January 2004

Proposals & Awards

R&SP Announces Partial Proposal Routing Procedure Research and Sponsored Programs (R&SP) normally requires that completed proposals be received by R&SP three (3) full working days before an agency’s stated proposal deadline. This allows R&SP the time required to do a thorough review of the proposal documents, resolve questions, and make any necessary revisions. R&SP is also aware that some investigators would like additional time to work on the technical section of their proposal. In order to allow investigators this additional time, the following change in the routing procedure is being implemented immediately. Please note that this procedure may be subject to future revision. If all portions of the proposal, except for the technical narrative, are submitted to R&SP ten working days prior to the agency deadline, the narrative section may be brought to R&SP the working day before the deadline and inserted into the proposal. All copies required for submission to the agency plus two copies that will be retained by R&SP should be routed. The required sections would include, but are not limited to, the following. Routing Sheet with all required signatures and clearly marked that it is a partial proposal Any required agency specific forms (face page, check list, etc.) Abstract if required by the agency (this may be a draft but should be so marked) All assurances and certifications All budget pages Budget justification If applicable, all Subcontractors’ documentation (budget, work plan, and the signature of an authorized institutional official) Documentation letters for any third-party cost-sharing (the dollar amount must be specified) R&SP will provide space for the investigator or their staff to insert the narrative section. The investigator is also responsible for delivering a copy of the narrative to the department and dean’s offices. Please note that no changes may be made to any other sections of the proposal at this time. Once assembled, R&SP will ship the completed proposal and bill the investigator’s dean’s office for the overnight shipping service (Federal Express or UPS). Proposal narratives must be received by noon of the working day prior to the deadline in order to be picked up by the daily courier. If the narrative is received later than noon (of the working day prior to the deadline), it may become the responsibility of the investigator to ship the proposal. As R&SP will not have the narrative section for reference, additional questions may arise that require information from the investigator or the contact person. Therefore it is imperative that the contact person named on the Route Sheet be someone who is familiar with the proposal and can answer questions R&SP or dean’s office staff might have. Please be sure the contact person’s phone number is accurate. If no contact person is listed on the Route Sheet or the contact person is not available in a timely manner, the project director will be contacted to resolve any issues. It is also critical that all sections of the Route Sheet be complete and accurate, particularly the lay description and the questions related to research risks. Investigators may still follow the normal procedure of routing proposals in their completed form. In this case, proposals must be received by R&SP three (3) full working days prior to the agency deadline. Remember to allow additional time for routing through the department and dean’s offices. Proposals that require electronic submission (i.e., through an agency’s web-based system or by e mail) must also follow the above routing requirements. Investigators should be aware that some agencies’ electronic systems may be unstable or become overloaded due to heavy access as a deadline approaches. It is strongly recommended that an additional working day be allowed for processing of electronic proposals so that there is time to resolve any technical problems that may be encountered. Questions may be directed to Pam McKeough, Director of Sponsored Program Administration, or any of the Grant Specialists in Research and Sponsored Programs at 274-8285. R&SP: 1/14/04 IU Negotiates New Contract Language for State Agreements Some of the more significant revisions are described below. Recognition that publication and dissemination of project results are of fundamental importance to the university. All information, data, findings, etc. developed or produced by the university under the contract will be jointly owned by the State and the university, rather than owned solely by the State. The university has the right to use or publish these materials without the consent of the State as long as there is no reference to the State of Indiana Patent rights will be negotiated based on the input of each party. Previously the State claimed ownership of all intellectual property Removal of the indemnification requirements Removal of the requirement that the university disclose personnel records and allow the State to conduct on-site job interviews of university employees Removal of the requirement to release employees from non-compete agreements Removal of the requirement that the university replace any personnel working on the contract if so requested by the State Language revisions recognizing that Indiana University is a hybrid entity as defined under the Health Insurance Portability and Accountability Act (HIPAA) The new boilerplate will be distributed to all State agencies by the Indiana Department of Administration with instructions encouraging its use. Use of the new language will expedite the review and processing of these agreements by Research and Sponsored Programs. Questions and inquiries may be directed to Sponsored Programs Administration at 274-8285 or rspinfo@iupui.edu. New Mileage Rates The new rates are as follows: 37.5 cents per mile (Effective January 1, 2004) for the first 500 miles 18.0 cents per mile for 501-3000 miles No reimbursement in excess of 3000 miles A direct link to the Travel Management Services web site is available at http://www.indiana.edu/~travel/car.html. Revised NIH Grants Policy Statement The revised NIHGPS incorporates NIH policy changes and public policy changes since the prior version was issued in March 2001. Sections of the NIHGPS have been rewritten for clarity. The full announcement which includes a summary of changes can be reviewed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-009.html. The revised NIHGPS is available in HTML and PDF formats at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Change in AHRQ Reporting Requirements All AHRQ investigators should review this document. During a transition period, the final progress report will be accepted by AHRQ in the old or new format but the new format will be required after April 1, 2004.

