IRB Advisor – April 1, 2003
April 1, 2003
View Issues
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Dealing with complaints: Listen, investigate, and report findings
Its a call an IRB office dreads getting a patient with a complaint about a study or a researcher, or an anonymous caller alleging problems with a clinical trial. -
Program emphasizes seeking facts, consensus
The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the colleges IRBs. -
Should participants have access to study results?
As genetics research yields more and more information about individuals predispositions to disease and illness, researchers are beginning to question whether study participants should have access to the genetic information obtained about them. -
Spotlight on Compliance: FDA issues guidance on use of electronic records
While the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is clearly getting all the headlines and a great deal of attention in the research community, the recent Food and Drug Administration (FDA) Guidance for Industry on Electronic Records indicates it is not the only game in town. -
Baylor uses its BRAAN to improve IRB operations
Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. They chose the latter. -
News Brief: VA mandates review of research programs
The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.