EXPIRED
RESEARCH ON CHILDREN EXPOSED TO VIOLENCE RELEASE DATE: April 7, 2003 PA NUMBER: PAR-03-096 EXPIRATION DATE: June 25, 2005, unless reissued National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) Fogarty International Center (FIC) (http://www.fic.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) Children's Bureau, Administration on Children, Youth, and Families, Administration for Children and Families (CB) (http://www.acf.dhhs.gov/programs/cb/) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/) Office of Special Education Programs, Department of Education (OSEP) (http://www.ed.gov/offices/OSERS/OSEP/) Substance Abuse and Mental Health Services Administration (SAMSHA) (http://www.samhsa.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.989 (FIC), 93.273 (NIAAA), 93.865 (NICHD), 93.279 (NIDA), 93.853 (NINDS), 93.670 (ACYF), 93.283 (CDC), 93.230 (SAMHSA), 84.329 (OSEP-ED) APPLICATION RECEIPT DATES: June 25, 2003, June 25, 2004, and June 24, 2005. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The above sponsoring Institutes and Agencies invite research grant applications in response to this Program Announcement with Set-aside (PAS) that will enhance our understanding of children exposed to domestic violence, community violence, and war/terrorism. This PA is designed to develop new knowledge in these areas and in the definition, identification, epidemiology, prevention, etiology, effects, early intervention, and mechanisms of violence exposure. This PA builds on recommendations from a recent multi-agency research agenda-building workshop held in Washington, DC in July 2002. A complete summary of the meeting presentations and recommendations is available at http://www.nichd.nih.gov/crmc/cdb/cdb.htm. Child exposure to violence is a serious public health, justice, social services, and education problem. Such exposure not only compromises the immediate health of children around the world, but also affects their growth and intellectual development, their long-term physical and mental health outcomes, their propensity for prosocial or antisocial behavior and substance abuse, their future relationships with partners and children, and their economic productivity as eventual wage earners. The need for more systematic and multi-disciplinary research in these areas provides the impetus for this PA. Although not participating in this program announcement, the National Institute of Mental Health (NIMH) shares an interest in this area of research. For specific information on NIMH interests, see http://www.nimh.nih.gov/grants/nimhviotrauma.cfm. RESEARCH OBJECTIVES Background While it is difficult to make any absolute statement about the numbers of children exposed to violence in their homes, schools, and communities, child exposure to violence is an internationally recognized public health problem. Several surveys in the United States have indicated that some form of marital aggression (verbal or physical aggression) occurs in as many as 12 percent of American households, with severe violence occurring in between less than one percent and four percent of households. These same surveys suggest that children under the age of 12 reside in approximately 50 percent of these households. Other research indicates that children are disproportionately present in households where there are substantiated incidents of adult female assault and that young children from birth to five years are more likely to be present in homes where domestic violence occurs. Research on community violence in the United States similarly suggests that a high number of children witness violence in their communities or schools. An estimated 60 to 90 percent of children have witnessed some form of physical violence (e.g., hitting, slapping, or punching) in their communities and approximately 13 to 45 percent have witnessed some form of weapon-related violence. Additionally, estimates suggest that between one and 47 percent of children have witnessed a murder. While few good data exist about the numbers of children exposed to civil strife/war/terrorism, international estimates suggest that in the past decade two million children have been killed in war- related injuries, four million have been disabled, one million have been orphaned, and 12 million have been dislocated from their homes. Research has suggested that child exposure to violence can take many forms ranging from indirect exposure (e.g., hearing about an event) to direct exposure (e.g., being an eyewitness to an event) and actual involvement or victimization (e.g., being coerced or injured). In addition, studies have identified a number of characteristics of violent events, including the type of violence, the specific acts, severity, resolution to the violence, perpetrator, frequency, child age at the time of exposure, intensity, proximity, and duration, that appear important in understanding the effects of exposure to violence on individual development. Research has also documented the short- and long-term detrimental effects of exposure to violence in children, adolescents, and adults. For the child witness to violence, exposure can result in immediate physical trauma (e.g., injuries and alterations in physiological arousal) and psychological trauma (e.g., post-traumatic stress symptoms) and contribute to chronic physical (e.g., sleep and eating disturbances, disease, and illnesses), developmental (disturbances or delays in social, cognitive, affective, and language development), neurological (e.g., changes in the central nervous system), emotional (e.g., depression, anxiety, and hostility) and behavioral (e.g., aggression and antisocial behavior, alcohol and drug abuse, dating violence, social withdrawal and suicide attempts) problems. Children exposed to