PA-03-161: RESEARCH ON THE REDUCTION AND PREVENTION OF SUICIDALITY

Department of Health
and Human Services (HHS)

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RESEARCH ON THE REDUCTION AND PREVENTION OF SUICIDALITY RELEASE DATE: August 7, 2003 PA NUMBER: PA-03-161 Updates: June 2, 2006 - The R01 portion of this PA has been reissued as PA-06-438 as of June 2, 2006. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R03, R21 and R34 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03, R21 and R34 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: June 2, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279, 93.891, 93.866, 93.393 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 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 National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), National Cancer Institute, and the National Institute on Aging invite grant applications for research that will reduce the burden of suicidality (deaths, attempts, and ideation). While NIMH has a long-standing commitment to studying the mental health-related factors contributing to suicide risk, NIDA, NIAAA, NCI, and NIA supported research in suicidality is growing and has provided a broader perspective on the range of risk and protective factors. For this PA, mental disorders, along with alcohol use disorders (AUDs) and substance use disorders (SUDs) and their respective trajectories, are of particular interest as they pertain to risk and protective factors and treatment efficacy and effectiveness for suicidality. The intent of the program announcement is to intensify investigator-initiated research on this topic, to attract new investigators to the field, and increase interdisciplinary approaches to developing effective strategies to reduce suicidality. RESEARCH OBJECTIVES Background In 2000, 29,350 persons died by suicide in the United States. Suicide deaths outnumbered homicide deaths by 5 to 3. Suicide was the third leading cause of death for 10-24 year olds, and the eighth leading cause of death for males. Vital statistics indicate that suicide rates vary dramatically by demographic characteristics. Males die by suicide more frequently than females by a ratio of 4 to 1. Older white males have the highest suicide rate, followed by young American Indian and Native Alaska males. In contrast, older African American females have one of the lowest rates. Married persons have lower rates than unmarried persons. Rural suicide rates exceed those in urban areas, and state rates vary by region, with Western mountain states having the highest suicide rates in the Nation. The health conditions most consistently associated with suicide are mental illness, SUDs and AUDs, affecting up to 90% of all people who die by suicide. The lifetime risk for suicide death among alcohol-dependent individuals has been estimated to be 7 to 10%, and among persons with affective disorders, 2 to 7%. Family history of suicide, an individual's prior history of suicide attempts and serious ideation are also significantly associated with subsequent suicide death. Despite these strong associations, only a small proportion of persons with these disorders and family history die by suicide, raising important questions regarding what protective factors operate among persons with multiple risk factors. Most medical illnesses are not associated with an increased risk for suicide. However, individuals diagnosed with HIV/AIDS, multiple sclerosis, brain cancers have been found to have increased risk for suicide. Patients with cancers who also have depression, unrelieved pain, and deteriorating functional ability, have been reported to have higher rates of suicide ideation. Suicide attempts and serious suicide ideation (e.g., thoughts that include suicide plans), each more frequent than suicide deaths, also carry a substantial health burden. For the year 2000, estimates of the number of persons treated annually for self-inflicted injuries, most of which are suicide attempts, range from 264,000 to 864,000. Another estimated 50 percent of persons who attempt suicide do not seek treatment. In addition to the burden from physical harm consequent to the behavior, suicide attempts are associated with an increase in the risk of later suicide death by 40-fold. Persons with mental disorders, SUDs and AUDs have increased risk for suicide attempts. Intentional overdose with drugs of abuse or prescription drugs is a common method of suicide attempt, particularly among women. Persons with AUD and a history of an attempt have a greater than 20-fold increased risk for subsequent suicide death. Among alcohol-dependent individuals, those with a history of suicide attempts are more often female, younger, currently unemployed, separated or divorced, and have fewer years of education. Serious suicide ideation is more frequent among youth than adults, and is associated with other high-risk behaviors. Annual surveys indicate that 1 in 5 high school students report suicide ideation in the past year. There have been substantial strides in our understanding of suicide risk factors, and early progress in clinical trials focused on reducing suicidal behaviors per se. Research in this area has been invigorated further by the recognition that suicidality, with its related mortality and morbidity, represents a significant, and usually preventable loss of human life. A number of recent federal, national and international reports have proposed a public health framework from which to develop strategies to reduce known risk factors and increase protective factors. The reports include those from the World Health Organization (http://www5.who.int/violence_injury_prevention/main.cfm?p=0000000117), the National Strategy for Suicide Prevention (http://www.mentalhealth.org/suicideprevention/default.asp), a recent IOM report (http://www.nap.edu/books/0309083214/html/), and various Surgeon General's Reports on suicide (http://www.surgeongeneral.gov/library/calltoaction/default.htm) and mental health (http://www.surgeongeneral.gov/library/mentalhealth/home.html and http://www.surgeongeneral.gov/library/mentalhealth/cre/). This program announcement highlights areas of research that can facilitate the development, implementation, and/or testing of interventions that show promise of preventing and reducing suicidality. Areas of Research Opportunities Investigators are advised to carefully consider definitions of suicidality (see O'Carroll, et al. (1996), Beyond the Tower of Babel: A Nomenclature for Suicidology, Suicide & Life-Threatening Behavior, 26 (3), 237-252) and approaches to measurement (see http://www.nimh.nih.gov/research/measures.pdf and http://www.nimh.nih.gov/research/adultsuicide.pdf), theoretical models of distal and proximal risk and protective factors, and models of behavioral and social change that have implications for reducing suicide risk. a. Risk and Protective Factors Psychological and Cultural Factors. Much has been learned about suicidality and associated psychological risk factors including hopelessness, shame, and the significance of stressful life events such as physical, psychological and sexual abuse, and interpersonal and financial losses. Less understood are other risk and protective factors and their interactions, such as: o Individually perceived protective factors (e.g., reasons for living) in the context of known risk factors, such as a history of sexual abuse, or a severe and recurring mental disorder, AUD and SUD o Trait or state dimensions, such as impulsivity or impaired executive functioning, that increase risk o The role of cultural factors and acculturative processes that can modify risk and its perception as well as influencing protective factors (e.g., religiousity) o The effects on trajectories of comorbid mental disorders, SUDs and AUDs and how those interface with suicidality Biological and Genetic Factors. Various serotonin receptor and noradrenergic system abnormalities have been linked to suicide death and attempts. There are estimates that the heritability of liability to suicidal behavior ranges from 30-50 percent, and this high loading is likely due to the potential contributions of multiple genes, in addition to shared family environments that include living with mental disorders and stressful life events. Research efforts to partition suicide risk to various genetic and neurotransmitter abnormalities have been limited by the short supply of characterized populations at high risk for suicide, as well as the low availability of autopsied brains of suicide victims. Studies of biological and genetic factors include: o Genetic samples from characterized populations at high risk for suicide that are reliable phenotypes (e.g., persons with suicide attempt histories) should be further studied for genetic analyses. Existing twin registries of mental disorders, SUDs and/or AUDs could be used to explore phenotypic reliability and gene/environment interactions. o Additional research to elucidate the neurobiological basis of suicide and suicidal behavior through cellular, neurochemical, and molecular studies. Examples include neuroimaging studies elucidating brain changes in treatment trials; postmortem brain analysis and human neuroimaging. o Determination of the biological and behavioral overlaps of mental disorders, AUDs and SUDs with regard to suicide risk. Do these conditions share similar neuronal circuit pathways? Do they interact in ways that cause an increase in severity of one or both conditions? o Studies using animal models to examine state/trait dimensions of impulsivity with in vivo techniques; examining developmental trajectories of animals with gene knockouts related to putative risk or protective factors b. Clinical Trials The established efficacy of most treatments for mental disorders is based on data from individuals at low risk for suicidal behavior. With the exception of the newly approved clozapine indication for reduction of suicidality among persons with schizophrenia, no psychotropic medications have been tested to determine whether they are effective in reducing suicidality in randomized trials. Almost 40% of treatment-seeking AUD patients report a history of attempting suicide. Several psychosocial and behavioral interventions targeting suicidality, provided in consort with treatments for mental disorders and SUDs, are showing promise. Sample topics include: o Improved measures of suicidality are needed to gauge the effectiveness of current treatments for mental disorders, AUDs and SUDs, and treatments under development for reducing suicidality, both in regard to immediate and long-term outcomes. Measures with cross-cultural acceptability and appropriateness are a priority. o Efforts to identify factors influencing clinical efficacy of medications using human laboratory behavioral pharmacology paradigms are needed. Prior to beginning phase 2 clinical trials, potential medications can be screened in the laboratory to determine the following: 1) the medication's impact to reduce craving and/or to diminish the negative symptoms of alcoholism; 2) likelihood of adverse events and/or suicide ideation, especially in the presence of SSRIs and alcohol; 3) pharmacokinetics for medication combinations; and 4) optimal dosing regimens. Studies are sought which develop and expand use of these human laboratory paradigms. o Studies to identify possible interactions of medications to treat suicidality among AUD and mental illness as well as interactions with alcohol are