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RESEARCH ON RURAL MENTAL HEALTH AND DRUG ABUSE DISORDERS RELEASE DATE: February 12, 2004 PA NUMBER: PA-04-061 EXPIRATION DATE: February 2, 2007, unless re-issued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Supplementary Instructions 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 This program announcement replaces PA-00-082. The National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) invite grant applications for research that will ultimately lead to a reduction in the burden of mental illness and drug abuse in rural and frontier populations. The purpose of this program announcement is to stimulate research on mental health and/or drug abuse problems in rural and frontier communities that will: (1) enhance understanding of structural (including community risk and resilience factors), cultural, and individual factors that may limit the provision and utilization of prevention and treatment services in these communities; and (2) generate knowledge to improve the organization, financing, delivery, effectiveness, quality, and outcomes of mental health and drug abuse services for diverse populations in rural and frontier populations. Applications may focus exclusively on mental disorders, drug abuse disorders, or on the co-occurrence of these and related disorders. Comparison of rural and urban populations and/or comparisons between rural populations is encouraged whenever possible, but this is not a requirement. RESEARCH OBJECTIVES Background The impact of mental illness and drug abuse upon the lives of people and nations has been profoundly underestimated and under-appreciated. A 2003 report from the President’s New Freedom Commission on Mental Health (http://www.mentalhealthcommission.gov) and other reports such as, “Mental Health: A Report of the Surgeon General,”(1999) (http://www.nimh.nih.gov/research/sgreports.cfm), document the enormous public health burden of mental health and co-occurring disorders in the United States. Much of the personal and societal burden of mental and drug abuse disorders could be prevented or alleviated if people at-risk for experiencing these disorders sought and received appropriate prevention and treatment interventions. These reports note that barriers such as limited insurance coverage, scarce availability of services, and stigma must be overcome in order to achieve further progress in preventing and reducing the toll of mental and drug abuse disorders. Other barriers such as lack of community resources and distance contribute to the lack of adequate prevention approaches in many rural areas. Much scientific progress has been made in understanding, treating, and preventing mental health and drug abuse disorders, and in understanding their emotional and financial costs to families and society. A variety of well- established prevention and treatment interventions are available for the range of mental, emotional, and drug-abuse problems that occur across all ages, racial and ethnic groups, and gender. However, these interventions are not reaching many who need them. The President’s New Freedom Commission Report noted that the public health burden of mental illness and drug abuse is great. Approximately 5% to 7% of adults have a serious mental disorder in any given year, and about 5% to 9% of children have a serious emotional illness. This means that millions of individuals are afflicted each year. The annual economic cost of these illnesses is estimated at $79 billion. Approximately $63 billion of this reflects lost productivity; mortality costs are $12 billion due to premature death, and almost $4 billion are attributed to productivity losses due to incarceration and the provision of family care. In the last 15 years, mental health spending has not kept pace with general health care. In 1997, the United States spent more than $1 trillion on health care. This included $71 billion to treat mental illnesses. The public health burden of drug abuse is also great, particularly in association with HIV-risk behavior, smoking, criminal activity, lost work productivity, interrupted educational careers, family violence, and other adverse health outcomes. The most recent findings from the National Household Survey on Drug Abuse found that in 2001, more than 7% of Americans age 12 and older had used an illicit drug within the past month. Despite the fact that effective prevention and treatment interventions exist to combat the behaviors and effects of drug use and abuse, too few individuals are provided with effective interventions. For example, for many of those who do receive treatment, the care provided is often inadequate — not intensive enough, not long enough, or lacking in important supportive health and social services. While inconclusive, research evidence suggests that the prevalence and incidence of mental illness and drug abuse for adults and children are similar for rural and urban populations. Suicide rates differ in these communities, however, with rural suicide rates exceeding urban rates. Much of the personal and societal burden of these disorders could be alleviated if people experiencing one or more of them sought and received appropriate treatment. However, research has shown that major barriers deter many individuals from entering treatment. For the United States as a whole, these barriers are primarily stigma, lack of parity placed on mental health and drug abuse insurance benefits in private health care, and a fragmented system of care. An estimated 45 million Americans are without any health care coverage. For those with insurance, mental illness and drug abuse visits carry a patient co-payment of about 50%, compared to 10% to 15% for other illnesses. Stigma remains a powerful barrier to people seeking help for mental illness and drug abuse addiction, and stigma is also reflected in the public’s reluctance to pay for treatments, particularly through insurance premiums or taxes. Nearly 60 million Americans living in rural and frontier communities face additional barriers to receiving effective prevention and treatment services for mental health and drug abuse problems. Access to and availability of mental health and drug abuse specialists, such as psychiatrists, psychologists, and social workers appear to be seriously lacking. Poverty, geographic isolation, and cultural differences further limit the amount and quality of mental health care and drug abuse prevention and treatment services available to individuals in rural and frontier areas. This means that rural residents often enter care later