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WOMEN'S MENTAL HEALTH IN PREGNANCY AND THE POSTPARTUM PERIOD RELEASE DATE: June 6, 2003 PA NUMBER: PA-03-135 EXPIRATION DATE: May 2006, unless reissued. National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279, 93.865 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 In this PA, the National Institute of Mental Health (NIMH), the National Institute of Drug Abuse (NIDA), and the National Institute of Child Health and Human Development (NICHD) encourage research on women's mental health in relation to pregnancy and the postpartum period. As illustrated by a few highly publicized cases, the consequences of severe untreated postpartum depression and psychosis can be devastating for individuals, families, and communities. In July 2002, NIMH held a major interdisciplinary conference to identify research needs in the areas of pregnancy-onset and postpartum depression and postpartum psychosis (hereafter referred to collectively as perinatal mood disorders). In February 2003, S 450 and HR 846 were introduced in the 108th Congress. The bills call for the Secretary of Health and Human Services, working through the Director of NIMH to provide for basic, epidemiological, diagnostic, clinical, and intervention research on postpartum depression and psychosis. RESEARCH OBJECTIVES Perinatal mood disorders are potentially devastating conditions that affect many women during pregnancy (often referred to as gestational or antepartum) and after pregnancy (often referred to as postpartum, puerperium or postnatal). Perinatal mood disorders are broadly termed maternal depression. Perinatal mood disorders are classified into three groups: the (postpartum) blues, which is a common and less severe form of postpartum depression; clinical mood and anxiety disorders, which can occur during pregnancy and following childbirth, usually within six months to a year later (depending on the definition used) and often necessitating treatment; and postpartum psychosis, which is the most extreme form of perinatal mental illness, usually occurring within a few weeks of childbirth and constituting a medical emergency. The causes of these conditions are complex and most likely heterogeneous, with putative distinct and shared risk factors. Biologically oriented explanations are likely to consider changes in levels of estrogen and progesterone following delivery, genetic vulnerability factors sensitive to hormonal changes, and hypothyroidism as possible triggering events. Environmental factors associated with perinatal mood disorders include difficult delivery, marital stress, and lack of social support. A personal or family history of mood disorders, particularly bipolar disorder or prior postpartum psychosis, is also a major risk factor for a perinatal mood disorder. A subset of women with perinatal mood disorders may also manifest mood disorders particularly in relation to other reproductive transitions such as those that occur during the premenstrual period. It is estimated that 8-15 percent of women having children suffer from a clinically significant postpartum mood disorder; of these women, many experienced depressive symptoms as well during pregnancy. An estimated .5 to 1 percent of women will experience a postpartum psychosis. There are limited epidemiological data on postpartum psychosis because of the low incidence. Perinatal mood disorders are under-diagnosed and under-treated. It is estimated that health care providers identify only 20-30 percent of these conditions. Maternal depression, anxiety, and stress during pregnancy are associated with a variety of poor physical and emotional outcomes in offspring. Untreated perinatal mood disorders can have a range of poor maternal functional outcomes, from substance abuse, loss of employment, and divorce to suicidal behavior or death by suicide. Untreated perinatal depression also impacts society through its effect on a mother's ability to promote the infant's cognitive and emotional development. Maternal depression has been associated with poorer child cognitive and psychological development. In extreme cases, such as postpartum psychosis, it has been associated with poorer neonatal outcomes, even infanticide. In addition to the mood disorders, many women enter the perinatal period with active and/or relapsing/recurring drug or alcohol use disorders as well as mental illness (anxiety disorders, eating disorders, schizophrenia) and with medical conditions related to substance abuse such as infectious disease (HIV, HBV, HCV). These conditions and other co-occurring conditions of higher prevalence in women such as autoimmune disorders must be explored at the level of basic, epidemiological, diagnostic, clinical, and intervention research in relation to maternal perinatal health. This PA encourages research on perinatal mood and other mental disorders in four areas: (1) clinical course, epidemiology and risk factors; (2) basic and clinical neuroscience; and (3) interventions; and (4) services. Research is encouraged both on perinatal non-psychotic mood disorders and on psychotic disorders. Clinical Course, Epidemiological and Risk Factors Research Current national epidemiology studies have paid surprisingly little attention to the postpartum period and even less attention to pregnancy in terms of risk for different kinds of perinatal mental disorders and distinguishing risk factors. This critical gap must be addressed, as clinical and epidemiology studies form the basis of intervention research. The prevalence of perinatal depression in different racial/ethnic groups of women is undetermined, with some reports of much higher rates in low-income and/or ethnic minority women and other reports of comparable rates among women. Below are examples of clinical, epidemiological, and risk factors research encouraged by NIMH: o Epidemiological studies to identify risk and protective factors for postpartum non-psychotic depression and anxiety disorders, especially in women with different clinical patterns and histories (e.g., reproductive-related mood changes, recurrent depression). o Clinical and epidemiological studies to identify the characteristics of pregnancy-onset depression and to examine its functional impact and course. o Studies of health disparities in perinatal