February , 2006
Research and Sponsored Programs
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VI, Issue 1 February , 2006 |
Research and Sponsored Programs
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Janice Froehlich, Chancellor’s Professor of Medicine, has been appointed Interim Vice Chancellor for Research and Interim Associate Vice President for Research. Dr. Froehlich replaces Mark Brenner who recently departed to serve as the Vice President for Research and Dean of the Graduate School at the University of Nevada, Reno. "I am extremely pleased to have Dr. Froehlich's leadership as Interim Vice Chancellor for Research,” said IUPUI Chancellor Charles R. Bantz. "She will review the new structure for research and sponsored programs, the president's compliance initiative, and my challenge to double research and make recommendations that will meet the needs of research investigators and will fuel our research program." Dr. Froehlich, a leading researcher and educator, holds a primary appointment as Professor in the Department of Medicine and joint appointments in the Department of Cellular and Integrative Physiology and in the Medical Neurobiology Program. Her research focuses on the biological basis of alcoholism and she serves as the Scientific Co-Director of the Indiana Alcohol Research Center.IUPUI HUMAN RESEARCH PROTECTION PROGRAM RECEIVES FULL ACCREDITATION In March 2005, the IUPUI Human Research Protection Program (HRPP) achieved qualified accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). To secure full accreditation, additional revisions to IRB policies, procedures, and forms were made. As a result of these additional revisions, the IUPUI HRPP achieved full accreditation in September 2005. To view the revisions, see Complete Details. FDA GIVES HIGH MARKS TO IUPUI/CLARIAN IRB SYSTEM The U. S. Food and Drug Administration (FDA), in a recent audit of the IUPUI/Clarian Institutional Review Board (IRB), determined that IUPUI is doing an excellent job of protecting human subjects participating in research. FDA Auditor, Kim Martin, Lieutenant Commander, U.S. Public Health Service, stated that she was impressed with the IRBs at IUPUI. She said that the IUPUI IRB system is very large and normally there are many problems associated with an IRB system of this size; however, this is not the case at IUPUI. In fact, Martin found the IUPUI IRB system to be very well organized and managed which is a rare achievement considering the size and scope of the IRBs at IUPUI. NIH ANNOUNCES PLANS TO TRANSITION FROM THE PHS 398 TO THE PHS 424 - GRANT APPLICATION FORM AND SUBMISSION OF THE NEW FORM WILL BE ELECTRONIC The National Institutes of Health (NIH) transition from the PHS 398 grant application form to the PHS 424 grant application form will occur on the following submission dates: February 25, 2006 — Academic Research Enhancement Awards (AREA) (R15) June 1, 2006 — Small Grant Programs (R03), Exploratory/Development Research Grant Awards (R21/R33), Clinical Trial Planning Grant Program (R34) October 1, 2006 — Education Projects (R25), Research Demonstration and Dissemination Projects (R18/U18), Research Facilities Construction Grants (C06/UC6) January 22, 2007 — NIH Director’s Pioneer Award Program (DP1) February 1, 2007 — Research Project Grant Program (R01) Complete Details NIH ANNOUNCES PLANS TO ELIMINATE MAILING OF SUMMARY STATEMENTS & PEER REVIEW OUTCOME LETTERS The National Institutes of Health (NIH) continues toward its goal of a paperless grants process through the elimination of the following notifications which had previously been sent in paper form: Summary Statements and Peer Review Outcome Letters. Investigators are instructed to use the eRA Commons to access this information. eRA Commons is a Web interface used by NIH and the applicant organizations to receive and transmit information about the administration of NIH proposals and awards. In order to set up an NIH eRA Commons account, please e-mail your full name and University user-ID to srsinfo@iupui.edu. Sponsored Research Services (SRS) will then establish an account in your name and will assist you with any questions concerning the use of the system. Once you have an eRA Commons account it will remain active until you leave the university. Complete Details IRB UPDATES SIMPLIFIED Research Compliance Administration is offering new guidance for investigators who have updates to a Clinical Investigator Brochure (CIB) and must be reported to the Institutional Review Board (IRB). In an effort to streamline reporting processes for investigators, these updates will now be reported to the IRB via an amendment. Complete Details IRB DOCUMENTS TO BE STAMPED Research Compliance Administration (RCA) would like to clarify information reported in the August R&SP Communicator. The “IRB Documents to be Stamped” article reported that the Institutional Review Board (IRB) must review any item that will be viewed by potential or enrolled subjects. This statement was not intended to imply that every item that subjects view must be reviewed by the IRB, rather those that have a direct influence on a subject’s