March 15, 2005
Responding to Investigator-Initiated Research Problems:
A Scenario-Based Audio Seminar
Seminar Addresses 3 Common Problem Situations Faced By Research Community
Growing concern over investigator-initiated research has forced research organizations and institutional review boards (IRBs) to acknowledge a gap in their oversight of medical studies. That, in turn, is leaving administrators, IRBs and researchers unsure of how to proceed. To assist the biomedical research community, Melamedia, LLC, publisher of Drug & Biologic Guidance Watch and Health Information Privacy/Security Alert is presenting Responding to Investigator Initiated Research Problems: A Scenario-Based Audio Seminar on March 15, 2005.
"Research administrators should adopt the approach of helping researchers meet the highest levels of quality possible that equals the rigor of clinical research for regulatory registration purposes," observed William Hirschhorn, MS, Director of Graduate Research Education and Policy at the Drexel University College of Medicine and a member of the seminar faculty. "The tone should be cooperative and collegial, not adversarial."
The seminar will discuss three common scenarios faced by IRBs, research institutions and investigators. In each scenario, this well-respected faculty will discuss what policies and procedures the institution and IRBs should have in place to monitor and assist researchers in meeting compliance goals. The briefing also discusses what researchers should consider and what they should do to avoid needless questions about their research and prevent regulatory interventions.
Seeking Forgiveness Rather Than Permission. In this scenario, national authorities review IRB and investigator options, requirements and risks they face when researchers fail to obtain IRB approval prior to beginning studies.
Where Did This Data Come From? In this scenario, a researcher obtains tissues, x-rays or other types of information from other researchers or other entities and operations. The faculty will discuss how HIPAA has played an increasingly important role as well as OHRP guidance on research involving coded private information or biological specimens.
The Perilous Road: Unrestricted Grants. In this scenario, participants will be briefed on what steps to take to address the special risks posed by unrestricted grants from drug, biologic and device makers.
Who Should Listen
Research Grant Managers
Institutional Review Board Members
Clinical Investigators and Study Coordinators
Contract Research Organizations
Medical Device Manufacturers
William Hirschhorn, MS, Director, Graduate Research Education and Policy, Drexel University College of Medicine. Prior to joining Drexel, Mr. Hirschhorn was the Director of the Office of Clinical Trials at the Temple University School of Medicine, where his duties included ensuring quality standards of performance and compliance for clinical trials, developing and teaching courses for house staff, attends physicians and clinical research coordinators on a variety of good clinical research practice topics. Mr. Hirschhorn frequently interacted with clinical investigators in designing independent clinical trials as well as investigator-sponsored INDs and was a member of the IRB. Before joining Temple, he was responsible for clinical research education and academic relations at Covance Clinical and Periapproval Service, Inc.
Kendra Dimond, J.D., partner with the national healthcare and life sciences law firm, Epstein Becker & Green. Ms. Dimond's clients include academic medical centers, hospitals, drug and device manufacturers, and clinical research and site management organizations. Previously, Ms. Dimond headed the National Institutes of Health Office of Legislative Policy and Analysis. She also has worked closely with the HHS Office of Research Integrity and OHRP.
Moderator: Dennis Melamed, Mr. Melamed is editor and publisher of Drug & Biologic Guidance Watch and Health Information Privacy/Security Alert. He is also the lead editor and writer of the well-received 3-volume HIPAA Handbook reference set and a frequent lecturer on research, privacy and date security.
Continuing Education Credits
- All seminar participants will receive a certificate of participation
The CD recording with all course materials are excellent educational and briefing resources: $275
Download the form at http://www.melamedia.com/031505.CD.pdf and fax it to 703.619.4912