The development and acceptance of a simple tool to aid IRB compliance.
The United States' Food and Drug Administration (FDA) has had an increase of warning letters issue' to institutional review boards (IRBs). These have been issued to IRBs of all experience levels, from the seemingly most inexperienced IRBs to IRBs accredited by the Association for Accreditation of Human Research Protection Programs. This exemplifies the fact that IRBs, no matter their size and experience, need compliance tools to assure that their activities and decisions are made within the confines of the regulations. A simple compliance tool was created for IRBs to improve their discussions and criteria-based decision making during convened meetings. The tool is a presentation of 14 slides consisting of the federal criteria for most major IRB decisions printed on 11-inch by 17-inch paper and then laminated to be used as placemats during convened IRB meetings. Recommendations for use were provided with this tool, but each IRB was free to use as desired. A survey was issued after 8 months of distribution to determine acceptance, methodology, and the perceived effect of the tool. While some IRBs did not utilize the tool, 80% of the responding IRB members and staff felt that it either somewhat or greatly enhanced their discussions and criteria-based decision making. The greatest satisfaction and perceived effect was when the tool was used in the recommended format. This results in a very inexpensive, customizable, and well-received compliance assurance tool that any IRB can easily adopt.
Clinical Services Group, Hospital Corporation of America, Nashville, Tennessee 37203, USA. David.Vulcano@HCAhealthcare.com
David M
DM
Vulcano
D003625:Data Collection; D003659:Decision Making, Organizational; D028744:Ethics Committees, Research; D019983:Guideline Adherence / Q000458:organization & administration*; D006268:Health Facilities; D014481:United States; D014486:United States Food and Drug Administration