As written in the Operational Strategic Plan for Research: “At a time of diminishing grant dollars and increasing competition, it is essential now, more than ever before, that investigators are provided with an outstanding research infrastructure that will enhance their productivity and the research enterprise. Moreover, there is a pressing need to foster an environment in which all investigators – whether working within UTHSC or collaboratively on a local, regional, national, or multi-national scientific initiative – have access to efficient support services and infrastructure, regardless of their physical location.”
The OSPR identified three specific infrastructure challenges that directly threatened the productivity of researchers at UTHSC and, as such, required specific attention by the Office of Research. These three challenges were: (A) the quality of the Laboratory Animal Care Unit (LACU), a critical “Institutional Core” serving the majority of campus investigators; (B) the need to expand and strengthen the Office of Grants and Research Agreements (GRA) in order to provide an integrated support center that facilitates the pace of research; and (C) review the activities and policies related to compliance (e.g., IACUC, IRB, IBC, etc.), with the goal of streamlining processes and reducing unnecessary burdens on investigators.
As you’ve read in past editions of The Research Rainmaker, the unification of all existing pre- and post-award functions under the Office of Research, as well as additional activities directly related to the research enterprise, is already underway. In May 2017, the Office of Sponsored Programs opened with Sarah White now serving as its Associate Vice Chancellor for Research. The unification has created an economy of scale by using a team-based approach. The unified model has also improved effective communication among personnel, thereby increasing efficiency. We estimate that the changes thus far have resulted in OSP turnaround times that are approximately three times faster, and faculty satisfaction has improved. Additional steps are continually being implemented to improve processes.
But what of the other two areas? As outlined below, significant progress has been made in the Laboratory Animal Care Unit (LACU) and the Institutional Animal Care and Use Committee (IACUC).
Laboratory Animal Care Unit (LACU)
Beginning in January 2017, the LACU underwent a complete reorganization of its staffing and leadership, as well as a rederivation of all standard operating procedures, policies and staff training practices. Fundamental to the reorganization process was the new requirement that all husbandry staff achieve a minimum level of American Association for Laboratory Animals Science (AALAS) certification appropriate for their position. These industry standard training certifications are now a routine part of the continual proficiency training for LACU staff. In this respect, the reorganization of the LACU included the creation and hire of a Director of Operations, an Assistant Operations/Quality Assurance Manager, and a Training/Quality Assurance Coordinator. These positions are responsible for the ongoing implementation and assessment of both initial and continued staff training, as well as facility quality assurance monitoring. These enhancements to the program recently led to a three-year re-accreditation of the facility by AAALACi (Association for Assessment and Accreditation of Laboratory Animal Care International) with no mandatory findings for correction. As noted by one reviewer during the AAALACi site visit, “you have an excellent program that is headed in the right direction.”
Institutional Animal Care and Use Committee (IACUC)
In order to promote research, while at the same time enhancing regulatory compliance, the IACUC has made a number of critically needed policy-related and operational changes. First, the IACUC completed an extensive review of all current policies related to animal research activities at UTHSC, as well as developed new ones.
“This activity served two main purposes, namely, to ensure that IACUC policies do not create unnecessary, self-imposed burdens on the research community, and to provide researchers with clear regulatory guidance related to their animal research activities,” said Steve Youngentob, PhD, senior associate vice chancellor for Research.
In addition, the IACUC initiated major procedural changes in the submission and review process of animal use protocols. The goal: decrease the IACUC protocol approval timeline while at the same time streamlining the submission and review process. All newly proposed animal-related activities are now required to undergo mandatory pre-review, prior to submission. Essential to this pre-review process, assigned reviewers and subject matter experts now interact collaboratively with investigators in order to foster the development of a quality protocol prior to submission. Further, the IACUC implemented the use of two IACUC meetings per month, and added the use of Designated Member Review (DMR) (i.e., two assigned reviewers who act on behalf of the committee), as a possible mechanism for protocol review. Two meetings per month (i.e., every two weeks) coupled with mandatory pre-review, has created what amounts to a rolling review process.
“The use of the DMR process for appropriate protocols has also permitted the IACUC to review and approve protocols outside a normally scheduled meeting and, thus, at a faster pace than those requiring Full Committee Review (FCR),” said Dr. Youngentob. “The result of these cultural and functional changes has exceeded expectations, reducing the average time of protocol approval from 9.3 weeks to about 21 days.
According to Francesca-Fang Liao, PhD, professor in the Department of Pharmacology, the recent changes to the IACUC protocol review process is “good news” and has drastically improved the faculty experience.
“Much less pain than in the past,” said Dr. Francesca-Fang Liao.
Weikuan Gu, PhD, professor in the Department of Orthopaedic Surgery and Assistant Vice Chancellor for Global Partnerships echoes Dr. Liao’s thoughts. “Thanks so much for the work efficiency,” said Dr. Gu. “This is a great improvement in the IACUC protocol committee. I appreciate it very much.”
To become a premier research institution requires not only highly qualified researchers and considerable resources, but also proficient administration and supporting units. Successful refining of these key research infrastructure areas will propel us towards this common goal.