August 2005

Brenner to Become VP at UNR; Departs IUPUI Aug 31

Mark Brenner came to Indiana University on October 27, 1998. He joined the Office of Research and Graduate Education (RESG) as Vice Chancellor with a staff of 24 and today directs a staff of 60. He will be remembered fondly by the RESG staff as a friend and mentor. “First and foremost, I've appreciated the professional and personal support he's given me throughout the last seven years. He's always trusted my judgment and given me the room and the confidence to both succeed and fail on my own,” Shelley Bizila, Director, Research Compliance Administration (RCA), recalls. Bizila worked diligently with Brenner to achieve many milestones for RCA that include: Increasing the number of Institutional Review Boards (IRBs) to manage additional workloads Creating the IRB Executive Committee to develop policies and ensure consistency for all IRBs systemwide Augmenting the RCA staff from 5.5 to 16.5 Initiating a highly successful Health Insurance Portability and Accountability Act (HIPAA) implementation program for IUPUI/Clarian Organizing all IUPUI/Clarian policies for research involving human subjects into a single set of Standard Operating Procedures (SOPs) Developing the IU Protection of Human Subjects in Research Certification, an online human subjects training course and test Creating the Auditing of Research Involving Human Subjects program Designing the soon-to-be-released Human Subjects Module for the Electronic Research Administration (ERA) System Creating the IUPUI BioHazard Committee (BHC) Achieving the Human Research Protection Program (HRPP) accreditation for IUPUI W. Sidney Johnson, Executive Director, Sponsored Research Services (SRS) relates that he appreciates Brenner’s support during his tenure here. “His management style has made it very easy to implement change and he provides advice and counsel to insure that faculty and staff needs are met,” Johnson said. Together, Brenner and Johnson shaped a new and improved SRS for IUPUI that includes the following highlights: Increasing staff from 1 fulltime contract administrator to 3, plus administrative support Devoting resources to enable the implementation of the award data base as a management tool and upgrade it to meet our needs Enabling SRS to reduce the processing time of contract awards, Material Transfer Agreements and other contracts to meet faculty expectations Developing a Contracts Processing procedure manual Creating the “customer service attitude” of the staff and encouraging new relationships with sponsors, including 33 Master agreements for clinical trials and research support “Mark Brenner was always supportive of my personal and professional development,” states Mercedes Randall, Director, Systems and Administration, Research and Graduate Education (RESG). “He also trusted my judgment and provided the necessary room for decision making, creativity and professional growth. It was good to work under his guidance and direction. He gave great lessons in perseverance, responsibility and accountability,” Randall said. The following features under Brenner’s direction and Randall’s support improved the administrative, financial, and systems operations of RESG: Creating numerous new positions and reclassifying key staff Significantly increasing funding to support growth and the establishment of new systems (i.e., the Electronic Research Administration (ERA) System) to streamline operations Recognizing under-funded and underpaid line positions and obtaining funding and approval for compensation adjustments to ensure retention Seeking and obtaining funding for the creation of the Computer Support Technician position, long needed to appropriately support RESG staff Strongly supporting new technology (Brenner’s vision resulted in great savings pertaining to money and staff time as well as efficient communications and work flow. A good example is the acquisition of the Polycom video conferencing system.) Recognizing the key importance of good communication both at the departmental (internal) and campus level (He held regular staff meetings with his senior staff as well as one-on-one meetings with his direct