MINORITY HEALTH AND HEALTH DISPARITIES INTERNATIONAL RESEARCH TRAINING PROGRAM GRANT RELEASE DATE: October 14, 2004 RFA Number: RFA-MD-04-004 (Reissued as RFA-MD-08-006) (This RFA has been amended, see NOT-MD-05-003) EXPIRATION DATE: December 16, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.ncmhd.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov) Fogarty International Center (FIC) (http://www.fic.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.307; 93.989 LETTER OF INTENT RECEIPT DATE: November 15, 2004 APPLICATION RECEIPT DATE: December 15, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 Supplementary Instructions 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 Center on Minority Health and Health Disparities (NCMHD) and Fogarty International Center (FIC) of the National Institutes of Health (NIH), invite applications for the Minority Health and Health Disparities International Research Training (MHIRT) awards. These awards will support programs that offer international research training opportunities to qualified undergraduate, graduate and health professions students who are from health disparities populations and/or are underrepresented in basic science, biomedical, clinical or behavioral health research career fields. Section 485E(a) of the Public Health Service Act (PHS Act) provided that the general purpose of the NCMHD includes the conduct of training with respect to minority health conditions and other populations with health disparities. Further, Section 485E(d) of the PHS Act provides that a population is a health disparity population if as determined by the Director of NCMHD, in consultation with the Director of Agency for Healthcare Research and Quality (AHRQ), there is significant disparity in the overall rate disease incidence, prevalence, morbidity, mortality, or survival rates in the populations as compared to health status of the general population. Based on the 1992 Minority Programs Fact-Finding Teams Recommendations Report, the recommendations provided guidance to the NIH for future development of policies on the support of minority training programs and initiatives. Additionally, Public Law 106-525 recognized a national need for increasing the number of well trained minority scientists in the fields of biomedical, clinical, behavioral, and health services research. The statute recognized that the inclusion of underrepresented minorities and women in the scientific, technological and engineering workforce will enable society to better address its diverse needs. Thus, the MHIRT program is a component of the National Institutes of Health's (NIH) long-term strategy to help establish a cadre of biomedical, clinical, behavioral and social science researchers that understands health disparities populations and will contribute to reducing and ultimately eliminating health disparities among racial and ethnic minority groups in the United States. Recent national and international events have underscored the importance of addressing the health disparities from a global health perspective. According to the Institute of Medicine (IOM) (2003, p.36), "for the health professionals, racial and ethnic disparities in healthcare . . . will be among the most significant challenges of today's rapidly changing health system." And, "from a public health standpoint, racial and ethnic disparities in healthcare threaten to hamper efforts to improve the nation's health (IOM, p.36)." Yet the health gap between minority and non- minority Americans has persisted, and in some cases, has increased in recent years (IOM, 2003, p.35). Thus, NCMHD, in collaboration with the FIC will support approximately 20 new MHIRT training programs that offer international research training opportunities for at least eight to ten qualified undergraduate, graduate and/or health professions students who are from health disparities populations that are underrepresented in the basic sciences, biomedical, clinical or behavioral research career fields. At least 75 percent of a grantee's MHIRT trainees must be undergraduate students. Applications are requested for innovative programs that provide international research training for the purpose of: Encouraging undergraduate, graduate and/or health professions students who are from health disparities populations to pursue careers in basic science, biomedical, clinical and behavioral health research fields. Broadening the research efforts and scientific training of undergraduate, graduate, and/or health professions students from health disparities populations to encompass international health issues. Assisting undergraduate, graduate and/or health professions students who are from such populations to participate in U.S. and international faculty collaborative research initiatives. Seeking innovative approaches to address problems and/or hindrances associated with closing health disparities gaps. RESEARCH OBJECTIVES MHIRT program awards are designed to enable U.S. institutions to offer short-term international research training opportunities for qualified eligible students in basic science, biomedical, clinical or behavioral research programs for at least 10-12 weeks during the summer or one semester during an academic year. More specifically, an applicant's research objectives should address the following programmatic aspects and be measurable with a defined timeline and expected outcome(s): Training MHIRT recipients in experimental research design, procedures for analyzing and interpreting data and the use of current scientific literature and analytical methods; Familiarizing MHIRT student researchers with the scientific literature associated with their individual research project; Addressing cultural, linguistic and ethical appropriateness and related issues affecting professionals who are engaged in scientific and public health research at the foreign site; Ensuring academic and/or professional forums for written and oral presentations by MHIRT recipients of their scientific research experience and results; and Mentoring MHIRT recipients through encouragement to complete current academic degree programs and pursue additional training leading to an advanced biomedical or behavioral health research career. MECHANISM OF SUPPORT This RFA will use NIH institutional training grant (T37) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. The anticipated award date is July 1, 2005. This RFA will not use the just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The participating ICs intend to commit approximately $5 million in FY 2005 to fund approximately 20 new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for total direct costs of up to $225,000 per year (http://grants2.nih.gov/grants/guide/ notice-files/NOT-OD-04-040.html). Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCMHD and FIC 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution has the following characteristic: o Domestic public or private university or college that offers at least the baccalaureate degree in fields relevant to basic science, clinical, biomedical, and/or behavioral health science. Only one application per institution will be accepted for review. An applicant institution may form a consortium with other postsecondary entities for the purpose of maximizing resources to support a MHIRT program. The application from a consortium of institutions should describe the specific plans for the management and participation of students and mentoring faculty at consortia institutions for all components of the applicant's proposed program plan. In keeping with the Presidential Executive Orders 12876, 12900 and 13270, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs) and Tribal Colleges and Universities (TCUs) are eligible to participate as a member of an applicant's consortium or apply directly for a MHIRT program grant under this RFA. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to serve as principal investigator by working with their institution to develop an application for support under this RFA. Individuals from health disparities populations, as well as individuals with disabilities are always encouraged to apply for NIH programs. More specifically, the person selected to head the MHIRT program should show evidence of experience at administering multifaceted international research programs involving significant student research training activities. The program director should be a full-time faculty member at the applicant institution and the principal investigator for the application. The program director will be responsible for coordinating all aspects of the proposed training activities, and submitting annual progress reports and trainee tracking data to the National Center on Minority Health and Health Disparities. SPECIAL REQUIREMENTS Trainee Eligibility Requirements: Citizenship Trainees must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa). Individuals on temporary or student visas are not eligible to participate in the MHIRT Program. Underrepresentation and Health Disparity Populations Trainees must be from health disparities groups that have been determined by the applicant institution to be underrepresented in basic science, clinical, biomedical or behavioral health research. The NIH particularly encourages applicants to recruit individuals from health disparities groups that are underrepresented in health-related research. Nationally, these groups include but are not limited to, African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Native Hawaiians and Pacific Islanders, and rural Appalachians. Programs should recruit trainees who could most benefit from a financially supported opportunity for an international scientific research experience. Programs should support students that are most likely to pursue basic science, clinical, biomedical or behavioral health research careers that will contribute ultimately to the elimination of health disparities in the U.S and between populations living in developing countries and the U.S. Applicants must describe, as well as provide demographic data on all categories of the eligible student populations that are available for recruitment to the program at their institution and consortium institutions. Program Evaluation The Program Director will be required to interact regularly with NCMHD staff in order to monitor the progress of the training program through review of annual progress reports and participation in network meetings. Grantees must submit data annually on each current and past trainee via a web-based tracking system that will be used to monitor the impact of the program on the careers of MHIRT trainees. Details of the required format for the narrative progress report and instructions for submission of data to the web-based tracking system will be provided by the NCMHD after grants are awarded. Contingency Plan Applicants should have contingency plans prepared in case a research country is placed on restricted travel by the U.S. State Department. Responsible Conduct of Research Applicants are required to provide all trainees with training in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction. However, the following areas should be included as a separate component of the research training plan: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of training in the international perspectives on these topics is strongly encouraged. The following information must be provided in the description of your plan: topics to be covered, format, faculty participation, instructional materials, frequency and duration of training and how trainee attendance will be monitored. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. 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: DeLoris L. Hunter, Ph.D. Director, Division of Research and Training Activities National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: Hunterd2@mail.nih.gov Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center Building 31 Room B2C39 31 Center Drive MSC2220 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: email@example.com o Direct your questions about peer review issues to: Lorrita Watson, Ph.D. Review Branch, Office of Extramural Activities National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: WatsonL@ncmhd.nih.gov o Direct your questions about financial or grants management matters to: Bryan S. Clark, MBA Chief, Office of Grants Management National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: ClarkB@ncmhd.nih.gov LETTER OF INTENT Each prospective applicant is asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that the letter provides will allow staff to estimate the potential review workload and plan the review. The letter of intent is to be received by the date listed at the beginning of this document. The letter of intent should be sent to: Lorrita Watson, Ph.D. Review Branch, Office of Extramural Activities National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: WatsonL@ncmhd.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001) with appropriate substitute pages as noted below. Applications must have a 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.dnb.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. You must use the National Research Service Award Substitute Form Pages 3, 4, and 5 in your application. Links to these pages are available at http://grants.nih.gov/grants/funding/phs398/instructions2/ p1_preparing_NRSA_app.htm. Click on Form Page 3; Form Page 4: NRSA Instructions; and Form Page 5: NRSA Instructions. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: The Training Plan Each MHIRT program grant application must include a comprehensive plan to support an international research training experience, under the collaborative mentorship of outstanding U.S. and foreign scientists, for at least eight to ten qualified eligible undergraduate, graduate and health professions students. While the NCMHD and its collaborator, FIC recognize that there are likely to be significant differences in applicant institutions, research environments, MHIRT trainees, and an applicant's approaches to international research training, all applicants must describe in detail the following components of their proposed research training programs: o Broad description of trainees' research plan o Procedures for trainee recruitment and application solicitation o Criteria for evaluation of trainee application and the trainee selection process o Cultural orientation and scientific preparation of trainees for an international research training experience o Criteria and process for matching trainees with U.S. and foreign faculty mentors and mentorship activities o Procedures for selection of a trainee research training assignment/ project under each foreign faculty mentor o Trainee evaluation of international research training experience o U.S. and foreign faculty mentors evaluation of MHIRT trainee performance during the research training experience o Criteria and requirements for written and oral presentation(s) by trainees about the international research training experience and their research results o Long-term tracking of each trainee's health research careers, including the impact of the MHIRT program experience on the trainee's career path. Types of Trainees Proposed programs should give undergraduate students priority when providing international research training opportunities by selecting approximately 75% undergraduate students as participants per year. It is strongly suggested that all undergraduate participants being considered for the program have completed at least two years of coursework in a major related to biomedical or behavioral health science, a minimum GPA of 3.0 and have demonstrated evidence of exceptional scientific research interest and talent, such as previous undergraduate research experience. Approximately 25% of the student participants may be graduate or health professions students in each budget. During the trainee selection process priority should be given to students who are interested in research pertinent to reducing and/or eliminating health disparities. All trainees must be involved in original data collection. Routine clinical or lab work, coursework or training in scientific techniques alone can not be supported by this RFA, except in those instances where such activities are allowing the trainees to pursue original data collection. Training Faculty U.S. faculty participants who will serve as mentors for student participants must have full-time academic appointments at the applicant institution or at an institution in an associated consortium. Applications should describe the specifics of the mentoring-experience, including documentation of the U.S. faculty's prior mentoring training of undergraduate, graduate, students and/or health professionals in international research. The international research training experience should be planned at foreign universities or research institutions where the mentoring U.S. faculty participants have ongoing collaborative research relationships. Applicants should also document prior and/or the ongoing collaborations between U.S. faculty mentors and faculty mentors from the proposed foreign training institution(s), including citing sources of joint funding for research and joint publications. Furthermore, the grant application must include a detailed description of the research resources and scientific educational environment available to the trainees during their foreign research training experience. With sufficient justification, U.S. faculty may serve as the international mentor for trainees at developing country training sites where adequate foreign mentorship is not available. In instances when it is proposed that a U.S. faculty will serve as the trainee's mentor at a developing country training site, the applicant must include curriculum vitae, biosketches and a letter from the participating U.S. faculty mentor defining the mentor's specific role, responsibility to the student and time commitment to the training program. Foreign research collaborators of U.S. faculty mentors with doctoral degrees and full-time positions should serve as mentors for students training at the proposed foreign training institution(s). Curricula vitae, biosketches, and letters from the participating foreign faculty mentors defining their specific roles, responsibility to the student and time commitment to the training program should be included in the application. Training Advisory Committee A training advisory committee of at least six members must be established to assist the program director with recruitment and trainee selection, scientific review of trainee research projects, evaluation of trainees and their international research training experiences and overall training program progress. This advisory group should be composed of both U.S. and foreign faculty who are directly involved in the MHIRT program. The committee should also include at least two faculty members (from biomedical, behavioral, or health disparity career fields), not involved in the MHIRT program, that have experience and understanding in addressing the training needs associated with preparing students from health disparities populations for international research opportunities. The applicant should describe the composition and expertise of the proposed training advisory group, the responsibilities of the group, and the processes and annual timetable by which the group will be expected to accomplish its responsibilities. Biosketches and letters from proposed members describing their commitment to serve in the training advisory committee should be included in the application. Budget Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive research training plan included in their application. The budgets may include costs to support the proposed training activities, trainees and faculty mentors during the training period at the foreign site, and costs for the administration of the program. Costs will be considered at levels higher than those included in this Request for Application but the