PA-04-044: RESEARCH ON PSYCHOPATHOLOGY IN INTELLECTUAL DISABILITIES (MENTAL RETARDATION)

Department of Health
and Human Services (HHS)

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RESEARCH ON PSYCHOPATHOLOGY IN INTELLECTUAL DISABILITIES (MENTAL RETARDATION) RELEASE DATE: December 23, 2003 PA NUMBER: PA-04-044 Update: -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. -This PA has been reissued as PA-06-431 for submission of R01 applications as of May 23, 2006 EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for R01 Applications: May 23, 2006 EXPIRATION DATE for R01 Collaborative Applications: October 2006, unless reissued. 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 This Program Announcement replaces PA-01-028. The National Institute of Mental Health (NIMH) invites research grant applications for research designed to elucidate the epidemiology, etiology, treatment, and prevention of mental disorders, including emotional and behavioral problems, in persons of any age with intellectual disabilities (mental retardation). This announcement uses the preferred term intellectual disabilities to designate conditions that in the past have been referred to with the term mental retardation , thus these two terms are to be understood as equivalent. Though precise epidemiological data regarding persons with both mental illness and intellectual disabilities are not available, clinical experience has shown that the full range of psychiatric disorders can be found among individuals with intellectual disabilities. This includes co-occurrence with schizophrenia, affective disorders, obsessive-compulsive disorder, anxiety disorders, and behavior disturbances with injurious and aggressive behavior directed towards self, others, or objects. Proper identification and effective treatment of these mental disorders are especially important for people with intellectual disabilities. In fact, while it is usually not possible to correct and reverse the underlying cognitive deficits, treatment of the behavioral and emotional problems often associated with intellectual disabilities can significantly improve functioning and quality of life. Both basic research into the pathogenesis of mental disorders among individuals with intellectual disabilities and studies aimed at clinical diagnosis, treatment, rehabilitation, and service delivery are of interest. This initiative calls for more research on: (1) the prevalence rates of mental and emotional disturbance among persons with intellectual disabilities; (2) the improvement of current diagnostic categories and the development of appropriate psychiatric assessment instruments for use with persons who are mentally retarded; (3) the precursors of childhood behavioral and emotional disorders in children who are mentally retarded or who are at risk for intellectual disabilities; (4) the effectiveness of mental health services for persons with intellectual disabilities, including the monitoring of drug effects and methods for enhancing treatment compliance while living in the community or attending special education classes; (5) early intervention programs designed to prevent emotional and behavioral problems in infants with intellectual disabilities; (6) integrated service delivery models that provide a range of supportive and therapeutic services to those suffering from both mental illness and intellectual disabilities; and (7) translation of basic neuroscience findings into clinical applications and development of novel approaches to diagnosing and treating mental illness in the context of intellectual disabilities. Although intellectual disabilities and autism often co-occur, a separate program announcement is relevant for investigators interested in autism: RESEARCH ON AUTISM AND AUTISM SPECTRUM DISORDERS (PA-01-051). (See http://grants.nih.gov/grants/guide/pa-files/PA-01-051.html) The research objectives of this PA have been stimulated by meetings held during the past few years. These include: A workshop entitled Emotional and Behavioral Health in Persons with Mental Retardation/Developmental Disabilities (November 29 -December 1, 2001) was convened by the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), the National Institutes of Health (NIH) Office of Rare Diseases, and the Joseph P. Kennedy Jr. Foundation. A report of this workshop can be found at http://www.ninds.nih.gov/news_and_events/proceedings/Emotional_Behavioral_Health_2001.htm A workshop entitled Mental Health Aspects of Fragile X Syndrome: Treatment Research Perspectives (November 16-17, 2001) was convened by the NIMH and the FRAXA Foundation. A report of this workshop can be found at http://www.nimh.nih.gov/research/fragilex.cfm A conference entitled Closing the Gap: A National Blueprint to Improve the Health of Persons with Mental Retardation (2002), was convened by the United States Surgeon General. A report of the Surgeon General's Conference on Health Disparities and Mental Retardation can be found at http://www.nichd.nih.gov/publications/pubs/closingthegap/index.cfm RESEARCH OBJECTIVES Background Prevalence estimates of mental and emotional disturbance among persons with intellectual disabilities in community and institutional settings vary widely depending on how the data were collected. The most often quoted figures indicate that mental disorders occur substantially more often in persons with intellectual disabilities than they do in populations without intellectual disabilities. Among the reasons for the difficulty in estimating these prevalence rates are sampling bias due to self-selection and difficulty in making reliable and valid psychiatric diagnoses. Research designs that can remedy these and other problems are needed. Inherent in efforts to improve our knowledge of the epidemiology of emotional disturbance among persons with intellectual disabilities is the development of more valid approaches to identifying mental disorders in the context of intellectual disabilities. One of the most important elements in prevention of mental disorders among individuals with intellectual disabilities is early identification. Research that can illuminate the precursors of childhood behavioral and emotional disorders in children who are mentally retarded or who are at risk for intellectual disabilities is lacking. Early identification and diagnosis of co-existing mental and emotional disorders in those with intellectual disabilities may provide an opportunity for early intervention and mitigation of psychopathology. Since many individuals with intellectual disabilities are already receiving treatment and support services, the development of effective regimens for treatment of behavioral and emotional dysfunction is of high priority. For instance, many individuals with intellectual disabilities are treated with psychotropic medications, but very few studies of the effectiveness of these interventions