FOGARTY INTERNATIONAL COLLABORATIVE TRAUMA AND INJURY RESEARCH TRAINING PROGRAM (ICTIRT) RELEASE DATE: April 2, 2004 PA Number: PAR-04-083

Update: The following update relating to this announcement has been issued:

EXPIRATION DATE: August 26, 2006 unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) World Health Organization (WHO) (http://www.who.int) Pan American Health Organization (http://www.paho.org) COMPONENTS OF PARTICIPATING ORGANIZATIONS: Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov) National Heart, Lung and Blood Institute (NHLBI/NIH) (http://www.nhlbi.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH) (http://www.nibib.nih.gov) National Institute of Nursing Research (NINR/NIH) (http://www.ninr.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH) (http://www.niaaa.nih.gov) National Institute of Mental Health (NIMH/NIH) (http://www.nimh.nih.gov) Office of Behavioral and Social Sciences Research (OBSSR/NIH) (http://obssr.od.nih.gov/) Office of Research on Women’s Health (ORWH/NIH) (http://www4.od.nih.gov/orwh/) National Center for Injury Prevention and Control (NCIPC/CDC) (http://www.cdc.gov/ncipc/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: FIC 93.989; NHLBI 93.837, NIBIB 93.286; NINR 93.361, NIMH 93.242, NIAAA 93.273 LETTER OF INTENT RECEIPT DATE: July 25, 2004; July 25, 2005; July 25, 2006 APPLICATION RECEIPT DATE: August 25, 2004; August 25, 2005; August 25, 2006 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Training and Training Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The Fogarty International Center (FIC), in partnership with the National Heart, Lung and Blood Institute (NHLBI), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute of Nursing Research (NINR), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Mental Health (NIMH), the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Research on Women’s Health (ORWH), the National Center for Injury Prevention and Control (NCIPC), Centers of Disease Control and Prevention (CDC), the World Health Organization (WHO) and the Pan American Health Organization (PAHO), invites applications from nonprofit, private or public, domestic educational and research institutions in developed countries to establish research training programs that contribute to the capacity of developing country investigators and institutions to conduct human trauma and injury research relevant to the health needs of the developing country. Applications are solicited to create innovative research training programs within existing NIH- or CDC-supported scientific collaborations between developed and developing country researchers to begin to build a critical mass of scientists, health professionals and academics with human trauma and injury expertise and a sustainable research environment at the collaborating developing country institution. The International Collaborative Trauma and Injury Research Training Programs will honor the memory of Dr. John "Jack" Furman Finklea, whose leadership and advice were instrumental in the creation and development of CDC's extramural injury control research grants program and a closely related FIC program, the International Training and Research in Environmental and Occupational Health (ITREOH) Program. The program will enhance and promote equitable international collaborations between investigators in the developed world and those in low- and middle- income nations (see World Bank definition at http://www.worldbank.org/data/databytopic/GNIPC.pdf) where a base level of institutional infrastructure for the advancement of sustainable trauma and injury science is already established. Each proposed program should provide opportunities to generate the combined expertise at the developing country institution that could contribute to the long-term goal of harnessing new injury knowledge and skills to assess, diagnose, prevent or ameliorate acute and long-term morbidity and mortality stemming from a health issue with a significant injury component. The burden of disease and the biological, behavioral, and psychosocial changes that result from such trauma and injury should produce substantial public health cost in that country. Programs should include training in one or more of the following areas: injury statistics and epidemiology, prevention, biological and behavioral sciences, clinical injury and trauma care, blood product research, rehabilitation programs or low-cost prosthetics, medical imaging such as low-cost imaging development, the use of technology to diagnose and localize injury, bioengineering methods and technology, mental health issues such as traumatic stress disorders (acute and post trauma phases), depression, suicide risk, post-trauma injury and nursing care issues and medical informatics. Expertise should be developed simultaneously on the ethical, social and legal implications of human trauma and injury research in each program, as well as address diversity issues on a national or institutional basis. Consideration of gender issues related to trauma is specifically encouraged. The training programs supported will begin to address and reduce the growing disparity in injury sciences between those nations that have been at the forefront of such research and those with a limited but growing capacity in injury science in developing regions of the world. RESEARCH TRAINING OBJECTIVES Background Trauma and injury encompass one of the leading causes of death and disability in the world, with a greater proportion of the burden falling in the developing world, where resources, both financial and medical, are sorely lacking. Six of the 15 leading causes of death in people 15 – 44 years old in the world are trauma-related. More than 5 million deaths per year are caused by trauma, intentional and unintentional. In addition, trauma and injury are major contributors to disability. In 1998, of the estimated 5.8 million people who died from