March 2005

Human Subjects

R&SP Announces Electronic Conflict of Financial Interest Disclosure Requirement All IUPUI faculty (both full and part time faculty) are required to complete Conflict of Interest Reporting forms and submit these forms to the head of the unit in which they hold their primary appointment (i.e., Chair, Dean, Director) or his/her designee. A new electronic reporting system, developed and managed by Research and Sponsored Programs, has successfully completed an extensive pilot period and is now being used by most schools on the IUPUI campus. The system can be accessed at http://webdb.iu.edu/iupuirsp/IU_COI_Reporting.htm. If you are a faculty member in the IU School of Medicine, you should use the following Web site to file your Conflict of Interest Reporting form: http://administration.iusm.iu.edu/coi/. More information regarding the Indiana University Policy on Financial Conflicts of Interest in Research can be found at http://www.indiana.edu/%7Eufc/docs/AY04/circulars/U5-2004.approved.htm . When potential conflicts of interests are identified that relate to the proposed work, the conflict must be eliminated or a management plan must be in place before approval can be granted for human subject research or before awards will be set up for sponsored projects. Improved IBC Form Now Available An updated format incorporating an abbreviated version for investigators utilizing transgenic and/or knockout rodents has been posted on the Research and Sponsored Programs Web site. Please note that the Biosafety Committee will not accept applications on previous versions of the submission form after March 2005. For the most recent version of the form, go to http://www.iupui.edu/%7Eresgrad/spon/download2.htm#ibc. VA Research Updates (February 2005): Reporting of All Study Site-Monitoring Visits and Results The VA R&D Committee has approved the following Policy and Procedure (Guidelines for Monitor Visits) for implementing that directive and applies only to monitoring visits conducted at the VA where the monitor will be physically present. Roudebush VA Medical Center Research Service Policy and Procedure Guidelines for Monitor Visits The Research Service must be made aware of all monitoring visits to VA research study sites by external monitors (e.g., pharmaceutical companies and Contract Research Organizations [CROs]). Such site visits may be routine or conducted for specific causes. In addition, the Research Service should be informed of any serious findings or issues of concern that result from monitoring visits. It is the responsibility of the investigator to assure that these requirements are met. The following procedures should be followed: ACOS/R&D or designee is to be notified by telephone at (317) 554-0000, extension 3032, of all monitoring visits to the VA by pharmaceutical companies or CROs as soon as possible before the visit. If the visit is unscheduled, the ACOS/R&D is to be notified as soon as the study personnel are aware of the visit. This is the immediate responsibility of the research staff person who participates in/schedules the monitoring visit. Visiting CRO or study monitor must sign in as a visitor at the research service office (D-3037). PI or other responsible investigator is to meet with the study monitor(s) prior to the beginning of their work: the role of the monitor shall be reviewed, including the requirement that any potential of actual serious finding should be conveyed to the investigator and the ACOS/R&D or his designee during an exit interview. Findings that require an exit interview include but are not limited to: any suspicions or concerns that serious non-compliance may exist, and all findings of serious non-compliance with the study protocol, IRB requirements or applicable regulations and policies (e.g., failure to consent subjects, entering subjects who do not meet entrance criteria into protocols, failure to report serious or unexpected adverse events). If no serious findings or concerns were found, the investigator or research coordinator must notify the research office in writing that no such findings were identified by the monitor. Monitoring reports should be submitted to the IRB at the time of continuing review. Contact person for questions: Margaret Hannon, AO for Research and Development, 317.554.0000, ext. 3032. February 2005 Minor Changes to the VA Informed Consent Template Please Note: Areas for the subject to initial each page may be deleted if desired from the footnotes. Contact person for questions: Margaret Hannon, AO for Research and Development, 317.554.0000, ext. 3032. Wishard Updates Clinical Research Approval Process Approval is not required for studies being conducted only in the primary care clinics using ResNet or for data extraction studies (i.e., those that do not require any direct patient contact or the use of Wishard services or facilities) that are conducted by the Regenstrief Institute. In these cases, separate approval processes and/or oversight already exist. For studies that were approved by the IRB prior to October 1, 2004, no additional approval from Wishard will be required. These studies will be considered “grandfathered in,” provided the researcher can provide, upon request, verification that the IRB approved conduct of the study at Wishard prior to October 1, 2004. Below you will find further detail regarding the research approval process and how to access medical records for research purposes at Wishard Heath Services. A. Approval Process Approval may be obtained by emailing the summary safeguard statement to Dr. Lisa Harris at leharris@iupui.edu . Flag this as urgent with the subject line of the email stating “research approval needed”. You do not need to wait until you receive IRB approval of the summary safeguard before forwarding. In fact, simultaneous submission to Dr. Harris at the same time of IRB submission is preferred. It is Dr. Harris’s intention to respond within 3 days. If you do not hear back within 3 days, resend to her. If you receive an “out of office” notice, please forward your request to Jessica Barth, Dr. Harris’s designee, at Jessica.barth@wishard.edu. B. Accessing Medical Records: If you need medical records from the Wishard Medical Records department during the conduct of the study, take the email approval from Dr. Harris, along with the completed medical records request form found at http://www.iupui.edu%7eresgrad/hipaa_menu.htm to the medical records office (across from the main elevators) at Wishard Hospital. If requesting copies of medical records from clinics, approval from the medical records office is also required. Please contact Dr. Harris at 317.630.7033 or the Clinical Trials Program (CTP) at 317.278.3858 if you have questions. Procedure Change for Adding and Deleting Co-Investigators from IRB-Approved Studies The investigator should ensure that the co-investigator(s) has taken and passed the online Human Subjects Protection Test. Additionally, for studies approved after July 1, 2004, co-investigators must submit documentation stating their willingness to participate in the study. This documentation may be in the form of an e-mail or signature next to their name in Section XX of the summary safeguard statement and must also be included with this request. Once RCA has verified that additional co-investigators have passed the human subjects protection test and documentation of acknowledgement of participation has been included, as appropriate, a copy of this request will be placed in the study file and an email will be sent to the PI acknowledging this revision. It should be noted that this procedure applies when the change in co-investigators involves only the summary safeguard statement. If other documents require revision (e.g., the informed consent), a study amendment must be submitted. Clarification of Co-Investigator Documentation for Participation in Research Study In an effort to alleviate the number of emails and paperwork sent to Research Compliance Administration with regard to this policy, principal investigators are asked to collect this documentation (i.e., emails and signatures) and submit it as a complete set to the IRB, as appropriate.

