This module manages the process of recording and approving animal ethics applications. It features sophisticated online workflow to allow the regulating committee to comment on all features of the application, which in turn allows for streamlined meetings. The Animal Ethics module is harmonised in its functionality with the Human Ethics module to provide consistent functionality, where the required functionality is common to both areas, e.g. online coversheets, formation of committees, management of meetings
The module features a sophisticated questionnaire builder which allows an institution to design their own questionnaires with embedded logic and decision trees. Questionnaires can be designed to ensure researchers are presented only with questions relevant to their application, minimising data entry. An application's level of risk can be determined automatically based on answers to questions and then directed within IRMA to ensure each application receives the appropriate level of review. The flexible design allows institutions to amend questionnaires very quickly and make these amendments available to their researchers immediately.
Institutions can design an unlimited number of online forms which capture all information required for an application, variation or report. When required the form can include a questionnaire and the ability to upload files. For each section of a form it is also possible to define help prompts and to provide links to websites. The level of approval required for each type of form can be defined and once a form is submitted online approvals are automatically sought. As with the questionnaires, the forms can be amended very quickly.
Online forms enable pre and post submission review of an application by administrators in addition to being reviewed at one or more meetings. The meetings functionality fully supports the processes associated with holding an ethics meeting including producing agendas and minutes. The IRMA screens used during a meeting are optimised for projectors and tablets meaning there is no need for printed material during a meeting.
The module allows for animal usage to be recorded on a country, jurisdiction, animal classification and invasiveness hierarchy; this delivers maximum flexibility to meet the reporting requirements of multiple jurisdictions whilst making it simple for researchers to enter animal usage. As animal classifications are defined for each jurisdiction, IRMA removes the need for post data capture manipulation and transformations of animal usage statistics for meet multiple reporting jurisdictions.
Along with animal usage, institutions are also able to record and track animal holding facilities; including use of facilities by protocols and researchers, facility approvals, facility inspections and documentation for each facility.
Key data elements stored in the system are:
- All investigators both internal and external, and both staff and students
- Affiliation data based on the internal structure of your institution, or the affiliation of external collaborators
- Questions defined by the institution
- Animal usage and animal re-use tracked by country, jurisdiction, classification / strain and invasiveness
- Workflow management of variations to a protocol
- Workflow to track the progress of reporting, including due dates for periodic reporting
- Workflow management of conditions on a protocol
- Committee decisions and minutes relating to a protocol
- Comprehensive workflow surrounding meetings of committees assessing protocols
- Researcher competencies associated with a specific protocol
- Facility tracking and management
- Snapshot of different versions of a protocol providing a full audit trail of changes to a record
- Relationships to records in other modules such as a related grant or publication
- Events, including adverse events
- Risk level and current status of a protocol