applicant must include convincing, detailed budget justification(s). These requested cost(s) should not be significantly in excess of any existing cost levels for comparable items at the applicant institution. Adequate resources to meet U.S. government requirements for training and training-related research should be included in the budget. Trainees Stipends Trainees may be paid a stipend to help defray living expenses during the foreign research training experience according to their academic professional level experience. The approved stipend levels are $1,000 per month for undergraduates (Junior/Senior), $1,400 per month for Post- baccalaureate/Master level degree students, and $1,900 per month for Pre- doctoral degree level students. Trainees are not viewed as employees of either the Federal government or the awardee institution. U.S. Faculty Mentors Applicants may request stipend support for one U.S. faculty mentor at a developing country training site where lack of adequate foreign faculty mentorship is available for trainees. U.S. faculty stipend support equivalent to U.S. institutional salary may be requested only if no institutional or federal salary support is available during the research training period as documented by the applicant institution administrative official. Applicants can request support for a maximum of two U.S. faculty mentors in two developing countries annually. Foreign Faculty Mentors Foreign mentors may be provided funds up to $500 for use in research support activities related to hosting the trainee. This amount may be offered to only the foreign mentors from developing country institutions that do not charge student bench fees or tuition. Foreign faculty honorarium may not be requested if support is requested for a U.S. faculty mentor for the research training period at that developing country site. Program Administration The applicant institution may request up to $50,000 to support the principal investigator and/or other personnel for administrative efforts related to the MHIRT program. The administrative duties and responsibilities and time commitments for personnel receiving salary support should be thoroughly described and justified in the application. Trainee-Related Expenses Funds to support trainee research costs (such as lab supplies, computer access, interpreters) at the foreign site may be requested for up to a maximum level of $850 per month per trainee. Additional funds may be requested for expenses such as photocopying, training materials and long distance phone/fax costs directly related to the MHIRT program activities. Funds may be requested to cover expenses related to specific MHIRT program activities, including program and cultural related orientation, responsible conduct of research training instruction and evaluation activities. Tuition, Fees and Insurance Funds for tuition, fees and self-only medical insurance expenses associated with the international research experience may be requested up to a maximum level of $1800 per trainee. Tuition at the U.S. institution or bench fees at the foreign institution during the 10-12 week foreign research training period will be allowed only if such charges are required of all persons in similar training status at the applicant or host foreign institution. Tuition for specific coursework related to the project, such as language courses at the U.S. or foreign institution can be supported. The program may provide funds to cover fees for passports, visas, Centers for Disease Control and Prevention recommended vaccinations and prophylactic drugs. The applicant must ensure that all trainees have comprehensive medical and international travel insurance for the duration of the trainees international research experiences. If institutional or personal medical insurance does not adequately cover trainees during foreign travel, self- only medical insurance may be charged to the grant. All expenses in the category of tuition, fees and insurance should be itemized and justified for each foreign site. Foreign Living Expenses Foreign site housing expenses of up to $1200 per month may be requested for trainees and U.S. faculty mentors (when appropriate and supported by applicant's program plan). Travel Expenses Airfare and local ground transportation to each foreign site may be requested for trainees and U.S. faculty mentors. Trainees from consortium institutions may be supported for travel and per diem expenses to attend orientation and responsible conduct of research training as well as post- travel activities associated with the MHIRT program at the program director's institution. U.S. faculty mentors from consortium institutions may be supported for travel and per diem expenses to attend training advisory committee meetings. Travel and per diem expenses may be requested for short-term visits (less than 1 month stay) of foreign faculty mentors to the U.S. applicant institution to participate in MHIRT program associated student training activities and/or training advisory committee meetings. Funds should be requested for the MHIRT program director to attend a two-day annual MHIRT network meeting in the Washington, D.C. area. Funds may be requested to support MHIRT trainees to present their research findings at one national or regional scientific conference. All travel expenses requested should be based on economy class round trip airfare on U.S. carriers (to the maximum extent possible) plus per diem at the standard U.S. government rates (http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm). Facilities and Administrative Costs Costs should be included in the budget request at a rate of eight percent of allowable costs (Checklist form page II). 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 TO THE NIH Submit a signed, typewritten original of the application, including the appendix (if any), the Checklist, and three signed, photocopies without appendices, 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 and all five copies of the appendix material must be sent to: Lorrita Watson, Ph.D. Review Branch, Office of Extramural Activities National Center on Minority Health and Health Disparities National Institutes of Health 6707 Democracy Blvd., Suite 800 MSC 5465 Bethesda, MD 20892-5465 Telephone: (301) 402-1366 FAX: (301) 480-4049 Email: WatsonL@ncmhd.nih.gov Appendices should be comprised of unbound materials, with separators between documents. Applications hand-delivered by individuals to the CSR will no longer be accepted. This policy does not apply to courier deliveries (i.e., FedEx, UPS, DHL, etc…) (See http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-012.html). 