injury-related causes, approximately 1.2 million died from road traffic accidents and violence, including 948,000 by suicide, 736,000 from homicide and 588,000 from war. The remainder died from other injuries, including falls, drowning, burns and poisonings. For every person who dies of injuries, several thousand injured persons survive, but many suffer life-long health consequences. The burden of disease attributed to injuries is expected to rise in the years ahead. In fact, by the year 2020, it is projected that injuries will be the third leading cause of death and disability worldwide. For people ages five to 44, trauma and injury account for at least five of the 15 most common causes of disability life years. The 1999 CDC report “Traumatic Brain Injury in the United States: A Report to Congress” identifies traumatic brain injury as the leading cause of death and disability among children and young adults. CDC also notes that worldwide, of all types of injury, those to the brain are among the most likely to result in death or permanent disability. In 1998, injuries accounted for 11 percent of deaths worldwide. Suicides were 16 percent of these. Alcohol is a major contributor to motor vehicle crash deaths and other unintentional injury deaths such as falls, drowning, burns, as well as intentional injury deaths. For example, in the United States, 41 percent of motor vehicle deaths involve a driver or pedestrian who had been drinking. A recent review of published medical examiner studies covering a 20-year period in the United States revealed that 38.5 percent of unintentional non-motor vehicle injury deaths tested positive for alcohol, as did 47percent of homicide deaths and 29 percent of suicide deaths. Americans suffer trauma while working or traveling abroad. Road traffic accidents are the second leading cause of death for Americans abroad, according to statistics culled by the Maryland-based Association for Safe International Road Travel (ASIRT), a nonprofit organization that tracks road conditions and accidents in 54 countries. These deaths and disabilities are most common in the poorest countries. According to World Health Organization (WHO) estimates, almost 90 percent of deaths due to injuries take place in poorer countries. This is true for all forms of such trauma including road accidents, war, homicides, and suicides. The WHO Division of Injury has shown that in developing countries more than 70 percent of traffic deaths are among those who will never be able to afford a car. Because infectious diseases and malnutrition are responsible for 16 million deaths per year, the impact of trauma and injury on premature mortality and long- term disability is often overlooked. The World Health Organization has deemed April 7, 2004 to be Road Safety Day. On that day around the globe, hundreds of organizations will host events to help raise awareness about road traffic injuries, their grave consequences and enormous costs to society. They will also contribute to spreading the word that such injuries can be prevented. Among its other research training purposes, this present PA is contributing to that effort. The technical definition of an injury is "a bodily lesion at the organic level, resulting from acute exposure to energy (mechanical, thermal, electrical, chemical or radiant) in amounts that exceed the threshold of physiologic tolerance. In some cases, for example, drowning, strangulation or freezing, the injury results from an insufficiency of a vital element." Professionals in the injury field divide the causes of injuries into two categories: "unintentional," which includes most injuries resulting from traffic accidents, burns, falls, and poisonings; and "intentional," which includes injuries resulting from deliberate acts of violence against oneself or others. Although injuries affect everyone regardless of age, sex, income or geographic region, some populations are more vulnerable than others. Data indicate that, for most types of injuries, people die at a higher rate in low- and middle-income countries and in the poorest sections of developed countries than in high-income countries. The poor are at high risk for injury because they are faced with hazardous situations on a daily basis. For example, pedestrians on unsafe, overcrowded, and poorly maintained roads are vulnerable to being hit by cars, buses, or other vehicles. People living in homes lacking safety devices and precautions are more vulnerable to the risk of fires and burns. While residents in resource-poor settings are at greater risk for trauma and injury than those in wealthier regions, it is not possible to simply transfer technologies from developed nations to developing nations because the context in which injuries occur is different. For example, road traffic injuries (RTI) are the leading cause of injuries across the globe. In developed nations, changes in automobile engineering have contributed to a reduction in RTI morbidity and mortality. In contrast, in developing nations, most of the injured do not own an automobile, making such technological changes of significantly less importance as protective factors. Instead, other approaches such as road safety education become more important, but also need to be validated. Similarly, developing nations face hazards— such as landmines—that are rarely seen in developed nations. These hazards create unique needs for low-cost technologies for trauma patients, e.g., prosthetics developed locally from local materials. Other differences between developing and developed countries include the absence of trained emergency medical services personnel in most developing countries that lengthens the critical time period before trauma victims are seen by clinicians and contributes to increased morbidity. For example, the mortality rates among seriously injured patients in Seattle was 35 percent; in Monterrey, Mexico, 55 percent; and in Kumasi, Ghana, 