The INDU Foundation and AIDS International Training Program (AITRP)Pilot Grant DUE DATE: MONDAY, JUNE 22, 2009 INVESTIGATOR’S PRIMARY INSTITUTION 1. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR PSYCHOSOCIAL RESEARCH 1a. NAME (Last, first, middle) 1g. MAILING ADDRESS (Street, city, state, zip code) No Yes 1b. POSITION TITLE / ACADEMIC RANK 1c. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 1d. MAJOR SUBDIVISION 1e. TELEPHONE (Area code, number and extension) AND E-MAIL TEL: E-MAIL: 2. TITLE OF PROJECT 3. HUMAN SUBJECTS 3b. Human Subjects Assurance No. RESEARCH No Yes 3c. Clinical Trial No Yes 4. VERTEBRATE ANIMALS 3d. NIH-defined Phase III Clinical Trial No Yes 4a. If “Yes,” IACUC approval Date No Yes 4b. Animal welfare assurance no. 3a. Research Exempt If “Yes,” Exemption No. No Yes 5. DATES OF PROPOSED PERIOD OF SUPPORT (month, day, year—MM/DD/YY) From 6. COSTS REQUESTED FOR PROPOSED BUDGET PERIOD (Indirect Costs not Allowed) 7. WILL THE PROJECT INCLUDE SUBAWARDS OR SUB-CONTRACTS ? Through YES NO Direct Costs ($): 8. APPLICANT VERIFICATION OF ELIGIBILITY 10. PLEASE CHECK ALL SHAREDRESOURCES TO BE (Applicants must be within six years of their first independent research or faculty appointment and may not have competitive national funding at the start UTILIZED IN THIS PROJECT: of the proposed IRG allocation) ANALYTICAL MICROSCOPY PI NAME: BIOSTATISTICS CELL THERAPIES _____________________________________________ _______________ SIGNATURE DATE CLINICAL TRIALS LAB DATA MANAGEMENT (CRSS) TISSUE CHAIR/PROGRAM LEADER NAME: _____________________________________________ _______________ SIGNATURE DATE 9. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE Name: Title: Tel: E-mail: FLOW CYTOMETRY HIGH THROUGHPUT SCREENING & CHEMISTRY BIOMEDICAL INFORMATICS MICROARRAY MOLECULAR BIOLOGY MOUSE MODELS PROTEOMICS PROTOCOL REVIEW & MONITORING SYSTEM STRUCTURAL BIOLOGY SURVEY METHODS This is the first, second, submission of this proposal third (final) Face Page Principal Investigator: [Click here and type last name, first name] NOTE: All BLUE text throughout this application is instructions for the template or applicant and can be deleted prior to submission. Specific Application Instructions Use English, avoid jargon and spell out all abbreviations. Applicants must use the templates provided. Font size must be 11 or 12 point black font (e.g., Arial or Times New Roman). Documents should be single-spaced with all text visible and within the .5 margins (all sides). The Principal Investigator’s name should be shown in the header of all application pages. All graphs, diagrams, tables, and charts presented in black ink. Do not include photographs, oversized documents, or materials that cannot be photocopied into the body of the application. Observe a 5-page limit for the section “Description of Research Proposed”. Pilot Research Grant 2 Principal Investigator: [Click here and type last name, first name] APPLICATION FOR A PILOT PROJECT GRANT BIOGRAPHICAL INFORMATION PI First Name, Last name, Degree(s) Academic Rank Institution/University Department School Year last degree conferred: Year of first independent position: Education Degree/year conferred Institution/Location Field of study Training Title Pilot Research Grant Mentor (If Applicable) Institution/Location 3 Dates Principal Investigator: [Click here and type last name, first name] PI First Name, Last name, Degree(s) Appointments Title Institution/Location Dates Other Research Support (Sponsor, Project Title, Project Number, PI, Project Dates, Your Effort, Annual Direct Costs, Brief Description of Major Goals) For the PI and any co-investigators, please list their: (1) current active support; (2) applications and proposals pending review of funding; and (3) applications and proposals planned or being prepared for submission. Include all Federal, non-Federal, and institutional research, training, and other grant, contract, and fellowship support at the applicant organization and elsewhere. If effort is part of a larger project, identify the PI/program director and provide the data for both the parent project and the sub-project. All pharmaceutical research projects are to be included. If none, state "none". Publications (use continuation page if necessary) Continued on next page Pilot Research Grant 4 Principal Investigator: [Click here and type last name, first name] PROJECT TITLE: PROGRESS REPORT (for competing renewals only; not to exceed one page). DESCRIPTION OF RESEARCH PROPOSED (5 pages maximum – use continuation pages as necessary) Sections A-E of the Research Plan should answer these questions: (1) What do you intend to do? (2) Why is the work important? (3) What has already been done? (4) How are you going to do the work? (5) What are future funding plans for this project? A. Specific Aims (1/2 page or less) State the broad, long-term objectives and describe concisely and realistically what the specific research described in this application is intended to accomplish along with the hypothesis (or hypotheses) to be tested. B. Background and Significance (1 page or less) Describe the background of the research proposed. Critically evaluate existing knowledge and identify specific gaps that the project intends to fill. Briefly state your research’s importance by relating the specific aims to the broad, long-term objectives. C. Preliminary Studies (1 page or less) Describe the PI's preliminary studies pertinent to the research proposed and/or any other information that will help to establish the experience and the competence of the investigator to pursue the proposed project. D. Experimental Design & Methods (2 pages) Outline the experimental design and procedures proposed to accomplish the specific aims of the project. Include the means by which the data will be collected, analyzed, and interpreted. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the investigation. Highlight any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. E. Future Plans (1/2 page or less) Identify how these funds will provide a foundation for your research work and the potential future sources of funding. For example, if the project submitted is the initial piece of a larger project, describe how this project will relate to the overall research goal and provide a timetable for such further applications. F. Human Subjects If your project will involve human subjects, you must indicate this on the Proposal Face Page. If you have designated no exemptions from the regulations, you must succinctly address the following six points: 1. Provide a detailed description of the proposed involvement of human subjects in the work previously outlined in the experimental design and methods section. Describe the characteristics of the subject population, including their anticipated number, age, ranges, sex, ethnic background, and health status. Identify the criteria for inclusion or exclusion. Explain the rationale for the involvement of special classes of subjects, if any, such as fetuses, pregnant women, children, human in vitro fertilization, prisoners or other institutionalized individuals, or others who are likely to be vulnerable. 2. Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data. Pilot Research Grant 5 Principal Investigator: [Click here and type last name, first name] 3. Describe plans for the recruitment of subjects and the consent procedures to be followed, including the circumstances under which the consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. 4. Describe potential risks -- physical, psychological, social, legal, or other -- and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects. 5. Describe the procedures for protecting against or minimizing any potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the data collected to ensure the safety of subjects. 6. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result. If a test article (investigational new drug, device, or biologic) is involved, name the test article, the sponsor, and state whether the 30day interval has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration. G. Women & Minorities Briefly describe how women and minorities will be included in any human subject populations. H. Vertebrate Animals If your project will involve vertebrate animals, you must indicate this on the Proposal Submission Form and succinctly address the following five points. 1. Provided a detailed description of the proposed use of the animals in the work previously outlined in the experimental design and methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work. 2. Justify the use of animals, the choice of species, and the numbers used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers. 3. Provide information on the veterinary care of the animals involved. 4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize discomfort, distress, pain and injury. 5. Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Association. If not, present a justification for not following the recommendations. I. Consultants/Collaborators (if any) J. Consultants/Contractual Arrangements (if any) K. Literature Cited Pilot Research Grant 6 Principal Investigator: [Click here and type last name, first name] TOTAL AMOUNT REQUESTED*: Rs PROJECT PERIOD: *Maximum request Rs 50,000 for 12 months PROPOSED BUDGET ITEMS Common Research Expenses Allowable Unallowable Research supplies and animal maintenance Secretarial/administrative salaries Technical assistance Tuition Domestic travel when necessary to carry out the proposed Foreign travel (special consideration given for attendance at Research program scientific meetings held in Canada) Publication costs, including reprints Books and periodicals Shared resources costs Membership dues Special fees (pathology, photography, etc.) Office and laboratory furniture Stipends for graduate students and postdoctoral assistants if Office equipment and supplies their role is to promote and sustain the project presented by the Rental of office or laboratory space junior faculty member Recruiting and relocation expenses Equipment costing less than $2,000. (Special justification is Non-medical services to patients necessary for items exceeding this amount) Per-diem charges for hospital beds Registration fees at scientific meetings Construction, renovation, or maintenance of buildings/laboratories Salaries for the Principal Investigator and administrative support are not appropriate budget items. Salaries for support personnel (i.e., dishwashers, animal caretakers, histopathology technicians, research technicians or associates, and in some instances data management personnel) may be requested. Whether or not salaries are requested, list the names and roles of all personnel who will be involved in the project during the 12-month budget period. NOTE: Double-click on the budget below to enter data. Be aware that some cells contain formulas. Be sure to scroll to the top of the spreadsheet, then click outside the budget to exit. DETAILED BUDGET - DIRECT COSTS ONLY EFFORT ON PROJECT PERSONNEL (Applicant organization only) NAME ROLE ON PROJECT INST. BASE % FTE FROM: THROUGH: 7/1/2008 6/30/2009 DOLLAR AMOUNT REQUESTED (omit paise) SALARY REQUESTED PI FRINGE BENEFITS TOTALS Not Allowable - SUBTOTALS EQUIPMENT (Itemize) List separately each item of equipment with a unit acquisition cost less than Rs2,000 and provide a detailed justification. Note: Requests for equipment require special approval from the Review Committee and generally are not appropriate for this small grant program. SUPPLIES (Itemize by category) Itemize supplies in separate categories such as glassware, chemicals, radioisotopes, etc. If animals are - - involved, state how many are to be used, the unit purchase cost, and the per unit cost of care. TRAVEL List details of domestic research-related travel OTHER EXPENSES (Itemize by category) Any items not previously listed. For example: animal maintenance, publication costs, shared - resources costs, etc. - TOTAL DIRECT COSTS FOR PRPOSED PROJECT PERIOD Pilot Research Grant 7 - Principal Investigator: [Click here and type last name, first name] BUDGET JUSTIFICATION: Describe the specific functions of the personnel, consultants, and collaborators. Briefly explain and justify items requested in B-D. This section is critical to the evaluation process. Any item not sufficiently justified may be cut from the project budget. Pilot Research Grant 8 Principal Investigator: [Click here and type last name, first name] CONTINUATION PAGE (Copy as needed) Pilot Research Grant 9