OHRP, National
Experts Discuss The Perils Of Investigator-Initiated Research
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.
The seminar features
a compliance oversight coordinator from HHS's Office of Human Research
Protections (OHRP) and other national authorities to provide guidance
to researchers and their organizations.
Participants will
be 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 Attend:
- Research Managers
And Administrators Research Grant Managers
- IRBs
- Clinical Investigators
And Study Coordinators
- CROs
- Pharmaceutical
Research And Marketing Professionals
- 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.
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