needed to determine what is safe, effective treatment. Pharmacokinetic studies might also be appropriate. o Trials to test the efficacy of innovative treatments for persons at high risk for suicidal behavior, in combination with established treatments for persons with mental disorders, SUDS and AUDs with high suicidality risk are needed. Determining whether treatment for SUDs and AUDs, such as psychosocial and behavioral treatments (e.g., "12 step" programs), reduces suicide risk, remains to be explored. o Efforts to evaluate the efficacy of established and novel pharmacological agents for AUD and SUD patients with comorbid psychiatric disorders are needed. Appropriate combination and sequencing of pharmacological, behavioral and psychosocial therapies need to be explored for patients suffering from suicidality and two or more concurrent disorders. o Innovative trials of suicide prevention and suicide related conditions (e.g., SUD and AUD) as part of multi-faceted service delivery approaches, such as short-term hospitalization or intensive day treatment in the public or private sectors are needed. o Trials are needed to test the efficacy of treatment approaches among understudied and/or vulnerable groups that experience suicidality, who have special needs or complex symptomatology or circumstances. These include pregnant and postpartum women; ethnic minorities and immigrant groups; rural populations; incarcerated youth; older adults with physical illness; and persons with multiple comorbid disorders (e.g., PTSD, AUD, SUD, depression). o Identifying the mechanisms of action of effective interventions for persons with suicidality and associated disorders (mental illness, AUDs, SUDs) in order to facilitate the eventual dissemination of evidence-based interventions are needed. o Further development of techniques for the engagement, retention, and adherence of comorbid patients in treatment (e.g., motivational interviewing, contingency management) as they may need to be adapted to address specific patterns of comorbidity and suicidality. c. Multi-level Prevention Approaches The IOM report, Reducing Suicide, highlighted the particular challenges in assessing population-based prevention approaches due to the relatively low base rate of suicide deaths, and the limited prevalence data on suicide attempts and ideations. However, it also highlighted the opportunities to examine whether the substantial number of preventive interventions that have proved successful in reducing early substance use, drinking and driving, binge drinking, and aggression, also reduce suicidality. These intervention approaches are developmentally specific and wide-ranging; involving parents, extended families, health professionals, schools, worksites and employee assistance programs, and community agencies and task forces. Including suicidality outcomes in these preventive intervention investments would be an efficient means of testing the potential power of these approaches in reducing suicide risk. Similarly, suicidality prevention and treatment interventions for youth may also confer some protection from involvement with alcohol and other substances. Other preventive intervention opportunities include: o Assessing the efficiency of prevention of early comorbid patterns; For example, does prevention of anxiety reduce the risk for depression and substance use, as well as suicidality? o Community-level and policy interventions, such as those to reduce underage drinking, alcohol-related community problems and other unwanted behaviors, can be evaluated for their potential effects on suicidality. Examples include evaluations of efforts to reduce commercial availability of alcohol to youth under age 21, increased enforcement of driving under the influence (DUI) laws, changes in laws and enforcement regarding antisocial behavior, and public education efforts to improve health and safety. o Some policy changes may occur that are not necessarily instituted for the purpose of reducing population risk, but may have unanticipated effects relevant to suicide. These policies may provide opportunities to conduct "natural experiment" studies. Such research may involve prospective longitudinal studies of intervention and control sites, comparisons across communities, or use of archival data. o Where risk of suicide is excessively high in particular communities (e.g., some American Indian tribes), it may be appropriate to approach the problem simultaneously at universal, selective, and indicated levels. Interventions could be adapted to subpopulations within the community according to their relative risk and the intensity of their interactions with vulnerable individuals (e.g., such an approach is being used to address the problem of Fetal Alcohol Syndrome [FAS] among American Indian tribes). o School-based suicide preventive interventions have included awareness training, screening, skills-building, and social support-building for students, and gatekeeper and post-intervention training for school staff, but few have been well specified or evaluated for efficacy or safety. Although a number of popular programs are assumed to be useful, the costs and benefits of such existing programs need more systematic evaluations. Refinement of existing programs, as well as tests of new theory-driven interventions, are also needed. o Prevention approaches that carefully consider cultural expectations and assumptions about suicidality when addressing both known higher risk (gay, lesbian, transgendered and bisexually active youth) and lower risk youth (African Americans) are needed to better match the needs of certain subgroups of youth, as well as avoid untoward intervention effects. d. Services Research Due to the lack of empirically-based assessment