Volume III, Issue 10
December , 2003
Research and Sponsored Programs
Human Subjects
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IUPUI/Clarian Standard Operating Procedure for Responsibilities of Principal Investigator Available for Public Comment; Comment Period Closed on Subject Confidentiality and Privacy 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 January 9, 2004:

Responsibilities of Principal Investigator

The comment period for the following SOP closed on November 21, 2003:

Subject Confidentiality and Privacy

Complete Details
New Authorization Form Available for Research with Healthy Subjects
A new version of the “IUPUI/Clarian Authorization for the Release of Health Information for Research Healthy Subject Research Participants” is available on the Research and Sponsored Programs (R&SP) Web site. This form is intended for use with healthy subjects, i.e., no medical records will need to be accessed and all Protected Health Information (PHI) will be obtained directly from the subject. The form may be accessed from the Research Compliance HIPAA page http://www.iupui.edu/~resgrad/hipaa/hipaa_menu.htm.


Requirements for Providing a Notice of Privacy Practice
If being recruited or enrolled into a research study is the patient’s first contact with the hospital/clinic/office of the health care provider at IUPUI/Clarian, a Notice of Privacy Practices must be given to the subject upon contact (e.g., this may also apply for subjects who are recruited through advertisement rather than recruited through clinics). The notice given should be the relevant notice of the facility or covered entity where the research is taking place (i.e., if the research is taking place in Wishard Hospital, Wishard’s Notice of Privacy Practice should be given to the subject). The patient/subject must sign and acknowledge that they received the notice for any studies involving direct treatment. Additional HIPAA information is located on the previously mentioned Research Compliance HIPAA page http://www.iupui.edu/~resgrad/hipaa/hipaa_menu.htm. For questions or more information, contact the Research Compliance Administration (317) 274-8289/resrisk@iupui.edu.

Proposals & Awards
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NIH Revises Policy on Mentored Career Development Awards
The National Institutes of Health (NIH) has modified its policy on mentored career development awards (K Awards) to allow award recipients to hold concurrent support from their career award and a competing research grant when recognized as a Principal Investigator or subproject director. Thus mentored career award recipients in the last two years of their support will be permitted to reduce the level of effort required for the career award and replace that effort with an NIH research grant or subproject. For full details and restrictions, see the NIH announcement at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Reminder: Routing of Electronic Proposals
Indiana University policy requires that all proposals for externally sponsored projects must be routed though the University in order to obtain proper review, approval and signature. (See Institutional Policy III-20 at http://www.indiana.edu/~vpcfo/policies/contract/iii-20.html). As funding agencies develop systems that allow proposals to be submitted electronically it is easy to lose sight of the routing procedure, especially when funding agencies appear to be encouraging individuals to submit proposals directly to the agency. Electronic proposals continue to be under the same guidelines as paper proposals and must receive institutional review and approval prior to submission to the funding agency.
Complete Details

Current Route Sheet
The current version of the Route Sheet for Transmitting External Proposals and Related Documents is dated September 1999. The version number appears in the lower right-hand corner of the form. Some departments continue to use the October 1995 version which is obsolete. The 1995 version does not include several required elements and should no longer be used.
Complete Details
What's New
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Holiday Closing Information for Research and Graduate Education
Christmas 2003/New Year 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, December 24, 2003 and reopen Friday, January 2, 2004 with regular business hours from 8:00 AM to 5:00 PM.
Complete Details

Events
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Dec 10 VA Town Hall Meeting
What: VA Town Hall Meeting for Research Nurses and Assistants - ask questions or tell us what's frustrating you
When: Dec 10, 2003, 10:00 AM
Where: Roudebush VA Medical Center, Room D-6005
Contact: Margaret (Peggy) Hannon, Administrative Officer R&D, Roudebush VA Medical Center, Phone: (317) 554-0000 ext 3032, Fax: (317) 554-0092

Jan 27 IU National Center of Excellence in Women’s Health 2003-2004 Monthly Lecture Series
What: “Diabetes” by Sue Kirkman, MD, Assoc. Professor of Medicine
When: Jan 27 (Tuesday), 2004, 12:00 - 1:00 PM
Where: Indiana Cancer Research Institute Auditorium, 1044 W. Walnut Street, Indianapolis, IN 46202 (IUPUI campus, across from Riley Hospital)
Live URL: http://video.indiana.edu:8080/ramgen/encoder/vic/womens_health_20040127.rm
Archive URL: http://video.indiana.edu:8080/ramgen/vic/womens_health_20040127.rm

Jan 19 - Mar 14 Scientists and Subjects Seminar Funded by NIH
What: An Online Seminar on the Ethics of Research with Human Subjects funded by the National Institutes of Health (NIH)
When: Course - Jan 19 - Mar 14, 2004 / Registration Deadline - Dec 19, 2003
Where: Online (refer to the URL provided below)
Audience: Researchers and research administrators who are concerned with the responsible conduct of research with human subjects
Cost: $100.00
Register: http://poynter.indiana.edu/ link to “Scientists and Subjects Seminar”

Submissions
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Submit Your News to the R&SP Communicator
We want to hear about what you are doing!
Complete Details

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