PA-04-075: MENTAL HEALTH CONSEQUENCES OF VIOLENCE AND TRAUMA

Department of Health
and Human Services (HHS)

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MENTAL HEALTH CONSEQUENCES OF VIOLENCE AND TRAUMA RELEASE DATE: March 12, 2004 PA NUMBER: PA-04-075 (see NOT-MH-04-005) This funding opportunity has been reissued as PA-07-312 (R01), PA-07-313 (R03), PA-07-314 (R21), PAR-07-315 (R34). All of these mechanisms now use the electronic SF424 (R&R) application. 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 R01 Non-AIDS Applications: November 2, 2006 EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 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 Through this Program Announcement (PA), the National Institute of Mental Health (NIMH) seeks to encourage investigator-initiated research to enhance scientific understanding about the etiology of psychopathology related to violence and trauma, as well as studies to develop and test effective treatments, services, and prevention strategies in this area. The NIMH mission encompasses the conduct and support of biomedical and behavioral research, as well as the translation and testing of scientifically generated information into clinical applications, interventions, and services. In the last several years, various programs of the NIH and NIMH have organized and participated in scientific meetings concerning acute reactions to trauma and risk for psychopathology, disaster mental health, mass violence (terrorism, bioterrorism), as well as exposure to domestic and community violence. This PA reaffirms the NIMH’s long-standing interest concerning mental health research on trauma and victimization and also reflects recent suggestions that have emerged from the above-mentioned scientific meetings. Emerging areas of particular interest to the NIMH concern acute reactions to trauma, risk for psychopathology, translation of basic behavioral and neuroscience findings on resiliency and risk for intervention development and testing, and strategies for effective service provision, particularly where non-specialty systems (i.e., primary care) may be required to provide mental health services. These areas incorporate research needs regarding interpersonal violence (e.g., victims/survivors of child abuse and neglect, violence against women, hate crimes); exposure to mass violence/major traumatic events (e.g., terrorism, major accidents, combat and war, refugee trauma and relocation, torture, natural and technological disaster); exposure to family, school, and community violence; violence in the media; and other types of trauma and victimization. Populations of concern include children, youth, adults, the elderly, men and women, and all racial and ethnic groups. A great deal has been learned and applied to improve the mental health of traumatically stressed persons. For instance, research on the course and expression of symptoms helped identify risk and protective factors, age-specific psychosocial and behavioral responses to traumatic stress, and new intervention strategies. Despite the growth of research on traumatic stress, predicting which traumatized individuals will go on to develop mental disorders and serious functional impairment remains a challenge. Other challenges include understanding how to maintain and enhance resilience; finding and refining effective treatments for all who suffer from often debilitating disorders; and achieving a better understanding of the most effective means of organizing, implementing, financing, and delivering mental health services, including quality and outcomes of care. The need for focused, systematic research in these areas provides the impetus for this PA. Although not participating in this program announcement, the National Institute of Child Health and Human Development (NICHD) shares an interest in this area of research. For specific information on NICHD interests, see http://grants.nih.gov/grants/guide/pa-files/PAR-03-096.html and http://www.nichd.nih.gov/crmc/cdb/p_cog.htm. RESEARCH OBJECTIVES Background The effects of experiencing traumatic stress, either as a witness or direct victim, are a major public health problem in the United States, with consequences of potentially severe psychological, behavioral, medical, and social dysfunction, including Post Traumatic Stress Disorder (PTSD) and other anxiety disorders, depression, and psychotic conditions, as well as injury and death. Gaps exist in the fundamental knowledge of psychosocial implications of traumatic stress, particularly with regard to the development of children and adolescents. It is clear that simple models about the direct effects of early exposure to trauma and adversity are incomplete. Early trauma does not equate simply and consistently to complex psychopathology. A variety of research approaches can provide needed insights into the nature, cause, and pathogenesis of posttraumatic psychopathology including: assessment and measurement research on violence exposure and its consequences, theory-guided research on risk and protective factors, studies of mediators and moderators of exposure to various and multiple forms of violence and their consequences, and basic research on cognitive processing, arousal, and memory, as well as neurobiological, neurophysiological, neuroanatomical, and functional consequences of exposure to traumatic stress. This information in turn can inform the further development of theoretically driven interventions and services, ultimately making prevention of trauma-related psychopathology a pragmatic goal. Trauma affects a large number of people. Self-report surveys suggest that millions of children are physically abused each year, and hundreds of thousands are victims of sexual abuse (National Clearinghouse on Child Abuse and Neglect Information http://nccanch.acf.hhs.gov/). School shootings in Littleton, Colorado and in other communities have caught the Nation’s attention and galvanized scientific and social concerns. While lethal violence has actually been decreasing over the last decade, levels of