63 percent; with the differences attributed primarily to differences in the percent of pre-hospital deaths. Among the reasons why trauma and injury are so devastating in the developing world are inadequate systems of emergency care at both the community and hospital levels and inadequate infrastructure, such as paved roads, inequities in access to emergency response systems, as well as inequities in access to pre-hospital and hospital emergency services between urban and rural areas. Other factors include constrained resources, need for enhanced administrative leadership in ministries of health due to poor recognition of the impact of trauma on national health, inadequate public education and public communication around injury prevention issues. Compounding the problem is the fact that responsibility for injury prevention cuts across many administrative domains including public health, criminal justice, and road safety, among others. The burden imposed by trauma and injury is not confined to the physical consequences of a single, acute event. There is risk of significant mental health consequences associated with trauma and injury stemming from experiences such as child and elder abuse, criminal victimization, domestic violence, rape, torture, war, terrorism, natural and technological disaster. In addition to psychiatric disorders such as post-traumatic stress disorder and depression, that can last for years, increased risk for severe functional impairment and disability creates a need for interdisciplinary researchers (e.g., public health, psychiatry, psychology, nursing, neuroscientists, biologists, prevention researchers, etc) to identify risk and protective factors for psychopathology, the development, testing and dissemination of innovative resource-modest models for outreach, prevention and treatment of trauma related disorders and adverse functioning among children, adolescents and adults within the developing country. Occupational injury and trauma are also of great importance. Data from the National Traumatic Occupational Fatalities Surveillance System (NTOF) indicate that 93,929 civilians in the United States were killed on the job from 1980 through 1995. The average annual fatality rate for this period was 5.3 per 100,000 workers. From 1980 through 1995, the number of deaths recorded by NTOF decreased by 28 percent (from 7,405 to 5,314), and the rate of death decreased by 43 percent (from 7.46 to 4.25 cases per 100,000 workers). The Census of Fatal Occupational Injuries (CFOI) fatality counts exceeded those of NTOF by about 1,000 in the years reported in both surveillance systems (1992– 1995). Based on CFOI data, the rate of fatal occupational injuries declined by 7 percent between 1992 and 1997. Of particular interest are industrial accidents as developing countries progress toward industrialization, farm injuries, and violent acts. For this PA, research training can include programs such as those related to prevention, treatment at the scene, emergency medical facilities and services, diagnostic imaging, post-acute care, and long- term care including rehabilitation. Diagnostic procedures especially low-cost techniques could be evaluated. Training may include topics such as low-cost surrogate technologies for CT and MRI Scan, ventilators, optimal resuscitation fluids, blood substitutes, and materials to cover wounds in burn victims, integration of psychosocial services with other systems providing assistance to victims. Training Objectives It is expected that each human trauma and injury research-training program supported will: 1. Substantially increase the expertise of trainees from developing countries in human injury-related research and thereby strengthen sustainable human trauma and injury research within the developing country institutions by providing a crucial level of human trauma and injury expertise. The building of capacity in developing countries to continue such research and research training for future generations of developing country scientists, nurses, and health professionals is a major part of this PA; 2. Simultaneously increase trainee expertise in the legal, ethical and social implications of trauma and injury research. o Address the many ethical questions that will arise in both treating the victims of trauma and injury who may not be able to give informed consent at the time of entry into the study and more generally in conducting research in developing countries. 3. Expand collaborative human trauma and injury research interactions between developed and developing country scientists, nurses, bioengineers and imaging researchers, or individuals, and other health professionals at the collaborating developing country institution; 4. Generate data for research-based (evidence-based) decision making in injury disease clinical treatment and prevention programs, for creating guidelines and procedures for conducting human trauma and injury research and for informing national health care policy in the collaborating developing country including critical demographic factors such as gender; and, 5. Stress an interdisciplinary approach that integrates behavioral, social, and basic human trauma and injury research with clinical training and public health priorities. 