violence are vulnerable to life-long disturbances in self-esteem, trust, and emotion regulation, as well as difficulties in relationships with others. Moreover, exposure to violence can lead to a variety of educational and juvenile justice outcomes such as lower grades, IQ, and reading ability, and an increased risk for juvenile offenses and serious criminal behavior. In communities that experience high levels of crime and violence, the effects may be as devastating as the effects of war or acts of terrorism. Frequently, children witness these acts of violence. Research suggests that drug use or drug dealing often can have a direct or indirect influence on violent crime involving young people. The long-term effects of these occurrences are unknown and remain to be studied. Research also is beginning to identify a number of mediating and moderating factors that can either ameliorate or exacerbate the consequences of violence exposure, such as characteristics of the child's experiences (e.g., nature, frequency, and severity of violence exposure, and prior history of trauma and violence exposure), the child's resources and vulnerabilities (e.g., temperament, intelligence, developmental stage, social competence, and coping strategies), and social support both within and outside the family. Despite the public health significance of child exposure to violence, progress has been slow in developing a scientific understanding of the incidence, prevalence, nature, and consequences of exposure to violence and in measuring the efficacy of interventions to prevent or reduce the effects of violence exposure on child development. In addition, research in this area has been hampered by a number of methodological issues and constraints including sampling and recruitment difficulties, ethical and reporting considerations, co-occurrence of multiple types of violence exposure and victimization experiences, and a failure to account for other family background or risk variables. Since these shortcomings remain, this PAS is intended to encourage research on the incidence, prevalence, nature, and consequences of child exposure to violence, as well as on interventions (including social service, legal, and policy interventions) designed to prevent or ameliorate the short- and long-term effects of violence exposure on child development. Research Goals and Topics Studies responsive to this PAS should focus on children exposed to domestic violence, community or school violence, or civil strife/war/terrorism in the United States and, or in comparison with, other countries. Examples of research areas responsive to this announcement include, but are not limited to, the following: (1) Theory-driven research on the identification, definition, classification, and measurement of children exposed to violence, including studies of: o theoretical approaches and models of defining and classifying children's exposure to violence and violent experiences; o measurement tools and instruments designed to measure characteristics of violent experiences and exposure to violence, children's definitions and perceptions of violence, or the effects of exposure to violence on children of different ages and developmental levels; o verification and modification of tools and instruments in cross-cultural contexts; o the nature of violence exposure including the range of intensity of violence exposure (e.g., verbal aggression through homicide); the range of behaviors involved (e.g., psychological control, threat of violence); the timing and patterning of exposure (e.g., age of onset, frequency of exposure, single versus multiple episodes, coincidence with important developmental transitions); the severity of exposure; and the child's degree of involvement (e.g., type of sensory input, such as directly seeing or hearing from another room, and the child's reaction such as attempts to intervene); o the co-occurrence of different types of exposure to violence (e.g., domestic and community); the co-occurrence of violence exposure with other types of violence (e.g., child abuse, sibling abuse); the co-occurrence of violence exposure with other risk factors (e.g., poverty, parental substance abuse or displacement from the home); o the differences between witnessing violence (domestic, community or school, and war/terrorism) and actual violence victimization (e.g., child abuse, or being the victim of gang or school violence); differences between exposure to war, civil strife, and terrorism; o community, cultural, and individual definitions and perceptions of violence as well as definitions of and perceptions of victims and perpetrators; o children's definitions and perceptions of violence, neighborhoods, and communities, as influenced by gender, age, and developmental level; o racial, national, ethnic, and cultural differences in defining and classifying violence and violence exposure. (2) Research on the epidemiology of children exposed to violence, including studies of: o the incidence and prevalence of children exposed to domestic or community violence in the population; population-based surveillance systems; direct investigation as a means of substantiation; different reporting methods and how they influence estimates of incidence and prevalence; multiple reporters to estimate violence exposure; the reliability and validity of different reporters (e.g., children or parents); o the incidence and prevalence of exposure to school violence or violence in the media in the United States and, or in comparison with, other countries; studies of the prevalence of bullying and peer victimization in schools; o the level of violence exposure and drug use and their long-term consequences for the health status and behavior of runaway youth; o the incidence and prevalence of