non-lethal violence in schools have not been decreasing and are of concern. Each year many children and adolescents sustain injuries from violence, they lose friends or family members, or they are adversely affected by witnessing a violent or catastrophic event. Annually, approximately 500,000 persons report rapes and sexual assaults. Other forms of physical assaults on women by their partners are widespread (Department of Justice http://www.usdoj.gov/). A recent review of disaster studies highlights that natural disasters, technological disasters, and mass violence, including terrorism in the U.S., other developed countries, and in developing countries, can have severe impacts on those affected (Norris, 2001). Although long-term mental health outcome data regarding the terrorist attacks of September, 2001 are not yet available, preliminary national data and early findings from studies conducted in the most directly impacted communities underscore the capacity of man-made disasters to cause clinically significant psychobiological disorders, emotional distress, and impairment. The World Health Organization report on Violence and Health (2000) underlines the heavy cost of violence and trauma in health effects, in both financial losses from injury and decreased productivity as well as psychological and behavioral problems that may extend to permanent physical and mental disability. Research Goals and Topics Several areas stand out as priorities for future research on the mental health consequences of traumatic stress. Broadly stated, needs include: basic, clinical, and genomic studies of the mental health consequences of traumatic stress and the development and testing of interventions to assist victims and survivors. Specifically, knowledge is sought regarding methods for measuring various types of exposure, the pathological sequelae of various types of traumatic events, gene- environment interactions that influence risk/susceptibility and resiliency, treatment alternatives, and preventive options. Much can be learned from research involving various types of trauma (e.g., interpersonal violence and crime, child abuse and neglect, family violence, and community violence) and from basic, pre-clinical, and clinical research (e.g., animal models of stress, as well as human studies of molecular and cellular brain function in the context of trauma). Major areas of interest for the NIMH include research assessing acute responses to trauma, risk for long-term adjustment problems, translational research to better understand early experiences, emotion regulation, and the development of stress-sensitive neurobiological systems and their relevance as targets for preventive interventions. Research in these areas will improve the ability to predict who is at greatest risk for developing mental disorders and what is the optimal time to intervene and how. Specific developmental areas that require additional exploration include defining critical aspects of exposure, taking into account cognitive, emotional, and neurobiological limitations in young children. The examination of potentially modifiable factors and processes involved in reactions to trauma, which are indicative of risk and resiliency, are also of interest to the NIMH. The events of September 11, 2001 and the ensuing national reactions to terrorism and threat of terrorist attacks highlight a significant long-term goal of developing and testing models for organizing and deploying emergency mental health response to mass trauma. Another major area of interest for the NIMH is research on the efficacy and transportability of various forms of therapy and counseling techniques. Cognitive restructuring, public education on symptoms and coping strategies, supportive counseling, and various types of exposure therapy may help reduce incidence, duration, and severity of Acute Stress Disorder, Posttraumatic Stress Disorder, and Depression in response to a variety of traumatic events. Areas ripe for exploration include approaches that seek to enhance coping and self- efficacy and teach cognitive skills for managing emotional and physiological responses. There is a need to study methods to rapidly deploy available effective interventions for large numbers of survivors/victims. Likewise, there are questions about the most appropriate time to intervene and with what type of intervention, and whether one type of intervention (or perhaps no intervention) is more appropriate immediately following the trauma. Novel collaborations among neuroscientists, behavioral scientists, and clinical scientists in order to develop integrative and cutting edge research projects are encouraged. This approach is consistent with the NIMH’s interest in translational research and the formation of cross-disciplinary groups of scientists interested in studying the etiology of trauma and stress related psychopathology and the implications for assessment and treatment. The topics listed below are additional examples of studies that fall under the scope of this program announcement. The list is not exhaustive; it is expected that investigators who respond to this program announcement will identify additional important topics. o Animal studies of the biological and behavioral effects of unpredictable and uncontrollable stress and trauma. o Prospective studies of groups of individuals who are at risk due to individual characteristics and/or occupational status, to identify risk and protective factors for developing a disorder following one or more traumatic events. o Mechanistic and descriptive studies of behavioral and biological regulation and dysregulation in humans associated with stress and trauma. o Clinical studies examining how the severity of trauma is linked to neural functioning, processing of memories, and interpretations of trauma (e.g., qualitative studies) and functional disability. o Interdisciplinary research to better understand biological and behavioral parameters important for extinction of negative imagery. o Studies of the bi-directional nature of parent-child