INNOVATION GRANT PROGRAM: APPROACHES IN HIV VACCINE RESEARCH RELEASE DATE: March 20, 2003 PA NUMBER: PA-03-082 (This PA has been reissued and modified, see PA-06-109) RECEIPT DATE Standard AIDS Receipt Date EXPIRATION DATE: December 23, 2005 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research No. 93.121, Oral Diseases and Disorders Research THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) 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 This program announcement (PA) is a continuation of the Innovation Grant Program for AIDS Vaccine Research, implemented by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), on the recommendation of the AIDS Vaccine Research Working Group (AVRWG). This program encourages the entrance of novel and innovative vaccine discovery and development concepts into the research pipeline. As such, the emphasis of this program is on supporting prophylactic vaccine research projects that are particularly innovative, novel, may be high risk/high impact, and that exhibit the potential to advance AIDS prophylactic vaccine design or evaluation. Applications are especially welcome from both experienced investigators not currently active in the field of AIDS research, and from young investigators beginning their work in this field. The Innovation Grant Program uses a grant mechanism that provides funding for projects that are exploratory and that are intended to generate preliminary data for further studies. Applications targeting any scientific area(s) related to AIDS prophylactic vaccine research are encouraged. Before application receipt dates, scientific areas of particular programmatic interest may be posted on the NIAID website http://www.niaid.nih.gov/daids/vaccine/innovation.htm. Periodically, these areas are chosen based on advice received from the AIDS Vaccine Research Working Group (AVRWG), and emerge from meetings, workshops, and discussions with program staff. Applicants are strongly encouraged to contact program staff and visit the website before submitting an application. Applications for research aimed at targeted areas are especially encouraged, but applicants are not required to focus on only those areas. RESEARCH OBJECTIVES All pertinent areas of investigation contributing to the development of an efficacious HIV/AIDS vaccine are welcome. These might include but are not limited to: methods to enhance antigen presentation/ processing; structural studies of HIV proteins as related to their antigenicity; nucleic acid vaccination; recombinant virus vectors; pseudovirion approaches; analyses of correlates of immunity; approaches to enhance HIV vaccine-induced immunologic memory; development of improved assays for antibody neutralization, CTL or other immune responses; vaccine approaches that target developing stronger mucosal immunity; strategies that use oral or nasal mucosa as the vaccination route; mobilizing antigen presenting cells to vaccination sites; strategies to induce broadly reactive neutralizing antibodies to primary isolates; determining vaccine effects during concurrent/inter-current infections (e.g., TB and malaria) common in HIV endemic areas; vaccine approaches exploring innate immunity, the use of biological adjuvants, and regulatory T cell responses. Research applications intended to produce preliminary data or precedent for a new idea or concept are particularly encouraged. Vaccine research focused solely on therapeutic applications is not within the scope of this program announcement. The safety evaluation of immunogens in infected animals or people can be included if these studies directly support the development of a prophylactic vaccine. For information on programs that support therapeutic vaccine development please contact program staff. MECHANISM OF SUPPORT This PA will use the NIH Exploratory/Developmental Research Project Grant (R21) award mechanism. The total requested project period for an application submitted in response to this PA may not exceed two years. The applicant will be solely responsible for planning, directing, and executing the proposed project. NIAID uses R21 grants to provide short-duration support for preliminary studies of a highly speculative nature, which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. This PA uses the just-in-time procedure for certain information. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, applications with direct cost budgets of $250,000 or less in each year must use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Applicants to this specific PA may request up to two years of support limited to $150,000 per annum in direct cost. Thus, applicants will request direct costs in $25,000 modules, up to a total of $150,000 direct cost per year. Current policy limits support of R21 grants to two years with no extensions or supplements. However, awardees may request no-cost extensions, if appropriate, nearing completion of the second year. A typical modular grant application requests the same number of modules in each year. The applicant is solely responsible for planning, directing, and executing the proposed project. Though applicants may request up to two years of support and up to $150,000 per annum in direct costs, exceptions can be made, with compelling justification. Examples of what might warrant exception would be the necessity for specific costly reagents, animals, specimens, or laboratory modifications to perform the studies. Program staff may be able to advise prospective applicants concerning NIAID- and NIDCR-sponsored resources that may be available to them. Contact the program