6. Where appropriate, the design of research projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impact of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies. Examples of research and training priorities include, but are not limited to, the application of epidemiologic methods and/or population- based studies that examine trauma and injury in low- and middle-income countries including, for example: o Patterns and trends in morbidity and mortality from different sources of trauma, outcome by demographic and gender characteristics; o Long-term impact related to rehabilitation needs, disability and loss of productivity; o Treatment of injury and trauma in the acute phase at the scene or at first healthcare institution; o Post trauma physical and psychological rehabilitation including low- cost prosthetics; o Development and testing of preventive interventions to shorten the course of psychological problems by early identification and rapid intervention o Post-trauma emotional rehabilitation to reduce chronicity of emotional problems, and prevent complications such as health, work or family problems o Development and testing of tools, models and algorithms which could facilitate assessment, utility and priority for injury services in developing countries; and be used in trauma or injury research studies; o Formation of interdisciplinary disaster research teams and protocols for rapid data collection efforts after trauma and injury in conjunction with national, state, and local authorities and researchers; o Identification of genetic factors that will maximize cerebral perfusion in the trauma or injury patient with brain injury; o Research to describe the symptoms of acute complications after trauma or injury and to identify the influencing factors; o Research on the ethical, legal and social implications of performing human injury research (as an adjunct to the other research training); and o Research related to the creation of low-cost diagnostic and treatment methods that might facilitate the recognition of specific sequelae to trauma and injury, and the development of preventive or ameliorative treatment options. The design of human trauma and injury research training programs must demonstrate that the critical mass of trauma and injury expertise at the collaborating developing country institution will increase over time (capacity building). This must include activities, including research and a support structure to encourage trainees to return to their home countries on completion of training. In addition, since trauma and injury is a multidisciplinary field, in order to build a critical mass of trauma and injury expertise at the developing country institution it is expected that trainees supported in each program will represent diverse academic backgrounds. Trainees may include pre- and post-doctoral behavioral or biomedical scientists, physicians, nurses, or individuals from a variety of other academic disciplines. Training Plan 1. Applicants should design a training plan that attempts to fill specific gaps in human trauma and injury research expertise and expertise in the ethical, legal and social implications of this research at the collaborating developing country institution. The end result should be a critical mass of scientists, nurses, and health professionals who will be able to conduct injury research, understand the pathophysiology and prevent or treat injury or the sequelae of injury in their country. Proposals may incorporate a wide range of long- or short-term research training opportunities or a mixture of training possibilities that can be offered to a wide range of possible developing country participants. A proposed training plan should include developed country grantee institution-based research training. However, applicants are expected to provide support and mentored research training that will be conducted at the trainees’ home institution in the developing country and overall at least 80 percent of the funding should be spent in the developing country or directly for the training of the developing country scientists. This should take place to the greatest extent possible in order to promote sustainable and ongoing collaborative research once the training is complete. Applicants are also strongly encouraged to include women and developing country ethnic minorities as trainees. FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups. Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies Applicants must address the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include an adequate representation of men, women and ethnic minorities or socially disadvantaged population groups among the developing country trainees. 2.Long-term training (usually a minimum of two years) may include studies leading to an advanced degree or a mentored post-advanced degree experience. Applicants should describe how the long-term training proposed would combine the acquisition of specific expertise to successfully answer a hypothesis-based or a technology-development driven human injury research question. This should include the opportunity to acquire multidisciplinary knowledge about the biomedical, behavioral and public health impact and the related ethical, legal and social implications of performing human trauma and injury research to the greatest extent possible. Research training opportunity may also include development or improvement of existing technology to prevent, diagnose and treat injury or trauma. Long-term training should include academic trauma and injury courses taken at the grantee institution, as well as instruction in the responsible conduct of research, medical informatics, technical writing and English as a second language, if necessary. 