in the course of their illness than their urban peers, enter care with more serious symptoms, and require more intensive and expensive treatment. Moreover, the cost of services —especially prescription medications- may be too high for many rural (as well as urban) Americans. The President’s 2003 report suggests, “Affordable and accessible transportation services may be unavailable, especially to rural children, the disabled, and the elderly.” And, “rural residents have longer periods without insurance coverage that their urban peers, and they are less likely to seek services when they cannot pay.” Questions also arise about whether available providers are adequately trained to deliver culturally sensitive care to different groups living in these communities. Primary care physicians are often the only providers of mental health and drug abuse services in rural communities, and many of them have not been trained and/or do not have the time to adequately treat these illnesses. Recent changes in the health care system (including managed care) that emphasize cost containment could further imperil access to mental health and drug abuse prevention and treatment services for people in rural and frontier areas. There is concern that, in the effort to trim health care costs, rural services could suffer disproportionately. There is a continuing need for studies to assess and monitor the availability, accessibility, quality and outcomes of mental health and drug abuse services for individuals in rural and frontier areas. Areas of Research Opportunities The following list of potential research topics is illustrative, not exhaustive. Researchers responding to this program announcement are invited to identify additional areas of inquiry that, when explored, will lead to the enhancement of the delivery of mental health and drug abuse prevention and treatment services to diverse rural and frontier populations. Moreover, given that many health care needs are developmentally-based, gender-based, and culturally/technically-based, and given the growing body of research indicating developmental, gender, and ethnic differences in the developmental trajectories of mental health and drug abuse problems, researchers are encouraged to take developmentally-based, gender-based, and culturally-based approaches in designing their research and proposing hypotheses. 1) Methodology Several methodological issues challenge researchers seeking to study the provision of health services in rural and frontier communities. Although rural typologies have been devised to guide researchers and policy makers, they often fail to capture the relationship between (rural/frontier) population characteristics that are relevant to mental health service and drug abuse treatment outcomes. Statistical definitions, for example, have been used for implementing public policy, but the term “rural,” operationalized by these definitions, is only a proxy variable for identifying differences in availability, access, need, and use of services. When current definitions are used to design and assess mental health and drug abuse services, it is impossible to differentiate why a particular intervention is effective in one “rural” community and not another. Rural and frontier studies also often encounter difficulty in obtaining a sufficient sample size and thus lack the power to allow “community” to be utilized as an explanatory variable. Investigators are encouraged to consider promising methodologies that would include: multi-level studies that would represent individuals within communities and communities within regions or geographic entities; multivariate analysis, including structural equations modeling; and state-of-the-art methods for analyzing small samples as well as longitudinal data. Investigators are encouraged to identify or develop and test: o New rural typologies that capture the relationship between (rural/frontier) population characteristics that are relevant to mental health service and drug abuse treatment outcomes. o New definitions of “rural” that include various ecocultural characteristics operationalizing the “cost of space” for rural populations under investigation. “Ecology” might include the resources and constraints of a community, including level and rate of economic development, dependability and consistency of economic resources; service use, social support and social networks, and factors that promote risk and resilience for individuals and families. “Culture” might include the beliefs and values that influence community decisions and demographics including racial/ethnic diversity. o Analytic strategies for overcoming the problems posed by small sample sizes. 2) Epidemiology Analyses of rural and frontier populations are needed to enhance the knowledge base about the prevalence of mental/drug abuse disorders and access to mental health/drug abuse prevention and treatment services in children and older adults. Results from available studies suggest that there is no difference in the prevalence of psychiatric disorders between metropolitan and non-metropolitan adults; however these results may be outdated due to demographic changes in rural areas and how rural is defined and measured. Existing studies also shed little light on intra-rural differences in the prevalence of psychiatric and drug abuse disorders. Similarly, little is known about differences in these disorders among rural and urban children. Thus, investigators are encouraged to: o Conduct meta-analyses of the epidemiology of mental health and drug abuse disorders in rural areas, using existing databases to inform the development of a typology that identifies rural communities at high risk of disorder/under utilization of services. It may be useful to supplement selected existing databases with community-level variables to examine social and economic predictors of intra-rural variation. o Analyze the factors associated with both the risk and resilience of families and individuals in diverse communities. o Build on the identification of high-risk areas nationwide through regional epidemiological studies of prevalence, service capacity, use of care, etc., to inform policy decisions about service provision to high-risk rural communities. o Exploration of behavioral epidemiology of factors associated with adverse mental and physical health outcomes, including substance use, HIV/STD risk behavior, and treatment adherence. o Conduct social network analyses in rural settings that enhance prevention of HIV/STD transmission, particularly among isolated communities with low HIV/STD risk perceptions. 