EXPLORATORY/DEVELOPMENTAL TRANSLATIONAL GRANTS FOR BORDERLINE PERSONALITY RELEASE DATE: September 4, 2003 RFA Number: RFA-MH-04-006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 LETTER OF INTENT RECEIPT DATE: November 14, 2003 APPLICATION RECEIPT DATE: December 18, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This is a reissue of RFA MH-03-001. The National Institute of Mental Health (NIMH) reaffirms its commitment to encouraging cutting-edge research and promoting the development of new investigators in the area of borderline personality disorder (BPD), which has not received research attention commensurate with its significance as a public health problem. In addition, based on the response to the previous Request for Applications (RFA), NIMH recognizes the potential of this extension of its translational research initiative to borderline personality for contributing to the desired research and correlated increase in research capacity. The purpose of this RFA is to invite new and amended exploratory/developmental (R21) applications that propose translations of basic science theories, methods and findings to clinical research concerning borderline personality disorder; examining BPD features and its relationship to putative causal factors and to other disorders, constructs, and variables. Applicants for exploratory/developmental R21 grants should be committed to pursuing the proposed line of research through subsequent research project grants (R01 or other appropriate grant mechanisms) using the outcome data obtained as a result of this RFA. Translations may involve basic theories, methods, and/or findings from modern psychometrics and measurement theory, basic behavioral science, social science, and neuroscience. The specific clinical research focus chosen by the applicant should reflect the potential for innovative, important, and scientifically sound translations to clinical research concerning borderline personality disorder. RESEARCH OBJECTIVES Borderline personality disorder (BPD) is a complex, serious, disabling disorder with significant mortality. Although prevalent in clinical settings it has not received research attention commensurate with its significance. Since only a small number of investigators have undertaken research concerning this disorder, the NIMH portfolio does not reflect this disorder's importance as a public health problem. With few researchers working in an area of study, there are few opportunities for training and mentoring of new researchers, which in turn perpetuates the limited amount of research being conducted and NIMH grants awarded for this area of study. Recently, several developments have occurred that offer the potential for increasing NIMH support for research concerned with BPD. First, in 1999, the Borderline Personality Disorder Research Foundation (BPDRF) generated a significant increase in BPD research by initiating support for research centers concerned with BPD in the United States (US) and in Europe. Subsequently, the BPDRF has sought to encourage government research funders in the US and in Europe to increase their support for BPD research and to encourage early career researchers to undertake programs of research on BPD. In support of those goals, in 2002, the BPDRF announced a grant program for individual investigators. The first awards under this program were made in the spring of 2003. Second, several years ago, NIMH launched a translational research initiative to encourage the involvement of basic researchers and clinical scientists in the translation of basic science theories, methods, and findings into the clinical arena. The number and quality of the resultant translational research applications has demonstrated the readiness and ability of the field to enhance the clinical research enterprise. This RFA seeks to build on the two developments mentioned above: 1) increased research activity and interest concerning BPD that the BPDRF has generated; and 2) utilize the new energy and cutting edge methods that the Institute's translational research initiatives have brought to clinical research. Specifically, this RFA seeks to extend the Institute's translational research initiatives to BPD research, and thereby bring cutting edge theories, methods, and findings from modern psychometrics and measurement theory, behavioral science, social science, and neuroscience to clinical research concerning BPD. Such extensions offer considerable promise for enabling advances in better measurement and understanding of the complexities of this disorder and its core features - the pervasive instabilities in affect, interpersonal relationships, behavior, concept of self, and cognition(s); and the co-occurrence of BPD with other disorders (e.g., depression, post-traumatic stress disorder, and substance abuse). Such extensions also offer the promise of developing and testing new science-based treatment models and procedures for use in the clinical setting. The potential for extending NIMH's translational research initiative to BPD research and for involving more researchers, particularly early career investigators, was proposed in the summer of 2001 at the conference, "New Directions in Borderline Personality," at Rockefeller University that was co- sponsored by NIMH and the BPDRF. It was further explored in the early summer of 2002 at a follow-through conference, "New Directions in Borderline Personality II," that the University of Minnesota Department of Psychiatry hosted. The number of applications submitted under the previous RFA (MH-03-001) and the potential of these applications has demonstrated that the field is interested and ready to extend translational research to BPD. Some possibilities for translation of basic science include: modern psychometrics and measurement theory, basic behavioral science, social science, and neuroscience. The exploratory/developmental grant mechanism is designed to enable researchers to develop procedures and data that will lead to the development of R01 applications. Areas of research interest sought under this RFA encompass all aspects of BPD, including, but not limited to, better specification of the