November, 2004
Research and Sponsored Programs
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| Volume
IV, Issue 11 November, 2004 |
Research and Sponsored Programs
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| Human Subjects | ||||||||||||||||||||||||||||
 New Release of IUPUI/Clarian SOPs Available for Public Comment until Dec 22 The new release of the Standard Operating Procedures (SOPs) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs) is available online for public comment. The comment period for the following SOPs will close Dec 22, 2004:
Complete Details IUPUI/Clarian IRB Announces Fee increase for Studies Funded by For-Profit Companies On October 28, 2004, IUPUI/Clarian investigators were notified by Mark L. Brenner, Vice Chancellor for Research and Graduate Education, IUPUI, that the Institutional Review Board (IRB) review fees have been increased to mitigate actual costs associated with new IRB operations and responsibilities. The new fee schedule goes into effect January 1, 2005 and applies only to studies funded by for-profit companies. There continues to be no charge for IRB reviews of research sponsored by federal, state, foundation, higher education, or campus funds. The fee schedule and the letter to investigators are available on the Complete Details page. IRB Instruction Packet Undergoes Update for 2005 Research Compliance Administration announces the publication of an updated version of the IUPUI/Clarian IRB Instruction Packet for investigators submitting a research protocol involving human subjects. The IRB Instruction Packet, which includes revised IRB submission forms and 2005 deadlines, can be accessed at http://www.iupui.edu/%7Eresgrad/spon/download2.htm. Note: It is not necessary for investigators to update their Summary Safeguard Statements with regard to these changes. A summary of the most recent IRB Instruction Packet revisions appears on the Complete Details page. |
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| Proposals and Awards | ||||||||||||||||||||||||||||
| Revised
NIH Forms Now Available The National Institutes of Health (NIH) announced on November 2, 2004 that many key forms were updated and now available. This includes the PHS 398 (new and competing applications) and PHS 2590 (non-competing progress report) as well as forms for the appointment of trainees, reporting inventions, and relinquishing a grant. Full announcements along with revised forms and instructions can be found at http://grants1.nih.gov/grants/forms.htm. In order to assist faculty with the transition, Research & Sponsored Programs (R&SP) has reviewed and noted key changes along with the effective date for utilizing the updated forms. Complete Details NIH Announces Revised Policy: Applications that Include Consortium/Contractual F&A Costs The National Institutes of Health (NIH) recently announced a change in policy for applications that include consortium facilities and administrative (F&A) costs. The new policy applies to both solicited and investigator-initiated applications where there is a limitation on direct cost and also impacts eligibility to submit a modular budget. Complete Details NIH Announces Updated Proposal Review Criteria The National Institutes of Health (NIH) has announced updated criteria for evaluating research grant applications. The updated criteria will be effective for proposals received on or after January 10, 2005. For full details see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html. NSF Revises Cost Sharing Policy On October 19, 2004, the National Science Foundation (NSF) issued guidance regarding implementation of the revised NSF cost sharing policy (NSB-04-157). The new policy eliminates program-specific cost sharing and requires only the existing statutory cost sharing requirement of 1% on all unsolicited research proposals. This includes all proposals submitted in response to NSF program announcements and those submitted solely in response to the NSF Grant Proposal Guide. For additional applicability information, see www.nsf.gov/pubs/policydocs/cspolicy1004.pdf. |
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| What's New | ||||||||||||||||||||||||||||
| Grants.gov:
Find Federal Dollars for Sponsored Projects Mark Your Calendar for Grants.gov at IUPUI Nov 30 Katie Root, Grants.gov Program Management Office, will speak to IU faculty and staff on Tuesday, November 30, 2004, at the Lilly Auditorium, University Library. Root will be in Indianapolis to promote Grants.gov, an online location to find and apply for grants across the Federal Government. Two sessions will be offered on November 30 — a 10:00 AM session is structured to provide specific information for research administrators and a 1:00 PM session will address the needs of faculty researchers. There will also be time set aside for Q&A during both sessions. All IU faculty and staff, from all campuses, are welcome to attend. Registration is requested but not required. Go to http://opd.iupui.edu/events.asp?unit=opd and click on “Register for this event” to register. Complete Details Register Now for the Sixth Annual Scientists and Subjects Online Seminar The sixth annual “Scientists and Subjects (SAS)” online seminar will meet via the World Wide Web and e-mail January 10-March 20, 2005. The SAS seminar is a unique and innovative Internet-based seminar designed for busy researchers and research administrators who are concerned with the responsible conduct of research with human subjects. Complete Details Opportunity to Meet NIH Staff The “National Institutes of Health (NIH) Regional Seminar on Program Funding and Grants Administration” will be held at Purdue University on June 22-24, 2005. Meet NIH program staff while learning about the grant application and review process and Federal regulations and policies. Complete Details Holiday Closing Information for Research and Graduate Education Thanksgiving 2004 The IUPUI Office of the Vice Chancellor for Research and Graduate Education and the Office of Research and Sponsored Programs will close at 3:00 PM on Wednesday, November 24, 2004 and reopen Monday, November 29, 2004 with regular business hours from 8:00 AM to 5:00 PM. Christmas 2004/New Year 2005 The IUPUI Office of the Vice Chancellor for Research and Graduate Education and the Office of Research and Sponsored Programs will close at 5:00 PM on Thursday, December 23, 2004 and reopen Monday, January 3, 2005 with regular business hours from 8:00 AM to 5:00 PM. Complete Details |
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| Events | ||||||||||||||||||||||||||||
| Nov
17 Computer Basics: Using EXCEL to Manage Research Related Information Description: Using a study budget template, learn to navigate and use some of the features of an Excel spreadsheet to better understand formulas and functions associated with data input; Q&A. Presenter: Cathy Heiny, VA Education Coordinator When: Wednesday, November 17, 2004, 11:00 AM – 1:00 PM Where: Veterans Hospital, Room A 2007 (second floor computer classroom above the main atrium lobby of the VAMC) CMEs: Pending, check CTP web site for update: http://medicine.iupui.edu/ctp/ Cost: None Registration: Limited to 15, Call Michelle Murray at 278-2868 by noon on 11/15/04 to register Nov 18 HIPAA Security and FDA Requirements for Clinical Research Databases Description: HIPAA security training is mandated for all staff. This session, geared specifically for clinical researchers, will meet this obligation. Content will include HIPAA security as well as the requirements of 21 CFR 11 for FDA regulated research as is relevant for those who access, collect, store, or transmit study data in electronic form. The content will focus on the requirements of the soon to be released IUPUI/Clarian Standard Operating Procedure (SOP) entitled "Security of Research Data". When: Thursday, November 18, 2004, 7:30 – 8:30 AM Where: Riley Outpatient Auditorium Presenters: School of Medicine Office of Compliance and Clinical Trials Program Staff CME’s: 1.0 Cost: None Registration: Register at the door Note: This presentation will be repeated on December 14, 2004, 12:00 – 1:00 PM, Riley Outpatient Auditorium and January 11, 2005, 5:00 - 6:00 PM, Riley Outpatient Auditorium. Nov 29 Computer Basics: Using Your Outlook Account to More Effectively Manage Research Related Processes and Documents Description: Beyond Email: how to use the calendar, signatures, Out of Office and Archiving/organizing tools to better manage research related processes; Q&A. Presenter: Steve Brizendine, VA IT Specialist When: Monday, November 29, 2004, 12:00 – 2:00 PM Where: IUPUI Business/SPEA (BS) 3003 Cost: None Registration: Limited to 20 participants with IUPUI email account. Call Michelle Murray by 11/26/04 at 278-2868 Nov 30 Find