3. Applicants are expected to develop, promote and facilitate short- term training opportunities targeted toward the specific injury and trauma research needs of their developing country collaborators, which will directly enhance their research capabilities. Short-term training may be offered on such topics as clinical or behavioral research methods, medical informatics, medical technologies such as tissue engineering, radiology, biostatistics, data management and intervention trial protocol development or in areas which support research efforts such as an institutional review board (IRB) and biosafety procedures, proposal writing and research administration skills. When a short training course or workshop is given by one human trauma and injury research training program, it is expected that this activity will be open to trainees from the other training programs supported by this PA to the extent that this is feasible. Likewise, training materials are expected to be shared, especially those developed in or translated into languages other than English. Types of Training Training may include any or all of the following: o Long-term pre-doctoral training in human trauma, traumatic stress, and injury research associated with a human trauma and injury research study leading to a masters, Ph.D. or equivalent degree for individuals with or without previous research experience in this field. Research training should relate directly to the Principal Investigator’s or co- investigator’s collaborative research in human trauma and injury at the developing country institution and may range from two to five years. o Long-term post-advanced degree human trauma, traumatic stress and injury research associated with a human trauma and injury research study for developing country scientists and health professionals including human injury-related clinical training for approximately two years duration. o Short-term training in either the grantee or developing country institution (typically two to four weeks) in specific research methods, clinical, field or administrative skills related to human trauma, traumatic stress, and injury research associated with human trauma and injury research study efforts at the collaborating developing country institution for technicians, health care professionals and research administrative staff. o Short-term training of three to six months duration for individuals with advanced degrees or health care professionals conducted in the grantee institution in research methods or other skills, in order to support specific collaborative human trauma, traumatic stress, and injury research efforts at the developing country institution. o Advanced research training support (“re-entry” funding), generally for one to two years, to enable trainees with advanced degrees or health care professionals to continue mentored human trauma, traumatic stress, and injury research in their home country or to initiate independent human trauma, traumatic stress, and injury research projects related to ongoing collaborative research at the developing country collaborating institution. It is expected that such research will be certified through the foreign country IRB, the domestic institution’s IRB and all such research projects will be reviewed by an independent peer review committee convened by the domestic institution. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) international research training grant (D43) award mechanism that limits facilities and administrative (F&A) costs to eight percent of allowable direct costs. F&A costs up to eight percent can be requested in applications which include a subcontract to a foreign institution (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. The applicant organization must provide the necessary management for the transfer of funds and material to the collaborating developing country institution. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The total project period for an application submitted in response to this PA may not exceed five years. Continued support during this period depends on satisfactory performance as judged by: annual progress reports; institution visits; participation in periodic meetings of program directors; career progress of trainees; continued “parent” research grant funding and the long term development of sustainable human trauma and injury research capacity at the collaborating developing country institution. The International Collaborative Trauma and Injury Research Training awards will provide up to $150,000 per year in direct costs for up to five years of support. Trainees Stipends Trainees (developing country graduate students and post-advanced degree participants) studying at the developed country grantee institution may be paid a stipend comparable to their professional experience similar to other equivalent trainees but not exceeding $45,000 per year in accordance with the grantee institutional policies while involved in long-term training at the grantee institution. Applicants may wish to refer to the NRSA stipend levels described on the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-023.html. (NRSA substitute pages, pre- or postdoctoral stipends) Salary for Developing Country Faculty Professional and clerical support staff at the grantee developed country institution who provide major program administration or extended long-term training or conduct collaborative research with trainees at the developing country institution may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all grantee faculty may not exceed $45,000 of direct costs per year in the budget request. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described in the budget justification. (Form 398 budget pages, personnel) Consulting Fees for Developing Country Faculty Developing country institution faculty who provide major program administration at the developing country institution or participate in long-term training of participants at the developing country institution and grantee faculty or developing country faculty who teach short courses may receive a consulting fee not to exceed $3,000, in accordance with their institution’s policies. No more than $10,000 of the direct costs per year may be requested for consultant fees. The administrative, training or teaching responsibilities and time commitment for personnel receiving consulting fees should be thoroughly described. (NRSA substitute pages- training related expenses) Tuition, Fees and Insurance for Trainees Funds for tuition, academic fees and self-only or family medical insurance for developing country trainees at the grantee institution may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for long-term trainees and tuition-free short courses. (NRSA substitute pages, tuition, fees, insurance) Travel