disorder and the criteria for diagnosis; determination of possible subtypes of BPD and their associated features and correlates; illumination of the role of gender, SES, and culture in the manifestation of the disorder; elucidation of the mechanisms of expression and moderation of the extreme temperament and behavioral traits that are presumed to account for this disorder; clarification of the relationship of BPD to other disorders and their mechanisms; identification of factors that are involved in the onset, escalation, and cessation of BPD features; development of more complete and accurate measurement of the pervasive instabilities of affect, interpersonal relationships, concept of self, behavior, and cognitions, and determination of factors involved in variations of time between extreme states, in the duration of extreme states, and in the moderation of expressions of extreme states of these features; the role of learning, biological factors, and the brain in the instabilities that characterize BPD; elucidation of factors that account for periods of self-injury and the mechanisms that support this type of behavior; and the development and preliminary testing of new treatment models and procedures that are based on translations of basic science. The specific research focus should reflect the opportunity for the innovative and scientifically meritorious translation of basic science to advance BPD clinical research. Applications submitted under this RFA must meet the six criteria presented below to be considered responsive. Applicants should explicitly address each criteria in the narrative of the application. 1. The proposed research must have as a major feature the translation (application) of basic science (theory, methods, or findings) to clinical research concerning BPD. 2. The principal researchers for the proposed research must have substantial expertise in both the area of basic science from which the translation is to be made and in relevant clinical research. Collaborations of basic and clinical scientists are encouraged. Collaborating scientists need not be at the same institution, but in such cases, the procedures for achieving collaboration during the project must be specified. Substantial expertise in the areas of science involved in the research is required so that the research team can look beyond the immediate research to other possibilities for translation and consider other clinical issues that might benefit from new basic research, and so that there can be broad training in translational research (see below). 3. Consistent with the need to develop a cadre of translational researchers, the project must include provision for an advanced graduate student, a post doc, or an early career researcher to receive additional training in the basic science area from which the translation for the research project is drawn (e.g., in modern measurement theory for the translation of item response theory for developing a measure of a BPD latent construct) and similarly to receive training in the clinical science involved in the research. The goal for this training is to prepare this person to initiate translational research. The project budget must include provision for this training and a training plan must be briefly described. The training may utilize various modalities, including courses, directed readings, tutorials, and visits to labs of other scientists, as well as active involvement in the proposed research as a collaborating junior colleague. 4. The proposed research must have clear, immediate, and compelling relevance to the clinical phenomena of borderline personality disorder. (It is anticipated that this requirement will most often be met by having persons who meet diagnostic criteria for BPD as the primary subjects.) 5. The proposed research will be a new line of investigation for BPD, and so, consistent with the exploratory/developmental mechanism. Preliminary data, while always desirable, is neither expected nor required. The proposed research should be scientifically sound and the qualifications of the research team appropriate. It is expected that funded projects will need to make adjustments based on their initial work, and the work plan and budget should provide for this. 6. The principal researcher(s) of the team should be committed to pursuing this line of research beyond the exploratory/development grant period if the data developed with the R21 grant support this course. The subsequent research that would proceed from the requested R21 grant support must be indicated. Applicants are strongly encouraged to contact the NIH program staff listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this RFA. Possible Research Topics The following research areas are presented only as illustrations of possible topics. The list is not intended to be comprehensive or restrictive. The topics are expected to reflect the opportunities for new and innovative applications of basic science to BPD and its features: o The application of taxonomic science to BPD to explore the possibility of subtypes of BPD and shared and distinct biological, development, clinical, and social factors. The DSM criteria for the diagnosis of BPD are that any 5 (or more) of 9 symptom criteria be met. Thus, scores of diverse combinations of symptom criteria enable the diagnosis of this disorder, suggesting the possibility that the disorder is not homogenous but consists of two or more subtypes. Identification of valid subtypes and their shared and distinct factors would advance diagnosis, treatment, and research. o The use of measurement theory and behavioral science to develop accurate, ongoing measures of one or more of the core features of BPD, e.g., instability in concept of self. The availability of such measures could enhance the accuracy of diagnosis and evaluation of interventions and advance the study of factors associated with potentially important facets of instability such as variation in the time between extremes. The availability of validated measures for two or more such features would enable research on the relationship of time variation in one to the other and the shared and unique factors