PAR-02-062: BUILDING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE

Department of Health
and Human Services (HHS)

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BUILDING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE RELEASE DATE: February 12, 2002 PA NUMBER: PAR-02-062 (This PA will remain active until reissued, see NOT-MH-06-105) 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. Replacement R24 (PAR-06-357), R21 (PAR-06-355), and R01 (PAR-06-356)funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R24 Applications: July 31, 2006 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) Application Receipt Dates: April 17, 2002, and standard application deadlines thereafter. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives Background General Objectives Part A: R21 Part B: R24 Research Topics o Mechanism(s) of Support Part A: R21 Part B: R24 o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application Page limits for research plan (sections a-d): R21, R24 General Instructions o Peer Review Process o Review Criteria General Review Criteria Other Review Criteria Part A: R21 Part B: R24 o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Mental Health (NIMH) and the National Institute on Drub Abuse (NIDA) seek to encourage the development of collaborative partnerships between scientists who study basic behavioral processes and those who study the etiology, diagnosis, treatment, and prevention of mental and behavioral disorders (including drug abuse and addiction) and the delivery of services to those suffering from those disorders. NIMH and NIDA are issuing this Program Announcement (PA) as part of a major, long-term commitment to (a) encourage the systematic translation of basic behavioral theory, methods, and findings into research designed to reduce the burden of mental illness and behavioral disorders and (b) encourage basic behavioral scientists to seek a further understanding of behavioral processes through an exploration of how those processes are altered by mental and behavioral disorders. This PA was developed in response to a report written by the National Advisory Mental Health Council"s Behavioral Science Workgroup, entitled "Translating Behavioral Science into Action," http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm. This PA contains two mechanisms to support varying types of translational research partnerships: (1) R21 Exploratory grants for the initiation of research partnerships, and (2) R24 resource grants for the development of a translational research capability. For convenience, the sections of this PA which contain instructions unique to each mechanism are denoted as Parts A and B, respectively (see Table of Contents, above). Please contact program staff, as listed below, for information regarding R01 grants in translational research. Although not formally participating in the PA, the Division of Cancer Control and Population Sciences within the National Cancer Institute is very interested in translational research in behavioral science as it relates to cancer control. This division supports an R21 grant mechanism focused on pilot projects and feasibility studies enabling investigators to develop interventions in cancer prevention, screening, or survivorship research areas. See http://grants.nih.gov/grants/guide/pa-files/PA-02-001.html for a complete description of this announcement. RESEARCH OBJECTIVES Background NIMH and NIDA have for many decades been primary sponsors of research in the basic behavioral sciences. This long-term investment in behavioral research has resulted in the development of a large body of knowledge in such areas as emotion, motivation, self-concept, personality, cognition, memory, social cognition and influence, family processes, social networks, and sociocultural variations (see http://www.nimh.nih.gov/publicat/basbehav.cfm). However, the theory, methods, knowledge, and insights from the basic behavioral sciences have not been fully utilized in understanding pressing public health issues in mental health and drug abuse: the etiology and assessment of disorders, the development of innovative preventive and treatment interventions, and the effects of interventions and services for diverse types of people in disparate social, economic, cultural, and environmental contexts. In 1999, the NIMH Director and the National Advisory Mental Health Council convened the Behavioral Science Workgroup to explore ways to increase the impact of behavioral science research on public mental health issues. The Workgroup was comprised of experts in social, cognitive, developmental, and clinical psychology, psychophysiology, anthropology, sociology, public health, and biostatistics. In their report, "Translating Behavioral Science into Action," they highlighted three priority areas of translational behavioral science research: o Basic behavioral processes in mental illness o Functional abilities in mental illness o Contextual influences on mental illness and its care Regarding these three areas, the Workgroup wrote: "These priority research areas are critical starting points for progress in translational science because they are at the interface of what end-users have identified as important and what behavioral science researchers regard as areas of opportunity. They offer the prospect of conducting exciting research, advancing scientific understanding of behavior-in health and in illness-and improving the mental health of our Nation." The workgroup recommended that NIMH "establish and publicize translational behavioral science research as a priority funding area...and develop a coherent strategy for its systematic development." With this current PA, NIMH and NIDA continue a long-term commitment to translational behavioral science research. Some researchers, working singly or in small groups, have already accomplished significant research of this nature, to a degree that augurs the significant potential value of this approach. At the current time, however, there is a clear need to foster a significant increase in collaborative efforts among basic and clinical researchers in order to realize the fullest potential of translational research. This PA is designed to address the needs of investigators in the