participation, i.e., advertisements, recruitment information/letters, communication/material containing information about risks/benefits, etc. Items such as appointment reminder cards, etc., do not require IRB review. For questions and guidance regarding items for IRB review, please contact the RCA office at 317.274.8289. UPDATE ON RISKS TO SUBJECTS OR OTHERS Research Compliance Administration (RCA) has received questions about the policy and forms related to unanticipated problems involving risks to subjects or others (UPIRTSO). Currently, the UPIRTSO policy states those events that 1) cause harm; 2) are unexpected; and 3) are related to the research intervention should be promptly reported to the Institutional Review Board (IRB) via the appropriate reporting form. However, the IRB recently clarified that only if such an event requires revision to the informed consent does it require prompt reporting to the IRB. As a result, question 2 under section IV on the Reporting Form for Events that Require Prompt Reporting to the IRB must indicate that the event requires revision to the informed consent for it to meet the prompt reporting requirements. All other events that occur on-site that do not meet the prompt reporting requirements must be reported to the IRB in summary format at the time of the study’s continuing review (as referenced in section IV.B. of the continuing review form. External (“off-site”) events that do not meet the prompt reporting requirements may be reported to the IRB at the time of continuing review (in summary format), but are not required. If you choose to report external events to the IRB with the continuing review, please differentiate those events from the events that occurred internally (“on-site”). As an option, RCA has developed a form to track events that do not meet the IRB’s prompt reporting requirements. It can be found at: http://www.iupui.edu/~resgrad/spon/download2.htm. Complete Details ACCESS TO THE HUMAN SUBJECTS TRACKING DATABASE In September 2005, all principal investigators (PIs) and contact individuals listed in the Research Compliance Administration (RCA) human subjects tracking database were informed about a web application enabling them access to selected “read-only” information in the database. The website includes Frequently Asked Questions (FAQs), examples, and explanations to assist in understanding the “codes” used by the RCA office. Subsequent to that announcement, RCA received many requests to grant access to other individuals. Unfortunately, at this time, granting access to individuals other than the PIs and contacts is not possible. Complete Details ELECTRONIC IRB SUBMISSION In December 2005, all principal investigators (PIs) and contact individuals listed in the Research Compliance Administration (RCA) human subjects tracking database were informed that, beginning January 17, 2006, all items to be submitted to the Institutional Review Board (IRB) for review must be submitted electronically to the RCA office. Additionally, a pilot program with the IRB-04 committee was to be initiated with its February meeting and associated deadline. The goal of this pilot program is to attempt to streamline the approval process by offering a pre-review prior to the meeting, resulting in a potentially faster, yet thorough, review and approval. Complete Details MAY 1 DEADLINE FOR RESEARCH SUPPORT FUND GRANT The next Research Support Fund Grant (RSFG) deadline is May 1, 2006. Grant guidelines and application forms are currently being revised. The March Research Communicator will contain directions to the website that contains the revised description of the mechanism and the revised application forms. Any questions can be directed to Etta Ward at emward@iupui.edu or 317.278.8427. NOTICE OF NEW INTERDISCIPLINARY RESEARCH FUNDING OPPORTUNITY NIH Roadmap Interdisciplinary Research Consortia ($3 million direct costs/yr for 5 yrs, 8 to be funded). Consortium refers to a series of linked applications (R01, R21, etc) from single or multiple institutions that will generally have different principal investigators. The required pre-application (due April 18, 2006) is expected to identify an important biomedically relevant problem, evaluate why previous disciplinary approaches have not solved the problem, justify why the proposed interdisciplinary approach will work, and identify the methods to maintain the focus and coordination of the interdisciplinary team. The review criteria for these pre-applications will involve the significance of the problem as well as the significance and feasibility of the interdisciplinary approach proposed to solve the problem. A successful interdisciplinary application is defined as an application that combines aspects of individual disciplines to provide a new conceptual approach to solving a problem that is likely to yield insights that could not have been achieved using the perspective of a traditional discipline or by combining (rather than integrating) approaches of multiple disciplines. Invitations to participate in Notice of Limited Competition issued Oct., 2006 with application due Dec. 19, 