September, 2004
Research and Sponsored Programs
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| Volume
IV, Issue 9 September, 2004 |
Research and Sponsored Programs
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| Human Subjects | |
| Revised
IUPUI/Clarian IRB Expertise Descriptions and 2005 Meeting Deadlines The Research Compliance Administration recently updated the IUPUI/Clarian Institutional Review Board (IRB) expertise descriptions and published the 2005 meeting deadlines. For more information, visit http://www.iupui.edu/%7Eresgrad/irbpacket/irbpacket12-03.htm#Section5. Authorization Clarification: To "pre-check" or not to "pre-check" — that is the question Questions often arise regarding the appropriate procedure for pre-checking or not pre-checking the response boxes that are included on the Patient/Subject Authorization form utilized by the IUPUI/Clarian Institutional Review Boards (IRBs). The Research Compliance Administration (RCA) recognizes this concern and provides procedural clarification. Complete Details OHRP Provides Review Guidance for IUPUI/Clarian IRB Procedures The Office for Human Research Protections (OHRP) recommends that Institutional Review Boards (IRBs) strengthen their initial and continuing review directives to investigators. In compliance with 45 CFR 46.111 of the Common Rule (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), IRBs must determine that certain requirements are satisfied prior to the approval of any research involving human subjects. In the most current (7.10.2002) “OHRP Compliance Activities: Common Findings and Guidance”, (http://www.hhs.gov/ohrp/compliance/findings.pdf) publication, OHRP found that IRBs are frequently approving research involving human subjects contingent upon substantive modifications or clarifications without requiring additional review by the convened IRB. Complete Details |
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| Proposals and Awards | |
| NIH
Announces New Address for Non-Competing Progress Reports The National Institutes of Health (NIH) has announced that it is centralizing the receipt and initial processing of all NIH non-competing progress reports. Effective with the October 1, 2004 deadline, all non-competing progress reports should be sent to the following address. This change is only for progress reports received by NIH institutes and centers. Progress reports for grants to other DHHS agencies that use the PHS 2590 or the 416-9 forms should continue to use the mailing addresses noted for those agencies. The full announcement can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html. NIH Announces Enhanced Public Access to Research Information and Requests Comments The National Institutes of Health (NIH) has announced a plan to enhance public access to NIH health related research. NIH intends to request that Principal Investigators provide NIH with electronic copies of all final version manuscripts if the research was supported in whole or in part by NIH funding. Manuscripts will be archived in PubMed Central (PMC), NIH’s digital repository for biomedical research. Six months after publication, manuscripts will be made available to the public through PMC. NIH encourages comments concerning this plan. Comments should be submitted no later than November 2, 2004. Full details about the plan and the address for comments can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html. |
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| What's New | |
| New
Faculty Invited to Breakfast on Oct 1, 8:30 -10:30 AM As a follow up to the New Faculty Orientation held in August, faculty new to IUPUI, are invited to attend a breakfast at the Center for Teaching and Learning (UL 1125M). This will be an opportunity for new faculty to meet informally with colleagues from across the campus and to learn more about resources available to assist them. The breakfast will be on Friday, October 1, 8:30 -10:30 AM, at the University Library, Room 1125M. Please register at http://opd.iupui.edu/events.asp?unit=OPD. Informatics Offers “Defining the Research Agenda” Conference Faculty, staff, and students are invited to attend a conference on the Bloomington campus hosted by the IU School of Informatics on September 10 – 12, 2004. The conference will bring together distinguished scholars, educators, and researchers to discuss what informatics is, and what its research challenges will be for decades to come. 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 5:00 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 Wednesday, 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 | |
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10-12 Informatics: Defining the Research Agenda Conference When: September 10-12, 2004 Where: The IMU and the School of Informatics at IUB Registration: http://www.informatics.indiana.edu/ra/ 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: http://www.iupui.edu/%7Eresgrad/spon/ncura_sept14_04.htm Sept 15 Introduction to Clinical Research: an overview of the clinical research process with an emphasis on resources for seeing a project from idea to completion What: Young investigators, fellows, or those interested in becoming clinical research investigators will learn about the basics of clinical research including such concepts as getting your project approved, financing your project, applicable regulations, and working with sponsors. Presenters: Sharon Moe, MD and the Clinical Trials Program Staff. When: Sept 15 (Wednesday), 2004, 1:00 – 5:00 PM Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor Cost: None Registration: Contact Michelle Murray at mimurray@iupui.edu or 278-2868 CMEs: 2 Sept 18 ACRP Exam What: The ACRP (Association of Clinical Research Professionals) exam will be offered in Indianapolis on 9.18.04. The application deadline was 7.30.04. When: Sept 18, 2004 More info: http://www.acrpnet.org/certification/fda/index.html Note: At the discretion of each department, a salary increase for certification has been endorsed by HR and SOM if the exam is passed. Sept 22 – 24 IU Research Coordinator Education Program What: The program is designed to introduce the new research coordinator to the world of clinical research and to provide specific guidance about how to conduct and coordinate clinical drug studies at Indiana University. The three-day session will be held September 22, 23, 24, 2004. It is mandated for all new coordinators in the School of Medicine with less than 2 years of clinical research experience at IUPUI/Clarian, who are employed by the Indiana University School of Medicine & Dentistry, Clarian Health Partners, Inc., the VA and Wishard Hospital. When: Sept 22 (Wednesday), 2004, 9:30 AM – 5:00 PM, Sept 23 and 24, 2004, 8:00 AM – 5:00 PM Where: Riley Outpatient Center (ROC), A&B Cost: $320 Registration: Go to http://nursing.iupui.edu. Click on Lifelong Learning, then to the left choose this program. For questions about the program contact Marta Sears at 274-3974, Gail Douglas or Pam DeWeese at 278-3858. For questions about the CE program and registration or payment, contact Diane Garner at IUSON Lifelong Learning/Continuing Education at 274-7779 or email censg@iupui.edu. Oct 1 New Faculty Orientation Breakfast When: October 1, 8:30 -10:30 AM Where: University Library, Room 1125M Registration: http://opd.iupui.edu/events.asp?unit=idd. Oct 8 Industry-Sponsored Research Budgets and Contracts: Your Need-To-Know Guide to Success What: 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. Presenters: Sharon Moe, MD and Pam DeWeese. When: Oct 8 (Friday), 2004, 12:00 - 1:30 PM Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor Cost: None Registration: Contact Michelle Murray at mimurray@iupui.edu or 278-2868 CMEs: Yes Oct 18 Grant Writing Workshop What: Learn grant writing skills that are essential for the promotion and success of academic investigators. When: Oct 18 (Monday), 2004, 8:00 AM – 5:00 PM Where: Riley Outpatient Center (ROC), Ruth Lilly Learning Center Auditorium, 575 West Drive, Indianapolis, IN Register and more info: http://cme.medicine.iu.edu/xcourses/grantwriting/default.htm |
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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 |