3) Demand and Need for Care Research is needed to identify factors that predict why some individuals recognize and accept the need for mental health care and/or drug abuse treatment and enter appropriate treatment. Metropolitan and non-metropolitan persons with psychiatric and drug abuse disorders have been reported as having comparable entry rates into care, though both populations have relatively low rates of entry into care. Some investigators have reported that rural residents are less likely than urban individuals to enter care, but these findings are difficult to interpret because they do not control for need. There is evidence that individuals in rural communities are more likely than their urban counterparts to use primary care providers, particularly if they are poor, a member of racial and ethnic groups, children, the elderly, individuals with substance abuse problems, or the severely mentally ill. Investigators are encouraged to: o Analyze how the following factors impact perceived access, need, and demand for care by rural at-risk individuals in high-risk communities: stigma, perceived service availability, accessibility, affordability, perceived communication, and cultural sensitivity of providers and social networks. o Test the effectiveness of interventions designed to heighten awareness of need for care, and the effectiveness of evidenced-based treatment, such as direct marketing and social network interventions. o Design research to study mechanisms that enhance and impede the dissemination and translation of research findings on mental health and drug abuse services into rural communities. o Analyze how health interventions designed for, and shown efficacious in, urban settings address the prevention needs of rural and small city populations. o Incorporate risk screening and prevention counseling into routine clinical care, STD clinics, substance abuse treatment, prenatal care or other medical settings, and study the feasibility, utilization, efficacy, and effectiveness of these health promotion interventions for rural populations. 4) Socio-cultural Beliefs About Mental Illness and Disparities in Use of Mental Health Services Rural and frontier communities are no longer viewed as being homogeneous, as more individuals from various racial and ethnic groups migrate to rural communities. Addressing these demographic changes is crucial to the delivery of effective health care. Research evidence suggests that cultural beliefs and values may shape one’s definitions of mental illness and drug abuse and influence one’s decision to seek formal or informal care and complete care. For example, studies have found that depressed and suicidal farmers are often reluctant to seek help because of their strongly-held values of self-reliance and concerns about confidentiality. Other studies suggest that members of ethnic and racial groups often may not seek care for mental illness or drug abuse due to distrust of outsiders, discrimination, religion, or a sense of fatalism. Investigators are encouraged to: o Study community readiness to identify and address mental health, health risk, and drug abuse problems; and care needs; and to develop appropriate responses and deliver effective interventions. o Analyze various community partnership processes required to identify mental illness, drug abuse, and related health problems and develop appropriate responses leading to the delivery of effective interventions and outcomes of care. o Analyze the socio-cultural factors that predict use of mental health and drug abuse services in rural areas, including the distribution of these factors across racial/ethnic groups. o Study the socio-cultural beliefs about mental illness, drug abuse, and treatment that influence how people of various racial and ethnic groups seek care; the cultural beliefs practitioners bring to the clinical encounter; and how these beliefs affect clients’ decisions to use or continue treatment. o Develop research to test interventions that improve the quality and outcomes of mental health services in culturally diverse populations. o Analyze factors that influence the efficacy of treatment and prevention interventions within a specific racial or ethnic group, and the adaptability of successful interventions to other racial or ethnic groups and geographical areas. o Design research to study the impact of severe psychological trauma on different subpopulations in the rural U.S., especially racial and ethnic groups, including how, if at all, trauma affects drug use and abuse, treatment seeking behavior, and retention in treatment. o Study the impact of social and community norms on the effectiveness of prevention programs that target socially sensitive health risk behaviors. o Design research to study the prevention needs of seasonal migrant populations, who may experience acute isolation, lack of access to mental health care, and considerable social, economic, and language barriers affecting mental health care utilization and public health in rural settings. 5) Access to and Quality of Care Investigators have raised questions about whether specific aspects of “rural” life contribute to differences in access to and quality of mental health care and substance abuse treatment among rural communities and between rural and urban communities. An alternative view is that larger societal and structural factors are responsible for differences in access to and quality of services in rural and frontier areas. This remains an open question, so investigators are encouraged to: o Study the extent to which successful urban and rural interventions for mental health and drug abuse problems have been implemented successfully in diverse rural and frontier communities, and how successful urban/rural interventions can be modified to work most effectively in rural and frontier settings. o Design research to analyze initiatives to improve the quality and outcomes of care for persons with co-morbid psychiatric and drug abuse disorders. o Design research to study the type, quality, accessibility, and availability of preventive interventions in rural and frontier communities. o Test the effectiveness of family, school, and community programs in addressing prevention in rural settings. o Study the extent to which “rural” or “frontier” status increases the effect of known barriers to care in these communities. For example, are the poor, elderly, children, homeless, or racial and ethnic populations in rural communities less likely to have access to treatment, or are less likely to demand, enter, and remain in care than their urban