October 2002

Human Subjects

IRB Revises Review Fee To:   Members of the Research Community From:   Dr. Mark Brenner     Vice Chancellor for Research and Graduate Education, IUPUI Associate Vice President for Research, IU Date:   October 7, 2002 Subject:   IRB Review Fee Policy As you know, research is one of our most important priorities at IUPUI. Research with human subjects is extensively regulated. With new regulations and recent interpretations by the Office for Human Research Protections (OHRP) and others, we are all, investigators and Institutional Review Boards (IRBs) alike, faced with the challenge of complying with these rules. In order to ensure compliance for our University and Clarian to continue in our research endeavor, added demands on the IRB, staff and investigators must be fulfilled. To aid in this ever-demanding time, the University has and continues to develop and expand its system for human subjects protection. In the past two years, a fifth IRB was added to redistribute the heavy workload of reviewing IUPUI/Clarian biomedical studies, and Standard Operating Procedures (SOPs) have been developed and are currently available for comment. In addition, steps are being taken for electronic submission of protocols, continuing reviews and adverse event reporting, new training modules for both investigators and IRB members are being developed and an audit program has been instituted. With the increase of these activities, additional funds are necessary to support them. IUPUI/Clarian has had an IRB Review Policy in place since January 1, 1997 to recover costs for reviews of research studies involving human subjects that are sponsored by for-profit organizations (e.g., pharmaceutical, device manufacture and for-profit start-up companies) being conducted at or on behalf of IUPUI/Clarian. It has been necessary to revisit this policy to ensure its effectiveness. Many Universities around the nation are either establishing similar charges or are redefining them to ensure its appropriateness to adequately recover their institutional costs. Effective January 1, 2003, the fee schedule for IUPUI/Clarian IRB Review is as follows: Type of Review Fee Initial, Full Board $1,500 Initial, Expedited $ 750 Exempt N/A Continuing Review N/A Amendment N/A The following applies to the IUPUI/Clarian IRB Review Fee: This fee applies to the IRB review of any new for-profit-sponsored project (not just clinical trials) involving human subjects as of the effective date. This fee encompasses the initial and continuing reviews, as well as reviews of amendments and adverse event reports for the duration of the study. Note: Contracts that were negotiated prior to January 1, 2003 will be subject to the previous IRB Fee Policy (effective December 1, 2000). The fee is a one-time upfront fee incurred at the time of initial IRB review. It is not based on the size of the study budget, the number of subjects enrolled, or whether or not the project is initiated, but rather on the level of IRB review the project receives. Indirect cost will not be calculated on the IRB Review Fee. The fee does not apply if the project recovers full indirect costs at the federally negotiated rate. Investigators and/or departments are responsible for payment of the IRB fee if the sponsor does not ultimately reimburse this fee. There are no anticipated exceptions to the applicability of this fee, however, in rare occasions and under exceptional circumstances, a request for a fee waiver/reduction may be made in writing directly to the Vice Chancellor for Research and Graduate Education. Any decision reached by the Vice Chancellor is final and is not subject to appeal.

Proposals & Awards

R&SP Releases Annual Report Information The State of Research Funding for IUPUI A healthy state of research funding continues for IUPUI and includes the following highlights: A Two Year Comparison by Unit shows a substantial increase for Public and Environmental Affairs and Social Work units. Excluding the INGEN award made in FY00-01, Medicine shows an 11.7% increase. (NOTE: Table does not indicate the schools that follow a two/three year cycle such as Liberal Arts and Nursing.) The Ten Year Summary illustrates an overall steady growth in research funding for IUPUI of 7% per year. Total Awards by Source and Unit points to the federal government as the largest provider of research funding for IUPUI. As indicated in Proposal and Miscellaneous Submissions Processed, the IUPUI faculty achieved an overall 16.5% increase in the number of proposals and submissions processed. State of IUPUI Research Funding PPT Slides. In conclusion, the exceptional research efforts of the IUPUI faculty and staff represent a dynamic contribution to IUPUI's standing as a model research institution. Research and Sponsored Programs (R&SP) looks forward to their continuing role to support the IUPUI research community. Together, researchers and staff will continue to build on their achievements.

Programmatic and Technical Reports The project director should prepare the reports according to the instructions in the agency's guidelines or in the award documentation. The reports should be submitted directly to the funding agency and a copy of the transmittal letter should be sent to Contract and Grant Administration (C&G) for audit purposes. It is not necessary to send copies of programmatic and technical reports to Research and Sponsored Programs or C&G. The project director should retain a copy of all reports. Failure to submit reports by the agency's stated deadlines could jeopardize funding for the project director or other investigators at Indiana University. Please see Important Notice No. 95-7 at http://www.fms.indiana.edu/cg/imp_notice/95-7.asp.