for Trainees o Funds may be requested for one round trip economy class airfare per year (on U.S. carriers to the maximum extent possible) and local ground transportation for each long-term developing country trainee to travel to the grantee institution or for developing country trainees to participate in short courses or to attend scientific conferences. Funds may also be requested for developing country trainees and developed country grantees to present their results at an annual network meeting at the NIH for all grantees. A mandatory annual meeting will occur for representatives of each awarded program. FIC program staff must approve additional travel. (NRSA substitute pages, trainee travel) o Funds may be requested for per diem and lodging for developing country trainees to participate in short courses or attend scientific conferences to present their results. (NRSA substitute pages, trainee travel) Training related expenses o Funds to support developing country participant training or research related costs at the grantee developed or developing country sites may be requested. (NRSA substitute pages, training related expenses) Faculty Travel for Developed Country Staff o Funds may be requested for one round trip economy airfare per year (on U.S. carriers to the maximum extent possible) for each grantee faculty participant providing extended training or participating in collaborative research to go to the developing country institution or teach short courses at the developing country institution. FIC staff must approve additional travel. (PHS 398 pages, travel) o Funds may be requested for per diem and lodging for grantee faculty to teach short courses at the developing country institution. (PHS 398 pages, travel) o Funds should be requested for airfare, per diem and lodging comparable to U.S. government rates (see http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm) for the Program Director and the primary foreign collaborator to attend an annual network meeting in Bethesda, Maryland. Inclusion of funds for trainees and other key personnel to attend these meetings is at the request of the applicant and at the discretion of FIC. (PHS 398 pages, travel) ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, health professional schools and research institutions capable of meeting the objectives of the PA o Domestic institutions/organizations o Faith-based or community-based organizations Only one application may be submitted from any given institution and an institution already having received an award may not apply for a second award from this same PA. However, there may be opportunities in the future to apply for competing supplements, depending on availability of funds. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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. SPECIAL REQUIREMENTS In order to be eligible, applicants must be the Principal Investigator or project director on an NIH, CDC, or Department of Transportation Trauma Centers “parent” research grant or training grant with appropriate infrastructure and interest related to trauma and injury topics, as outlined in the Research Training Objectives Section, with at least 18 months of active research support remaining at the time of application. NIH- or CDC-sponsored research project grants (R series) or center grants, program project grants or cooperative agreements (P and U series) from one of the co-sponsoring NIH Institutes or Centers or from the CDC qualify as “parent” research grants. Equivalent research or related institutional research training grants from NIH, CDC or other sources may qualify as “parent” research grants if approved by the FIC program officer before submission of the application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. The applicant training institution must demonstrate either an ongoing collaborative research relationship or high potential for development of collaborative research with the human trauma and injury researcher named as the primary foreign collaborator from a single foreign institution. The foreign collaborators should be from Africa, Russia and Eastern Europe, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Island region (except Australia and New Zealand), the Middle East (except Israel), Latin America and the Caribbean. The primary foreign collaborator must either hold a full-time faculty research position or should have a full-time faculty position with a strong research commitment. The individual may be based at a public or private university, health professional school (including school of public health, dental school, nursing school or medical school) or research institution that will allow him or her adequate time and provide appropriate facilities and resources to participate in the proposed human trauma and injury research training program. Training in the Ethical, Legal and Social Implications of Injury Research: Applicants should address specifics related to training in the ethical, legal and social implications of trauma and injury research. Training in Responsible Conduct of Research: Applicants must include plans for training in responsible conduct of research for long-term trainees and short-term trainees. An award will not be made unless a description of such training is included. The description should include the topics, format, faculty participation, instructional materials and the frequency and duration of the training provided. Recruitment and Selection Plan: The applicant institution must include a detailed plan describing the recruitment criteria and selection procedures for trainees and what criteria will be used to demonstrate that trainees will be reintegrated into their institution of origin upon return. Degree candidates must meet all entrance requirements of the grantee degree-granting institution. If applicable, proposals should describe the mechanism for internal peer review