May 2003

Human Subjects

Revised IRB Instruction Packet Guidance For all studies that will be enrolling new subjects on or after April 14, 2003 the most current version of the summary safeguard statement (SSS) (3/03) must be on file with the IRB office. For ongoing studies, this does not require the immediate submission of an amended form, but rather the PI is required to submit a revised SSS at the time of next IRB submission as described below: Amendments: If at the time of the next amendment submission the changes affect information contained in the SSS, the PI must complete and submit the most current SSS form. Note: If this is the first time this version of the SSS will be submitted to the IRB, this may require the completion of the checklist to determine covered entity status and/or the Recruitment Checklist, depending on responses to Section I and IV of the new SSS. Continuing Reviews: At the time of the next continuing review, the most current SSS form must accompany the submission. If this is the first time this version of the SSS will be submitted to the IRB, a Recruitment Checklist (if applicable*) must also be submitted at this time. The IRB must consider recruitment practices (for studies still enrolling new subjects) that were approved prior to the HIPAA effective date (4/14/03) to ensure their compliance with the guidelines. * A recruitment checklist does not need to be submitted if the PI answers “no” to Section I.B. of the SSS (PI is not part of a covered entity, nor plans to involve a covered entity as part of the research). However, the checklist to determine covered entity status must be submitted. The most current forms can be found at: http://www.iupui.edu/%7Eresgrad/spon/download2.htm. For questions or more information, contact the Research Compliance Administration office at 274-8289 or e-mail resrisk@iupui.edu.

ERA

Sign Up to Be an ERA Tester This is not a training session, but rather a way for you to help find problems before the next release. You do not need to have already seen the new functionality to attend; documentation on what items should be tested will be provided at each session. To help with system access issues, please RSVP to Bethany Davis (bedavis@indiana.edu) prior to the date you’ll be assisting us: IUPUI: May 28th, 2003 UN 544 1:00 – 4:00 (ending time is flexible) BL: June 2nd, 2003, PO W183 9:00 – 12:00 (ending time is flexible) ERA’s Partnership with OneStart: This is a substantial change from how Approvals are currently done. Awareness sessions will be held on both the IUPUI and Bloomington campuses to help familiarize you with the process of accessing the Action List in OneStart and introduce you to the new Routing Form. This will be an informational session only. Please check the ERAcommunication website for the time/location for these sessions (http://www.indiana.edu/~era/training.html). R&SP and ERA Listserv announcements will also be made. In order to assist with the conversion, we are strongly encouraging current ERA Routing Form users to not electronically route any new forms between June 6th and June 12th, 2003. This will allow time for any existing forms to make it through the routing process. Those accidentally routed will be processed separately after the release. You can create routing forms in the current system between those dates, but please walk them through the approval process instead of submitting them into routing.

IT Research

New Fellows Program Announced; Proposal Deadline June 16 The Program is designed to further advance research and application of information technology in a world where computing, telecommunications, and information are truly pervasive. Additionally, the Program is designed to help create and promote the workforce opportunities needed to attract and retain highly trained Indiana graduates. IU faculty and staff on all campuses are invited to submit proposals for projects that effectively integrate pervasive technologies into research, teaching and learning, and/or IT environments. Proposals should consider the aims and aspirations of the IPCRES Initiative and, ideally, coalesce with research ongoing in at least one of the Pervasive Technology Labs. The deadline for proposals is Monday, June 16. For more information, including eligibility and application requirements, visit the Pervasive Technology Labs Fellows Program Web page at: http://pervasivetechnologylabs.iu.edu/fellows/.

Events

June 16 SoCRA Chapter Education Meeting Society of Clinical Research Associates (Indiana) Chapter Education Meeting Attendance & food are free and open to SoCRA and non-SoCRA members. CEUs are free to SoCRA members and $5.00 per CEU to non-SoCRA members.

Submissions

Submit Your News to the R&SP Communicator Send us your news...... Deadline for R&SP Communicator news article submission: 5:00 PM on the tenth day of each month R&SP Communicator readers: IUPUI faculty, staff, and students interested in or involved with the conduct of research or other sponsored programs Submit news articles to: Shannon Walden Coordinator of Educational Programs for Responsible Conduct in Research UN 618 620 Union Drive, Room 618 Indianapolis, IN 46202-5167 Phone - (317) 274-8285 Fax - (317) 274-8744 E-mail: sfwalden@iupui.edu

Subscribe/Unsubscribe 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