The Johns Hopkins University Schools of Medicine, Nursing, and Public Health First Friday Research Coordinator Brown Bag Lecture Series Provided by The Institute for Johns Hopkins Nursing   The lecture will be held in HURD HALL and will be simulcast from Hurd Hall to the Carroll Auditorium on the Bayview Campus.   Bring your lunch. Drinks and cookies will be provided at the Hurd Hall location. Admission is FREE. Registration is requested, but not required.

DATES PROGRAM FORMAT January 4, 2008 Reporting to the IRB: Problems, Events, Deaths and Deviations   Presented by: Joan Pettit, JD, MA Human Subjects Regulatory Affairs Specialist The Johns Hopkins School of Medicine IRB   The lecture will describe the steps taken at three levels to proactively build safety into your studies View Lecture February 1, 2008 The Promise and Perils of the Latest "Hot Thing": Genome-Wide Association Studies Presented by: Jack Schwartz, JD Assistant Attorney General and Director of Health Policy Maryland Attorney General's Office   Genome-wide association studies (GWAS), which examine variation across the entire human genome to identify genetic associations with diesase risk, have generated much excitement. Althoug GWAS are seen as an important tool for understanding the etiology and pathophysiology of disease, they raise significate ethical issues about confidentiality and privacy and the scope of informed consent. View Lecture March 7, 2008 Information Security for Research:  The Basics Presented by: Arthur Giovannetti, CISSP Information Systems Security Officer Johns Hopkins Bloomberg School of Publc Health   This presentation will cover basic information security best practices for researcher. It will focus on Johns Hopkins University paolicy and resources with a focus on HIPAA. Recording not available this month. Handouts April 4, 2008 Quality Management in Clinical Research Presented by: Claudia Baxter, RN, BSN Nurse Consultant National Institue of Allergies and Infectous Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID) Office of Clinical Research Affairs (OCRA)   Introduce concept and utility of quality management plans as necessary tools for validating clinical resarch procedures and processes.   Draw analogy with structure of buildings, planning, foundations, framework implementation of plans, and evaluation of the efficacy of the plan.   Considerations for "building" clinical quality management plans.   Site infrastructure: policies, funding agreements, best practices, and regulations supporting clinical research. View Lecture May 2, 2008 Adverse Events and Ethical Decision-Making for Research Coordinators Presented by: Adil E. Shamoo, PhD Professor University of Maryland School of Medicine   Adverse events reporting is a key to the integrity of clinical trials. There is evidence that there is a great deal of under-reporting of adverse events. Moreover, research coordinators are at the frontline of ensuring accurate and honest reporting of adverse events to the sponsor and the FDA.  Research coordinators come under pressure to downplay adverse events.  This creates a serious moral dilemma to the research coordinators.  We will disucss the steps necessary in the ethical decision-making process. View Lecture Handouts June 6, 2008 Clinical Research Billing Initiative Presented by: Martha Weiner Sr. Director, Office of Billing Quality Assurance Office of Clinical Research Billing and Quality Assurance   Patricia Travis, PhD Associate Director, Clinical Trials Contracting Johns Hopkins University, School of Medicine, Research Administration   Karen Roz, MS Associate Director, Clinical Research Supportive Services Johns Hopkins University, School of Medicine, Research Administration   John Lowery, RN, BSN, MHA, FACHE Sr. Director, Johns Hopkins Medicine Access Services Johns Hopkins University, School of Medicine     The session will address clinical research billing and the development of a "virtual" clinical trials office comprised of new and existing functions to meet the needs of clinical research faculty and staff. View Lecture Handouts July 11, 2008 Become Familiar with Clinical Research Management System Presented by: Diana Gumas Director of Clinical and Clinical Research Information Systems   Dorothy Damron, M.S. Director, Oncology Clinical Research Administration The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Amy Goodrich, M.S.N., C.R.N.P. Research Associate/Nurse Practitioner The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Stacie Jeter, CCRP Senior Clinical Research Program Manager, Breast Cancer Program The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins   The Team will be presenting a new Clinical Research Management System that has been developed for Clinical Researchers at Hopkins. This system will be rolled out for use in July 2008.  Recording not available this month     Handouts August 1, 2008 Stored Tissue: From Informed Consent to Ownership- Issues for the Research Coordinator to Think About   Presented by Mark T. Hughes, MD, MA Assistant Professor of Medicine Core Faculty, Berman Institute of Bioethics Core Faculty, Florence R. Sabin College Director, Course on Research Ethics This lecture will address some of the key issues involved in obtaining biospecimens from human research subjects during clinical trials. View Lecture Handouts September 5, 2008 How to Obtain "Legally Effective" Informed Consent  Presented by: Joan C. Pettit, JD, MA, CIP   Regulatory requirements for obtaining legally effective informed consent. Recording not available this month   Handouts October 3, 2008 Creating the Future Clinical Research Environment at Johns Hopkins Presented by: Daniel E. Ford, MD, MPH Vice Dean for Clinical Investigation   The lecture will describe the current state of clinical research at Johns Hopkins, introduce new Institute for Clinical and Translational Research, and describe plans for research IT. View Lecture Handouts November 7, 2008 Top 10 Things You Should Know About the eIRB Upgrade Presented by: Judith Carrithers, JD, MPA, CIP Director, Human Subjects Research Operations Johns Hopkins University School of Medicine   John Olsen Clinical Research Systems Manager   Miye Schakne Senior Usability Specialist   The lecture will address the overview of changes to eIRB that will be implemented in December. These changes will affect study coordinators, study team members, and principal investigators. View Lecture Handouts December 5, 2008 Topic: Informed Consent in Research: What Works and What Doesn't Presented by: Nancy E. Kass   The lecture will provide a conceptual overview of informed consent in research and provide data as well as literature on what research participants do and do not understand and what types of interventions to improve understanding have been effective. View Lecture Handouts