IRBs often struggle with decisions regarding the reporting of adverse events and unanticipated problems, and the recent increases in IRBs workloads do not help the situation, experts say.
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is SERIOUS and should be reported when the patient outcome is the following.
A debate that has become more heated in the 21st century is whether all embryonic research should be subject to human subject research protection and IRB review.
The furor surrounding the derivation and collection of embryonic stem cells has eclipsed the many other ethical, legal, and social issues that should be examined before these therapies move from the laboratory to human clinical application, say researchers working at Johns Hopkins University in Baltimore.
In the year 2000, Health Care Financing Administration (now known as the Centers for Medicare & Medicaid Services) issued its National Coverage Determination (NCD) extending Medicare coverage to routine costs of qualifying trials, as well as those items and services made necessary to diagnose or treat complications arising from clinical trial participation.
