RFA-DA-00-005: BASIC BEHAVIORAL, COGNITIVE, AND NEUROLOGICAL RESEARCH: APPLICATIONS TO HIV/AIDS AND DRUG ABUSE

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BASIC BEHAVIORAL, COGNITIVE, AND NEUROLOGICAL RESEARCH: APPLICATIONS TO HIV/AIDS AND DRUG ABUSE Release Date: December 16, 1999 RFA: DA-00-005 National Institute on Drug Abuse Letter of Intent Receipt Date: February 29, 2000 Application Receipt Date: March 29, 2000 THIS REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT AND JUST-IN- TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) requests applications for research projects in the basic behavioral, cognitive, and neurosciences that can address the complex relationship between drug abuse and addiction and HIV/AIDS transmission and progression. Basic research is needed to characterize the antecedent variables and processes, such as psychosocial and emotional factors and decision processes, associated with increased risk for contracting HIV/AIDS and to determine the neurological, immunological, behavioral, and cognitive consequences potentially caused by combined effects of the virus, drugs of abuse, drug abuse pharmacotherapies, and/or anti-HIV medications. HIV can cause a cascade of neuroimmune processes that have profound and potentially toxic effects on the brain. Because drugs of abuse can also have adverse effects on neuronal and immune function and, in some cases, can cause cell death, it is important to characterize the changes in neuronal and neuroimmune function and the related cognitive and behavioral changes associated with disease progression and drug abuse. In addition, the recent development of anti-HIV medications requires adherence to complex medication regimens. It is important, therefore, to understand the basic cognitive and behavioral processes associated with treatment compliance, the influence of drug abuse and addiction on these fundamental processes, and changes in brain function associated with level of adherence. Overall, basic research in these areas will lead to a better understanding of the effects of HIV/AIDS and drugs of abuse on behavioral, cognitive, and brain function, which will aid in the development and refinement of treatment and prevention interventions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS- led national activity for setting priority areas. This RFA, BASIC BEHAVIORAL, COGNITIVE AND NEUROLOGICAL RESEARCH: APPLICATIONS TO HIV/AIDS AND DRUG ABUSE, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Awards to foreign institutions under R-series awards are generally limited to 3 years. MECHANISMS OF SUPPORT The mechanisms of support will include the investigator-initiated research project grant (R01), small grant (R03), and exploratory/developmental (R21) grant. In addition, competitive supplements to add a research component to an existing grant will be eligible. Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information and specific application procedures. For research in methods development, the R03 or R21 mechanisms are particularly appropriate. The small grants (R03) are limited to 2 years and exploratory/developmental (R21) grants are limited to 3 years. Both are non- renewable and limited in direct cost amount per year (R03, $50,000; R21, $100,000). The R03 mechanism gives funding priority to newer, less experienced investigators, investigators at institutions without well- developed research traditions and resources, or experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific information on individual research mechanisms can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html. Support may be requested for a period of up to 5 years for R01 grants and shorter periods of time for the other mechanisms. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Modular budgeting procedures apply for grants under $250,000. See http://grants.nih.gov/grants/funding/modular/modular.htm for further information about modular budgets. The anticipated award date is September 30, 2000. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applications judged to be nonresponsive to the RFA will be returned to the applicant. FUNDA AVAILABLE It is anticipated that 10-12 awards may be funded in FY2000 at a total cost of $2 million. RESEARCH OBJECTIVES Background: It is well established that drug abuse is a major risk factor for contracting HIV/AIDS. In the context of drug abuse and addiction, research is needed to enhance our understanding of the behavioral and cognitive antecedent variables associated with HIV transmission. Basic behavioral and cognitive science research can enhance our understanding of the complex interrelationship between drug abuse and addiction, impulsive and risk-taking behaviors, and decision-making processes that can lead to contracting the virus. Basic behavioral and cognitive science research using either animal models or involving human volunteers that examines fundamental aspects of risk behavior and related decision processes is encouraged. However, the applicant would need to provide a clear statement indicating how proposed research might advance the understanding of reducing risk behaviors associated with injection drug use and other drug abuse related risky behaviors associated with HIV transmission. Understanding these fundamental processes will lead to a better understanding of decisions, attitudes, beliefs, and behaviors involved in unsafe needle sharing and in risky sexual encounters, for example. Once these fundamental processes are understood, steps can be taken to modify or reduce their occurrence. Information gained from basic research in this area will aid in developing and refining prevention interventions. Little is known about potential neuropathological, and neuroimmune changes produced by the combination of the virus and drugs of abuse. In addition, research is needed to determine (1) the effects of the various combinations of anti-HIV medications, drug abuse pharmacotherapies, and drugs of abuse on behavioral, cognitive, neurological, and disease processes; (2) how virus exposure, anti-HIV medications and drugs of abuse, and/or drug abuse pharmacotherapies affect behavioral, cognitive, neural development, and immune system following prenatal exposure; and (3) how the virus progresses in the central nervous system and how this disease progression affects drug seeking, subjective effects of drugs of abuse, or drug withdrawal. Approaches using animal models of HIV [e.g., transgenic animal models, SIV, FIV, severe combined immunodeficient (SCID) mice, or other animal models related to HIV/AIDS] would be most appropriate for studying the consequences of HIV/AIDS progression and drugs of abuse on basic behavioral, cognitive, and brain function. For