Computerized information management for institutional review boards.
The use of human subjects for medical research in most industrialized nations requires the scientific and ethical scrutiny of research proposals by a governing institutional review board (IRB) or its equivalent. As part of their primary charge to protect human subjects, IRBs are responsible for the regulatory oversight of not only the research protocol itself but also the research conduct of the investigators and, if applicable, the funding sponsor. This article will discuss the regulatory requirements for an accurate account of IRB protocols and investigators and present an overview of the general flow of information for an IRB protocol. The current and potential uses of information management systems by IRBs will also be reviewed and accompanied by a discussion of the potential advantages and disadvantages of various computerized information systems for management of clinical research.
Hood
Maureen N
MN
Department of Radiology and Radiological Sciences, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA. mhood@usuhs.mil
Gugerty
Brian
B
Levine
Richard
R
Ho
Vincent B
VB
D028744:Ethics Committees, Research / Q000458:organization & administration*; D006801:Humans; D008331:Management Information Systems; D015399:Nursing Research / Q000458:organization & administration; D035842:Research Subjects; D012984:Software; D018511:Systems Integration; D014481:United States