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IMAGING – SCIENCE TRACK AWARD FOR RESEARCH TRANSITION (I/START) RELEASE DATE: February 6, 2002 PA NUMBER: PAR-02-058 EXPIRATION DATE: May 14, 2005, unless reissued PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) Application receipt date is May 14, 2002 with next receipt date of October 1, 2002; standard receipt dates thereafter. THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Funds Available 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 Citation PURPOSE OF THIS PA The National Institute on Drug Abuse (NIDA) seeks to facilitate the entry of new investigators in the area of brain imaging/clinical neurobiology research. This Program Announcement invites applications for the Imaging Science Track Award for Research Transition (I/START) program, which is a new program developed by NIDA to foster new investigators in areas of brain imaging and drug abuse research. The application of brain imaging has become widespread; however, it is sometimes difficult for new investigators to obtain independent funding in this area. In many research domains, junior investigators are given institutional support sufficient to conduct preliminary studies. However, in contrast, the costs of obtaining preliminary data for clinical neurobiology techniques such as brain imaging (e.g., PET and MRI scans) often serve a prohibitive barrier to starting investigators. This award will allow for the design and collection of "proof of concept" brain imaging data that can then be used in the transition to more extensive research proposals. The I/START program uses a brief application form and a rapid review process to ensure expedited funding decisions. Funding is limited to direct costs for one year of up to $150,000 and is non-renewable. RESEARCH OBJECTIVES All areas of research dealing with the clinical neurobiology of drug abuse and addiction and encompassing a wide array of research studies that incorporate brain imaging are sought under this announcement. Areas of interest that would allow preliminary data to be obtained within the I/START time and budget requirements include, but should not be limited to: (a) the neurobiology of addiction and the assessment of structural and/or functional alterations due to drug abuse and the addiction process; (b) neurobiological effects on human development/maturation due to prenatal or adolescent drug exposure; (c) neural mechanisms underlying cognitive processes that are altered by drugs of abuse; (d) neural mechanisms of cognitive or behavioral processes that may contribute to the initiation, progression/maintenance, or relapse to drug abuse/addiction; (e) neurobiological basis of individual differences in response to drug of abuse including differences in transition from drug use to addiction; (f) assessment of neurobiological changes resulting from pharmacological and/or behavioral treatment for drug abuse/addiction; (g) neurobiological and neurobehavioral factors underlying comorbid mental and addictive disorders; (h) characterization of interactions between drug abuse/addiction and HIV infection on brain; and (i) neurobiological processes involved in human pain and analgesia. Research proposed under the I/START program need not be conducted in drug- abusing populations or involve drug administration; however, the potential relevance to understanding drug abuse needs to be established. MECHANISM OF SUPPORT This PA will use the NIH Small Grant (R03) award mechanism. For this specific announcement, an award may not exceed $150,000 in direct costs and is for a period of one year only. The award is not renewable. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This PA uses the just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE NIDA estimates that approximately $1 million in total funds will be available under this PAR in FY2002. It is expected that this program would continue in subsequent fiscal years at about the same funding level. ELIGIBLE INSTITUTIONS You may submit an application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to conduct the proposed research is invited to work with his or her 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. To be eligible for an I/START award, the proposed principal investigator must be independent of a mentor at the time of award and be at the beginning stages of her/his research career. The proposed principal investigator may not have been supported previously as principal investigator on a National Institutes of Health (NIH) or federally supported research project or component (except a dissertation research grant or a Small Grant award/R03) or have received similar support from another federal agency; e.g., the National Science Foundation. Previous receipt of a National Research Service Award Individual Fellowship and of mentored K-awards is permissible. Individuals in their last year of training status may apply so long as they will be independent investigators at the time of the I/START award. Because this program is targeted at newly independent investigators, individuals who are more than five years beyond training status should consider other mechanisms of support. SPECIAL REQUIREMENTS Because this announcement targets newly independent investigators, this mechanism is ideal for obtaining preliminary data that could serve as the basis for a subsequent grant application using other mechanisms of support. Therefore, under this PA, inclusion of preliminary data is not a requirement and is not encouraged. Resubmission of an I/START application is not permitted. Also, the principal investigator on an I/START award may not be replaced. Transfer of an I/START award with the principal investigator to another institution may be requested, as needed. 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: Joseph Frascella, Ph.D. Chief, Clinical Neurobiology Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4237, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-4877 Fax: (301) 443-6814 Email: jf80t@nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 E-mail: tl25u@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 E-mail: gf6s@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) 435-0714, e-mail: GrantsInfo@nih.gov. Before submitting an application, investigators are strongly encouraged to contact the program contact listed under INQUIRIES in order to assess the responsiveness of their proposed project to the mission of NIDA and to the goals of this PA. Sections a-d of the Research Plan must not exceed 10 pages in total. Appendix material may not be submitted. APPLICATION RECEIPT DATES: In 2002, the first receipt date will be May 14th; the next will be October 1, 2002; and subsequent receipt dates will follow 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. 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) To permit an expedited review of the applications, applicants must simultaneously send two additional copies of the application to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt date of May 14, 2002; all subsequent submission dates are 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 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 assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse 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 reviewers 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. (1) SIGNIFICANCE: Does this preliminary study address an important problem? If the aims of this application were achieved, how would they be used to advance to the next level of a more comprehensive study? (2) APPROACH: Are the conceptual framework, design, methods, and analyses well integrated and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative approaches? A strong rationale, conceptual framework, and appropriate method could be considered sufficient for establishing the feasibility of the project, in lieu of preliminary data. (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project provide a firm basis for challenging existing paradigms? (4) INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? (5) ENVIRONMENT: Does the scientific environment in which this 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). BUDGET: The reasonableness of the proposed budget. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Appropriateness to the goals of the I/START program o Availability of funds and program priority 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. 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 the recommendations of the Council 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 Funding or may be obtained by calling (301) 443-2755. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE Researchers funded by NIDA who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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. 93.279, 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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