Administrative Core may include modest expenses for members of the Advisory Committee. o Trainee Expenses: As indicated above, funds for prospective trainees should be provided on a separate budget, with indication of the number of positions requested and to what extent these funds will be used for salaries. Individual trainees are eligible for up to $75,000 per year in salary, in addition to fringe benefits, consistent with their institution's salary scale; this may not be supplemented with other Federal funds unless specifically authorized by that Federal program. For each trainee, up to $10,000 in additional funds may be budgeted each year to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by the trainee's research in the laboratories of the established investigators who serve as mentors. In specific cases, grant funds may also be used for tuition, fees, and books related to career development. Up to $3,500 per trainee in travel funds may be budgeted to attend annual PCCSD functions and other professional meetings. Total awards to individual trainees need not be equal across these different budget categories. Salary and research expenses are not appropriate for Phase II trainees; however, the K12 grant may provide travel funds to allow them to attend annual PCCSD meetings. Facilities and administrative costs on K12 awards are limited to eight percent of modified total direct costs. Items that may NOT be supported with K12 grant funds include: 1. Direct support of the mentors' laboratories beyond those expenses directly attributable to the trainee's project; 2. Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges; 3. Salary and support for administrative activities such as institutional public relations or health and educational services; 4. Travel of the Principal Investigator, the Program Director, or other established investigators to scientific meetings beyond those associated with the administration of the PCCSD program; 5. Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the trainees' research; 6. Alterations and renovations. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome 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: Carol Nicholson, M.D., M.S. Pediatric Critical Care and Rehabilitation Research Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6843 FAX: (301) 402-0832 Email: nicholca@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Kathy Hancock Acting Chief, Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kh246t@nih.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 program o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD 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: Carol Nicholson, M.D., M.S. Pediatric Critical Care and Rehabilitation Research Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6843 FAX: (301) 402-0832 Email: nicholca@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Budget Instructions The application should include DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD (page 4), COMPOSITE BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT (page 5), and appropriate justifications in narrative form. As described above, the administrative core may include Personnel, Supplies, Travel Expenses (for the Principal Investigator and Program Director to annual PCCSD meetings), and Other Expenses. Funds for prospective trainees should be listed on a separate budget page with indication of the number of positions. Facilities and administrative costs on K12 awards are limited to eight percent of modified total direct costs. Biographical Sketches A biographical sketch is required for all key personnel to assess each individual's qualifications for their specific role in the program, as well as to evaluate the overall qualifications of the training network. Include information on current research projects and those completed during the last three years. For Advisory Board nominees, include a brief justification for their role in the PCCSD program. For proposed mentors, provide a paragraph on the relevance of their research to pediatric critical care medicine. No more than four pages may be used for each person. 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 THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) 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 eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the NICHD in accordance with the review criteria stated below. As part of the initial 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, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of these goals: (1) Probable impact of the PCCSD program on the development of well- qualified medical PCCM investigators, advancement of pediatric critical care research, and the application of basic research developments to significant clinical problems. (2) Commitment of a broadly based and productive network of established investigators to the goals of the PCCSD program, especially in research areas relevant to current NICHD interests and programmatic needs. (3) Institutional commitment of the applicant organization and potential training sites, as demonstrated by salary support, equipment, core laboratory support, or other contributions to the success of the program. (4) Evidence for the availability of a pool of prospective trainees, who could benefit from participation in this program and are likely to develop into productive independent researchers. (5) Novel mechanisms for recruiting candidates, especially qualified individuals from under-represented minority groups, and for connecting them with potential mentors. (6) Evidence of a sound and equitable system for evaluating candidates and monitoring their research progress and career development. (7) Availability of potential faculty positions at participating PCCM institutions for investigators trained in this PCCSD program, and strong evidence of institutional commitment to these individuals as they become independent investigators. (8) Quality of the proposed training in the responsible and ethical conduct of research. 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 17, 2003 Application Receipt Date: October 16, 2003 Peer Review Date: March 2004 Council Review: June 2004 Earliest Anticipated Start Date: July 01, 2004 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH 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 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 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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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