Proposals and Awards

New Stipend Rates Released by NIH, AHRQ, & HRSA The new rates are effective for all awards made with FY2005 funds. NRSA awards issued on or after October 1, 2004 which used the FY2004 stipend schedule will be revised by the funding agency to reflect the new stipend levels. The new rates and additional details can be viewed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html. NIH Clarifies Submission of Grant Applications Policy The following is a summary of NIH proposal submission policy: NIH expects that all grant applications will be submitted on time. The standing dates of submission are listed in the application kits and on the NIH Web site at http://grants.nih.gov/grants/funding/submissionschedule.htm. These are submission or postmark dates; thus, applications are on time if they are sent on or before these dates. When these dates fall on a weekend or holiday, the deadlines are extended to the next business day. However, proposals submitted in response to Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates must be received on or before the dates designated in the announcements to be considered on time. This should be clearly noted in the text of each RFA/PAR. If you have any questions concerning the required submission date of your proposal, please contact Sponsored Program Administration at 317.274.8285. Miss an NCURA Video Conference? Check the R&SP Archive These conferences cover a variety of topics on pre- and post-award, financial, compliance, contracting, and other research administration issues. In an effort to assist faculty and staff that may be unable to attend, Research and Sponsored Programs subscribes to the series and maintains a video tape library of the conferences. If you have been unable to attend a session and would like to view the tape, please contact R&SP for further information. A list of available tapes can be found at http://www.iupui.ed/~rspcommu/2005/video_list.pdf.

Proposal Development

Limited Submission Process at IUPUI Reminder Limited submission funding opportunities are funding opportunities where the agency has placed a limitation on the number and sometimes kind of proposals they will accepted for consideration during a given funding round. These types of funding opportunities are becoming more and more prevalent. With this in mind, it is necessary to remind everyone of the IUPUI’s process for determining who will be allowed to submit. All limited submissions are tracked by Research and Sponsored Programs. Etta Ward, Director of Sponsored Program Development, is the lead contact person for these funding opportunities. When a limited submission opportunity is announced, the deans and/or associate deans for research are notified and work closely with Ms. Ward to set an internal deadline and, if needed, coordinate the internal peer review process to select the ideal candidate to move forward with a full submission. Once the candidate has been selected, Ms. Ward will contact the successful candidate with instructions to move forward. The candidate’s dean or associate dean for research will be informed, as well. If you have any questions about the limited submission process, please feel free to contact Etta Ward at 317.278.8427 or emward@iupui.edu. R&SP Announces Two New Funding Opportunities Seed Grants for the NIH “Roadmap” Initiative Proposals must be collaborative and include faculty PIs from 2 or more IUPUI schools. Proposals will be evaluated based on scientific merit and how well they fit into the “Roadmap” initiative. The Vice Chancellor for Research and Graduate Education will make the awards after receiving input from a faculty peer review panel and the Deans. The deadline for submission of proposals to the Office of Research & Sponsored Programs is April 15 by 4:30 PM. Awards will be announced in the week of May 16. Additional information (including requirements, proposal format and finding collaborators) is available on the Office of Research & Sponsored Programs Web site (http://www.iupui.edu/%7Eresgrad/spon/nih_roadmap/nih_roadmap_initiative.htm). Research Support Fund Grant (RSFG) The grant period will normally not exceed 12 months. Application materials must be submitted with a signed Internal Grants Face Page/Route Sheet to the Sponsored Program Development Director, UL 1140, IUPUI, by 5:00 PM on April 15. Additional information is available on the Office of Research & Sponsored Programs Web site (http://www.iupui.edu/%7Eresgrad/spon/rsfg/rsfg_guidelines.htm).