exposure to war or terrorism in the United States and around the world. (3) Research on the short- and long-term consequences of exposure to violence, including studies of: o the effects of exposure to violence on child physical, cognitive, social, and emotional development and socio-emotional behavior (e.g., memory and learning, moral development, peer relations, emotion regulation, attachment relationships, dating behavior, gender role attitudes, antisocial or risk- taking behavior, drug or alcohol abuse, self-esteem, social competence, delinquency, and adult criminal behavior); o the educational and functional consequences of exposure to violence (e.g., need for and access to special education and related services; characteristics of children exposed to violence in the preschool years; school readiness, school adaptation, and academic achievement of children exposed to different types of violence; and work abilities or job performance); o the impact of exposure to violence on medical and health outcomes (e.g., immune system functioning or vulnerability to infections or autoimmune disorders); o the neurobiological consequences of exposure to violence (e.g., arousal, sympathetic and parasympathetic function, functional brain activity, neuroendocrine functioning, and sleep disorders) as a function of age, gender, and duration of exposure; o the neuromaturational consequences of exposure to violence (e.g., alterations in the time course and development of the startle inhibition, attentional capacity, regulation of affect, stress reactivity, control of motor activity, executive functions, and linguistic and cognitive capacities); o the developmental consequences of chronic exposure to low levels of violence (e.g., verbal conflicts or attacks among parents) or to extreme forms of violence (e.g., homicide or suicide); consequences of chronic versus acute war/terrorism situations; o the effects of anticipatory preparedness for war, terrorism or other violent situations on individual development; o the additive or cumulative effects of exposure to multiple types of violence and/or stressors (or secondary effects of violence such as loss of a parent), as well as the independent effects of exposure to particular types of violence (e.g., domestic, community, and school violence, and war and terrorism). (4) Research on processes and mediators accounting for or influencing the effects of exposure to violence, including studies of: o psychosocial and psychobiological mechanisms by which exposure to violence results in harmful effects; the impact of violence exposure on individual development during infancy, childhood, adolescence or adulthood; processes of risk and resilience among children exposed to violence; o individual and social protective factors (e.g., relationships with teachers, family members, and other sources of social support; coping style; cognitions/attributions; temperament; and access to community resources or services), and subgroups of at-risk populations; o differences in the impact of exposure to violence depending on characteristics of the child such as age, gender, temperament, intelligence, family relationships or presence of disabilities; o the influence of family functioning on children's responses to violence exposure (i.e., the extent to which family cohesiveness, parental monitoring, and environmental influences such as neighborhood disadvantage, drug use and trafficking impact the behavior of children both positively and negatively); o biological, psychological, and socio-environmental mediating and moderating factors that affect child and adolescent responses to violence exposure (e.g., child cognitions/attributions, family organization and relationships, family interaction, relationships with extended family, parenting behaviors, parent coping, poverty, life stress, community responses, refugee or immigration status, and socioeconomic and cultural factors). (5) Research on prevention and intervention programs and services for children exposed to violence, including studies of: o children's contacts with formal (e.g., healthcare, mental health, educational, child protection, and criminal justice) and informal (e.g., relatives, neighbors, and religious and community groups) systems and consequences of these contacts for children and families; o the impact and consequences of media campaigns or educational efforts (e.g., programs designed to increase awareness of domestic violence among key sentinels such as police, medical personnel or teachers) designed to increase awareness about different types of violence or violence exposure, or about the effects of violence exposure on children o knowledge and behaviors of health care providers or other service personnel that influence early detection or evaluation of children exposed to violence; development and validation of biomarkers, indices or classificatory systems that aid health providers, teachers or other community members to recognize children exposed to violence; o the effectiveness of current shelter programs and how they influence outcomes for children and families both in the short- and long-term, including indirect consequences on family functioning, socioeconomic status, and parenting; o theory-driven prevention strategies to reduce the risk for exposure to violence (e.g., domestic or community violence) or to prevent the harmful consequences of exposure to violence on children; o parent skills training interventions for children exposed to violence, including foster parents, divorced parents with children, etc.; o early intervention as a means of preventing initiation and progression of long-term health and behavioral disorders and other problems (e.g., aggression, substance abuse, criminal behavior, sexual health-risking