ERA

ERA Budget Module Enhancement & Training Update Indiana University Electronic Research Administration (ERA) Budget Module Enhancement & Training Update: Enhancements New Academic 9 Month (10 Pay) / Summer Personnel Detail Screen - Users can now enter both the Academic Year (AY) and Summer effort on one screen versus the two entries that were previously required. The AY grid did not change, but a Summer grid has been added. The '% Effort' field in this grid is for the Summer period only. Therefore, it is possible to have 100% effort in the AY grid and 100% in the Summer grid. New Hourly Salary Personnel Detail Screen - Users will no longer enter hourly staff on a % effort basis. ERA now calculates the compensation for hourly staff by multiplying a user-entered hourly rate by the number of hours specified in a period. New Graduate Student Personnel Detail Screen - Health Insurance rates for graduate students have now been integrated into ERA. The figures provided are dependent upon the selected campus and will change annually to correspond with the Important Notice. Fee remissions are now also entered on this screen. The user will need to know the number of credit hours being remitted, amount per credit hour, and any miscellaneous fees. The system will calculate the totals for you and return the amount to the Main Budget Page. Multiple Output Options - Available after October 3, 2002. Currently, the system prints one output page that is a summary of all periods and all tasks. The generic agency output has been redesigned, and we hope to have different levels of detail available. Printing budgets by task as well as at a summary level will also be available. Future output plans include creating National Institutes of Health (NIH) and National Science Foundation (NSF) outputs that meet agency requirements. Training Budget Module training for users in the early adopter departments has been scheduled for October. BL: October 11th, 2:00 - 4:00 PM, PO W183 IUPUI: October 14th, 9:00 - 11:00 AM, UN 544 Registration is currently open on a first-come, first-serve basis. Please contact Bethany Davis either by phone (812-855-7110) or e-mail (bedavis@indiana.edu) to enroll. Additional classes will be added based on the need and interest of the users. For those who would like to start using the Budget Module before the training, the "Help" links are to aid you with navigation on each page.

Events

October 21st SOM Faculty Clinical Research Training Workshop Offered 2002 Fall Faculty Clinical Research Training Course Date: October 21, 2002 Location: Cancer Research Institute Auditorium (R4, Room 101) Description: This program is designed primarily for IU School of Medicine faculty, trainees, and fellows interested in clinical research. The seminar is designed to teach the investigator the components necessary for the proper performance of clinical research at Indiana University. Registration: For more information, please call (317) 274-8353. October 19th ACRP and HOG Presents Fall Symposium 2002 The Fall Symposium 2002, Preparing for an FDA Audit, is presented by the Circle City Chapter of the Association of Clinical Research Professionals (ACRP) and the Hoosier Oncology Group (HOG) on Saturday, October 19, 2002 at University Place Conference Center and Hotel, Indianapolis, Indiana. The course fee is $125 before October 5, 2002 or $150 after October 5, 2002. This program is open to anyone interested in HOW to PREPARE for an FDA AUDIT. Contact Hours are available. Attendance is limited to the first 125 registrants. For more info, go to http://www.walther-hog.org/brochure.pdf or, if you need Adobe Acrobat http://www.adobe.com/products/acrobat/readstep2.html. To register, please print out the brochure. Mail Registration Form w/ your check payable to: Circle City ACRP, Post Office Box 1161, Indianapolis, IN 46206-1161. If your dept/division is paying: Inform your business manager that the "Circle City ACRP" is available on TOPS and that it is NOT the "Association of Clinical Research Professionals". November 12th Mather Speaks on Metabolic Clamp Studies at IU "Metabolic Clamp Studies at IU" SPEAKER: Kieren Mather, MD School of Medicine Dept of Medicine Div of Endocrinology WHEN: 11/12/02 (Tues) at 12noon WHERE: Cancer Res Institute Aud #101 LUNCH: Provided with Thanks to Amylin Pharm CME: Accreditation: The Indiana University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit: The Indiana University School of Medicine designates this educational activity for a maximum of 1.0 hours in Category 1 credit towards the AMA Physician's Recognition Award. Each physician should claim only those hours of credit that he/she actually spent in the educational activity. Speaker(s) To Be Followed By - Additional Important TOPICS: R&SP Updates Shelley Bizila, R&SP, Director Research Compliance Administration CTP Updates Pam Deweese, CTP, Clinical Research Consultant

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 last working day of each month R&SP Communicator readers: IUPUI faculty, staff, and students interested in or involved with the conduct of research 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

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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