counterparts? o Compare the quality of care delivered in rural and urban communities and determine factors associated with discrepancies in quality, such as clinicians who may not be providing evidence-based care, individuals who choose not to enter care, or to a combination of other local, regional, or national factors. o Analyze the frequency of use and outcomes of alternative or nontraditional care (e.g., faith-based care) for mental disorders and drug-abuse addiction in rural communities. o Study how to maintain client confidentiality in rural service delivery and research, including: 1. Studying the most effective ways to overcome stigma as a means of helping individuals enter and remain in care until treatment is completed, 2. Analyzing the relation between organizational characteristics (structural and cultural) and the provision of confidential services to rural patients, and 3. Analyzing the relation between organizational and culture issues and the management of care-giving systems and patient utilization of services. o Study the contextual supports necessary to promote compliance with treatment regimens for severely mentally ill (SMI) and drug addicted patients, particularly when they are discharged from care centers that are a great distance from their community and when they live in communities where little or no follow-up care is available. o Define the cultural components of care needed to sustain recovery in the local community, and study interventions that deliver these components to determine their impact on subsequent hospitalization rates for rural SMI and drug addicted clients. o Study whether telecommunication technologies can be cost-effectively used to increase access toand availability of and quality care for rural SMI and drug- addicted clients. o Design research to determine if the barriers to disseminating evidence-based care models for SMI and drug-addicted clients in rural areas are related to provider, patient, community factors, or a combination of these factors. [For further discussion of this issue see: Research on Community Reintegration for People with Psychiatric Disabilities – PA-03-144]. 6) Suicide in Rural and Frontier Areas Higher rates of suicide are found in rural versus urban areas. Also, states vary by region, with Western mountain states having the highest rates of suicide in the nation. Investigators are encouraged to: o Study why rates of suicide are greatest in selected rural states and communities. o Analyze risk and protective factors that explain rural-urban and intra-rural differences in suicide rates, such as psychological and cultural issues, biological and genetic characteristics, access to care by mental health and addictions specialists, etc. o Design research to test interventions that address modifiable factors related to suicide risk. [For further discussion of this issue see: Research on the Reduction and Prevention of Suicidality – PA-03-161]. o Study the efficacy of interventions to identify and intervene with socially isolated, rural residents who experience frequent or serious suicidal ideation, particularly among those living with HIV or other health/mental health conditions that lead to increased life stress. 7) Economics of Mental Health Care and Drug Abuse Service It is important to determine the impact of different costs and financing models on service delivery in rural and frontier communities. The health care plans for mental health and drug abuse services and the service systems that provide care to rural populations differ from plans and service systems for urban populations. Rural and frontier populations are less likely to have managed care, and there is a lack of mental health and addiction specialists to provide these specialized services. Studies are sought on the economics of mental health and drug abuse services for treatment and prevention, especially for research on alternative payment systems, public and private financing systems, and the design of insurance. Investigators are encouraged to: o Study the financing of mental health and drug abuse treatment and prevention services in rural and frontier communities, including whether carve-outs differentially affect entry into care or the quality of care in rural areas. o Analyze alternative delivery systems and managed care practices in rural and frontier communities. o Conduct cost-benefit, cost-effectiveness, and cost-utility analyses to examine the costs and production of mental health and drug abuse treatment and prevention services. [More information on NIDA’s program of research on the economics of drug abuse prevention or treatment is available in PA-01-013.] o Compare managed health care plans and services for mental health and drug abuse problems in rural versus urban areas. o Analyze how, if at all, rural/urban differences in credentialing, selective contracting, and risk sharing, moderate the impact of managed health care services for mental health and drug abuse problems. 8) Use of Technological Innovations In the Diagnosis and Delivery of Care Rural advocates suggest that the use of telecommunications technology may offer an opportunity to overcome many barriers to service delivery and to enhance the quality of care provided to underserved rural and frontier populations. However, until there is evidence that services can be effectively delivered via telemedicine, third party payers are unlikely to reimburse for such services. Investigators are encouraged to: o Study the extent to which telecommunications are used in the delivery of mental health care and drug abuse treatment in rural and frontier communities, and study barriers that exist to implementing this technology. o Study whether individuals with various mental/drug abuse disorders can be effectively diagnosed and treated via telemedicine. o Design research to study whether certain mental and drug abuse disorders are more amenable to effective diagnosis and treatment face-to-face versus long distance, including whether the type of or severity of mental disorders or drug abuse problems influences the effectiveness of long distance treatment. 