November 16, 2004
Managing The Perils Of Investigator-Initiated Research
OHRP, National Experts Discuss Strategies for Compliance
Medical professionals' frequent failures or refusals to recognize that some of their activities constitute research put their research institutions at substantial legal risk and threaten acute public embarrassment. While the line between clinical trials and the practice of medicine can be blurry, policymakers and the public are demanding more openness and accountability from research institutions and physicians.
Frequently, clinicians and investigators are unaware that even off-label use or the dispensing of higher doses of approved medicines or minor modifications to medical devices may trigger Food & Drug Administration and HHS regulations governing patient protection and research oversight. In turn, when something goes wrong, institutions can face stiff sanctions in addition to appearing out of control to the public.
To provide medical centers and researchers with a better understanding of when physicians and other medical professionals trigger requirements for research oversight, Melamedia LLC, publishers of Drug & Biologic Guidance Watch and Health Information Privacy/Security Alert is producing a 90-minute audio seminar:
Managing The Perils Of Investigator-Initiated Research
Participants are briefed on:
- Determining when the practice of medicine turns into regulated research;
- When IRB reviews are needed for innovative treatments and retrospective chart reviews;
- Points to consider in developing policies and procedures that define activities that require oversight by Institutional Review Boards;
- When IRBs and grants offices should be involved;
- When off-label prescribing goes beyond treatment and enters the realm of research and oversight;
- When modifications to medical devices may trigger research oversight;
- How HIPAA increases the pressure on researchers to seek IRB oversight of studies.
Who Should Listen
IRBs
Clinical Investigators And Study Coordinators
CROs
Medical Device Manufacturers
Healthcare Attorneys
Healthcare Consultants
The Faculty
Carol Weil, J.D., is a compliance oversight coordinator for HHS' Office of Human Resources Protection. In that capacity, she evaluates allegations of regulatory noncompliance and recommends and assesses the adequacy of corrective actions. Prior to that she was a senior counsel in the HHS Inspector General's Office investigating Medicare fraud.
Kendra Dimond, J.D., is a partner with Epstein Becker & Green. Her clients include academic medical centers, 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.
Dr. Michael R. Hamrell, Ph.D, is president of Moriah Consultants, a regulatory affairs/clinical research and information systems consulting firm. A former drug application reviewer for FDA's Drug Center and a research professional within the National Institutes of Health, Dr. Hamrell has more than 20 years of experience in drug development, clinical research and regulatory affairs He is an Adjunct Associate Professor of Molecular Pharmacology and Toxicology at the University of Southern California School of Pharmacy and Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences. Dr Hamrell served as a founding Editorial Board member for Applied Clinical Trials and serves as the Editor-in-Chief of the DIA Forum.
Continuing Education Credits
- All seminar participants will receive a certificate of participation
CD Ordering
The CD recording with all course materials are excellent educational and briefing resources: $275
Download the form at http://www.melamedia.com/111604.CD.pdf and fax it to 703.619.4912