February 2003

 

Proposals & Awards

NSF Returns Proposals for Noncompliance with Format Requirements Please read and follow the NSF guidelines carefully. Some examples of common problems are as follows: The Project Summary must clearly address in separate statements (within the one-page summary) (1) the intellectual merit of the proposed activity and (2) the broader impacts resulting from the proposed activity. Font size, margins and page length continue to be scrutinized by NSF for nonconformance. Be aware that a 10 point font may still have a type density which exceeds the 15 characters per 2.5 cm allowed. Collaborators listed on the Biographical Sketches pages must list the institution of the collaborator. Biographical Sketch should include no more than ten publications.

Human Subjects

New FDA Form 1572 Available Effective immediately, if you need to complete/submit a FDA form 1572, you should utilize the new version. To make sure you’re using the correct version: Version date (1/03) is located at the bottom left hand corner on page one and two of the form. Also; the version expiration date (1/31/06) is seen in the upper right hand corner on page one. New HIPAA Research Compliance Training Scheduled HIPPA Research Compliance Training Feb 24 (12 -1:30 PM.) - RT 101 (Quarterly Research Coordinator's meeting - space is limited) Feb 24 (4:30-6:00 PM) - ROC Auditorium Feb 25 (7:00-8:30 AM) - ROC Auditorium Feb 26 (10-11:30 AM) - Methodist Hospital WG33 Mar 5 (12-1:30 PM) - ROC Auditorium March 21 (7-8:30 AM) – ROC Auditorium

What's New

IU Initiates Clinical Investigator Training Enhancement (CITE) Program DATE: FEBRUARY 10, 2003 FROM: KURT KROENKE, M.D., PROGRAM DIRECTOR RE: CLINICAL INVESTIGATOR TRAINING ENHANCEMENT (CITE) PROGRAM The Clinical Investigator Training Enhancement (CITE) Program allows enrollees to integrate formal research training with a fellowship or faculty position in one's own department. Approximately 6 credit hours per semester will be taken along with clinical research in one’s own discipline. As part of the CITE Program, participants receive a Masters of Science in Clinical Research degree through the Indiana University Graduate School. More information is provided below along with a brief description of the CITE program for posting in your department, division, or section. More detailed information is available at www.regenstrief.org. If you have any questions, please contact me at kkroenke@regenstrief.org or call the Program Manager, Suzanne Galbraith at (317) 630-7870. Indiana University Clinical Investigator Training Enhancement (CITE) Program For physicians, nurses, dentists, and Ph.D. clinical scientists Combination of course work and practical research experience Formal training in Clinical research methods Biostatistics Grant preparation Scientific writing Clinical trials Clinical epidemiology Research ethics Masters of Science in Clinical Research Program is partly supported through an NIH K-30 Award For fellows, faculty, or others with career interest in clinical research For further information, contact Kurt Kroenke, MD Professor of Medicine CITE Program Director Kkroenke@regenstrief.org PH: (317) – 630-7870 (Sue) FAX: (317) – 630-6611 >>> Aim your “CITE’s” High on a Career in Clinical Research <<< What's New at R&SP? Sid brings considerable expertise to the office. Sid was the Director for Research Contract Management and the Associate Dean for Research and Sponsored Programs at IUPUI from 1973 through 1986. For the past 12 ½ years he has been director of the statewide Industrial Research Liaison Program based in Bloomington. From 1990 to 1995, Sid also served as the Chief Executive Officer of the Indianapolis Center for Advanced Research. Prior to that, Sid spent four years working in the health services private sector. Please join us in welcoming Sid back to R&SP! To view the complete R&SP organization chart, see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm.