ERA

ERA Bytes How to access the ERA application: The ERA application is offered on the ERA Group page in the OneStart portal. Access OneStart @ http://onestart.iu.edu . Safeword authorization is not required for ERA. Use your IU network account name and password for logon. The ERA Group page should be a tab. If not, then click the tab “more…” If ERA Group page is still not visible, please send an email to era_admin@indiana.edu, with the subject as ERA Group Page Request. Once on the ERA Group page, click the link “Launch ERA application“. You have just accessed the ERA application. For more information about ERA, please contact Avery Nelson, ERA Systems Administrator, 317.274.8285 or avnelson@iupui.edu.

What's New

Save the Date April 14 for the Spring Research Symposium! Following the theme of “Facing the Challenges of Research and Sponsored Programs Administration Together”, the Research Symposium features IU Vice President for Research Michael A. McRobbie as the keynote speaker. Breakout sessions will focus on Proposal Development, Getting Started with Research at IU, and Pre- and Post Award Administration. This is your chance to meet with other faculty researchers, administrators, and graduate students and learn the tips and techniques that work in the “real” world of award administration. Registration and more information available at http://www.iupui.edu/~resed/symposiumspring05intro.htm. Collaborative Research: Avoiding Pitfalls and Sharing Credit Offered Apr 22 Collaborative research, like marriage, is fraught with peril for the unprepared. A panel of experienced researchers will share insights into how hazards can be avoided. Special attention will be paid to assigning authorship credit. Questions and discussion will be encouraged. Registration and more information available at http://www.iupui.edu/~resed/collaborativereswkshp05intro.html. Vice Chancellor for Research and Graduate Education to Present at the Sixth Annual Symposium Highlighting the Research of Faculty, Staff, and Students of Color This event is sponsored by the Office for Multicultural Professional Development, Indiana University-Purdue University Indianapolis and the Office for Institutional Development and Student Affairs and the Office for Strategic Hiring and Support, Indiana University Bloomington. To register, contact Natasha Flowers, Office for Multicultural Professional Development at mltprfdv@iupui.edu or 317.278.0243. New Research at Indiana University Web Site Introduced The new site is designed to provide easy access to IU information about grant opportunities, compliance procedures and research policies. Also included in the new site design are highlights of numerous research and creative activities in progress on all of IU's eight campuses. Each month a new research focus will be featured on the home page. New features will appear at the beginning of each month. The month of March features more exciting research and creative activities among IU’s best. The beautiful ballet, Cinderella, will be performed March 25 and 26 at the Musical Arts Center, and is the department's most challenging work to date. Learn more about the Center for Urban Policy and the Environment where the research is all about improving quality of life. Find out about a newly discovered genetic mutation that holds great promise for future testing and treatment of Parkinson's Disease, and read about how patient care and student learning improve when nursing students at IU East have information at their fingertips. For more information, please contact Sherry Fisher, OVPR, at 812.856.0504 / safisher@indiana.edu. Research Coordinator Education Program Scheduled for March 23-25, 2005 The program is designed to introduce the research coordinator new to Indiana University to critically important concepts, requirements, and practical aspects of coordinating research studies across all types of clinical research at Indiana University. Besides core curriculum, breakout sessions are offered for both clinical and behavioral trials. This program is MANDATED for all new coordinators within the School of Medicine with less than 2 years of experience coordinating studies on the IUPUI/Clarian campuses. Some of the topics covered will include: An overview of drug development; GCPs and drug law; study feasibility assessment; budgeting, contract review, and routing the proposal; study startup and the study approval process; pre-study preparation; study conduct (including the informed consent process and adverse event reporting); audits and study closeout; special interest breakout sessions and identification of clinical research resources available at Indiana University. For the agenda and more detailed information, please click on the following link for the Research Coordinator Education Program http://nursing.iupui.edu/LifelongLearning/default.asp?/LifelongLearning/ProgramsAndConferences/RECEP/2005/RECP_0305.htm. To go directly to the registration page click the following link: https://nursing.iupui.edu/llreg/forms/researchcoord.asp.

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 IU working day of each month Submission format: Email, fax, or mail information to Shannon Walden (contact information provided below). Please use Arial 10 point font and plain text format. 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