Managing Variability in the Local IRB Process: Survivers’ Guide for Multi-Site Researchers

Session number: 1154

Workshop title: Managing Variability in the Local IRB Process: Survivers’ Guide for Multi-Site Researchers

Author(s):
WG Best
B Cuccherini
L Rubenstein

Objective(s): Working with multiple local site IRBs has become one of the most daunting aspects of carrying out multi-site health services research studies. Studies that focus on translating research into practice, such as those sponsored by the Quality Improvement and Research Initiative (QUERI), frequently pose additional problems related to involving local sites in intervention design and implementation and the close link between the research and ordinary clinical practice. While it is tempting to consider standardizing the IRB process at a national level, this approach is not without risk and is unlikely to be implemented any time soon. The objective of this workshop is to present approaches for coping with the variability in IRB review processes across multiple sites that can be implemented in the intermediate or near term. To accomplish this, we will: 1. Present the results of a collaboration of multi-site VA researchers from around the country to identify key IRB issues resulting in delays, expense, or compromise to study design; and 2. Discuss solutions used by the VA Cooperative Studies Program 3. Discuss strategies being piloted in new QUERI and HSR&D health services research projects at VA Greater Los Angeles and VA Puget Sound.

Activities: Although this workshop will feature a panel of subject matter experts with a variety of perspectives, we will encourage audience participation. We will use case examples culled from a variety of multi-site studies, and encourage the audience to amplify on these from their own experiences. We will then present possible solutions. Finally, we will ask the audience to prioritize key problems that require additional attention from Research Service or IRB experts.

Target audience: The current workshop targets VHA researchers with experience, or interest in conducting multi-site research projects, research fellows and new investigators and is a follow-on to the VA HSR&D 2001 National Meeting workshop “Human Subjects Issues: Operational Lessons in Conducting Multi-site and Multi-institutional Studies”.

Audience familiarity: The workshop will be appropriate for researchers interested in developing new approaches for working with variation among local IRBs or sharing approaches they have developed. Familiarity with basic IRB requirements is recommended; we will not review these requirements directly.