of re-entry funding applications by a committee composed of grantee and developing country investigators from participating institution(s) to support human trauma and injury research projects at the developing country institution relevant to an injury-related health problem in that country to be conducted by returning trainees. Trainee Tracking System: Applicants should describe their plans to track their trainees with respect to the short- and long-term impact of both human trauma and injury training and training in the ethical, legal and social implications related to trauma and injury research studies on their trainees. Awardees will be required to track and document the long-term impact of this training program on: (1) the careers of all trainees; (2) the research capacity at the collaborating developing country institution from which the trainees originated in the developing world; (3) positions trainees assume upon completion of training; (4) the contributions of trainees to future international human trauma and injury research and intervention trial efforts supported either by NIH, CDC, or by other granting institutions. Examples of training impact might include data on (1) how training may have enabled participants to assume more responsible positions upon returning home, (2) how collaborations with former trainees resulted in the funding of human trauma, traumatic stress, and injury intervention trials or (3) collaborative research projects on which trainees were either PIs or co-investigators, or (4) research publications authored or co-authored by trainees supported by this program and (5) the impact of current and former trainees and training-related research supported under this PA on trauma and injury public health programs and policies in the foreign country. The evaluation and impact of training resulting from each program will be considered an important criterion during this PA. The Fogarty International Center is developing a centralized trainee tracking system and awardees will be required to submit the above data to this system when it becomes live. Research Involving Human Subjects: Applicants must inform the FIC program staff that approval of research protocols involving human subjects has been obtained from U.S. and developing country ethics review committees registered under Institutional assurances with the Office of Human Research Protection, as well as foreign government agencies’ clearances, before research involving human subjects is initiated. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Aron Primack, M.D., M.A. Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 Fax: (301) 402-0779 Email: primacka@mail.nih.gov o Direct your questions about peer review issues to: Hilary D. Sigmon, Ph.D., R.N. Scientific Review Administrator, RM 5216 International Collaborative Programs, AARR Division of Biologic Basis of Disease Center for Scientific Review 6701 Rockledge Drive, Rockledge 2 Bethesda, MD 20892 Telephone: 301-594-6377 Fax: 301-480-2241 Email: hilary.sigmon@nih.gov o Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Office Fogarty International Center National Institutes of Health Building 31, Room B2C29-2220 Telephone: (301) 496-1670 Fax: (301) 594-1211 Email: butrumb@mail.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 research o Name, address and telephone numbers of the Principal Investigator o Names of other key personnel o Name and address of participating institutions o Number and title of this PA 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 CSR staff to estimate the potential review workload and plan the review. Further information about this PA can be found at http://www.fic.nih.gov. The letter of intent should be sent by the date listed on the face page. The letter of intent should be sent to: Aron Primack, M.D., M.A. Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive Bethesda, MD 20892-2220 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, five signed, photocopies, and all appendix materials 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) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this PA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a selection 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 committee or board. 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 evaluate the application in order to judge the likelihood that the proposed 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 Applicants must demonstrate specific relevant research support from NIH or CDC (eligible parent grant) or another funding source that will serve as the foundation for the research training proposed. The scientific evaluation of each application will include an assessment of linkage between the proposed training and human trauma and injury research support for the PI and other co-Investigators and developing country collaborators. Evidence of support for initiating the proposed human trauma and injury research-training program from the collaborating developing country institution and country must be submitted with the application. The application does not need to be strong in all categories to be judged likely to have a major scientific or public health 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. The need for the specific human trauma and injury research training proposed to fill the identified gaps in human trauma and injury research expertise at the collaborating developing country institution. 2. The expected public health and scientific contributions related to the proposed human trauma and injury research training to address major health issues in the collaborating developing country. 3. The potential to achieve independent and sustainable trauma and injury research capacity at the developing country institution through the proposed training efforts. APPROACH 1. The clarity and feasibility of the research training objectives. 