depression, other peri-natal mental disorders, and in co-occurring behavioral and medical conditions. o Clinical and epidemiological studies of women with bipolar disorder or schizophrenia to identify risk factors for perinatal mood disorders onset; studies to aid in the early identification and treatment of serious perinatal psychosis among high-risk women. o Clinical and epidemiological studies of pregnancy complications and birth and neonatal outcomes in women with perinatal mood or anxiety disorders or psychosis. o Clinical and epidemiological studies of treated versus untreated perinatal mood, anxiety, and other mental disorders during pregnancy and lactation in relation to child outcomes such as development and mental health. o Research on psychiatric and social functional status associated with infertility, miscarriage, stillbirth, and elective abortion. NIDA encourages research in the following area: o Studies exploring the effects of current or lifetime drug abuse, including treatment status and comorbid conditions, on onset and course of mental disorders during the perinatal period. Basic and Clinical Neuroscience Very little basic neuroscience research is currently aimed specifically at addressing the neurobiology of perinatal mood disorders. There is a need to apply the knowledge of hormone-sensitive brain circuits and neurotransmitter systems to developing an understanding of the neurobiology of perinatal mood disorders in clinical populations. The development of appropriate models of the peripartum period will be essential for understanding the neurobiology of perinatal mood disorders. Consideration of combined genetic and environmental influences on postpartum hormonal status, emotionality, and maternal behavior is also appropriate for model development. Finally, new tools are needed to advance the understanding of neuroendocrine control of mood and cognition in humans, non-human primates, and other species. The following are examples of clinical neuroscience research encouraged by NIMH: o Studies aimed at identifying neurobiological, endocrine, and behavioral characteristics that distinguish perinatal mood disorders from perinatal psychotic disorders and from mental disorders occurring at other times across the lifespan. o Neuroimaging studies of normal and patient populations of women during different perinatal intervals to identify functional changes in brain neurochemistry in relation to hormonal transitions. o Studies to identify unique hormone sensitivities in women with histories of perinatal mental disorders in order to predict risk of subsequent perinatal mood disorders and to identify subsets of women vulnerable to developing mood disorders following other hormonal events (e.g., menstruation; menopause). o Studies to identify genetic polymorphisms/markers of vulnerability in women at high risk for the development of perinatal mood disorders or postpartum psychosis. The inclusion of subsets of women with more homogeneous psychological symptoms during pregnancy and post-partum is particularly encouraged. o The inclusion of women with a history of perinatal mood disorders in genetic studies of depression and bipolar disorder in order to identify additional vulnerability markers for the disorders in relation to perinatal triggers. Below are examples of model development research encouraged by NIMH: o The development of models of hormone changes occurring during and after pregnancy for neurobiological and behavioral studies. o The development of models to examine the combined environmental and genetic influences of resilience and vulnerability to mood and cognitive disorders during the perinatal period. o The development of models to study the impact of perinatal disorders during pregnancy and lactation and pharmacological treatments for the disorders on the behavioral and neural development of offspring. o Identification of relevant objective and quantitative measures including assessment of neuroendocrine activity (pituitary, gonadal, thyroid hormone systems), brain activation (EEG, PPI, ERP), and the development of simplified behavioral measures with parallel application across species including humans, non-human primates, and/or rodents. Below are examples of tool development research encouraged by NIMH: o Development of research tools to visualize the influence of post-partum hormonal changes on brain gene expression and on activation of brain circuits regulating mood and cognition. o Development of more selective hormone receptor ligands and radioligands (e.g., estrogen receptor ß agonists and thyroid receptor ligands) for basic and clinical research. o Development of novel tools and approaches to visualize activation of steroid hormone receptors in brain imaging studies across the reproductive cycle and throughout pregnancy. NIDA encourages research in the following area: o Studies elucidating the effects of drug abuse or drug abuse history and other comorbid conditions (e.g., HIV infection, hepatitis) on maternal neurobiology during the perinatal period. NICHD encourages research in the following area: o Mechanistic studies of the impact of perinatal mood disorders on human fetal and infant nervous system development. Interventions Research There is a need to develop more systematic knowledge about the impact of known pharmacological and psychosocial depression treatments for perinatal mood disorders. There is also a need to develop new behavioral interventions for these conditions, in particular interventions that can be adapted to general medical or group settings. The following are examples of the kinds of intervention studies encouraged by NIMH: o Studies of the efficacy, safety, pharmacokinetics, and pharmacodynamics of pharmacotherapies for treatment of perinatal mood disorders, especially those occurring during pregnancy and lactation. o Maintenance studies to develop effective non-pharmacological interventions to prevent postpartum relapse. o Studies of pharmacological maintenance treatments during pregnancy and postpartum for women with serious mental illnesses such as psychosis and studies of pharmacological prophylaxis strategies for these conditions in women at high risk for a recurrence of psychotic perinatal conditions. o Controlled studies of non-pharmacological interventions, such as psychosocial therapies or