and Human Services (HHS)
EXPIRED
This Program Announcement expires on November 30, 2004 unless reissued. STATISTICAL METHODS IN HIV/AIDS RESEARCH Release Date: November 29, 2001 PA NUMBER: PA-02-024 (see amendment NOT-AI-04-038) National Institute of Allergy and Infectious Diseases National Institute of Mental Health THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), invite applications for the development of original statistical methods to advance the understanding, treatment, and prevention of human immunodeficiency virus (HIV) disease/AIDS. NIH Support of Research on this Topic Although this Program Announcement is being issued by NIAID and NIMH, the other components of NIH listed below also have an interest in and support research on the topics covered. Applicants may wish to contact each of these NIH components listed in INQUIRIES to find out about other funding opportunities. Institutes and Centers at NIH use different grant mechanisms to support their portfolio of research; the components listed here may not use all of the mechanisms specified for this Program Announcement. NCRR: Mathematical models of basic biological processes. NCI: Epidemiology of AIDS/retroviral-associated cancers. NICHD: Statistical methods and designs for analyzing the determinants of sexual behavior related to HIV risk and the impact of interventions to modify sexual behavior, including techniques to improve the accuracy of self-report data; demographic approaches to modeling the spread and impact of HIV within the population. NIDA: Mathematical models of transmission related to drug abuse and effects of behavioral prevention programs. Applications submitted in response to Program Announcements are assigned according to established PHS referral guidelines. When the subject of an application is of interest to more than one component of NIH, dual assignments are made. 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 Program Announcement (PA), "Statistical Methods in HIV/AIDS Research", is related to the priority areas of HIV infection, sexually transmitted diseases, immunization and infectious diseases, and surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01 and R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/01). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. A notice of modification and update (OD-00-046) regarding modular grants was released on 7/24/00 and can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html. RESEARCH OBJECTIVES Background The AIDS epidemic has posed unique challenges for the design of therapeutic and prevention trials, and epidemiologic and basic science studies, and for the analysis of data resulting from each of these. New statistical methods have been developed to handle such problems as the tracking and prediction of number of AIDS cases, the use and assessment of immunologic and virologic measurements, and the analysis and monitoring of clinical trials with censored and missing data. Recent years have seen an increasing array of available drugs, diversity of affected populations and viral characteristics, and an increased appreciation of the dynamic, multivariate, and multiphasic nature of HIV disease. Research in this changing and ever more complex environment presents great methodological challenges. Research Objectives and Scope Innovative statistical methods are expected to continue to play an important role in the investigation of new AIDS therapies and prevention strategies. Such methods need to be attuned to the particular features of HIV/AIDS biology and epidemiology. The evolving circumstances of the epidemic and the expanding set of research tools also need to be considered. For instance, new and improved statistical methods are needed for the effective utilization of immunologic and virologic measures, for explaining the relationship between surrogate markers and clinical outcomes and for making decisions on when to start and switch treatment. Developments of such statistical methods provide new approaches for evaluation of HIV therapies and vaccines, and the study of HIV transmission and pathogenesis. NIH guidelines for the use of antiretroviral agents provide a backdrop for the design of ethical clinical and prevention trials, but questions remain in the use of highly, though not universally, effective treatment regimens. Little is known, for instance, on how to optimally use virologic and other laboratory measures in decisions about when to start and when to switch therapy and the sequence of regimens. The appropriate and efficient utilization of multiple endpoints, clinical as well as laboratory, in efficacy studies needs further consideration. Mathematical models have provided some clues for effective treatment strategies, but further development is required to capture enough features of disease dynamics to produce reliable and relevant inferences. The areas of research listed below are not all-inclusive, but are intended to provide guidance as to the types of research that are of interest. 