reports. Also the R&SP Communicator was established under his direction.) Pam McKeough, former Director of Sponsored Program Administration said “I would like to echo the comments of the other Directors. Mark Brenner had always been very supportive of his staff, of R&SP, and the IUPUI research mission. During his tenure the number of proposals submitted by faculty grew 52% from 1,620 to 2,459 and awards increased by more than 96% to all-time high of $265 million in FY04. He has helped the office expand and improve to meet the increasing demands resulting from this growth. The development of the ERA Routing Form and Budget Modules, streamlined procedures for proposal submission, participation in the Federal Demonstration Partnership, and development of a Conflict of Interest tracking system are just a few examples. In addition, his efforts have enhanced the visibility and reputation of IUPUI and Indiana University on the national level.” “Mark Brenner has been an exceptional leader for Research and Graduate Education at IUPUI. He encouraged me to expand on my ideas even when I wasn’t sure my ideas were good ones or feasible,” Shannon Walden, Coordinator of Educational Programs for the Responsible Conduct in Research, recalls. “I will always be proud of our development of the electronic newsletter, the R&SP Communicator, and my role as general editor. Early in his tenure at IUPUI, Brenner identified the need for an electronic newsletter to communicate timely research related announcements, articles, and program information to the IUPUI research community. Today, the R&SP Communicator is read by more than 2,600 subscribers at IUPUI and other IU campuses. Since the R&SP Communicator was first published in April 2001, it has chronicled all major Research and Sponsored Programs (R&SP) events, policy and procedural enhancements, and services — all of which would not have been possible without the steadfast guidance of Mark Brenner,” Walden said. Etta Ward, Director, Scholarly and Creative Activity Program / Sponsored Program Development, remembers Brenner as a tremendous mentor both professionally and personally. “He made my transition to the directorship a smooth one, by offering me the support and encouragement needed to advance the efforts to the Sponsored Program Development (SPD) Office. He has been instrumental in my ability to effectively interact with and engage faculty, staff and graduate students in the services provided by this unit. As a result of his guidance, advice, encouragement and support, I have been able to establish my own service provision niche throughout the campus. He is an avid supporter of professional development, on all levels, and encouraged many to pursue further academic studies to support future career goals and advancement,” Ward said. Ward reflects on the following SPD accomplishments guided by Brenner’s management: Increasing efforts to link faculty with research and project funding that has the potential to bring additional revenue to the campus Increasing proposal development support Coordinating and implementing successful internal grant programs to provide seed and professional development funds that would ultimately lead to the submission and award of external funding Establishing coordinated efforts to facilitate and increase research collaboration throughout the campus Developing and implementing the IUPUI Preparing Future Faculty Program that now fosters collaborative partnerships with Ivy Tech Community College, Butler University, and three Indiana University campuses Under Brenner’s leadership, Research and Sponsored Programs has increased and improved the service it provides to the IU research community. However, it is the manner in which he touched individuals that will be remembered most. Etta Ward summarizes his legacy, “As a personal mentor, Dr. Brenner always took the time to provide me and the rest of Research and Sponsored Program staff with the encouragement, guidance, advice, and a certain level of flexibility and freedom needed to explore the possibilities and potential for personal and professional growth. We appreciate all he has done in his seven year tenure and will miss him greatly.”