formative stages of the collaborative research process. For investigators who are just beginning to explore translational research questions, there is the exploratory R21 grant. For investigators who have initiated some collaborative partnerships and want to build a translational research capability, there is the R24 grant. Both the R21 and R24 mechanisms are intended to foster novel and innovative collaborations that are still in relatively initial stages of development, accordingly, the intent is to support work that has not yet amassed substantial preliminary data. Priority for R21 and R24 applications will be given to these relatively new collaborative arrangements. Each of these mechanisms will be discussed below. Investigators who have a specific translational research question, and sufficient pilot data to warrant an R01 research project grant or investigator-initiated Collaborative R01, may wish to consider PA-02-061, "Translational Research Grants in Behavioral Science," (http://grants.nih.gov/grants/guide/pa-files/PA-02-061.html). General Characteristics Regardless of mechanism, all applications to this PA must demonstrate that a research partnership between basic behavioral scientists and clinical and/or services researchers exists or will be developed and nurtured. For purposes of this PA, a basic scientist is defined as one who has demonstrable expertise in one or more lines of basic research, and for whom a preponderance of his or her research effort (typically, 50% or more) has involved non-clinical populations, as measured by publications, grant support, presentations, or other scholarly work. The minimum collaborative arrangement would thus involve two investigators, although larger groups of actual and potential collaborators are encouraged. While the emphasis in this PA is on behavioral science, collaborations that include relevant biological measures as integrative components are also encouraged, particularly from disciplines such as behavioral neuroscience and psychophysiology in which such integration is implicit. Research teams are to be conceptualized by the nature of the translational research goals and need not be limited by geographical or department boundaries. Collaborations among different institutions are encouraged in view of the typical distinctions between basic sciences and clinical/services settings. However, the applicants must show how communication will occur across these boundaries so that fully developed collaborative research partnerships can occur. Part A: R21 Exploratory Grants The primary purpose of the exploratory R21 mechanism is to provide an avenue for basic and clinical investigators to initiate and explore the potential of research collaborations. The R21 will be awarded as a single grant to a group of investigators. The minimum number of investigators for this mechanism is two (one each basic and clinical), while there is no cap on the maximum number of investigators, the application needs to discuss how the contributions of each member will be integrated in the enterprise. The activities of an R21 grant could include discussions of the clinical research problems to be addressed, the ways in which the basic research being conducted by the group members (as well as other relevant basic areas) could be applied to the clinical issues, critical evaluations of relevant research literatures, visits among the various laboratories and clinics to familiarize members with each others" work in detail, possible modifications to paradigms and methods that might be necessary for use with patient populations, determination of other expertise that might need to be added to the group, new statistical approaches or methodologies that may need to be developed, priorities for instantiating a translational research program, and design and execution of small, preliminary studies to demonstrate feasibility or obtain pilot data. A primary outcome of the activities of this mechanism should be the specification of a translational research agenda. This research program should comprise clinical research studies that clearly reflect the integral contributions of the basic science areas, and, where relevant, basic research studies to address critical gaps in the literature or methodological questions important to the clinical issues. These exploratory grants will have the following characteristics: o The purpose of this mechanism is to foster initial development of collaborative work, accordingly, investigators need not demonstrate any history of prior collaboration. However, those factors in the investigators" background and/or institutional circumstances that would facilitate success in collaboration should be clearly delineated. o The application must contain a cogent description of one or more specific topics in basic behavioral science, the clinical/services domains to which the basic science is to be applied, and a compelling justification for the potential of the research collaboration with respect to the translation of one or more basic science areas into clinical research. o Relevant areas of basic behavioral science can include models of behavior, cognition, social functioning, etc., specific paradigms developed for the investigation of basic behavioral processes, and statistical models or methods. In all cases, however, a strong knowledge base should already be available that is germane to the translational effort. o The application should provide a clear plan for the development of the collaboration. Such efforts could include travel among sites for informal meetings, workshops and small conferences, consultants, and analyses of extant data sets, using new methodologies or approaches. The purpose of these activities will be to refine conceptual frameworks for organizing translational research and to identify which specific research questions show greatest promise for advancement. o R21 grants may also include pilot studies, with subjects drawn from clinical, high-risk, and/or non-clinical populations, in order to demonstrate feasibility of certain aspects of the research approaches and develop further translational research projects. o R21 grants may provide for salary support for faculty, research assistants, and other professional staff