| dc.description.abstract | Institutional Review Boards (IRB) have consistently innovated flexible and creative approaches to their work where federal research regulations and published literature are noticeably silent. For example, federal regulations establish the required criteria for approval for the conduct of human subjects research but do not provide researchers with a straightforward roadmap of how to prepare a high-quality IRB application. There are significant gaps in what is known, empirically and descriptively, about how IRBs and researchers characterize a quality IRB application. The existing literature identifies the need for a greater understanding of quality within the field of human subjects research (Abbott & Grady, 2011; Lynch, et al., 2019; McDonald & Cox, 2009; Nicholls, et al., 2015; Resnik, 2021; Scherzinger & Bobbert, 2017; Taylor, 2007; Tsan, 2019; Vawter, et al., 2004). However, this focus has been primarily on IRB review quality and not IRB application quality. Characterizing IRB application quality from the perspectives of both IRB professionals and researchers can help academic and scientific communities to establish expectations of quality and deploy resources facilitating quality application preparation. This project used a qualitative, descriptive, cross-sectional design to gather individual perspectives from both IRB professionals and researchers on the concept of a “quality” IRB application. This paper describes, via eight core findings and eight recommendations, quality from both IRB professionals’ and researchers’ perspectives, the pedagogical effectiveness of IRB training and support models, and promising new ideas for educating researchers of all experience levels. Appeals for a definition of IRB application quality, and how to achieve it, have been continuous and IRBs cannot afford further delay. IRBs can use findings from this project as standards of evidence on quality and educational strategies that will facilitate quality IRB application preparation. In doing so, IRBs will be better positioned to assess the regulatory, ethical, scientific, and administrative requirements of a proposed human subjects research study, strengthen the research-practice nexus at their organization, and ultimately enhance the protection of human subjects. | |