associated with the expression of these features. o The use of systematic observations of behavior and emotions to determine patterns of dyadic interactions and to test learning theory, pharmacological and other intervention methods to determine the role of different approaches and factors in preventing the escalation of anger and aggression and in obtaining therapeutic change in interpersonal relationships. o The use of item response theory (irt) to develop items measuring the latent constructs of BPD that are not influenced by gender, socioeconomic status (SES), and culture/ethnicity, and thus reflect pure expressions. And, conversely, to identify sets of items that reflect gender, SES and culture/ethnicity specific expressions of BPD so that the mechanisms by which these factors affect the differential expression of BPD symptoms can be investigated. o Application of methods and principles from affective neuroscience to explicate dimensions of mood and emotional response in BPD, employing standard paradigms for which normative data exist and recording multiple response systems in order to contribute to an integrative understanding of the biobehavioral organization of affect and/or social cognition in BPD. o Studies that attempt to define more precisely the relevant temperament and other biobehavioral dimensions relevant to BPD, and to specify which combinations of dimensional characteristics may contribute to subtypes, severity, or risks for disorder. Such studies might employ designs that are intended to explore the full range of these dimensions by combining patient groups, non-clinical subjects at high risk or with elevated scores on screening questionnaires, and non-clinical subjects scoring low on screening measures. o The translation of new basic science findings to a new treatment model or procedure, and the development and preliminary testing of this approach. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory/Developmental (R21) award mechanism. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $125,000 per year. Direct costs of up to $150,000 per year may be requested to allow for facilities and administrative (F&A) costs on consortium arrangements. Both new applications and amended ones that were submitted under the previous RFA may be submitted. Amended applications should follow the standard guidelines as noted in the PHS 398 kit (including a 3 page introduction and marking text that has changed). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is August 1, 2004. This RFA uses just-in-time concepts. It also uses the modular budgeting format (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. RESUBMISSION OF UNFUNDED APPLICATIONS Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications only, as described at NOT-OD-03-019 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html). These NEW applications must be submitted on the standard receipt dates (https://grants.nih.gov/grants/funding/submissionschedule.htm and will be expected to conform to the requirements of the standard NIH Exploratory/ Developmental Grant award mechanism, which limits the award to 2 years with a combined direct cost budget of up to $275,000 for the 2-year period (with no single year exceeding $200,000), as well as a 15-page research plan (see https://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). FUNDS AVAILABLE The NIMH intends to commit approximately $1.2 million total cost in FY 2004 to fund up to eight new grants in response to this RFA. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIMH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 institutions/organizations o Faith-based or community-based organizations o Foreign institutions are not eligible to apply. 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 inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about mental health scientific/research issues to: James Breiling, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6179 Bethesda, MD 20892 Telephone: (301) 443-3527 FAX: (301) 443-4611 Email: jbreilin@mail.nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892 Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: mkozak@nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertib2@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. James Breiling Division of Mental Disorders, Behavioral Research and AIDS (DMDBA) National Institute of Mental Health 6001 Executive Boulevard, Room 6179 Bethesda, MD 20892 Telephone: (301) 443 3527 FAX: (301) 443 4611 Email: jbreilin@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 https://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. PLEASE NOTE THAT THE RESEARCH PLAN IS LIMITED TO 15 PAGES. APPENDIX MATERIAL IS LIMITED TO 5 ITEMS. 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 https://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 https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9663 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (303) 443-4720 Email: jnoronha@mail.nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NIMH. Incomplete and nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Mental Health Council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate your 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 these criteria in assigning your application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o 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). o 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o 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. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 14, 2003 Application Receipt Date: December 18, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: August 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS DATA SAFETY AND 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: https://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 AMENDMENT "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA 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 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 https://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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