behaviors, and sleep or immune system problems); o interventions tailored for use in different ethnic, social, and cultural groups, or different types of communities (e.g., urban versus rural, and high or low violence); comparisons of new interventions with existing interventions/services; comparisons of different types of intervention approaches; o intervention models in various social and community settings for ameliorating the effects of violence exposure on later development; the influence of setting (e.g., shelter, child care, school, clinic, foster care), personnel, and various levels of intervention (e.g., a single versus ongoing visits) on program participation and outcomes; o studies to establish the short- and long-term efficacy of interventions for different types of violence exposure including studies of "disaster preparedness" programs, school interventions, parent education, and family interventions; o population characteristics, societal values or intervention components that may affect identification, help-seeking, or access to services; barriers to intervention availability, delivery or effectiveness as a function of social group membership or factors in the setting (e.g., shelters, foster care, special education) in which the intervention occurs; o legal processes, protective services, and health and mental health services as the means of preventing exposure to violence or ameliorating the consequences of exposure to violence on children. (6) Other topics/special issues, including studies of: o the effects of new legislation and policies designed to better protect or help victims of domestic violence and their children, including their impact on children and families and unintended consequences; o international and local gun control policies and their effects on community violence; o the effects of specific acts of terrorism (such as the attacks on September 11, 2001) on children, including the effects of direct versus indirect (e.g., through the media) exposure to such acts, the differential effects of varying degrees and types of exposure to such acts based upon age of the child, and identification of risk or protective factors that moderate the effects of exposure to such acts. Types of Research Projects Although the R01 is the mechanism of support for this PA, research projects not traditionally supported with this mechanism are also encouraged. These may include not only large-scale research grants characteristic of more mature fields of study, but also exploratory, preliminary or innovative research projects, with sound methodology and strong rationales, that provide a basis for future continuing or expanded applications. Also of interest are short-term projects, studies submitted by less experienced investigators, collaborative studies submitted by or involving investigators in a developing country, and feasibility studies testing methods, measures or techniques new to the research on children exposed to violence. MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (R01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. FUNDS AVAILABLE The co-sponsors intend to commit approximately $2.75 million total costs [Direct plus Facilities and Administrative (F and A) costs] in FY 2004 to support eight to nine new and/or competing continuation grants in response to this PAS. Because the nature and scope of the proposed research 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 ICs provide support for this program, awards pursuant to this PAS 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 any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations 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 Though reviewed by NIH, some applications will be funded in part by one or more of the federal partners listed at the beginning of this program announcement, through funds transferred to NIH. Submission of an application implies willingness for NIH to share the complete file with staff from these other federal agencies. It is anticipated that a successful grant application will address the following considerations: Annual Meetings Principal Investigators of grants resulting from this PAS will be asked to participate in annual meetings to share findings, research approaches, and core instruments or data elements. Requests for funds to support attendance at these meetings, to be held in the Washington DC area, should be included as part of the application budget request. Theoretical Framework To the extent possible, studies should be presented within a developed or developing theoretical framework. Studies should be designed to assess hypotheses derived from existing theory while allowing for the extension or modification of existing theory. Definition of the Sample and Subject Selection Criteria The samples for study must be rigorously defined to permit complete independent replication at another site. Within this context, the ascertainment/referral sources should be described in detail, including the definitions and criteria employed to identify children exposed to violence. It is expected that not all children exposed to violence will be identified according to the same definitions and criteria. Consequently, applicants should provide clearly documented and operationalized definitions of the criteria employed in the identification of children exposed to violence. Description of subjects as exposed to violence according to vague referral sources (e.g., "agency-identified" witnesses to domestic violence) is discouraged unless accompanied by the explicit identification criteria employed by the protective service agency/health care provider, etc. In addition, all study samples should be defined, to the maximum extent possible, with reference to age, gender, grade level (if