2006. http://grants.nih.gov/grants/guide/pa-files/PAR-06-122.html#PartII NOTICE OF FUNDING OPPORTUNITY FOR NANOMEDICINE DEVELOPMENT CENTERS Up to $12 million will be allocated competitively among centers. Two to four awards are anticipated. Each multidisciplinary center will consist of a team of clinicians, biologists, engineers, physical scientists, and mathematicians that work together to investigate the physical properties of molecules and molecular complexes in living cells in order to understand design principles of the native molecular machinery that operates inside cells. The long-term (10-year) goal is to engineer molecular components and complexes in cells to treat disease and/or repair tissue. A Center may choose a model system or pathway, such as a particular signaling pathway, a system of molecular motors, a proteasomal degradation pathway, an energy transduction system, or the transport of materials across membranes. Alternatively, a Center may choose a model cell type or disease. http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-007.html#PartII Concept Approval Letter (5 pages + literature citations) due Mar. 15, 2006. Invitations to submit a full proposal will be issued Apr. 7, 2006. Full proposals due Jun. 23, 2006. NEW NIH GRANT PROGRAM FOR POSTDOCTORAL FELLOWS The Pathway to Independence Award is a pilot initiative designed to support postdoctoral fellows in the early stage of their research career. It will provide up to five years of support in order to assist fellows in securing a research position during the critical transition to independent funding. The award is divided into two phases. The initial phase will provide 1-2 years of mentored support for highly promising postdoctoral fellows. The second phase will provide up to 3 years of independent support contingent on the applicant securing an independent research position. Award recipients will be expected to compete successfully for R01 support from the NIH during the career transition award period. It is expected that 150 - 200 awards will be made in year one. Applications are due April 7, 2006. For compete information see: http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html . MULTIPLE PRINCIPAL INVESTIGATORS ON FEDERAL GRANTS All Federal research agencies are currently preparing for the implementation of policies and procedures to formally allow more than one Principal Investigator (PI) on individual research awards. This presents a new and important opportunity for investigators seeking support for projects or activities that clearly require a “team science” approach. The multiple-PI option is targeted specifically to those projects that do not fit the single-PI model, and therefore is intended to supplement, and not to replace, the traditional single PI model. The overarching goal is to maximize the potential of team science efforts, responsive to the challenges and opportunities of the 21st century. The NIH will make the multiple-PI option available for applications submitted in response to a selected group of Requests for Applications (RFAs) and Program Announcements (PAs) with May-June 2006 receipt dates. It is expected that the multiple-PI option will become available for most investigator-initiated research grant mechanisms submitted for January 2007 and later application receipt dates. For additional information on NIH plans: http://grants2.nih.gov/grants/multi_pi/ IU CFAR GRANTS PROGRAM The Indiana University Center for AIDS Research (IU-CFAR) is pleased to announce its new grants program. The purpose of this program is to foster and enhance AIDS research and to ultimately increase the extramural support for AIDS research on this campus. Complete Details CENTRAL INDIANA COMMUNITY FOUNDATION APPLICATIONS Effective immediately, applications to the Central Indiana Community Foundation (CICF) can be processed through the Indiana University Foundation. The only exception to this policy is the CICF Library Fund which should continue to be routed through Sponsored Research Services (SRS). Questions concerning this announcement can be directed to Michelle Artmeier, Director of Proposal Services, 317.278.8644. SRS IMPLEMENTS NEW SCANNING PROCEDURE The IUPUI Office of Sponsored Research Services (SRS) will electronically scan all fully executed contracts after completion and return the documents to principal investigators, study coordinators and business administrators in a PDF format. SRS will no longer return hard copies to recipients, effective February 1, 2006. SRS HAS NEW E-MAIL ADDRESS The IUPUI Office of Sponsored Research Services (SRS) has a new e-mail address (srsinfo@iupui.edu) for general inquiries. Please note that inquiries sent to the old e-mail address (rspinfo@iupui.edu) will continue to be monitored. In order to ensure there are no delays in processing your request, however, please update your contact lists and files with the new information. To Contact SRS: Phone: 317.278.3473 New E-mail: srsinfo@iupui.edu |
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COMMENTS, QUESTIONS to: Shannon Walden - Editor |
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