April 2005

Human Subjects

Human Research Protection Program Receives AAHRPP Accreditation Educational Series on Ensuing Changes to IRB Policies, Processes and Forms Details are included below and may be found under "Educational Seminars in Clinical Research 2005" on the Clinical Trials Program Web page: http://medicine.iupui.edu/ctp/pdf/2005%20Educate.rtf APRIL Date: April 7, 2005 Time: 12:00 - 1:30 PM Location: Tudor Auditorium, 5th Floor Wishard Title: IRB Changes to Procedures and Forms for Initial Project Approval CME: Pending Speaker: Shelley Bizila, Director, Research Compliance Administration Details: The recent accreditation process has necessitated IRB changes in policy, procedure and forms. The purpose of this session will be to inform investigators and coordinators regarding those impending changes, their rationale, and practical advise regarding how they will affect the initial approval process. Registration: Space is limited to the first 50 registrants. Contact Michelle Murray @ 317.278.2868 or mimurray@iupui.edu Date: April 11, 2005 (repeat of 4/7/05) Time: 3:30 – 5:00 PM Location: ROC Auditorium Title: IRB Changes to Procedures and Forms for Initial Project Approval CME: Pending Speaker: Shelley Bizila, Director, Research Compliance Administration Details: Content same as April 7, 2005.(repeat) Registration: Contact Michelle Murray @ 317.278.2868 or mimurray@iupui.edu MAY Date: May 6, 2005 Time: 12:00 - 1:30 PM Location: Tudor Auditorium - 5th Floor Wishard Title: Changes to IRB Procedures and Forms Affecting Project Management and Reporting During the Conduct of Your Approved Study, i.e., Expectations After IRB Approval CME: Pending Speaker: Shelley Bizila, Director, Research Compliance Administration Details: The recent accreditation process has necessitated IRB changes in policy, procedure and forms. The purpose of this session will be to inform investigators and coordinators regarding those impending changes, their rationale, and practical advice regarding how they may impact your reporting and managing your approved project, e.g., continuing reviews, amendments, adverse events, and unanticipated risk to subjects. Registration: Space is limited to the first 50 registrants. Contact Michelle Murray @ 317.278.2868 or mimurray@iupui.edu Date: May 20, 2005 Time: 12:00 - 1:30 PM Location: Tudor Auditorium - 5th Floor Wishard Title: Changes to IRB Procedures and Forms Affecting Project Management and Reporting During the Conduct of Your Approved Study, i.e., Expectations After IRB Approval CME: Pending Speaker: Shelley Bizila, Director, Research Compliance Administration Details: Content same as May 6, 2005. (repeat) Registration: Contact Michelle Murray @ 317.278.2868 or mimurray@iupui.edu Please contact Research Compliance Administration, 317.274.8289, or the Clinical Trials Program, 317.278.3858, should you have any questions. Mark L. Brenner, Vice Chancellor for Research and Graduate Education, is responsible for the Human Research Protection Program at IUPUI. The Research Compliance Administration staff, led by Director Shelley Bizila, oversees the day to day HRPP operations. The Human Research Protection Program at IUPUI continues to proactively protect the rights and welfare of human research participants recruited to participate in research conducted under the auspices of Indiana University. Learn more about the Human Research Protection Program at IUPUI and how the Institutional Review Boards (IRBs) for Indiana University-Purdue University Indianapolis (IUPUI) and affiliated organizations are responsible for the review and approval of all research involving human subjects at http://www.iupui.edu/%7Eresgrad/spon/hrpp.htm. More information about the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and their standards, not only to ensure compliance, but to raise the bar in human research protection by helping institutions reach performance standards that surpass the threshold of state and federal requirements at http://www.aahrpp.org/www.aspx?PageID=5.

Proposals and Awards

Updated Instructions to the PHS 398 (DHHS Public Health Service Grant Applications) Now Available Updates of note since the initial November 2004 release include: - Additional acceptable fonts are specified. Applicants may now use an Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.) - Instructions for the budget fields on the Face Page and the various Budget Form Pages have been revised to provide clearer guidance for applications that include consortium F&A costs. - A clarification has been made regarding Appendix material. Appendix material can be two-sided as appropriate. While the font requirements imposed in the rest of the application do not apply to the Appendix, all material must be clearly legible. - Minor formatting revisions have been made to some form pages to improve usability. - Significant revisions have been made primarily in Part II, Human Subjects Research Supplement, to further address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. Minor revisions and formatting changes have been also been made in the PHS 398, Parts I and III. - On Form Page 3, Research Grant Table of Contents, the ordering of items in the Human Subjects Research section of the Research Plan has been revised. - Chapter V of the PHS 398 has been revised to reflect that the modular budget format no longer applies to SBIR/STTR grant applications. The full text of this announcement is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-039.html. Please direct questions concerning this notice to Research and Sponsored Programs at 274-8285.

April 14 Research Symposium

Register Now for the Spring Research Symposium! Breakout sessions will focus on “Getting Started with Research at IU”, “Pre- and Post-award Administration”, and research “Hot Topics”. Sessions include: Nuts and Bolts of Research Compliance Electronic Research Administration — Routing and Budget Financial Audits: What Agencies Target Getting Started with Research Collaboration SIS and Graduate Student Issues Policy Made Practical: Understanding Conflict of Interest Visit the SPA: Healthy Projects from Start to Finish with Sponsored Programs Administration Navigating Electronic Resources to Find Funding A-21 Effort Reporting — Policy and Current Developments Confronting the Challenges of Sponsored Programs 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 schedule information available at http://www.iupui.edu/~resed/symposiumspring05intro.htm.

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

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