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Protecting Study Volunteers in Research 
In addition to addressing current and emerging issues that are critical to our system of human subject protection oversight, Protecting Study Volunteers in Research has been expanded to include a chapter on how to implement the HIPPAA Privacy Rule in research. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2003, page 47342) and was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual is referenced routinely for ethical considerations and insights and for a comprehensive review of regulations and guidelines not conveniently found elsewhere.
Protecting Study Volunteers in Research has become required reading in many academic institutions, IRBs, and investigative sites and is a suggested training resource by regulatory agencies and research sponsors. Biopharmaceutical and CRO companies have also made this manual mandatory reading for their staff.
Written by Cynthia Dunn, MD, of Western Institutional Review Board and Gary Chadwick, PharmD, MPH of the University of Rochester, Protecting Study Volunteers in Research has been developed in accordance with ACCME. Readers can apply for CME credits or nursing contact hours. An exam is provided with each manual and is available online.
Book features:
- How to comply with the HIPAA Privacy Rule
- Conflict of interest and disclosure
- Participant Recruitment and Retention in Clinical Trials
- Research with Secondary Subjects, Tissue Banks, Repositories, Databases and Records Review
- Historical perspectives on human subject research
- Updated ethics and federal regulations
- Roles and responsibilities of institutions and independent sites
- Roles and responsibilities of investigators and study staff
Faculty: Cynthia McGuire Dunn, MD, and Gary L. Chadwick, PharmD, MPH, CIP
Accreditation:
The University of Rochester School of Medicine and Dentistry is accredited
by the Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians.
The University of Rochester School of Medicine and Dentistry designates
this educational activity for a maximum 7.5 hours in category 1 credits
toward the AMA Physician’s Recognition Award. Each physician should
claim only those credits that he/she actually spent in the activity.
This activity has also been approved by the New York State Nurses
Association’s Council on Continuing Education, which is accredited by
the American Nurses Credentialing Center’s Commission on Accreditation,
and is assigned approval code 5WSR4D-04. This has been assigned 9.0 contact
hours.
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100% Money-Back Guarantee
AHC Media's 100% Money-Back Guarantee makes this the safest subscription
in health care. If at any time during your subscription you are not
completely satisfied, your payment for the entire year's issues will be returned in full.
No Questions Asked. You Risk Nothing.
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