CFAR Administrative Supplements in "Outside-the-Box" AIDS Vaccine Discovery – FY2009 Awards |
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PURPOSE The purpose of this administrative supplement announcement is two fold:
Applications must clearly demonstrate how the proposed research will directly contribute to the design of an effective prophylactic HIV vaccine that prevents infection and/or disease. This is especially important if the development of a new technology or assay is proposed. BACKGROUND The identification of a safe and effective prophylactic vaccine to prevent HIV infection and disease is among the highest priorities of NIAID. Major gaps exist in our basic understanding of how to develop a vaccine that prevents HIV infection and/or controls disease progression. In September 2007 the Merck STEP Trial was halted after the MRKAd5 trivalent vaccine was judged to be ineffective and potentially harmful. The NIAID convened a Vaccine Summit in March 2008 to solicit ideas from investigators/attendees about the status of the field and the research approaches that should be pursued to reinvigorate the effort. One of the strongest recommendations was to substantially invest in fostering new discoveries that improve understanding of the types of immune responses most relevant in preventing HIV infection, and novel approaches for generating those responses. Advancement toward these goals will require a broader base of discovery research in virology, immunology, cellular and structural biology, and host genetics. Furthermore, major advances in these fields are often preceded by advances in fields such as physics where new discoveries can inform design of more sophisticated measurement techniques. It is for these reasons that new, truly “outside-the-box” approaches to vaccine design including transfer of new information in the physical sciences to biological areas of investigation is encouraged. Support is designed to promote studies in these areas to assist investigators in the development of preliminary data, or begin a program, that can enable long-term funding by standard research funding mechanisms, such as R21, R01, P01, etc. CFARs are strongly encouraged to identify projects appropriate for collaborative efforts with investigators and disciplines not usually involved in AIDS vaccine development that will utilize the strengths of each group. Mentoring of junior scientists is strongly encouraged as appropriate. Studies that are an expansion of previously funded CFAR supplements, or previously submitted or funded NIH applications are not eligible for funding under this announcement. ELIGIBILITY REQUIREMENTS The grantee institution must be a currently funded CFAR institution that will have at least one year remaining in its current project period at the time of the supplement award, assumed to be July 1, 2009. Each CFAR is limited to submitting a maximum of two applications. CFARs are encouraged to collaborate with other CFARs. Core and program groups within the CFAR institution are encouraged to collaborate on their applications, and to collaborate with appropriate individuals not currently involved in AIDS research. Project leaders are restricted to new investigators (please see NIH definition of new investigator) and to established investigators in non-HIV fields who have never received an NIH research award for HIV/AIDS studies. Mentorship and collaboration by the project director with established AIDS investigators is strongly encouraged. FUNDING SUPPORT Grants will be made as one year supplements. The maximum funding allowed per application is $100,000 Direct Costs. Awards are dependent upon the scientific merit of the applications and funding availability. Funding will be as a supplement to the Developmental Core with funds restricted for the proposed funded study(s). RESEARCH OBJECTIVES The primary goal of this program is to build research capacity at the CFAR institution in the area of vaccine discovery. This supplement is intended to complement ongoing domestic and International HIV/AIDS research efforts of the NIH and, in the case of international collaborations, to respond to the research priorities in the foreign country. REQUIREMENTS Applications will include: the background and rationale for the proposed study; a description of the activities to be undertaken, and roles of key staff; expected outcome of these activities; expected follow-up plan upon completion of the supplement; a description of how the supplement and follow-up plan are expected to achieve this outcome (“value-added”); and plans to monitor and evaluate the ability of the activities to achieve the outcome. Most importantly, applicants must clearly indicate how the proposed research activities are expected to lead to development of an HIV vaccine. Mentorship and collaborations must be explained as appropriate. If the research plan involves clinical studies or work with clinical samples the applicant must:
Before any funds can be expended for a research plan involving clinical studies or work with clinical samples in a foreign country, the grantee institution must:
NOTE: Studies involving clinical trials are not allowed. APPLICATION INSTRUCTIONS Applicants are asked to submit, by March 2, 2009, supplement application(s) following the instructions for competing supplements in the PHS 398 with the following modifications: Face Page:
Checklist:
SUBMITTING AN APPLICATION For applications in response to this supplement announcement the page limitation is FIVE (5) pages for the research plan, excluding letters of collaboration, the PHS398 form pages, checklist, budget and biosketches, and human subjects or animal care and use information. Submit a letter of collaboration endorsing the proposed study from each of the following participants: investigator performing the study and any collaborators, foreign investigator(s) (if applicable), foreign institution (if applicable). SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, plus the application on a CD in one package to:
Applications must be received (not postmarked) by March 2, 2009. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CFAR program officer for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to this announcement, the application will be returned without review. Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by an internal NIH review group convened by the NIAID in accordance with standard NIH review procedures. REVIEW CRITERIA The following criteria apply to all applications. Each of these criteria will be addressed and considered by the reviewers, weighing them as appropriate for each request. The administrative supplement request does not need to be strong in all categories in order for it to receive a favorable evaluation. Factors to be considered in the evaluation of each application include: Significance – The effect that a collaborative competitive supplement would have on the overall AIDS vaccine discovery effort at the institution(s).
Approach – The quality of the CFAR scientific project proposed, including planning, management, and training (as appropriate) process
Innovation - The identification of a unique, “outside-the-box” approach to solve a significant question or gap in AIDS vaccine research
Investigator - Choice of appropriate scientists to lead the identification and development of the collaborative competitive supplement project
Environment – The likelihood that the proposed project will lead to the development of an HIV vaccine
In addition, for applications involving international collaborations:
Reviewers will also examine the appropriateness of the budget, in consideration of the research environment, for the scientific projects and cores. ALLOWABLE COSTS Funding may be requested for any category normally funded by a CFAR grant that is required to fulfill the goals of the proposed study, and must be fully justified. SCHEDULE FOR APPLICATIONS
AWARD CRITERIA The following will be considered in making awards:
INQUIRIES Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions, with the NIH contacts below. For questions concerning eligibility of the CFAR to respond to this announcement, and any other administrative issues:
For questions concerning the scientific research plan:
For questions concerning budget and fiscal matters:
This page is in progress and any comments or suggestions are most welcome. Please forward to an107z@nih.gov. Last updated December 15, 2008 (alt) |