In a series of articles, we will present the newest in research administration from the Journal of Research Administration. To read the full JRA, please see here.
Authors:
Andrea Pescina Liberale, University of Houston; Jamison V. Kovach, University of Houston
Introduction
Research activities, such as clinical trials for example, involve enrolling human subjects as volunteers to participate in research studies (Gabriele, 2000). Given that a substantial portion of research is sponsored by the federal government through money collected from U.S. taxpayers, investigators and research institutions have a responsibility to ensure research funding is not used in ways that harm or unnecessarily risk harming subjects participating in research studies. Given the volume of regulations, guidelines, etc. regarding research involving human subjects at the federal, state, and local levels, however, it can often be challenging to maintain compliance (Steinert, 2002). This research investigates how to reduce the time to review and render approval/ denial decisions for research protocols that involve human subjects.
To ensure the ethical conduct of research involving human subjects, institutions that receive federal funding for research are required to establish an institutional review board (IRB). The intent of the IRB is to protect the ethical rights and welfare of human subjects from research risks through the initial and continuing review of research protocols, adverse events, amendments, and other issues. The policies and procedures used to guide this process within each institution assists investigators with maintaining compliance with federal regulations (Steinert, 2002). That is, the modifications to research protocols, consent forms, recruitment materials, etc. often requestedby IRB committees are meant to balance the risks and benefits of a proposed research protocol (Gabriele, 2003; Gearhart, 2010).
Due to the competitiveness of research environments, it is imperative that institutions continuously improve their administrative support processes in order to help investigators effectively fulfill the requirements associated with their research activities (Kakande & Namirembe, 2012). One reason for investigator dissatisfaction is often the long wait times associated with obtaining IRB approval/denial decisions for research protocols (Whitney et al., 2008). Following an action research approach (Reason & Bradbury, 2008), researchers worked closely with IRB program administrators at one leading public research university to reduce the time to obtain IRB approval/denial decisions. Through a case study, this research demonstrates how this issue was addressed using the Lean Six Sigma methodology, which is a structured, problem-solving approach to improve process performance that combines Lean and Six Sigma tools to increase quality and reduce waste (Pepper & Spedding, 2010). Improving the efficiency of this process helps investigators conduct their research in a timelier manner, while also ensuring compliance.
The following sections provide details on the background, methodology, and the case study with results and conclusions. In the background section, information is provided regarding the IRB review process and some methods others have used previously to improve this process. The methodology section discusses the approach used to guide this research. This is followed by the case study section, which provides a detailed description of the work performed to improve the IRB review process. It also includes a description of the institution in which this research was conducted, as well as a discussion regarding how each phase of the Lean Six Sigma methodology was applied. Finally, the results of this improvement effort are summarized along with some concluding remarks regarding the implications of this research and areas for future work.
To read the full manuscript, please click here.
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