9) Primary Care and Mental Health/Drug Abuse Services Up to 80% of the mental health care in rural communities is delivered by primary care physicians, social workers, and psychiatric nurses. Availability of and access to mental health and drug addiction specialists remains a serious problem in many places. Several questions have been raised about the effects of provider distribution on the quality and outcomes of care. Studies of primary care providers and mental health/drug abuse treatment are needed to understand several issues. Thus, investigators are encouraged to: o Study whether rural primary care providers are adequately trained to deliver high quality and effective mental health care and drug abuse treatment services to a range of client populations. Can primary care providers be trained to use mental health and drug addiction guidelines for treating various disorders? o Study whether primary care providers are adequately trained to deliver culturally appropriate care to the increasing number of minority groups moving to rural areas. o Study what non-mental health and non-addictions specialists in rural communities can do to increase effective diagnosis and treatment of individuals with mental disorders and drug abuse problems. 10) Juvenile and Adult Justice and Mental Health/Drug Abuse Care Rural communities are often called upon to respond to mental health and substance needs of offenders identified through the criminal justice system. In addition to managing the mental health and substance abuse issues of offenders initially entering the juvenile and adult criminal justice systems, rural areas increasingly need to address the treatment and service needs of offenders returning to their communities following incarceration. Studies are needed to identify, develop, and test other more effective therapeutic strategies for responding to persons in the justice sytem with mental illness and drug addiction problems who live in these remote areas. Investigators are encouraged to: o Conduct research to understand the mental health/drug abuse treatment currently being delivered to mentally ill/substance abusing offenders in rural communities, and how this treatment is linked or coordinated with criminal justice requirements. o Design research to study how rural organizations or agencies dealing with mentally ill/substance abusers can improve their interactions to achieve better public health, public safety, and individual outcomes. o Analyze the role the criminal justice system plays in the delivery and financing of mental health/drug abuse services in rural areas. MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01), small grant (R03), and exploratory/developmental grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The objective of the R01 is to support a discrete, specified project. The objective of the R21 is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of how to more effectively deliver high quality services to underserved rural and frontier populations. Exploratory/developmental grants (R21) are limited to 2 years of support with a combined budget for direct costs of up to $275,000 for the two-year period. Normally, no more that $200,000 may be requested in any single year. Information on the Exploratory/Development (R21) grant is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Information on the Small Grant (R03) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html Investigators might also want to consider relevant Institute-specific mechanisms, such as the NIMH R34 mechanism for exploratory interventions and services research grants “From Intervention Development to Services: Exploratory Research Grants”, PAR-03-078, which is located at http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html. Competing supplements to existing descriptive studies of risk and resilience factors in rural areas can also be used. Secondary analyses of existing data have been successfully used to determine the incidence and prevalence of disorders in rural versus urban areas. This PA uses just-in-time concepts. It also uses the modular budgeting format. (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 budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit institution 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 institutions/organizations 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. WHERE TO SEND YOUR INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Anthony Pollitt, Ph.D. Office of Rural Mental Health Research National Institute of Mental Health 6001 Executive Boulevard, Room 7130 Bethesda, MD 20852 Telephone: (301) 443-4525 FAX: (301) 443-4045 Email: apollitt@mail.nih.gov Beverly Pringle, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4222 Bethesda, MD 20892 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: bpringle@mail.nih.gov Carmen Moten, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7146 Bethesda, MD 20892 Telephone: (301) 443-3725 FAX: (301) 443-4045 Email: cmoten@mail.nih.gov Andrew Forsyth, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6201 Bethesda, MD 20892 Telephone: (301) 443-8403 FAX: (301) 443-9719 Email: aforsyth@mail.nih.gov o Direct your questions about financial or grants management matters to: Joy R Knipple Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115 Bethesda, MD 20892 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: knipplej@mail.nih.gov Catherine Mills Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: cm108w@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B;) Data Universal Numbering System 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 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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 applications kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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 person staff at least 6 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 checklist, and five 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) APPLICATIONS PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 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 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 written critique o Receive a second level review by the appropriate national advisory council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive the field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plane 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 REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data-sharing plan in their application. The reasonableness of the data sharing plan or the rationale for reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. 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. 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 Safety and 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 more than $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 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 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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