Human Subjects

New Policies and Procedures for Reporting Unanticipated Problems Involving Risks to Subjects or Others and Noncompliance Effective Sept 1 Significant revisions include: Unanticipated Problems Involving Risks to Subjects or Others and Noncompliance SOP Clarification added to definitions for “related to research procedures,” “unanticipated problems,” and “unexpected.” Clarification added to Appendices A and B regarding the use of the Tracking Log for Adverse Events Not Requiring Prompt Reporting to the IRB. Tracking Log for Adverse Events Not Requiring Prompt Reporting to the IRB Removed the requirement for PI to initial and date each adverse event listed. Now the log, when used, only requires the PI to sign once (for all adverse events listed). Reporting Form for Events that Require Prompt Reporting to the IRB Section II: Added link to SOP; Item A. clarifies when an event should NOT be reported using this prompt reporting form; and Clarifies what additional sections on the form need to be completed depending on the event being reported. Section IV: Item 1 asks investigators to consider if the event is consistent, not only with the informed consent document, but also with the severity and/or frequency with available literature. Item 1 permits the option of citing the specific event description from the informed consent document, rather than only requiring attaching a copy of the informed consent demonstrating the event’s consistency with it. Items 2 and 3 permit the option of submitting a needed amendment to change the informed consent or protocol at a later date if certain circumstances exist such that the amendment cannot be submitted with the report. IRB Documents to be Stamped Here is a list of documents that will be stamped: Informed consent statement Assent statement Advertisement Authorization for the release of health information for research Please note the above documents (if applicable) will be returned with the final approval letter or amendment form. In addition, these documents shall be submitted by the investigator with the study’s continuing review and copies of these documents, showing an updated stamp, will then be returned to the investigator once the continuing review is approved. Should the investigator utilize subject surveys and/or questionnaires, etc., the “proof” that these documents were originally submitted to and reviewed and approved by the IRB is found on the Documentation of Review and Approval (DRA) or amendment form. In Section IV of the DRA, Research Submission and in Section 6 of the amendment form, the investigator should list these documents as included with the research submission. Note that these documents do not need to be resubmitted at the time of continuing review, but it is sufficient that copies will be maintained in the investigator’s study file. However, if investigators feel they require evidence of submission to the IRB, the document(s) should be included with the continuing review and listed under “Attachments” in the continuing review form. In summary, the survey, questionnaires, etc. will not be stamped; the investigator will instead utilize the DRA, amendment form, or the continuing review form as evidence these documents were reviewed by the IRB. If investigators submitted these ancillary documents for review by the IRB originally but this was not reflected on the approved DRA, there are two courses of action investigators may take to resolve the issue: Request an email from the RCA. When doing so, please note the PI and study number along with the documents which were not originally indicated on the DRA. RCA will subsequently respond with a formal email noting the documents were in fact reviewed and approved by the IRB. This email will suffice as adequate documentation. Submit to the IRB as a general information item, the documents that were not included on the original DRA. The IRB will review the general information item and the minutes from the meeting will be provided to the investigator. These minutes will provide evidence the documents were reviewed by the IRB. If you have additional questions, please contact Research Compliance Administration at 317.274.8289.