1. Design and analysis of novel clinical trials involving, for example, multiple or combined endpoints, treatment changes or multicomponent treatment strategies, or sequential evaluation of therapies 2. Trial designs for the evaluation of HIV vaccine candidates and other interventions such as STD diagnosis and treatment, behavioral counseling, microbicides, chemoprophylactic agents, and antiretroviral therapy which assess the indirect as well as direct effects of intervention 3. Statistical methods for assessing the impact of HIV genetic and antigenic variation on the effectiveness of HIV vaccines 4. Design and analysis of explanatory clinical studies, for example, nested studies within clinical trials to explore questions regarding HIV pathogenesis or to assess the validity of biological markers such as viral load as surrogate endpoints 5. Statistical methods to assess the timing and correlates of HIV perinatal transmission and to address unique features of pediatric HIV disease 6. Design and analysis of early stage therapy studies (including preclinical studies and Phase I and II clinical trials) for the efficient screening and evaluation of drugs, drug combinations, or doses 7. Mathematical or statistical modeling of HIV pathogenesis including acute infection, resistance, interactions among multiple pathogens, and the course of HIV disease 8. Mathematical or statistical modeling of the potential population- level effects of HIV vaccination programs and other prevention strategies on the control of HIV transmission 9. Design of animal challenge studies for assessing the effects of HIV (or analogous) vaccines and chemoprophylactic strategies 10. Methods for the statistical evaluation of data quality in large, multicentered clinical trials 11. Mathematical or statistical modeling of HIV transmission and spread within at-risk populations 12. Design and analysis of Phase I and II safety and immunogenicity studies of HIV vaccine candidates 13. Improved methods for obtaining self-report data and use of multiple methods (e.g., behavioral and biological) to establish psychometrics 14. Improved methods for assessing family systems and social networks, and data analysis strategies for multiple data points in longitudinal studies of family and social systems 15. Mathematical models using available seroincidence data for linking behavioral change with reduction in HIV transmission at different levels of seroprevalence and social mixing To address these issues, a multidisciplinary approach is strongly encouraged. The mathematical/statistical modeling of the potential impact of HIV vaccination, for example, would benefit from a research team, which includes persons with expertise in demography, STD control, behavioral science, and vaccine development, in addition to statistics and/or mathematics. TERMS AND CONDITIONS OF AWARD When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. Terms and Conditions of Award will be included with awards. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf 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 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 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 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 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 Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 the following website: 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/01) at http://grants.nih.gov/grants/forms.htm must be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: [email protected]. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard 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 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 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? (3) Innovation: Does the project employ novel concepts, approaches or method? 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. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the requested budget and the requested period of support as it relates 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Misrak Gezmu, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Room Number 4242, MSC-7620 6700-B Rockledge Drive Bethesda, MD 20892-7620 Telephone: (301) 435-3722 FAX: (301) 402-0145 Email: mailto:[email protected] Willo Pequegnat, Ph.D. Office on AIDS Research National Institute of Mental Health Parklawn Building, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: [email protected] Direct inquiries regarding fiscal matters to Mary Ledford Grants Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B24 Bethesda, MD 20892-7610 Telephone: (301) 402-6446 FAX: (301) 480-3780 Email: [email protected] Other NIH Institutes and Centers with related research interests: Christine A. Bachrach, Ph.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, MD 20892-7510 Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: [email protected] Vaurice Starks, M.S. Analytic Epidemiology Research Branch Division of Cancer Control and Population Sciences Executive Plaza North, Room 5103 6130 Executive Blvd. MSC 7324 Bethesda, MD 20892-7395 Telephone: (301) 402-9375 FAX: (301) 402-4279 Email: [email protected] Dr. Peter I. Hartsock Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse National Institutes of Health 6001 Executive Boulevard, Room 5198 Bethesda, MD 20892-9593 Phone: (301) 402-1964 Fax: (301) 480-4544 email: [email protected] Michael C. Chang, Ph.D. Comparative Medicine National Center for Research Resources National Institutes of Health One Rockledge Center, Room 6174 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. The PHS strongly encourages all grant and contract 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, and 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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