and treatment approaches to reducing suicidality, there are few practice guidelines to implement in order to improve the quality of care provided in emergency, specialty, or primary care sectors. Alternatively, there may be helpful practice policies that are not adequately implemented, while other policies may unintentionally limit efforts to provide better care. Topics include: o Tests of emergency care approaches to adequately assess, treat, and facilitate follow-up care of suicide attempters are needed. o Research within settings where high-risk populations can be found are also a priority, such as juvenile detention, unemployment offices, farm credit offices, home health care, and youth and women's shelters. Investigators are encouraged to identify emotional states or conditions most associated with suicidality, including loss of self-worth, perceived loss of desired level of functioning, hopelessness, and depression. Investigators are encouraged to draw from the behavioral science literatures on identity, self-esteem, culture, and emotion dysregulation. o Research is needed to improve the quality of: suicidality assessment, referral, treatment and management, and consequent system changes for specific settings that reach large segments of the population, such as schools, primary care, the criminal justice system, and the workplace. o Information on the effectiveness of screening for suicidality in primary care in reducing suicide risk, and information on the possible costs of such efforts, or unintended harms, is needed. o Because few males access traditional sites of care prior to suicide death, tests of acceptable outreach and referral practices through non-health care settings (e.g., unemployment offices, workplace, DWI court, agricultural loan offices) are needed. o Many states have initiated their own suicide prevention plans, most of which involve multiple sectors (education, mental health, law enforcement). There is a critical need to develop evaluation strategies to assess the safety and effectiveness of these efforts, in collaboration with suicide prevention and SUD, AUD and mental illness services advocates, and state officials. e. Contagion, Media Campaigns, and Health Education Public health approaches have used mass-media campaigns to varying success to reduce smoking, alcohol and other substance use, but few evaluation efforts have been implemented to test campaigns to reduce suicide. Evidence of suicide contagion from media coverage of youth suicide deaths has been one reason for concern in mounting broad campaigns. If the National Strategy for Suicide Prevention is to be adequately implemented, safe approaches to building awareness in the public about suicide and its risk factors must be developed. o Further research on methods of disseminating information and messages related to suicidality (e.g., stories about celebrity decedents; descriptions of types of suicide methods; descriptions of mental illness, AUD/SUD as risk factors) for various subgroups (youth at risk; parents of youth not at risk; adult men; alcohol abusers) is needed, specifically to understand the risks of untoward effects (e.g., possible suicide contagion). Research by multi-disciplinary groups (social psychology, marketing, health education) is considered essential. (See addendum to related PA-02-131, "Dissemination and Implementation Research in Mental Health," http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-009.html) o Due to the "triple stigma" around suicidality, mental illness, and AUDs and SUDs, safe and innovative education and referral efforts are needed to reach persons least likely to seek help (e.g., white males; traditionally underserved populations skeptical about mental health or SUD treatment). In addition, research on the effectiveness of alternative methods of education and referral efforts, such as faith-based or other community organizations, is needed. o Research on the inclusion of information on suicidality within ongoing dissemination efforts for related mental illnesses (e.g., depression, bipolar illness) or harm reduction campaigns for AUDs and SUDs by industry, nonprofit, and federal efforts, is encouraged. f. Ethical and Safety Issues o The study of the competency of individuals at high risk for suicidal behavior to participate in research is needed. Various approaches to addressing questionable competency (e.g., advance directives) need to be evaluated. o Potentially unique issues to suicide research, such as whether repeated assessment of suicidality increases risk, needs to be determined for various subgroups (e.g., youth) and contexts (schools, primary care) for screening and intervention research. o Development and evaluation of risk management strategies that could be incorporated into intervention trials in order to optimize the inclusion of persons at high risk for suicidality is needed. o Innovative research on the ethics and safety of mass-media public service campaigns, specifically around determining, and minimizing unintended negative consequences of these campaigns, is encouraged. Other institutes and agencies with relevant resources and related interests: The Substance Abuse and Mental Health Services Administration (SAMHSA) Office of Applied Studies supports surveys assessing prevalence of suicidality and related risk factors (see http://www.drugabusestatistics.samhsa.gov/). SAMHSA's Center for Mental Health Services supports the National Suicide Prevention Resource Center (see: http://www.sprc.org), the National Suicide Strategy Indicators project (see http://www.nsspi.org) as well as demonstration programs in the prevention and treatment of mental and substance abuse disorders, including suicide prevention. Demonstration funding