Sponsored Research Services

NIH Announces Public Access Policy for Archived Funded Research Publications Dear Extramural Research Community, The National Institutes of Health (NIH) published its Public Access Policy (Policy) in the NIH Guide for Grants and Contracts on February 3, 2005, and in the Federal Register on February 9, 2005. These announcements and additional relevant information, including Questions and Answers regarding copyright and other concerns, are available at the NIH Public Access Web site: http://www.nih.gov/about/publicaccess/. The purpose of this announcement is to provide a summary of the Policy and to furnish guidance to NIH investigators on the submission of manuscripts. Please feel free to distribute to others who may have an interest in reading this message. Summary of the Policy The Policy becomes effective May 2, 2005. The Policy requests and strongly encourages all NIH-funded investigators to make their peer-reviewed author's final manuscripts available to other researchers and the public at the NIH National Library of Medicine's PubMed Central (PMC) [see http://www.pubmedcentral.nih.gov] immediately after the final date of journal publication. At the time of submission, authors are given the option to release their manuscripts at a later time, up to 12 months after the official date of final publication. NIH expects that only in limited cases will authors deem it necessary to select the longest delay period. The Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs1 from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. NIH is requesting that authors submit publications resulting from 1) currently-funded NIH research projects or 2) previously-supported NIH research projects where manuscripts were accepted for publication on or after May 2, 2005. Publications resulting from non-NIH-supported research projects should not be submitted. We welcome comments and suggestions about the submission process. Please contact us at PublicAccess@nih.gov. The NIH Manuscript Submission System The password-protected, Web-based, NIH Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov) has been developed to facilitate the submission process. This system allows easy identification of NIH grant numbers (past and present) and NIH intramural project numbers by associating them with the corresponding extramural or intramural Principal Investigator (PI) of the research study. Currently, manuscript files from NIH Intramural PIs can be submitted to the NIHMS system by the PI or designated NIH staff. Manuscript files from extramural PIs may be submitted by the PI only. Beginning July 6, 2005, manuscript files may be submitted to the NIHMS system by either the extramural PI or a third party on the PI's behalf (e.g., administrative personnel, graduate students, librarians, publishers, etc.). In all cases, approval of the submitted materials and the determination of the public release date require the PI's review and authorization. Currently, the system is designed for individual submissions, but procedures for batch processing of multiple submissions are being explored and may be developed in the future. No further formatting of the manuscript is necessary beyond that required by the accepting journals. Special arrangements will be available for unusual cases. Please see the NIH Public Access Web site (http://www.nih.gov/about/publicaccess/) for more information about the Policy. How to Submit the Manuscript Login to the NIHMS (http://www.nihms.nih.gov). Select the appropriate login option (Note: the same login should be used for all subsequent visits to the NIHMS system): NIH extramural investigators select "eRA Commons" (see "What is the NIH eRA Commons?" below). NIH intramural employees select "NIH." Provide basic information, including the journal title, PI, contact information, and associated NIH award number(s). Upload the complete text of your manuscript(s). The NIHMS supports a wide variety of file types (MS Word, Word Perfect, PDF, PowerPoint, Excel, etc.). Upload any corresponding, supplemental image files that contain figures, tables, or supplementary information along with the manuscript. Just as required by publishing journals, submit high-resolution images to ensure that they can be viewed properly in PMC. The supplemental material that has been submitted to the accepting journal in support of the manuscript will be accepted. The NIHMS will generate a receipt of the uploaded files in PDF format. The PDF receipt summarizes the information entered into the system and merges the manuscript's files into one viewable document. Confirm that the manuscript and any additional supporting documents have been successfully received by NIHMS, and verify the document. Review and approve the terms and conditions of a submission agreement and specify the timing of posting of the final manuscript for public accessibility through PMC (this must be completed by the PI). Authors and/or their institutions should ensure that their final manuscript submissions to PMC are consistent with any other agreements, including copyright assignments that they may have, or enter into, with publishers or other third parties. Upon approval of the submission by the PI, the manuscript will be converted into XML - the standardized digital format used by PMC. Review the XML manuscript as it will appear in PMC once the conversion has taken place (PIs will be notified by e-mail when the document is ready for review) and correct any errors, if necessary. After PI approval, the article will be publicly accessible through PMC after the time-delay specified by the PI. Note: Users are able to track the status of their manuscripts throughout the process. Need Help? Do you have questions about the submission process? Refer to the NIHMS FAQ. The NIHMS system also maintains a help desk to assist users with manuscript submissions and answers to any questions related to the submission process. Contact (http://web.nihms.nih.gov/db/sub.cgi?page=email&from=home) the help desk with your queries. What is the NIH eRA Commons? The NIH eRA Commons is a system developed to facilitate the discrete exchange of essential information between NIH and applicant organizations. The "Commons" is a Web interface, available at https://commons.era.nih.gov/commons/, where NIH and the grantee community are able to conduct their extramural research administration business electronically. For example, this system allows PIs and institutional officials to have various degrees of online access to the status of their grant applications and details associated with their grant awards. An NIH eRA Commons account is required for PIs to enter into the NIHMS system and submit final manuscripts. Submitting authors do not need to be a currently-funded NIH investigator in order to create quickly a Commons account number. If you have questions, problems, or comments regarding the NIH eRA Commons system, please contact the Sponsored Research Office (or equivalent) at your institution or contact the NIH eRA Commons Help Desk at commons@od.nih.gov (Phone: 866-504-9552). 1. Costs that can be specifically identified with a particular project or activity. NIH Grants Policy Statement, Rev. 12/2003; http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#_Toc546 00040. Best wishes in your research endeavors. Sincerely, Jo Anne Goodnight Acting Director, Office of Extramural Programs Office of Extramural Research National Institutes of Health Department of Health and Human Services 6705 Rockledge Drive Rockledge I Building, Room 3534 Bethesda MD 20892 ph: 301-435-2688 fax: 301-480-0146 email: jg128w@nih.gov

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