adaptation to stress and trauma. o Studies of interactions among psychosocial, contextual, and biological risk; and protective factors that increase or decrease risk for and course of psychopathology (escalation, persistence, and cessation), including the role of social supports, community factors, cultural issues, etc. o Research on the contributions of sleep patterns, comorbid disorders including substance abuse, and pathophysiological indicators of stress and anxiety, including the failure to extinguish negative imagery. o Studies of stress responses following a trauma to determine if PTSD symptom severity, if PTSD symptom persistence, and/or if efficacy of treatment/intervention/services depends on the type of trauma and any gene- environment interactions that may take place. o Studies that examine the neurobiological and functional consequences of exposure to violence; and the brain regions/systems that are vulnerable and how these regions/systems are further affected by age, pre-trauma, trauma, and post-trauma characteristics/factors. Studies that examine alterations in attentional capacity, regulation of affect, stress reactivity, control of motor activity, executive functions, linguistic and cognitive capabilities, community and role functioning, etc. o Theory driven intervention studies that test the efficacy and refinement of individual, family, organizational, and/or community-level models; and, methods of referral and diagnosis, prevention, treatment, and services. o Longitudinal studies that examine the potential value of early interventions for trauma-exposed children and adults, for prevention of anxiety, depressive, and substance use disorders. o Research on combined therapies involving new medications and/or psychosocial therapies, and/or other rehabilitation strategies to achieve a rapid onset of clinical response, maintain symptom reduction, or maximize community integration and functioning. o Research on whether particular interventions like those involving prolonged exposure are more appropriate after a certain time period has passed since the traumatic event, and/or specific symptomatology has developed. o Pilot studies to explore combining and sequencing interventions (psychosocial and medication) over time. o Feasibility studies to assess the efficacy of novel drug candidates alone and in combination with psychosocial therapy to reduce clinical symptoms and provide prophylactic protection. o Studies of the organization, delivery, outcomes, and financing of care in nontraditional mental health settings (e.g., school, faith-based, or primary care) and systems that become default providers in times of crisis (e.g., after disasters, school shootings, and other types of mass trauma) o Studies to identify neurobiological and functional mechanisms underlying effective interventions. o Studies to identify the decision-making, provider-client interaction, organizational, and systems level factors underlying effective service delivery. o Intervention studies that explore patient and treatment parameters relevant to optimizing interventions for trauma-exposed children and adults. o Studies related to the identification and treatment of PTSD in trauma-related anxiety and depression among high-risk and vulnerable populations (e.g., incarcerated and homeless populations, including juveniles). MECHANISM(S) OF SUPPORT This PA will use the NIH Research Project Grant (R01), Exploratory/Developmental Grant (R21), Clinical Exploratory/Developmental Grant (R34), and Small Grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this PA may not exceed 5 years. The Exploratory/Developmental Research Grant (R21) provides 2 years of funding with a maximum of $275,000 direct costs for each year over the entire budget period; with no single year exceeding $200,000 (see 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 single 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 (see http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html). The Small Grant (R03) provides 2 years of funding with a maximum of $50,000 direct costs for each year (see http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html). This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. 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 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 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 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: Dr. LeShawndra Price Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-5944 Email: lprice@mail.nih.gov Dr. Denise Juliano-Bult Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7146, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 Email: djuliano@mail.nih.gov Dr. Susan Brandon Division of Neuroscience & Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7218, MSC 9651 Bethesda, MD 20892-9651 Telephone: (301) 443-9400 Email: sbrandon@mail.nih.gov o Direct your questions about financial or grants management matters to: Rebecca Claycamp, CRA Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6122, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2811 Email: rclaycam@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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. The title and number of this program announcement must be typed on line 2 of the face page of the application 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 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 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 the 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. 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 or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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 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 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 not sharing research data will be assessed by the reviewers. However, 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 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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