Events

Feb 24 HIPAA Research Compliance Training What: HIPAA Research Compliance Training When: Feb 24, 2003 Options: 12-1:30 PM - RT 101 (Quarterly Research Coordinator's meeting - space is limited) 4:30-6:00 PM - ROC Auditorium Feb 25 HIPAA Research Compliance Training What: HIPAA Research Compliance Training When: Feb 25, 2003, 7:00-8:30 AM Where: ROC Auditorium Feb 26 HIPAA Research Compliance Training What: HIPAA Research Compliance Training When: Feb 26, 2003, 10-11:30 AM Where: Methodist Hospital WG33 Feb 28 Data Management II: Copyright and Patents “Working Together: Rules, Regulations, and Etiquette of Collaborative Research“ What: “Data Management II: Copyright and Patents” When: Friday, February 28, 2003, 10:00 -11:30 AM Where: State Room East, IMU Second Floor, IUB Register online: http://poynter.indiana.edu/rugs/reg.html Third in a series of four workshops sponsored by the Office of Research and the University Graduate School and the Poynter Center, Indiana University, Bloomington. * Beth Cate, J.D., Associate University Counsel and Special Assistant for Policy and Procedures at the Office of Research and University Graduate School and the University Counsel * Judy M. Johncox, M.A., Vice President of Technology Transfer at the Advanced Research and Technology Institute Mar 4 NCURA 2003 Video Workshop What: Subawards and Subcontracts: A Workshop Primer on Managing Collaborative Projects. When: Tuesday, March 4, 2003, 11:30 AM - 3:30 PM Where: Riley Outpatient Center (ROC) - Auditorium Registration: Contact Mrs. JoAnn Pipkin rspinfo@iupui.edu Additional Information: http://www.iupui.edu/~resgrad/spon/ncura-3-03.htm Mar 4 SoCRA’s Crossroads (Indiana) Chapter Meeting When: 3/4/03 at 6pm to 7:30pm Where: Indiana Cancer Pavilion, Aud #101 RSVP: dfinch@iupui.edu Dinner: Provided CME: 1.5 Provided Mar 5 HIPAA Research Compliance Training What: HIPAA Research Compliance Training When: Mar 5, 2003, 12-1:30 PM Where: ROC Auditorium Mar 7 Mentors and Protégés “Working Together: Rules, Regulations, and Etiquette of Collaborative Research“ What: “Mentors and Protégés” When: Friday, March 7, 2003, 10:00 -11:30 AM Where: State Room East, IMU Second Floor, IUB Register online: http://poynter.indiana.edu/rugs/reg.html Last in a series of four workshops sponsored by the Office of Research and the University Graduate School and the Poynter Center, Indiana University, Bloomington. * Thomas F. Donahue, Ph.D., Professor of Biology * Julie Knost, J.D., Director of Affirmative Action Mar 12-14 IU Research Coordinator Education Program What: The School of Medicine, the Clinical Trials Program, the Outpatient Clinical Research Facility, and the Indiana University School of Nursing (in collaboration with the General Clinical Research Center) have developed this course for the education of research coordinators. The course is designed to introduce the new research coordinator to the world of clinical research and to provide specific guidance about how to conduct and coordinate clinical studies at Indiana University. The three-day session will be held March 12, 13, 14, 2003. Why: • To provide a formalized training experience for study coordinators involved in industry-sponsored clinical research. • To provide a local, cost-effective training mechanism for study coordinators as an alternative to the other more distant, more expensive training programs. • To comply with the School of Medicine mandate that all new research coordinators must attend this course. A variety of investigational studies are conducted on this campus and utilize some of the same knowledge basis. The research coordinators involved in most of them will benefit from this program. While the major thrust of the three days is spent on industry sponsored drug and device trials, additional information relevant to behavioral studies will also be presented. For Whom: The program is targeted for the new study coordinator with less than 2 years of research experience employed by the Indiana University School of Medicine, Dentistry, Clarian Health Partners, Inc., the VA and/or Wishard Hospital. By Whom: The program's presenters include highly qualified Indiana University persons with diverse clinical research experience as well as several experienced presenters from outside the University. Topics Covered: The first two days will include presentations on the topics listed below. The third day will concentrate on the practical application of these concepts at any of the institutions affiliated with the IUPUI/Clarian IRB. A study simulation will take place covering all aspects of study conduct and allowing for interactions with presenters and participants. • An overview of drug development • GCPs and drug law • Study feasibility assessment, budgeting, contracts, and routing the proposal • Study startup and the study approval process and IRB forms • Pre-study preparation, study conduct (including the informed consent process, adverse event reporting, and other IRB requirements) • Audits and study closeout • Clinical research resources available at Indiana University Particular emphasis will be placed on conducting research projects and identifying resources available at Indiana University. Cost: Cost of the program is $320 if registered by February 21, 2003. After February 21, the cost is $370. Payment from grant accounts or other IU accounts is acceptable. The cost includes a.m. and p.m. snacks, as well as reference materials: a resource manual, all presenter handouts/slides, and a copy of the FDA Code of Federal Regulations and Good Clinical Practices reference book. Where: The program will be held in the basement level of Riley's new Outpatient Building, “The ROC” in the "Ruth Lilly Learning Center" Conference Rooms A & B. Contact Hours: Will be provided by the IU School of Nursing, an accredited provider of continuing education in nursing by the American Nurses Credentialing Center’s Commission on Accreditation. Registration: A registration form is attached. Online registration is also available. Go to http://nursing.iupui.edu. Click on Lifelong Learning, then to the left choose this program. Participation is limited to 40 registrants. Because a waiting list already exists, it is important to sign up early. If you have asked to be placed on this waiting list please submit a Registration Form. The Registration Form is attached. Questions: For questions about the program contact Marta Sears at 274-3974. For questions about the CE program and registration or payment, contact Diane Garner at IUSON Lifelong Learning/Continuing Education at 274-7779 or e-mail censg@iupui.edu. Mar 21 HIPAA Research Compliance Training What: HIPAA Research Compliance Training When: Mar 21, 2003, 7-8:30 AM Where: ROC Auditorium Apr 4 Fourth Annual IUPUI Symposium Highlighting the Research of Faculty, Staff and Students of Color What: “Fourth Annual IUPUI Symposium Highlighting the Research of Faculty, Staff and Students of Color” When: Friday, April 4, 2003, 8:30 AM to 4:00 PM Where: IUPUI University Library Register online: http://opd.iupui.edu/multicultural/Symp2003Regis.htm Apr 8 Indiana University Research Symposium Spring 2003 Participants will learn the tips and techniques that work in the “real” world of award administration. For additional information, see the Research Symposium Web site http://www.iupui.edu/~resed/symposiumintro.htm. What: “Indiana University Research Symposium Spring 2003” When: Tuesday, April 8, 2003, 8:00 AM to 12:30 PM Where: IUPUI University Library Lilly Auditorium Audience: IU researchers and research administrators Register online: http://www.center.iupui.edu/common/events.asp?unit=OPD Scroll to event for Tuesday, April 8, 2003. Registration is limited to 100 participants. Help/Questions: Contact Research and Sponsored Programs at 317.274.8285/rspinfo@iupui.edu

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

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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