involved with the project. o Each exploratory grant should present a description of the anticipated longer-term goals of the collaboration as it develops. Such goals might variously include an application for a resource development grant (R24), an R01-based research collaboration, or a larger center mechanism. Part B: R24 Grants for Translational Research Development The primary purpose of these larger R24 resource-related grants is to provide support for enhancing the capability to conduct translational research. As such, it is expected that the primary components of these projects will involve activities designed to foster the development of appropriate resources that support the initial implementation of research capabilities and feasibility studies. Resources may be both physical (e.g., a laboratory at a clinical site where paradigms derived from basic science can be used with patient subjects) and/or scientific (e.g., development of needed methodologies, paradigms, assessment instruments, etc.). These developmental activities will have the following characteristics: o The principal investigator must have demonstrated the capability to organize, administer, and direct collaborative, interdisciplinary research activities, and show a minimum time commitment of 20 percent. Other investigators must also allot a percentage of effort that is commensurate with their role in the project. o A development project is expected to include a group of investigators who integrate ideas from diverse scientific and disciplinary realms. While it is not necessary that all members of the project have independent research funding, investigators are expected to demonstrate a strong record of scientific productivity and innovation. o The investigators are expected to develop a specific set of hypotheses related to translational research that define the mission of the project. The project should address relevant theoretical and empirical literature in both the basic and clinical/services areas to be studied, and identify the goals of the translational research effort. o The project may develop methodological and/or statistical capabilities in a range of areas. Such methodologies could be developed initially in basic research areas, and then applied to issues in clinical or services research. o The project may include plans for the common reduction, management, and analysis of data across multiple activities and sites. Such work would be directed toward facilitation of comparing multiple data sets, and allowing direct comparisons of databases from clinical and non-clinical populations. o As part of the developmental activity, seed money and start-up funds may be requested to support new, innovative pilot projects that reflect: (1) research that is needed to facilitate the development of basic behavioral science to prime its relevance to applied research, and (2) research in clinical and/or services domains that incorporates the theories and/or methods of basic behavioral science. o Resource development projects are encouraged to include opportunities for young investigators to be mentored in one or more areas of specialization, with emphasis on the application of basic research principles to clinical or services issues. Projects are encouraged to make maximum use of the variety of mechanisms available to foster the development of scientists with expertise in translational research (e.g., minority supplements, mentored K awards). o The goal of a project of this type is to support the development of a significant potential for conducting innovative translational behavioral science research. Accordingly, the project should clearly describe the scope and goals of intended future work, including scientific goals and anticipated mechanisms of support (e.g., Collaborative R01 submissions, centers) that are anticipated to emerge from the developmental process. Plans for future work should include a description of anticipated research
apprenticeship opportunities. Research Topics The following are examples of broad research topics that might be the focus of translational research. This list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. o Research pertaining to the factors that maintain the engagement of patients with treatments for mental disorders, including drug abuse or addiction, whether psychosocial or pharmacologic o Studies of cognitive, attentional, and/or emotional processes in attention- deficit/hyperactivity disorder o Research devoted to an understanding of the nature of specific functional deficits in mental or drug abuse disorders (e.g., deficits in attention, memory, emotion-regulation, social interactions and relationships), and development of targeted interventions for rehabilitation and relapse prevention o Research regarding neurocognitive and emotional functioning related to severely disabling mental disorders or drug abuse, such as schizophrenia, bipolar illness, depression, and addiction o Studies of cultural factors involved in the diagnosis, prevention, treatment, and delivery of services in mental disorders, including drug abuse and addiction o Research regarding behavioral and neurodevelopmental factors in disorders characterized by impaired affiliative behavior and social functioning such as autism and schizophrenia o Studies of decision making as it affects the behavior of patients and providers in mental health or drug abuse services settings MECHANISMS OF SUPPORT Part A: R21 Exploratory Grants This application will use the National Institutes of Health (NIH) Exploratory Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted for the R21 mechanism in response to this PA may not exceed 3 years. Applicants must clearly specify in the application which mechanism is being requested. For the R21 grant, 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, this award is nonrenewable. Direct costs of up to $150,000 per year may be requested to allow for facilities and administrative (F&A) costs on consortium arrangements. This mechanism uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). You are required to use the modular format for the R21 mechanism. Part B: R24 Grants for Translational Research Development This application will use the National Institutes of Health (NIH) Resource- related Research Project Grant (R24) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted for the R24 mechanism in response to this PA may not exceed 3 years. Applicants must clearly specify in the application which mechanism is being requested. The R24 mechanism is used to support research projects that will enhance the capability of resources to serve biomedical research. