and Human Services (HHS)
EXPIRED
TRANSLATIONAL RESEARCH GRANTS IN BEHAVIORAL SCIENCE RELEASE DATE: February 12, 2002 PA NUMBER: PA-02-061 EXPIRATION DATE: February 10, 2005, unless reissued. PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives Background General Characteristics Research Topics o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 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. 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 who have a specific translational research question, and sufficient pilot data to warrant an R01 research project grant or investigator-initiated Collaborative R01. Investigators who are in the earlier, formative stages of the collaborative research process may wish to consider PAR-02-062, "Building Translational Research in Behavioral Science," (http://grants.nih.gov/grants/guide/pa-files/PAR-02-062.html). General Characteristics 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. The primary purpose of these R01 grants is to support fully implemented research projects with a translational focus. Applications submitted with a single principal investigator will be expected to include one or more additional investigators forming a collaborative team that includes basic and clinical/services expertise, clearly defining the roles of all investigators in the translational research, for investigators at multiple institutions, the collaborative arrangements will typically be indicated via one or more consortium/subcontract arrangements. The NIMH Collaborative R01 mechanism may also be used for investigators at two or more institutional sites, with a separate principal investigator for each constituent R01 application. R01 research projects will have the following characteristics: o Translational grants must include one or more components of basic behavioral science. The inclusion of relevant physiological measures, in addition to concepts, paradigms, and theories drawn from basic behavioral science, is encouraged but not required. o The principal investigator of a single-R01 project may be an individual with a primary research background in either basic or clinical/services areas. Submissions using the Collaborative R01 mechanism may include one or more separate R01 applications in each of the basic and clinical/services domains. o The clinical or services component of the proposed application may include any aspect of relevant work. This component is to include research with patient populations, that is, studies conducted with persons diagnosed with mental disorders, including drug abuse and addiction, or with organizations that provide mental health or drug abuse services. The clinical/services research program will reflect the contributions of basic behavioral science, including concepts, principles, extant literatures, paradigms, measures, statistical approaches, etc., integration of comparable work from neuroscience is also encouraged where appropriate. It is important to show the potential of the research to foster significant advances in understanding, developing new interventions, or providing services for the disorder(s) being investigated. o The clinical or services component of the proposed application must focus on populations in need of treatment or services for the symptoms and/or functional deficits associated with mental disorders and/or drug abuse. o The basic behavioral science component must represent a meaningful contribution to the overall program of research, rather than serving a limited consultative role. Although not required, this component could include an active program of experimentation, methodological or statistical development, or other scientific work that is relevant to the clinical/services application. These efforts might involve initial studies laying a necessary groundwork for projects with clinical/services populations, and/or studies to address basic research questions arising from results with samples drawn from clinical or services settings. Basic behavioral studies typically involve non-clinical populations, but may also involve high-risk populations. o Each application must demonstrate the ability to translate and integrate data between basic and clinical studies. Each component must demonstrate the ability to inform, and be informed by, the results of the other component(s). 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 MECHANISM OF SUPPORT This application will use the National Institutes of Health (NIH) Research Project Grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this PA may not exceed 5 years. Applicants must clearly specify in the application which mechanism is being requested. A translational research project (R01) may involve either a single Principal Investigator or a group of investigators using the Collaborative R01 mechanism, applicants may request a project period of up to 5 years, with a budget determined by the work proposed. Applicants for the Collaborative R01 Grant are strongly encouraged to familiarize themselves with the NIMH announcement (http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) and direct questions to program staff listed in this announcement. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an R01 application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. 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 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: 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 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 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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of 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? 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. 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. 93.3242 (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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