April, 2004
Research and Sponsored Programs
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| Volume
IV, Issue 4 April, 2004 |
Research and Sponsored Programs
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| Human Subjects | |
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Compliance Administration (RCA) Institutes Online Adverse Event Reporting
System RCA has been piloting an online adverse event reporting system. The pilot period has proven very beneficial in fine-tuning the system to make it an easy to use functional tool. The system is now ready for prime-time! Complete Details IRB Instruction Packet Revisions A new version of the IRB Instruction Packet, including IRB forms is now available. The revisions were a result of IRB policy changes, as well as requested clarifications. Please use the current versions of the forms (04.04) for any new submissions. For existing studies, it is not necessary to update the summary safeguard statement to the current (04.04) version. See Complete Details for a detailed listing of the major revisions. New Clinical Research Studies Patient Education Brochure Available The patient education brochure that includes information about patient protection, questions patients should ask, interesting statistics, and where patients can get additional information about Clinical Research Studies is now available on the Clinical Trials Program Web site. View this new guide to participating in Clinical Research Studies at Indiana University: http://medicine.iupui.edu/ctp/pdf/patient%20brochure1.pdf. In addition to this brochure, an online introduction for patients is available at: http://medicine.iupui.edu/ctp/patients.html. IRB Institutes New Telephone Line for Subject Questions or Concerns The IRB requires that informed consent statements contain telephone numbers for subjects to call if they have questions or complaints about their research participation. Complete Details
The final version of the most recent 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 viewing. Complete Details Required Signature Lines in the Informed Consent Statement In a recent IRB application packet revision, the informed consent template was modified to clarify the signatures that are required on the informed consent statement. Complete Details Listing the Number of Subjects in IRB Study Documentation Currently, the IRB requires that study documentation (including informed consent statements) identifies the total number of subjects to be enrolled in the study. Complete Details |
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| Proposals & Awards | |
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Option for NIH Modular Grant Applications Indiana University now provides another budget option for NIH modular grant applications. In place of a detailed or simplified budget you may complete the Indiana University Budget Information Sheet for NIH Modular Applications. Complete Details NIH Announces Second Change in Salary Cap The National Institutes of Health (NIH) has announced a second revision to the salary cap. On March 3, 2004, an Executive Order was signed to implement a retroactive pay increase for federal employees. As a result, salary cap increased from $174,500 to $175,700. For full details, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-034.html. |
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| What's New | |
| Take
the Web Site Redesign Survey for the Office of the Vice President for
Research The Indiana University Office of the Vice President for Research (OVPR) is in the process of redesigning its Web site. Your participation will aid the project team in developing a new site, and help them assess what is important to faculty, staff, and students and how the design can best reflect their needs. Complete Details What’s New at R&SP? Research and Sponsored Programs (R&SP) proudly announces that Michelle Artmeier has accepted the position of Associate Director and Angie Kelly has been promoted to Grant Specialist, Sponsored Program Administration. Jody Harland has been promoted to Associate Director, Research Compliance Administration. Complete Details |
| Events | |
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Apr 8 IUPUI Symposium Highlighting the Research of Faculty, Staff and Students of Color What: “Fifth Annual IUPUI Symposium Highlighting the Research of Faculty, Staff and Students of Color” sponsored by the IUPUI Office for Multicultural Professional Development When: April 8, 2004 (Thursday), 8:15 AM to 3:30 PM Where: Lilly Auditorium, IUPUI University Library Register online: http://opd.iupui.edu/ompd/symposium/ Apr 13 IU Research Symposium Spring 2004 What: “Facing the Challenges of Research and Sponsored Programs Administration Together” When: April 13, 2004 (Tuesday), 8:30 AM - 12:30 PM Where: Lilly Auditorium, IUPUI University Library Audience: For faculty, graduate students, and staff involved in the administration or management of any IU sponsored program. Anyone involved in the conduct of research at all Indiana University campuses or their affiliates is welcome to attend. Registration and more info: http://www.iupui.edu/~resed/symposiumintrospring04.htm. Apr 23 HIPAA and Medicare Update for Clinical Researchers What: A refresher course regarding the impact of HIPAA and Medicare on clinical research When: April 23, 2004 (Friday) 12:00 - 1:30 PM Where: Tudor Auditorium – Wishard Outpatient Wing 5th floor Registration: At the door Complete Details May 5 SoCRA Presents Electronic Data Capture, A Study Coordinator’s View -Lilly’s Use What: The Society of Clinical Research Associates (SoCRA), local "The Crossroads Chapter", is offering an evening meeting and featuring a presentation on “Electronic Data Capture: A Study Coordinator’s View -Lilly’s Use of InForm” When: May 5, 2004 (Wednesday) 6:00 – 7:00 PM Where: Indiana Cancer Pavilion (RT) Auditorium #101 RSVP: alee4@clarian.org Complete Details |
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| Submissions | |
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Submit
Your News to the R&SP Communicator We want to hear about what you are doing! Complete Details |
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Send COMMENTS,
QUESTIONS to: |
Research and Sponsored Programs UN 618 General - 317 274-8285 Research Compliance - 317 274-8289 Sponsored Program Development - 317 278-0249 |
