An Observational Descriptive Study of IRB Decision Making

Background: Institutional Review Boards (IRBs) are the primary organizations designed to protect research subjects from harm and assure that they participate voluntarily. At the same time, many researchers feel that they intrude into the research process without making research safer. Goals: • Identify which issues about applications are the focus of IRB attention; e.g., the scientific validity of a protocol, issues of risk, informed consent • Clarify how, if at all, the occupants of different roles (chair, community member, attorney, scientific expert, etc.) differ in their discussion of applications • Describe how IRB members identify problems in applications; what information resources they use and how they use them • Identify how IRBs organize the work of application review through the use of staff, pre-meeting review, and formatl meeting