I'd like to welcome you to the first issue of our new IRB Newsletter and share with all of you a few details of our recent IRB reorganization.

The key to our reorganization is a new, professional team. Our primary goal is to provide efficient, high-quality reviews for you, the research community. The following elements of the reorganization have been specifically designed to enhance our services to you.

The focus of this reorganization is to increase compliance with Human Research Protection by enhancing communication and providing services for our research teams. One of these services is the Investigator Liaison position held by Kim Diccianni. Kim is available on a part-time basis to assist you with the IRB process and human subject protection regulations. By setting up a meeting, you will be provided with one-on-one guidance and support going through the IRB process. Assistance may be provided in the following areas: (1) Application Process; (2) Overview of IRB review types; (3) Pre-review of IRB submissions; (4) Document revision assistance and (5) one-on-one education in human research subject protection. At this time, Kim is available on Mondays and Wednesdays. Please contact her at kim.diccianni@med.nyu.edu or (212) 263-4116.

Our Assistant Director, both Research Analysts and I are handling all expedited reviews internally. Bringing expedited reviews "in house" will give the administrative team a better understanding of all studies. By specializing in this type of review, we aim to decrease their turn-around time significantly.

Research Analysts and newly hired professional IRB coordinators will conduct comprehensive pre-reviews of all full board submissions - New, Continuing and Requests for Amendment – checking for completeness and accuracy of submissions and identifying issues for the IRB Committee. Because all expedited reviews are handled by IRB administrative staff, the full board is free to focus on those studies that require rigorous and careful consideration.

IRB assigned reviewers will be encouraged to work directly with Investigators. The goal is to identify/clarify any substantive questions and deficiencies prior to a convened meeting. Additionally, Investigators will be asked to send in electronic copies of their submissions to the IRB via email so that staff can correct non-substantive consent form deficiencies via word/track-changes. This has the benefit of presenting the Board with the most complete, well-prepared submissions possible, and reduces the number of conditions and deferrals issued by the Board.

Sincerely,

Key to our recent improvements are the new IRB staff members and position additions/changes.

Helen Panageas joined the Administrative Office of the Institutional Board of Research Associates in April 2005. Ms. Panageas came to New York University School of Medicine from her position as Director of the Institutional Review Board at Winthrop University Hospital. Ms. Panageas led a successful restructuring of the IRB at Winthrop and has brought many exciting service and educational programs with her to NYU SoM. Ms. Panageas has gained her extensive experience through various areas of research administration including grant management and sponsored programs work first at Memorial Sloan Kettering Cancer Center and than at North Shore- Long Island Jewish Health System. Ms. Panageas holds a bachelor’s degree dual major English and Political Science and is currently completing her Masters in Health Administration. Ms. Panageas is a Certified IRB Professional and is an active member of the National Council of University Research Administrators and serves on the Planning Committee of the National IRB Professional Conference of Applied Research Ethics National Association and Public Responsibility and Medicine and Research.

Paul Thompson, as the IRB IT Manager, assists the IRB with the implementation of the InfoEd modules, managing our technical assets, helping with strategic technical planning and helping develop several in-house systems that will accelerate our move to a fully paperless process. Paul has an extensive technical background spanning business analysis, project and process management, hardware and software tools, database design and development, systems programming, networking and security.

The IRB Administrator positions have been elevated to a professional-level Research Analyst. These positions have been filled by individuals with extensive scientific background and experience in clinical research. The analysts  oversee study-specific administrative activities and serve as internal expedited reviewers for ongoing studies.

Richard Kline joins the IRB as our new Research Analyst for Board B. Prior to joining NYU Rick served as the IRB Manager at Columbia University Medical Center for three years. Rick brings with him in-depth experimental and theoretical biomedical research experience and sophisticated statistical and quantitative techniques. Rick holds a Masters in statistics and physics in addition to a Ph.D. in physics & neuroscience.

Germaine Cuff joins the IRB as the Research Analyst for Board A. Prior to joining the IRB Germaine served as the Director of Research for the Department of Anesthesiology. Germaine holds a BSN in Nursing and a Masters in Public Health.