Federal Dollars for Sponsored Projects Description: Katie Root, Grants.gov Program Management Office , will be in Indianapolis to promote Grants.gov, an online location to find and apply for grants across the Federal Government. Two sessions will be offered. Audience: All IU faculty and staff, from all campuses, are welcome to attend When: Tuesday, November 30, 2004, 10:00 AM - 12:00 noon (for Research Administrators) and 1:00 PM - 3 PM (for Faculty and Researchers) Where: University Library, Lilly Auditorium, Indianapolis, IN Registration: http://opd.iupui.edu/events.asp?unit=opd Dec 3 Initiating and Closing Out a Study Description: What to expect from the sponsor; The difference between a site evaluation and a start up visit; Questions you should be prepared to answer; What are sponsors looking for; Organizing the supplies and records; What must be kept and what can be thrown out; How to prepare documents for long term storage. Presenters: Gail Douglas, CTP and Helen Kallamani, Amgen When: Friday, December 3, 2004, 12:00 - 1:30 PM Where: Tudor Auditorium - Wishard Outpatient Wing 5th Cost: None CME: 1.5 Registration: At the door Dec 8 Indiana University Research Symposium Fall 2004 Description: If you are involved in the conduct of research, don't miss the 2004 Fall Research Symposium presented by the IU sponsored programs offices! Connect with your colleagues, other administrators, and researchers to share ideas and experiences. Learn the tips and techniques that work in the "real" world of award administration. When: Wednesday, December 08, 2004, 8:00 AM – 12:30 PM Where: Georgian Room, Indiana Memorial Union, Bloomington Sponsored by: Contract and Grant Administration and the Office of the Vice President for Research, Research and Sponsored Programs and Sponsored Research Services. Registration and more info: http://www.iupui.edu/~resed/symposiumintrodec04.htm Dec 14 HIPAA Security and FDA Requirements for Clinical Research Databases Description: HIPAA security training is mandated for all staff. This session, geared specifically for clinical researchers, will meet this obligation. Content will include HIPAA security as well as the requirements of 21 CFR 11 for FDA regulated research as is relevant for those who access, collect, store, or transmit study data in electronic form. The content will focus on the requirements of the soon to be released IUPUI/Clarian Standard Operating Procedure (SOP) entitled "Security of Research Data". Presenters: School of Medicine Office of Compliance and Clinical Trials Program Staff When: Tuesday, December 14, 2004, 12:00 – 1:00 PM Where: Riley Outpatient Auditorium CME’s: 1.0 Cost: None Registration: Register at the door Note: This presentation will be repeated on January 11, 2005, 5:00 - 6:00 PM, Riley Outpatient Auditorium. Dec 15 Computer Basics: Using Your Outlook Account to More Effectively Manage Research Related Processes and Documents Description: Beyond Email: how to use the calendar, signatures, Out of Office and Archiving/organizing tools to better manage research related processes; Q&A. Presenter: Steve Brizendine, VA IT Specialist When: Wednesday, December 15, 2004, 9:00 – 11:00 AM Where: IUPUI Business/SPEA (BS) 3003 Cost: None Registration: Limited to 20 participants with IUPUI email account. Call Michelle Murray by 12/13/04 at 278-2868 Jan 10 - Mar 20 Scientists and Subjects Seminar Funded by NIH Description: An Online Seminar on the Ethics of Research with Human Subjects funded by the National Institutes of Health (NIH) Audience: Researchers and research administrators who are concerned with the responsible conduct of research with human subjects When: Course - Jan 10 - Mar 20, 2005 / Registration Deadline - Dec 10, 2004 Where: Online http://poynter.indiana.edu/sas/ Cost: $200.00 Register: http://poynter.indiana.edu/sas/ Jun 22 - 24 NIH Regional Seminar on Program Funding and Grants Administration Description: Meet NIH program staff while learning about the grant application and review process and Federal regulations and policies. When: June 22 – 24, 2004 Where: Purdue University Cost: Registration: 250.00 and Pre-Seminar Labs: 50.00 Register: http://www.purdue.edu/research/NIHSeminar/ |
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Research and Sponsored Programs UN 618 General - 317 274-8285 Research Compliance - 317 274-8289 Sponsored Program Development - 317 278-0249 |