Seminar Addresses 3 Common Problem Situations Faced By Research Community
March 15, 2005. 2-3:30 Eastern
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.
SCENARIO 1
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.
SCENARIO 2
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.
SCENARIO 3
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 ATTEND
· Research Managers and
Administrators
· Research Grant Managers
· Institutional Review Board Members
· Clinical Investigators and Study Coordinators
· Contract Research Organizations
· Pharmaceutical Research And
Marketing Professionals
· Medical Device Manufacturers
· Biologics Manufacturers
· Healthcare Attorneys
· Healthcare Consultants
THE FACULTY
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.
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