The Incorporation of a Research Study Plan to Enhance Support of Research Oversight Activities


Rationale: The IACUC has a responsibility for oversight of ongoing animal activities within the institution. Often times the IACUC reviews and approves activities under a single animal use protocol which includes several studies set to occur over a three to five year period.  Details for specific study activities are outlined in the animal use protocol; however, the actual schedules for these studies are not usually provided.  A simple and transparent method (“Research Study Plan”) to provide the IACUC, post-approval monitors, veterinary staff, or other support entities information regarding the actual studies ongoing at any given time will increase the ability for the IACUC to provide effective continuing oversight of animal activities.  These study plans would be used for timely post-approval monitoring for the IACUC, as well as by research management to help with strategic planning and evaluation. Another benefit is that completion of study plans with the knowledge that the IACUC will be reviewing them encourages research staff to frequently review and reference their approved IACUC animal use protocols.

Objectives: In order to improve the transparency and oversight of in vivo research activities, our organization has put a new program in place requiring that an individual study plan (titled, “Research Study Plan”) be submitted to the Animal Welfare and Governance team for each individual animal use study to be conducted.

Methods: A standardized template (a simple one page form) was developed by a team consisting of research personnel and IACUC members. The form was piloted for several weeks and subsequently modified using input from the user groups. Methods for distribution, collection, and review of the study plans were implemented. All research personnel received training consisting of why the program was implemented, how it will benefit our program, and instructions for its use.

Results: By increasing the transparency of the ongoing animal use activities within the vivarium, our support teams are better able to provide continuing oversight of animal activities. We have been able to improve animal welfare by reviewing potential protocol deviations before they occur, by better risk-based targeting post-approval monitoring observation, and by preplanning veterinary observations of animals post procedure.

Conclusions: Integration of the “Research Study Plan” program has proved a useful resource for reporting to the IACUC regarding compliance of ongoing activities within the vivarium. The increased transparency of ongoing daily activities has improved our animal welfare program.