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 assignment within 8 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the National Center on Minority Health and Health Disparities and/or Fogarty International Center. 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 NCMHD in accordance with the review criteria stated below. 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 o Receive a second level review by an appropriate National Advisory Council or Board. REVIEW CRITERIA The goals of NCMHD-supported research training are to advance the trainees' understanding of behavioral and biological systems and encourage participants to pursue biomedical or behavioral health research careers focused on enhancing the overall health and well-being of health disparities populations. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed international research training will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. SIGNIFICANCE 1. What is the likelihood that the proposed program will provide international research training experiences that will encourage participants to pursue biomedical or behavioral health research careers? 2. What will be the effect of these student-focused research training opportunities on furthering the advancement of individuals from health disparities populations in career fields that address problems related to the elimination of health disparities? APPROACH 1. Are the design, methods, and analyses adequately developed, well- integrated, and appropriate to achieve the aims of the training plan? Does the applicant acknowledge potential problem areas and consider alternative approaches? 2. Is the trainee selection process adequate? o Are there a recruitment plan and application process that capture a pool of the best qualified eligible candidates who could benefit most from an international research experience that encourages their pursuit of a biomedical or behavioral health research career? o If applicable, is there a participation plan for involvement of students and faculty in the recruitment and application process? o Does the applicant present a process to achieve the best match of trainees to U.S. and foreign faculty mentors and research projects at a foreign institution? o What methods and criteria will be used in selecting students and U.S. and foreign faculty participants? 3. Does the applicant's plan provide adequate trainee instruction in: A) the responsible conduct of research, particularly addressing ethical and cultural issues, associated with research at the foreign sites, lab safety, statistical methods and data analyses, and scientific literature reviews related to their research; and B) the preparation of written and oral scientific presentation of research results by trainees. 4. Does the applicant's description of the proposed research training at the foreign site(s) include: o A broad description of the students' research training projects, training schedules and research skills to be taught o U.S. and/or foreign faculty mentorship o Research experiences related to health disparities in U.S. and/or developing countries populations 5. Are the processes used by the program adequate to monitor and evaluate the short- and long-term impact of the international research training experience on trainees and their career path? 6. If applicable, are the plans adequate for the management and participation of the students and mentoring faculty of the consortium institutions? INNOVATION 1. Does the program design allow for and offer enriching international research training experiences to the program's trainees? 2. Does the project use approaches to encourage the pursuit of biomedical and behavioral research careers that address health problems disproportionately affecting the different populations in the U.S.? INVESTIGATOR 1. Is the principal investigator appropriately trained and well suited to carry out this international research training program? 2. Is the work proposed appropriate to the experience level of the principal investigator and other proposed researchers/mentors? 3. Are the qualifications of the proposed program director, and U.S. and foreign faculty participants adequate to direct the international research training activities of the student projects and act as effective mentors for the trainees? ENVIRONMENT 1. Does the scientific environment in which the work will be done contribute to the probability of success? 2. Do the proposed research training efforts take advantage of unique features of the scientific environment or employ useful collaborative arrangements? 3. Is there evidence of institutional support? 4. Is there a contingency plan for safety of the trainee while in a foreign environment? 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: PREVIOUSLY FUNDED APPLICATIONS: The career progress and accomplishments of previous undergraduate and graduate student trainees supported by the MIRT program award will apply for applications for competitive renewal. These applications should provide tables listing all former MIRT trainees and current data on their post-training completion of academic degrees, entry into graduate and health professional programs or pursuit of other biomedical and behavioral health or international careers, presentation of MIRT research results at scientific meetings, peer reviewed publication of MIRT research results and related honors or awards. 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 in the sections 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. ADDITIONAL REVIEW CONSIDERATION BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research training will be addressed. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2004 Application Receipt Date: December 15, 2004 Peer Review Date: March/April 2005 Council Review: June 2005 Earliest Anticipated Start Date: July 1, 2005 AWARD CRITERIA Award 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 ANIMAL WELFARE PROTECTION Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/ legislat/usdaleg1.htm), as applicable. 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 are 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. 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. 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. 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 PA 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 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.healthypeople.gov/. 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 307 and 485E of the Public Health Service Act as amended (42 USC 2421 and 287c-31) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 63a 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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