ERA

ERA Release and Training Information The following outlines a partial list of added features: Overall New navigation for better module movement. The main header tabs (Home, Routing Form, Budget, etc.) are accessible throughout the application making navigation between modules much easier. Users no longer have to exit one module to move to a new one. The logout link saves the data and removes the user’s session information. An hourglass image should appear on all pages when there is a delay. Routing Form A calendar icon was added to help with the Due Dates and Project Dates section. Dates can still be entered manually. A blank row is now the default for the Human Subjects, Animals and Biosafety sublevel detail screens. A calendar icon was also added to help with date entry. Dates can still be entered manually. Cost Share: Organizations added show in the approval hierarchy. Subcontracts: These are now added via a search using the FIS subcontractor table. Other IU campuses, schools or units: The hierarchies of the default IU campuses, schools or units should now appear on the approvals page – these include any Co-PD or Cost Share orgs that differ from the PD’s organization. Permissions: Routing Form permissions will be combined with Budget Permissions if a Budget is linked to a Routing Form. Budget Parameters: A calendar icon was added to help with the Dates section. Dates can still be entered manually. Modifying Fringe Benefit Rates – “View/Modify IU fringe rates by appointment type” functionality was added. The user may update the fringe benefit rates for a specific appointment type in a budget. Subcontracts: These are now added via a search using the FIS subcontractor table. Personnel Detail: The appointment type drop down list now defaults to “Please select an appointment type”. Training Information: Please contact the ERA Systems Administrator at era_admin@indiana.edu to set up a training session.

What's New

Clinical Research Educational Opportunities A comprehensive schedule for the year will soon be published; however, we are anxious to announce the following opportunities that are confirmed for January and February: "SOS for the SSS" - IRB Basics And "Budgets and Contracts - the 'Business' of Clinical Research" #1: "SOS for the SSS" - IRB Basics Content: Are you unclear about how to fill out certain sections of the Summary Safeguard Statement (SSS)? Are you confused by changes made to the SSS last year? This session will discuss the initial IRB application packet with particular emphasis on the SSS to include discussion of new sections as well as help in understanding how to complete all sections. Some "real life" scenarios will be discussed and adequate time will be reserved for questions and answers from the audience. Speaker: Jody Harland, Assistant Director, Research Compliance Administration When: January 30, 2004, 9:30 AM – 11:00 AM Where: Riley Outpatient Center (ROC) A & B Cost: None Registration: At the door. Seating limited to approximately 60 CMEs: Pending #2: "Budgets and Contracts - the 'Business' of Clinical Research" Content: Are you sure you are being adequately compensated for your work on clinical trials? Are you calculating your real costs? Are you receiving what you are due? Are you protecting your legal rights as an investigator? In this session you will learn how to develop an adequate study budget, calculate real costs, identify "hidden" costs, establish appropriate billing mechanisms to prevent insurance fraud, identify potential problems in contracts, and develop communication and tracking tools to make sure you are paid what you are due. Speaker: Sharon Moe, M.D - Associate Dean for Research Support; Medical Director, Clinical Trials Program; Associate Professor of Medicine and Pam DeWeese, MA, CCRP - Administrative Director, Clinical Trials Program When: February 6, 2004, 9:30 AM – Noon Where: Riley Outpatient Center (ROC) A & B Cost: None Registration: At the door. Seating limited to approximately 60 CMEs: Pending

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 25th 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

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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