the study of neural and neuroimmune processes, in vitro models would also be appropriate. For some aspects of this research, less invasive studies involving human volunteers may also be appropriate. Recent advances in effective treatment for the HIV/AIDS virus often involve strict and complex anti-HIV medication regimens. Research is needed to determine the fundamental behavioral and cognitive processes that underlie and may ultimately optimize adherence to anti-HIV medication regimens. Importantly, basic research is needed in order to assist in the development of effective behavioral and cognitive strategies and approaches to improve adherence to medication regimens in substance abusing or substance-abuse treatment populations. Basic behavioral and cognitive science research does not need to directly study adherence to medications, but rather could study fundamental behavioral and cognitive processes that may have potential application to the design and development of anti-HIV medication adherence protocols. Basic research is also needed to determine how drug abuse and/or drug abuse pharmacotherapies, and level of adherence to retroviral medications, influence or modulate behavioral, cognitive, neural, and neuroimmune processes. Information gained from basic research will prove valuable for developing and refining rehabilitation and treatment interventions. Illustrative examples of research within the scope of this RFA are outlined below. The following examples serve as a guide and are not meant to subsume all research topics that would be appropriate under this RFA. - Identify and determine the importance of antecedent variables, such as drug use patterns, episodes of craving, attitudes toward injection drug use and HIV/AIDS, and psychosocial and emotional factors that lead to increased (or reduced) risk taking, impulsivity, and discounting as they relate to contracting HIV/AIDS. - In the context of drug abuse and addiction, develop basic behavioral and cognitive approaches or interventions that may improve compliance and adherence to anti-HIV medication regimens. - Characterize the cognitive and behavioral deficits associated with the combined effects of drug abuse and HIV/AIDS progression, and explore and evaluate the effects of cognitive and behavioral rehabilitation procedures on reversing these deficits. - Using animal models of HIV, study changes in neural, and cognitive function, and/or behavior, as a function of infection progression, its interaction with drugs of abuse, and environmental factors (e.g., social hierarchy, exposure to acute or chronic stress) - Assess combined effects of anti-HIV medications and drugs of abuse and/or pharmacotherapies (e.g., methadone) on basic cognitive, behavioral, and neural function. - Use animal models of HIV (e.g., SIV, FIV, transgenic animal models, or other animal models as they relate to HIV/AIDS) to determine the effects of the infection on drug self- administration and subjective effects of drugs of abuse. - Assess the effects of prenatal exposure to anti-AIDS medications and drugs of abuse on behavioral and cognitive performance, neural development, and the immune system. - Study the neuro-toxic interactions associated with drugs of abuse and HIV and/or other appropriate lentiviruses. - Examine the effects of drugs of abuse and viral action on the regulation and expression of chemokines and cytokines, and their relevance to pathogenesis. - Study the apoptotic actions of HIV, especially its effects on lymphocytes, macrophages, and glia, and determine if drugs of abuse modulate these effects. - Study the role of drugs of abuse on macrophage transport of HIV-type lentiviruses to target sites. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's home page at http://www.nida.nih.gov under "What's New" or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit by February 29, 2000, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions; and the number and title of the RFA in response to which the application is being submitted. A letter of intent is not required, is not binding, and does not enter into the review of a subsequent application. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. When applying under mechanisms other than the R01, the applicants should obtain a copy of the relevant announcement from the Grants Management Branch at NIDA (301-443-6710), or NIDA's home page (http://www.nida.nih.gov). These announcements contain instructions for the preparation of grant applications that must be strictly adhered to, as well as other useful information. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the Form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last 3 years; and - List selected peer-reviewed publications, with full citations. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 Item 2 of the face page of the application form and the "YES" box must be marked. The RFA number must be typed on the label as well. The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (courier/delivery service) Applications must be received by March 29, 2000. If an application is received after that date, it will be returned to the applicant without review. 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the CSR and for responsiveness by NIDA. Applications judged to be incomplete and/or non- responsive to the RFA will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Small grant applications (R03) do not receive a second-level Council review. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (For the R21 mechanism, a strong rationale and conceptual framework are normally sufficient for establishing the feasibility of a project, in lieu of extensive preliminary data.) (3) Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research, or justification for exclusion. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. Schedule Letter of Intent Receipt Date: February 29, 2000 Application Receipt Date: March 29, 2000 Peer Review Date: Summer 2000 Council Review: September 2000 Earliest Start Date: September 30, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit (as determined by peer review), availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David Shurtleff, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: ds171a@nih.gov Applicants who may be interested in applying topics in this RFA to clinical issues may contact: Sander Genser, M.D., M.P.H. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 443-1801 FAX: (301) 443-6566 Email: sg73f@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 443-6847 Email: gf6s@nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285), and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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