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $225,000 per year, excluding F&A costs on consortium arrangements, this award is also nonrenewable, and is not transferable to another institution. Applicants may request up to an additional $75,000 per year for such items as per-patient costs in services settings or neuroimaging charges, these additional funds must be strongly justified, and not used simply to augment the scope of the project. Regardless of budget amount, this mechanism uses the traditional, non-modular budget format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic only o Faith-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. SPECIAL REQUIREMENTS Any research project which involves a Phase I or Phase II Clinical Trial must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures, each project is further required to include a Data and Safety Monitoring Plan. See the Federal Citations section, below, for further information and references. 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Bruce N. Cuthbert, Ph.D. Adult Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6184, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: bcuthber@mail.nih.gov Lisa Onken, Ph.D. Behavioral Treatment Development Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4241, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-2235 FAX: (301) 443-6814 Email: lo10n@nih.gov Herbert Weingartner, Ph.D. Translational Research Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1321 FAX: (301) 594-6043 Email: herbw@nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Chief, Extramural Review Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: (301) 594-0702 Email: mkozak@mail.nih.gov o Direct your questions about financial or grants management matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3119, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.nih.gov SUBMITTING AN APPLICATION Page limits for the research plan (sections a-d): R21 Exploratory Grants: 15 pages R24 Grants for Translational Research Development: 25 pages Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All R21 applications 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. 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 must be sent to: Jean G. Noronha, Ph.D. NIMH Referral Liaison National Institute of Mental Health 6001 Executive Blvd, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@nih.gov APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates indicated on the first page. 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. 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 by NIMH in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project and to the type of application, i.e., R21 or R24? 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: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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) DATA SHARING: The adequacy of the proposed plan to share data, where relevant to the proposed work. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: Given the requirement for explicit collaborations between basic and clinical researchers, and the differences among the two mechanisms, the following review criteria are also to be used in evaluating applications submitted under this PA. SIGNIFICANCE: What is the application"s overall judged potential to contribute to substantive progress in clinical research through the application of the behavioral science area(s)? This potential will depend on three factors, to which approximately equal weighting should be given: the quality of the basic research that is being translated, the strength of the clinical research team and their ability to implement the basic research, and the appropriateness of the basic science area and paradigms to the clinical research problem. An important aspect concerns the experience of the basic research team with the approach that is being developed, and the experience of the clinical investigators with the clinical population and problem that is to be investigated. INNOVATION: What is the potential of the research to foster significant advances in understanding, developing new interventions, or providing services for the disorder(s) being investigated? APPROACH: The type of mechanism should be considered in evaluating the approach, as follows: Part A: R21 Exploratory Grants o The R21 exploratory grant essentially involves a group of investigators convening to discuss possible areas of translational research. This mechanism does not require any pilot data, nor any extensive research plans, evaluation primarily involves the likelihood of how successful the collaboration might be, given the background and prior work of the investigators, plans for the work that is proposed, and the promise of the basic science area for the clinical research. Part B: R24 Grants for Translational Research Development o The resource development R24 will typically involve development of both laboratory resources and scientific capabilities, accordingly, the R24 also does not require extensive pilot work, and the experiments that are proposed are to be of a large-scale pilot nature. It is not necessary for the investigators to have worked out in full all of the details of the procedures this is the point of the application, however, it should appear likely that these procedural and/or paradigmatic aspects can be worked out, and that the subsequent full-fledged experiments would make a substantial contribution. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (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. 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 No. 93.242 (NIMH) and 93.279 (NIDA), 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 administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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