Problem. Multi-site research in a network of community-based settings presents new challenges for the protection of subjects by Institutional Review Boards (IRBs) and researchers. There is a variance between the requirements underlying human subject research and the process required for a rigorous and meaningful study. The purpose of this paper is to discuss the challenges encountered in multi-site intervention research across nursing centers in the Midwest. Framework. The Health Belief Model in concert with Lundeen’s Nursing Center Model guided this study. Method. The IRB applications to seven institutions for a multi-site study were subjected to content analysis. Results. Due to changes suggested or required by individual IRBs, potential threats to the study’s reliability and validity were identified. The following issues were recognized. 1) One proposal for multiple-site research meant that the methods, especially for data collection needed tailoring to meet local IRB requirements. 2) Site IRBs varied in interpretation of HIPPA requirements, 3) Experience with the IRB application process and multi-site studies varied among site investigators, resulting in lengthened approval times. 4) Each IRB member varied in understanding of community-based research. 5) The IRBs and researchers faced challenges related to subjects from community-based populations, such as the hesitance to participate in the research if legal signatures were required. 6) Low literacy of many subjects lead to concerns over the lengthy consents. Conclusion. Research in practice-based research networks of nursing centers can provide subjects in significant numbers across sites to positively influence nursing practice. The resultant research develops the evidence needed to change primary care practice. Strategies to lower IRB barriers to multi-site studies could include a consortium IRB, site investigator input into the proposal preparation, a template protocol for IRB submission, and a template for consent forms.
Funded: Robert Wood Johnson Foundation
Session #1122 - Midwest Nursing Centers Consortium Research Network: A Novel Approach to Physical Activity and Nutrition Interventions across Nursing Centers
The 29th Annual MNRS Research Conference (April 1-4, 2005)