light therapy for perinatal depression. o Development of innovative non-pharmacological interventions as alternatives to traditional one-on-one interventions for identifying, preventing, and treating perinatal mood disorders (e.g., self-help; support groups; Web-based approaches to reduction of subsyndromal symptoms before they become disorders). o Development of outcome measures of maternal functioning and/or child functioning, which can be incorporated into assessments of the effectiveness of interventions. o The development of innovative interventions for preventing and treating perinatal mood disorders, which are aimed at the reduction of risk for poor parenting and child psychopathology and that can be easily adapted to medical and other real-world settings (e.g., community-based mental health centers). NIDA encourages research in the following area: o Studies of the effects of current or lifetime diagnosis of drug abuse and comorbid conditions on behavioral and pharmacological treatment of maternal mental disorders during the perinatal period. Services Research Increased screening and referral to accurate, accessible, and sustainable mental health assessment, treatment, and needed services is a public health strategy with the potential to improve outcomes in perinatal mood disorders. To determine the effectiveness of such an approach, a variety of factors must be evaluated at the individual, practitioner, organizational, community, and systems levels. The following are examples of services research encouraged by NIMH: o Studies dealing with clinical decision-making in personal-encounter care for individual patients with perinatal mood disorders; research to identify risk factors for the development of such disorders in clinical settings; factors that are important in the natural history of these disorders, including co-morbid conditions. o Studies that elucidate the critical components of effective collaborative models for screening/referral partnerships within and across systems of care (e.g., between primary care and mental health care, between public and private health care systems, or between health care providers/systems and employers). Such studies should seek to understand issues relevant to successful implementation of effective models. o Research on the impact of various forms of managed care and physician payment methods on the detection, assessment, referral and treatment of perinatal mood disorders, and performing economic analyses of practice patterns of different health providers and systems in addressing such disorders. o The development of community collaborative models for screening/referral partnerships between researchers and public and private health care systems and between health care providers/systems and employers. o Studies of the mechanisms by which stigma associated with perinatal mental illness affects the behavior of providers and consumers in terms of creating barriers to recognition, help-seeking, or referral for or acceptance of treatment. o Studies that provide insights into differences in quality and outcomes of care in various practice types, and analysis of the appropriateness of treatment, including medications. o Studies to determine the need for and barriers to utilization of mental health services for mothers with postpartum mood disorders, including assessment and rehabilitation of functional disability. o Studies exploring the feasibility and efficacy of parenting-related services that address special issues of parenting and illness management for women with serious mental illnesses. o Research related to issues of culture, social systems, and social networks as they relate to help-seeking, use and provision of services, and effectiveness, quality, and outcomes of services. MECHANISM(S) OF SUPPORT This PA uses the NIH Research Project Grant (R01), Small Grant (R03), and Exploratory/Developmental Grant (R21) mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) provides two 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 two years of funding with a maximum of $275,000 direct costs over the entire budget period with no one year exceeding $200,000. It is intended for development and pilot testing of novel models, sensitive neurochemical measurements, interventions and other aspects of intervention development. Instructions for R21 applications can be found at (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). The total project period for an R01 application submitted in response to this PA may not exceed five years. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. 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. Applicants are strongly encouraged to consult with program staff listed under INQUIRIES. 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: Mary C. Blehar, Ph.D. Chief, Women's Mental Health Program National Institute of Mental Health 6001 Executive Boulevard, Room 8125, MSC 9659 Bethesda, MD 20892-9659 Telephone: (301) 443-2847 FAX: (301) 4438552 Email: mblehar@mail.nih.gov Catherine Y. Spong, M.D. Chief, Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6894 FAX: (301) 496-3790 Email: spongc@mail.nih.gov Deborah M. Smith, MD, MPH, FACOG Special Expert and Chief, Medical Consequences Unit Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) National Institute of Drug Abuse 6001 Executive Boulevard, Room 5198 MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-0924 FAX: (301) 480-4544 Email: dsmith1@mail.nih.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Grants Management Branch 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: jk173@nih.gov Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-5482 FAX: (301) 480-4782 Email: kh246t@nih.gov Gary Fleming, J.D., M.A. 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: gf6s@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) 435-0714, 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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. 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. MONITORING PLAN AND DATA AND SAFETY 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 02-001.html); a complete copy of the updated Guidelines 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.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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