have been conducted. Careful analysis of both positive and negative effects of these drugs, such as effects on learning and adaptive behaviors, or emergence of tardive dyskinesia and other unwanted side effects, is especially needed. Persons with intellectual disabilities who also exhibit emotional problems may present great difficulties to their families, whether they live at home or elsewhere. Research on family structure, process, and interaction may illuminate ways in which family-focused treatment and intervention programs might be devised. One of the most difficult problems faced by persons with intellectual disabilities and emotional disturbance is their relationship with the service delivery systems. Since many local jurisdictions have separate service systems for those with intellectual disabilities and mental illness, the extent of coordination between these systems is an important area for study. Some illustrative examples of research topics that may be addressed under this program announcement are: o Research on prevalence estimates of mental and emotional disturbance in the mentally retarded that controls for common problems such as sampling bias due to self-selection and difficulty in making reliable and valid psychiatric diagnoses o Developing animal models to explore how genetic abnormalities give rise to intellectual disabilities o Research on genetic and environmental factors that influence the heritability of cognitive and behavioral traits, and treatment outcomes o Research using neuroimaging techniques to assess treatment outcomes o Research that identifies behavioral features, emotional problems, and psychiatric diagnoses and increases understanding of the interaction between genes, brain, and behavior in specific neurodevelopmental syndromes that are typically accompanied by intellectual disabilities, such as Down syndrome, Fragile X, and Prader Willi syndrome o Longitudinal studies that describe the developmental trajectory of behavior and skill acquisition in genetic disorders or syndromes associated with intellectual and developmental disabilities o Developing and adapting appropriate diagnostic instruments and procedures applicable to individuals with intellectual disabilities and developmental disabilities and improving the validity of the diagnosis of mental disorders in persons with intellectual disabilities o Understanding the factors of prenatal and perinatal pathophysiology as well as psychosocial and ecological variables that might precede, mediate or moderate the emergence of emotional and behavioral disorders in children with intellectual disabilities o Developing and testing early intervention programs designed to prevent emotional and behavioral problems in infants and young children with intellectual disabilities, using a variety of research methodologies o Studying the precursors of childhood behavioral and emotional disorders in children who are mentally retarded or who are at risk for intellectual disabilities o Developing treatment interventions for individuals with intellectual disabilities who suffer from behavioral and emotional dysfunction, and testing their effectiveness o Comparing the relative effectiveness of behavioral, psychosocial, educational, natural supports, and pharmacological treatment programs and their combinations for individuals with intellectual disabilities who suffer from behavioral and emotional dysfunction o Careful analysis of both positive and negative effects of psychotropic medications. o Studying how manifestations of particular emotional, behavioral and psychiatric disorders and the response to treatment may vary as a function of cognitive or functional disability or developmental level o Studying how the applications of human subject protection provisions including the Common Rule, minimal risk rule and informed consent process impact research in persons with intellectual disabilities o Studying the effectiveness of mental health services for persons with intellectual disabilities o Developing and testing methods for enhancing treatment compliance while living in the community or attending special education classes o Examining family structure, process, and interaction in order to illuminate ways in which family-focused treatment and intervention programs might be devised o Examining models of family involvement in delivery of services o Identifying and characterizing individual, family, and/or cultural factors that facilitate or impede early identification, detection, and treatment of mental illness in persons with intellectual disabilities o Identifying and characterizing current practice patterns for persons with intellectual disabilities with chronic and impairing mental illness, studying variables that affect quality of care, and developing and testing interventions designed to improve quality of care for persons with these disorders o Comparing family-driven service delivery with provider-driven services o Investigating integrated service delivery models that provide a range of supportive and therapeutic services to persons suffering from both mental illness and intellectual disabilities (may include broad survey studies as well as smaller, more focused clinical investigations) o Examining the cost-effectiveness of various models of coordinated services MECHANISM(S) OF SUPPORT This PA will use the NIH Research Project Grant (R01), Collaborative R01, Exploratory/Development Grant (R21), Clinical Trial Planning Grant (R34), and Small Research 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 five years. Awards made under the R21, R34, and R03 support mechanisms are not renewable past the original project period. 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 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: Rebecca DelCarmen-Wiggins, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6191, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-9230 FAX: (301) 480-4415 Email: rdelcarm@mail.nih.gov Edgardo Menvielle, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7147, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: emenviel@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: jk173r@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 form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below).http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 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 REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for 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. A description of the requirements can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html. 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 more than $500,000 in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? . Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because 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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