Volume IV, Issue 5
May, 2004
Research and Sponsored Programs
Vision for Research
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Bantz and McRobbie Highlight Vision for Research
An enlightening keynote address, focusing on doubling research at IUPUI and creating an IU vision for research, was provided by IUPUI Chancellor Charles R. Bantz and IU Vice President for Research Michael A. McRobbie on April 13, 2004, at the IUPUI University Library as the prelude to the "Indiana University Research Symposium Spring 2004: Facing the Challenges of Research Administration Together". If you missed this event, presented by the Sponsored Programs Offices of Indiana University, you may view the entire keynote address video on the Office of Vice President for Research Web site at http://www.indiana.edu/~ovpr/index.html.
Human Subjects
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IUPUI/Clarian SOP for Exempt and Expedited New Study Approval Process Available for Public Comment
The new release of the Standard Operating Procedure (SOP) 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 SOP will close June 14, 2004:
Exempt and Expedited New Study Approval Process

Complete Details
IRB 2004 Deadline and Meeting Schedule Revised
The Research Compliance Administration (RCA) has revised several deadline and meeting dates in 2004 for the IUPUI/Clarian Institutional Review Boards (IRBs) to allow investigators more flexibility and options for IRB submissions.
Complete Details
Adverse Event Reporting Policies Clarified by IRB Executive Committee
Adverse event reporting policies concerning open studies at external sites and reporting off-site deaths were clarified by the IUPUI/Clarian Institutional Review Board (IRB) Executive Committee.
Complete Details
Co-Investigator Signatures Required On New IRB Study Submissions
To ensure that all co-investigators have knowledge of and have agreed to participate in a study, the IUPUI/Clarian Institutional Review Boards (IRBs) will begin to require written acknowledgement from all co-investigators for new IRB applications submitted to IRBs meeting in July and all subsequent meetings.
Complete Details
New Continuing Review Form and Informed Consent Wording for HUD
The IUPUI/Clarian Institutional Review Board (IRB) Executive Committee recently approved a new continuing review form specifically for Humanitarian Use Devices (HUD) studies.
Complete Details
FDA Revises MedWatch Adverse Event Reporting Forms
The Food and Drug Administration (FDA) has revised the MedWatch Voluntary Reporting Form (FDA Form 3500), the Mandatory Reporting Form (3500A) and their respective instructions. To download instructions and forms, click on
Complete Details
Proposals & Awards
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NIH Announces Change in Direct Cost Limitations
The National Institutes of Health (NIH) has announced a revision of its policy on direct cost limitations for solicited applications published after April 30, 2004. Proposals in response to Program Announcements (PAs) and Requests for Applications (RFAs) that include a limitation on direct costs are to exclude from that limit the Facilities and Administrative (indirect) costs requested by the consortium participants. For full details, see the announcement at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html.
Proposal Development
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IU Registers for Indiana Solicitation Opportunities Program
Governor Joe Kernan announced the development of "Opportunity Indiana", a program designed to make Indiana companies more aware of business opportunities with Indiana state government. Indiana University is considered a registered bidder and has been set up to receive notification of these opportunities.
Complete Details
What's New
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What’s New at R&SP?
 Research and Sponsored Programs (R&SP) proudly announces that Maltie Maraj has accepted the position of Contract Administrator in Corporate Contracts Administration. Maltie, an IU Law School graduate with previous experience with the Center for Nursing Research, will be reviewing and negotiating corporate and industrial contracts for faculty research and material transfer agreements. Please join us in welcoming Maltie! To view the complete R&SP organization chart, see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm.
Events
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May 19-22 Teaching Research Ethics:
A comprehensive course in training in the responsible conduct of research.
When: May 19 – 22, 2004 (Wednesday-Saturday), May 19, 2:00 PM to May 22, 12:00 PM
Where: IU-Bloomington
Registration: Contact Ken Pimple, PhD, TRE Project Director Poynter Center, 812.855.0261 / pimple@indiana.edu / http://poynter.indiana.edu/tre/
CMEs: Contact Ken Pimple
Presenter: TBD
May 19 SoCRA Certification Exam Preparation Class
When: May 19, 2004 (Wednesday), 12:00 – 1: 30 PM
Where: Riley Outpatient Center (ROC) Classroom A
Cost: None
Registration: Contact SoCRA local chapter president Cindy Stoner or CTP, 317.278.3858
CMEs: No
Presenters: CTP staff and SoCRA members from the community TBD
Content: A review for those planning on taking the Society of Clinical Research Associates (SoCRA) certification exam.
May 25 IU National Center of Excellence in Women’s Health 2003-2004 Monthly Lecture Series: Ethics in Medicine
When: May 25, 2004 (Tuesday), 12:00 – 1:00 PM
Where: Indiana Cancer Research Institute Auditorium, 1044 W. Walnut Street, Indianapolis, IN 46202 (on the IUPUI campus, across from Riley Hospital)
Presenter: Eric Meslin, PhD, Director, IU Center for Bioethics
Live URL: http://video.indiana.edu:8080/ramgen/encoder/vic/womens_health_20040525.rm
Archive URL: http://video.indiana.edu:8080/ramgen/vic/womens_health_20040525.rm
Jun 4 Adverse Event Reporting
When: June 4, 2004 (Friday), 12:00 - 1:30 PM
Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor
Cost: None
Registration: At the door
CMEs: 1.5
Presenter: Linda Rohyans, Clinical Research Nurse and Sara Ellis, Research Compliance Administration
Content: The difference between adverse events and serious adverse events, reporting criteria and requirements, tracking tools, electronic reporting.
Jun 15 NCURA Video Conference: Project Management
When: June 15, 2004 (Tuesday), 10:30 AM - 2:30 PM
Where: TBA
Registration: http://www.iupui.edu/~resgrad/registration/ncura_6_04/registration_ncura_6_15_04.htm
Jun 18 Industry-Sponsored Research Budgets and Contracts: Your Need-To-Know Guide to Success
When: June 18, 2004 (Friday), 12:00 - 1:30 PM
Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor
Cost: None
Registration: Contact Michelle Murray at mimurray@iupui.edu or 317.278.2868
CMEs: 1.5 hrs
Presenter: Sharon Moe, MD and Pam DeWeese, Administrative Director Clinical Trials Program
Content: Developing an appropriate study budget, identifying hidden costs, establishing appropriate billing mechanisms to prevent insurance fraud, making sure sponsors pay you what you are due, preventing contractual problems, developing communication and tracking tools.
Jun 22 IU National Center of Excellence in Women’s Health 2003-2004 Monthly Lecture Series: Domestic Violence
When: June 25, 2004 (Tuesday), 12:00 – 1:00 PM
Where: Indiana Cancer Research Institute Auditorium, 1044 W. Walnut Street, Indianapolis, IN 46202 (on the IUPUI campus, across from Riley Hospital)
Presenter: DaWana Stubbs, MD, Clinical Asst. Professor of Medicine
Live URL: http://video.indiana.edu:8080/ramgen/encoder/vic/womens_health_20040622.rm
Archive URL: http://video.indiana.edu:8080/ramgen/vic/womens_health_20040622.rm
Sept 14 NCURA Video Conference: Conflict of Interest Management
When: Sept. 14, 2004 (Tuesday), 10:30 AM - 2:30 PM
Where: Riley Outpatient Center (ROC) – Auditorium
Registration: TBA
Submissions
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Research and Sponsored Programs
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General - 317 274-8285
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