appropriate), race, ethnicity, SES, geographic region, presence of disabling/handicapping conditions, socio-emotional behavioral status (e.g., antisocial behavior, delinquency, alcohol and drug use, etc.), caretaker status (if appropriate), characteristics of home/family environment, and type and nature of exposure to violence (domestic or community violence, or war/terrorism, and characteristics of the exposure such as whether the exposure is direct or indirect, and frequency, and timing of exposure), including combinations of types if present. Measurement Criteria Given the current state of defining and measuring exposure to violence, studies that use multiple methods and measures are specifically needed. Interviews, surveys, questionnaires, observational measures, standardized measures, and other assessment procedures used for the identification of exposure to violence across physical, emotional, and academic domains must be described in sufficient detail to permit independent replication. Measures with known reliability, validity, and appropriateness for the population under study should be employed when available. If reliability and validity characteristics are not yet known for a particular assessment procedure, the application should contain specific plans for establishing these features. Opportunities for Definition and Classification of Exposure to Violence A critical public health task for amelioration of the harmful effects of violence exposure on children is the development of a set of operational definitions and a classification system for different types of violence exposure appropriate for persons of differing ages and from different familial and cultural contexts. Definitional clarity and classification are necessary to develop prevention, early intervention, and treatment programs, to identify distinctions and interrelationships between types of exposure to violence, to ascertain the consequences of different types and levels of violence exposure, and to understand the relationships between different types of exposure and individual, familial, social, cultural, and geographic variables. Applicants should consider research protocols that are capable of identifying well-defined subgroups that exist within the population of children exposed to violence. Within this context, investigators may wish to cast the sampling net wide enough to ensure a representative number of children experiencing different types and/or levels of violence exposure. Secondary Data It is acceptable to propose analyses for data collected for other purposes that might yield insight on children exposed to violence. In these instances, investigators should be specific about how violence exposure is operationalized, limitations of the data, and how the analyses will be structured. Investigators should also be clear when such analyses are descriptive or designed to model a process or test a hypothesis. Feasibility Feasibility issues must be clearly addressed. Plans for implementation of interventions should include procedures for: obtaining and maintaining the necessary community relations, training and supervising staff, insuring implementation fidelity, securing ongoing access to the subject population pool, recruiting a representative sample of the target population, recruiting minorities for the staff of the research intervention, including appropriate comparison groups or conditions, and monitoring subject participation over time. Applicants are encouraged to document the commitment, support, cooperation, and nature of proposed collaboration of community agencies or other entities or settings outside the applicant organization whose support is essential for the conduct of the research. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity 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: Margaret Feerick, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6882 FAX: (301) 480-0230 Email: [email protected] o Direct your questions about peer review issues to: Karen Sirocco, Ph.D. Division of Clinical and Population Studies Center for Scientific Review 6701 Rockledge Drive, Room 3176, MSC 7848 Bethesda, MD 20892-7848 Telephone: (301) 435-0676 FAX: (301) 480-3962 Email: [email protected] o Direct your questions about financial or grants management matters to: Ms. Dianna Bailey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A07E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6978 FAX: (301) 402-0915 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on June 25, 2003, June 25, 2004, and June 24, 2005. TECHNICAL ASSISTANCE WORKSHOP: An information/technical assistance pre-application workshop addressing the scientific and administrative issues associated with this initiative will be held in April 2003, 2004, and 2005 in Bethesda, Maryland. The purpose of the workshop is to: (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of programmatic emphasis, and (3) respond to potential applicants' technical questions about application format, procedures, etc. Logistic information, including time and location, will be posted at http://www.nichd.nih.gov/PA/PAR-03-096/ PAR-03-096.htm and may be obtained from program staff listed under WHERE TO SEND INQUIRIES, above. For those who cannot attend the workshop, a written summary will be posted at that web site. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates listed above. The 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 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 Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific 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: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT- OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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