opportunities can be found at http://www.samhsa.gov/. The Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control (NCIPC), focuses on addressing the need for effective, population-based prevention and intervention strategies regarding self-directed violence. NCIPC's activities fall into four categories: disseminating information about suicidal behavior and its prevention and supporting the implementation of proven programs and policies; applying scientific methods to evaluate the effectiveness of intervention and prevention programs; enhancing the knowledge base about risk and protective factors and the consequences of suicidal behavior; and continuing to improve methods for data collection in order to describe and track suicidal behaviors. The NCIPC internet site is http://www.cdc.gov/injury. The Indian Health Service (IHS) supports suicide prevention activities through consultation and technical assistance to tribes through 12 Area Offices. Additionally, IHS operates nine regional alcohol and substance abuse treatment centers for youth 12-18 years of age (see http://www.ihs.gov). Reports on the prevalence of various markers of Indian health by region, including suicide mortality, are available at http://www.ihs.gov/publicinfo/publications/index.asp. Health Resources and Services Administration supports suicide prevention activities through the Bureau of Primary Health Care, the HIV AIDS Bureau, Maternal and Child Health Bureau (MCHB), and Office of Rural Health Policy (see http://www.hrsa.gov). The MCHB provided funding for the Children's Safety Network that has developed youth suicide prevention activity inventories across various states (see http://www.childrenssafetynetwork.org/links/youthsp.asp) MECHANISMS OF SUPPORT This PA will use the NIH research project grant (R01), small grant (R03), and exploratory/developmental grant (R21, R34) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Ancillary studies to clinical trials (e.g., see http://grants.nih.gov/grants/guide/pa-files/PAR-00-095.html) and/or competing supplements to existing descriptive studies of risk and protective factors related to suicidality, can also be used. The Small Grant (R03) provides 2 years of funding with a maximum of $50,000 direct costs for each year. Instructions for the R03 application can be found at (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html). The Exploratory/Developmental Grant (R21) provides 2 years of funding with a maximum of $275,000 direct costs over the entire budget period; with no 1 year exceeding $200,000. Instructions for the R21 application may be found at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. The R34 mechanism provides up to $450,000 direct costs for 3 years with no one year exceeding $225,000 for research on 1) the development and/or pilot testing of new or adapted interventions, 2) pilot testing interventions with demonstrated efficacy in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development. Instructions for R34 applications can be found at (http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html). 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 format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Jane L. Pearson, Ph.D. Chair, Suicide Research Consortium National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-3598 FAX: (301) 594-6784 Email: jp36u@nih.gov Lynda Erinoff, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1972 FAX: (301) 480-2543 Email: le30q@nih.gov Charlene E. LeFauve, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-9401 FAX: (301) 443-8774 Email: clefauve@NIAAA.nih.gov Ann O'Mara, Ph.D., M.P.H., RN Division of Cancer Prevention National Cancer Institute 6130 Executive Boulevard, Room 2011, MSC 7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: omaraa@mail.nih.gov Sidney M. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Room 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Sidney_Stahl@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, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173r@nih.gov Catherine Mills Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: cm108w@nih.gov Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2434 Email: jsimons@niaaa.nih.gov Jane Paull Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-2184 Email: Jp97x@nih.gov Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippl@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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 application kit. 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 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 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 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 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. 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 your 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 your application's overall score, weighting them as appropriate for each application. Your 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. (1) 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 this field? (2) 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? (3) 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? (4) 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)? (5) 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). 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 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). Investigators are also referred to http://www.nimh.nih.gov/research/highrisksuicide.cfm for safety and ethical issues specific to suicidality research. 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. 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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