staff listed under WHERE TO SEND INQUIRIES for further information. This award is non-renewable. However, it is hoped that successful grantees funded through this exploratory/developmental research program will elect to seek continuing support for research further along the development pipeline through R01or P01 grant mechanisms utilized by the HIV Vaccine Research and Development Program and/or the Integrated Preclinical/Clinical AIDS Vaccine Development Program. ELIGIBLE INSTITUTIONS The applicant may submit (an) application(s) if the 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 o Faith-based or community-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 under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Awardees may be expected to attend a meeting convened by NIAID and NIDCR to showcase the progress of the work funded under this program. Details of this meeting will be provided post-award. Thus, applicants should include in their budget request funds for the PI to attend one two-day meeting in the Washington, DC area over the two-year performance period of the 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. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/ NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. WHERE TO SEND INQUIRIES We encourage 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. The NIAID Division of AIDS (DAIDS) has a website (http://www.niaid.nih.gov/daids/vaccine) for AIDS vaccine research with an emphasis on facilitating applications for AIDS vaccine research funds and access to other resources available to AIDS vaccine investigators through the Division. The website has information describing the various programs targeting AIDS vaccine research and listings of currently active AIDS vaccine-related program announcements and contracts and their associated deadlines. Updates concerning the continuing Innovation Grant Program: Approaches in HIV Vaccine Research will also be posted there. Applicants are encouraged to explore the NIH AIDS Research and Reference Reagent Program (http://www.niaid.nih.gov/reposit) for the availability of various human and animal specimens, as well as small quantities of viruses, antibodies, HIV and SIV proteins and peptides, plasmids, and other reagents. o Direct questions about scientific/research issues to: NIAID Jon Warren, Ph.D. Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases Room 4104, MSC-7628 6700-B Rockledge Drive Bethesda, MD 20892-7628 Telephone: (301) 402-0633 FAX: (301)402-3684 Email: jw374e@nih.gov NIDCR Mostafa Nokta, M.D., Ph.D. Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research 45 Center Drive Building 45, Room 4AN-18H, MSC-6402 Bethesda, MD 20892-6402 Telephone: (301) 594-7985 FAX: (301) 480-8319 Email: Mostafa.Nokta@nih.gov o Direct questions about peer review issues to: Maryclare Walker, Ph.D. Center for Scientific Review Room 5104, MSC-7710 6701 Rockledge Drive Bethesda, MD 20892-7710 Telephone: (301) 435-1165 FAX: (301) 480-2241 Email: mw31y@nih.gov o Direct questions about financial or grants management matters to: NIAID Jeannette Gordon Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2122, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5065 FAX: (301) 493-0597 Email: jg82s@nih.gov NIDCR Mary Daley Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN44B, MSC-6402 45 Center Drive Bethesda, MD 20892-6402 Phone: (301) 594-4808 FAX: (301) 480-3562 Email: md74u@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, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard AIDS-related application deadlines (typically May 1, September 1, and January 2). It is advisable to verify these deadlines 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. SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: To apply, please follow the PHS 398 instructions for submission of a single project (R01) research grant application, modified for submission of an R21 application as listed below: 1) The description (abstract) must include a brief explanation of the proposed activity, and how it is consistent with the exploratory/developmental nature of the R21 mechanism as described in this notice. 2) Although preliminary data are neither expected nor required for an R21 application, they may be included. 3) Sections a-d of the Research Plan may not exceed 10 pages, including tables and figures. 4) Appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to five publications, including manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. o Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 10-page limit of items a-d of the research plan. Include five collated sets of all appendix material, in the same package with the application, following all copies of the application. Identify each item with the name of the principal investigator. 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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 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: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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. 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? 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? 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? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. 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. This policy announcement is 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ 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. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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