Volume IV, Issue 6
June, 2004
Research and Sponsored Programs
Human Subjects
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IUPUI/Clarian SOP for Obtaining and Documenting Informed Consent Available for Public Comment; Comment Period Closed on Exempt and Expedited New Study Approval Process SOP
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 July 12, 2004:

Obtaining and Documenting Informed Consent

The comment period on the following SOP closes on June 14, 2004:

Exempt and Expedited New Study Approval Process
Complete Details
Additional Deadlines and Meetings for Neurology Studies
New Neurology studies can now be submitted to two (2) different IRBs effective July 1, 2004. Previously, Neurology studies could only be submitted to IRB-02; however, beginning July 1, 2004, new Neurology studies can be submitted to both IRB-02 and IRB-04. See the IRB Instruction Packet for the submission deadline dates at http://www.iupui.edu/%7Eresgrad/irbpacket/irbpacket12-03.htm#Section5.
Proposal Development
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Indiana Solicitation Opportunities Program Clarification
The May issue of the R&SP Communicator incorrectly stated that Indiana University receives notifications from "Opportunity Indiana", a program designed to make Indiana companies more aware of business opportunities with the Indiana state government. Although Indiana University is a registered bidder with "Opportunity Indiana", IU and other bidders do not receive subsequent notification of opportunities. Potential bidders must visit the State of Indiana Solicitations Web site at http://www.ai.org/cgi-bin/idoa/cgi-bin/bidad.pl to view state opportunities.
Complete Details
What's New
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Take the Research Gateway Web Site Redesign Survey
The Indiana University Office of the Vice President for Research (OVPR) is in the process of redesigning its website, with plans to merge the Research Gateway site into the overall design. Your participation will aid the project team in developing this site, and help them assess what is important to faculty, staff, and students and how the design can best reflect their needs.
Complete Details
Research & Sponsored Programs (R&SP) Staffing Updates
 Heather Gipson has accepted the position of Compliance Program Analyst. Heather’s position is a dual appointment between the Research Compliance Administration in R&SP and the Office of Compliance Services, Indiana University School of Medicine. Heather will assist researchers with HIPAA and research compliance issues.

Cindy Lester has been hired as an Administrative Support Assistant for the Research Compliance Administration office. Cindy will provide clerical and receptionist support to the office.

Lynn Grunloh has joined the Sponsored Program Administration area as a Legal Assistant. Lynn is a second year law student at Indiana University School of Law - Indianapolis and will be assisting with the review, negotiation, and processing of contract and grant awards from federal, State, and non-profit agencies.

Heidi Bredemeyer had been named Senior Contract and Grant Administrator. This change reflects recent changes in Heidi's responsibilities and her important role in Sponsored Program Administration.

Please join us in welcoming Heather, Cindy and Lynn and in congratulating Heidi! To view the complete R&SP organization chart, see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm. 
Events
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  Jun 15 NCURA Video Conference: Project Management
When: June 15, 2004 (Tuesday), 10:30 AM - 2:30 PM
Where: NU 108
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
Jul 10 SoCRA Certification Exam: Certification Qualification Exam
When: July 10, 2004, time TBD
Where: IUPUI Cancer Pavilion
Cost: Contact SoCRA
Registration: Contact SoCRA
CMEs: none
Presenter: SoCRA facilitator
Special note: IUPUI research coordinators who pass the exam are eligible for a 5% raise.
Jul 13 ACRP Circle City Chapter Meeting
Topic / Speaker: “HIPAA Requirements for Clinical Research- One Year Later”, Danelle Marks, JD, Attorney for the firm Baker & Daniel’s, Specializing in Health Care and Medical Technology
When: July 13, 6:00 - 7:30 PM
Where: Indiana Cancer Pavilion, Room 101 Auditorium, 535 Barnhill Drive, Indianapolis, IN 46202
CEU: 1 will be requested for this program
Questions: Contact Joni S. Hoop, 317.274.2745, jhoop@iupui.edu
Jul 23 Source Documents & Case Report Forms: If it’s not documented - it didn’t happen
Note: This represents a date and place change
When: July 23, 2004, 12:00 - 1:30 PM
Where: Riley Outpatient Center (ROC) Classrooms A&B
Cost: None
Registration: Register at the door
CMEs: 1.5
Presenters: Gail Douglas, Clinical Trials Program and Mary Arnould, CRA, Bristol Myers Squibb
Content: Methods and requirements for creating, collecting, and organizing source documents and case report forms in paper and electronic formats.
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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Submit Your News to the R&SP Communicator
 We want to hear about what you are doing!
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Send COMMENTS, QUESTIONS to:
RSPCOMMU@iupui.edu.


Research and Sponsored Programs
UN 618
General - 317 274-8285
Research Compliance - 317 274-8289
Sponsored Program Development - 317 278-0249