Nadia Kunan joins the IRB as the new Coordinator for Board B. Nadia comes to us from Columbia University Medical Center’s IRB and a holds a BS in Microbiology and Biochemistry.

Many of you might already be familiar with the remainder of the IRB team:

• Quality Assurance & Improvement Specialist – Aileen Kunitz will begin implementation of a new interactive Quality Improvement Program
• Investigator Liaison - Kim Diccianni - joined the IRB in February 2003. Kim came to New York University School of Medicine with an extensive career background in IRB and research/clinical trial management. She will utilize her experience to assist Investigators and Coordinators in the NYU SOM IRB process and human research subject protection process. Kim, a Certified IRB Professional, holds a BA in Biopsychology and has completed course work in her continued pursuance of a Masters in Medical Humanities.
• Silvia Jimenez is our Assistant Coordinator. She joined the IRB in March of 1999 as a part time assistant to the IRB, was quickly promoted to a full time position to be the liaison for the Bellevue Research Committee and the GCRC Committee. These days, Silvia is in charge of processing SAEs and study closures. She is also in charge of data quality for the IRB's InfoEd database.
• IRB Assistants, Fareeha Khaleel and Brian Desmet will continue to provide administrative support for board coordinators and analysts. Brian holds a BA in Philosophy from the University of Missouri and comes to the IRB with a background in administration and theater management. In his free time, he DJs and helps produce comedy shows. Fareeha Khaleel joined us in September of 2002. She is responsible for assembling the agendas for both Boards, as well as coordinating various communications between the administrative staff and research teams.
• Teresa Laury who joined us in January 2005 as the IRB Receptionist is the first voice one hears when calling the IRB office. She has been promoted to Administrative Coordinator with additional responsibilities.

By hiring individuals with substantial human subjects experience and a high level of commitment to providing service to the research community, we expect a significant improvement in the performance of the IRB and the appreciation for the work that we do.

We are certain that you will be as pleased as we are that these new individuals have joined the IRB. It is our mission to provide top-quality guidance and support to the research community and help researchers navigate all of their study’s compliance requirements with exceptional knowledge and service. We believe the NYU SoM research community deserves no less.

We are very pleased to announce that Thomas Blanck, M.D., Ph.D., Chairman of the Department of Anesthesiology, has accepted appointment as the new Chair of the IRB. His term as Chair of both IRB boards began January 2, 2006.

As many of you know, Dr. Blanck joined our faculty in 2001 as Professor and Chair of Anesthesiology, after distinguished accomplishments in research and clinical service administration at Cornell University Medical College, Johns Hopkins University and Hospital for Special Surgery. At these prestigious institutions, Dr. Blanck held faculty appointments not only in anesthesiology, but also in pharmacology, biomedical engineering, physiology and biophysics. He is a graduate of the University Of Pennsylvania School Of Medicine and also of the University of Pennsylvania Graduate School of Arts and Science, from which he earned his Ph.D. in biochemistry.

Dr. Blanck brings to the IRB Chairmanship broad experience in clinical research and human subjects protection. An active researcher, he has been principal investigator on more than 20 NIH grants. He has been a member of our IRB for the past year. Previously, he served on the Hospital for Special Surgery IRB from 1995-2001, where he also was a member of the Research Executive Board for the same period. While at Cornell Medical College, Dr. Blanck was Vice Chairman of Research, Department of Anesthesiology; he chaired the Research Committee of the Department of Anesthesiology at Cornell from 1992-1995 and served on the Committee on Human Rights in Research for the same period. He also served as a member of the Committee on Research of the American Society of Anesthesiologists from 1992-1997. Prior to that, at Johns Hopkins, Dr. Blanck served on the Joint Committee on Clinical Investigations for five years.

Research is defined in the Federal Regulations as any systematic investigation designed to develop or contribute to generalizable knowledge. All Human Subjects Research is subject to review and approval by the IRB. If your research involves: (1) obtaining data, through intervention or interaction, (2) obtaining identifiable private information, or (3) involves the use of an FDA regulated product with human subjects, your research constitutes Human Subjects Research and must be submitted for IRB review.

Phone: (212) 263-4110

Fax: (212) 263-4147

Web: http://www.med.nyu.edu/irb