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 requested by IRB committees are meant to balance the risks and benefits of a proposed research protocol (Gabriele, 2003; Gearhart, 2010).
Due to the competitiveness ofresearch 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.
Protocols for research involving human subjects typically fall into one of three review categories: 1) exempt (i.e., studies involving collecting new or existing data in such a manner that subjects cannot be identified, which are reviewed only by IRB program administrators); 2) expedited (i.e., studies posing minimal risks to human subjects, such as the collection of biological specimens via noninvasive means, which are reviewed by only one IRB committee member); or 3) full review (i.e., studies involving a larger range/higher level of potential risks to human subjects that do not qualify as exempt or expedited, which are reviewed by a full IRB committee) (Steinert, 2002). A recent study by the Association for the Accreditation of Human Research Protection Programs (AAHRPP, 2015) found that in the U.S. research protocols requiring full review take the longest amount of time (i.e., the median time from submission to an approval/denial decision is 39 days).
Many factors play a role in determining how long it takes to obtain IRB approval/denial decisions for a research protocol. There is a large body of regulatory requirements that must be referenced during research protocol reviews. Protocols must also be reviewed prior to the initiation of research activities and annually thereafter for on-going protocols (Gabriele, 2000). In addition, IRB program administrators and/or committee members often have heavy workloads. For example, nearly 40 percent of research intuitions have only one IRB committee, and a median of 471 protocols require full review by each institution annually in the U.S. (AAHRPP, 2015). Given this workload, there can often be insufficient time for IRB program administrators and/or committee members to meticulously review protocols (Gabriele, 2000). Furthermore, IRB committee meetings often tend to be time consuming, and/or it can be difficult to obtain a quorum. Both of these issues contribute to long wait times for consideration of new protocols or reconsideration of revised protocols.
Investigators also contribute to the length oftime needed for the IRB review process by not always providing sufficient information in their research protocols so they can be adequately reviewed. This situation, unfortunately, often leads to multiple cycles of revisions and re-reviews (Blustein, Regenstein, Siegel, & Billings, 2007; Green, Lowery, Kowalski, & Wyszewianski, 2006; Shalala, 2000). This situation is often further exacerbated when institutions' IRB program administrators have insufficient resources and/or poorly organize/use available resources to support the review process (Andrews, Moore, Mean, & Weinberg, 2012).
Suggestions for reducing the time to obtain IRB approval/denial decisions include encouraging investigators to start working on their IRB applications as early as possible. Also, they can schedule meetings with IRB committee members to obtain guidance regarding potential risks and how to address them in advance of submitting their research protocol for review. Providing templates that address typical issues covered in IRB applications, including research questions, study design, sampling approach, recruitment procedures, and consent processes/forms, that investigators can tailor to meet their needs have been used previously to streamline the review process (Blustein et al., 2007). Finally, to avoid imposing requirements that are not appropriate for the proposed research, which unnecessarily extends the revision and re-review process, systems are needed to ensure IRB committee members have the correct experience and understanding to conduct reviews for their assigned protocols (Green et al., 2006).
To improve the IRB review process, one research institution recently developed metrics within a structure-process-outcome model to systematically analyze various aspects of their process for efficiency and determine the ethical issues that tend to prolong the review process (Adams et al., 2014). Another institution addressed this problem by reducing the size of each IRB committee, doubling their total number of committees, increasing the frequency of committee meetings, but scheduling meetings for shorter periods of time. This approach not only reduced the time to obtain IRB...