2. Adequacy of the research training plan to achieve the proposed research training objectives including: o A trainee recruiting, application and selection process that captures the most qualified individuals with the appropriate variety of professional backgrounds from the developing country who could most benefit from the training proposed (the proposed qualifications of potential candidates should be well described in terms of academic status and previous accomplishments and experience); o The process for determining appropriate trainee skill development plans, research project participation and mentorship; o For proposed long-term research training, the adequacy of the training opportunities to provide a breadth of knowledge in either academic-based or other studies including the legal, ethical and social implications of human trauma and injury research, while providing human trauma and injury research training to fill recognized gaps in expertise at the collaborating developing country institution; o If short courses or non-degree training are proposed, the adequacy of the mixture of long- and short-term training opportunities within the program as a means to achieve the overall objectives stated; o Appropriate assessment and enhancement of background skills through training in research-related areas such as those related to research safety, technical writing, statistical methods, good clinical practice, medical informatics, English as a second language (if necessary), etc; o Process for periodic evaluation of short- and long-term trainee progress and mentoring activities; o Methods to monitor the long-term impact of the human trauma and injury research training experience on the subsequent careers of the trainees and on the capacity for human trauma and injury research in the collaborating developing country; and o Plans to include an adequate representation of women and ethnic minorities in the collaborating developing country among the developing country trainees. INNOVATION 1. Innovation in strategies for trainees to become actively involved in human trauma and injury research, clinical or public health research, development of ethical, legal and social guidelines and procedures for conducting human trauma and injury research or intervention trials conducted at the developing country institution. 2. Innovation in training strategies to produce a critical mass of independent human trauma and injury researchers and build a sustainable human trauma and injury research training environment at the developing country collaborating institution during the course of the program. 3. Creativity of plans to use modern information technology training to facilitate trainee access to electronic information resources, distance learning and collaborative interaction. INVESTIGATORS 1. Qualifications of the program director to lead and other faculty from the grantee and the collaborating developing country institution to participate as mentors in the proposed research training program. (The human trauma and injury research experience and training accomplishments should be included in addition to Biographical Sketches and Other Support forms for each faculty participant.) 2. Qualifications of the program director or other faculty to provide research training and, if proposed, mentorship in research on the ethical, legal and social implications of performing human trauma and injury research in developing countries. 3. Adequacy of the ongoing collaboration between the grantee and developing country investigators and their institutions to provide a suitable framework in which the proposed training will occur. 4. Commitment to building a long-term partnership with the developing country institutions to develop a sustainable trauma and injury research capacity. ENVIRONMENT 1. The adequacy of the teaching and research facilities and other resources and the overall training environment at the grantee and developing country institutions. 2. The grantee and developing country institutional commitments to international human trauma and injury research and training in the ethical, legal and social implications related to the trauma and injury research. (Letters of commitment from appropriate institutional officials must be included in the application.) 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: o The reasonableness of the proposed budget and duration in relation to the proposed research training program. o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research involving human subjects. Plans for the recruitment and retention of subjects will also be evaluated. o The adequacy of the proposed protection for participants, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o The extent to which proposed training programs support and complement FIC and other NIH and CDC international human trauma and injury research efforts o The availability of funds o Program balance among critical research and public health training areas of emphasis, including the scientific interests of the co-funding NIH and CDC partners in this program o The geographic distribution among countries included in applications under consideration, including the strength of the rationale for a given program to be carried out in a specific country 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 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: Starting with the October 1, 2003 receipt date, 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. 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. 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). 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 PA 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 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b) 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 (also cite other relevant policies) 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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